HIV/AIDS HEALTH SECTOR REVIEW 2007 - 2010 Medical Products Building Block

Morris Okumu, Gloria Dusabe, Fred Wabwire-Mangen

November 2010 Uganda MoH Health Sector Review 2007-2010

HIV/AIDS HEALTH SECTOR REVIEW 2010

MEDICAL PRODUCTS BUILDING BLOCK

Morris Okumu, Gloria Dusabe, Fred Wabwire-Mangen

November 2010

Ministry of Health

Kampala, Uganda

Recommended citation:

Morris Okumu, Gloria Dusabe and Fred Wabwire-Mangen, (2010); Uganda HIV Health Sector Review – Medical Products Building Block. Published by the AIDS Control Program, Ministry of Health Government of Uganda, Kampala, Uganda, November 2010.

ii Uganda MoH Health Sector Review 2007-2010

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TABLE OF CONTENTS

ACKNOWLEDGEMENTS...... VII

1. INTRODUCTION AND BACKGROUND ...... 1

1.1. OVERVIEW OF THE BUILDING BLOCK ASSESSMENT...... 2 1.2. RATIONALE FOR THE BUILDING BLOCK IN THE NATIONAL HEALTH SYSTEM...... 3 1.3. TERMS OF REFERENCE...... 5 1.4. UNDERSTANDING THE TERMS OF REFERENCE...... 6 1.5. OBJECTIVES OF THE BUILDING BLOCK ASSESSMENT...... 7

2. METHODOLOGY ...... 8

2.1. OVERVIEW OF THE METHODOLOGY...... 8 2.2. DESCRIPTION OF THE DATA COLLECTION PROCESS...... 8 2.3. QUALITATIVE METHODS OF DATA COLLECTION...... 9 2.4. QUANTITATIVE METHODS OF DATA COLLECTION...... 9 2.5. ANALYTICAL FRAMEWORK AND REVIEW QUESTIONS...... 10 2.6. DATA ANALYSIS, TRIANGULATION AND INTERPRETATION...... 12

3. LIMITATIONS OF THE STUDY ...... 12

4. FINDINGS OF THE STUDY ...... 13

4.1. FINDINGS OF THE DISTRICT RESPONSE...... 13 4.2. FINDINGS OF THE NATIONAL RESPONSE...... 27 4.3. SUMMARY OF FINDINGS/SWOT ANALYSIS...... 37

5. CONCLUSIONS ...... 40

5.1. BY ASSESSMENT OBJECTIVES...... 40 5.2. KEY EMERGING MESSAGES...... 41

6. RECOMMENDATIONS ...... 42

6.1. POLICY LEVEL RECOMMENDATIONS...... 42 6.2. PROGRAM LEVEL RECOMMENDATIONS...... 42

7. BIBLIOGRAPHY ...... 44

APPENDICES ...... 45

APPENDIX 1: TRACER LIST OF PRODUCTS USED...... 45 APPENDIX 2: CURRENT NATIONAL DISTRIBUTION SYSTEM FOR ARVS...... 46 APPENDIX 3 DATA COLLECTION TOOLS USED...... 47

KEY INFORMANT INTERVIEW FOR PARTNERS ...... 82

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LIST OF TABLES AND FIGURES

LIST OF TABLES Table 1: District and types of health facilities accessed...... 13

Table 2: Availability of ARV medicines on day of visit...... 14

Table 3: Availability of OI and STI medicines on day of visit...... 15

Table 4: Availability of all tracer products by region...... 15

Table 5: Availability of tracer list by level of level of facility...... 15

Table 6: Availability of Cotrimoxazole on day of survey...... 15

Table 7: Reported main causes of stock outs at health facilities...... 16

Table 8: Stock-outs of ARV medicines in review period of 2009/2010...... 16

Table 9: Stock-outs of OI/STI medicines in review period of 2009/2010...... 17

Table 10: Stock-outs of ARV medicines in review period of 2008/2009...... 17

Table 11: Stock-outs of OI/STI medicines in review period of 2008/2009...... 17

Table 12: Stock-outs of ARV medicines in review period of 2007/2008...... 18

Table 13: Stock-outs of OI/STI medicines in review period of 2007/2008...... 18

Table 14: Factors that were reported to affect quantities of products to order...... 20

Table 15: Are supplies received in conformity with orders?...... 21

Table 16: Methods of stock replenishment for health facilities...... 21

Table 17: Main problems encountered during collection of products from different sources...... 22

Table 18: Availability of complete records per facility for all tracer products...... 22

Table 19: Regional trend in strength of record keeping over the period of review...... 23

Table 20: Presence of Partner specific records by product category...... 24

Table 21: Availability of expired products in health facilities...... 25

Table 22: Reported major causes of expiries in health facilities...... 26

Table 23: Allocation and utilisation of funds for ARV medicines during review period...... 29

Table 24: Funding, procurement and storage systems for ARV medicines in 2009/10...... 30

Table 25: Summary of different procurement methods for ARV medicines...... 31

Table 26: Options analysis for NMS distribution costs...... 32

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LIST OF FIGURES

Figure 1: WHO building blocks and health systems goals (14)...... 4

Figure 2: Health facilities accessed by level and ownership...... 13

Figure 3: Summary of Three-year stock-out days for ARV medicines...... 19

Figure 4: Summary of Three-year stock-out days for OI/STI medicines...... 20

Figure 5: If allocation is not in conformity, how are the products?...... 21

Figure 6: Reported lead time for different supply sources...... 22

Figure 7: Strength of record keeping per district of survey...... 23

Figure 8: Strength of record keeping by type of health facility...... 24

Figure 9: Timely submission of reports by facilities...... 25

Figure 10: Most reported cause of expiries in health facilities by sector...... 26

Figure 11: Ranking of the most common causes of expiries in order of priority...... 27

Figure 12: NMS and JMS Customer Collection comparison...... 33

Figure 13 : National ARV supply channels in relation to funding source...... 46

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ACKNOWLEDGEMENTS

We would like to express our sincere appreciation to the numerous people that contributed to the completion and success of this survey. In particular, we would like to express our gratitude to Members of the Technical Working Group and Dr. Zainab Akol (Program Manager MoH STI/AIDS Control Program), Mr Lawrence Mumbe (logistics Officer – ACP) and other Staff of ACP, Dr Beatrice Crahay (WHO Uganda), and Mr Joseph Mwoga (NPPP/Essential Medicines WHO/Uganda) for their technical input and guidance in the planning and management of the review process. Wholehearted appreciations goes to the MoH, UNFPA, CDC Uganda and WHO for funding different aspects of the review.

Great thanks to the team of external consultants Dr Taylor Ogori (WHO/Nigeria), Dr Chijioke Okoro (CDC/GAP Atlanta), and Dr. Micheal Friedman (CDC/HSTP Atlanta) for their valuable and passionate in-put in both the planning and process for the review. Without your inputs and insights, this study wouldn’t have been achieved to this level. Dr Ogori in particular was instrumental in the design and initial planning of the activities. She provided direct technical support to the team in both coordination and technical aspects.

Our particular appreciation goes to the Directors of District Health Services and the many health facility personnel who dedicated their time to answering the survey questionnaire from the districts of Kampala, Gulu, Arua, Pader, Katakwi, Kamuli, Tororo, Kiboga, Mbarara and Kamwengye. Special thanks and appreciation goes Mr Martin Oteba (ACHS in Charge of Pharmaceuticals), Mr. Thomas Ocwo Obua (Senior Pharmacist MoH), Ian McConnell (CHAI), (CHAI), Dr Alice Namale (CDC/GAP), Mr. Moses Kamabare (NMS), Mr Opio (JMS), Mr Andrew (JMS), Mr (NMS), Ms Trap Birna (SURE Project), Dr Donna Kabatesi (CDC Uganda), Mr Reuben Haylett (US Mission Uganda), Mr Sowedi Muyingo (Medical Access Uganda Limited), Rebecca Copeland (USAID Uganda) and Mr Khalid Mohamed (SURE Project). In addition, we thank the respondents from CRS/AIDS Relief, MJAP, Baylor Uganda, JCRC, Quality Chemicals Industries Limited, among others.

Finally, we acknowledge and thank the members of the data collection team who carried out the field work with dedication and provided the results for the assessment: Dr Christine Nalwadda (Study Coordinator), Max Walusimbi (Study Administrator), Gloria Dusabe, Chris Asiimwe Oyaga, Monica Amuha, Kalid Rajab, Hope Ninsiima Agaba, and all the different team leaders for district level data collection.

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ACRONYMS AND ABBREVIATIONS

(c)GMP (Current) Good Manufacturing Practice ACP STD/AIDS Control Program AIDS Acquired Immune Deficiency Syndrome ART Antiretroviral Therapy ARV Antiretroviral agent CDC Centers for Disease Control and Prevention CHAI Clinton Foundation Health Access Initiative CPDS Coordinated Procurement and Distribution System CRS Catholic Relief Services DHO District Health Office FDA US Food and Drugs Administration HIV Human Immuno-deficiency virus HSHASP HIV/AIDS Health Sector Strategic Plan 2007/8 – 200/10 HSSP – II Health Sector Strategic Plan II IEC Information, Education and Communication IP Implementing Partner JCRC Joint Clinical Research Centre JMS Joint Medical Store MAUL Medical Access Uganda Limited MFPED Ministry of Finance, Planning and Economic Development MoH Ministry of Health NDA Uganda National Drug Authority NDP National Drug Policy NMS National Medical Stores NPSSP I National Pharmaceutical Sector Strategic Plan I NSP National HIV/AIDS Strategic Plan 2007-12 OI Opportunistic Infection PEP Post-Exposure Prophylaxis PEPFAR United States President’s Emergency Plan For AIDS Relief PMTCT Prevention of Mother to Child Transmission of HIV QCIL Quality Chemicals Industries Limited SCMS Supply Chain Management Systems STI/D Sexually Transmitted Infection/Disease SURE Securing Uganda’s Rights to Essential Medicines and Health Supplies UNICEF United Nations Children’s Fund USAID United States Agency for International Development WHO World Health Organization

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EXECUTIVE SUMMARY

Background:

The multi-sectoral approach to HIV/AIDS has enabled Uganda’s HIV prevalence to drop from above 18% to now at 6.3% with geographical and regional variations. Newer predisposing factors to transmission, survival and disease progression have been identified over the years and these have implication on aligning the health sector response to match the trends of development. The introduction of ART precipitated the demand for scarce quality medical products while maintaining equitable access, cost-effectiveness and rational use. Increased funding for HIV/AIDS response in the health sector has led to emergence of vertical programs, complex response systems, more advanced data needs and strong emphasis on continuity of essential health products, medicines, and laboratory supplies. The MoH/ACP has over the years been using different agencies to manage the HIV/AIDS commodities as a form of direct technical assistance. This has been very critical in ensuring the success of the emergency response phase but may now be questionable despite the great progress made by the country over the years. To better understand all these coordination and implementation challenges, MOH/ACP together with development partners instituted the review of the health sector response from 2007 to 2010. The HIV Health Sector Review entailed a review of the HIV response at all levels of the health sector including at the national, district, sub-district and health facilities using a specific toolkit for medical products as proposed by WHO methodology.

Methodology:

In order to ensure a comprehensive review, a mix of methods was used comprising of desk review, qualitative and quantitative data collection as well as a case study of ACP. Field study involved examination of ten districts, sub districts, and health facilities, purposely selected to reflect regional, urban/rural, high/low volume, poorly/better performing characteristics and as well the heterogeneity of HIV infection in Uganda by geographical areas. In addition to district level, national level review was conducted involving the key players and stakeholders. In each target district, health facilities were stratified into public, private (private for profit – PFP and private not for profit – PNFP), and uniformed forces. At each of these facilities, staffs involved in management of medical products were interviewed and the storage and distribution system were assessed using pretested tools. Fourteen (14) products were selected to be traced for the survey. The selection of these products was based on previous surveys and took into account the need for adult ART needs, pediatric ART needs, PMTCT products and the drugs for STIs and OIs.

Results:

A total 61 health facilities and eight district stores were accessed as part of the district level review. Out of the health facilities, there were 29 public, 5 unformed forces, 22 PNFP and 5 PFP facilities comprising of a total of 23 hospitals, 20 health centre 4s, 16 health centre 3s and 2 specialist clinics. From the district level review, it was observed that the country design of the HIV/AIDS medical products management systems operates directly from central level to the health facilities and the communities excluding the DHO making them not to be adequately equipped to fully provide support supervision for the ARV management system. In addition, there has been little training for the DHT in logistics management.

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In terms of availability, district stores had the lowest availability of all the products with NGO clinics and hospitals being better stocked with the products and this trend was similar for all ARVs and other tracer products. Generally, the private sector is better stocked than public sector but both showed similar trends. Cotrimoxazole was available in 78% of health facilities visited including district stores and with public sector standing at 73.8% of all facilities visited. 85.2% of all private health facilities had usable quantities in stock as opposed to 73.8% of health facilities in the public/uniformed sectors.

When reviewed for causes of stock-outs, it was notable that the top cause of stock outs was delayed deliveries from suppliers, delivered quantities not in conformity to orders, limited availability of funds and errors in quantification/forecasting process. 31% of facilities reported receiving supplies conforming to orders with the proportion much higher in public sector. In terms of record keeping, multiplicity of records is a common occurrence with 26 facilities having at least one partner—specific records in place. In addition, many facilities prepare reports to both the partner and the MoH.

The funding for HIV/AIDS medical products have come from a number of sources with the top four funding sources being PEPFAR, Global Fund, Government of Uganda, and a combination of other sources. The different sources of funds are allocated at different times of the year and this as well affects their immediate availability for use. Since 2008/2009 funding year, PEPFAR funding became flat-lined with no expected net increment in overall funding but re-allocations can be carried out between different funding priorities.

The forecasting and quantification process for the HIV/AIDS medical products vary according to both the partner concerned as well as whether the product is ARV or non-ARV medicine. The country forecasting and quantification processes for HIV/AIDS medical products have since 2003 been carried out with technical assistances (TAs) first from USAID then from a collection of different partners. In 2009, the first comprehensive national quantification exercise was carried out by the SCMS project on behalf of MoH yielding a lot of information on estimated national need for medicines.

Principally at national level, there are three key players in procurement of ARV medicines and they are based on the source and nature of funding. The CHAI/UNITAID in-kind donations and the PEPFAR funding are the most fragmented forms of procurement in the country. Their fragmentations are related to the early inception of the two programs and in particular, the need to support rapid scale-up and reduce the level of un-met needs in the country. They therefore played very critical roles in the rapid scale-up of ART in Uganda during the review period. Mixes of methods are used in the national procurement and are once again tied down to the source of funds. In addition to the key terms dictated by the source of funds, other factors also play a great role in the method applied.

The current major distribution systems for HIV/AIDS medical products are structured along the funding mechanism and nature of procurement for the products. Efforts to harmonise the distribution systems in the past have been unsuccessful due to multiple factors that included lack of good will from partners, insufficient operational capacity within pharmacy division in MoH, increased support for vertical programs, and products quite often are used across programs and therefore difficult to place under one vertical program. Generally, close to half of the ARV medicines used in the country are distributed through the private sector channels with the top primary channels being MAUL and JMS. Table 25 showed the different recipients for the various national

x Uganda MoH Health Sector Review 2007-2010 storage systems. The current multiple distribution systems have contributed to complacency at health facilities as private sector delivery systems have appeared more responsive than NMS. There is now an attempt to create a central unit within the MoH to coordinate procurement and distribution of all essential medicines and health supplies (EMHS) but the process of initiation is being hampered by complex red-tape within and outside the MoH. It is still evident in the current arrangement that it is cheaper for NMS to outsource distribution function as opposed to carrying out the full continuum of supply management right from quantification through to distribution for the national system.

Comprehensive LMIS have been coordinated by institutions offering TA to the public sector with support of development partners. Although they have provided great data for use in both planning and management of medical products, they have remained largely vertical and without continuity once such partner’s contractual period comes to an end. Transition from different agencies to another has often created more challenges including stock-outs as it was noted in the period from June 2009 to May 2010 when SCMS closed and SURE was being rolled-out. Over the years, the HIV/AIDS sector has continued to hop from one information system for medicines management to another based on multiple factors, some beyond the scope of this review. The most notable factors have been the nature and predisposition of TA partner, funding, and desired program design.

Over the period of review, the coordination of medical products processes have undergone multiple transformations, some due to policy shifts while others were dictated by the nature of the HIV/AIDS response that characterized by need for massive scale-up and increased flow of financial resources in period up to December 2009. With the reduction/stasis in funding, the need for coordination and strategic management became a reality. Within the MoH, medical products for HIV/AIDS are overseen by ACP with assistance of TA from development partners. Fluconazole under the Diflucan Partnership Program (DPP) has remained to be exclusively managed within ACP with TA with orders being allocated directly to NMS. In relation to Medical Products, ACP is not suited to manage the products because in absence of TA, they are not technically prepared and planned to do so. The elevation of pharmacy within MoH from a unit to a division created an expanded entity meant to support the cocktail of functions meant to ensure continuous, cost-effective and access to EMHS in the country. Whereas the roles were expanded greatly, the required capacity within was not expanded to meet the true demand. Pharmacy division is still grossly understaffed to attend to all the vertical programs as well as coordinate the various activities in the MoH. NMS is a semi- autonomous body reporting directly to the minister of health; this made NMS to continuously take technical decisions without the involvement of both ACP and pharmacy division whenever HIV/AIDS medical products were concerned. The private sector has largely remained uncoordinated and it is through this sector that the multiple challenges with managing supply and availability of medicines has been exacerbated. The ministry therefore has not been able to fully watch over the supply side of HIV/AIDS service delivery.

The entry of donations and other schemes of supply has been one loophole for uncoordinated management of HIV/AIDS products. Whereas a donation guideline exists from NDA, many players within the MoH including ACP are not fully aware of the implementation modalities and key restrictions. Introduction of tougher laws limiting importation of donations into the country eased the process but there are still so many loopholes.

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Conclusion:

On the overall, ACP is has over the period of review been in charge of the coordination and key decisions regarding medical products for HIV/AIDS. A lot of support for the activities came directly from technical assistance projects from ADPs and other partners. Whereas the policies exist for the different management and coordination aspects of the medical products for the HIV/IADS response, their implementation and coupled with lack of clear framework for coordination of public entities and other private sector players, a lot of duplications, wastages and uncoordinated alignments have happened. The current donations guidelines together with regulations for importation of ARVs are not tight enough to prevent entry of both unlicensed and excessive quantities of ARV medicines into the country hence making accurate planning and coordination a very complex role.

The country distribution system for HIV/AIDS products are the most complex and are not aligned to the national system for other EMHS making it generally inefficient and full of duplications of efforts. The distribution systems are structured based on funding and procurement mechanisms that each cannot lay trust on the other to handle part of the chain. This together with the multiple procurement mechanisms have therefore hampered effective delivery of the products and hence introducing a complex system that eventually lead to multiple stock-outs at health facility level.

The current procurement systems in the country are so diverse and henceforth make the country to lose money through inefficiency. Utilizing the GoU funding for only two out of the minimum 14 formulations required for the national response makes it unable to provide a complete treatment regimen. The GFTAM procurement is unresponsive to needs and has often been an associative factor for non-availability of ARV medicines in the country. PEPFAR mechanisms vary according to the USG agency and there is now a deliberate effort to harmonise the processes and strengthen overall performance.

All ARV medicines used in Uganda to meet at least minimum quality standards ranging from local to international depending on funding mechanism. However, the PEPFAR limitations to US FDA registration/approval makes the national system unable to utilize funds to procure cheaper generics not registered and this creates challenges especially during periods of emergency procurements. FDA approved generics are generally more expensive than the non-approved ones.

The country still continues to experience stock-outs of HIV/AIDS medical products and the situation worsens with each additional distance from Kampala. In addition, there is generally poor record keeping throughout the country with the northern region having the weakest records despite showing tremendous improvement over the three years of review. Whereas the country had more than enough money to procure all the required ARV medicines needs, this was never translated into availability as a result of duplication of efforts through multiplicity of partners, double counting of patients, and inefficient distribution systems.

The country HIV/AIDS commodities continue to be in short supply despite adequate funding. The coordination and management of these products continue to be poor and complicated by the role paled by TA projects that do not report directly to the ministry and if reporting directly to the ministry, it is to the wrong office(s). it is evidently clear that although the roles of ACP, pharmacy division and NMS are spelt out in HSSP-II and to some extent in the HSHASP, it is not fully implemented in real practice and this created friction in their overall coordination.

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The country distribution and utilization systems for HIV/AIDS products continue to be heavily partner driven just like the overall health sector response. This therefore has created a complex web of distribution channels and multiple facility level record systems translating into heavy workloads for already stretched human resources. The end result has been diminished reporting to national systems and as well stock-outs and expiries.

Although required national policies and guidelines exists, their implementations remains without required frameworks. Policies are not fully disseminated and this together with limited capacity of MoH to carry out regular and comprehensive support supervisions for the HIV/AIDS medical products is a precursor for constant growth of parallel systems.

Recommendations

The key recommendations for consideration by ACP and the MoH as a whole are:

Policy recommendations: i) MoH should consider strengthening and expanding the pharmacy division in terms of staffing and capacity building to be able to manage the increased demands of the vertical programs. This should come out clearly in both the revised pharmaceutical sector strategic plan and the HSSP-III to ensure a sustainable long-term solution to reliance on TA for management of essential medicines and health supplies (EMHS), which HIV/AIDS medical products are, part of. ii) MoH should in the immediate future set out a policy to coordinate the pharmaceutical sector procurement and distribution systems with a long-term target of one national procurement plan, one national distribution mechanism/structure and one reporting system under direct supervision of the relevant units of the ministry. iii) The current national guidelines for drug donations should be revised and expanded to provide stronger control in area of drug importation and to prevent entry of excessive quantities of unlicensed medicines. The pharmacy division together with NDA should strengthen the implementation including dissemination of the relevant sections of the national guideline on drug donations. iv) MoH should consider introducing a framework to guide the coordination of the semi- autonomous entities (NMS and NDA) with the pharmacy division and the programs in the ministry including ACP. Currently both NMS and NDA report directly to the minister and make little consideration of role of the other players in decision making.

Program level Recommendations i) ACP should consider separating the role of medicines formulations selection from the role of regimens selection. ACP should concentrate on the clinical aspects of the medicines and work with both pharmacy division and relevant TA mechanism on the

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choice of formulations, products quality assurance and logistics management so as to maximize the benefit to the country. ii) Include a recommendation somewhere to SURE and Pharm Div are working on this. A committee like the CPDA (spell this out) cannot do day-to-day work that would be done in the QPP, they should have an advisory/analytical role instead for streamlining the data management for HIV/AIDS medical products. iii) The MoH should support/fast track the establishment of a central Quantification and Procurement Planning Unit (QPPU) in the pharmacy division or MOH. This together with fast- tracking the process of making the CPDS committee operational will provide a support mechanism for managing national drug requirements. The QPPU will be tasked with streamlining the data management for medical products including those for HIV/AIDS. iv) The pharmacy division together with ACP should increasingly review the list of products used in both public and private sector to ensure they are in conformity with national guidelines. This should include strengthening of role of pharmacy division to continuously evaluate the cost-effectiveness of the medicines used in the country. v) MoH/ACP should take the driving seat in determining gaps in service delivery and translating them into requirements for development partners so that support should be within national priorities and hence implementation in a more sustainable manner. In addition, all transitions of technical assistances should be under supervision of the relevant office within the MoH to ensure continuity of services. vi) ACP should coordinate policy and guidelines changes with both NMS and pharmacy division to ensure smooth transition from one set of selected medicines to another. vii) The MoH/GoU should review the arrangements related to Local manufacturing of ARVs and the role of QCIL in the response to ensure both sustainability and more importantly cost-effectiveness of the utilization of products procured from QCIL and any other manufacturer in future.

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1. INTRODUCTION AND BACKGROUND

Uganda has over the last 15 years made great progress in terms of development with peace and security being restored to most parts of the country. The multi-sectoral approach to HIV/AIDS has enabled the country HIV prevalence to drop from above 18% before 1992 to now 6.3% in 2010(1;1;2). By end of 2007, an estimated 1.1 million persons were believed to be living with HIV with over 350,000 in need of antiretroviral therapy (1). In addition, the number of people who are not aware of their HIV status continues to be high despite increased efforts to scale-up HIV prevention through counseling and testing. Prevalence continues to vary by geographical locations with central region having the highest at 8.5%, northern at 8.2% through to 2.3% in the West Nile region(1). Newer predisposing factors to transmission, survival and disease progression have been identified over the years and these have implication on aligning the health sector response to match the trends of development(3).

Since the first country case was described in 1982 in Rakai, the epidemic has rapidly spread throughout the country resulting into a mature and generalized epidemic with heterosexual contact as the main route of transmission later on evolving into a heterogeneous epidemic affecting different population subgroups and resulting into multiple and diverse epidemics with different transmission dynamics(3). The diversity of the populations calls for greater and more complex responses and interventions that are heavily dependent on the population sub-type and level of impact of the disease on to the macro and micro economic situations. The introduction of antiretroviral therapy (ART) in 2003 created newer dimensions to the HIV/AIDS response. The introduction of ART precipitated the demand for scarce quality medical products while maintaining equitable access, cost-effectiveness and rational use(4).

Over the years, various drivers have fuelled the epidemic and they included mobile populations, commercial sex workers, armed and uniformed forces, internally displaced persons, among others. However lately, the peak population at risk has shifted from the young and unmarried to the old and married persons and this demonstrates the need for more appropriate and diverse approach to the response(3). In addition, there has been long years of the Lord’s Resistance Army (LRA) insurgency in the north and Allied Democratic Forces (ADF) in the west that created internally displaced persons (IDP) camps that created newer epicenters for stable transmission in the affected areas.

Uganda in 1987 created the health sector HIV/AIDS response coordination unit that later was transformed into the AIDS Control Program (ACP). The country HIV/AIDS response has continued to center around the principles of the “three ones” namely One agreed HIV/AIDS Action Framework that provides the basis for coordinating the work of all partners; One National AIDS Coordinating Authority, with a broad-based multi-sectoral mandate; and One agreed country-level Monitoring and Evaluation System(2). In line with this, the Uganda AIDS Commission (UAC) was created by act of parliament in 1992 to oversee the national multi- sectoral and all-embracing response to the epidemic.

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Increased funding for HIV/AIDS response in the health sector led to emergence of vertical programs, complex response systems, more advanced data needs and strong emphasis on continuity of essential health products, medicines, and laboratory supplies(5). The need for continuity calls for effective selection, quantification, procurement, storage, distribution and rational use of the medicines; with strong support of policy, supply chain and planning. Multiple approaches and interventions targeting strengthening the supply management functions and overall HIV/AIDS medicines management processes were instituted over the last two decades. These have acted as a catalyst for overall health systems and in particular medicines management strengthening in Uganda(6).

However, resent trends on assessments of health systems component has shown that this is not the case(5;7). The HIV/AIDS response has been cited as cause for weakening of existing primary health care system with its vertical programming approach let alone heavy donor funding. The HIV/AIDS responses introduced complex, multiple and time demanding pharmaceutical management systems that took away the focus of core pharmacy management staff from overall pharmaceutical management to HIV/AIDS supplies management(8). Introduction of direct HIV/AIDS sector funding through PEPFAR and other agencies increased the pressure on pharmaceutical system by attracting skilled human resources to be disease-specific(8). This internal human resources brain drain continues to impact on the complexity of the HIV/AIDS response relationship with the overall health care system. Uganda’s HIV response is also suffering from the effects of the global economic downturn on major HIV funding sources, including GFTAM, and transition to PEPFAR II.

1.1. Overview of the Building Block Assessment

The HIV/AIDS response’s success relies heavily on the six building blocks of a comprehensive health system, but particularly requires a sustainable, cost-effective and reliable medicines management system to be in place. The MoH/ACP has over the years been using different agencies to manage the HIV/AIDS commodities as a form of direct technical assistance(6). This has been very critical in ensuring the success of the emergency response phase but may now be questionable. Capacity to fully plan for, procure, store, distribute and ensure rational use of ARV and opportunistic infections medicines in the country continues to vary significantly at each level of the health system. There has been evidence of deviations away from policies that exist and where no policy exist, a continuum of variations in the quality, processes, and use of the HIV/AIDS medicines(9;10).

A well-functioning health system ensures access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost effectiveness. According to the WHO framework for health systems, this is one of the six building blocks of health systems and this requires(11;12):

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i) National policies, standards, guidelines and regulations that support policy. This includes evidence-based selection of medicines, vaccines, and technologies according to international standards.

ii) Information on prices, international trade agreements and capacity to set and negotiate prices.

iii) Reliable manufacturing practices and quality assessment of priority products.

iv) Procurement, supply and storage and distribution systems that minimize leakage and other waste.

v) Support for rational use of essential medicines, commodities, and equipment, through guidelines, strategies to assure adherence, reduce resistance, maximize patient safety and training.

Since 2003, Uganda government has continued to benefit from direct technical assistance activities in the area of management of specifically HIV/AIDS products. In the early years, JSI/Deliver project provided support towards the development of country systems and this was followed by the SCMS project from 2006 to 2009. Both projects were headed and coordinated by external experts, were awarded to US based organizations and received funding from PEPFAR through USAID. Currently, the SURE Project is responsible for providing the expanded role beyond HIV/AIDS.

This evaluation of the HIV/AIDS Health Sector response will provide key evidence in the pharmaceutical sector for HIV/AIDS to inform the MoH in the process of developing the National Health Policy, 2010-2020, and the Health Sector Strategic Plan III, 2010-2015 (HSSP III). In particular, it will address the key gaps regarding pharmaceutical management not previously included in the national health plans and policies. Strengths, weaknesses and gaps in the pharmaceutical management for HIV/AIDS will be highlighted and this could provide critical information for the overall health system beyond HIV/AIDS.

1.2. Rationale for the Building Block in the National Health System

The Health Sector Strategic Plan II, 2005/06 – 2009/2010 (HSSP II), defines the National Health System line with the WHO definition as: ‘All institutions, structures, and actors whose actions have the primary purpose of achieving and sustaining good health, [the boundaries of which] encompass the public sector including the health services of the army, police and prisons; private health delivery systems comprising private-not-for-profit organizations (PNFP), private health practitioners (PHP), traditional and complementary medicine practitioners; and communities’(13). The WHO health system framework describes health systems in terms of six core building blocks: finances, health workforce, information, governance, medical products and technologies, and service delivery(12). These building blocks interact with each other to produce overall goals and outcomes for the health systems as shown in figure 1.

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Figure 1: WHO building blocks and health systems goals (14)

The core building blocks contribute to the strengthening of health systems in different ways with some building blocks being cross-cutting (governance and information systems), relate to core inputs for production of health (financing and human resources for health), and the rest reflects the immediate outputs of the health system, namely the availability and distribution of care, namely, medical products and technologies and service delivery.

Uganda made great progress in HIV/AIDS service delivery and is one of the few African countries that reached the target of people under treatment for HIV set by the “Three by Five” initiative(14). Despite progress, there remain challenges to programme management and coordination of the health sector response to HIV with parallel systems of service delivery being created. While all bilateral and multilateral partners have signed agreements to align their support to national plans and programmes, some created distinct implementation and funding systems which do not necessarily support the established MoH priorities complicating the coordination of the HIV response at the central level. This coupled with difficulty in obtaining necessary planning data, has made it difficult for ACP to ensure the coverage, quality, and cost-effectiveness of some HIV services. Though many of Uganda’s partners in the response to HIV are still active, some are scaling down or closing. Financial resources for the response seem to have reached a peak, calling for a closer look at the health sector’s interventions to ensure “value for money” with a need for the Government must take on additional financial responsibility.

The MOH in the process of developing the National Health Policy, 2010-2020, and the Health Sector Strategic Plan III, 2010-2015 (HSSP III). Major changes have occurred in the HIV/AIDS response since HSSP II. Thus, it is important to provide evidence to refocus the activities of the ACP for the coming years. It is against this background that the current management of the ACP desired to document strengths, weaknesses, and gaps in the health sector’s approach to HIV/AIDS, rethink strategies and re-programme the response.

4 Uganda MoH Health Sector Review 2007-2010

1.3. Terms of Reference 1.3.1. Key tasks for the assessment The tasks were to Assess and document:

i) The availability of national policies, standards, guidelines and regulations for ensuring access, quality and rational use of HIV related medicines (ARVs, OIs and STIs)

ii) The different funding/donations mechanisms for ARVs, OI and STI medicines

iii) The current procurement and supply management systems in place for ARVs, OIs and STI medicines established by the government and different partners in the public and private sectors as well as their linkages.

iv) ACP involvement in the whole procurement and supply management cycle

A. Plans a) The existence, comprehensiveness, alignment and relevance to the objectives of the HSHASP, of a detailed procurement and supply plan for HIV medical products. b) The translation of policies into guidance to support the procurement and supply management of ARVs, OIs and STI medical products (guidelines, checklists, SOPs)

B. Quality and safety a) Methods available for assuring the quality of procured HIV medical products (WHO prequalification, GMP assessment of manufacturers, Good Distribution and Warehousing Practices, quality control). b) The pharmaco-vigilance system established to monitor the safety of HIV medicines and its integration into the national and international (WHO) pharmaco-vigilance systems

C. Management a) The systems established for the selection, quantification, forecasting, ordering, tendering, quality control, warehousing, distribution, prescribing and dispensing of HIV medical supplies at all levels of the public sector including those for all partners. b) The relationships, linkages, alignment of procurement and supply systems for all actors in the health sector as well as the coordination of all stakeholders and the extent to which the established systems are integrated into the national system. c) Financial resources available to support the procurement and supply management of all HIV medical products by the government and partners d) The availability, adequacy, training and re-training of different cadres of personnel for the management of HIV medical products e) Availability and system set up to manage information to support procurement and supply planning and management of HIV medical products

5 Uganda MoH Health Sector Review 2007-2010

1.4. Understanding the Terms of Reference

The main task is to analyze and document access to HIV/AIDS medical products used for ART, PMTCT and PEP under four main categories namely:

i) Assessment of the structures put in place to ensure uninterrupted access, quality, and rational use of medical products

ii) Evaluation of the processes established for the procurement, supply, storage and distribution of medical products

iii) The current status of access to medical products in terms of availability, accessibility, pricing, quality and rational use. Coordination and integration into the national system of the structures and processes put in place by the various funding and supply sources

iv) Role of ACP in the coordination and management of medical products for HIV/AIDS

1.4.1. Structures put in place to ensure access to medical products a) The existence, availability and appropriateness of up to date legislations, regulations, policies, guidelines and standards that will support the management of medical products b) The existence and comprehensiveness of plans for management and use of HIV medical products of all actors and their alignment with national systems

1.4.2. Processes established to manage procurement, supply and use of medical products a) The processes established by all stakeholders to manage selection, quantification, forecasting, ordering, tendering, receiving, quality assurance, warehousing, distribution, transportation, storage, supplier monitoring, inventory management, dispensing, counseling, safety and adherence monitoring, training. This is to evaluate how the systems function to minimize waste, ensure transparency, efficiency and sustainability.

1.4.3. Status of access and rational use of medical products in health facilities a) The outcomes of the current structures and processes put in place to ensure access to medical supplies. This will include but not limited to evaluation of the availability of key medicines at the facilities, security of product supplies over a three year period, wastage due to expiry, adequacy of storage systems, adherence to guidelines etc

1.4.4. Coordination and integration of all funding and supply sources a) The extent to which all funding and product sources align their structures and processes with the National program in order to avoid duplication of efforts and optimal utilisation of available resources

6 Uganda MoH Health Sector Review 2007-2010 b) The extent to which the supplies of medical products are coordinated to ensure efficient management and utilisation of resources c) The integration of the supply management system for HIV medical products with the National procurement and supply system for other essential medicines

1.5. Objectives of the Building Block Assessment

1.5.1. Broad objective

Assess and document the comprehensive situational analysis overall coordination, implementation and management of the HIV/AIDS and opportunistic infections medicines in the Health sector of Uganda with a greater focus on gaps, weaknesses and strengths of the system from 2007 to 2009.

1.5.2. Specific objectives

The specific objectives were to asses and document:

a) The coordination, role and level of involvement of AIDS Control Program (ACP), enabling environment and the implementation (if any) of the relevant national policies, standards, plans and guidelines for HIV medicines (ARVs and medicines for OI) to ensure their rational selection, distribution and use.

b) The current medicines supply systems (including procurement) used at both central and facility levels and how they interact with each other taking into account public, private not for profit, private for profit and NGO sectors.

c) The quality assurance systems for overall management of HIV/AIDS medicines in Uganda and how they affect the access.

d) The rational use and access (availability, affordability and sustainability) taking into account the geographical and financial aspects.

e) Obtain and provide recommendations for further improvement of programme planning, implementation, coordination and collaboration of the HIV/AIDS response in the Health Sector

7 Uganda MoH Health Sector Review 2007-2010

2. METHODOLOGY 2.1. Overview of the Methodology

The HIV Health Sector Review was national in scope. It entailed a review of the HIV response at all levels of the health sector including at the national, district, sub-district and health facilities. Though the review was driven and co-ordinated by the ACP, all key partners including public, uniformed services, PNFPs, PFPs and traditional institutions were included.

The basis of the review was the Health Sector HIV/AIDS Strategic Plan, 2007–2010 (HSHASP). The HSHASP focuses on three thematic areas: Prevention, Comprehensive HIV/AIDS Care and Support, and Institutional Capacity Building. This process reviewed each of the above mentioned thematic areas in accordance with the WHO framework of the six Health System Building Blocks (figure 1), adjusted to 7 for by addition of laboratory services. Laboratory as service delivery and products/technologies was taken as a different building block to provide emphasis on its central role in the HIV/AIDS response.

A specific toolkit for medical products as proposed by WHO methodology was used for this review. This specified the possible sources of information, measurement strategies, core indicators and issues related to improving data availability and quality as well as investments that might be needed.

2.2. Description of the Data Collection Process

In order to ensure a comprehensive review, a mix of methods was used comprising of desk review, qualitative and quantitative data collection as well as a case study of ACP. Field study involved examination of districts, sub districts, and health facilities, purposively selected to reflect regional, urban/rural, high/low volume, poorly/better performing characteristics. In addition to district level, national level review was conducted involving the different stakeholders. Key players in national response ranging from MoH (ACP, Pharmacy division), development partners, key implementing partners, national supply systems were selected.

2.2.1. Selection of the District Field Study Sites

A total of ten districts were selected for this review based on the eight national sero- behavioural Survey regions as the primary categorization, which clearly indicate heterogeneity of HIV infection in Uganda by geographical areas. The selected districts were; Central (Kiboga, and Kampala), Southwest (Mbarara), Western (Kamwenge), East Central (Kamuli), Eastern (Tororo), Northeast (Katakwi), North Central (Pader, and Gulu) and Northwest (Arua). However, the two districts of Kampala and Gulu have been selected because of their special circumstance in terms of the level of urbaneness, high HIV prevalence and being the capital town city (Kampala district), and recent internal conflicts that could have had impact on the health system (Gulu district).

8 Uganda MoH Health Sector Review 2007-2010

Other factors included as selection criteria were: i) Ensuring a balance in urban/rural divide in the eight districts, as defined by Uganda Bureau of Statistics (UBOS). Thus from rural (Kamwenge, Kiboga, Kamuli and Katakwi) and from urban (Arua, Mbarara, Tororo and Pader) ii) Performance in reporting health information as defined by the league table iii) Availability of at least one health facility (whether private or public) that is engaged in provision of HIV/AIDS care and services, and iv) Duration of district existence that should be at least ten years because most recent ones tend to report to their parent districts

2.2.2. Selection of health facilities

In each target district, health facilities were stratified into public, private (private for profit – PFP and private not for profit – PNFP), and uniformed forces. All uniformed forces facilities, regional referral hospitals, district hospitals, PNFP/PFP hospitals, and district health office were automatically sampled. In addition, at least one facility representing the health centres 3 and 4 were selected. At each of these facilities, staffs involved in management of medical products were interviewed and the storage and distribution system were assessed using semi-structured questionnaires.

2.2.3. Selection of tracer list of products

A list of fourteen (14) products was selected to be traced for the survey. The selection of the products was based on previous surveys and to take into account the need for adult ART needs, pediatric ART needs, PMTCT products and the drugs for STIs and OIs. The full list of products used for the review together with rationale for inclusion of each is attached in appendix 1 of this report.

2.3. Qualitative Methods of Data Collection

Qualitative methods of data collection were employed primarily at national level. For specific respondents at national level, structured questionnaires seeking to obtain in-depth information and explanation for observations from district levels were used. The questionnaires are attached in appendix 3.

2.4. Quantitative Methods of Data Collection

Quantitative methods were applied in obtaining data from medical stores, health facilities, district health offices and implementing partners for HIV/AIDS service delivery. Standardised pre-tested questionnaires from previous WHO work in Nigeria were adapted for use in Uganda. A set of tools for central medical stores, health facilities stores, health facilities key informant, and partners key informant interviews were employed and are attached in appendix 3.

9 Uganda MoH Health Sector Review 2007-2010

2.5. Analytical Framework and Review Questions

Cross-cutting issues/themes Policy, guidelines and enabling Processes, quality assurance Management environment s n t

o Are there adequate policies and legal What is the role of ACP and other key players What is required for a harmonized and i n t e a n

n frameworks to guide country (NMS, Pharmacy division, NDA)? coordinated national supply system for HIV/AIDS i o d p

r management of medical products for Is there a working mechanism for sharing of medicines? m o o o c c

HIV/AIDS? information between the different national How technical assistances are initiated and t d n n

e What LTIA and coordination mechanisms level players? structured for HIV/AIDS medical products? a

t m n e exist, and if present how have they been Who takes lead role for HIV Medical products? What roles do districts play in the management of e g a m

n implemented? HIV/AIDS Medical products? e a g a m

n s a e n M i c i d n e o Which documents guide the selection of How is the selection process carried out? Who coordinates selection of medical products in i t M c

e ARV and OI products for use in Uganda? Are there considerations for long term both public and private sectors? l e

S How often are they updated? efficiencies in the process? Are all ARVs used in the public sector on What quality assurance mechanisms are used Is a single selection unit for the country possible the EML? for the selection of products? and what should be done to create one? g

n What policy and guiding documents are How is the quantification process carried out? Who coordinates the national quantification of i t s

a used in the quantification process? Which data and tools are used for the HIV/AIDS products in both public and private c e

r quantification of national needs? sectors? o f

d What quality assurance mechanisms are used n

a Is there a recognised and functional quantification in making the quantification and forecasting? n

o unit within the MoH? i

t Use/management? a c i f i t n a u Q

10 Uganda MoH Health Sector Review 2007-2010

Cross-cutting issues/themes Policy, guidelines and enabling Processes, quality assurance Management environment t n Which policies guide the national How much fund is allocated to medical Who is responsible for the national procurement e m procurement process? products and from who? of HIV/AIDS medical products? e r u

c What is the funding mechanism in place? What basis is used in allocation of funds? o r

P Is there a national guideline for Which procurement methods are used for both donations and how is it implemented? public and key private sector procurements? Are procurement prices compared to a reference price and how often? e g Which national regulations guide the Which approaches are used to manage the How are the different storage systems for HIV a r o storage of EMHS? storage system? products aligned and who coordinates them? t S Are there guidelines for national storage systems? n

o How the overall medical products What are the different distribution mechanisms Who provides technical oversight to the country i t u distribution system is structured? in place and why? HIV medical products distribution mechanisms? b i r t

s Is there a harmonised policy on What are the order refill rates? i D medicines distribution? t c Is there a policy on harmonisation of How available are tracer products in the health Who provides support supervision to health u d o facility level product use processes? facilities? facilities in relation to HIV medical products? r P e s u s

m Is medical products supply data collected What are the information systems in place? Is there a functional national system for data e t s at the MoH resource centre? capturing for HIV medical products? y s n o i t a m r o f n I

11 2.6. Data Analysis, Triangulation and Interpretation

Data collection: involved use of both qualitative and quantitative methods using structured and semi-structured questionnaires for partners, health facilities, stores and key informants. Collected data cleaned to ensure completeness and accuracy. All collected data were exclusively handled by the review team members to ensure confidentiality.

Quantitative data: quantitative data were coded where applicable and entered using Ms Access™ data base and analyzed using Stata™ 10.0 release.

Qualitative data: were transcribed and analyzed using Atlas-ti™ version XX to develop thematic areas. Responses from different people were triangulated to develop key themes to inform and provide explanation for the observations from quantitative data.

3. LIMITATIONS OF THE STUDY

Although this study was national in scope, it could not handle all aspects of the HIV medical products management system. They key limitations for this building block were: i) This building block excluded all laboratory products supply and management systems ii) Apart from specific cases provided in the results and the discussions, in-depth economic analyses of the HIV medical products in the HIV response were not conducted. This review did not attempt to conduct economic evaluation iii) Whereas the national storage systems are part of this review, no attempt was made to conduct a deliberate and in-depth review of the performances of NMS, JMS and Medical Access as the key supply sources for HIV medical products. Emphasis was placed on their contribution and outputs towards the national HIV response as opposed to their performances. These have been covered in other specific reviews already and did not require replication here. iv) This review is not meant to replace previous recommendations in place but to augment and provide alternative views and recommendations to improve the national HIV health sector response. v) Rational use of ARV medicines was not included as part of this review process. We hope that other reviews in future will seek to answer further questions in this area. 4. FINDINGS OF THE STUDY

4.1. Findings of the District Response

A total of ten districts were accessed during the period of review. Table 1 below present the summary of districts and number and type of health facilities reached during the survey while Table 2 provides a summary of the health facilities by level and ownership.

Table 1: District and types of health facilities accessed

Health facility type District Region District Public Uniformed PNFP PFP totals Kampala 3 3 6 4 16 Central Kiboga 2 0 4 0 6 Regional total 5 3 10 4 22 Mbarara 3 0 2 0 5 Western Kamwengye 5 0 1 0 6 Regional total 8 0 3 0 11 Gulu 2 1 2 1 6 Arua 3 0 2 0 5 Northern Pader 3 0 1 0 4 Regional total 8 1 5 1 15 Kamuli 3 0 2 0 5 Katakwi 2 0 1 0 3 Eastern Tororo 3 1 1 0 5 Regional total 8 1 4 0 13 National total 29 5 22 5 61

Figure 2: Health facilities accessed by level and ownership

Hospital Health centre IV Health Centre III NGO clinic

PFP 2 1 2 1

PNFP 11 4 4 1

Uniformed 3

Public 7 15 10

0 5 10 15 20 25 30 35

4.1.1. District Level Current country design of the HIV/AIDS medical products management systems operates directly from central level to the health facilities and the communities. Below here are the key findings from the district level on the HIV medical products: a) The current national distribution system for care and treatment ARVs does not include the District Health Office (DHO). As such, the District Health Team (DHT) is not adequately equipped to fully provide support supervision for the ARV management system. In all the districts visited, only PMTCT products supply plans are known at DHT level. In addition, all ARV products are distributed directly to the health facilities while the other essential medicines and health supplies (EMHS) are channeled through the DHO for all facilities below hospital level. b) Members of the DHT have not been provided with trainings in HIV/AIDS supply management system for the country. Only 12.5% of the respondents from the DHO were trained and only 36% percent are aware of the national system. Many past training in ARV logistics targeted primarily the health facilities and excluded the DHT.

“DHOs don’t even know what these ARV s look like to tell you the truth. They don’t! Even the training does not include them. You cannot go and supervise ART because you can’t provide information. It is not uncommon for a DHO) to ask which one is Nevirapine, who likes to do that when you are in authority?” – a district level respondent c) Orders for ARV medicines are sent by health facilities directly to NMS/MoH while for other EMHS including Cotrimoxazole go through the DHO. This created a challenge with follow-up, control and quality assurance. Although all health facilities from the districts are expected to send a copy of the reports to the DHO, this wasn’t the case in the survey districts. This coupled with the limited capacity of the DHT person responsible for the management of EMHS to fully check for accuracy of the report makes errors to go un-noticed in the reports.

“The health facilities do not give us copies of their orders and reports as expected. This together with (our) limited understanding of medicines management makes it difficult to detect errors in many orders”, - a district level respondent

4.1.2. Health Facility Level a) Availability of tracer products

All health facilities were assessed for availability of tracer list of products both on day of survey and over the previous three calendar years. None of the facilities had all the tracer medicines on day of survey and no single product was available throughout all health facilities indicating non-continuity of supply. Tables 2 – 5 illustrate the availability of the usable and expired products by different categorizations.

Table 2: Availability of ARV medicines on day of visit

# of facilities who had it in # of facilities with Product stock on day of survey expired stocks Public Private Total Public Private Total Efavirenz 600mg 26 17 43 1 3 4 Lopinavir/Ritonavir 200/50mg 22 10 32 2 1 3 Nevirapine 200mg 18 13 31 1 0 1 Zidovudine/Lamivudine 300/150mg 35 19 54 2 2 4 Lamivudine 1mg/ml 13 11 24 1 2 3 Nevirapine 10mg/ml 20 14 34 0 3 3 Stavudine 1mg/ml 7 1 8 0 0 0

Table 3: Availability of OI and STI medicines on day of visit

# of facilities who had it in # of facilities with Product stock on day of survey expired stocks Public Private Total Public Private Total Acyclovir 200mg 23 18 41 2 1 3 Benzathine penicillin 2.4 Mega Units 25 21 46 0 1 1 Ciprofloxacin 500mg 25 23 48 0 1 1 Cotrimoxazole 400mg/80mg 31 23 54 0 0 0 Doxycycline 100mg 26 21 47 3 1 4 Fluconazole 200mg 17 15 32 3 0 3 Metronidazole 400mg 28 23 51 0 1 1

Table 4: Availability of all tracer products by region

All Products (N=14) ARVs only (n=7) STI/OI medicines (n=7) # of Region Mean %age Mean %age Mean %age facilities availability availability availability availability availability availability Central 16 8.44 60.3% 3.38 48.2% 5.06 72.3% North 20 7.60 54.3% 3.32 46.4% 4.35 62.1% East 16 7.13 50.9% 2.94 42.0% 4.19 59.8% West 17 8.47 60.5% 3.52 50.4% 4.94 70.6% National Public 42 7.52 53.7% 3.36 48.0% 4.17 59.5% Private 27 8.48 60.6% 3.15 45.0% 5.33 76.2% All 69 8.0 57.2% 3.26 46.5% 4.75 67.9% facilities

Table 5: Availability of tracer list by level of level of facility

All tracer medicines ARVs only STI/OI medicines Health facility # of Mean %age Mean %age Mean %age type facilities available available available available available available Health centre 36 7.64 54.8% 3.23 46.2% 4.43 63.3% District store 4 1.5 10.7% 0.5 7.1% 1 14.3% Hospitals 28 8.63 62.0% 3.57 51.0% 5.11 73.0% NGO clinics 6 10 71.4% 4 57.1% 6 85.7%

District stores had the lowest availability of all the products with NGO clinics and hospitals being better stocked with the products and this trend was similar for all ARVs and other tracer products. Generally, the private sector is better stocked than public sector but both showed similar trends. However, OI medicines were more available in private sector. Owing to it’s importance in the HIV/AIDS response, availability of Cotrimoxazole on day of survey was reviewed as in table 6 below.

Table 6: Availability of Cotrimoxazole on day of survey # of # with Cotrimoxazole Proportion Sector facilities in stock by sector Private 27 23 85.2% Public 42 31 73.8% All 69 54 78.3% In addition, Cotrimoxazole was available in 78% of health facilities visited including district stores and with public sector standing at 73.8% of all facilities visited (Table 6 below). 85.2% of all private health facilities had usable quantities in stock as opposed to 73.8% of health facilities in the public/uniformed sectors. b) Stock-outs of tracer medicines

Health facilities were asked about the main causes of stock-outs and they were asked to rank the reasons with first being the most probable. The results are illustrated in table 8. Delayed delivery from supply sources (JMS, NMS, and partners) was ranked highest followed by incomplete supply of ordered quantities.

Table 7: Reported main causes of stock outs at health facilities Number of facilities Ranking of response in Main reasons reported reporting order of importance Public Private Total 1st 2nd 3rd Delay in delivery from suppliers 33 17 50 36 10 4 Quantities delivered not in conformity 26 12 38 6 16 10 with quantities ordered Funds not available for the order 20 11 31 11 11 7 Errors in forecasts/quantifications 14 9 23 4 8 4 Inadequate stock control 6 4 10 2 2 2 Transport means not available 11 5 0 5 3 7

The stock-out durations for the different health facilities were reviewed over period of three years dating back from day of survey. Tables 8 to 13 below show the stock out days for different products over the years of review. Table 14 summarizes the mean stock out days for the different periods.

In the period 2009/10, Nevirapine was the most stocked out product and AZT/3TC was the least stocked out (Table 8).

Table 8: Stock-outs of ARV medicines in review period of 2009/2010 Number of # of facilities facilities that that had stock Mean annual Product managed the out in review stock-out days product period Efavirenz 600mg 34 21 (61.8%) 111

Zidovudine/Lamivudine 300/150mg 39 23 (59%) 56

Lopinavir/Ritonavir 200/50mg 24 12 (50.0%) 103

Stavudine 1mg/ml 9 2 (22.2%) 70

Lamivudine 1mg/ml 18 3 (16.7%) 130

Nevirapine 10mg/ml 24 9 (37.5%) 110

Nevirapine 200mg 28 19 (67.9%) 137

In the period 2009/2010, Fluconazole was the most stocked out OI/STI medicine and Cotrimoxazole was the least stocked-out. Acyclovir and Doxycycline were also high on the list of products that stocked out (Table 9). Table 9: Stock-outs of OI/STI medicines in review period of 2009/2010 Number of # of facilities that facilities that Mean annual Product had stock out in managed the stock-out days review period product Acyclovir 200mg 34 17 (50.0%) 104 Cotrimoxazole 400mg/80mg 44 20 (45.5%) 56 Fluconazole 200mg 28 16 (57.1%) 134 Metronidazole 400mg 44 21 (47.7%) 81 Benzathine penicillin 2.4 MU 35 12 (34.3%) 67 Ciprofloxacin 500mg 44 24 (54.5%) 85 Doxycycline 100mg 45 22 (48.9%) 108

In 2008/9 calendar year, Stavudine syrup was the most stocked-out and Efavirenz 600mg tablet was the least stocked out. This period also witnessed the introduction of dispersible tablets for pediatric formulations by CHAI in the country. Although the availability of the dispersible formulations was realized much later, there was a running procurement pipeline up to late 2009 and early 2010 for some institution. The public sector was the last to fully absorb the new formulations as opposed to the NGO and PNFP sectors of the HIV/AIDS response indicating a delayed policy shift. This is illustrated in table 10.

For 2008/2009 period, Fluconazole continues to be the most stocked-out STI/OI product and Metronidazole and Benzathine were the combined lowest stocked-out products in the period of review (Table 11). However, none of the products stocked out for a combined period of less than 2 months indicating a major challenge to their access.

Table 10: Stock-outs of ARV medicines in review period of 2008/2009 Number of # of facilities facilities that that had stock Mean annual Product managed the out in review stock-out days product period Efavirenz 600mg 29 12 (41.4%) 50 Zidovudine/Lamivudine 300/150mg 31 17 (54.8%) 77 Lopinavir/Ritonavir 200/50mg 20 9 (45.0%) 78 Stavudine 1mg/ml 10 2 (20.0%) 229 Lamivudine 1mg/ml 18 8 (44.4%) 165 Nevirapine 10mg/ml 25 10 (40.0%) 129 Nevirapine 200mg 26 13 (50.0%) 109

Table 11: Stock-outs of OI/STI medicines in review period of 2008/2009

Number of facilities # of facilities that Mean annual Product that managed the had stock out in stock-out product review period days Acyclovir 200mg 29 14 (48.3%) 102 Cotrimoxazole 400mg/80mg 39 13 (33.3%) 79 Number of facilities # of facilities that Mean annual Product that managed the had stock out in stock-out product review period days Fluconazole 200mg 28 16 (57.1%) 119 Metronidazole 400mg 40 21 (52.5%) 73 Benzathine penicillin 2.4 MU 40 19 (47.5%) 73 Ciprofloxacin 500mg 41 22 (53.7%) 108 Doxycycline 100mg 31 12 (38.7%) 105

Table 12: Stock-outs of ARV medicines in review period of 2007/2008 Number of # of facilities that Mean annual facilities that Product had stock out in stock-out managed the review period days product Efavirenz 600mg 24 13 (54.2%) 71 Zidovudine/Lamivudine 300/150mg 14 4 (28.6%) 54 Lopinavir/Ritonavir 200/50mg 19 10 (52.6%) 132 Stavudine 1mg/ml 23 7 (30.4%) 94 Lamivudine 1mg/ml 16 6 (37.5%) 192 Nevirapine 10mg/ml 17 7 (41.2%) 113 Nevirapine 200mg 6 2 (33.3%) 72

Lamivudine Syrup was the most stocked out product with more than 6 months of total non- availability in the country. This was followed by Alluvia (Lopinavir/Ritonavir) adult formulation. The least stocked out product was Zidovudine/Lamivudine and Efavirenz. During this period, the country program had promoted the use of Stavudine-based regimens for ART. In addition, pediatric care was beginning to scale-up and forecasting for the pediatric formulations as well and needs for children was a major challenge for the country. During this period as well, there was a rebound demand for second line adult ART products following their expiry in 2006/2007 calendar year and this created a major demand gap.

The most stocked –out OI/STI medicine in period of 2007/8 was Doxycycline and the least stocked- out was Cotrimoxazole (Table 13). Comparatively fewer facilities managed Fluconazole as opposed to the other two years of review.

Table 13: Stock-outs of OI/STI medicines in review period of 2007/2008 Number of # of facilities that facilities that Mean annual Product had stock out in managed the stock-out days review period product Acyclovir 200mg 20 11 (55.0%) 127 Cotrimoxazole 400mg/80mg 29 16 (55.2%) 85 Fluconazole 200mg 17 8 (47.1%) 126 Metronidazole 400mg 28 16 (57.1%) 81 Benzathine penicillin 2.4 MU 23 17 (73.9%) 111 Ciprofloxacin 500mg 27 14 (51.9%) 120 Doxycycline 100mg 25 16 (64.0%) 148 Figure 3: Summary of Three-year stock-out days for ARV medicines

Over the three years, the most widely stocked-out ARV medicine was Lamivudine suspension followed by Stavudine oral solution. The adult formulations were more available than pediatric. The least stocked out ARV medicine over the years was AZT/3TC adult formulation. Stock-out of single Nevirapine continues to rise every year despite the product being used for both PMTCT and adult first line treatment using Tenofovir-based regimens.

Figure 4: Summary of Three-year stock-out days for OI/STI medicines

Fluconazole remains the most-stocked out OI/STI medicine with Cotrimoxazole being the least. Despite being relatively cheaper, Doxycycline and Benzathine penicillin were stocked out for an average of 3-4 months/year during period of review. c) Ordering and distribution process

Facilities were reviewed for different reasons that affect the ordering and distribution processes for the products. First, an assessment of associative factors that affects the quantities to order was done as shown in table 14. It was notable that allocations and donations from different sources were the top ranking reasons for difficulty in determining quantities to order. This was more significant with ARV medicines than with other essential medicines and this is consistent with other previous surveys.

Table 14: Factors that were reported to affect quantities of products to order OI STI Reported factors (N=61) ARVs medicines medicines Availability of finances n/a 41 41 Unreliable consumption data 6 7 7 Donations provided by partners/donors 13 13 12 Allocation from MoH 14 9 9 Allocation from NMS 29 11 11 Allocation from partners 7 4 4 When asked whether supplies received were in conformance with orders, only 23 facilities (31.7%) accepted that this is the common occurrence (Table 15 and figure 3). This was higher in private sector than in public sector facilities at 32.6% and 44.4% respectively indicating difference in strength of the distribution systems. This compared closely with the difference in order refill/pick up rates for NMS and JMS as reported in the SURE project policy option analysis report 2010. In addition, lower public health facilities are now on a modified push system of supply from NMS.

Table 15: Are supplies received in conformity with orders? Responses by sector Sector type Yes No Total Public (N=34) 11 23 34 Private (N=27) 12 15 27 All facilities (N=61) 23 38 61

If the allocations were not in conformity with ordered amounts, facilities were asked about how the products are usable and their shelf life. It was notable that the three top frequently occurring responses were illustrated in figure 3 below. Figure 5: If allocation is not in conformity, how are the products?

Always Mostly Rarely Never

2 11 Near expiry 4 s n

o 2 i t a

c Made in quantities that 1 o l

l 9

a can be consumed by

f 6 o

facility before expiry

e 3 m

o 0 c t

u Useful to the facility 11 O 7 1 0 2 4 6 8 10 12 Frequency of response

Two facilities noted that the forced allocations are always near expiry. No facility however reported that the allocations are never useful to them but agreed that they are rarely in quantities that can be consumed by the facility before expiry. These responses were equally distributed in both public and private health facilities visited during the period of review. The health facilities showed no difference in the method of obtaining their stocks (Table 16). The different health facilities therefore rely on both replenishments using supplier delivery means as well as their own means of stocks pick-up from the sources showing willingness to use both methods of replenishment.

Table 16: Methods of stock replenishment for health facilities

How are your stocks/products replenished? Method of replenishment Public Private Total Delivered by supplier 31 15 50 Picked up by facility’s own means 31 14 49 Use of both methods 28 12 40

The reported median lead time for replenishment of stocks for NMS was 8 times that of JMS and the longest time reported was three times more for NMS as shown in figure 4 below. Whereas the minimum time is similar for supply from districts, NMS and JMS, the median time is significantly differing indicating difficulties in obtaining supplies from NMS. Figure 6: Reported lead time for different supply sources

District JMS NMS

90 e r Maximum 60 u s 180 a e m

1

e Minimum 1 m i 1 t

d

a 3 e

L Median 7 56

0 50 100 150 200 Duration in working days

Whereas 40 (65.6%) facilities indicated they are able to both receive and pick supplies at the same depending on needs, there were varying degree of challenges encountered during collection of products from different supply sources. Many of the challenges are related to availability and usability of means of transport at the facility (table 17). It is therefore indicative that the health facilities continue to lack proper means of transport as well as sufficient funds to manage them.

Table 17: Main problems encountered during collection of products from different sources

Number of facilities reporting (N=61) Problem Public Private Total Lack of vehicle 17 9 26 Lack of fuel 14 3 17 Inadequate structure of available vehicle 7 3 10 Poor condition of vehicle 6 3 9 Poor road network 4 0 4 d) Inventory management and reporting

Facilities were assessed for strength of record keeping. The presence of up to date record for at least six month per year for previous three years was assessed for the different health facilities. When the mean availability of records over the three years were compared for the tracer products (Table 18), it was realized that the overall national record system for HIV/AIDS medical products had improved although they remained below 50% for the tracer list of products per facility. This is also in agreement with the fact that the national HIV/AIDS program has over the years matured much more and more capacity building and systems strengthening efforts have been realized.

Table 18: Availability of complete records per facility for all tracer products

N Minimum Maximum Mean Std. Deviation Year 2007/8 66 0% 100% 30.30% 33.46% Year 2008/9 65 0% 100% 42.11% 34.26% Year 2009/10 65 0% 100% 48.70% 32.56% Three year mean 65.33 0.00% 100.00% 40.37% 33.43% When the completeness of records was compared by region of the country (Table 19), it was evident that the central region of the country had better record keeping followed by western region with the northern region being the worst. On the overall, the western region showed the best improvement in record keeping followed by north while the central remained at a stable level. The improvement in the north and west can be attributed to improved security in the regions following the decline in civil strife and resumption of normal health services delivery at the health facilities.

Table 19: Regional trend in strength of record keeping over the period of review Three year Year 2007/8 year 2008/9 Year 2009/10 Region N average Std. Std. Std. Std. Mean Mean Mean Mean Dev. Dev. Dev. Dev. Central 15 50.0% 38.6% 47.1% 40.6% 50.0% 38.9% 49.0% 39.3% Eastern 15 40.0% 32.0% 46.7% 31.2% 50.0% 31.4% 45.6% 31.5% Northern 19 18.4% 27.3% 27.4% 30.8% 33.8% 33.2% 26.6% 30.5% Western 17 17.7% 26.9% 49.2% 32.4% 62.2% 20.9% 43.0% 26.7% National 66 30.3% 33.5% 42.1% 34.3% 48.7% 32.6% 40.4% 33.4%

When this is compared in the different districts (as illustrated in figure 7 overleaf), it is notable that the northern districts had poorer record keeping while Kamuli district had the best overall record completeness followed by Mbarara and Kampala districts. Generally, the 2007/2008 year had very poor records with only Kampala district being above the three years national average during this period.

Figure 7: Strength of record keeping per district of survey

When records completeness was compared by type of health facilities, PNFP hospitals and Health centre fours were better in record keeping while the PFP clinics had the worst performances overall for the three years compared (Figure 8). Figure 8: Strength of record keeping by type of health facility

70% Year 2007/8 Year 2008/9 Year 60% 2009/10

50%

40% n a e M 30%

20%

10%

0%

Facility type

This is indicative of the level of supervision and support provided by implementing partners as well as ministry of health to those facilities over the years. PNFP facilities tended to generally manage their record keeping much more than the other facilities. District stores were the worst performing units in the public sector and generally they were out of stock for many products on day of survey. i) Presence of partner-specific records

For all the health facilities, the presence of partner-specific records was assessed to ascertain the extent of parallel programming and multiplicity of records. It was notable that 26 facilities (42.62%) reported having partner-specific record for different products. When the 26 facilities were assessed to find out for which products those records are for, all reported having partner-specific records for ARV medicines and 10 facilities (38.5%) had additional records for other essential medicines (Table 20).

Table 20: Presence of Partner specific records by product category

Number of facilities by Sector (N=26) Product category Public Private Total ARV medicines 16 10 26 OI medicines 10 4 14 STI medicines 8 3 11 Other essential medicines 7 3 10

The presence of partner-specific records is one of the major supporting factors for vertical HIV/AIDS programming in the country but itself in its own does not provide causation. However, it is evident that many partners have utilized the parallel record keeping as a tool for strengthening presence on ground and henceforth weakening of the national health system. ii) Submission of reports

On reporting, 85% of health facilities reporting submitting the last monthly reports on time and 65% of those reporting submitting report on time had copies of the repot available (figure 9).

Figure 9: Timely submission of reports by facilities Was last report submitted on time? If yes, was copy of report seen?

Whereas this indicates high level of report, it may not indicate completeness and accuracy of those reports by the different institutions. Health facilities continue to as well submit reports to MoH/ACP, NMS, DHO’s office and as well to the implementing partner supporting the relevant HIV/AIDS program found in their facility. This creates double work and increases the risk of errors in key data elements required for the management of medical products. e) Drug use processes and Expiries

Health facilities were reviewed to assess those with at least one expired product on the tracer list on day of survey. The facilities were clustered into hospitals and other health facilities and compared across public and private sectors (table 21).

Table 21: Availability of expired products in health facilities

Facilities Public Private Total When Facilities with at least one expired product 13 7 20 asked about are Hospitals with at least one expired tracer product found 5 6 11 the Health centres with at least one expired tracer product found 8 1 9 commonest causes of expiries in their facilities, respondents reported a number of reasons. They then ranked them in order of priority and the top three rankings and the major responses are shown in table 22 and figures 10 and 11. Donations and/or supply of products with short expiry was the top factor for expiries and 18 (42.9%) of the public facilities agreeing to this ranked it as top. This is therefore indicative of the upstream challenges with the procurement, distribution and supply systems for the products at central level. It is also realized that the two top major causes of expiries are related to factors outside the health facility.

Table 22: Reported major causes of expiries in health facilities Main reasons reported Number of facilities Ranking of response in reporting order of importance Public Private Total 1st 2nd 3rd Error in forecast or quantification 14 8 22 6 12 3 Inadequate stock control 3 6 9 0 4 3 Donations/supplies with short shelf-life 28 17 45 28 12 3 Non-compliance to clinical guidelines by 7 3 10 0 3 3 prescribers Modification of clinical guidelines during 3 6 9 2 1 2 the course of the year Medicines pushed to the facility 24 13 37 18 13 2

Figure 10: Most reported cause of expiries in health facilities by sector

Public Private Total

Medicines pushed to the facility

Modification of clinical guidelines during the course of the year Non-compliance to clinical guidelines by prescribers

Donations/supplies with short shelf-life

Inadequate stock control

Error in forecast or quantification

0 5 10 15 20 25 30 35 40 45 50 Number of facilities reporting

Figure 11: Ranking of the most common causes of expiries in order of priority

1st 2nd 3rd

Medicines pushed to the facility

Modification of clinical guidelines during the course of the year

Non-compliance to clinical guidelines by prescribers

Donations/supplies with short shelf-life

Inadequate stock control

Error in forecast or quantification

0 5 10 15 20 25 30 Number of health facilities per rank

4.2. Findings of the National Response The national level provided the second phase of the review and it is from this level that the HIV/AIDS response is coordinated. At national level, the ministry of health staffs at both ACP and pharmacy division were interviewed. The three major HIV/AIDS products storage and distribution systems were assessed namely National Medical Stores (NMS), Joint Medical Store (JMS), and Medical Access Uganda Limited (MAUL). In addition, development partners, key funding agencies and selected implementing partners were interviewed during this phase of the study.

4.2.1. Funding for HIV medical products

The funding for HIV/AIDS medical products have come from a number of sources with the top four funding sources being PEPFAR, Global Fund, Government of Uganda, and a combination of other sources. The different sources of funds are allocated at different times of the year and this as well affects their immediate availability for use. Since 2008/2009 funding year, PEPFAR funding became flat-lined with no expected net increment in overall funding but re-allocations can be carried out between different funding priorities. a) GOU Funding for ARV medicines:

In 2008, the government introduced funding purely for HIV/AIDS commodities and antimalarials with a direct procurement arrangement. In this regard, all the products to for this fund must be procured directly from Quality Chemicals Industries (QCIL), a plant initially subsidized by the government to manufacture ARVs and antimalarials for initially local consumption. An initial annual funding of sixty billion Uganda shillings (UGX 60bn) or US$ 30m was announced with half dedicated to ARV medicines. This fund was channeled through MoH and finally utilized by NMS that therefore acted as the procurement, storage and distribution agency, all within interlinked one management. b) UNITAID/ CHAI funding:

2006/2007 noted the entry of Clinton Foundation HIV/AIDS Initiative (CHAI), now known as Clinton Foundation Health Action Initiative (CHAI) that focused at increasing both demand and accessed to pediatric and adult second line ARV medicines. By creating demand, this would support the economy of scale for manufacturers and henceforth drive prices down internationally. CHAI received funding from UNITAID that raised funds from charging fees on top of air tickets and other aspects in developed world. This initiative was planned to end in December 2008 but has been extended twice to December 2010 and provided ARV medicines as in-kind donations up to point of entry in Uganda with recipients meeting the related handling charges. An exception was later on created for MoH where additional funds were created for this purpose. The exit of CHAI is expected to be off-set by the other funding mechanisms available especially the GOU funding and as well by introduction of cost-saving and cost-effectiveness measures in procurement and distribution systems. c) PEPFAR funding in Uganda:

The PEPFAR funding provided the most available source for medical products including buffering other sources since September 2004. Initially PEPFAR funds were exclusively tagged to patient numbers but in late 2008 following massive stock-out of key products in public sector, the funding restriction was relaxed to provide buffer stocks for patients receiving ARV medicines procured from other sources. This shift in implementation arrangement meant difficulty in purely tagging numbers of patients reached with different ARV medicines procurement to the funding and as well created room for double counting and overlaps of efforts.

Within PEPFAR in Uganda, there existed three major agencies for channeling funds for HIV/AIDS products namely CDC Uganda, USAID Uganda and the global mechanism for CRS AIDS Relief. CDC Uganda grantees procure both ARV and OI medicines. USAID Uganda directly supports ARV medicines procurement and work with IPs and health facilities to maximize savings from different activities already funded to be able to procure the required non-ARV medicines. This however has been a flexible arrangement with the IPs directly procuring their products locally in times of scarcity from the other sources.1 The CRS/AIDS Relief mechanism supports both the ARV and non-ARV medicines but through different procurement mechanisms. Non-ARV medicines are funded through sub-granting arrangements with partner institutions while ARV medicines are procured centrally at global level and distributed through the national supply system for faith-based organizations. CDC has supported both central and facility level funding for Cotrimoxazole with direct allocation of funds to NMS and at the same time allocating funds to the IPs to procure the same product with an aim if reducing the national gap in availability and hence reducing the need for ART. d) Global Fund for Treatment of Tuberculosis, AIDS and Malaria GFTAM):

Since 2003, GFTAM has provided grants for ARV medicines, Cotrimoxazole and related medical products for the country. The funding is channeled through ministry of finance. Following suspension in 2005 for corruption, the fund has since then been managed by third party agent creating additional and tougher bottlenecks to timely release and utilization. The release of the funds has been relatively much slower than needs and this has been one of the attributed causes of stock-outs of ARVs from the public sector supply system. e) Public sector funding through vote 116 to NMS credit line:

Since the enactment of the local government act in 1997, there has been a policy for empowerment of the different health facilities under supervision of districts to request for required health products. Later on, the credit line was introduced and over the years it has evolved to be a major player in determining availability of essential medicines that include key OIs and STI medicines. In 2009/2010 financial year, there emerged a new dimension that required health facilities to only control 33.3% of the funds with the rest transferred to NMS hence strengthening the role of NMS as set by the NMS Act to be the public sector procurement agency. f) Other funding mechanisms:

In addition to all the above sources of funds and out of pocket expenditures, other sources of funds are also recognized. They include UNICEF, ECHO through different humanitarian Agencies, and Pharmaceutical companies. The one key source from Pharmaceutical companies has been the Diflucan™ Partnership Program (DPP) that has for over eight years provided Fluconazole in-kind free of charge throughout the country. This program was instrumental in reducing costs of non-ARV medicines in both public and private sectors. The humanitarian agencies have continued to provide buffer stocks of both ARV and non-ARV medicines especially in periods of acute stock-outs.

Table 23 below provides the confirmed/official allocation of funds from different sources and how they were spent (if known) for ARV medicines over the period of review for both cash and in-kind donations. The continuous delays reported in release of funds have hampered the full utilization of the needs for the country. The current funding pipeline would have been adequate for ARV medicines if the funds were released in a timely manner.

Table 23: Allocation and utilisation of funds for ARV medicines during review period‡ Funding source Amounts in millions of US Dollars Year 2007/8 Year 2008/9 Year 2009/10

1 At time of completion of this review, PEPFAR announced additional funding was being made available immediately for scaling-up ART treatment, including ARV procurement, to increase net enrolment by at least 36,000 patients in 2010. The additional funding also included $5.5million in emergency procurement of ARVs Allocated Spent Allocated Spent Allocated Spent* CHAI/UNITAID 12 11.6 13.5 13.1 10.1 13.5 GOU - - 15 8.2 15 12.6 GFTAM 11.5 5.3 11.5 4.2 10.4 N/A PEPFAR 36.1 17.5 39.2 19.2 38.6 N/A UNICEF - - - 0.3 - N/A Others - - - 0.4 - N/A Totals 59.6 34.4 79.2 45.4 74.1 26.1 ‡ Data obtained from MoH National Medicines Procurement Plan 2010/2011 *2009/2010 spent figures does not include all expenditures for complete period.

4.2.2. Forecasting and quantifications for medical products at national level

The forecasting and quantification process for the HIV/AIDS medical products vary according to both the partner concerned as well as whether the product is ARV or non-ARV medicine. The country forecasting and quantification processes for HIV/AIDS medical products have since 2003 been carried out with technical assistances (TAs) first from USAID then from a collection of different partners. a) 2009 National HIV/AIDS quantification exercise:

In 2009, the first comprehensive national quantification exercise was carried out by the SCMS project on behalf of MoH. This exercise yielded a lot of information on estimated national need for medicines for next four years up to June 20132. This initiative was a breakthrough in harmonization of national needs but had multiple gaps that included lack of defined needs by regimen, quantification of products already being phased out, no plan for inclusion of newer and superior formulations (e.g dispersible tablets and fixed-dose formulations for children), among other. b) National Procurement Plan:

As part of the funding mechanism for Global fund and as annual requirement for public sector budgeting, a national procurement and supply management plan is put in place. Until the planning period for 2010/2011 financial year, many plans are rarely updated and sometimes not referred to during implementation. A lot of procurements are made on emergency basis. c) NMS quantification for Vote 116:

The government of Uganda US$ 15m for ARV medicines is quantified for at NMS using past consumption as basis for quantification. Almost no consideration is made for the national scale-up plan and current policy environment including projected change in demand. This in essence coupled with the long lead time often leads to either under or over-delivery of the required products procured using this fund. The quantification is not routinely aligned to the national PSM plan which should be the cardinal guiding document for public sector.

“ Another challenge we are going to head for seriously is the new policy shift of government of sending money directly from finance to NMS, it has left us in the program and pharmacy department helpless because originally money would come to the ministry, then the program and pharmacy department would sit and say for this quarter this is what we require, quantify and it goes through the procurement process. Now the money is going direct to NMS, and for ARV procurement from Quality Chemicals, they use their own method of quantification”, - a respondent from Ministry of Health 2 By time of completing this review, SURE project was in the process of conducting a review of the national quantification exercise in preparation for Global fund round 10 application for Uganda 4.2.3. National level Procurement of medical products a) Key players in the procurement:

Principally at national level, there are three key players in procurement of ARV medicines and they are based on the source and nature of funding. The summary of funding source, procurement agency and storage mechanism for ARV medicines is shown in table 24 below.

Table 24: Funding, procurement and storage systems for ARV medicines in 2009/10 2009/10 National Funding Procurement value (millions storage Product recipient (s) agency agent of US$) system GOU Public and private sector health 15.0 NMS NMS (Vote 116) facilities Crown Public and private sector health GFTAM 10.4 NMS Agents facilities Public and private sector health NMS CHAI/UNITAD 10.1 CHAI facilities CDC Implementing partners MAUL supported facilities JMS CRS/AIDS Relief supported facilities ~9.2 SCMS JMS IRCU, NUMAT PEPFAR Baylor Uganda, MJAP, IDI, TASO, 12.3 MAUL MAUL Mildmay Uganda, Mbuya Reach Out, EGPAF, PREFA, ~3 CRS Global JMS CRS/AIDS Relief Supported sites

The CHAI/UNITAID in-kind donations and the PEPFAR funding are the most fragmented forms of procurement in the country. Their fragmentations are related to the early inception of the two programs and in particular, the need to support rapid scale-up and reduce the level of un-met needs in the country. They therefore played very critical roles in the rapid scale-up of ART in Uganda during the review period. b) Procurement mechanisms/methods utilized:

Mixes of methods are used in the national procurement and are once again tied down to the source of funds. In addition to the key terms dictated by the source of funds, other factors also play a great role in the method applied. Table 25 provides a summary of the different methods based on funding source and notable restrictions. The noted difference in restriction and widely varying approaches to the procurement based on funding mechanism is also associated with the increasing complexity in obtaining key procurement information. Whereas development partners are not mandated to supply all this information to the ministry of health, little initiative have been made before in having them shared and possible practices harmonized.

Table 25: Summary of different procurement methods for ARV medicines Funding source Procurement method (s) Notable restriction (s) GOU (Vote 116) Direct/Single Source All medicines must be procured from Quality Procurement Chemicals Industries Limited manufactured stocks GFTAM Competitive All procured medicines must meet the Global Fund International tender Prequalification standards and should be from accredited manufacturing plants. Products must be registered in Uganda CHAI Negotiated international All procured medicines should be from WHO pooled procurement certified plants and registered in country of origin PEPFAR (SCMS) International open All procured products must be US FDA and NDA competitive tender registered and as well those recommended for use in Uganda as per the national guidelines PEPFAR (MAUL) Negotiated international All procured products must be US FDA and NDA procurement registered and as well those recommended for use in Uganda as per the national guidelines PEPFAR (CRS) Open International All products must be US FDA registered and on the pooled procurement AIDS Relief product list

4.2.4. National level storage and distribution systems

The current major distribution systems for HIV/AIDS medical products are structured along the funding mechanism and nature of procurement for the products. Efforts to harmonise the distribution systems in the past have been unsuccessful due to multiple factors that included lack of good will from partners, insufficient operational capacity within pharmacy division in MoH, increased support for vertical programs, and products quite often are used across programs and therefore difficult to place under one vertical program. a) ARV medicines logistics management system:

The USAID funded JSI|DELIVER Project did commendable work in setting up the current ARV logistics system for the public sector. Over the years and with program maturity, modifications have been made along the way to suit for changes and demands within the health system.

“To tell you the truth I was close to those people and the concept was new to all of us. Even persons within MoH who thought they were wasting time appreciated their role after being exposed to their work and the DELIVER slogan of “No product No Program”. So that TA was useful…. They even went out of their way to help us with the policy aspect, they also supported us with distribution…” – a respondent from the Ministry of Health

The ordering system uses a pull model with health facilities submitting reports at bi-monthly intervals and these reports doubles as facility level orders. This system has largely matured and facilities cannot get re- supply without the orders. In addition, health facilities have a minimum and maximum stock level of 2 and 4 months of stock respectively. Reporting periods were changed from 28 days to calendar months and this eased reporting as it was in line with the existing reporting mechanism for HMIS. b) ARV medicines distribution systems/channels:

Generally, close to half of the ARV medicines used in the country are distributed through the private sector channels with the top primary channels being MAUL and JMS. Table 25 showed the different recipients for the various national storage systems. A summary of the various distribution modalities and their sources of products are shown in the figure in appendix 2. It is notable that the current systems all maintain buffer stocks at varying levels in addition to having differing response rates to requests or orders from health facilities and/or implementing partners.

The current multiple distribution systems have contributed to complacency at health facilities as private sector delivery systems have appeared more responsive than NMS. As such, facilities continue to fall back and not report on time and this makes a cumulative effect of having diminished reporting level centrally hence poor data for national quantification. There is now an attempt to create a central unit within the MoH to coordinate procurement and distribution of all essential medicines and health supplies (EMHS) but the process of initiation is being hampered by complex red-tape within and outside the MoH. A ministerial policy statement in addition to having the required staffing is being seen as best option to make this unit fully operational this unit as well as improving the coordination and related aspects. c) NMS and Distribution performance

A study conducted by and Boston University in May 2000(15) for DISH II revealed that District-based delivery costs were excessive relative to what should be achievable. It was however concluded that the solution would not be in turning the district distribution function over to the NMS. Estimates from the study suggested that distribution costs would be 82% higher if the NMS took over responsibility for delivery to the HSDs relative to the prevailing District-based delivery approach.

The 2010 SURE Project Policy Option Analysis study of NMS distribution system compared outsourcing and use of NMS to deliver to Health Sub-District (HSD) and to District Health Office (DHO) (Table 26). It was evident in the current arrangement that it is cheaper for NMS to outsource distribution function as opposed to carrying out the full continuum of supply management right from quantification through to distribution for the national system. Comparing the high cost of distribution by NMS to the time customers take to collect their products from ordering with JMS, the private sector option showed that there is gross under- performance.

Table 26: Options analysis for NMS distribution costs Option 1 Option 2 Scenario 1 Scenario 2 Scenario 1 Scenario 2 NMS to NMS to Option description NMS to DHO outsource to NMS to HSD outsource to DHO HSD NMS cost (UGX Billion) 3.1 1.3 3.6 1.3 Outsource cost (UGX Billion) 0 0.3 0 0.4 Total 3.1 1.6 3.6 1.7 (Source: SURE Project 2010)

Figure 12: NMS and JMS Customer Collection comparison

(Source: MSH SURE Project 2010) 4.2.5. Logistics Management Information System (LMIS) and M&E for Medical products

Comprehensive LMIS have been coordinated by institutions offering TA to the public sector with support of development partners. Although they have provided great data for use in both planning and management of medical products, they have remained largely vertical and without continuity once such partner’s contractual period comes to an end. Transition from different agencies to another has often created more challenges including stock-outs as it was noted in the period from June 2009 to May 2010 when SCMS closed and SURE was being rolled-out. a) Relationship between available information systems

Over the years, the HIV/AIDS sector has continued to hop from one information system for medicines management to another based on multiple factors, some beyond the scope of this review. The most notable factors have been the nature and predisposition of TA partner, funding, and desired program design. Whereas they have been for the best interest of the country, they created key challenges that include: - Data incompatibility between systems: many of the newer systems have not been able to fully integrate to other existing information systems and hence a lot of manual data transfer at each time of decision making has been encountered. Typical cases include incompatibility between warehouse information system at NMS and the Supply Chain Manager and Pipeline. This created a major challenge in generation of both quantifications/order allocations as well as reports required for decision making. - Uncoordinated transition from one system to another has often led to transcription errors and sometimes altogether failed transfer during data migration. In 2009 NMS changed from Tally and this has rendered all previous information before October 2009 inaccessible. - Limited local capacity building for use of newer systems is another aspect. In cases where capacity building (or training) was provided, it was in many cases provided to the people who do not manage the systems or have no interest in using them. - For the HIV/AIDS sector, there has been limited coordination of where the required Logistics data should be housed with ACP calling for an “in-house system” while pharmacy division calls for “an integrated EMHS system” focusing on vertical and horizontal programming respectively. b) Allocation of orders and supply quotas

Orders and supplies for public sector facilities are allocated at the different medical stores. Currently NMS allocates 20% of all available ARV medicines to JMS to serve the PNFP and faith-based facilities. However, this quota has been shown to be in-adequate and does not match the growth already experienced in those facilities owing to many of them being relatively more organized.

At NMS, allocated orders and not picked according to list and orders are served based on non-scientific judgment. The dispatch officials determine quantities to serve based on judgment of quantity on order with no due consideration of the size and scale-up plans made in the previous report used for order allocation. This therefore relates to the lower stock-out days for health facilities below a hospital because their orders normally are of smaller quantities and therefore easily get near complete refill during they cycle. c) Data sharing and information gathering

Many facilities at central level are unable to fully share their data especially those related to procurements, stocks pipeline and performances. In addition, there is always a parallel set of data collection on similar indicators and in many instances, the collected data and associated reports are not widely shared or stored at a central location for future quick references. This arrangement therefore created an overload of data request at different levels of the health system in both quick succession and in parallel creating massive duplication of efforts in data collection.

4.2.6. Coordination and management of medical products

Coordination and management (governance) forms central pillar for the successful management of the medical products. Over the period of review, the coordination of medical products processes have undergone multiple transformations, some due to policy shifts while others were dictated by the nature of the HIV/AIDS response that characterized by need for massive scale-up and increased flow of financial resources in period up to December 2009. With the reduction/stasis in funding, the need for coordination and strategic management became a reality.

We now consider the coordination in terms of the different sectors taking into account the overall leadership, technical support function, support supervision and partnerships below. a) Coordination within the MoH and public institutions

Within the MoH, medical products for HIV/AIDS are overseen by ACP with assistance of TA from development partners. Fluconazole under the Diflucan Partnership Program (DPP) has remained to be exclusively managed within ACP with TA with orders being allocated directly to NMS. Whereas the DPP arrangement has been relatively working well, the others have always had multiple ups and down. These arrangements are not in line with the HSSP-II that mandates pharmacy division to manage all EMHS on behalf of the ministry. This has henceforth created difficulties in bringing both entities in MoH to be able to fully agree on best approaches to ensure continuous availability and access to the products.

“…the program officer/medical officer at ACP is tasked with some of these roles yet there are technical and pharmacy issues. The pharmacy department disengaged from ACP and the dissemination from NMS and there is technical assistance from SCMS or SURE and they are not really sure of what the issues are” – a central level respondent

Capacity and role of ACP: in relation to Medical Products, ACP is not suited to manage the products because in absence of TA, they are not technically prepared and planned to do so. ACP therefore has maintained their role of clinical and policy guidance for HIV/AIDS and expanded to include provision of oversight to the management of product. This arose primarily as an approach to cover a gap in service delivery then when the pharmacy was still a unit within the ministry. Following the elevation of pharmacy to a division in 2008, slight growth in capacity was realized in the department and with request from ACP and other disease control programs; a Senior Pharmacist was posted to the MoH to support the vertical programs. ACP has however not fully divorced itself from the role it has to play due to other challenges within the ministry and in working with semi-autonomous public institutions such as NMS and National Drug Authority. In the organization assessment of ACP, it was recognized that ACP is not meant to carry out this role but continued to do so because the relevant entities have not been able to be part of the then urgent national response quite quickly enough.

“… and then at the national level we must have real capacity. In the ACP we must have a pharmacist, whether he sits here (in ACP) or sits down (at pharmacy department) but is particularly addressing our issues tracking medicines because that should not be my work although now I do it. It’s given that the sources are multiple. I need somebody who understands medicines and who can track. And I tell you even at NMS, those skills are not obvious….” A respondent from Ministry of health

Capacity and role of pharmacy division: the elevation of pharmacy within MoH from a unit to a division created an expanded entity meant to support the cocktail of functions meant to ensure continuous, cost- effective and access to EMHS in the country. Whereas the roles were expanded greatly, the required capacity within was not expanded to meet the true demand. Pharmacy division is still grossly understaffed to attend to all the vertical programs as well as coordinate the various activities in the MoH. This has created a challenge on part of the staff to be able to attend to all the busy schedules (meetings, support supervision, desk work, programs review, etc) and hence the creation of demand for super-human staffs. This in addition with the unwillingness of the division to utilize in-house TA has continuously hampered performances. Although the division has been able to get capacity building for necessary competencies related to the HIV/AIDS programming, it has been a little difficult for them to be able to utilize these skills to full potential. In addition, due to staff constrains, the NGO sector received only minimal supervision if any from this department.

“I am not a pharmacist but I think there has been poor coordination and disengagement with the partners. If you could strengthen that pharmacy department to oversee this issue of product list and harmonization, it would go a long way to improve national list of products.” – a central level respondent

“… for me, the best solution to this is issue is strengthening pharmacy division up to a department. It has already been proposed. This will enable us to build capacity.... if we had a department and we would have more than the four persons… Things would have worked!.... in the end you are lost into many things and you do not have any capacity in the division. If we had the capacity, we should be the one managing the quantification not a TA…..” - a respondent from Ministry of Health

Coordination of NMS: over the year NMS has been pivotal in the public sector response especially in relation to procurement, storage and distribution of HIV/AIDS products. NMS just like NDA are semi-autonomous bodies reporting directly to the minister of health. This set-up has made NMS to continuously take technical decisions without the involvement of both ACP and pharmacy division whenever HIV/AIDS medical products were concerned. Whereas naturally NMS is meant to share updates on stocks situation, it is not regular and often this leaves a planning gap. In addition to that gap, NMS currently determines their own priority HIV/AIDS products within Vote 116 and this in the long run coupled with the shift to modified push might lead to greater challenges of coordination within the public sector leave alone cost-effectiveness of managing HIV/AIDS medical products. b) Coordination within development partners

The key development partners have been able to organize themselves under the umbrella of the AIDS Development Partners (ADPs) to try to harmonize roles and avoid duplication of efforts. This is a great stride into the future especially in situation of diminishing funding with expanding service demands in the country. The ADP however has been driving the ACP as opposed to ACP being in the driving seat. This is partly due to ACP being lost into so much more than they are able to fully accomplish with the limited resources and increasing inability to fully gain leverage from within for key functions such as management of medical products. There is therefore need for ACP to be more proactive and be able to engage the ADPs and as well gain support where appropriate. The PEPFAR country coordination mechanism has put together plans for harmonization and by time of reporting had started working towards implementation of the OGAC recommendation of 2009. c) Coordination of the private sector

The private sector has largely remained uncoordinated and it is through this sector that the multiple challenges with managing supply and availability of medicines has been exacerbated. The ministry therefore has not been able to fully watch over the supply side of HIV/AIDS service delivery. One key case was the uncoordinated entry of the ARV Access for Africa (AA4A) project in 2008 that focused on creation of buffer stocks to cover for stock-outs. However, this project could not meet the real need of the country which was provision of continuous supply as opposed to buffering. d) Donations and regulation of drug registration and importation

The entry of donations and other schemes of supply has been one loophole for uncoordinated management of HIV/AIDS products. Whereas a donation guideline exists from NDA, many players within the MoH including ACP are not fully aware of the implementation modalities and key restrictions. Introduction of tougher laws limiting importation of donations into the country eased the process but there are still so many loopholes.

However, the influx of donations as well created a major milestone in improving the formulations of pediatric ARV medicines; a role led by CHAI and to date, the formulations are much better and more user-friendly. There is need to strengthen donation process and also improve review of products pipeline to ensure quicker transition to superior formulations. This role should be critically taken by pharmacy division as part of their strategic and key responsibility on behalf of the MoH.3 e) Role of Technical assistances

All previous TAs except current SURE Project were provided directly to the ACP with minimum involvement of the pharmacy division of the ministry of health. Whereas these technical assistances provided excellent cushion and required support for the then country program strengthening in phase of rapid scale to meet the 3 by 5 target, it created a number of challenges for both immediate and long term sustainability of the national HIV/AIDS response in the country. The TAs provided the necessary support in rapid set-up of country program, development of tools, SOPs and all relevant system for scale-up. However, the TAs strengthened the vertical programs and created parallel systems at national, local government and health facility levels in addition to creating lack of local ownership and continuity.

4.3. Summary of Findings/SWOT Analysis

In light of all the findings above, we here present the summary of the finding in terms strengths, weaknesses, opportunities and threats in relation to first the ACP as whole and then in particular to the medical products for HIV/AIDS in Uganda.

4.3.1. Strengths i) The country program has matured and basic infrastructures to manage the whole continuum of supply are in place. The different systems already in place can provide greater chances for future program rationalization and expansion. ii) Currently ACP is in a strong coordination role for program implementation and has been recognized to be playing major lead roles in driving the country programming despite the high level of influence from development partners. iii) There are policies and guiding documents including the Health Sector Strategic plan, national ART guideline, etc that have created harmonization to a great degree. The country has been able to switch to newer practice approaches relatively early enough. iv) There are regular updates of key guiding program documents related to selection and use of medicines for HIV/AIDS program. The updates in whatever form have been very critical in ensuring the country is kept in line with latest recommendations. v) Inventory management and specifically use of standard record keeping has improved over the three years with more facilities being able have minimum records for products at an annual average of 6%.

3 By time of compiling the report, the pharmacy division had started working on fast-tracking the availability of information on donation to all persons in the ministry. vi) The country has been able to control the quality of ARV medicines used over the years and there is stronger regulation and control of prequalification standards. All imported ARV medicines are subjected to mandatory laboratory analysis by NDA and there some degree on control over donations entering the country.

4.3.2. Weaknesses i) The coordination of HIV/AIDS medical products is currently not harmonized; ARVs are partly with ACP, TA Projects, Pharmacy division and NMS while Fluconazole is with ACP. This creates parallel approaches not in line with both HSHASP and HSSP II. ii) The HSHASP gave little attention to coordination of medicines within ACP and therefore no clear definition of boundaries. This created an expanded role for ACP beyond clinical guidance and product selection to as well manage the quantification, procurement, and parts of distribution and use. iii) There is limited coordination between the different entities in the public sector namely NMS, ACP and pharmacy division and each has in the past three years preferred to work semi-independently from each other. This lack of synergy in efforts has led to delays in responses and stock-outs as well as expiry of key products. iv) There are multiple procurement and distribution mechanisms creating duplications and possible double- dipping in the country. The distribution mechanisms are still not within a streamlined direction and hence a lot of opportunities to treat patients are being lost to inefficient procurement mechanisms. v) Private sector medicines distribution systems to public institutions are not coordinated and this created an avenue for smart dumping. vi) NMS has been inefficient if their distribution to health facilities. Health facilities surveyed noted that rarely do ordered quantities get served fully and many times the pushed products are of short expiry or not required. The inefficiency at NMS created opportunities for growth of private sector channels alongside parallel arrangements. vii) The District Health Office remains excluded from the management of HIV/AIDS medical products and very few received training on logistics management. As such, the DHT remains ill-equipped to provide support supervision as well as management oversight for the HIV/AIDS medical products hence contravening the Local Government Act 1997. viii) There is no single point for provision of accurate country data on HIV/AIDS medical products. A lot of data collection exercises are under-taken at regular intervals by the MoH and different partners. However, the collected information remain in different places and not easily accessible especially for decision making.

4.3.3. Opportunities i) The MoH in 2009/2010 financial created the coordinated procurement and distribution system (CPDS) that is meant to be housed within the ministry. Members have been appointed and this committee will look at issues related to harmonization of procurement, distribution and use of products as well as rationalization. If made fully operational, the CPDS can be a milestone for improved management of medical products for HIV/AIDS and eventual integration of systems. ii) The goodwill from the ADPs and other agencies to provide direct and indirect support towards strengthening of the pharmaceutical sector. If this opportunity is taken, the pharmacy division of MoH could be expanded to fully take on their roles. iii) The introduction of government funding for antiretroviral medicines will go a long way in cushioning the departure of other funding mechanisms. If used equitably well, this funding will go a long way into strengthening the responsiveness of the supply system. iv) The continued funding from different sources for medical products is a good opportunity to take on with cost-effectiveness and overall systems strengthening in mind. Over the period of review, the country generally had more funding than required for the HIV/AIDS medical products. v) Strong private sector ARV medicines supply systems notable JMS and Medical Access Uganda Limited. If utilized well with the aim of stronger public-private sector arrangement in mind, they could create additional system for the public sector alongside NMS especially in areas of facility-level distribution. vi) Presence of Quality Chemicals Industries Limited (QCIL) as a local manufacturer of ARV medicines can offer long-term solutions to availability of the widely used formulations. If supported by the government to break even through other means including market expansion in the East African region, QCIL can provide the country needs.

4.3.4. Threats i) There is now a stasis in funding with major decline expected to be felt in the next one to two years starting with the planned exit of UNITAID funding through CHAI. The country demand for HIV/AIDS medical products is on the rise and there is need to urgently look for opportunities to increase funding as well as rationalize therapy. ii) The HIV/AIDS medical products have largely been managed by technical assistance programs not reporting directly to the MoH. This heavy reliance on TA without a transition plan for local ownership and systems strengthening continues to leave the response in period of uncertainties whenever there is transition from one TA to another. In addition, different TAs have come and in many instances started on new approaches including immediate introduction of new tools without building on previous activities. This has created disruption in continuity of supplies and key roles. iii) Lack of clear coordination mechanism for NMS, pharmacy division and the vertical disease control programs in the ministry leaves the continuity of different aspects of medicines management to be desired. iv) The current composition and number of staff at pharmacy division remains largely inadequate to fully handle all the country needs for medical products. Without leverage of efforts from partners and other units, it is virtually impossible for all the roles of managing HIV/AIDS medical products to be fully transitioned there. v) The national HIV/AIDS response continues to be donor driven and this has led to strengthening of first vertical programs and then secondly parallel systems within and outside existing health infrastructure. vi) The modifications of Vote 116 and expanding roles of NMS despite their inefficiencies will put the country continuity of medicines in clear challenge. The different changes at NMS are carried out without wider stakeholder involvements are potential leads to failed medicines supply system which is not desirable for the national HIV/AIDS response. 5. CONCLUSIONS

5.1. By Assessment Objectives

5.1.1. Objective 1: Assess the coordination, role and level of involvement of ACP, enabling environment and the implementation of the relevant national policies, standards, plans and guidelines for HIV medicines to ensure their rational selection, distribution and use.

On the overall, ACP is has over the period of review been in charge of the coordination and key decisions regarding medical products for HIV/AIDS. A lot of support for the activities came directly from technical assistance projects from ADPs and other partners. Whereas the policies exist for the different management and coordination aspects of the medical products for the HIV/IADS response, their implementation and coupled with lack of clear framework for coordination of public entities (NMS, NDA, ACP and pharmacy division) and other private sector players, a lot of duplications, wastages and uncoordinated alignments have happened. The current donations guidelines together with regulations for importation of ARVs are not tight enough to prevent entry of both unlicensed and excessive quantities of ARV medicines into the country hence making accurate planning and coordination a very complex role.

5.1.2. Objective 2: Assess the current medicines supply systems (including procurement) used at both central and facility levels and how they interact with each other taking into account public, private not for profit, private for profit and NGO sectors

The country distribution system for HIV/AIDS products are the most complex and are not aligned to the national system for other EMHS making it generally inefficient and full of duplications of efforts. The distribution systems are structured based on funding and procurement mechanisms that each cannot lay trust on the other to handle part of the chain. This together with the multiple procurement mechanisms have therefore hampered effective delivery of the products and hence introducing a complex system that eventually lead to multiple stock-outs at health facility level.

The current procurement systems in the country are so diverse and henceforth make the country to lose money through inefficiency. Utilizing the GoU funding for only two out of the minimum 14 formulations required for the national response makes it unable to provide a complete treatment regimen. The GFTAM procurement is unresponsive to needs and has often been an associative factor for non-availability of ARV medicines in the country. PEPFAR mechanisms vary according to the USG agency and there is now a deliberate effort to harmonise the processes and strengthen overall performance.

5.1.3. Objective 3: Assess the quality assurance systems for overall management of HIV/AIDS medicines in Uganda and how they affect the access

All ARV medicines used in Uganda to meet at least minimum quality standards ranging from local to international depending on funding mechanism. However, the PEPFAR limitations to US FDA registration/approval makes the national system unable to utilize funds to procure cheaper generics not registered and this creates challenges especially during periods of emergency procurements. FDA approved generics are generally more expensive than the non-approved ones.

5.1.4. Objective 4: Assess the rational use and access (availability, affordability and sustainability) taking into account the geographical and financial aspects

The country still continues to experience stock-outs of HIV/AIDS medical products and the situation worsens with each additional distance from Kampala. In addition, there is generally poor record keeping throughout the country with the northern region having the weakest records despite showing tremendous improvement over the three years of review. Whereas the country had more than enough money to procure all the required ARV medicines needs, this was never translated into availability as a result of duplication of efforts through multiplicity of partners, double counting of patients, and inefficient distribution systems.

5.2. Key Emerging Messages

The country HIV/AIDS commodities continue to be in short supply despite adequate funding. The coordination and management of these products continue to be poor and complicated by the role paled by TA projects that do not report directly to the ministry and if reporting directly to the ministry, it is to the wrong office(s). it is evidently clear that although the roles of ACP, pharmacy division and NMS are spelt out in HSSP-II and to some extent in the HSHASP, it is not fully implemented in real practice and this created friction in their overall coordination.

The country distribution and utilization systems for HIV/AIDS products continue to be heavily partner driven just like the overall health sector response. This therefore has created a complex web of distribution channels and multiple facility level record systems translating into heavy workloads for already stretched human resources. The end result has been diminished reporting to national systems and as well stock-outs and expiries.

Although required national policies and guidelines exists, their implementations remains without required frameworks. Policies are not fully disseminated and this together with limited capacity of MoH to carry out regular and comprehensive support supervisions for the HIV/AIDS medical products is a precursor for constant growth of parallel systems. 6. RECOMMENDATIONS

In light of all the above findings, we would like to recommend the following issues for consideration by ACP and the MoH as a whole:

6.1. Policy Level Recommendations v) MoH should consider strengthening and expanding the pharmacy division in terms of staffing and capacity building to be able to manage the increased demands of the vertical programs. This should come out clearly in both the revised pharmaceutical sector strategic plan and the HSSP-III to ensure a sustainable long-term solution to reliance on TA for management of essential medicines and health supplies (EMHS), which HIV/AIDS medical products are, part of. vi) MoH should in the immediate future set out a policy to coordinate the pharmaceutical sector procurement and distribution systems with a long-term target of one national procurement plan, one national distribution mechanism/structure and one reporting system under direct supervision of the relevant units of the ministry. vii) The current national guidelines for drug donations should be revised and expanded to provide stronger control in area of drug importation and to prevent entry of excessive quantities of unlicensed medicines. The pharmacy division together with NDA should strengthen the implementation including dissemination of the relevant sections of the national guideline on drug donations. viii)MoH should consider introducing a framework to guide the coordination of the semi- autonomous entities (NMS and NDA) with the pharmacy division and the programs in the ministry including ACP. Currently both NMS and NDA report directly to the minister and make little consideration of role of the other players in decision making.

6.2. Program level Recommendations viii) ACP should consider separating the role of medicines formulations selection from the role of regimens selection. ACP should concentrate on the clinical aspects of the medicines and work with both pharmacy division and relevant TA mechanism on the choice of formulations, products quality assurance and logistics management so as to maximize the benefit to the country. ix) Include a recommendation somewhere to SURE and Pharm Div are working on this. A committee like the CPDA (spell this out) cannot do day-to-day work that would be done in the QPP, they should have an advisory/analytical role instead for streamlining the data management for HIV/AIDS medical products. x) The MoH should support/fast track the establishment of a central Quantification and Procurement Planning Unit (QPPU) in the pharmacy division or MOH. This together with fast-tracking the process of making the CPDS committee operational will provide a support mechanism for managing national drug requirements. The QPPU will be tasked with streamlining the data management for medical products including those for HIV/AIDS. xi) The pharmacy division together with ACP should increasingly review the list of products used in both public and private sector to ensure they are in conformity with national guidelines. This should include strengthening of role of pharmacy division to continuously evaluate the cost- effectiveness of the medicines used in the country. xii) MoH/ACP should take the driving seat in determining gaps in service delivery and translating them into requirements for development partners so that support should be within national priorities and hence implementation in a more sustainable manner. In addition, all transitions of technical assistances should be under supervision of the relevant office within the MoH to ensure continuity of services. xiii) ACP should coordinate policy and guidelines changes with both NMS and pharmacy division to ensure smooth transition from one set of selected medicines to another. xiv) The MoH/GoU should review the arrangements related to Local manufacturing of ARVs and the role of QCIL in the response to ensure both sustainability and more importantly cost- effectiveness of the utilization of products procured from QCIL and any other manufacturer in future. 7. BIBLIOGRAPHY

(1) MoH STD/AIDS Control Progam (ACP). The Status of HIV/AIDS Epidemic in Uganda: HIV/AIDS Epidemiological Surveillance report 2005 - 7. Kampala, Uganda: MoH, republic of Uganda; 2009 Jan 6.

(2) Uganda AIDS Commision (UAC). Moving Towards Universal Access: National HIV/AIDS Strategic Plan 2007/8 - 2011/12 (NSP). Kampala, Uganda: UAC, Republic of uganda; 2007 Jan 7.

(3) Fred Wabwire-Mangen, Martin Odiit, Wilford Kirungi, David Kaweesa Kisitu, James Okara Wanyama. Uganda HIV Prevention Response and Modes of Transmission Analysis. Kampala, Uganda: UNAIDS and Uganda AIDS Commission; 2009 Mar 1.

(4) Bartlett JA, Shao JF. Successes, challenges, and limitations of current antiretroviral therapy in low-income and middle-income countries. The Lancet Infectious Diseases 2009 Oct;9(10):637-49.

(5) Saul Kidde. The Supply Chain System for EMHS in Uganda. Kampala, Uganda: Management Sciences for Health; 2010.

(6) Ofuso Barko, Yolander Mikaele, Paschal Mujasi, SCMS Uganda Staff. SCMS Uganda Technical Assistance and Procurement Final Activity Report. Arlington, VA: Supply Chain Management Systems (SCMS); 2009 Jan 12.

(7) Copeland Rebecca, Cecilia sewagudde, Briton Bieze. Uganda Health Facilities Survey 2006: Peformance of HIV/AIDS and Family Planning Commodities Logistics Systems. Arlington, VA: DELIVER for U.S. Agency for International Development (USAID); 2006.

(8) Ooman Nandini, Michael Bernstein, Steven Rosenzweig. Seizing the opportunity on HIV/AIDS and Health systems. Washington, DC: Center for Global Development; 2008.

(9) Deogratius Kimera, Samul Malamba, Ashraf Kasujja, Morris Okumu, Sowedi Muyingo. Prescribing and Dispensing Practices for Antiretroviral Medicines in the Central region of Uganda. Kampala, Uganda: Medical Access Uganda Limited and Ministry of Health Uganda; 2010 Jan 31.

(10) MoH STD/AIDS Control Progam (ACP), The HIVDR Technical Working Group for Uganda. Tracking HIV Drug Resistance for Facilities Providing Antiretroviral Therapy in Uganda: Report of the Assesment for Early Warning Indicators Assesment 2008. Kampala, Uganda: MoH, republic of Uganda; 2009 Oct 1.

(11) World Health Organisation (WHO). Toolkit for monitoring Health Systems Strengthening: Medical Products, Vaccines and Technologies. Geneva, Switzerland: WHO; 2010.

(12) World Health Organisation (WHO). Measuring Health Systems Strengthening and Trends: A Toolkit for Countries. Geneva, Switzerland: WHO; 2010.

(13) Ministry of Health (MoH) Uganda. Health Sector Strategic Plan II 2005/6 - 2009/10. Kampala, Uganda: MoH, republic of Uganda; 5 A.D. Jan 7.

(14) World Health Organisation (WHO). Summary Country Profile for HIV/AIDS Treatment Scale-up, Uganda Fact sheet. Geneva, Switzerland: World Health Organisation; 2004 Jul 1.

(15) Taryn vian. Uganda: Assessing the Costs of Distribution to Health Sub-Districts, A case Study in Financial Analysis. Boston University School of Public Health; 2003 Jul 1. APPENDICES

APPENDIX 1: TRACER LIST OF PRODUCTS USED

Product Category Efavirenz 600mg Adult 1st line ARV Zidovudine/Lamivudine 300mg/150mg Adult 1st line ARV Lopinavir/Ritonavir 200mg/50mg Adult 2nd line ARV Stavudine 1mg/ml Pediatric 1st line Lamivudine 1mg/ml Pediatric 1st line/PMTCT Nevirapine 10mg/ml Pediatric 1st line/PMTCT Nevirapine 200mg PMTCT Acyclovir 200mg OI medicine Cotrimoxazole 400mg/80mg OI medicine Fluconazole 200mg OI medicine Metronidazole 400mg OI medicine Benzathine penicillin 2.4 Mega Units STI medicine Ciprofloxacin 500mg STI medicine Doxycycline 100mg STI medicine APPENDIX 2: CURRENT NATIONAL DISTRIBUTION SYSTEM FOR ARVS

Figure 13 : National ARV supply channels in relation to funding source APPENDIX 3 DATA COLLECTION TOOLS USED

KEY INFORMANT INTERVIEW IN HEALTH FACILITIES

Sector (public, private)

Facility type (National referral, RRH, District Hospital, Hospital, Health centre, clinic)

Name of facility

Name of region

Name of district

Qualification of the person in charge of the pharmacy unit

List of persons interviewed : Date of interview Cadre of interviewee Tel :

List of assessors : Surname/First name Structure/Function Tel : Comments Email :

Note: The assessment of medicines procurement and supply management system will be on the following category of products: . ARVs (adult and paediatrics) . Medicines for opportunistic infections . Medicines for STIs . Laboratory products Indicators for monitoring medical products 1. % key products that are available

2. % tracer products that are expired

3. Average stockout duration of key products in the past 3 years

4. Proportion of facilities keeping adequate records

5. Proportion of facilities with adequate conservation conditions and handling of medicines at storeroom and dispensing area

6. % of facilities with relevant clinical guidelines

7. % of facilities with current EML

Survey form 1: Pharmacy In stock Expired medicines Key products (ARVs, OIs, STIs, Lab) Yes=1, No=0 Yes=1, No=0 [A] [B] [C] 1. Efavirenz 600mg

2. Lopinavir/Ritonavir 200mg/50mg

3. Nevirapine 200mg

4. Zidovudine/Lamivudine 300mg/150mg

5. Lamivudine 1mg/ml

6. Nevirapine 10mg/ml

7. Stavudine 1mg/ml

8. Cotrimoxazole 400mg/80mg

9. Fluconazole 200mg

10. Doxycycline 100mg

11. Metronidazole 400mg

12. Ciprofloxacon 500mg

13. Benzathine penicillin 2.4 Mega Units

14. Acyclovir 200mg Total Percentage Survey form 1: Pharmacy Estimate percentage of products that expired in the store in the previous year Name of products that Dosage form Strength Pack size Qty procured in Qty expired in % of procured that expired in the store in 2009 2009 2009 expired Survey form 3a: Pharmacy 2007-08 Indicators: Average stock-out duration Adequate record keeping

Records Only collect data for medicines with records cover at least covering at least 6 months within the past 12 months Key Products (ARVs, OIs, STIs, 6 months Number Number of days Equivalent number within the Laboratory) of days covered by the of days of stock past 12 out of review (from out per year months stock 180 to 365 [E] = C x 365 ÷ D Yes=1, No=0 days) [A] [B] [C] [D] [E] Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Zidovudine/Lamivudine 300mg/150mg Lamivudine 1mg/ml Nevirapine 10mg/ml Stavudine 1mg/ml Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Acyclovir 200mg Total Percentage

Survey form 3b: Pharmacy 2008-09 Indicators: Average stockout duration Adequate record keeping

Records Only collect data for medicines with records cover at least covering at least 6 months within the past 12 - 24 months Key Products (ARVs, OIs, STIs, 6 months Numbe Number of days Equivalent within the Laboratory) r of covered by the number of days past 12 - 24 days review (from 180 of stock out per months out of to 365 days) year Yes=1, No=0 stock [E] = C x 365 ÷ D [A] [B] [C] [D] [E] Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Zidovudine/Lamivudine 300mg/150mg Lamivudine 1mg/ml Nevirapine 10mg/ml Stavudine 1mg/ml Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Acyclovir 200mg Total Percentage Survey form 3c: Pharmacy 2009-10 Indicators: Average stockout duration Adequate record keeping

Records cover Only collect data for medicines with records covering at at least 6 least 6 months within the past 24-36 months Key Products (ARVs, OIs, STIs, months within Number of Number of days Equivalent number Laboratory) the past 24 - days out of covered by the of days of stock out 36 months stock review (from 180 per year Yes=1, No=0 to 365 days) [E] = C x 365 ÷ D [A] [B] [C] [D] [E] Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Zidovudine/Lamivudine 300mg/150mg Lamivudine 1mg/ml Nevirapine 10mg/ml Stavudine 1mg/ml Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Total Percentage

Survey form 4: Pharmacy/Warehouse

Indicator: Adequate conservation conditions and handling of medicines at storeroom Checklist * Storeroom Dispensing True=1, False=0 Area/Room True=1, False=0 [A] [B] There is a method in place to control temperature (e.g. air conditioners). There are windows that can be opened or there are air vents. Direct sunlight cannot enter the area (e.g. window panes are painted or there are curtains/blinds to protect against the sun). Area is free from moisture (e.g. leaking ceiling, roof, drains, taps, etc.). There is a cold storage in the facility There is a regularly filled temperature chart for the cold storage Medicines are not stored directly on the floor. Medicines are stored in a systematic way (e.g. alphabetical, pharmacological). Medicines are stored first-expiry-first out (FEFO). There is no evidence of pests in the area. Medicines are not handled with bare hands Total Percentage Review of the Ugandan Health Sector HIV/AIDS Response - Key informant interview for Stores Survey form 6: Health facility: Rational Use of Medicines information

Indicators: Availability of Clinical Guidelines (STG) Availability of Essential Medicines List (EML)

National Clinical Guidelines for HIVs, STDs and OIs available Yes=1, No=0 guidelines Yes = 1; No=0 [A] ART STIs OIs

Essential Medicines List (EML) updated in the last 3 years with Yes=1, No=0 HIVAIDS included [B] National EML

[B1] =At least one current EML is present =

52 Review of the Ugandan Health Sector HIV/AIDS Response - Key informant interview for Stores GOVERNMENT/PARTNER/PRIVATE SECTOR STORES

DETAIL OF STORES

Name of Stores:

Type (Public/PNFP/PFP):

Address :

Tel/Fax/email :

Head of Store :

Academic qualification of the Head :

LIST OF ASSESSORS Surname/First name Tel : Email :

LIST OF PERSONS INTERVIEWED Date Surname, first name Designation Tel : Email :

Note: The assessment of medical supplies procurement and supply management system will be on the following category of products: 1. HIV/AIDS medicines 2. Medicines for opportunistic infections 3. Pediatric formulations for HIV/AIDS 4. Products for management of STIs 5. Reagents for laboratory 6. Diagnostics for HIV/AIDs

53 Review of the Ugandan Health Sector HIV/AIDS Response - Key informant interview for Stores STRUCTURE OF THE STORE Yes =1; No=0 1. What is the year of creation of the store? 2. Is it backed by legislation? 3. What is the structure Autonomous Semi-autonomous Private for profit Private not for profit Others (specify)

4. What are the core functions of your stores? Yes =1; No=0 Selection Quantification 4Procurement Warehousing Distribution Managing Others, please specify

5. Does the store have the following structure Yes =1; No=0 Board of Directors Management Committee Financial autonomy Separate bank account

4 Procurement is tendering, ordering, purchasing

54 Review of the Ugandan Health Sector HIV/AIDS Response - Key informant interview for Stores

g y s g g n n n r r n

6. Which of the following functions for n n o o o i e e i i i i i s v t t t r s h i u t c a e u l each of the categories of products does a o e c e d b h O l i i h n c f e r D i e r t

the store carry out? e t r S s u n T i a P a D u Yes = 1; No = 0 W Q

ARVs Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

55 7. Which of the following are served by the store? Yes =1; No=0

Public health facilities

Private sector

Faith based organization

Non governmemntal organization

Others (specify) 8. Does the store have branches? 9. If yes, how many? 10. Who are they meant to serve? Yes = 1; No = 0 Regions Districts Facilities Others specify 11. Is there policy/legislation which requires that all public health facilities to procure medical products from the national stores?

SELECTION OF PRODUCTS

12. Are the following documents available at Yes = 1; No = 0 Date of last Review the STORE? If yes, specify the dates on which they were last reviewed Essential medicines list

Uganda Clinical Guidelines

National ART guidelines

Guidelines for Treatment of opportunistic infections

Guidelines for the management of STIs

Guidelines for medical supplies and diagnostics

Others (specify)

Yes = 1; No = 0 13. Are procurements at the STORE limited to the EML 14. If no, rank in order of importance the main reasons why you may Ranking of procure out of the EML? priority (#1 is the most important) Limiting procurement to the EML is not defined in the National Medicines Policy The last version of the EML is not available The EML has not been revised and does not conform with recent HIV/AIDS guidelines The EML does not address local needs or demands The prescribers are not familiar with the UCG The prescribers do not agree with the UCG The need to procure medicines for emerging diseases Others (Please specify)

QUANTIFICATION/FORECASTING 15. Which of the following information is ARVs Paeidatric OIs Reagents Diagnositics used in need quantification for medicines and ARVs for blood for other medical supplies? Yes = 1; No = 0 stafety HIV/AIDS Available finances Prices Consolidated forecasts data from lower levels Consolidating distribution data (issue data at each level) Disease prevalence/morbidity Consumption Donations provided by partners/donors Seasonal and regional variations Standard Treatment Guidelines (UCG) Stock on hand at all levels Stock on hand at central level Stock on order Stock out duration Shelf life of stock on hand Losses and adjustments Others (please specify)

16. Are any tools used in the quantification of medicines and medical supplies? (Quantimed, Esther software, management software, support manual etc…..) Yes/No 17. If yes, indicate in the table what specific tool is used for each category of product Product Category Tools Used Developed/supplied by ARVs for adults Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

18. Over what time period are needs for medicines and medical supplies quantified? Yes=1; No = 0 Quantification Period Yearly Every 2 years Every 3 years Others (specify) ARVs for adults Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

19. How often are quantfications reviewed? Yes=1; No = 0 Quantification Period Every 3 Every 6 Every 12 Others (specify) months months months ARVs for adults Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

Yes = 1; No = 0 20. Is there a procurement plan? 21. If yes, provide a copy (Provided = 1; Not provided = 0) 22. How many years does the plan cover? 23. Is there a committee responsible for the development of the procurement plan? 24. If yes, provide the list of members. (Provided = 1; Not provided = 0) 25. Does the procurement plan include medicines and supplies financed by partners? 26. If yes, is there a mechanism in place to coordinate procurement among the various partners? 27. If yes, briefly state the mechanism

PROCUREMENT

Yes=1; No=0 28. Does the store have a procurement unit 29. Indicate the percentage of each type of procurement method used in the past year for each type of product. ARVs Paeidatric OIs Reagents for Diagnositics ARVs blood stafety for HIV/AIDS International competitive tendering Restricted tendering (suppliers pre-selected) Negotiated tender Local competitive tendering Direct procurement Others (specify)

30. What is the average lead time for each of the following procurement method? Procurement Methods Average time in days from the publication of tender to signing a contract with the supplier International competitive tendering Local competitive tendering Negotiated tender Restricted tendering (suppliers pre-selected) Direct procurement Others (specify) 31. Does the store have a written procedure (SOP) for call of tender specific for the procurement of medicine and medical supplies? Yes/No 32. Is there pre-qualification of suppliers by the STORE? Yes/No 33. If Yes, provide the written procedure for pre-qualification of suppliers. Provided = 1; Not provided = 0

34. Which of the following Incoterms are used for contracting procurement? Yes = 1; No =0 ARVs Paeidatric OIs Reagents for Diagnositics for ARVs blood stafety HIV/AIDS FOB (Free On Board) CIF (Cost Insurance and Freight) C&F (Cost and Freight) CPT (Carriage pre-paid to) DDU (Delivered Duty Unpaid) DDP (Delivered Duty Paid) Others, please specify

35. Arrange in the order of priority the criteria considered in awarding contracts? (#1 being the most important) Criteria for award of contract ARVs Paeidatric OIs Reagents for Diagnositics for ARVs blood stafety HIV/AIDS Quality of product Performance of supplier Price Stated delivery time (lead time) National preference Supplier terms of payment Others, please specify

Tender details Yes =1; No=0 36. Is there a technical committee to analyse tenders? 37. Is the award of tender done by a committee/board ? 38. If yes, which of these? Award body National Tenders Board Ministerial Tenders Board? STORE/entity Tenders Board Others (please specify) 39. Are the results of the tender published?(websites, notice boards, etc)

Pricing information Yes =1; No=0 40. Are the procurement prices compared to standard reference prices? 41. If yes, which standards? MSH MSF price list National price list Others (specify)

42. How often are procurements Once a Twice a Every 2 years Others (specify) made for each of the products? year year Yes = 1; No=0 ARVs Medicines for OIs Pediatric ARVs Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

43. State in US$ the contract awarded in the previous year for each category of product at the various suppliers mentioned in the table below. Sources of Procurement Category of Products Internationa International Local Local Others l supplier manufacturer Distributor Manufacturer Specify US$ US$ US$ US$ US$ ARVs Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

ORDERING 44. What is the frequency of ARV Paeidatric OIs Reagents for Diagnositics ordering at the stores? Yes = s ARVs blood stafety for 1; No = 0 HIV/AIDS Quarterly Semi-annually Annually According to the needs Others, to specify

45. What is the average lead time for deliveries by suppliers # of days through the following routes? By air Nakawa Malaba Other point of delivery (specify) 46. How far is the store (in km) from the following? # of Kms By air Nakawa Malaba Other point of delivery (specify) 47. What is the average time it takes to remove products # of days from the following to the STORE? By air Nakawa Malaba Other point of delivery (specify) 48. Which are the major problems encountered during the customs clearance of products from: Inland ports

The air port

The border

Yes = 1; No = 0 49. Is the performance of the supplier monitored? 50. If yes, provide a copy of the supplier monitoring form. (Provided = 1; Not provided = 0) 51. If yes, which of these performance indicators are evaluated? Products delivered conform to the order Respect of agreed delivery time schedule Respect of storage conditions Others, please specify

52. What was the volume of medicines and medical supplies imported in 2009 for the store? Number of 40 feet Number of 20 feet Volume in m3 for Volume in m3 by Others, specify containers containers the maritime or airfreight surface shipping

STORAGE/ STOCK MANAGEMENT 53. What is the storage capacity in cubic meters at the store? Other stock managment infromation Yes =1; No=0 54. Is there adequate storage capacity for forecasted quantities of medicines and medical supplies? Yes =1; No=0 55. Are there clearly defined and separated areas in the store for the following: Storage area Reception of products Quarantine of products Storage of flammable and highly corrosive products Product requiring cold chain <8°C Main storage Products returned from customers Expired/damaged products Delivery/dispatch of products Products from various partners(programs) Others, specify 56. Which of the following stock management techniques Adult Paediatric OIs Reagents for Diagnostics are used in the store? Yes = 1; No = 0 ARVs ARVs laboratory for HIV/AIDS Stock cards are available Partner specific stock management tools exist for products financed by the partners (if so, name the partner and attach a copy) The distribution of products is done on basis of “first expired, first out” A system for traceability of batches is in place Minimum stock level (threshold of alarm) is defined Maximum stock levels are defined Replenishment of stock respects minimum stock levels Replenishment of stock is based on another method, specify

57. At what intervals are inventory controls/physical counts carried out? Frequency per year Adult ARVs Paediatric OIs STI Reagents for Diagnostics for ARVs products blood stafety HIV/AIDS Once

Twice

Thrice

Four times

Others, specify

58. At what intervals are audits carried out? Frequency per year Adult ARVs Paeidatric OIs STI Reagents for Diagnositics for ARVs products blood stafety HIV/AIDS Once

Twice

Thrice

Four times

Others, specify

59. Indicate and rank the causes of stock out in the store from the following:

Causes of stock out Yes =1; No=0 Ranking of priority No 1 is the most important Delay in delivery

Quantities delivered not in conformity with quantities ordered

Transport means not available

Funds not available for the order Stock cards are not up to date Minimum and maximum stock levels not regularly updated

Error in forecast

No stock control

Insufficient staff

Limited storage space

Unqualified staff

Others, specify

Yes=1; No=0 Order of priority 60. What are the causes of exiry at the stores No 1 is the most important Non respect of the rule “first expired, first out” Error in the forecast Indequate stock control Donations with short shelf-life None compliance to the clinical guidelines by prescribers Modification of the clinical guidelines in the course of the financial year Failure to execute a distribution plan Unqualified staff Others, specify

Donation information Yes = 1; No = 0 61. Are there published drug donation guidelines? 62. Are donations limited to the EML? 63. Does the store manage donations from partners? 64. If yes name the partners and the ARVs Paeidatric OIs STI Reagents for Diagnositics products managed? ARVs products blood stafety for HIV/AIDS Yes = 1; No = 0

DISTRIBUTION Distribution details ARVs Paeidatric OIs STIs Reagents Diagnositics ARVs for blood for stafety HIV/AIDS 65. Is there a distribution schedule? Yes=1; No=0 66. Provide the copy? Copy seen = 1; Not seen = 0 67. Are there orders from facilities Yes=1; No=0 68. Provide the copy? Copy seen = 1; Not seen = 0 69. What are the main methods of distribution Yes=1; No = 0 On the basis of a schedule for distribution Distribute according to the orders received The customers collect the products by their own means The store distributes products to customers Others, specify

70. What is the frequency of distribution? Upon request Weekly Monthly Every 2 months Quarterly Others, specify

Distribution details Yes = 1; No = 0 71. Is transportation managed by a private company? 72. Is the level of performance satisfactory 73. Why?

74. If the store distributes, what is the number, the type and the capacity of the vehicles available for distribution? Type of vehicle Number of vehicles Capacity of the vehicle in m3

75. Does the store have adequate number of vehicles to pick up and distribute medicines and medical supplies? 76. Arrange in order of priority the main problems encountered during the delivery/pick up of medicines and medical supplies? Problems encountered Yes=1; No=0 Order of priority No 1 is the most important Lack vehicle Poor condition vehicles High cost of transport No driver Poor road network Dangerous road network Long distance to cover Climatic problems Others, specify

Distribution details Yes = 1; No = 0 77. Is there a specific distribution system for products financed by partners? 78. If yes, which of the following categories of products have a specific system of distribution? ARVs Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs QUALITY ASSURANCE SYSTEM 79. Which of the following criteria are used to assure the quality of Yes = 1; No = 0 medical supplies procured? Products registered in the country (National Drug Authority standards) Products from pre-selected suppliers Products pre-qualified by WHO Products qualified by United States FDA Products registered in a country with high pharmaceutical regulation (ICP/ICH Others (specify)

80. Among the following products bought in 2009, to which quality standards did they conform? Tracer products Quality standards (NDRA, WHO prequalified, FDA etc..) Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Stavudine 1mg/ml Zidovudine/Lamivudine 300mg/150mg Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Acyclovir 200mg Condoms

Quality control information Yes = 1; No = 0 81. Are samples of each batch procured systematically taken for quality control analysis? 82. Which structure is used for the quality control of products procured? The quality control laboratory of the store The national quality control laboratory Sub-regional quality control laboratory An external laboratory

83. Which of the following applies to the QC laboratory used for Yes = 1; No = 0 quality control of products? Pre-qualified by WHO? Accredited in accordance with the ISO17025 or EN45002? Accepted by a Regulatory Authority ICP/ICH

Yes = 1; No = 0 84. Has a pharmaceutical inspection been performed at the STORE within the 3 last years? 85. If yes, specify the year 86. What are the strengths and weaknesses of the Store 3 strengths 3 weaknesses

87. Does the store have written procedures for Yes = 1; No = 0 Copy seen the following processes? Yes = 1; No = 0 Selection of the products Quantification of needs Placing of orders Reception Storage Stock management Inventory control Destruction of expired/damaged products Returned products Redistribution of products overstocked Distribution Order picking Dispatch Quality assurance Financial management Monitoring and evaluation/supervision Recruitment of personnel Others, specify

RATIONAL USE 88. What pharmaceutical information sources are available at the stores? Information Sources Yes = 1; No = 0 Is it the current edition Yes = 1; No = 0 British National Formulary Local National formulary Donation Guidelines Essential Medicines List Internet Manufacturers information Martindale National Formulary UCG Others, specify

FINANCING 89. Please state the various sources of financing available to the STORE for the procurement of each category of the following products? Give expenditures in 2009, the budget for 2010 and the type of financing: Sources of Funds 2009 2010 % budget Type of financing Category of Products (Government, Expenditure Budget 2010 (Drug revolving Fund, Loan, Grant, subsidy…) Global Fund, US$ US$ MSF…) ARVs OIs Paediatric ARVs Products for management of STIs Reagents for laboratory HIV test kits

90. Indicate in the table below if available funding for each category of products is Adequate funds adequate for procurement of forecasted quantities? Yes = 1 No = 0 ARVs Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs 91. If inadequate why? Yes = 1 No = 0 Insufficient government allocations for procurement of medical supplies Delay in the release of government budget Inadequate funding from partners Delay in the release of funds from partners Inadequate capital for the STORE Lack of funds allocation for distribution of the products Others, specify

Yes = 1; No = 0 92. Is there budgetary allocations for medical supplies distribution and stock management in the budget allocated for the procurement of medical products? 93. If yes, what percentage of the medical products budget? 94. Do partners allocate funds for the activities listed below? 95. If yes, indicate the partner and the percentage allocated for each activity Names of Partners (UNDP, WB, MSF, PEPFAR etc) Name: Name Name Name Name Name

Yes/No % Yes/No % Yes/No % Yes/No % Yes/N % Yes/No % o Warehousing/storage Medical supplies distribution (vehicle…) Remuneration for warehousing staff Overheads charges Staff training Supervision Others, specify

96. What is the percentage of administration fee added to each category of % Administration fee products? ARVs Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs

97. Which of the following terms of payment is required of customers to Yes = 1; No = 0 the STORE? Type of payment Prepayment Payment on delivery date of products 30 days after delivery Immediate cash payment Others, specify

98. Where are the Revenues generated from sales of medical products deposited? Yes = 1; No = 0 Private bank account of STORE Public Treasury account Others, specify

99. How are the generated revenue spent Yes = 1; No = 0 % Revenue Procurement of medical supplies Staff salary Running cost Others, please specify

Yes = 1; No = 0 100. Is the revenue allocated for stock replenishment always available? 101. If not for what reaasons?

INFORMATION MANAGEMENT Yes =1; No = 0 102. Is the information used for the quantification of the needs available through a management information system for medical supplies 103. If not, which procedure is used to obtain and validate the data necessary for quantification 104. What information monitored regularly at the STORE? Yes =1; No=0 Quantities received Average monthly consumption Expired medicines Stock on hand Expiry dates Purchase orders Others, specify 105. Are there reports available on medical supplies management information systems? 106. To who is the report submitted Head of facility Region STORE 107. What percentage of the report was submitted on time in 2009? 108. Are the following processes managed with the assistance of a data-processing software? Process Yes =1; No=0 If yes, specify the name of the software Quantification Purchase (Call for tender) Ordering Stock management Distribution Financial management Others, specify 109. Is there a specific management information system for the products financed by partners? 110. If yes, how many are there?

MONITORING AND EVALUATION Yes = 1; No = 0 111. Does the stores carry out supervision of its customers? 112. If yes, at what frequency? 113. Which of the following activities are carried out during supervision visits? Review of need quantification Review of ordering process Checking the conditions of storage Physical inventory Checking stock cards and reports Monitoring financial Need assessment to improve performance Training Others, specify

114. Is the schedule for supervision respected? 115. Is there a separate system of supervision for products financed by partners? 116. If yes, how many systems are there? 117. Which performance indicators are regularly evaluated at the STORE? Rate of stock out No of stock out days % expiry % incomplete delivery % late delivery % products not in conformity 118. Are there specific indicators and tools for monitoring and evaluation of the procurement system for products supported by partners? 119. If yes, produce copies (copies attached = 1; copies not attached = 0)

HUMAN RESOURCES 120. State the number per category of professionals involved in procurement and supply management of medical supplies at the store and specify the adequacy of their number Professional category Number Adequate Initial PSM training Continuous PSM training conducted conducted Yes = 1; No = 0 Yes = 1; No = 0 Yes = 1; No = 0 Pharmacist Pharmacy technician Medical doctor Supply chain specialist Procurement specialist Medical assistant Nurse Computer specialist Administrative officer Other, specify STORE OUTCOME FORM

Sector (public, private)

Facility type (National referral, RRH, District Hospital, Hospital, Health centre, clinic)

Name of facility

Name of region

Name of district

Qualification of the person in charge of the pharmacy unit

List of persons interviewed :

Date of interview Cadre of interviewee Tel :

List of assessors:

Surname/First name Structure/Function Tel : Comments Email :

Note: The assessment of medicines procurement and supply management system will be on the following category of products: . ARVs (adult and paediatrics) . Medicines for opportunistic infections . Medicines for STIs . Laboratory reagents and test kits Indicators for monitoring medical products 8. % key HIV, STD and OI medicines and laboratory reagents and test kits available

9. % laboratory reagent and test kits; and medicines for HIV, STD and OI expired

10. Procurement /acquisition cost of key HIV, STD and OI medicines; and laboratory reagents and test kits

11. Average stock-out duration of key products in the past 3 years

12. Proportion of facilities keeping adequate records

13. Proportion of facilities with adequate conservation conditions

14. % of facilities with current EML Survey form 1: Warehouse

Indicator: availability of key products

In stock Expired medicines Key products (ARVs, OIs, STIs) Yes=1, No=0 Yes=1, No=0 [A] [B] [C] 1. Efavirenz 600mg

2. Lopinavir/Ritonavir 200mg/50mg

3. Nevirapine 200mg

4. Zidovudine/Lamivudine 300mg/150mg

5. Lamivudine 1mg/ml

6. Nevirapine 10mg/ml

7. Stavudine 1mg/ml

8. Cotrimoxazole 400mg/80mg

9. Fluconazole 200mg

10. Doxycycline 100mg

11. Metronidazole 400mg

12. Ciprofloxacon 500mg

13. Benzathine penicillin 2.4 Mega Units

14. Acyclovir 200mg

Total Percentage Survey form 2a: Warehouse

Indicator: Procurement /Acquisition cost of tracer products [1] Key medicines (ARVs, Product Brand or Manufacture Pack Acquisitio Unit OIs, STIs) Type/ origin generic r size n price of acquisitio product one n cost name(s) pack ( 4 digits) local local currency currency [A] [B] [C] [D] [E] [F] [G] =[F]÷[E] Efavirenz 600mg Stocrin/Sustiva Lowest priced generic Lopinavir/Ritonavir Alluvia/Kaletra 200mg/50mg Lowest priced generic

Nevirapine 200mg Viramune Lowest priced generic Stavudine 1mg/ml Zerit Lowest priced generic Lamivudine 1mg/ml Epivir Lowest priced generic Nevirapine 10mg/ml Viramune Lowest priced generic Zidovudine/Lamivudine Combivir 300mg/150mg Lowest priced generic

Cotrimoxazole Septrin 400mg/80mg Lowest priced generic

Fluconazole 200mg Diflucan Lowest priced generic Doxycycline 100mg Innovator Brand Metronidazole 400mg Lowest priced generic Cipro Ciprofloxacon 500mg Lowest priced generic Innovator Brand Benzathine penicillin 2.4 Lowest priced generic Mega Units Innovator Brand Acyclovir 200mg Lowest priced generic Survey form 2b: Warehouse

Indicator: Procurement /Acquisition cost of key medicines [1] Key medicines (ARVs, Product Brand or Manufacture Pack Acquisitio Unit OIs, STIs) Type/ origin generic r size n price of acquisitio product one n cost name(s) pack ( 4 digits) local local currency currency [A] [B] [C] [D] [E] [F] [G] =[F]÷[E] CD4/CD8 reagent Innovator Brand Lowest priced generic Dry blood spot Kit Innovator Brand Lowest priced generic VDRL/TPHL Innovator Brand Lowest priced generic Unigold HIV test kit Innovator Brand Lowest priced generic Stat Pack HIV test kit Innovator Brand Lowest priced generic Determine HIV test kit Innovator Brand Lowest priced generic Chlorine releasing Innovator Brand agent Lowest priced generic Survey form 3: Warehouse

Estimate percentage of products that expired in the store in the previous year Name of products that Dosage form Strength Pack size Qty procured in Qty expired in % of procured that expired in the store in 2009 2009 2009 expired Survey form 4a: Warehouse 2007-08

Indicators: Average stock-out duration Adequate record keeping

Records cover Only collect data for medicines with records covering at least 6 at least 6 months within the past 12 months months within Key medicines (ARVs, OIs, STIs) Number Number of days Equivalent number the past 12 of days covered by the of days of stock months out of review (from 180 to out per year Yes=1, No=0 stock 365 days) [E] = C x 365 ÷ D [A] [B] [C] [D] [E] Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Zidovudine/Lamivudine 300mg/150mg Lamivudine 1mg/ml Nevirapine 10mg/ml Stavudine 1mg/ml Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Acyclovir 200mg CD4/CD8 reagent Chlorine releasing agent Dry Blood Spot Kit Determine HIV test kit Stat Pack HIV test kit Unigold HIV test kit VDRL/TPHL Total Percentage/Average Survey form 4b: Warehouse 2008-09 Indicators: Average stockout duration Adequate record keeping

Only collect data for medicines with records covering Records cover at least 6 months within the past 12 - 24 months at least 6 months within Number of Number of days Equivalent number Key medicines (ARVs, OIs, STIs) the past 12 - 24 days out of covered by the of days of stock months stock review (from out per year Yes=1, No=0 180 to 365 [E] = C x 365 ÷ D days) [A] [B] [C] [D] [E] Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Zidovudine/Lamivudine 300mg/150mg Lamivudine 1mg/ml Nevirapine 10mg/ml Stavudine 1mg/ml Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Acyclovir 200mg CD4/CD8 reagent Chlorine releasing agent Dry Blood Spot (DBS) Kit Determine HIV test kit Stat Pack HIV test kit Unigold HIV test kit VDRL/TPHL Total Percentage Survey form 4c: Warehouse 2009-10 Indicators: Average stockout duration Adequate record keeping

Records cover Only collect data for medicines with records at least 6 covering at least 6 months within the past 24-36 months within months Key medicines (ARVs, OIs, STIs) Number Number of days Equivalent number the past 24 - 36 of days covered by the of days of stock months out of review (from 180 out per year Yes=1, No=0 stock to 365 days) [E] = C x 365 ÷ D [A] [B] [C] [D] [E] Efavirenz 600mg Lopinavir/Ritonavir 200mg/50mg Nevirapine 200mg Zidovudine/Lamivudine 300mg/150mg Lamivudine 1mg/ml Nevirapine 10mg/ml Stavudine 1mg/ml Cotrimoxazole 400mg/80mg Fluconazole 200mg Doxycycline 100mg Metronidazole 400mg Ciprofloxacon 500mg Benzathine penicillin 2.4 Mega Units Acyclovir 200mg CD4/CD8 reagent Chlorine releasing agent Dry Blood Spot (DBS) Kit Determine HIV test kit Stat Pack HIV test kit Unigold HIV test kit VDRL/TPHL Total Percentage Survey form 5: Warehouse

Indicator: Adequate conservation conditions and handling of medicines at storeroom Checklist * Storeroom Dispensing True=1, False=0 Area/Room True=1, False=0 [A] [B] There is a method in place to control temperature (e.g. air conditioners). There are windows that can be opened or there are air vents. Direct sunlight cannot enter the area (e.g. window panes are painted or there are curtains/blinds to protect against the sun). Area is free from moisture (e.g. leaking ceiling, roof, drains, taps, etc.). There is a cold storage in the facility There is a regularly filled temperature chart for the cold storage Medicines are not stored directly on the floor. Medicines are stored in a systematic way (e.g. alphabetical, pharmacological). Medicines are stored first-expiry-first out (FEFO). There is no evidence of pests in the area. Medicines are not handled with bare hands Total Percentage Survey form 6: STORE

Indicators: Availability of Essential Medicines List (EML)

Essential Medicines List (EML) updated in the last 3 years with Yes=1, No=0 HIVAIDS included [B] National EML

[B1] =At least one current EML is present = KEY INFORMANT INTERVIEW FOR PARTNERS

Name of organisation:

Address:

Tel/Fax/email:

List of persons interviewed: Date Name Designation Product(s) managed Tel : Email :

Name of Research assistants

The mapping of the procurement and supply management system will be on the following category of products: 1. HIV/AIDS medicines 2. Medicines for opportunistic infections 3. Pediatric formulations for HIV/AIDS 4. Products for management of STIs 5. Reagents for laboratory 6. Diagnostics for HIV/AIDs 1. Which of the following categories of products are being supported by this organization in procurement and/or supply management? Please complete the table: Yes= 1 No= Starting Year State type of State type of Category of Products 0 Year foreseen to support (Financial, financial support end technical, others..) (loan, grant, support donation others..) Adult HIV/AIDS medicines Pediatric formulations for HIV/AIDS Medicines for opportunistic infections Products for management of STIs Reagents for the laboratory Diagnostics for HIV/AIDs

1. List in the table below the amount spent in 2009 and budget allocation for 2010 for the procurement of medicines and supplies in each product category. Amount Allocated Suppliers in 2009 Category of Products Spent in Budget for International International Local Local 2009 2010 (USD) supplier manufacturer Distributor Manufactur (USD) ‘000 US$ (2009) US$ (2009) US$ (2009) er ‘000 US$ (2009) HIV/AIDS medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for of STIs Reagents for laboratory Diagnostics for HIV/AIDs

2. Who selects products in each category to be procured? Indicate Yes= 1 No= 0

Category of Products Selected by

Donor Ministry of Health Others specify (ACP) HIV/AIDS medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs 3. Who is responsible for the quantification of needs? Indicate Yes= 1 No= 0

Quantified by Category of Products Donor Ministry of Health (ACP) Stores Others specify HIV/AIDS medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Reagents for laboratory Diagnostics for HIV/AIDs

2. Which of the following criteria is considered for procurement of medicines and other Yes= 1; No= 0 medical supplies: Procurements are limited to products on the EML Procurements are made on the basis of a plan Procurements are made according to needs

3. Do you belong to a working group in the country that coordinates procurement activities? Yes = 1; No = 0 4. If yes, which of the following leads this working group? Yes = 1; No = 0 ACP CDC/PEPFAR USAID/PEFAR UNICEF World Bank WHO UNDP Others (Please specify)

How often does this working group meet? Yes = 1; No = 0 Monthly Quarterly Two times a year Yearly Others (please specify)

5. Are products procured on the basis of a plan? Yes = 1; No = 0 If yes; who makes the procurement plan? Yes= 1; No = 0

ACP Central Medical Store Privately contracted Agent The organization itself Working group Others (Please specify) 6. Which of the following is responsible for the procurement (preparing tender and Yes = 1; No = 0 awarding contract) of products financed by this partner?

ACP

Central Medical Store

Privately contracted Agent

The organization itself

Others (Please specify)

7. Do you as a partner/organization have a specific policy for the procurement of essential medicines and medical supplies? Yes = 1; No = 0

8. If yes, which of the following criteria are considered in procuring products? Yes = 1; No = 0

WHO pre-qualified suppliers and products

Products registered in the country of origin

Products registered in the importing country

Others (Please specify)

Yes = 1; No = 0 9. Who is responsible for making orders for products financed by you as partner? ACP National Medical Store Privately contracted/procurement Agent UNICEF The organization itself Others (Please specify)

10.Is there a supplier monitoring system? Yes = 1; No= 0 If yes, provide copy of the supplier monitoring form (form provided = 1, not provided = 0)

Are samples systematically taken from batches procured and sent for quality analysis?

Yes = 1; No= 0

If yes, to which of the following laboratories are the samples sent?: Yes = 1; No = 0 National Quality Control Laboratory Regional Quality Control Laboratory Laboratory in Donor country Others (Please specify) 11. Has your organization as a partner provided special tools to facilities to manage the Yes = 1; No = 0 following information? Daily dispensing

Delivery/receipt of products

Discrepancy report

Expired products

Inventory Control

Issue Voucher

Requisition form

Stock card

Others (Please specify)

Are products distributed on the basis of a plan? Yes = 1; No = 0 If yes; who makes the distribution plan? Yes = 1; No = 0 ACP National Medical Store Privately contracted Agent The organization itself Working group Others (Please specify)

12. Which of the following structures is responsible for carrying out the actual distribution of Yes = 1; No = 0 products procured by you as a Partner?

ACP

National Medical Store

Privately contracted Agent

The Partner itself

Others (Please specify)

13. Does the procurement plan consider some budget allocation for the following activity Yes = 1; No = 0 areas?

Medicines & medical supplies distribution

Warehousing and storage

Top up salary for staff Staff training for supply chain management

Computerization of inventory control

Quality Control

4. Delivery Points: Indicate for each product category supported by your organization which of the following is the first, second and third points of deliveries of products after procurement? National Medical Stores (NMS) Regional Stores (RS) District Stores (DS) Health facility (HF) Joint medical Stores (JMS) Medical Access Uganda (MAUL) Others (Please specify) First Point of Second Point of Third Point of delivery Category of Products delivery delivery HIV/AIDS medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS Products for management of STIs Reagents for laboratory Diagnostics for HIV/AIDs - KEY INFORMANT INTERVIEW IN HEALTH FACILITIES

Sector (public, private) Facility type (National referral, RRH, District Hospital, Hospital, Health centre, clinic) Name of facility Name of region Name of district Qualification of the person in charge of the pharmacy unit

List of persons interviewed : Date of interview Cadre of interviewee Tel :

List of assessors : Surname/First name Structure/Function Tel : Comments Email :

Note: The assessment of medicines procurement and supply management system will be on the following category of products: . ARVs (adult and paediatrics) . Medicines for opportunistic infections . Medicines for STIs . Laboratory Products STRUCTURE

Question Yes = 1; No = 0 1. How is the pharmacy department organised in your facility? Briefly describe

2. Does the ART clinic have a separate pharmacy unit? 3. If yes, how many managment units for medicines does the pharmacy have (number) 4. Is a committee responsible for managing procurement (selection, quantification, ordering etc) in the facility 5. Is the head of pharmacy a part of this committee 6. Is the Ugandan Essential Medicines List (EML) available at the pharmacy 7. Does the facility have its own EML 8. Are the following clinical guidelines available at the pharmacy? If yes, specify the dates on which they were last reviewed Clinical guidelines Yes = 1; No = Year of publication 0

National Anti-retroviral Therapy clinical guidelines in adults and paediatrics

National Anti-retroviral Therapy clinical guidelines in paediatrics

National Anti-retroviral Therapy clinical guidelines in adults

National treatment protocols for managment of opportunistic infections

National guidelines for management of STIs

Dosing wheels for ARVs

Others (Please specify) Yes = 1; No = 0

ORDERING 9. Who is responsible for the determination of quantities of supplies to order? Product category Staff responsible for quantification Qualification of staff ARVs Medicines for opportunistic infections Products for management of STIs Other essential medicines Laboratory Reagents and test kits

10. Which of the following affects the determination of ARVs OI medicines STI medicines quantities to order? Availability of finances/credit line Consumption data Donations provided by partners/donors Allocation from MOH Allocation from NMS Allocation from partners Others (please specify)

Question Yes=1; No=0 11. Are supplies received in conformity with orders? 12. When you receive allocations, are they always requested? 13. If no, respond to the following: Always Mostly Rarely Never Allocated supplies are useful to the facility Allocated supplies are made in quantities that can be consumed by the facility within the shelf life Allocated supplies are near expiry Others (specify)

14. Over what time period are orders made? Quantification Period HIV/AIDS medicines OI medicines STI medicines Other essential medicine Monthly Every 2 months Every 3 months Every year Others (please specify)

15. How far is the facility (in km) from the following? Distance in Km The national medical stores Private sector medical stores (JMS/MAUL) The regional/district store

16. What is the average time (lead time) it takes to receive products ordered from the higher level Lead time The national medical stores Private sector medical stores (JMS/MAUL) Regional/district Store

Indicators Yes/No 17. Is supplier performance monitored? 18. If yes, produce supplier monitoring form? (Form shown 1; Not shown = 0) 19. If yes, which of these performance indicators are evaluated? Products delivered conform to the order Respect of agreed delivery time schedule Respect of recommended storage conditions during transportation Products supplied have adequate shelf life Others, please specify

1. How are ordered products delivered? Yes = 1; No=0 Delivered by the supplier? Collected by the facility own means?

20. If collected by the facility, what is the number and type of vehicle available at the health facility Type of vehicle Number of vehicle 21. Arrange in order of priority the main problems encountered during the collection/pick up of medicines and medical supplies? Problems encountered Yes = 1; No = 0 Order of priority (No 1 is the most important) Lack of vehicles Indequate structure of available vehicle Vehicle has no driver Poor condition of vehicles Lack of fuel Poor road network Dangerous road network Poor climatic conditions Others, specify

STORAGE/ STOCK MANAGEMENT Yes = 1; No=0 22. Is there adequate storage capacity for storage of supplies? 23. Are there clearly defined and separated areas in the store for the following? Storage of dangerous (inflammable) products Product requiring cold chain <8°C Storage of expired/damaged products Products from various partners Products from various programs Others, specify

24. At what intervals are inventory controls (physical counts) ARVs OI medicines STI medicines carried out? Monthly Every two months Every three months Half yearly Others, specify

25. Indicate and rank the main causes of stock out in the Yes = 1, No= 0 Ranking of priority (No 1 is the pharmacy store from the following: most important) Delay in delivery from suppliers Quantities delivered not in conformity with quantities ordered Transport means not available Funds (credit line) not available for the order Error in forecast inadequate stock control

26. From the following, arrange in order of priority the main Yes = 1; No = 0 Order of priority causes of expiry (No 1 is the most important) Error in the forecast Indequate stock control Donations/supplies with short shelf-life None compliance to the clinical guidelines by prescribers Modification of the clinical guidelines in the course of the year Medicines pushed to the facility Others, specify

DISPENSING Dispensing Yes =1; No =0 27. Is there a partner specific register for recording dispensed medicines 28. If yes, which of the following categories of products have recording systems? ARVs OI medicines STI medicines Other essential medicines

29. Does the pharmacy have written procedures (SOP) for Yes = 1; No = 0 SOP seen the following processes? Yes = 1; No=0 Ordering Receiving Storage Stock management Destruction of expired/damaged products Redistribution of overstocked products Dispensing Others, specify RATIONAL USE 30. What pharmaceutical information sources are available to the pharmacy? Yes = 1; No=0 Internet British National Formulary Donation Guidelines Essential Medicines List National Formulary UCG Others, specify

INFORMATION MANAGEMENT Question Yes = 1; No=0 31. Who do you submit reports to? MOH (ACP) Head of facility Region CMS 34. At what frequency are the reports submitted? Mothly Every 2 months Quarterly Semi annually Annually Others (specify) 35. Was the last scheduled reporting submitted on time? 36. Is there a separate reporting for the products financed by the partners?

MONITORING AND EVALUATION 37. Which performance indicators are regularly evaluated at the pharmacy? Yes = 1; No=0 Stock out rate Number of stock out days % expiry % incomplete delivery % late delivery % products not in conformity with specification in orders 38. Are there tools for monitoring products in the pharmacy from MOH? 39. Are there partner specific tools for monitoring products in the pharmacy? 40. If yes, how many different tools do you have in the pharmacy?

41. What is the frequency of monitoring? (indicate all that apply) Yes = 1; No=0 Mothly Every 2 months Quarterly Semi annually Annually Others (specify)

HUMAN RESOURCES 42. State the number per category of professionals involved in the Number Adequate pharmacy department and specify if the number is adequate Yes = 1; No=0 Pharmacist Pharmacy technician/dispenser Medical doctor Clinical officer/medical assistant Nurse Other, specify below

43. State the number per category of professionals involved in the Qualification Year obtained pharmacy department and specify if the number is adequate Highest pharmacy related qualification of the head of pharmacy Highest pharmacy related qualification of staff (list below)

Question Yes = 1; No=0 44. Is regular continuous training offered to staff involved in dispensing and stock management? 45. If yes, please indicate the number of staff members that went for at least one pharmacy related training in the past year? 46. If yes, please specify the type of training and the number of staff members that attended