HANDBOOK

for Accreditation of Community Action (COPA) Model in Nigeria

HANDBOOK

for Accreditation of Community Pharmacists Action (COPA) Model Pharmacies in Nigeria

CONTRIBUTORS

Howard University Global Initiative Nigeria (HUGIN): 1. Dr. Dorothy Oqua Country Director 2. Pharm Seun Asieba Deputy Project Director 3. Dr. Kenneth A. Agu Associate Director 4. Dr. Onuche Omeh Associate Director 5. Dr. Nnenna Ekechukwu Senior Manager 6. Pharm. Zainab Adeyanju Pharmacy Specialist 7. Pharm. Timothy Ukeje Technical Assistant, Pharmacy 8. Pharm. Afusat Adesina Senior Pharmacy Specialist, Lagos 9. Pharm. Peter Agada Senior Pharmacy Specialist, Cross River State 10. Pharm. Anthony Achanya Senior Pharmacy Specialist, Akwa- Ibom State 11. Pharm. Festus Agu Senior Pharmacy Specialist, Rivers 12. Pharm Reuben Eniolorunda Resident, WAPCP 13. Pharm Maduka Elizabeth Resident, WAPCP

Pharmacists Council of Nigeria 14. Pharm NAE Mohammed Registrar 15. Pharm Thomas Ilupeju Director of Pharmacy Practice 16. Pharm Peter Iliya Deputy Director, Public Relations 17. Pharm Mojisola Aizobu Pharmacy Practice Department 18. Pharm Ibrahim Jatau Pharmacy Practice Department

Association of Community Pharmacists of Nigeria (ACPN) 19. Pharm (Dr.) Albert Kelong Alkali National Chairman 20. Pharm Gbenga Olubowale Former Chairman, Pharmaceutical Society of Nigeria, Lagos State 21. Pharm Sunday Ike Chairman, ACPN FCT, Abuja 22. Pharm Nankap Wuyep National Assistant Secretary 23. Pharm Gafar Madehin Olanrewaju National Treasurer 24. Pharm Iyiola Gbolagade National Secretary, Pharmaceutical Society of Nigeria

DISCLAIMER This is an official publication of Association of Community Pharmacists of Nigeria (ACPN) with technical support from Howard University PACE (HU PACE) Center, Pharmacists Council of Nigeria (PCN) and Pharmaceutical Society of Nigeria (PSN). The development and printing of this publication was supported by Howard University PACE (HU PACE) centre through Sustainable Financing Initiative (SFI) in Strengthening Integrated Delivery of HIV/AIDS Services (SIDHAS) project with funding support from United States Agency for International Development (USAID), Nigeria. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of USAID Nigeria, HU PACE and SIDHAS project.

Table of Contents

Foreword Acknowledgements Acronyms and Abbreviations

CHAPTER 1: Introduction 1.1 Background 1.2 Community Pharmacists Action (COPA) Centre 1.3 Why COPA? 1.4 What is a COPA Centre? 1.5 Who is the COPA initiative for?

CHAPTER 2: COPA Assessment 2.1. Manpower 2.2. Materials and Supplies 2.3. Methodology

CHAPTER 3: Follow up / Monitoring 3.1. Validity 3.2. Monitoring and Evaluation (M&E) 3.3. Re-assessment of Community Pharmacy

REFERENCES ANNEX I: Quality Assessment for Model Pharmacies (COPA Centres) ANNEX II: Quality Assessment for Model Pharmacies - Scoring Sheet ANNEX III: COPA Signage

FOREWORD This Handbook is the culmination of the thoughts of the Association of Community Pharmacists of Nigeria (ACPN) on her branding initiative for achieving continuous quality improvement and quality care standards in community pharmacy practice in Nigeria. The branding initiative which is tagged “Community Pharmacists Action” (COPA) is a continuous quality improvement initiative aimed at promoting best practices in community pharmacy in Nigeria. It is actively promoted by ACPN members and supported by Pharmacists Council of Nigeria (PCN).

The main objectives of COPA are to reposition community pharmacy as a model to influence surrounding pharmacies to brace up to modern and pharmacy best practices as well as serve as a means of improving the standards of pharmacy practice thereby optimizing patient outcomes by ensuring the rational use of . COPA centres are so designated through an accreditation process which has been outlined and discussed thoroughly in this handbook. COPA Centres showcase pharmacy best practices, quality pharmaceutical care service provision including adherence counselling, pharmacovigilance (e.g. fake drug alert etc.), handle drug information collation and dissemination as well as drug distribution (dispensing) with good documentation/reporting system as well as good financial and logistics system along with any other public health services which would benefit the patients and community in general.

The COPA Accreditation process entails inspection, approval, certification and support supervision for maintenance of achieved standards. It is a process in which certification of competence, authority and/or credibility is presented and it is designed to be supportive, consistent and objective. The PCN in keeping with its regulatory mandate of developing and enforcing standards for pharmaceutical premises, personnel and practice is in support of the COPA Accreditation process as a way of encouraging peer review of standards alongside its own regulatory mechanism. I encourage more community pharmacists to subject themselves to the COPA accreditation process as a way of repositioning their practice to achieve global best practices. Thank you.

Pharm N. A. E. Mohammed, FPSN, FNIM, FPCPharm, FNAPharm Registrar, Pharmacists Council of Nigeria (PCN), Nigeria.

ACKNOWLEDGEMENTS The COPA initiative is a quality assurance project that has defiled implementation by several Leaders of the Association of Community Pharmacists of Nigeria (ACPN) over the years till the current collaboration between the ACPN and Howard University Global Initiative Nigeria (HUGIN). This relationship has resulted in the operationalisation of COPA, the formation of a COPA accreditation team and development of this Handbook. With the Community as a major beneficiary of this project, it is therefore expedient to appreciate key stakeholders for all the efforts put in the project especially the development of this COPA Handbook.

The Association of Community Pharmacists of Nigeria (ACPN) acknowledges the uncommon support of Howard University Global Initiative Nigeria’s (HUGIN) team led by the Country Director Dr. Dorothy Oqua, the team members include the Deputy Project Director Pharm. Iyeseun Asieba, Dr. Kenneth Agu and others, the implementers of the Pharmaceutical Services components of the Strengthening Integrated Delivery of HIV/AIDs Services (SIDHAS) project funded by the United States Agency for International Development (USAID) in the operationalization, implementation of Community Pharmacy Action (COPA) and the development of the COPA Handbook.

The Handbook was developed with the combined efforts of staff of Pharmacists Council of Nigeria (PCN), the Leadership of Pharmaceutical Society of Nigeria (PSN) and Association of Community Pharmacists of Nigeria (ACPN) at both the National and State level particularly the National President of the PSN, Pharm. Ahmed Yakassi FPSN, FNIM; and all PSN & ACPN state Chairmen, coordinated by the HUGIN team. The Registrar of Pharmacists Council of Nigeria Pharm. N.E. Mohammed FPSN, FNIM for releasing the PCN staff for the programme. All the Directors of Pharmaceutical Services in Lagos, Cross Rivers, Rivers and Akwa Ibom States for their support.

Also, I will like to appreciate the National Agency for Food, Drug Administration and Control (NAFDAC) for their solidarity to the COPA initiative.

Finally, I wish to appreciate the first sets of COPA accredited Pharmacies for their willingness to improve their standard of practice by way of voluntary application for accreditation by the COPA Assessment Team. It is our strong believe that this Handbook will guide more Community Pharmacists to apply for COPA accreditation of their Pharmacies with the resultant improvement of Pharmaceutical Service delivery by Community Pharmacists in Nigeria.

Dr. Alkali Albert Kelong FPCPHARM National Chairman

Acronyms and Abbreviations

ACPN Association of Community Pharmacists of Nigeria CP Community Pharmacist COPA Community Pharmacists Action Centre DPS Director of Pharmaceutical Services FIP International Pharmaceutical Federation GPP Good Pharmacy Practice HUGIN Howard University Global Initiative Nigeria HU PACE Howard University Pharmaceutical Care And Continuing Education M&E Monitoring and Evaluation PCN Pharmacists Council of Nigeria PSN Pharmaceutical Society of Nigeria ROI Return on Investment SFI Sustainable Financing Initiative USAID United States Agency for International Development WHO World Health Organization

CHAPTER ONE: INTRODUCTION

1.1 Background The health of the public is central to the happiness and welfare of all people. Barriers to good health include poor access to quality medical products, lack of access to trained health professionals and care, an inadequate health workforce, unaffordable cost of care and poor standards of education of health-care professionals (FIP/WHO, 2011). Medicines are an essential part of health-care services in all cultures and societies. Substandard, adulterated, unlicensed and spurious/falsely-labelled/falsified/counterfeit medicines are a growing problem that compromise health. Quality assurance system for supply chain is critical for the prevention of disease and the treatment of patients. This includes system for the detection of spurious/falsely-labelled/falsified/counterfeit medicines, ensuring proper storage, quality preparation of medicines, proper prescribing of medicines, instructions for use are clear, medicine–medicine and medicine–food interactions are prevented; known and predictable adverse medicine reactions, including allergies and other contraindications, are avoided; unnecessary treatments are minimized and the cost of medicines is considered (FIP/WHO, 2011).

Community Pharmacists are frontline health-care professionals and primary health care providers charged with the management of the distribution of medicines to consumers, contribute to health improvement and to engage in appropriate efforts to assure safe and efficacious use of these medicines. Their professional responsibilities and accountabilities include seeking to ensure that people derive maximum therapeutic benefit from their treatments with medicines. Promoting excellence in community pharmacy practice setting for the benefit of those served involves: • being readily available to patients with or without an appointment; • identifying and managing or triaging health-related problems; • health promotion; • assuring effectiveness of medicines; • preventing harm from medicines; and • making responsible use of limited health-care resources.

Good Pharmacy Practice (GPP) is the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal, evidence-based care (FIP/WHO, 2011). GPP requires that a pharmacist's first concern in all settings is the welfare of patients and that the core of the pharmacy activity is to help patients make the best use of medicines which should be clearly defined and effectively communicated to all those involved. Additionally, an integral part of the pharmacist's contribution is the promotion of rational and economic prescribing, as well as dispensing. The relationship between pharmacists should be one of colleagues seeking to improve pharmacy service, rather than acting as competitors. Pharmacists in community practice setting should accept personal responsibility for maintaining and assessing their own competence throughout their professional working lives through self- monitoring. However, an element of assessment and monitoring by the national pharmacy professional organizations would also be relevant in ensuring that pharmacists maintain standards and comply with requirements for continuous professional development. To support good pharmacy practice, it is essential that there be an established national framework of quality standards and guidelines.

When considering a patient-oriented approach, quality of pharmacy services represents optimum patient care to meet patient’s needs. Hence, structures and processes are necessary to measure the patient care provided and, subsequently, measure quality. These structures and processes are presented in Quality Care Standards. These standards can confirm the effectiveness of the pharmacist intervention in patient care, present a process that will assist the pharmacy profession to gain confidence in the services it provides, and demonstrate the good standard professional services provided by community pharmacists. Any process where there is no form of quality assessment may constitute a threat to society and to the profession. Quality Care Standards present processes which monitor professional pharmacy services.

1.2 Community Pharmacists Action (COPA) Centre COPA is an ACPN’s branding initiative actively promoted for her members and is accepted by Pharmacists Council of Nigeria (PCN) for achieving continuous quality improvement and quality care standards in community pharmacy practice in Nigeria. It is a continuous quality improvement initiative aimed at promoting best practices in community pharmacy in Nigeria. Quality Care Standards in Community Pharmacy was developed by a working group commissioned by the International Pharmaceutical Federation, FIP (FIP, 2005). The FIP’s Quality Care Standards in Community Pharmacy and the FIP Good Pharmacy Practice document served as the basis for the COPA Model Pharmacy for Nigeria. COPA was developed in collaboration with key pharmacy stakeholders – Pharmacists Council of Nigeria (PCN), Pharmaceutical Society of Nigeria (PSN), and Association of Community Pharmacists of Nigeria (ACPN), Community Pharmacists and service users.

COPA implementation is based on a step-by-step process of quality improvement. The elements of COPA are divided into three stages of a Quality Care Standards programme (COPA I, COPA II, and COPA III). These represent the three tiers of accreditation for COPA (in order of increasing performance standards achieved by the Community Pharmacy). Accreditation is a process of inspection, approval, certification and supportive supervision for maintenance of the COPA status.

1.3 Why COPA? The COPA centre initiative is designed to reposition community pharmacy as a model to influence surrounding pharmacies to brace up to modern and pharmacy best practices. It is a means of improving the standards of pharmacy practice thereby optimizing patient outcomes by ensuring the rational use of medicines in Nigeria. COPA centres will strive to promote professional excellence and high-quality operations in community pharmacies. Similar accreditation is already being implemented by other professional bodies. The benefits of accreditation and branding for Community Pharmacy are: • Professional gains – Stands the Community Pharmacy out as a provider of unique package of pharmaceutical care and public health services in the community – Professional recognition by clients, colleagues, regulators etc. – Serve as a Model Community Pharmacy for aspiration by other community pharmacies – Aligns pharmacy practice in Nigeria with global best practices – Motivates Community Pharmacists for practice excellence – Improved practice image attracts funding from local and international donors • Business/financial gains – Increased clientele – Indirectly increases Return on Investment (ROI) through Loyalty • Community gains – Increased respect, confidence and greater demand for professional services by community members

1.4 What is a COPA Centre? A COPA Centre represents a Community Pharmacy which serves as centre for: ✓ pharmacy best practices ✓ quality pharmaceutical care service provision including medication adherence counselling, pharmacovigilance including fake drug alert ✓ drug information collation and dissemination, ✓ quality drug distribution (dispensing), ✓ good documentation and reporting system ✓ good financial and logistics system and ✓ any other public health services which would benefit the patients and community.

1.5 Who is the COPA initiative for? This initiative is open to any licensed Community Pharmacist in Nigeria desiring to improve the quality standards of pharmaceutical care services provided to his/her clients for improved health outcomes and better satisfaction of both the clients and providers. Achieving a COPA status is not mandatory but can be used to plan and deliver best possible care and services. This initiative supports the government's vision for a healthcare system focused on delivering the best possible health outcomes. CHAPTER TWO: COPA ASSESSMENT

2.1. Manpower The coordinating institution for COPA assessment is the Pharmacists Council of Nigeria (PCN). The assessment team consists of the representatives of: ✓ Association of Community Pharmacists of Nigeria (ACPN) in the state, ✓ Pharmacists Council of Nigeria (PCN) in the state. ✓ Pharmaceutical Society of Nigeria (PSN) in the state, ✓ Supporting Implementing partner, Howard University Global Initiative Nigeria (HUGIN), where available. ✓ State Director of Pharmaceutical Services (DPS) and ✓ the applicable superintendent pharmacist. The quorum of the assessment team should be 3 team members from ACPN, DPS, PSN, PCN, HUGIN in addition to the superintendent pharmacist of the Community Pharmacy planned to be assessed.

2.2. Materials and Supplies The materials and supplies needed for this assessment include: ✓ Copies of the COPA Assessment Checklist – a tool developed collaboratively by PCN, PSN, ACPN, and HUGIN. The checklist has 3 different sections for the three tiers of accreditation (COPA I, COPA II, and COPA III). This checklist describes the specific requirements for community pharmacies under various areas of interest and domains for improving the standards of pharmacy practice in Nigeria with the necessary documentation and reporting systems. ✓ Assessment Summary template ✓ Pen ✓ Notebook or notepad ✓ Accreditation Certificate by PCN ✓ COPA signage which will be hung under the existing Neon Sign – Pharmacy Emblem (ACPN produces the signage). Currently, there are no special equipment or technology required for this assessment and accreditation.

2.3. Methodology • Requirements from Community Pharmacy: ✓ All PCN licenses remain valid and COPA accreditation will by no means undermine the statutory PCN licenses for the premises or pharmacist. ✓ PCN valid registration and licensure is a pre-requisite for assessment for a COPA Centre. ✓ The Community Pharmacy must be 2 years’ post PCN registration and operation in the community to qualify for assessment for a COPA Centre. ✓ COPA assessment is done in a supportive and non-judgmental manner, should be a partnership for quality improvement and not an audit exercise. ✓ COPA accreditation is entirely voluntary and the process is commenced at the request of the Community Pharmacist. • the community pharmacist will request for accreditation from the coordinating institution, the PCN. ✓ On request by the community pharmacist, the Superintendent pharmacist will be given the COPA Assessment checklist for the COPA branding for familiarization and preparation. ✓ Cost of accreditation will be solely borne by the Community Pharmacist requesting for this quality improvement process.

• Assessment Team ✓ The quorum for an assessment is three (3) team members in addition to the superintendent pharmacist. ✓ A minimum of three (3) assessors (excluding the superintendent pharmacist) are required for a COPA assessment. ✓ Each assessor will apply the COPA checklist and the Assessment Summary Template as appropriate. ✓ The overall score for the Community Pharmacy will be the average of the scores by the three assessors. ✓ Once the CP meets the accreditation criteria, a Certificate with the appropriate COPA level will be issued by PCN. Pass mark is 100% for each of the COPA status. ✓ The appropriate COPA signage will be issued by ACPN to be hung under the Neon Sign – Pharmacy Emblem. ✓ Assessment team should see the exercise as a partnership for quality improvement, and not an audit exercise.

CHAPTER THREE: FOLLOW UP / MONITORING

3.4. Validity ✓ The COPA branding is valid for two (2) years only. ✓ It is the sole responsibility of the Superintendent Pharmacist to ensure the maintenance of the COPA status during the validity period, and call for re-assessment thereafter.

3.5. Monitoring and Evaluation (M&E) ✓ During the two (2) years period of validity, a supportive monitoring not initiated by the community pharmacy would be implemented annually by the PCN-led quality assurance monitoring team comprising of the representatives of ACPN and HUGIN for maintenance of COPA status. ▪ Some funds from the initial payment for COPA assessment should be withheld for this purpose. In addition, professional development fund from ACPN can be leveraged on for this activity.

3.3. Re-assessment of Community Pharmacy ✓ Re-assessment for maintenance of COPA status is due after 2 years. ✓ Re-assessment for accreditation after initial failure to attain a COPA status or for improvement of the existing COPA status to higher level will be done at the request of the Community Pharmacist. ✓ All re-assessments are subject to payment of applicable fees prescribed by PCN

REFERENCES International Pharmaceutical Federation (FIP). Quality Care Standards in Community Pharmacy: Report of a Working Group. Community Pharmacy Section, Denmark, September 2005 Available at: https://www.fip.org/files/fip/CPS/Quality%20Care%20Standards%20final.pdf.

Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services. WHO Technical Report Series, No. 961, 2011, Annex 8, 310- 323. Available at: http://apps.who.int/medicinedocs/documents/s18676en/s18676en.pdf ANNEX I: QUALITY ASSESSMENT FOR MODEL PHARMACIES (COPA CENTRES)

COPA stage I (Minimum requirements)

Domains Criteria Yes No Remarks [1] [0] General 1 The certificate of registration is clear, valid and displayed in the Pharmacy 2 The Pharmacy Emblem in its unaltered trademarked form and acquired from ACPN is prominently and appropriately displayed in a manner that is easily visible to the public either before entering the Pharmacy or immediately after entering 3 Relevant information and signs are posted in an area where they can be easily seen by clients 4 The Pharmacy has been in existence in that location for a minimum of two years in the community. Standards for Accreditation 5 The Pharmacy floor area is not less than 30m² (Setting of the pharmacy) 6 The Pharmacy has a separate and distinct office or patient consultation area offering "audiovisual privacy" 7 The Pharmacy layout permits the effective cleaning of all surfaces including the walls, floors and ceilings 8 There is a comfortable waiting area with toilet facilities within or attached to the pharmacy 9 The Pharmacy layout is conducive, clean and customer friendly. 10 The dispensary (area where ethical drugs are stored) is designed and maintained so that it is not accessible to the public 11 The dispensary has an adequate work surface for preparation and dispensing of drugs adequate for the safe and appropriate operation of the Pharmacy 12 The dispensary has facilities for the appropriate cleaning of equipment as well as a separate hand washing facility 13 The dispensary has a refrigerator that is of adequate size and used to store only medicines (no food). 14 All refrigerators that store medicines are maintained at a temperature between 2 and 8 °C with evidence of monitoring. 15 The pharmacy has a computer system that includes a secure backup and recovery system. 16 The pharmacy is well secured against burglary and has a functional fire extinguisher 17 The pharmacy is well ventilated and has alternative source of electricity in case of public power failure. 18 There is a registered Superintendent Pharmacist with valid practicing license in the Pharmacy 19 The Pharmacist is identifiable, and the dress code is in conformity with the ethics of the profession 20 The Pharmacy support staff are identifiable, and the dress code is in conformity with the ethics of the profession 21 There is a poison register in the Pharmacy - available, in use and up to date 22 There are current reference books in the Pharmacy 23 The Pharmacy has processes in place to ensure that dispensing is done under sanitary conditions (no direct contact with medicines dispensed). 24 The Pharmacy has evidence of documentation and quarantine of expired/defective prescription and non-prescription medicines, and chemicals (used for compounding) in a timely manner 25 The Pharmacist takes steps to identify forgeries, loss and theft of controlled medicines and reports such incidences to appropriate authority within 10 days 26 The Pharmacist is responsible for ensuring that all controlled medicines are secured under lock and key to ensure restricted access Professional development 27 There is evidence of participation in continuing professional development Drug Schedules 28 The pharmacist undertakes personal and direct dispensing of all controlled medicines. 29 All controlled medicines are sold from the dispensary, where there is no public access and no opportunity for patient self-selection, after assessment by a Pharmacist. 30 The Superintendent Pharmacist has ensured that other pharmacy personnel are knowledgeable regarding the necessity of pharmacists to consult with patients about controlled medicines (confirm by asking them questions or request for the drugs) 31 Controlled medicines are not visible to the public

Medication Review 32 For all NEW & REFILL prescriptions, the pharmacy has evidence of the pharmacist assessing the appropriateness of therapy such as indication, allergies, medical conditions, prescription history, adherence, use of over the counter/natural health products, and changes to health status. 33 The pharmacist has evidence of red flagging drug therapy problems such as hypersensitivity, adverse drug reactions, drug interactions, drug abuse/ misuse, precautions and contraindications through discussion with the patient and/or prescriber. 34 The pharmacy has a process in place to enable pharmacists to document the communication that occurred between health care professionals and patient. 35 The pharmacy has a process in place to enable pharmacists to document consent when appropriate from the patient or patient’s agent. 36 The pharmacy maintains client’s medical and medication records. 37 There is evidence of clients’ assessments by the pharmacist Standards of Practice 38 The Pharmacy has workflow processes in place to ensure prescription records are authorized at the time of dispensing and prior to release to the patient 39 The Pharmacy has workflow processes in place to ensure dispensing records are stored in such a manner that they are readily retrievable 40 The Pharmacy ensures prescriptions originate from the prescriber and authenticity is established 41 The Pharmacy ensures that all prescriptions dispensed are properly labelled including the trade and generic names, address and telephone number of the Pharmacy 42 The Pharmacy ensures that confidential information of patients is protected 43 The Pharmacy either maintain records in a paper, an electronic format or is moving towards a complete electronic record. All patient records, regardless of form are readily retrievable and maintained appropriately for a period not less than 2 years from the last professional pharmacy service. 44 The Pharmacy has policies and procedures in place that minimize errors, incidents and unsafe practices, including supporting staff in their obligation to report adverse events 45 There is a functional referral systems in place with evidence of documentation 46 There is evidence of reporting of pharmacovigilance activities. 47 There is evidence of procurement in accordance with National Drug Distribution Guidelines 48 There are robust inventory management and control measures in the pharmacy 49 There are separate waste disposal containers for general waste, biological waste, hazardous waste & sharps as applicable. 50 Processes and procedures are in place for disposal for all types of waste are in place. TOTAL SCORE PERCENTAGE SCORE

Assessors Names Assessors Signature 1. 2.

Superintendent Pharmacist Name Superintendent Pharmacist Signature

Date: Remarks:

COPA Stage II (Minimum requirement): To earn stage II rating, the Community Pharmacy must score 100%, in addition to meeting the requirements for COPA stage I rating Domains Criteria 1 The Pharmacy has patients’ information, education and health communication Health promotion materials (leaflets etc.) for distribution to patients. activities 2 There are health promotion advertisements or posters visibly displaced in the Pharmacy (in paper form or electronic) 3 The Pharmacy conducts or participates in health promotion campaigns or outreaches within the community (check for evidence). Diagnostics 4 The Pharmacy provides diagnostic tests e.g. blood pressure monitoring, blood cholesterol testing, blood glucose testing, malaria diagnostic tests, HIV rapid tests, monitoring of peak expiratory flow rate, pregnancy testing, body weight monitoring 5 The Pharmacy ensures proper documentation of diagnostic tests carried out (check for records) Pharmacotherapy 6 There is documented evidence of pharmaceutical care plans developed for Monitoring patients in the Pharmacy 7 Patient monitoring is an integral part of pharmaceutical service provision in the Pharmacy (check for evidence) 8 There is process for identification and documentation of medication-related problems in the Pharmacy. 9 Interaction with prescribers are documented in the Pharmacy Research and development 10 The Pharmacy conducts or participates in research (check for previous publications in peer-reviewed journals, abstract presentations) Audit/ Finance Systems 11 The Pharmacy has standard operating procedures, organograms, schedule of duties for various activities and operations 12 The Pharmacy has a good financial and accounting systems 13 There is evidence of professional indemnity 14 The premises is covered by an insurance policy 15 There is evidence of tax payment to the relevant government agencies TOTAL SCORE PERCENTAGE SCORE

Assessors Names Assessors Signature 1. 2.

Superintendent Pharmacist Name Superintendent Pharmacist Signature

Date: Remarks:

COPA Stage III (Minimum requirement): To earn stage III rating, the Community Pharmacy must score 100%, in addition to meeting the requirements for COPA stage II rating Domains Criteria

Domiciliary services 1 The Pharmacy provides pharmaceutical services to house-bound persons in the community 2 The Pharmacy has standard operating procedures (SOP) for the provision of pharmaceutical services to house-bound persons. On-line services 3 The Pharmacy is equipped with telephone, an active internet connection with an active e-mail address 4 The Pharmacy provides on-line pharmacy services 5 The Pharmacy has a process in place to ensure all prescriptions if sent through the mail are sent only by registered mail or, if delivered by another method, are delivered in a method that is traceable and auditable. 6 The Pharmacy has a process in place to ensure confidentiality of all delivered prescriptions. 7 There is evidence of routine computer system maintenance and update that includes a secure backup and recovery system in the Pharmacy. 8 There is functional website for the Pharmacy

Pre-registration training 9 The Pharmacy accepts and supports the training of pre-registration trainees (intern pharmacist) 10 The Pharmacy maintains the minimum monitoring and documentation requirements for internship training 11 The Pharmacy keeps records of the activity description for trainees (Intern Pharmacists) in the premises. 12 The Pharmacy has proper equipment for compounding that undergoes regular maintenance and calibration Compounding 13 The Pharmacy has a compounding record that includes the name, lot number and expiry date of each active ingredient, the quantity required and weighed, the date of preparation and the expiry date of the compounded product, the authorization of the compounder and/or the pharmacist responsible for the preparation and checking and a reference to the formula used when applicable 14 The Pharmacy ensures that the label for compounded products includes the name and concentration of each of the active ingredients (check for evidence). 15 The Pharmacy ensures that the label for compounded products includes the expiry date and storage instructions of the compound based on available references (check for evidence). Para-pharmaceuticals 16 The Pharmacy stocks medical devices, homeopathic products, and other para- pharmaceutical and non-pharmaceutical items 17 The para-pharmaceuticals are visibly displayed in the Pharmacy 18 There is ready access to information on para-pharmaceuticals in the Pharmacy Customer perceptions 19 The Pharmacy has a process for collection of confidential feedbacks, satisfaction (external audit) or the views of customers on pharmaceutical services provided 20 The Pharmacy has a process for confidential documentation of the expectations of customers from the pharmacist. TOTAL SCORE PERCENTAGE SCORE

Assessors Names Assessors Signature 1. 2.

Superintendent Pharmacist Name Superintendent Pharmacist Signature

Date: Remarks:

ANNEX II: QUALITY ASSESSMENT FOR MODEL PHARMACIES - SCORING SHEET

COPA stage I (Minimum requirements)

Domains Criteria Score Grading S/N

Score 0: If current and valid Certificate of Registration is unavailable The certificate of registration is clear, valid and Score 1: If Certificate of Registration is clear and valid but not

displayed in the Pharmacy displayed in the Pharmacy Score 2: If Certificate of Registration is clear, valid and displayed in 1 the Pharmacy

The Pharmacy Emblem in its unaltered Score 0: If Valid Pharmacy Emblem obtained from ACPN is trademarked form and acquired from ACPN is unavailable prominently and appropriately displayed in a Score 1: If Pharmacy Emblem obtained from ACPN is available but

manner that is easily visible to the public either not conspicuously visible to the public General before entering the Pharmacy or immediately Score 2: If Pharmacy Emblem is available and conspicuously visible 2 after entering to the public

Score 0: If relevant information and signs are unavailable in the Pharmacy Relevant information and signs are posted in an Score 1: If the available information and signs do not provide

area where they can be easily seen by clients appropriate guidance to clients Score 2: If relevant information and signs are available and 3 provides appropriate guidance to clients

Score 0: f the Pharmacy has been in existence in this location for

4 less than two years Score 1: If the Pharmacy has been in existence in this location for The Pharmacy has been in existence in that less than two years but in operation for more than two years in location for a minimum of two years in the another branch and location community. Score 2: If the Pharmacy has been in existence in this location for two years or above

Score 0: If the entire floor area is less than 30 square meters Score 1: If the entire floor area is greater than 30 square meters The Pharmacy floor area is not less than 30m² but the floor area available for pharmacy practice exclusively, is less than 30 square meters Score 2: If the floor area available for pharmacy practice 5 exclusively, is 30 square meter or greater

Score 0: If a separate and distinct office or patient consulting area is unavailable The Pharmacy has a separate and distinct office or Score 1: If the available separate and distinct office or patient patient consultation area offering "audiovisual consulting area does not offer audiovisual privacy privacy" Standards of Score 2: If the available separate and distinct office or patient Operation 6 consulting area offers audiovisual privacy

Score 0: If the pharmacy layout does not permit effective cleaning of any surfaces including the walls, floors and ceilings The Pharmacy layout permits the effective Score 1: If the pharmacy layout does not permit effective cleaning cleaning of all surfaces including the walls, floors of all surfaces including the walls, floors and ceilings and ceilings Score 2: f the pharmacy layout permits effective cleaning of all 7 surfaces including the walls, floors and ceilings

Score 0: If there is neither a comfortable waiting area nor toilet There is a comfortable waiting area with toilet facilities within or attached to the pharmacy

facilities within or attached to the pharmacy Score 1: if only one of the two i.e Comfortable Waiting area or 8 Toilet facilities is within/attached to the Pharmacy Score 2: If both comfortable waiting area and toilet facilities are within or attached to the Pharmacy

Score 0: If the Pharmacy layout is NOT conducive, clean and customer friendly The Pharmacy layout is conducive, clean and Score 1: If the Pharmacy layout has a maximum of two out of the

customer friendly. three attributes been assessed Score 2: If the Pharmacy layout is conducive, clean, and customer 9 friendly

Score 0: If the dispensary is freely accessible to the members of the The dispensary (area where ethical drugs are public stored) is designed and maintained so that it is not Score 1: If members of the public can pick some ethical drugs from accessible to the public an open shelf in the dispensary, without a pharmacist guide 10 Score 2: If ethical drugs are kept under restricted access

Score 0: If work surface for preparation and dispensing of drugs is not available The dispensary has an adequate work surface for Score 1: If work surface for preparation and dispensing of drugs is preparation and dispensing of drugs adequate for available but not adequate for safe and appropriate operation of the safe and appropriate operation of the the Pharmacy Pharmacy Score 2: If work surface for preparation and dispensing of drugs 11 adequate for the safe and appropriate operation of the Pharmacy

Score 0: If there is neither facilities for the appropriate cleaning of equipment nor separate hand washing facility The dispensary has facilities for the appropriate Score 1: If there is either facilities for the appropriate cleaning of cleaning of equipment as well as a separate hand equipment or separate hand washing facility washing facility Score 2: If there are both facilities for the appropriate cleaning of 12 equipment and separate hand washing facility

Score 0: If there is no functional refrigerator for thermolabile medicines The dispensary has a refrigerator that is of Score 1: If the functional refrigerator houses both thermolabile adequate size and used to store only medicines medicines and food items (no food). Score 2: If the functional refrigerator is reserved exclusively for 13 thermolabile medicines

Score 0: If there is NO evidence of maintaining refrigerator temperature between 2 and 8°C All refrigerators that store medicines are Score 1: If Temperature chart reveals occasional temperature maintained at a temperature between 2 and 8 °C excursions outside the standard range of 2 and 8°C with evidence of monitoring. Score 2: If Temperature Chart reveals that the refrigerator is 14 always maintained within 2 and 8°C

Score 0: If there is NO functional computer system in the Pharmacy The pharmacy has a computer system that Score 1: If the available functional computer system does not have

includes a secure backup and recovery system. a secured backup or recovery system Score 2: If the available functional computer system has a secured 15 backup and recovery system

Score 0: if the pharmacy is well secured against burglary but has no functional fire extinguisher The pharmacy is well secured against burglary and Score 1: If has only one of the two conditions specified: well

has a functional fire extinguisher secured against burglary and functional fire extinguisher Score 2: if the pharmacy is well secured against burglary and has a 16 functional fire extinguisher

Score 0: If the Pharmacy is poorly ventilated and does not have an The Pharmacy is well ventilated and has alternative source of electricity in case of public power failure alternative source of electricity in case of public Score 1: If the Pharmacy can only boast of one of the two power failure. 17 underscored conditions Score 2: If the Pharmacy is well ventilated and has alternative source of electricity in case of public power failure

Score 0: If there is no registered Superintendent Pharmacist supervising the Pharmacy outlet or if Superintendent Pharmacist has other Pharmaceutical job elsewhere or not always available to There is a registered Superintendent Pharmacist discharge his duties in the outlet.

with valid practicing license in the Pharmacy Score 1: If the Superintendent Pharmacist' is stable/available but has an expired license Score 2: If the Superintendent Pharmacist is stable/available and 18 has a current and valid license

Score 0: If the Pharmacist(s) dress is not in consonance with the ethics of the profession or if he/she is not wearing a ward coat The Pharmacist(s) is/are identifiable and the dress Score 1: If the Pharmacist(s)' dress is in consonance with the code is in conformity with the ethics of the professional ethics but NO Clinical overall or vice versa profession Score 2: If the Pharmacist(s)' dress is ethical and has his/her 19 clinical overall on

Score 0: If the Pharmacy support staff is not identifiable by neither name tag and appropriate uniform The Pharmacy support staffs are identifiable and Score 1: If the Pharmacy support staff is only identifiable by one of the dress code is in conformity with the ethics of the following: name tag or appropriate uniform the profession Score 2: If the Pharmacy support staff is identifiable by both name tag and appropriate uniform in conformity with the ethics of the 20 profession

Score 0: If there is NO poison register in the Pharmacy. There is a poison register in the Pharmacy - Score 1: If there is a poison register in the pharmacy but it is not in

available, in use and up to date use and up to date Score 2: If there is a poison register in the Pharmacy - available, in 21 useand up to date

Score 0: If there are no pharmacy reference books in the Pharmacy. There are current standard pharmacy reference Score 1: If there are pharmacy reference books in the Pharmacy

books in the Pharmacy but they are outdated Score 2: If there are current standard pharmacy reference books in 22 the Pharmacy such as BNF, EMDEX, MIMS, Martindale, USP, BPC

Score 0: If dispensing is done under unsanitary conditions The Pharmacy has processes in place to ensure Score 1: If there is some direct contact with medicines such as that dispensing is done under sanitary conditions tablet sand capsules dispensed (no direct contact with medicines dispensed). Score 2: If the Pharmacy has processes in place to ensure that dispensing is done under sanitary conditions (no direct contact 23 with medicines dispensed).

Score 0: If there are NO robust and updated records for defective or short-dated or Expired Medicines or compounding ingredients The Pharmacy has a process to document and and if there are NO separate storage area for these categories of quarantine expired/defective prescription and products

non-prescription medicines, and chemicals (used Score 1: If record is available but not updated or if there is no for compounding) in a timely manner clear-separate storage area and vice versa Score 2: If records as regard these categories of medicine is up-to- 24 date and there is a clear separate storage area for them

Score 0: If the Pharmacist does not periodically check, validate and The Pharmacist takes steps to identify forgeries, reconcile the records captured in the poison book and or cases of loss and theft of controlled medicines / targeted forgeries, loss and theft of controlled substances were not reported

substances, and reports such incidences to to the appropriate authorities within 10days appropriate authority within 10 days Score 1: If records are checked by the Pharmacist but there is 25 communication gap as regard how H/She handles abnormalities Score 2: If records in the poison book are periodically checked by the Pharmacist and if appropriate reports (to the authorities) were made in cases of forgeries, loss and theft of controlled substances.

Score 0: If the Pharmacist is not the person responsible for security of control drugs and controlled medicines can be found in an open shelf. The Pharmacist is responsible for ensuring that all Score 1: If all the controlled medicines are kept in a poison controlled medicines are secured under lock and cupboard but there is no lock key to ensure restricted access Score 2: If all the controlled medicines are kept in a poison cupboard, under lock and key and that the Key is in the custody of 26 the Pharmacist[s]

Score 0: If the highest qualification of the Pharmacist is B.Pharm and has not participated in any of PCN-MCPD Modules or any other relevant professional development since graduation There is evidence of participation in continuing Score 1: If the Pharmacist is currently undertaking his or her first Professional professional development post B Pharm program [PCN-MCPD; Masters, certificate course development etc.] Score 2: If the Pharmacist has completed [with evidence] at least 27 one post- graduation program or professional development course

Score 0: If the operation of the Pharmacy gives room to the non- Pharmacists to dispense controlled medicines directly to clients The pharmacist undertakes personal and direct Score 2: If the Pharmacist is the only one who personally

Drug Schedules dispensing of all controlled medicines. undertakes the dispensing of controlled medicines directly to clients and if all the controlled medicines dispensed are counter- signed by the Pharmacist[s], in the space provided in the poison 28 book

Score 0: If the poison cupboard is visible to the public, transparent and or its content are displayed in a manner that gives the public/patients the opportunity for self-selection. All controlled medicines are sold from the Score 1: If the poison cupboard is hidden to the public but dispensary, where there is no public access and no transparent and its content are displayed in a manner that gives opportunity for patient self-selection, after an the public/patients the opportunity for self-selection assessment by a Pharmacist. Score 2: If the poison cupboard and its content is completely hidden to the public and does not give the public/patients the 29 opportunity for self-selection

The Superintendent Pharmacist has ensured that Score 0: If other Pharmacy personnel can provide or recommend other pharmacy personnel are knowledgeable controlled medicines upon request (Test) regarding the necessity of pharmacists to consult with patients about controlled medicines (confirm Score 2: If other Pharmacy personnel insists that a client must see 30 by asking them questions or request for the drugs) the Pharmacist for any controlled medicine to be dispensed

Score 0: If controlled medicines are visible to the public Controlled medicines are not visible to the public 31 Score 2: If controlled medicines are not visible to the public

Score 0: If the Pharmacy does not have tools or records to show assessment of appropriateness of therapy For all NEW & REFILL prescriptions, the pharmacy has evidence of the pharmacist assessing the Score 1: If the Pharmacy has relevant tools but no evidence of appropriateness of therapy such as indication, routine assessment of appropriateness of therapy

Medication Review allergies, medical conditions, prescription history, Score 2: If the Pharmacy has evidence of routine assessment of adherence, use of over the counter/natural health appropriateness of therapy including records of indication, products, and changes to health status. allergies, medical conditions, prescription history, adherence, use of over the counter/natural health products, and changes to health 32 status.

Score 0: If there is no documented evidence on identification and interventions about drug therapy problems encountered by the The pharmacist has evidence of red flagging drug patients. therapy problems such as hypersensitivity, Score 1: If there is documented evidence on identifications but not adverse drug reactions, drug interactions, drug interventions as regard drug therapy problems encountered by the abuse/ misuse, precautions and contraindications patients through discussion with the patient and/or Score 2: If all the interventions as regard drug therapy problems prescriber. on the patients are kept or maintained in an easily retrievable 33 format

Score 0: If the pharmacy does not document relevant information for medical review The pharmacy has a process in place to enable Score 1: If the pharmacy does not document relevant information pharmacists to document relevant information for for medical review in a timely manner medication reviews in a timely manner Score 2: If the pharmacy has a process in place to enable pharmacists to document relevant information for medication 34 reviews in a timely manner

Score 0: If there is no evidence of communication that occurred Standards of between health care professionals and patient Practice The pharmacy has a process in place to enable Score 1: If the pharmacy has patient register computerized or pharmacists to document the communication that manual, for keeping medical information supplied by the Patient occurred between health care professionals and but is not regularly or generally maintained patient. Score 2: If the pharmacy has patient register computerized or manual, for documenting communication between the healthcare 35 professionals and patients

The pharmacy has a process in place to enable Score 0: If the pharmacy does not have informed-consent forms to pharmacists to document consent when capture patients' or care-givers' acceptance as regard some 36 appropriate from the patient or patient’s agent. medical advice Score 1: If the pharmacy has an unutilized or under-utilized informed-consent forms to capture patients' or care-givers' acceptance as regard some medical advice Score 2: If the pharmacy has informed-consent forms to capture patients' or care-givers' acceptance as regard some medical advice

Score 0: If there is no evidence of maintenance of client medication and medical records The pharmacy maintains client’s medical and Score 1: If the pharmacy maintains only either medication or

medication records. medical records of clients Score 2: If the pharmacy maintains both client’s medical and 37 medication records.

Score 0: If there is no evidence of prescription records The Pharmacy has workflow processes in place to Score 1: If there is evidence of prescription record but ethnicity of ensure prescription records are authorized at the prescriptions is not verified prior to dispensing

time of dispensing and prior to release to the Score 2: If the pharmacy has workflow processes in place to ensure patient prescription records are authorized at the time of dispensing and 38 prior to release to the patient

Score 0: If dispensing records are not maintained in the pharmacy Score 1: If dispensing records are maintained but not easily The Pharmacy has workflow processes in place to retrievable ensure dispensing records are stored in such a Score 2: If the Pharmacy has workflow processes in place to ensure manner that they are readily retrievable dispensing records are stored in such a manner that they are 39 readily retrievable

Score 0: If some of the treated prescription sheet does not contain The Pharmacy ensures prescriptions originate some of the required standard information, an ideal prescription from the prescriber and authenticity is established 40 should have before they were treated. Score 2: If all the treated prescription sheet contains the required standard information, an ideal prescription should have before they were treated.

Score 0: If the drugs are dispensed without labelling The Pharmacy ensures that all prescriptions Score 1: If drugs are dispensed with some labelling but does not dispensed are properly labelled including the trade include standard requirements such as trade and generic names,

and generic names, address and telephone address and telephone number of the Pharmacy number of the Pharmacy Score 2: If Pharmacy ensures that all prescriptions dispensed are properly labelled including the trade and generic names, address 41 and telephone number of the Pharmacy

Score 0: If Patients' confidential information are easily assessed on loose sheets or open registers Score 1: If Patients' confidential information are stored and maintained in a system not secured by password or registers The Pharmacy ensures that confidential available to unauthorized persons information of patients is protected Score 2: If Patients' confidential information are stored in a way that ensures that confidential information of patients is protected - maintained in a system secured by password or in books/registers 42 kept under lock and key

Score 0: If the Pharmacy has no appropriate records for both The Pharmacy either maintain records in a paper, patients and products an electronic format or is moving towards a Score 1: If all the Pharmacy records, including Patients' records are complete electronic record. All patient records, maintained in a paper (with evidence of moving towards a regardless of form are readily retrievable and complete electronic format) or readily retrievable electronic format maintained appropriately for a period not less but for a period, less than 2 years. than 2 years from the last professional pharmacy Score 2: If all the Pharmacy records, including Patients' records are service. maintained in an appropriate and readily retrievable format for the 43 at least 2 years.

Score 0: If there is no evidence of policies, procedures and support to minimize errors, incidents and unsafe practices The Pharmacy has policies and procedures in place Score 1: If the policies, procedures and support put in place to that minimize errors, incidents and unsafe minimize errors, incidents and unsafe practices as well as reporting

practices, including supporting staff in their adverse events are not adequate obligation to report adverse events Score 2: If appropriate policies, procedures and support are in place to minimize errors, incidents and unsafe practices including 44 evidence of reporting of Adverse Drug Reactions

Score 0: If there is no referral system in place There is a functional referral system in place with Score 1: If there is a functional referral system described but no

evidence of documentation evidence of documentation of same. Score 2: If there is a functional referral system in place with

45 evidence of documentation

Score 0: If there is no evidence of pharmacovigilance activities

There is evidence of reporting of Score 1: If pharmacovigilance activities are visible (e.g. with some

pharmacovigilance activities. filled ICSR forms) but no evidence of reporting of same. Score 2: If there is evidence of reporting of pharmacovigilance

46 activities.

Score 0: If procurement of drugs is not done in accordance with the National Drug Distribution Guidelines e.g. drugs are bought There is evidence of procurement in accordance from the open market with National Drug Distribution Guidelines Score 2: If evidence of procurement in accordance with National

47 Drug Distribution Guidelines

There are robust inventory management and Score 0: If inventory management and control is unorganized and

48 control measures in the pharmacy not adequately documented. Score 1: If there are gaps in inventory management and control e.g. documentation, stock reconciliation, storage practices, FeFo etc Score 2: If here are robust inventory management and control measures in the pharmacy - here are robust inventory management and control measures in the pharmacy e.g. good documentation, stock reconciliation, good storage practices, FeFo etc. are in place

Score 0: If wastes are not segregated before disposal There are separate waste disposal containers for Score 1: If wastes are segregated but not adequately - general waste, biological waste, hazardous waste unavailability of separate waste disposal containers for sharps & sharps as applicable. Score 2: If there are separate waste disposal containers for general

49 waste, biological waste, hazardous waste & sharps as applicable

Score 0: If there is no evidence of standard waste disposal

Processes and procedures are in place for disposal practices

for all types of waste are in place. Score 2: If adequate processes and procedures are in place for

50 disposal for all types of waste are in place.

Date:

COPA Stage II (Minimum requirement): To earn stage II rating, the Community Pharmacy must score 100%, in addition to meeting the requirements for COPA stage I rating Domains Criteria Remarks

Score 0: If the Pharmacy has NO patients' information, education The Pharmacy has patients’ information, and health communication materials for distribution to patients education and health communication materials Score 2: If the Pharmacy has patients' information, education and (leaflets etc.) for distribution to patients. 1 health communication materials for distribution to patients

Score 0: If there are NO health promotion advertisements or poster in the Pharmacy There are health promotion advertisements or Score 1: If the available health promotion advertisements or posters visibly displayed in the Pharmacy (in paper poster in the Pharmacy, are not well visibly displayed form or electronic) Score 2: If there are health promotion advertisements or poster Health promotion 2 visibly displayed in the Pharmacy activities

Score 0: If the pharmacy does not conduct or participate in health promotion campaigns or outreaches within the community Score 1: If there are NO documented evidence by way of activity The Pharmacy conducts or participates in health reports as regard the health promotion and outreaches conducted promotion campaigns or outreaches within the or participated in, by the Pharmacy, within the community community (check for evidence). Score 2: If there is documented evidence such as activity report on health promotion and outreaches conducted or participated in, by 3 the Pharmacy, within the community.

Score 0: If the Pharmacy does not conduct diagnostic tests

The Pharmacy provides diagnostic tests e.g. blood Score 1: If the Pharmacy has active kits for only a few of the simple pressure monitoring, blood cholesterol testing, diagnostic tests listed (less than 5 of the listed) blood glucose testing, malaria diagnostic tests, HIV Score 2: If the Pharmacy routinely provides diagnostic tests e.g. Diagnostics rapid tests, monitoring of peak expiratory flow blood pressure monitoring, blood cholesterol testing, blood glucose rate, pregnancy testing, body weight monitoring testing, malaria diagnostic tests, HIV rapid tests, monitoring of peak expiratory flow rate, pregnancy testing, body weight 4 monitoring

Score 0: If the Pharmacy has no records of diagnostic tests conduced Score 1: If the Pharmacy has appropriate tools or records where The Pharmacy ensures proper documentation of ONLY some of the diagnostic tests performed are entered and

diagnostic tests carried out (check for records) maintained for the Patients OR records are incomplete Score 2: If the Pharmacy has appropriate tools or records where all diagnostic tests performed are entered and maintained for the 5 Patients

Score 0: If there are no pharmaceutical care plans developed and There is documented evidence of pharmaceutical documented in the pharmacy

care plans developed for patients in the Pharmacy Score 2: If there is documented evidence of pharmaceutical care 6 plans developed for patients in the pharmacy

Score 0: If there is no evidence of patient monitoring within the Patient monitoring is an integral part of provision of pharmaceutical care pharmaceutical service provision in the Pharmacy Score 2: If there is evidence of patient monitoring is an integral (check for evidence) 7 part of pharmaceutical service provision in the pharmacy

Score 0: If the Pharmacy has neither Pharmacovigilance ADR Pharmacotherapy forms nor any record for the documentation of adverse reactions monitoring or other medicated related problems Score 1: If the Pharmacy has Pharmacovigilance ADR forms or a There is process for identification and record for the documentation of adverse reactions reported by the documentation of medication-related problems in patients but no documentation is maintained for other medication- the Pharmacy. related problem e.g. medication errors, drug interactions, hypersensitivities etc. Score 2: If the Pharmacy has Pharmacovigilance ADR forms or a record for the documentation of adverse reactions reported by the 8 patients and its consistently been utilized

Interaction with prescribers are documented in Score 0: If the Pharmacy has NO record where interactions with

9 the Pharmacy prescribers are documented Score 1: If the Pharmacy has a record where interactions with prescribers are documented bur are rarely used Score 2: If the Pharmacy has a record where interactions with prescribers are documented and this is consistently being used

Score 0: If the Pharmacy has NO publication in any peer-reviewed journal or presented abstract The Pharmacy conducts or participates in research Score 1: If the Pharmacy is involved in researches but does not Research and (check for previous publications in peer-reviewed have any article in a peer-reviewed journal or abstract accepted for development journals, abstract presentations) conference presentation Score 2: If the Pharmacy has publications in peer-reviewed 10 journals or abstracts accepted for conference presentations

Score 0: If the Pharmacy has NO manuals developed for the pharmacy system The Pharmacy has standard operating procedures Score 1: If the manuals developed for the pharmacy system are and schedule of duties for various activities and incomplete or inadequate operations Score 2: If the Pharmacy has manuals developed for the pharmacy system such as standard operating procedures and schedule of Audit/ Finance 11 duties for various activities and operations Systems Score 0: If there is no evidence of sound accounting and financial systems in the pharmacy Score 1: If there is some system in place for finance and The Pharmacy has good financial and accounting accounting but it is not adequate with maintenance of relevant

systems accounting books and routine development of financial reports Score 2: If the pharmacy has good financial and accounting systems evidenced by standard accounting books and routine 12 financial reports including audited annual financial statements

There is evidence of professional indemnity Score 0: If pharmacist does not subscribe to any professional

13 coverage indemnity policy Score 2: If there is evidence of professional indemnity insurance coverage

Score 0: If there is no insurance policy in place The premise is covered by an insurance policy Score 2: If the premise is covered by an insurance policy to cover at 14 least burglary and fire accidents

Score 0: If there is no evidence of tax payments to relevant government agencies There is evidence of tax payment to the relevant Score 2: If there is evidence of tax payment to the relevant government agencies government agencies at the local government, State and National 15 levels

TOTAL SCORE

PERCENTAGE SCORE

Assessors Names Assessors Signature

1

2

Superintendent Pharmacist Name Superintendent Pharmacist Signature

Remarks: Date:

COPA Stage III (Minimum requirement): To earn stage III rating, the Community Pharmacy must score 100%, in addition to meeting the requirements for COPA stage II rating

Domains Criteria Remarks

Score 0: If the Pharmacy does not provide pharmaceutical services to house-bound persons in the community The Pharmacy provides pharmaceutical services to Score 1: If the Pharmacy provides skeletal pharmaceutical services

house-bound persons in the community to house-bound persons in the community (evidence produced) Score 2: If the Pharmacy provides robust pharmaceutical services Domiciliary 1 to house-bound persons in the community (evidence produced) services Score 0: If the Pharmacy does not have standard operating procedures for the provision of pharmaceutical services to house- The Pharmacy has standard operating procedures bound persons in the community. (SOP) for the provision of pharmaceutical services Score 2: If the Pharmacy has detailed standard operating to house-bound persons. procedures for the provision of pharmaceutical services to house- 2 bound persons in the community (evidence produced) The Pharmacy is equipped with telephone, an Score 0: If the Pharmacy does not have any of the following: On-line services active internet connection with an active e-mail separate office telephone line(s), active internet connection and an 3 address official functional email address Score 1: If the Pharmacy has only one or two of the following: a separate office telephone line(s), active internet connection and an official functional email address Score 2: If the Pharmacy has a separate office telephone line(s), active internet connection with an official functional email address Score 0: If the Pharmacy does not provide on-line Pharmacy services at all The Pharmacy provides on-line pharmacy services Score 1: If the available on-line Pharmacy Services is inefficient Score 2: If the Pharmacy provides a robust and active on-line 4 Pharmacy Services Score 0: If the pharmacy does not deliver online prescriptions The Pharmacy has a process in place to ensure all Score 1: If the pharmacy delivers online prescriptions but methods prescriptions if sent through the mail are sent only of delivery are not auditable and traceable by registered mail or, if delivered by another method, are delivered in a method that is Score 2: If the pharmacy has a process in place to ensure all traceable and auditable. prescriptions if sent through the mail are sent only by registered mail or, if delivered by another method, are delivered in a method 5 that is traceable and auditable. Score 0: If the Pharmacy does have a process to ensure The Pharmacy has a process in place to ensure confidentiality of all delivered prescriptions.

confidentiality of all delivered prescriptions. Score 2: If the pharmacy has a process in place to ensure 6 confidentiality of all delivered prescriptions. Score 0: If the Pharmacy has no functional computer system at all. Score 1: If the Pharmacy has computer system(s). However, There is evidence of routine computer system maintenance and updates including secure backup and recovery maintenance and update that includes a secure system in the Pharmacy are sparingly and irregularly done. backup and recovery system in the Pharmacy. Score 2: If the Pharmacy has evidence of routine computer system maintenance and updates including secure backup and recovery 7 system in the Pharmacy There is functional website for the Pharmacy Score 0: If the Pharmacy has no website at all 8 Score 1: If the Pharmacy has a website. However, it is not regularly updated or functional. Score 2: If the Pharmacy has a functional and regularly updated website. Score 0: If the Pharmacy lacks the required facilities that enables them to accept and supports the training of pre-registration trainees (intern pharmacist) The Pharmacy accepts and supports the training of Score 1: If the Pharmacy has all it takes to accept and support the

pre-registration trainees (intern pharmacist) training of pre-registration trainees (intern pharmacist) but are currently not doing so. Score 2: If the Pharmacy accepts and supports the training of pre- 9 registration trainees (intern pharmacist) Score 0: If the Pharmacy does not have the minimum monitoring Pre-registration and documentation requirement for internship training training The Pharmacy maintains the minimum monitoring Score 1: If the Pharmacy the minimum monitoring and and documentation requirements for internship documentation requirement for internship training, but is either training under-utilized or not used at all Score 2: If the Pharmacy maintains the minimum monitoring and 10 documentation requirement for internship training Score 0: If the Pharmacy does not keep records of the activity The Pharmacy keeps records of the activity description for trainees (Intern Pharmacists) in the premises. description for trainees (Intern Pharmacists) in the Score 2: If the Pharmacy adequate records of the activity premises. 11 description for trainees (Intern Pharmacists) in the premises. Score 0: If the Pharmacy does not have proper compounding equipment The Pharmacy has proper equipment for Score 1: If the Pharmacy has proper compounding equipment but compounding that undergoes regular no records of maintenance and calibration maintenance and calibration Score 2: If the Pharmacy has proper compounding equipment with Compounding 12 records of maintenance and calibration The Pharmacy has a compounding record that includes the name, lot number and expiry date of Score 0: If the Pharmacy has no compounding record at all each active ingredient, the quantity required and 13 weighed, the date of preparation and the expiry date of the compounded product, the authorization of the compounder and/or the Score 1: If the available compounding record is not comprehensive pharmacist responsible for the preparation and to included stated criteria checking and a reference to the formula used when applicable Score 2: If the Pharmacy has the required detailed compounding record including stated criteria Score 0: If there are no duplicate labels of dispensed compounded products available for assessment The Pharmacy ensures that the label for Score 1: If the available duplicate labels of compounded products compounded products includes the name and does not provide either the name or concentration of each of the

concentration of each of the active ingredients active ingredients (check for evidence). Score 2: If the duplicate labels of dispensed compounded products provides the name and concentration of each of the active 14 ingredients Score 0: If there are no duplicate labels of dispensed compounded products available for assessment The Pharmacy ensures that the label for Score 1: If the duplicate labels of dispensed compounded products compounded products includes the expiry date provides only one of the following information: Expiry date,

and storage instructions of the compound based storage instructions, based on available references on available references (check for evidence). Score 2: If the duplicate labels of dispensed compounded products provides information on Expiry date, storage instructions, based on 15 available references Score 0: If the Pharmacy does not stock any of the following; medical devices, homeopathic products, other para- pharmaceutical and non-pharmaceutical items The Pharmacy stocks medical devices, Score 1: If the Pharmacy stocks only some of the following; homeopathic products, and other para- Para- medical devices, homeopathic products and other para- pharmaceutical and non-pharmaceutical items pharmaceuticals pharmaceutical and non-pharmaceutical items Score 2: If the Pharmacy stocks medical devices, para- 16 pharmaceuticals and non-pharmaceutical items The para-pharmaceuticals are visibly displayed in Score 0: If there are no para--pharmaceuticals available in the

17 the Pharmacy Pharmacy Score 1: If the available para--pharmaceuticals are not visibly displayed in the Pharmacy Score 2: If the para--pharmaceuticals are visibly displayed in the Pharmacy Score 0: If there is NO access to information on para- pharmaceuticals in the Pharmacy There is ready access to information on para- Score 1: If the source of information as regard para-

pharmaceuticals in the Pharmacy pharmaceuticals in the Pharmacy not readily available and current Score 2: If there is ready access to up to date information on para- 18 pharmaceuticals in the Pharmacy Score 0: If there is no client feedback data on pharmaceutical care service provision in the pharmacy The Pharmacy has a process for collection of Score 1: If the client feedback on pharmaceutical care services are confidential feedbacks, satisfaction or the views of available but not confidential customers on pharmaceutical services provided Score 2: If pharmacy has a process for collection of confidential Customer feedbacks, satisfaction or the views of customers on perceptions 19 pharmaceutical services provided (external audit) Score 0: If there is no process for collection of customers’ The Pharmacy has a process for confidential expectations in the Pharmacy documentation of the expectations of customers Score 2: If the pharmacy has a process for confidential from the pharmacist. documentation of the expectations of customers from the 20 pharmacist.

TOTAL SCORE

PERCENTAGE SCORE

Assessors Names Assessors Signature 1 2

Superintendent Pharmacist Name Superintendent Pharmacist Signature

Remarks: Date:

ING SHEET ANNEX III: COPA Signage