ISSN: 2520-4327

Editorial Policy

In this Issue The Pharmaceutical Journal of (PJZ) operates an open editorial policy and PSZ President’s Message internal peer review process. All articles published are reviewed to ensure only Editorial CommentVolume 2, Issue 3 relevant and quality articles are published. June 2017 Special Edition The views expressed by the authors of Contributors & Editorial Team articles featured in the Journal are their own and do not necessarily represent those Letters to the Editor of the publisher or the editorial staff, and must not be cited or quoted as such. News in Brief Every care is taken to reproduce articles as Feature Article: Proceedings and Outcomes of the Third accurately as possible but the publisher accepts no responsibility for errors, Annual Pharmacy Research Conference to Promote Reduction of omissions or inaccuracies contained Disease Burden through Pharmaceutical Care and Research, held therein. on 19th - 20th July 2016 in Lusaka, Zambia. Articles published in this Journal may not be reprinted, copied or used in any Articles commercial context, except by express permission of the Chief Editor. COMMENTARY: Antimicrobial Resistance–The Role of Pharmacists in Resource Limited Countries. For article submission or advertising contact the Editor: [email protected] REVIEW: Total Quality Management in Pharmaceutical Manufacturing towards increased Pharmaceutical Care and Health The Pharmaceutical Journal of Zambia is a Promotion. professional and scholarly journal. It will carry only advertising which is likely to be COMMENTARY: Developing Patient–focused Pharmacy Services: of interest to the pharmacy profession and The Case of 24/7 Pharmacy Services in Zambia. which does not reflect unfavourably, directly or by implication on the profession Research Abstracts of Pharmacy or the professional practice of pharmacy in Zambia. Profile Focus: Dr Lungwani Tyson Muungo Advertising which does not comply with this policy will be rejected. It is the Pharmaceutical Crossword Puzzle responsibility of the advertisers to comply Puzzle: with the relevant Zambian laws and regulations pertaining to advertising. Notice Board & Upcoming Events Advertisement in the Journal does not constitute an endorsement by PSZ of the claims, products or services promoted.

Pharmaceutical Journal of Zambia is an indexed publication.

ISSN-2520-4327 (Print)

Published by: PHARMACEUTICAL SOCIETY OF ZAMBIA ©Pharmaceutical Society of Zambia, 2017. All Rights Reserved.

Dear colleagues and friends, We meet again for this year’s 36th Annual Scientific Conference where we share pharmaceutical knowledge and plan the way forward. I cordially welcome you. Please feel free to contribute and participate. Our theme this year is ‘Shifting paradigms towards pharmaceutical research, disease prevention and antimicrobial resistance’. There is no better time than now for this theme. As a profession, we need to do an introspection on how well we have participated in the area of pharmaceutical research, disease prevention and reducing antimicrobial resistance. Are we adding value to the well-being of Zambians out there? We talk everyday of evidence based practices-how much evidence have we generated to add to the body of knowledge? How willing are we to develop and participate in research? When research has been done, does our work get disseminated or published in scientific journals? The pharmacy profession has many career tracks that provide opportunities beyond dispensing prescription drugs at the dispensary. We can conduct extensive research into new drugs and their actions, discovering and testing of new medicines and manufacturing in pharmaceutical companies, and engage in the overseeing of research projects. There is need for new ways to reach out and serve the millions of Zambians out there to attain quality health. The many increasing chronic diseases are preventable and/or manageable. Our role therefore needs to expand beyond just dispensing to active participation in health promotion, chronic disease prevention and monitoring of treatment outcomes as part of the primary healthcare team. We therefore urge government under the Ministry of Health to build strong relationships with community pharmacies and pharmacy personnel, including other strategic stakeholders in disease prevention. The Pharmaceutical Society of Zambia is ready to promote public health and integrate it into our professional practice. It is of paramount importance that we get involved in public health policy decision-making, planning, development, and implementation of public health efforts. The pharmacy profession can improve public health by providing population-based care; developing disease prevention and control programs; providing health education; collaborating with state and local authorities to address local and regional health care needs, including emergency preparedness and response; advocating for sound legislation, regulations, and public policy regarding disease prevention and management; and engaging in public health research. Amongst the significant discoveries ever made in human history, are antibiotics. They have saved countless lives from morbidity and mortality worldwide. However, the increasing threat of antibiotic resistance in the community is of utmost concern. As a profession, is there anything we can do about it or are we also contributing to the spread of the antibiotic resistance? Let us gauge ourselves, our practice and roles to prevent the emergence of antibiotic resistance. The answer lies in us to utilize effective strategies within our grasp such as the implementation of antimicrobial stewardship. I challenge members of the profession of Pharmacy to shift paradigms by taking up the leadership role in preventing and reducing antibiotic resistance – it starts with each one of us being a part of the solution and not part of the problem. Finally, hence forth, let us change the way we practice Pharmacy with constant innovation in our practice. Let us change the way we view ourselves and pick up on those vital roles we are expected to play in the lives of Zambians. It calls for hard work and dedication to duty which will eventually change the environment in which we practice. Enjoy the Pharmaceutical Week!! God bless the profession of Pharmacy, God bless us All. David C. Banda Editorial Comment

President, Pharmaceutical Society of Zambia

Members of the Pharmaceutical fraternity in Zambia and the region, partners and stakeholders of the pharmacy profession, ladies & gentlemen, it is that special time of the year once again when the Pharmacy profession showcases its contribution of healthcare in Zambia. It is the 2017 Annual Pharmaceutical Awareness Week. This is perhaps the most important week in the calendar for pharmaceutical personnel in Zambia as it is a time set aside by the nation to recognise and appreciate the role of pharmacy in the national agenda. Importantly, it is a great opportunity for Pharmacists and Pharmacy Technologists to showcase their valuable roles and contributions to healthcare provision both at individual and collective levels. This years’ annual pharmaceutical awareness week culminates into the Scientific Conference and Annual General Meeting (AGM) for the Pharmaceutical Society of Zambia (PSZ). This year’s theme is “Shifting paradigms towards pharmaceutical research, disease prevention and antimicrobial resistance”. The theme for this year’s pharmaceutical week reflects growing recognition of the need for pharmacy as a profession to shift the paradigms of knowledge, skill and attitude towards scientific research, disease prevention and combating antimicrobial resistance. Undoubtedly, over 13 million Zambians face a huge burden of preventable diseases coupled by the increasing threat of antimicrobial resistance that risks increasing morbidity and mortality by tenfold. At the base of these and other related health problems is the lack of locally generated scientific evidence that research is supposed to inform regards pharmaceutical practice and policy. Minus locally relevant research evidence generated by the pharmaceutical sectors, the problem of limited or inadequate access to quality pharmaceutical care services will continue to impede the contribution of pharmacy to the national healthcare agenda. The time to shift paradigms is now!

Following the success of the previous edition, the Pharmaceutical Society of Zambia brings to you this special edition of your favourite journal – The Pharmaceutical Journal of Zambia (PJZ) which has been published as a key feature of information for this year’s pharmaceutical awareness week. In this issue, you will enjoy fantastic informative articles and scholarly abstracts from distinguished researchers drawn from within the profession and outside the fraternity.On behalf of the Journal Editorial Team and indeed on my own behalf, I would like to sincerely thank all of our contributing authors for their thought-provoking and fascinating articles. It has been a privilege and great pleasure working with you all on this wonderful edition. To our readers, please do enjoy this edition of your favourite journal and we look forward to your feedback. We welcome articles for future editions, so if you would like to contribute or comment, please contact the Editor at: [email protected] or call +260 977 800 311.

Thank you for your continued support,

Aubrey Chichonyi Kalungia, BPharm, MSc Pharm, MSc GHS, MPharmSZ Chief Editor

‘Knowledge is power only when it is shared’

Contributors Editorial Team

Featured Contributors: Friday Sakala Mario Musonda Jimmy Hangoma Thikondane Mphande Aubrey Chichonyi Kalungia Scott K. Matafwali Chief Editor Tumelo M. Akapelwa Ephraim Phiri Brian Halale Yapoma Nkhoma Mukumbi Kabesha Deputy Editor Graphic Design & Printing New Horizon Printers LLC

Advertising Manager Andrew Bambala Andrew Bambala News Editor Quality Supervisor Machi Hampango

Executive Director Michelo Banda David C. Banda Assistant Editor

PJZ Advertising Rates Mario Musonda Cover Pages Assistant Editor Front Cover Inside K6,250 A4 Back Cover K6,250 A4 Back Cover Inside K5,000 Inside Pages Tania Nyirongo A4 Full Page K3,750 Assistant Editor A4 Half Page K1,875 A4 Quarter Page K1,250

Hope Kalasa Assistant Editor

LETTERS TO THE EDITOR Letters are invited from anyone wishing to comment on issues relevant to the scope of this journal or the profession of Pharmacy. However, any letters adjudged by the Editor to be potentially defamatory or damaging to others will not be published. Letters should be no more than 200 words long. Letters can be sent via email to the Editor at: [email protected]

Dear editor As a pharmacist, I am profoundly delighted to read the Pharmaceutical Journal of Zambia. This is something we had been looking forward to having as a profession. Please continue with this zeal of hard work in ensuring that the journal continues to inform and educate the members of the profession and the public at large. Victor Chanda, Pharmacist.

Dear Editor I have enjoyed reading the March edition of the journal and it has brought out a lot of interesting facts and articles. However, you could consider using a different font theme and size for future editions. Nevertheless this is very good work. Please do keep it up!!

Sharon Kabwe, Pharmacy Technologist

Dear Editor I enjoyed reading Volume 2 Issue 2 of the Pharmaceutical Journal of Zambia. I particularly enjoyed the article done by Mario M. J. Musonda on promoting sustainable local pharmaceutical manufacturing in Zambia. This article could not come at any better time than this for the nation and especially the profession of Pharmacy. We should be focused on promoting local manufacturing of medicines as opposed to importation. This will surely have a spiral effect on national development. I am looking forward to seeing more articles on local pharmaceutical manufacturing and growth of the industry in the future editions.

Geofrey Ngulube, Intern Pharmacist, University Teaching Hospital

NEWS IN BRIEF NRB Pharma Zambia Limited officially launched

By: Chichonyi A. Kalungia NRB Pharma Zambia Limited Company situated in Lusaka South Multi-facility Economic Zone (LS-MFEZ) was officially launched on 26th April 2017 by His Excellency the President, Mr Edgar Chagwa Lungu. The official launch was also graced by senior government officials, the Secretary General of the ruling Patriotic Front, the Minister of Health Hon. Dr Chitalu Chilufya MP, the Minister of Commerce, Trade & Industry Hon. Margaret Mwanakatwe MP, her Royal Highness Chieftainess Nkomesha Mukamambo II, the Chairman of NRB Group Mr Narayan Bandekar, Permanent Secretaries of the Ministry of Health, Directors of NRB Pharma, and other invited guests who included the President of the Pharmaceutical Society of Zambia (PSZ).

Speaking at the launch, H.E President Edgar Lungu noted that the commissioning of a pharmaceutical manufacturing plant at NRB Pharma Zambia Limited was a sign that the manufacturing industry is growing. The President highlighted some of the benefitsof manufacturing drugs locally. The President said, “Manufacturing of drugs locally will make a difference for people not only in Zambia but also in the neighbouring countries and the continent at large. Such modern facilities will also provide an opportunity for students to do their practicals using modern facilities”. NRB Group chairman Mr Narayan Bandekar said the company had decided to get involved in pharmaceutical manufacturing in order to supplementgovernment’s efforts towards improving delivery of health services. Mr Bandekar further disclosed that the manufacturing facility had been constructed at a total cost of US$20 million. Speaking at the same event, the Honourable Minister of Health Dr Chitalu Chilufya said President Lungu has been the architect of good health services as the country has witnessed both robust infrastructure development and employment of about 9000 health workers under two years from the time the President assumed office. Commerce, Trade & Industry Minister, Margaret Mwanakatwe said her ministry will ensure that NRB Pharma flourishes in production and exportation of drugs manufactured in Zambia.

UNIVERSITY TEACHING HOSPITALS GO 24/7 PHARMACY SERVICES

By Thikondane Mphande and Maitri Suthar, Intern Pharmacists –University Teaching Hospitals

Implemented on 29th December 2016, the practice of 24-hour pharmacy services at the University Teaching Hospitals (UTH) took the healthcare system by storm. Every pharmacy personnel was running around in order to organize and adjust their normal work schedules. Since inception of the 24-hour programme, following directives from the Minister of Health, Dr Chitalu Chilufya, almost all the hospital pharmacy outlets at UTH have remained open 24 hours a day, 7 days a week. This entails that at all times, a pharmacist will always be present to provide the needed pharmaceutical care to the clients. While this helps with the more seamless running of the hospital, it also provides an opportunity for better accountability of the movement of the largest budget holder of any hospital - the medicines. Currently, only the most crucial pharmacy outlets remain open 24/7 and these include: Main dispensary and various specialized satellite outlets such as Internal Medicine, Surgery, Main Intensive Care Unit, Obstetrics & Gynaecology, and Paediatric Pharmacies, respectively. The other pharmacy outlets such as the Adult and Paediatrics Centres of Excellence Pharmacies (where anti-retroviral medicines are dispensed) have since increased working hours from 06:00 hours to 18:00 hours instead of 08:00hrs to 16:30hrs. The 24/7 service has been welcomed by the pharmacy department at UTH. However, 24/7 pharmacy service has come with various challenges especially the human resource challenge as the number of pharmacy personnel is still inadequate for the provision of the services. Nevertheless, the service has to run and being conducted without lapses and at no extra remuneration at the moment. The 24/7 pharmacy service has helped bring the pharmacist closer to their goal, which is to be able to fully serve the patient at the right time all the time.

CONGRATULATIONS!! LABOUR DAY AWARDEES FOR 2017

By Andrew Bambala Since 1900s the May Day or the International Workers Day has been celebrated throughout the world to pay tribute to working men and women. This day was set aside to celebrate the contributions workers have made to the prosperity and well- being of the country. This year’s labour days celebrations were held under the theme: “Securing Decent Work for Sustainable Social-Economic Development’’. The Labour Day celebrations were held throughout the country in the various districts with the main celebrations being held in Lusaka and graced by his Excellency the President of the Republic of Zambia, Mr Edgar Chagwa Lungu. The Pharmacy profession was not left out in these celebrations as members of the profession were recognized and awarded for the great work they are doing in their various Institutions. The Pharmaceutical Society of Zambia (PSZ) and Hospital Pharmacists Association of Zambia (HOPAZ) wish to take this opportunity to congratulate the following members of the profession of Pharmacy who were awarded at their respective institutions during the 2017 Labour Day cerebrations and award giving:

NAME Professional Organisation Category of Award Category Billy Chabalenge Pharmacist Zambia Medicines Most Improved and Regulatory Authority Hardworking Employee Vincent Lukali Pharmacist Zambia Medicines Most Improved and Regulatory Authority Hardworking Employee Chile Phiri Pharmacist Manyinga District Health Most Dedicated and Punctual Office Employee Tionenji Daka Matibula Pharmacist University Teaching Most Hardworking Hospitals –Lusaka Adult Pharmacist Hospital Lawrence Chibwali Pharmacist Mulobezi District Health Most Committed Employee Office Mupeta Chibenda Pharmacist Nchanga North General Medical Superintendent’s Hospital Award for the Most Hardworking Employee Doreen Namalongo Pharmacy Mukinge Mission Hospital Most Hardworking Employee Technologist of the Year Lupapa Chiti Pharmacy Kalulushi General Hospital Most Hardworking Employee Technologist of the Year Mwape Banda Mwambezi Pharmacy District Medical Outstanding Performance Technologist Office –Chiwempala Clinic Dumisani Mneti Pharmacy Centers for Infectious Committed & Hardworking Technologist Diseases Research in Zambia Employee Tiara Namukonda Pharmacy Hospital Most Committed Employee Technologist Chitalu Mwenya Pharmacy Arthur Davison Children’s Most Disciplined Employee Technologist Hospital Mbuywana Likando Pharmacy Cancer Diseases Hospital – Most Honest Employee Technologist University Teaching Hospitals Hunsley Matongo Pharmacy Cancer Diseases Hospital – Most Dedicated Employee Technologist University Teaching Hospitals Rona Ndlovu Pharmacy Zambia Medicines Most Improved and Technologist Regulatory Authority Hardworking Employee Mbambara Mapiki Pharmacy Hospital Most Dedicated Employee Technologist

FEATURE ARTICLE Proceedings and Outcomes of the Third Annual Pharmacy Research Conference to Promote Reduction of Disease Burden through Pharmaceutical Care and Research, held on 19th - 20th July 2016 in Lusaka, Zambia. Chichonyi A. Kalungia1*, Mumbi M. Musosha2, Billy Mweetwa3, Helen B. Mulenga4,Muhau Mubiana4, Christropher Sakala5, Freddie Masaninga3, James Mwanza6, Machi Hampango7 Author Affiliations: 1Department of Pharmacy, University of Zambia, Lusaka, Zambia. Email: [email protected] 2Management Sciences for Health, Zambia Prevention Care and Treatment (ZPCT IIB), Lusaka, Zambia, Email: [email protected] 3World Health Organization Country Office, Lusaka, Zambia. Email: [email protected] 4Pharmaceutical Services Department, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. Email: [email protected] 5Lusaka Apex Medical University, Faculty of Pharmacy, Nutrition & Dietetics, Lusaka, Zambia. Email: [email protected] 6Department of Psychiatry, University of Zambia, Lusaka, Zambia. Email: [email protected] 7University Teaching Hospitals, Children’s Hospital, Lusaka, Zambia. Email: [email protected] *Correspondence:[email protected] or [email protected]

ABSTRACT The 3rd Annual Pharmacy Research Conference held from 19th to 20th July, 2016 in Lusaka brought together pharmacists, pharmacy technologists, pharmaceutical scientists and researchers from within Zambia to share and promote research activities relevant to key thematic areas of healthcare. The theme of the conference was: ‘Reducing disease burden through pharmaceutical care and research’. The conference attracted quality abstracts and presentations aligned to the following areas: HIV/AIDS, non-communicable diseases, rational drug use, pharmacovigilance and pharmaceutical service delivery among many others. Deliberations around these themes were held that provided an opportunity for participants to share ideas and innovative ways of reducing the country’s disease burden and health challenges using locally generated evidence. The conference resolutions resulted in a number of agreed research activities to be conducted and supported for dissemination at the next conference in July 2017.

KEY WORDS: Pharmacy, Research conference, Reducing disease burden, pharmaceutical services, Zambia

INTRODUCTION 2015 sponsored by CIDRZ and WHO among other partners, including support from MoH and The Annual Pharmacy Research attracted 80 delegates. In 2016, the 3rd Annual Conference brings together pharmacists, Pharmacy Research Conference was held from pharmacy technologists, pharmaceutical 19th to 20th July in Lusaka under the theme: scientists and researchers within Zambia to ‘Reducing disease burden through promote and showcase relevant research pharmaceutical care and research’. The conducted in key thematic areas of healthcare. conference provided a platform and opportunity The 1st Annual Pharmacy Research for pharmacists, pharmacy technologists, Conference was held in August 2014 co- pharmaceutical scientists and researchers to sponsored by CIDRZ and ABBVIE disseminate research findings and share Pharmaceutical Company, with support from evidence of best practices that potentially may MoH and WHO. The 2nd Annual Pharmacy inform dialogue and health policy formulation to Research Conference took place in August improve healthcare services in Zambia. The Nakululombe Kwendeni from CHAI gave an conference drew delegates from Ministry of update on the new WHO 2016 HIV/AIDS Health (MoH), Zambia Medicine Regulatory consolidated guidelines [2], highlighting the Authority, academia, World Health main changes to diagnosis, treatment options Organization (WHO), non-governmental and service delivery. Importantly, new organizations, including public and private inclusions to the guidelines such as point-of- pharmacy sectors [1]. The conference was held care testing for CD4 in children and at-birth at Taj Pamodzi hotel in Lusaka. nucleic acid testing, including implementation of provider training and community involvement PROCEEDINGS was also highlighted in addition to the drug The conference was opened by the Head regimen changes for adults and children. of Pharmaceutical Services at the Centre for Thereafter, delegates engaged in a discussion Infectious Diseases Research in Zambia on when and how to treat, and use of (CIDRZ), Helen Bwalya Mulenga who combination prevention strategies involving welcomed the delegates marking the start of biomedical, behavioural, and structural Day 1. She proceeded to present the historical interventions. background to the Annual Pharmacy Research Subsequently, Andrew Chali, a pharmacy Conferences which started in 2014. Landmark graduate from the Lusaka Apex Medical achievements of the previous years’ University (LAMU), discussed a study that conferences were highlighted. The 3rd Annual investigated the association between gender Pharmacy Research Conference (APRC) differences and CD4 immunological failure brought on board more co-operating partners among treatment naïve patients on such as Clinton Health Access Initiative (CHAI) antiretroviral therapy at Itezhi-tezhi District and Zambia AIDS-Related Tuberculosis project Hospital. Results showed differences in (ZAMBART). This conference attracted 14 immunological failure between treatment naïve quality presentations in the following key adult men and women in the district. This thematic areas: HIV/AIDS, rational drug use, evidence generated interest for future potential pharmacovigilance, non-communicable pharmacogenetics research to explore ways to diseases, and pharmaceutical service delivery improve clinical management of treatment among many others. A total of 90 delegates naive HIV/AIDS patients. consisting of pharmacists, pharmacy technologists, pharmacy students and other Pharmacovigilance health care experts participated in the two day Mwewa Siame from the Zambia conference, thereby attaining the objective of Medicines Regulatory Authority (ZAMRA) widening the profile of participants. presented the current pharmacovigilance Over the years, the conference has activities in Zambia. A key highlight was the witnessed a remarkable growth in the number legal basis for spontaneous reporting of of delegates, the quality of presentations, adverse drug reactions (ADRs). Importantly, in learning activities, and participation from Zambia, ADR report forms were voluntarily sent different pharmaceutical sectors in Zambia. from health facilities via email, fax or phone to The APRC continues to demonstrate the the National Pharmacovigilance Unit (NPVU) at growing influence of research in the ZAMRA. A total of 38 ADR reports were pharmaceutical sector and health care services forwarded to the NPVU by June 2016. Low in general. The following are the extracts of the rates of spontaneous reporting were attributed conference’s presentations: to massive under-reporting, which affected appropriate decision-making to impact drug HIV/AIDS safety locally. Implementation of effective

strategies to overcome challenges such as observed high rate of antibiotic prescribing at under-reporting of ADRs, low sensitization and UTH. inadequate training, including insufficient In a similar study, Ephraim Phiri, a lecturer from resources were identified as gaps that should Evelyn Hone College Pharmacy Section be prioritized to improve the current ADR presented findings of a study on the rational reporting rates in Zambia. Delegates proposed use and availability of antimicrobials in primary other innovative approaches which included: level health facilities under the establishing online e-reporting platforms, public community health office in 2015. An average toll-free lines and increased budgetary 79% of first-line essential antimicrobials were allocation to support pharmacovigilance- available throughout the year 2015. Amoxicillin related activities. and Metronidazole were the most prescribed Chichonyi Kalungia, a researcher at the antimicrobials at 32% and 17% respectively in University of Zambia (UNZA), presented most health facilities in Lusaka district. findings of a situational analysis of Non-communicable diseases management Pharmacovigilance training in pre-service undergraduate health professions programmes An assessment of clinicians’ at UNZA. Among the 6 undergraduate health management of first-episode schizophrenia at training programmes offered at UNZA School Chainama Hills Hospital in Zambia was of Medicine, only 3 programmes taught presented by James Mwanza, a postgraduate pharmacovigilance concepts in their pharmacy student at UNZA. The results curriculum. The bachelor of pharmacy showed that adherence to clinical guidelines programme taught the subject as a component was generally poor among clinicians managing in pharmacology course in the final year [3]. schizophrenia with both psychiatrists and Integrating pharmacovigilance subject as a general physicians prescribing higher doses component of undergraduate curricula for all than the recommended doses of antipsychotic health programmes was identified as one way drugs with treatment given for less than one to ensure that the knowledge acquired from year, thereby increasing the chances of pre-service training translated into professional adverse effects and relapse [5]. However, practice. Pre-service training in given the preliminary nature of this study and pharmacovigilance is another identified the debate about the optimal care for first- strategy to improve knowledge, attitude and episode schizophrenia patients, additional practice of ADR reporting that will require to be educational interventions were recommended supported for both public and private health to align clinical management with published practitioners. evidence-based practice guidelines. Rational drug use Michelo Banda, a pharmacist and postgraduate student at UNZA, presented a Winter Mudenda, Clinical Pharmacist at systematic review of the putative role that the University Teaching Hospital (UTH), uncoupling of cell respiration and oxidative discussed findings of a study on prescribing phosphorylation has in obesity. The potential patterns and medicine use at UTH in Lusaka. for further biomedical research to explore ways The study revealed that various categories of this pathway can uncover was highlighted [6]. irrational drug use indicators were high during the period reviewed. Antibiotics were among Drug discovery research the categories of drugs irrationally prescribed at 53% of all prescriptions reviewed [4]. Further Christopher Sakala, a researcher at study needs to be done in the out-patient LAMU, presented findings of an evaluation of departments to understand reasons for the the aphrodisiac potential of Pseudarthria viscida (Fabaceae) root extract in male rats for possible treatment of male sexual dysfunction 1) Assessment of the rational use and (loss of libido and ejaculation). On the basis of availability of antimicrobials at primary the results obtained, Pseudarthria viscida root level health facilities under the Lusaka extract demonstrated good activity with no DHO, Zambia. The study to focus on adverse effects observed in male rats [7]. investigating availability of Further pharmacological and pharmaceutical antimicrobials and reasons for high elucidation of active constituents was antibiotic prescribing among clinicians in recommended. Existing and emerging health facilities. opportunities in the discovery and development 2) Community ART project: Some of the of herbal formulations was also highlighted [8, 9]. suggestions included assessing the work load effect on the pharmacy Day 2 of the conference discussed key personnel servicing different issues around pharmaceutical service delivery communities; investigate the degree of and promotion of research in pharmacy. professional responsibility of the Role of the Pharmaceutical Society of pharmacy personnel over ART patients Zambia in promoting pharmacy research in communities. 3) The NPVU at ZAMRA called for The Pharmaceutical Society of Zambia research to investigate why there was (PSZ) through its National Secretary, Machi under-reporting of ADRs and Hampango, discussed its role in promoting pharmaceutical research. PSZ is charged with addressing the importance of ADR the responsibility of promoting and preserving identification and reporting by health the pharmacy profession through ensuring workers. quality provision of pharmaceutical care. PSZ 4) Conduct a nationwide study to analyze highlighted its role of promoting research as a clinical characteristics of TB-related driver to reducing the disease burden through infections, including verification of the generated evidence to inform policy formulation causes of mortality in TB patients, and promote best practices. The Society treatment default rates and prevalence encouraged its members to undertake research of MDR and XDR-TB in Zambia. seriously as a mode to contribute effectively to These research activities will be supported, the body of knowledge and public health evaluated and reported on at the next annual problem solving tool. PSZ reported working on pharmacy research conference to be held in strengthening the professional journal as a 2017. platform for possible publication of research studies within and outside Zambia. The feedback received on the quality of research abstracts, presentations and CONCLUSION discussions from all the delegates that The 3rd Annual Pharmacy Research attended the conference was positive with calls Conference was a success and concluded with for more local and regional participation from all delegates agreeing on key action points that the various sectors of pharmacy and health would be further elucidated and developed as care in general. part of proposed research activities for 2016 The conference was officially closed by the and 2017. Furthermore, as a result of Lusaka District Pharmacist on behalf of the discussions held to review potential ideas to Deputy Director for Pharmaceutical Services, build on future research, the following concepts Ministry of Health. He acknowledged that the were selected: conference was successful and productive. The delegates were encouraged to look forward with much enthusiasm to participate at University of Zambia. 2016. [Unpublished next year’s annual conference that will Dissertation] University of Zambia, Lusaka. showcase research outcomes that can 4. Mudenda W., Chikatula E., Chambula E., Mwanashimbala B., Chikuta M., Masaninga F., potentially influence pharmaceutical policy and Songolo P, Vwalika B., Kachimba J.S., Mufunda J., practice in Zambia. Mweetwa B. Prescribing Patterns and Medicine Use Acknowledgements and financial at the University Teaching Hospital, Lusaka, disclosure Zambia. Medical Journal of Zambia, 2016. Vol. 43 (2): pp 94 – 102. We would like to thank the sponsors of the 5. Mwanza J., Muungo L.T., Paul R. Assessing 3rd Annual Pharmacy Research Conference as clinicians’ management of first episode schizophrenia at Chainama Hill Hospital. Southern follows: MoH, CIRDZ, WHO, CHAI and African Journal of Psychiatry. 2016 (In Press) ZAMBART for the fiscal and logistical support 6. Banda M, Lwanga G., Mukabila M. and Sijumbila G. for the event. Special thanks also extend to the Uncoupling of cell respiration and oxidative Taj Pamodzi Hotel in Lusaka for their excellent phosphorylation: its possible role in obesity, facilities and hospitality. International Journal of Current Research, 2016; 8 (2), 26130-26135. Author contributions 7. Sakala C., Pierre Y., Angadi K.K., and Kumar, S.D. Evaluation of Aphrodisiac Potential of All authors declare no conflict of interest Pseudarthriaviscida (L) Wight and Arn. (Fabaceae) associated with this work. HBM and BM led the Root Extract on Male Rats. JGTPS, 2015, Vol. 6(4): conceptualization of the manuscript, ACK, MM, 2899 – 2904. BM, MMM, JM, CS and FM drafted and edited 8. Sakala C., Pierre Y., and Kumar, S.D. Regulation the manuscript. All authors contributed inputs and Standardization of Herbal Medicines in Zambia. to writing up and internal review. JGTPS, 2016. (In Press) 9. Sakala C., Pierre Y., Angadi K.K., and Kumar, S.D. REFERENCES Current trends in standardization of herbal formulations. JGTPS, 2016. (In Press) 1. CIDRZ and MoH. Report of the 3rd Annual 10. Kalungia A.C., Kamanga T. (2016). Patients’ Pharmacy Research Conference held 19th – 20th Satisfaction with Outpatient Pharmacy Services at July 2016. Lusaka, Zambia. the University Teaching Hospital and Ndola Central 2. World Health Organization. Consolidated guidelines Hospital in Zambia. Journal of Preventive and on the use of antiretroviral drugs for treating and Rehabilitative Medicine. Vol. 1, No. 1, pp. 13-18. preventing HIV infection: Recommendations for a DOI:10.21617/jprm.2016.0101.3 public health approach, 2nd ed. June 2016. Available (http://medicine.unza.zm/research/journal) at: http://www.who.int/hiv/pub/arv/arv-2016/en/ 11. World Health Organization (WHO) – Regional Office 3. Konga K., Kalungia A.C., Prashar L. Situational for Africa. African Health Observatory, Country analysis of pharmacovigilance training in pre- Profiles: Zambia – Quality of Care, 2010 – 2014. service health professions’ programmes at

COMMENTARY Antimicrobial Resistance – The Role of Pharmacists in Resource Limited Countries

By: Friday Sakala, Cert.Pharm, Dip. Pharm, B.Pharm, MPSZ Pharmacist – Health Office, Chipata, Zambia Correspondence: [email protected] Background tend to be the main reservoirs of resistant micro-organisms. Patients who are carriers Anti-microbial resistance is recognised as one of the greatest threats to global health. It of resistant micro-organisms act as a threatens the effective prevention and source of infections for others; and treatment of an ever – increasing range of  Weak surveillance systems contribute to infections caused by bacteria, parasites, the spread of drug resistance. viruses and fungi. The cost of health care for The role of pharmacists in combating and patients with resistant infections is higher than preventing antimicrobial resistance in for patients with non- resistant infections due to resource limited countries longer duration of illness, additional tests and use of more expensive drugs. Antimicrobial Pharmacists, as custodians of medicines resistance has become a global health problem from drug discovery to usage, have a more over the past years as the use and misuse of critical role to play than any other health antimicrobials has increased the number and profession in the health care delivery system in type of resistant organisms; consequently, resource limited countries. In Zambia for many infectious diseases in future may become example, where fiscal resources to procure unmanageable. There are many causes of drug antimicrobial medicines to cater for a growing resistance and most noted ones are: population of about 15 million people are limited and coupled by a high infectious  Inappropriate use of medicine – i.e. disease burden, Pharmacists’ knowledge of overuse, underuse and misuse of medicine discovery, development, formulation, can contribute to antimicrobial resistance; management and rational use of antimicrobial  Lack of quality medicine – most drug medicines becomes a useful resource for the quality assurance systems are weak, nation. especially in resource-limited countries like Zambia. This can lead to poor quality There are a number of activities in which pharmacists can actively participate in order to medicines, thereby exposing patients to reduce antimicrobial resistance. These are as sub-optimal concentrations of follows: antimicrobials, consequently creating the conditions for resistance to develop; 1. Formulation of clinical guidelines that  Animal husbandry – sub-therapeutic doses assure compliance– evidence based of antibiotics used for prevention of clinical guidelines are a critical diseases in animals can result in pre- component which pharmacists can take exposure of antibiotics to humans thus a lead in formulation in order to promote causing resistance to micro-organisms; rational use of medicines.  Poor infection prevention and control can 2. Review and development of treatment amplify drug resistance and this is mostly protocols for most encountered common among hospitalised patients who diseases in health facilities, wards or

units is critical and vital to optimise the antimicrobial resistance. Antimicrobial use of the already limited resources. stewardship has been used in most developed 3. Identifying areas which are proliferating and industrialised countries to promote rational antimicrobial resistance in the health use of antimicrobials. It is an effective approach care system or at facility levels, and to improve antimicrobial use in hospitals using develop strategies on how to address an organised antimicrobial management those areas in a systematic way while programme. The programme uses multidisciplinary approaches where the involving a multi- disciplinary team. expertise and resources of pharmacists, 4. Ensure that there is uninterrupted infectious disease physicians, and clinical access to essential medicines of microbiologists are utilised. assured quality, safety and efficacy. 5. Public awareness programmes against In Zambia, pharmacists in settings where misuse of antibiotics. Public awareness an antimicrobial stewardship programme is not on rational use of antibiotics has been yet in place can take up leadership in initiating reported to below in Zambia (Kalungia et such programmes as they are essential in improving appropriate antimicrobial use, al, 2016), how antibiotics are currently patient care and safety when antimicrobials are over prescribed (Mudenda et al, 2016). used. Pharmacists have unique roles and Irrational antibiotic use and over responsibilities in antimicrobial stewardship prescribing practices are recipes for programmes which include: antibiotics resistance. 6. Participating fully in initiatives or  Providing expert advice and education programmes which enhance infection to relevant hospital staff. prevention and control – poor infections  Contributing to rational use knowledge control in any setting will greatly at ward rounds, consultations and increase the spread of drug resistance. hospital therapeutic committees. Pharmacist’s role is to ensure correct  Participating in policy development and selections of disposal systems, the application and maintenance of cleaning/disinfecting agents, etc. antimicrobial formulary and prescribing 7. Fostering research, innovations and guidelines. development ofnew tools which will  Implementing and auditing activities that introduce new antibiotic molecules on promote safe and appropriate use of the market. antimicrobials. 8. Initiating Antimicrobial Stewardship  Getting actively involved in research programmes in hospitals and other activities related to antimicrobial sectors where antimicrobials are used. stewardship. 9. Advocate and promote rational  Monitoring antimicrobial use. prescribing among prescribers.  Point of care interventions.

Antimicrobial stewardship – an opportunity Introducing, enhancing and embracing for Zambian pharmacists to take the lead programmes like antimicrobial stewardship Zambia and many other countries in the among the Zambian pharmacists will surely be Southern Africa Development Community one positive way the system of healthcare can (SADC) are yet to fully explore the potential that benefit and help in reducing the rate at which Antimicrobial Stewardship programmes have antimicrobials are becoming resistant against as means of combating and preventing common pathogens that cause infectious diseases in the population.

Conclusion Antimicrobial resistance is recognised as one of the greatest threats to global health and pharmacists need to act now if the country is to realize gains that come with arresting antimicrobial resistance. If not effectively managed, antimicrobial resistance will lead to deaths as a result of common infections that will not be able to respond to antimicrobial drugs and many medical interventions. With antimicrobial resistance, infections will become impossible to manage. The time for pharmacists to act is now! Bibliography

1. WHO/Antimicrobial resistance – www.who.int/mediacentre/factsheets/fs194 2. Margaret Duguid, Marilyn C. Antimicrobial Stewardship in Australian Hospitals -2011 3. University Teaching Hospital Microbiology Laboratory Data-2015 4. Infectious disease Society of America. www.Idsociety.org 5. University Teaching Hospital (UTH) – Antibiotic Policy -2015 6. Kalungia A.C., Burger J., Godman B., de Oliveira Costa J., Simuwelu C. (2016). Non-prescription sale and dispensing of antibiotics in community pharmacies in Zambia, Expert Review of Anti- infective Therapy, DOI: 10.1080/14787210.2016.1227702 7. Mudenda W., Chikatula E., Chambula E., Mwanashimbala B., Chikuta M., Masaninga F., Songolo P., Vwalika B., Kachimba J.S, Mufunda J., Mweetwa B. (2016). Prescribing patterns and medicine use at the University Teaching Hospital,Lusaka, Zambia. Medical Journal of Zambia, Vol.43 (2): pp 94

REVIEW ARTICLE

Total Quality Management in Pharmaceutical Manufacturing towards increased Pharmaceutical Care and Health Promotion By: Mario M.J. Musonda1*, Erastus M. Mwanaumo2, Lungwani T. Muungo3 1Lecturer, Evelyn Hone College & Part-time Lecturer - University of Zambia, Lusaka, Zambia 2Assistant Dean- Postgraduate studies, Department of Civil and Environmental Engineering School of Engineering, University of Zambia, Lusaka, Zambia 3Lecturer, Department of Pharmacy, University of Zambia, Lusaka, Zambia

*Correspondence: [email protected]

ABSTRACT The quality of pharmaceutical care largely depends on the quality of the pharmaceutical products used in the treatment and management of health conditions and diseases. It has been published by World Health Organisation, the United States Food and Drugs Administration as well as other international pharmacovigilance monitoring centres that use of medicines with poor quality has fatal and sometimes permanent damage causing effects. Medicines with poor quality also partly contribute towards development of drug resistance which results in high cost of treatment and re-treatment thereby increasing the cost of pharmaceutical care and health promotion. Therefore, rational use of medicines can only be effective with the use of quality medicines. The quality and effectiveness of pharmaceutical care and health promotion depends on the quality of the medicines used in treatment and management. Total Quality Management (TQM) requires quality standards in; human resources, raw and packaging materials, machinery and equipment, procurement procedure, building and infrastructure, utilities (water, air, electricity, steam), methods and protocols. The above quality standards have international and national minimum current Good Manufacturing Practice requirements that ensure compliance and satisfaction of quality by design techniques through building quality into the product and eventual inspection through quality control testing and clinical studies as verification of compliance of the medicine’s quality, safety and efficacy. Quality of the inputs is ensured through one-off, regular and periodical building, infrastructure, supplier, utilities and human resource qualifications with requirements as well as validations of methods, protocols, processes, equipment and respective good calibration practices. Effective TQM has a direct effect on increasing the effectiveness and efficiency of pharmaceutical care and contribute towards health promotion. This in addition is done to reduce drug resistance coupled with other good pharmaceutical care practices in pharmaceutical management and rational use of the medicines.

Key Words: Good Manufacturing Practices, Health, Medicines, Pharmaceutical Care, Promotion, Quality, Total Quality Management

1. Introduction: Quality Medicines in diseases. Quality of the medicine to be used is Pharmaceutical Care and Health thus critical as it affects the therapeutic Promotion performance of the medicine. The World Health Medicines are essential inputs in health delivery Organisation (WHO) and Mezher (2015) both by both public and private facilities. This is as a affirm that poor medicines contribute to the result of the human right to health for every rising cases of disease resistance such as citizen (UNDP 2016). Therefore, malaria and tuberculosis, making these pharmaceutical care and health promotion illnesses even more difficult to treat with largely depend on the use of medicines in standard quality treatments. Newton, Green & prevention, treatment and management of Fernández (2010) elaborate further by providing

the impacts of poor quality medicines as 2. Total Quality Management (TQM) in provided below: Pharmaceutical Manufacturing Companies all over the world involved in  Increased mortality and morbidity, manufacturing and service industries are  Engendering of drug resistance and loss of implementing TQM tool to increase business medicine efficacy performance and customer satisfaction in the  Loss of confidence in health systems and face of increasing business competition (EDU health workers 2013), (Islam and Haque 2012). TQM has  Economic loss for patients, their families, successfully proven to be a management tool health systems, and the producers and that manufacturing companies have used to traders in good-quality medicines increase business performance. However, not  Adverse effects from incorrect active all sectors of manufacturing have adopted and ingredients implemented it. The study carried out by  Waste of enormous human effort and Hassan, et al. (2013) agree that successful financial outlay in development of implementation of TQM and its elements medicines, optimising dosage, carrying out increases organisational (business) clinical trials, discussing policy change, and performance of Pakistan manufacturing manufacturing medicines companies. The results of this study are  Increased burden for health workers, supported by results of studies done by Agus, medicine regulatory authorities (MRAs), Ahmad and Muhammad (2009) and Alsughayir customs officials and police officers (2013) that TQM has a positive impact on organisational productivity and profitability. WHO and Medicines Regulatory Agencies Bhaskar, Sanjib and Abhishek (2011) agree (MRAs) are promoting rational drug use as a that it is possible to implement TQM in measure in reducing drug resistance. However, pharmaceutical manufacturing in addition to Newton, Green and Fernández (2010) already existing Quality Management Systems conclude by indicating that improving quality of (QMS). production of the medicine contributes towards combating drug resistance. This is simply Pharmaceutical manufacturing uses the same because the quality of the medicines that are principle concepts of manufacturing with a rationally used require compliance to the standard category of inputs and functions. expected standards in order to produce the Figure 2.1 shows the fishbone structure of the intended therapeutic outcome. required input functions towards quality productivity (Tom and Norman 2008);

Figure 2.1: Optimum quality fishbone (Tom and Norman 2008)

Figure 2.1 provides an understanding that to (FPP)/medicine depends on the achieve the optimum result (quality medicine) manufacturing and quality of the API in medicine manufacturing, the 6 critical (WHO 2003). This process is assured input/functions need to meet the expected through qualifying the manufacturer and quality standards. It is the responsibility of the verification of the quality through country’s health ministry or the MRA to provide laboratory testing. The inactive raw guidelines and regulations with regards to the materials (excipients) are also tested by standards of the inputs (WHO 2003). In the manufacturer before being released Zambia, the Zambia Medicines Regulatory for sale to the FPP manufacturer (WHO Authority (ZAMRA) has the mandate to 2003). In addition to the chemical raw regulate the manufacturing of medicines to materials (API and excipients), water is a ensure that manufacturers comply with critical raw material which is used in the required current Good Manufacturing Practices manufacturing process (wet granulation) (cGMP) and other quality systems that produce and cleaning of the manufacturing quality assured medicines (NAZ 2013). The rooms, accessories and equipment. The inputs and processes have required standards water used in manufacturing is required as briefly explained below; to be produced from a system that assures consistent water quality as 2.1 Environment (Building and required. The performance consistency infrastructure) of the water production system is done Pharmaceutical manufacturing has to be through a stage/phase wise qualification done in a controlled environment to (WHO 2003). The chemical raw prevent contamination, degradation, materials and water are always verified cross-contamination and other material for quality compliance by quality control effects that can affect the physical and testing laboratories routinely before chemical properties of the raw materials approving them for use in the and machines. In Zambia, ZAMRA has manufacturing processes (WHO 2003). adopted and applies WHO guidelines Therefore, the vendor/manufacturer that provide guidelines for building and qualification assures procurement of infrastructure requirements, temperature quality chemical raw materials and the and humidity conditions (WHO 2003). To water production system performance ensure that the expected requirements qualification provides for consistent are satisfied, buildings under-go facility quality water production. These raw qualification while the quality of the air, materials are required be tested for temperature and humidity in the compliance with the required standards manufacturing environment is assured before being used for manufacturing. through qualifications and validations of the Heating, Ventilation and Air 2.3 Equipment & Machines Conditioning (HVAC) system (WHO The equipment and machinery used in 2003). the manufacturing of the medicines are required to meet required performance 2.2 Raw Materials outputs that assure that they will Generally pharmaceutical manufacturing consistently process the materials within requires the use of chemical raw the standards. To assure their materials and water with specific performance, they under-go a process of standards. There is a unique requirement qualification which ends with that the procurement/sourcing of the Performance Qualification (PQ) that Active Pharmaceutical Ingredient (API) is demonstrate the ability of the done consistently from the same equipment/machine to process the manufacturer as the quality of the materials at required quality level (WHO Finished Pharmaceutical Product

2003). The equipment will have to be manufacturing has already been expected to regularly checked to ensure that they increase the company efficiency (Bhaskar, remain within the expected performance Sanjib and Abhishek 2011). Focusing on the ranges/limits through the process of quality of manufacturing, it can be deduced that calibration (WHO 2003). the assurance of the quality of the inputs will give an output of a quality product. 2.4 Methods and processes Consequently, the quality of the Laboratory testing methods, pharmaceutical care in prevention, treatment manufacturing processes and cleaning and management of diseases would improve. protocols are critical in assuring the This would also provide for improved outcome quality of the manufactured medicines. in the combating of drug resistance as poor The quality of the methods, processes quality of the medicines is one of the and protocols to consistently produce the contributing factors. same results is done through analytical method validation, manufacturing Effective and efficient TQM implementation for process validation and cleaning process optimum output also requires that all critical validation (WHO 2003). The methods quality contributing factors are objectively also include testing verification for the benchmarked. Therefore, ZAMRA and WHO’s efficacy of the FPP through clinical study provision for the quality of the personnel testing for innovator products and Bio- qualifications, training, knowledge and skills is availability (BA)/Bio-equivalence (BE) not explicit with regards to the specific studies for generic products. standards. This is one weak area where 2.5 Personnel implementation of TQM would be compromised Generally, international and national as there is no standard/benchmark to verify the guidelines do not directly provide the compliance. Other inputs and areas have quality standards for the level of general minimum standard requirements to qualification, knowledge and skills that which compliance is required and can be personnel working in the manufacturing verified. area should possess. However, ZAMRA has implemented the same guidelines as 3. Conclusion and Recommendations provided by WHO which generally Despite WHO providing minimum guidelines require the personnel to have minimum which countries can adopt, these guidelines qualification and trained in the activities have to be adapted by individual countries to to be performed (WHO 2003). ensure that they are being applied within an environment that clearly understands the 2.6 Management expectations and the necessity for total Pharmaceutical manufacturing company compliance. This should be a national strategy is considered as a cooperate institution in which the national guidelines can provide for which requires a clear governance of its a framework which provides country specific operations. Therefore, management is a minimum quality standards/benchmarks. critical component as it provides the These guidelines would be developed through quality direction through the company’s consideration of the applicability while quality policy (ISO 2008). The respecting regional and international management gives direction on how guidelines. TQM can effectively be understood and The recommendations are as follows; implemented by all personnel in their  Conducting an empirical study to operations. provide correlational evidence that TQM TQM provides for consideration of all quality can facilitate improvement of attributes of the process, product and services pharmaceutical care and health that a company offers. TQM in pharmaceutical promotion,

 Review the feasibility of developing and medicines towards reported cases of implementing national manufacturing drug resistance in Zambia. guidelines with specific quality requirements for the personnel

qualifications, training, knowledge and skills,  Conducting a study that would show the percentage contribution of poor quality References Agus, Arawati, Mhd.Suhaimi Ahmad, and Jaafar Muhammad. 2009. “An Empirical Investigation on the Impact of Quality Management on Productivity and Profitability: Associations and Mediating Effect.” Contemporary Management Research 5 (1): 77-92. Alsughayir, Abdulrahman. 2013. “The Impact of Quality Practices on Productivity and Profitability in the Saudi Arabian Dried Date Industry.” American Journal of Business and Management 2 (4): 340-346. Bhaskar, Mazumder, Bhattacharya Sanjib, and Yadav Abhishek. 2011. “Total Quality Management in Pharmaceuticals: A Review.” International Journal of PharmTech Research 3 (1): 365-375. EDU, SAMPSON ABEEKU. 2013. Total Quality Management Practices among Manufacturing Firms IN GHANA. MPhil Thesis, University of Ghana, Accra: University of Ghana. Hassan, Masood ul, Saad Hassan, Sadia Shaukat, and Muhammad Saqib Nawaz. 2013. “Relationship between TQM Elements and Organizational Performance: An Empirical Study of Manufacturing Sector of Pakistan.” Pakistan Journal of Commerce and Social Sciences 7 (1): 01-18. Islam, Ariful, and Anwarul Haque. 2012. “Pillars of TQM Implementation in Manufacturing Organization- An Empirical Study .” Journal of Research in International Business and Management 2 (5): 128-141. ISO. 2008. ISO 9001:2008. Geneva: International System of Standardization. Mezher, Michael. 2015. “Poor-Quality Medicines a Global Pandemic.” American Journal of Tropical Medicine and Hygiene 1 (1). NAZ, National Assembly of Zambia. 2013. Zambia Medicines and Allied Substances Act No. 3. Lusaka: National Assembly of Zambia. Newton, Paul N, Michael D Green, and Facundo M. Fernández. 2010. “Impact of poor-quality medicines in the ‘developing’ world.” Trends in Pharmaceutical Sciences 3 (3). Tom, Cochrane, and Greig Norman. 2008. Holistic SPC. London: Quality Manufacturing Today, Cranbrook Media Ltd. UNDP. 2016. How local production of pharmaceuticals can be promoted in Africa. Assessment, UNDP, Geneva: UNDP. WHO, World Health Organisation. 2003. Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles. Technical Report Series, World Health Organisation, Geneva: World Health Organisation.

COMMENTARY

Developing Patient–focused Pharmacy Services: The Case of 24/7 Pharmacy Services in Zambia

By: Friday Sakala, Cert. Pharm, Dip.Pharm, B.Pharm Pharmacist, Chipata District Health Office, Chipata, Zambia Correspondence: [email protected]

Background General Hospital in Lusaka and Kitwe Central The pharmacy profession in Zambia stands at Hospital in Kitwe have had uninterrupted the brink of evolving its practice and working pharmacy services being offered since 2014. procedures. The increase in demand for However,the renewed 2017 Government pharmaceutical expertise in patient care, position to have pharmacy services provided management of pharmaceutical products in on 24/7 basis in all public health sector facilities hospitals, community pharmacies and industry has put the pharmacy profession ontest to has already opened up possibilities of new respond to implementing this mandate more as ways of providing pharmaceutical services for a call to duty than for reward. This call to action both pharmacists and pharmacy technologists comes at a time when the profession of alike. The era of patient-focussed care has pharmacy has been advocating for improved dawned in Zambia’s primary health care service conditions for its members serving in system. Testament to this, the honourable the public sector health facilities. Unless Minister of Health, Dr Chitalu Chilufya recently pharmacists embrace these opportunities and directed that pharmacy services in all public developments that are being presentedor health facilities be provided round the clock (24 change their service orientation and practices hours) 7 days a week. This is in tandemwith the in order to fit well into the national agenda, the patient-focussed primary care model that the profession may risk facing practice challenges Ministry of Health is implementing in Zambia. in the public sector health facilities, and stagnation in terms of policy considerations. 24/7 Pharmacy Services in Zambia: The call Embracing the call to services rather than for leadership and initiative resisting it is the way to go. However, the As health professionals, the leadership and interesting question still remains: Is the initiative of pharmacists will be vital in profession of pharmacy ready for 24/7 developing new patient–focused pharmacy pharmacy services in all public health care services that will add value to patientcare in any facilities across the country? If so, will the pharmacy practice context (whether public or professionals sustainably put patient care first private sector). Moreover, at this crucial time, ahead of limited incentives for working 27/7? the profession would do well to consider how it can lead and embrace development of new Why 24/7 pharmacy services for Zambia? pharmacy services such as 24/7 in the way that Absence of round the clock pharmaceutical will ensure that the value of such services will services can result into compromised patient be appreciated by not only the government, care as patient access to medicines and other other healthcare providers and the public, but pharmaceutical services arelimited to day time ultimately the patient as the key stakeholder in hours when the pharmacy is opened the services delivered. The concept of24/7 (Swearingen, 2014). The presence of pharmacy services is not very old in Zambia; pharmacist and pharmacy technologists on two hospitals namely, Levy Mwanawasa 24/7 basis has a lot of benefits on patients care and health systems. Several pieces of  Management of prescribed medicines: - evidence from studies have showed where patient counselling, dispensing (to in- 24/7 pharmacy services have been offered the and out-patients), and development of following benefits have been noted in both rational treatment protocols at facility short and long term: level. 1. Reduction in preventable medication  Management of chronic conditions: - errors in the hospitals monitoring of therapeutic outcomes, 2. Increased access to pharmacists by reviewing patients’ medication charts patients, physicians and nurses. and files, including repeat prescriptions. 3. Improved pharmacist interventions on  Advice and support for health care patients. professionals: - provision of information 4. Improved patients drug collection and on clinical and technical aspects of use administration time. of medicines. 5. Reduction in time delay for nursing care  Promotion and support of life style: - team in the wards from moving about health promotion, health screening. wards in cases of stock-outs as drugs  Management of common ailments: - on 24/7 are easily accessible. counselling, recommendation of line 6. The nursing staff have ample time doing action. nursing care than dispensing drugs. Conclusion 7. Prevention of over stocking of essential In many hospitals in the developed and drugs in hospitals. developing countries, emergency-after-hours 8. Reduced expired drugs in the hospitals, pharmacy services have been replaced by 9. Improved drug monitoring for those uninterrupted 24/7 pharmacy services. Zambia drugs with narrow therapeutic range. is therefore on the right track of delivering 10. Improved side effects monitoring and quality pharmaceutical services to patients by reporting system. adopting the 24/7 model of pharmacy services. 11. There is timely medication Consequently, pharmacists and pharmacy administration to patients. technologists need to embrace this 12. Reduced cost of pharmaceutical development as it will add value to patient care. services to patients in public health Bibliography facilities. 1. Strong D.K. & Tsang G.W. (1993). Focus and impact of pharmacists’ intervention, Can J hosp pharm, Since the 24/7 pharmacy services concept has 46(3); 101-8 come to stay as an integral component in the 2. American Society of Health System Pharmacists implementation of health care delivery in (2009). Emergency after – Hours Pharmacy Services. Zambia, leadership is needed to ensure 3. Aldridge V.E., Park H.K., Bounthavong Morreale A.P., (2009). The Implementation of Comprehensive 24 – actualization of full potential of pharmaceutical hours Emergency department program (EDPP). care to patients in clinical areas of the American Journal Health –System pharm. 46(3):78- hospitals. The five mains areas where 90. pharmacists in the new age of 24/7 pharmacy 4. Longley M (2006). Pharmacy in a new age: start of a services can measure their contribution to new era? Pharm J 277:256. patients care will include:

ABSTRACT Paradigm shift in pharmaceutical manufacturing through Quality by Design and Process Analytical Technologies By: Mario M.J Musonda, BSc, M.Eng, MPSZ, MISPE University of Zambia/Evelyn Hone College, Lusaka, Zambia

Correspondence: [email protected]

Background reports by researchers and companies, the Pharmaceutical development and Medicines and Allied Substances Act (MASA) manufacturing have been done traditionally No. 3 of 2013, Zambia Medicines Regulatory with the main focus of regulatory compliance of Authority Good Manufacturing Practices the finished Active Pharmaceutical Ingredient (GMP)s regulations and guidelines. The (API) and/or the Finished Pharmaceutical exclusion and inclusion criteria was used so Products (FPPs) by the manufacturer. that only literature on pharmaceutical Pharmaceutical Manufacturers (PMs) in many manufacturing of FPP and published between developing countries like Zambia are hesitant 2007 and 2017 was considered to increase to implement Quality by Design (QbD) and reliability and validity of this review and also Process Analytical Technologies (PAT) retain objectivity of the discussion. because of perceived “rigid” regulatory systems Results that do not provide sufficient tolerance for The results indicated that implementation of the innovation and system improvements. The QbD and PAT has significant benefits in PMs are thus confined to following and only promoting disease prevention and fighting complying with the provided regulations in Antimicrobial Resistance (AMR). The results manufacturing by the regulator. Consequently, also showed that effective and efficient the regulator makes regulatory decisions implementation of QbD and PAT increases without sufficient scientific and risk based data manufacturing performance and assists the which should be patient centred/focused. regulator in decision making. It was revealed Aims & objectives that the local PMs consider the regulator to be The main aim of this review and discussion was “rigid” in its enforcement of the MASA and to provide qualitative benefits of employing regulations as they do not provide for enough QbD and PAT in pharmaceutical manufacturing flexibility and room for innovation to the in Zambia. In addition, the review included an systems. However, the reviewed regulations evaluation of the status of implementation of and guidelines showed that provision is there QbD and PAT by local PMs and also reviewed for a PM to implement systems that are the provided guidelines by the regulator in scientific and risk based principles that assure relation to provisions of innovation and quality, safety and efficacy of the FPPs. continuous improvement of manufacturing Therefore, this review and discussion shows systems. that there is need for PMs to shift from Methods compliance manufacturing to QbD and PAT The review and discussion was done through based. literature review of published reports, studies, international guidelines and standards of Conclusion practice in pharmaceutical manufacturing of Pharmaceutical manufacturing in QbD and FPPs. The literature that was reviewed under PAT environments increases performance and this discussion was from World Health efficiency in the manufacturing and testing Organisation (WHO), International Conference processes while facilitating decision making by on Harmonisation (ICH), the United States the regulator. This professional collaboration by Food and Drug Administration (USFDA), the manufacturer and the regulator brings the European Medicines Agency (EMA), published patient at the centre and increases pharmaceutical care. It is recommended that PWC(2015). Process Analytical Technologies (PAT) QbD and PAT is promoted and sensitized to the and Quality by Design (QbD), Lusaka: PWC. local PMs and regulatory officers. An empirical Ministry of Health Technical Working Group. (2017). study should be conducted to correlate the Report of strategic to improve local pharmaceutical effect of QbD and PAT with promoting disease manufacturing for Ministry of Health, Lusaka: Techinical prevention and fighting AMR in Zambia. Working Group.

Key Words: Good Manufacturing Practices, Local USFDA & Services (2004). Guidance for Industry PAT pharmaceutical manufacturing, — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Process analytical technologies, Rockville: USFDA. Quality by design Bibliography: WHO, (2004). Technical Report Series 986, Geneva: World Health Organisation. Government of the Republic of Zambia (2013). Medicines and Allied Substances Act No. 3 , Lusaka: WHO, (2016). WHO Technical Report Series 996, Governement Printers. Geneva: World Health Organisation.

ABSTRACT Antibiotic Prescribing Patterns among Physicians at the University Teaching Hospital in Lusaka, Zambia Jimmy M. Hangoma1*, Lungwani T. Muungo2, Pierre Yassa3, Bellington Vwalika4, Yakub Ahmed4

1University Teaching Hospital, Department of Pharmacy, P/Bag RW1X, Ridgeway, Lusaka, Zambia. 2University of Zambia, Department of Pharmacy, P.O. Box 50110, Lusaka, Zambia. 3University of Zambia, Department of Internal Medicine, P.O. Box 50110, Lusaka, Zambia. 4University Teaching Hospital, Department of Obstetrics and Gynaecology, P/Bag RW1X, Ridgeway, Lusaka. Corresponding author: [email protected]

Background OBGY, IM, SGY and Pharmacy at the time of Inappropriate antibiotic prescribing and the the study were purposively sampled. Only increasing levels of antibiotic resistance are records of patients admitted to hospital units of now issues of global concern (Charani et al, OBGY, IM and SGY; physicians practicing in 2010). Recent evidence suggests that a the named departments at the time of data significant proportion of antibiotic prescriptions collection and clinical heads of units of the within hospitals have been described as named departments as well as the head of inappropriate (Davey et al, 2005) and up to pharmacy department at UTH were included. A 50% of antibiotic use is inappropriate (Ashiru- data extraction tool for patient treatment Oredope et al, 2012). Prescribing patterns can records was used to determine the dose, route greatly have a negative impact on patient care of administration, dosage interval and duration outcomes if not underpinned by use of ideal of antibiotic treatment. A structured self- standards and evidence-based medicine. administered questionnaire for physicians and heads of clinical departments (i.e. IM, OBGY, Aims & Objectives SGY and Pharmacy) was used to collect data The overall aim of this study was to determine on antibiotic prescribing practices, factors the antibiotic prescribing patterns among influencing antibiotic prescribing and physicians at the University Teaching Hospital structures, systems or processes regulating (UTH) in Zambia and compare compliance of antibiotic use at UTH. Data collection was antibiotic prescribing with adopted conducted over a period of four months. The recommended standards (Gyssens, 2011), Statistical Package for Social Sciences (SPSS) Zambian Standard Treatment Guidelines and version 16.0 was used for all statistical the Royal College of Pathologists & Medical calculations. Ethical approval was granted by Microbiologists traffic-light system. the University of Zambia Biomedical Research Ethics Committee (UNZABREC) and written Methods permission was obtained from the Senior A cross-sectional descriptive study utilizing Medical Superintendent at UTH. quantitative methods was conducted at UTH in Results the departments of Internal Medicine (IM), Out of the 385 patient records evaluated, 270 Surgery (SGY) and Obstetrics/Gynaecology (70%) had antibiotic(s) prescribed for the (OBGY). A representative sample of 385 patient. The average number of antibiotics per patient records were systematically selected prescription was 1.8. Across the three clinical and a convenient sample of 34 physicians (5 departments (OBGY, IM and SGY), antibiotics consultant physicians, 5 senior registrars, 8 were mostly prescribed for empirical registrars, 4 senior residence medical officers prophylaxis (n = 177), definitive treatment (n = and 12 junior resident medical officers) 197) while other prescriptions had no indication including clinical heads of departments of stated. Among the 270 patient records that had antibiotics prescribed, a total of 478 antibiotics recommendation regarding appropriateness of were prescribed among which 95% (n= 453) a prescription, the Royal College of indicated the dose, only 42% (n=113) antibiotic Pathologists & Medical Microbiologists traffic- prescriptions specified the treatment duration light system and the Zambia National Standard or review date. Regarding route and frequency Treatment Guidelines, respectively. This is a of dose administration, 94% of the prescriptions cause of concern which calls for improvements with antibiotics had dosing frequency indicated in the proper prescribing of antibiotics among whereas route of administration was indicated physicians in order to reduce the growing threat on 92% (n= 440) of the antibiotic prescriptions of antibiotic resistance in Zambia. reviewed. Only 36% (n = 97/270) of antibiotic Key words: Prescribing patterns, Physicians, prescriptions complied with recommendations Antibiotics, Culture and sensitivity, by Gyssens et al (2011) pertaining to Appropriateness appropriateness of a prescription. This was less than 85% (Red category) according to the REFERENCES traffic-light system indicating serious need to 1. Charani E, Cooke J, and Holmes A, 2010. Antibiotic improve antibiotic prescribing habits among Stewardship Programmes – What’s missing? J Antimicrob. Chemother.; 65: 2275 – 2277. prescribers at UTH. Non-compliant 2. Davey P, Brown E, Fenelon L, Finch R, Gould I, prescriptions (64%) had either the wrong Hartman G, et al. 2005. Interventions to improve antibiotic choice, wrong dose, duration, dosing antibiotic prescribing practices for hospital frequency or route of administration not inpatients. Cochrane Database Syst. Rev; 19: documented. About 58% (n = 167/290) CD003543 3. Ashiru – Oredope D, Sharland M, Charani E, prescriptions complied with the national McNulty C. and Cooke J. 2012. Improving the Standard Treatment Guidelines (STG) quality of antibiotic prescribing in the NHS by recommendations in terms of antibiotic choice developing a new Antimicrobial Stewardship for the condition and right dose. From the 270 Programme: Start Smart - Then Focus. J. patient records that has antibiotics prescribed, Antimicrob. Chemother.; 67(1): i51–i63. 4. Sharma P, and Kapoor B, 2003. Study of only 32% (n=86) had bacteriological tests Prescribing Patterns for Rational Use Therapy. JK ordered. Antibiotic availability (n = 23), Science; 5(3): 107. pharmacy operating hours (n = 12), inadequate 8. Lukwesa C. 1998. A Survey of Antibiotic Prescribing laboratory facilities (n = 11), disease patterns (n Patterns and In-vitro Antibiotic Susceptibility = 9), bacteria resistance patterns (n = 9), Patterns at The University Teaching Hospital, Lusaka, Zambia; MPH thesis, University of Zambia: previous prescribing experience (n = 9), and Zambia. cost of antibiotics (n = 8) were highlighted as 9. Akande TM, Olege M, and Medubi GF. 2009. factors that influenced antibiotic prescribing Prescribing Patterns and Cost. Int J Trop Med.; 4(2): among prescribers at UTH. Prescribers and 50-54. Head of Clinical Departments (OBGY, IM and 10. Palikhe H, 2004. Prescribing Practice of Antibiotics in Hospital in-patients. Kathamandu University Med SGY departments, respectively) stated there J.;4(1): 6-12 was only the Medicines and Therapeutics 11. Makhado M, 2009. Comparison of Antimicrobial Committee (MTC) as the organizational Prescribing Patterns with Standard Treatment structure or system that was dealing with Guidelines and Essential Drug List in Primary aspects of rational use of antibiotics at UTH. Healthcare Facilities in Vhembe District, Limpopo Province.; Master of Science in Medicine-Pharmacy Conclusion thesis, Department of Pharmacy, Faculty of There was frequent prescribing of antibiotics Healthcare Sciences, Medunsa Campus: South among physicians at UTH. Antibiotic Africa. prescribing at UTH could be rated poorly when 12. Gyssens IC, . Antibiotic Policy. j. ijantimicag. 2011; assessed against the Gyssens et al. standard 38 S: 11-20.

ABSTRACT Assessment of Prescribing and Dispensing Practices at Selected Public Healthcare Centers in Lusaka, Zambia By: Yapoma Nkhoma, Dip.Pharm, BPharm Pharmacist, Medical Stores Limited, Choma, Zambia

Background: Irrational prescribing and dispensing was 83.4%, 94.2% and 95.4% respectively. The of medicines in supply chain is a global problem and average dispensing time was 112.2 seconds, at 152 a local concern for Zambia. Recent local evidence seconds and 144 seconds at LMGH, CLIH and suggests that antimicrobial prescribing in out- KHC, respectively. According to WHO, prescribed patient populations remains high in Zambia drugs should be 100% dispensed. However, in this (Hangoma, 2014) (Mudenda et al, 2016). For study the actual drugs dispensed at LMGH, KHC instance, Mudenda et al reported an antibiotic and CLIH was 71.4%, 78.3% and 93.1% prescribing rate of 54% at the University Teaching respectively, of which only 17.6% at KHC, 50.8% at Hospital in Lusaka with generic prescribing at only CLIH and 51.8% at LMGH were adequately 56%. This high rate of antibiotic prescribing was labelled. At the time of data collection, neither higher than the recommended standard for health copies of the Essential Drug List (EDL), Standard facilities by World Health Organization (WHO). It Treatment Guidelines (STG) nor the national remains to be determined how the prescribing and formularies were available at the three health care dispensing practices are in the other health care facilities, respectively. facilities (both public and private) in Zambia. Conclusion: Overuse of antibiotics, polypharmacy, Prescribing and dispensing practices were poor labelling, non-availability of most prescribed investigated at three public healthcare centers as drugs and use of non-generic names were follows: Levy Mwanawasa General Hospital indicators that revealed irrational prescribing and (LMGH), Chipata Level I Hospital (CLIH) and dispensing practices at the three public healthcare Kalingalinga Health Center (KHC) in Lusaka in facilities surveyed. These findings suggested there Zambia. was need for continuous monitoring of rational Aims & Objectives: To assess the prescribing prescribing and dispensing practices and and dispensing practices among health care strengthening of systems that support rational providers in supply chain. prescribing and dispensing practices in the public Methods: The study was cross-sectional and health supply chain. descriptive in nature. Nine hundred (900) encounters from outpatient departments were Key words: Prescribing, Dispensing practice, analyzed. Three (3) facilities were selected Rational drug use, Zambia randomly from a stratified list. Patients’ prescriptions or files were enlisted using maximum Bibliography 1. Hangoma, J. (2014). Antibiotic prescribing patterns variation sampling. The World Health Organization among physicians at the University Teaching (WHO) prescribing and facility indicators were used Hospital in Lusaka, Zambia. Masters dissertation: to assess prescribing and dispensing practices. University of Zambia, Lusaka. Results: The average number of drugs prescribed 2. Mudenda, W., Chikatula, E., Chambula, E., per encounter at CLIH was 2.86 (SD ± 0.68) drugs, Mwanashimbala, B., Chikuta, M., et al (2016). at KHC was 2.92 (SD ± 0.93) and at LMGH was 3.5 Prescribing patterns and medicine use at the (SD ± 1.15) drugs with low rate of prescribing by University Teaching Hospital,Lusaka, Zambia. generic names at CLIH was 7.5%, at KHC was Medical Journal of Zambia, 43 (2): pp 94 21.92% and at LMGH was 41.2%. Antibiotics 3. World Health Organization (2017). How to prescribing was 70.6%, 96% and 96.7% at LMGH, investigate Drug Use in Health Facilities: Selected Drug Use Indicators. EDM Research Series No. KHC and CLIH respectively. Prescription of 007. Available at: Injections was 17.3%, 22% and 30.7%, at CLIH http://apps.who.int/medicinedocs/en/d/Js2289e/ KHC and LMGH respectively. The drugs (Accessed: 05/2017) prescribed from the EDL at LMGH, CLIH and KHC

ABSTRACT Impact of Clinical Pharmacists’ Interventions on the Cost of Drug Therapy at the Paediatric Intensive Care Unit at University Teaching Hospital in Lusaka, Zambia By: Machi Hampango1, Cert.Pharm, Dip.Pharm, BPharm, MClinPharm and Stephen L. Chisha2, Dip. Pharm, BPharm 1Paediatric Intensive Care Unit, Children’s Hospital, University Teaching Hospitals, Lusaka 2Candidate for MClinPharm, Department of Pharmacy, University of Zambia Correspondence: [email protected] Background Methods Clinical pharmacy has been defined by the The pharmacist intervention forms were used in American College of Clinical Pharmacy as “a the evaluation. These forms are routinely used health science discipline in which pharmacist by clinical pharmacists at PICU to record provide patient care that optimizes medication interventions and collect information such as therapy and promotes health, wellness, and the adverse drug reactions, pharmacotherapy disease prevention” (ACCP, 2012). For a regimen monitoring and other patient data clinical pharmacist, it is necessary to know and pertaining to pharmacotherapy. A three months decide the goal of therapy, best drug choice, period was used for the review based on the choosing the alternative, risks and risk-benefit quarterly reporting system that is used in the ratio, knowledge of adverse drug events (ADE) hospital. The category of drugs considered in and drug interactions. In addition, clinical the study were parenteral antimicrobials and pharmacists should be well aware on how to cardiovascular drugs, which are considered the use the drug (Buch, 2010). most frequently used in PICU. A comparison was made between pre- and post-pharmacist The cost of drug therapy and care for patients intervention in relation to cost of drug therapy. in PICU can be costly if not well managed. Lack Pre-intervention being the pharmacotherapy of inter-professional collaboration can be cited status before the clinical pharmacist’s as one of the contributing factors to the intervention, and post-intervention being the prolonged patient stay in the PICU and hence pharmacotherapy after the clinical pharmacist’s the increased cost of care. The absence of a intervention. The interventions were clinical pharmacist in PICU contributes categorized as follows: omission of therapy, immensely to non- optimized drug therapy and dosage adjustments and review of therapy. irrational drug use. As a result, it increases the cost of patient management. Therefore the Results findings of this study contribute to the body of Clinical pharmacists’ intervention lead to a total knowledge on the impact of clinical pharmacy cost avoidance of ZMW 565.60 on the cost of on cost of pharmacotherapy. pharmacotherapy which was 38.4% of the pre- intervention cost. There was an increase on the Aims & Objectives cost of pharmacotherapy of about 435.20 ZMK The principle aim of this clinical audit was to translating to 29.6% of the pre-intervention determine the impact of clinical pharmacists’ cost. The increase in cost was mostly due to interventions on the cost of pharmacotherapy under dosing and omission of therapy. At pre- at the paediatric intensive care unit at the intervention, the total cost of the Children’s Hospital of the University Teaching pharmacotherapy was ZMW 1,417.20. Among Hospitals in Lusaka. the 21 drugs audited in pre –intervention and post- intervention phase, there was a Key Words: Clinical Pharmacist, Drug Therapy downward dose adjustment on 6 drugs Cost, Paediatric Intensive Care, Pharmacist avoiding a cost of ZMW 290.00 translating into intervention 19.7%, discontinuation of therapy involved 5 References drugs with a cost avoidance of ZMW 275.60 1. American College of Clinical Pharmacy ACCP, translating into 18.7% and only 16 drugs were 2012. Clinical Pharmacy Defined. considered in pharmacotherapy out of the initial (Accessed Buch J. PDU Medical College; Rajkot: 2010. Clinically Oriented common types of interventions which clinical Pharmacology. pharmacists undertook included: correcting 2. Buch J. PDU Medical College; Rajkot: 2010. suboptimal doses, medication omissions, Clinically Oriented Pharmacology. making dosage adjustments and requests to 3. Holdford D.A., Brown T.R. American Society of review therapy. Health-System Pharmacists; Bethesda: 2010. Introduction to Hospital & Health-System Conclusion Pharmacy Practice. This clinical audit provided further evidence 4. Maclaren R., Devlin J.W., Martin S.J., Dasta J.F., Rudis M.I., Bond C.A. Critical care that clinical pharmacist interventions can result pharmacy services in United States in substantial reduction in cost of hospitals. The Annals of pharmacotherapy. Pharmacotherapy. 2006;40(4):612– 618. [PubMed] Recommendation 5. Parthasarathi G., Nyfort-Hansen K., Nahata A larger population of clinical pharmacists’ M.C. Orient Longman Private Limited; India: practice will need to be considered in the local 2004. A Text Book of Clinical Pharmacy setting in order to have well represented Practice. 6. Saokaew S., Maphanta S., Thangsomboon P. evidence of clinical impact to influence review Impact of pharmacist’s interventions on cost of of current policy and practice of pharmaceutical drugs therapy in intensive care unit. Pharmacy care. Practices. 2009;7(2):81–87.[PMC free article] [PubMed

ABSTRACT Knowledge, Attitude and Practice of Contraceptive Use among Women of Child Bearing Age in , Zambia By: Brian Halale, BPharm Intern Pharmacist, Livingstone Central Hospital, Livingstone, Zambia Correspondence: [email protected]

Background chemical methods (spermicides). About 198 of In Zambia, reproductive health services such 246 (80%) of participants believed that there as family planning continue to face a number of were dangers associated with use of social, geographical and cultural barriers. conventional contraceptives. The major Several factors hinder women of child bearing reasons for not utilizing contraceptive methods age from accessing reproductive health by most women were fear of side effects (39.7 services freely offered by the health system. In %) followed lack of knowledge of most rural areas, the problem may be compounded conventional family planning methods (20.6%). by inadequate healthcare facilities and skilled health personnel to provide the services (MoH, Conclusions 2015). As a result of some of these barriers, Although the awareness of family planning women experience a lot of unwanted and services among women was considerably high unplanned pregnancies. among women of child-bearing age in Kalomo district, it did not necessarily translate in Aims & Objectives increased uptake and utilization. Fear of side The main aim of this study was to determine effects of most systemically administered knowledge and practice of contraceptive use contraceptives negatively influenced women’s among women of child bearing age in Kalomo attitude towards uptake and utilization of district of Zambia. contraceptives. It is therefore essential to Methods increase promotion and sensitization on the The study was a quantitative descriptive design benefits of contraceptive methods so as to using a structured questionnaire administered reduce misconceptions and increase access to 246 women of child-bearing age in Kalomo and utilization of family planning services. district. Variables of interest were age, marital Reproductive health, status, socio-cultural beliefs, knowledge and Key Words: Contraceptives, Utilization, Zambia practice of family planning methods. Descriptive statistical methods were used to References analyze the data using Statistical Package for 1. Askew I. (2013). Reviewing the evidence and Social Sciences (SPSS) software version 16.0. identifying gaps in family planningresearch:The Ethical clearance was granted by the University unfinished agenda to meet FP2020 goals. New of Zambia, School of Medicine Research Ethics York:The Population Council, Inc. Committee (UNZASOMREC). 2. Dehne. K.L and Riedner. G (2010). Adolescence a dynamic concept. Reproductive Health Matters 9, Results 11-15. Oral Contraceptive Pills (OCPs) and injectable 3. MOH (2011-2015).Adolescent Health Strategic contraceptives were known among 89.4% Plan (AHSP) Lusaka: Ministry of Health Zambia participants but were least used at 5.8% and 4. Mona Sharan, 2014. Family Planning Trends in 8.5% respectively. There was very minimal Sub-Saharan Africa: Progress, Prospects, and Lessons Learned. knowledge about other types of contraceptive 5. WHO (2004).Adolescent friendly health services in methods such as intrauterine devices (IUDS), South East Asia region: Report of 9 Regional implants, emergency contraception (EC) and consultation, 9-14 February 2004, Bali, Indonesia.

ABSTRACT Study of the exocarp, mesocarp and seeds of Adansonia digitata L. fruit growing in Zambia and its possible use in pharmaceutical formulations By: Tumelo M. Akapelwa, MScPharm, MClinPharm Lusaka Apex Medical University Correspondence: [email protected] Background tablets were then tested for hardness, Adansonia digitata L. (Bombacea) baoba is coefficient of abrasion, disintegration and indigenous to Zambia, particularly grows in the dissolution. Average weight of the tablet with a valleys of Southern province of Zambia. It is standard deviation was determined. The oil of used for many purposes among its local people baobab was extracted using N-hexane via ranging from providing shelter to being a cyclic method of extraction and the iodine source of traditional herbal medicine. Some of value, refractive index and oxidation index were the traditional medicinal uses include: for determined. It was later homogenized into a rehydration, as a source of vitamins, as an cream were 5g of oil was added to a base 0.25g astringent, among many other uses. Arepsol in emulsifying agent Tween-80 Considering the above, exploring potential use combined in 50g water. in pharmaceutical formulations of the plant is important. Results Percentage content of the exocarp, pulp and Aims & Objectives seed of baobab fruit was 43%, 15% and 40% The aim of this study was to describe the respectively. The aqueous pulp extract tested properties of exocarp, mesocarp and seeds of positive for; starch, condensed tannins and the baobab fruit (Adansonia digitata L.) as a pectin. The pH of the aqueous extract was potential use in pharmaceutical formulations. 2.18+/- 0.02. Quantity of organic extracts was 65.4+/- 2.36%. Hydrophyllic fractions make up Materials & Methods 35% of phytochemicals of the exocarp and 70% This was a descriptive laboratory-based study of the pulp phytochemical while the lipid conducted at the departments of fraction of the seed –10 %.The physical Pharmacognosy and Pharmaceutical properties of the pulp and the pulp mixed with technology of the Russian People’s Friendship excipients are summarized in the table 1. The University’s Pharmacy Faculty in Russia. best mixture proved to be the mixture with a 1:1 Extraction and collection of the baobab fruit ratio of excipient and pulp as highlighted in the pulp was by pulverization followed by sieving it table. using a mesh size 0.5mm. The pulp was later microscopically assessed for the physicochemical properties that can allow its use ina tablet formulation before directly compressing it into a tablet dosage form. The constitution of the tablets produced were as follows: One type with excipients Tabullose SC and Ludipress prepared in ratios 1:2; 1:1 and 1:3 and the other type without excipients. The

Table 1- Physical properties of baobab powder

density Flowability, Angle of repose, Specimen (V= 30cm, m of cylinder Moisture % g/sec degrees 37,11g), g/cm3 Pure pulp 1,93±0,48 38,3±0,6 0,386±0,02 0,484±0,009 9,68

pulp +tabullosa 1,84 ± 0,39 39,3± 0,5 0,10+0,01 0,377±0,013 4,90 ( 50: 50) pulp + tabullosa 0,57+ 0, 25 39,0 + 0,9 0,11+ 0,03 0,48+0,020 5,98 ( 80: 20) pulp + ludipress 0,52+0,30 39,7+ 0,8 0,12 + 0,02 0,46+0,020 6,00 ( 80: 20) pulp +ludipress 0,70+ 0,50 39,3+0,8 0,10+ 0,03 0,377+0,013 4,98 ( 50: 50)

The results for the quality of tablet are presented in table 2. Table 2- Physical properties of baobab tablet produced

Feature Average weight of Tablet +/- SD Coefficient of abrasion Disintegration Strength

Result 0,300 + 0,015 g 0,60% 18 sec 79 N

The microscopic analysis is shown in the pictures presented below:

Starch granules in the cells

Pulp cells

Fruit fibers

Fruit exocarp

Figure 1- Baobab pulp microscopy

Cork

Sclerenchyma tissue

Vascular bundle

Figure 2- Transverse section of exocarp Figure 3- Vascular bundle

Oil droplets

. Part of Seed cotyledon Figure 3- Baobab seed powder before extraction Extraction yielded 11 % oil with the following properties; Table 3- Physico-chemical properties of baobab oil

Test Iodine value Oxidative index Refractive index result 98.0 0,2 1.4690 Conclusion Aqueous pulp extract of Adansonia digitata L. tested positive for starch, condensed tannins and pectin. Percentage content of the exocarp, pulp and seed of baobab fruit was 43%, 15% and 40% respectively. The pharmaceutical formulations prepared may require to be perfected and assessed for potential medicinal effects. Key Words: Baobab Fruit, Adansonia digitata, Phytochemicals, Formulation References

1. Alexeiv K.V. Technological aspects producing modern Tablet formulation. Medicines according to GMP/K.B. Alexeiv// Journal of Medical business- M., 205 - No 6 ; 12-14. 2. Alexeiv K.V. theoratic and experimental base for rare acrylic polimers used in production of soft pharmaceutical formulations (ointments and gels) and biopreparations: AutorevDicd.f.n - M., 1993-p59 3. Baobab Dried Fruit Pulp – An application for Novel Foods Approval in the EU as a food ingredient.Mr. Cyril Lombard- PhytoTrade Africa 4. Silvia Vertuani, Elena Braccioli, Valentina Buzzoni, Stefano Manfredini./Antioxidant capacity of Adansoniadigitatafruit pulp and leaves. ActaPhytotherapeutica Vol. V, n. 2, 2002; 2-7

ABSTRACT Assessment of Prescribing Practices and Availability of Antimicrobials at Primary Level Public Health Facilities in Lusaka District, Zambia By: Ephraim Phiri, BPharm, MPH Evelyn Hone College of Applied Arts and Commerce, School of Applied and Health Sciences, Pharmacy Section Correspondence: [email protected]

Background (health centres) in Lusaka District, from which Irrational use of medicines, particularly 20 primary health facilities were sampled using antimicrobials, remains a key health problem in a combination of purposive and random many developing countries including Zambia. sampling. Inappropriate, ineffective and inefficient use of Results medicines is common in health facilities at all There were more Clinical Officers (55%) than levels. There are many factors influencing Medical Doctors (25%) and Registered Nurses irrational prescribing and dispensing of (20%) in charge of prescribing at the primary antimicrobials which include: patients, level public health facilities surveyed. The main prescribers, dispensers, the supply system dispensers were Pharmacy Technologists (including industry influences), government (85%); there were no Pharmacists available at regulations and medicines information and any of the facilities. Across all the facilities, a misinformation. mean of 2.94 medicines were prescribed per Aims & Objectives prescription, with an extremely low rate of The aim of the study was to assess the prescribing drugs by generic name (36.7%). prescribing practices and availability of The proportion of prescriptions having an antimicrobials at primary level health facilities antibiotic was 36.2% whereas 3.4% included under the Lusaka district community health an injectable drug. However, despite the office, Zambia. Specifically, the study average use of injections demonstrated in this embarked: (i) the type and level of health staff study being relatively low (3.4% ranging handling prescribing and dispensing roles; (ii) between 0 - 20%), inappropriate prescribing of to describe the commonly prescribed injections was observed at Lilayi clinic (13.3%), antimicrobials; (iii) to determine availability of Kabwata clinic (15%) and the highest at the essential medicines list at each facility; and Kanyama clinic (20%). Furthermore, among all (iii) to determine availability and access to the 217 diagnoses recorded in the study none prescribed drugs at the facilities. of them had adequate severity to warrant injectable antimicrobial use especially that they Methods were prescribed to out-patients. Amoxicillin and This was a cross-sectional study that evaluated metronidazole were by far the most commonly 800 patient encounters, 520 medicines prescribed antimicrobials at 32% and 17.2% of inventory records, and other baseline data. The total antimicrobials prescribed, respectively. study adapted the World Health Organization The essential drugs list was available in 80.0% (1993) guideline on ‘How to investigate drug of facilities and among all medicines prescribed use in health facilities’. Key indicators were (including antimicrobials), a high percentage of assessed for availability and use of medicines were prescribed from the essential antimicrobials. The study population included medicines list (81.2%). This study found that all the 30 public primary level health facilities only about half (54.3%) of the prescribed References antimicrobials were actually dispensed, and 1. Fowler T., Walker, D. & Davies, S. C. (2014). The patients were required to purchase these risk/benefit of predicting a post-antibiotic era: Is the alarm working? Annals of The New York Academy medicines from the private pharmacies. of Sciences, 1323: 1-10. 2. World Bank Group, (2016). Drug-Resistant Conclusions Infections-A Threat to Our Economic Future, There was considerable polypharmacy and Washington DC, USA. Available at: inappropriate prescribing, particularly http://www.worldbank.org/en/news/press- injectable antimicrobials at the primary health release/2016/09/18/by-2050-drug-resistant- care facilities in Lusaka District. Amoxicillin and infections-could-cause-global-economic-damage- on-par-with-2008-financial-crisis Metronidazole were the most prescribed 3. World Health Organisation. (1993). How to antimicrobials. Nearly half of the medicines investigate drug use in health facilities: selected prescribed were available and actually drug use indicators. World Health Organization, dispensed to patients. Geneva. 4. World Health Organization. (2012). The world medicines situation 2011-Rational use of Key Words: Rational drug use, Antimicrobials, medicines. World Health Organization, Geneva. Availability, Public healthcare facilities, Lusaka

ABSTRACT Assessment of Neonatal Seizure Control Rates with Antiepileptic Drug Therapy at the University Teaching Hospital, Lusaka

Thikondane Mphande1, BPharm and Martin Kampamba2*, DipPharm, BPharm, MClinPharm 1Pharmacy Department, 1University Teaching Hospital, Lusaka 2Department of Pharmacy, University of Zambia, Lusaka, Zambia Correspondence: [email protected]

Background first line treatment. Only 27 cases out of 56 were Treatment selection for neonatal resolved with Phenobarbitone treatment used seizures remain restricted despite their alone, giving Phenobarbitone a seizure control relatively common occurrence even with the rate of 48%. The other 22 cases out 56 were introduction of several new antiepileptic treated with Diazepam as second line therapy of medications over the last two decades. In which 14 cases resolved giving it a seizure addition, there is significant variation in control rate of 65%. approach to the treatment of neonatal seizures, Conclusion both in medication choice and in when or Findings of this study revealed that whether to treat the condition. Phenobarbitone was the most prescribed Aims & Objectives antiepileptic drug for neonatal seizures at NICU This study aimed to describe seizure followed by Diazepam as second line treatment. control rates of antiepileptic drugs used in the In this sample, Diazepam had higher seizure management of neonatal seizures at the control rates than Phenobarbitone, despite the Neonatal Intensive Care Unit (NICU) of the latter being the first line option. University Teaching Hospital in Lusaka. Methods Key Words: Antiepileptic drugs, Neonatal A retrospective descriptive study was seizure, University Teaching Hospital undertaken in which total number of 286 patient records were reviewed. The target population References for this study included early term and full-term 1. Bergman, I, Painter M. J. and Hirsch R. P. (1993). neonates (≥37 weeks of gestation) with clinical Outcome in Neonates with Seizures Treated in an Intensive Care Unit. Annals of Neurology, 14:642-7. apparent seizures not responding to treatment 2. Bittigan, P. (2002). Antiepileptic drugs and apoptotic of hypoglycaemia, hypocalcaemia or any other neurodegeneration in the developing brain. Proc metabolic disorders presented at the Neonatal Natl Acad Sci, Issue 99, pp. 15089 - 94. Intensive Care Unit of the University Teaching 3. Boylan, G. (2004). Second-line anti-convulsant Hospital for the period October to December treatment of neonatal seizure. a video-EEG monitoring study. Neurology,Volume 62, pp. 486-8. 2015. 4. Castro Jr, C. (2005). Midazolam in neonatal Results seizures with no response to phenobarbital. Out of the 286 neonatal patients’ records Neurology,Volume 64, pp. 876-9. reviewed, 56 cases of clinical seizures were 5. Van-Rooij, L. G. (2013). Seminars in Fetal and identified representing a prevalence of 19.5% Neonatal Medicine. [Online] Available at: http://www.dx.doi.org/10.1016/j.siny.2013.01.001 during the period under review.All 56 cases of [Accessed 10 November 2015]. neonatal seizures received Phenobarbitone as

PROFILE FOCUS

LUNGWANI TYSON MAKOYE MUUNGO, Dip.Pharm, BSc.Pharm, M.Phil, PhD, LMPSZ Lecturer & Founding Head of Pharmacy Department, University of Zambia Early Childhood life Born in 1954 and raised in a village in Monze, Southern Province, Lungwani Tyson Makoye Muungo had a typical Zambian childhood. A very athletic boy he excelled at football and running. His companions nicknamed him ‘Simon Kapwepwe’ for his prowess on the sports pitch and ‘Muleya’ for his prowess on the ‘tracks’. One of the brightest stars of Banakayila Primary School, to date, he remains the only pupil to have ever qualified to Hillcrest Technical High School. The school is still considered one of the best in the country and continues to enrol pupils from among the cream of the country. He continued with running 400m, 800m and cross- country where he represented Hillcrest at national level. His football fell away at this level as he admits he found competition on the pitch at Hillcrest. He completed is secondary school in 1976. Education advancement For a man who has so much passion for the profession, it’s difficult to believe that pharmacy was not his initial career choice. He was accepted to the University of Zambia in the School of Education but ironically had no interest in becoming a teacher. He opted to go to Evelyn Hone College with the intention of studying accountancy. On learning that he was at a technical school the College Principal felt he would be better suited to study a course related to the sciences. Pharmacy was suggested and the young Lungwani Muungo gladly agreed to give it a try. Once he got started with Pharmacy, he never looked back since then. In 1980, Dr Muungo obtained a Diploma in Pharmacy Technology from Evelyn Hone College. After a short stint at the University Teaching Hospital and the Lusaka Provincial Medical Office, he proceeded to Aberdeen, Scotland on a British Council scholarship to study Pharmacy. He studied at Robert Gordon University where he obtained a Bachelor of Science in Pharmacy degree in 1987. Robert Gordon University has trained a good number of Zambian pharmacists. Dr Muungo would later return to Scotland to obtain a Masters of Philosophy (MPhil) in Pharmaceutics in 1992 and thereafter a Doctor of Philosophy (PhD) in Pharmaceutical Formulations in 1995, respectively from the Robert Gordon University, Aberdeen Scotland. Family life Having grown up in a community that upheld Christian values, Dr Muungo has not departed from that. He describes himself as a Christian and a family man. He met his wife who is a psychiatric nurse at UTH in 1978. As a student of Evelyn Hone College doing his attachment at that time, the young nurse caught his eye. The two got to know each other and began courting. They have been happily married for almost 40 years. They have four children and eight grandchildren. Life mentors & Inspirations When asked to mention some of his mentors the late Mr Smith, a man who he met in Aberdeen sprung to mind. Mr Smith was his mentor during the time he studied for his first degree. Professor Winfield was also one of Dr Muungo’s mentors. He was privileged to have been supervised by Professor Winfield at both Masters and PhD level. Winfield is widely known by many pharmacy students and practicing pharmacists as the man that is a guru in pharmacy and accomplished scholar who has authored a number of reference books such as Pharmaceutical Practice.

Hard work and determination have made Dr Muungo the man he is today. Not ashamed to admit that he was perhaps an average student he confesses that he faced many challenges throughout his academic life. Not one to easily give up, he got back up every time he was knocked down and has kept rising to this day. Professional career For most of his professional career, Dr Muungo has been as a Lecturer and was the founding Head of Pharmacy Department at the University of Zambia (UNZA). He was called by Professor Munkonge a man he looks up to and respects to pioneer the establishment of the pharmacy degree at the University of Zambia. His first appointment with UNZA was June 1999. He has been very instrumental in coming up with curricula for the various institutions offering pharmacy training in the country. Academia is definitely his forte and he is recognised not only in Zambia, but in several countries in the region. Namibia, Botswana and Zimbabwe are some of the countries where he serves as an external examiner. Other jobs of interest he had were as a lecturer at Health College in Riyadh, Saudi Arabia under the Ministry of Health; Practising pharmacist in Warehousing and Production Management at Medical Stores Limited; Part-time Research Assistant at Zeneca Group of Pharmaceuticals. The boards he has sat on and currently sits on both as chair and member are too numerous to mention. Various departments of various schools of the University of Zambia, Lusaka Apex Medical University and the Health Professions Council of Zambia are among some of these the institutions. Achievements, Awards and Accolades A well distinguished man, Dr Muungo has received the following professional awards: 1999: Pharmaco/Initial Companies for ‘Value at Work’ Award Scheme by Pharmaco and Initial, UK 2005: Outstanding Dedication and Leadership Award to Pharmaceutical Management in Zambia by MSH Plus 2009: Awarded ‘Life Membership Certificate’ by the Pharmaceutical Society of Zambia 2009: Founding Member of FIP UNESCO-UNITWIN Global Pharmacy Education Development Network for Zambia at the University of Zambia 2011: Mwape Peer Awards for the Category of Professional Innovators 2014: Founding Member of FIP Centre of Excellence for Zambia in Pharmacy Training for Africa UNESCO UNITWIN Global Pharmacy Education Development Network Project Continuous Professional Development Aside from his academic qualifications he has numerous short courses and trainings to his belt. Among them are Respiratory Masterclass, Research Ethics Training, Pharmacovigilance Training of Trainers, Utilization of Medicinal and Aromatic Plants in Turkey.

Advice and Wise Words to the Young Pharmacists and those upcoming for the future A man who strives to epitomise integrity Dr Muungo bemoans the apparent lack of professional ethics exhibited by a number of young pharmacists. His appeal to the next generation of pharmacists is for them to abide by the Hippocratic Oath they swear at the time of induction into the profession of Pharmacy. His dream for the profession is for it to be at the same level academically as other countries. Dr Muungo strongly believes that there are now enough pharmacists in the country for pharmacy to stand on its own two feet and be self-sustaining. The need for specialisation in Pharmacy has never been stronger than now. The future of pharmacy is very bright as long as the profession remains united to work towards the common goal of building the profession.

PHARMACEUTICAL WORD PUZZLE

ACROSS DOWN

1 2 3 4 5 6 1. The group of atoms 2. Colloquial. Roommate (4) in the molecule of

a drug responsible 7 for the drug’s 8 9 actions (13) 10 7. Prefix. Seven (4) 3. Abbrev. Angiotensin Converting Enzyme 11 12 13 14 Inhibitor (4) 15 8. Antiplatelet, 4. Abbrev. Oral Rehydration 16 analgesic (7) Salts (3) 17 11. Important detail 5. An excess of blood in a 18 19 about patient on part (9) prescription (4)

14. Suffix; blood 6. Ability of a drug to achieve 20 21 condition (4) the desired effect (8) 22 15. Oxygen carrier in 8. A person with asthma (9) 23 the hemoglobin molecule (4 16 Second letter of the 9. Last four letters of a Greek alphabet (4) calcium channel blocker (4) 18. Pharmacognosy; 10. A protozoal infection (7) Camellia Sinensis(3) 19. Abbrev. Co- 12. Denoting time before enzyme A (3) noon (2) 20. On a prescription; 13. Relating to vomiting (6) “2 tabs qid” means - Two tablets to be taken every …… hours (3) 22 (trade name) for 17. One common side effect the first line of most drugs (6) treatment of malaria in Zambia (7) 23 Mnemonic for fat 19. Bladder (4) soluble vitamins (4) 21. Abbrev.a hormone system that is involved in the regulation of the plasma sodium concentration and arterial blood pressure. (3)