2023.08.15_National Drug Polices_3rd years.pptx

Pharmacy and law

1. National Drug Policy LINDA SIACHALINGA-BPHARM, Msc.SPHARM & PHARM POLICY

2. Drivers for National D rug Policy Equity access to drugs, drug effectiveness, quality and safety, and rational use of drugs Access to goods and services include of course the provision of essential medicines necessary for the prevention and treatment of prevalent diseases In addition, access to essential medicines is fundamental to human rights 2

3. National Drug Policy (NDP) The National drug policy process brings all interested parties; together focusing on political improvement and also policy guidance legislation/regulation quality control, local production education of consumers, prescribers, dispensers drug evaluation, selection and registration and rational use 3

4. Key Stakeholders In National Drug Policy The Ministry of Health is the main leader in developing such policies Other government departments also have roles to play in the procurement, processing, distribution and rational use of drugs A mong them those responsible for Planning Finance Education commerce Home affairs 4

5. Elements of National Drug Policy Legislation and regulation Medicine registration Essential drugs selection Quality assurance of pharmaceuticals and related p roducts Local p roduction of pharmaceuticals Drug allocation in the health budget/public sector financing policy Public sector procurement procedures Public sector distribution and logistics Pricing policy Information and continuing education on drug use Human Resource Development Research and Development Traditional Medicines International Co-operation 5

6. Challenges Associated With Drug Use Drug shortages or stock outs at the point of service delivery Inefficient management of drug supply at point of service delivery Inequitable distribution of medicines and medical products Irrational use of medicines High prices for drugs Problems in government’s drug supply system, damages, credibility of government health services in general I nefficient , inadequate or not at all control over quality, entry, registration, marketing, and use of pharmaceuticals An ideal National Drug Policy should be one which will able to tackle all above problems 6

7. National Drug Policy in Zambia The hierarchy of the legal framework included: Acts enacted by the Parliament of Zambia to provide legal mandate Regulations issued by the Minister of Health to provide further clarity to the principal law Guidelines issued by the Authority to provide more detail and clarity to the provisions of the Acts and Regulations 7

8. National Drug Policy in Zambia The NDP is a p rincipal h ealth vision of providing all Zambians with equity of access to cost - effective, quality health care as close to the family as possible Involves the use of medicines in the prevention, diagnosis, treatment or alleviation of disease and illness in our population The effectiveness of the health care is also dependant on the availability of medicines Ensures that priority is given to those drugs which satisfy the health needs of the majority-of our population 8

9. 9 Drug Legislation and Regulation Vision: Develop pharmaceutical legislation and regulation to effectively control the importation, manufacture, storage, distribution and supply of medicines and allied products and practice of pharmacy To ensure the effective enforcement of such legislation and regulations Aim: To ensure that all medicines and drug information conform to agreed standards for quality, efficacy and safety , throughout the chain of manufacture, importation/exportation, distribution, storage and supply To ensure that only appropriately qualified persons carry out relevant pharmaceutical practices

10. 10 Drug Legislation and Regulation The govt shall establish a Pharmaceutical Regulatory Authority (PRA ) The establishment will repeal the Pharmacy and Poisons Act, 1940 and the Therapeutic Substances Act, 1968

11. 11 Drug Legislation and Regulation The said PRA shall be autonomous and shall carry out the following: Enforcement of drug l egislation Drug registration Pharmaceutical licensing Pharmaceutical inspection Pharmaceutical Quality Control Drug Information and monitoring of drug promotion/advertising Post market drug surveillance and adverse drug reaction monitoring Control of Clinical trials International cooperation/ networking on drugs/pharmaceuticals/medicines Implementation of drug policy Appropriate database management Registration of pharmacists and pharmacy technologists and Drug selection and formulary activities

12. 12 Drug Legislation and Regulation The Pharmaceutical Act, 2004, established the PRA F unding for the PRA shall include income generated from fees charged by the PRA for its services and a grant voted by Parliament The Medicines and Allied Substances Act, 2013 repealed the Pharmaceutical Act, 2004 The new act has established, the Act continues the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority (ZAMRA)

13. 13 Quality Assurance of P harmaceuticals To ensure that the consumer has access to quality assured pharmaceuticals and related products in Zambia Quality, safety and efficacy of all pharmaceutical products shall be registered with and approved by the PRA before being marketed in Zambia The World Health Organisation's Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce shall be enforced All those engaged in Manufacture, Import, Distribution, Retail 'or Supply pharmaceutical products are licensed by the PRA Pharmaceutical inspectorate system shall be established which shall carry out regular inspections including one for renewal of license and another for monitoring

14. 14 Quality Assurance of pharmaceuticals All newly trained Pharmacy graduates shall be required to undergo a prescribed period of pre-registration training (internship) of twelve months Internship will ensure that the individuals understand the requirements pertaining to pharmacy laws and standards of pharmaceutical practice in Zambia After completing this period they shall be required to pass a pre-registration examination set by the PRA

15. 15 Quality Assurance of pharmaceuticals National Drug Quality Control Laboratory shall be established to ensure Quality, safety and efficacy of all pharmaceuticals Traditional Healers shall be encouraged to patent, register and have basic standardization of the herbal medicines Drug donations shall be acceptable only in accordance with guidelines set for drug donations by WHO at the time in force

16. Financing, Procurement, Storage & Distribution To ensure provision of sufficient funding for good quality essential drugs which are professionally, efficiently and cost effectively procured, stored and distributed as close to the family as possible Establishment of a reliable and transparent procurement system for generics at competitive prices which shall support the National Health Care Package Decentralisation of procurement shall be encouraged 16

17. Financing, Procurement, Storage & Distribution To establish a body that is independent, autonomous, professional and accountable and shall ensure the availability of essential drugs using the Zambia National Tender Board regulations The body shall comprise, Hospital Boards, Suppliers, NGO's and other interested parties Medical Stores Limited shall be restructured and commercialized Procurement at all levels shall be strengthened and carried out in accordance with Good Procurement Practices 17

18. Financing, Procurement, Storage & Distribution All warehousing facilities shall be required to meet minimum acceptable standard requirements for Good Storage Practices for Pharmaceuticals There shall be integration of procurement, storage and distribution of essential drugs and medical supplies with the vertical programmes Information system for distribution of essential drugs shall be integrated with the Health Information Management System The Govt shall encourage the expansion of community pharmacy The Government shall explore the possibilities of contracting or franchising out pharmaceutical services to community pharmacies 18

19. Local Production of pharmaceuticals The vision of local production of pharmaceuticals is an integral part of the NDP to ensure provision of good quality, safe and efficacious drugs which are affordable and to contribute to the country's economic growth and balance of payment No imported finished pharmaceuticals shall receive more favourable duty treatment than inputs for pharmaceutical manufacturing Any existing discriminating tariffs or duties in favour of finished imported pharmaceuticals shall be abolished or at least equalised with those for pharmaceutical manufacturing inputs To achieve this the MoH shall work closely with the Ministries of Commerce, Trade and Industry and Finance Specific incentives and structures to stimulate local pharmaceutical manufacturing industry shall be strengthened 19

20. Local Production of pharmaceuticals Govt will support the harmonization of registration of pharmaceutical products MOH shall use Government Drug Funds to procure locally manufactured pharmaceuticals in preference to finished products as much as possible MOH shall encourage donor drug' funds to be used to procure pharmaceutical raw materials which shall be used by local pharmaceutical manufacturers in producing essential drugs based on the essential health package In evaluating drug tenders, if a locally manufactured pharmaceutical product has a price which is 20% higher than that of an imported finished product then the local product shall be treated as at par Priority shall be given to those drugs which appear on the Zambia Essential Drug List and Zambia National Formulary 20

21. Rational Drug Use To achieve good prescribing, dispensing and compliance in all treatments at the lowest possible cost To ensure that all access to drugs is accompanied by adequate information necessary for rational use To eradicate unnecessary and inappropriate drug use at all levels of society RDU shall be achieved through regulation, better management and through education These interventions shall deal with the root causes of inappropriate use and change attitudes in the community as well as in practitioners in health facilities 21

22. Rational Drug Use Only drugs with proven efficacy, safety and quality shall be registered by the PRA Pharmaceutical manufacturers and importers shall register the locally manufactured or imported products they trade in and business restricted to those products This shall regulate the number of items on the market, ensure quality and eliminate unwanted products Drug promotion shall be required to conform to standards approved by the PRA based on the WHO criteria for the promotion of medicinal drugs A classification of Drugs as Prescription Only Medicines (POM). Pharmacy Medicines (P) and (General Sale List (GSL) shall be introduced and adhered to Prescribing shall be according to the level of care of a health facility Dispensing shall be required to have a minimum set of information and labelling of drugs 22

23. Rational Drug Use S trategies shall be structured to guide decisions of patients, managers, prescribers, dispensers, traders and the general public Standard Treatment Guidelines (STG) shall be introduced at all levels of health care and published together with ZNF Monitoring and Evaluation of the prescribing and dispensing practices with feedback to practitioners and managers shall be done at suitable intervals Educational activities shall be introduced to inform both practitioners and patients about drugs and their proper use Courses and Continuous Professional education in rational drug use shall be incorporated in medical and pharmacy schools Training of clinical officers, nurses and pharmacy technologists and other health care practitioners Public education campaigns via radio, TV, posters, community and print media 23

24. Drug selection T he selection process shall use a bottom up approach and the basic principle of efficacy, safety, quality and cost to develop drug list for most common diseases and conditions prevalent in different parts of Zambia All drugs in the drug list shall be selected by their generic names and drugs shall be selected as first, second and third line alternatives At all major hospitals (Central, Provincial and Private) Drug and Therapeutic Committees (DTC) shall be formed Essential Drug List shall be developed for each health care level (community, health centre , first, second & third referral) for all health care sector The lists shall be updated yearly and harmonized with the Standard Treatment Guidelines 24

25. Drug selection The DTC at the district and hospital levels in collaboration with the ZNFC shall be responsible for the development of essential drug lists S elected EML is the basis on which the National Essential Drug List and the ZNF shall be derived This however has remained ineffective as the private sector is able to prescribe medicines and medical supplies which are not on the National Essential Drug List The activities of the ZNFC have not been to speed with what is currently happening on the ground This trend tends to affect public health issues such as antimicrobial resistance and antimicrobial stewardship activities 25

26. Human Resource Development To provide a well motivated personnel working in a conducive environment Ensure personnel with appropriate competencies are available to provide equity of access to safe, cost effective and good quality medicines which are rationally used Human Resource Development aim to develop an efficient and effective pharmaceutical service in both the public sector and the private sector T he Government shall actively support the development of a pharmacy degree programme at University level with the aim of increasing the output of suitably trained pharmacists The government shall ensure an increase in output of pharmacy technologists at Evelyn Hone College 26

27. Human Resource Development Pharmacy degree programme at University level was established at the UNZA School of Medicine – Department of Pharmacy in 2001 and so far over 1000 graduates have been trained This is from the 1996 situation analysis which quantified the total number of Zambian pharmacist to be sixty-five (65) of which (forty-nine) were in private and sixteen (16) were in the public sector) Private Universities have added the current number of graduates:Lusaka Apex Medical University (LAMU ), Texilla American University , Levy Mwanawasa University, Copperbelt University, Mulugushi University, University of Lusaka, Cavendish University, Eden University Evelyn Hone college has training the largest population of pharmacy technologists 27

28. Human Resource Development However , anomalies in conditions of service have continued and still a huge burden to the retention of pharmaceutical personal Another challenge is inadequate funding for employment of more pharmaceutical personnel into govt (main employer) and lack of promotions 28

29. Research and Development The following Institutions are involved in drug Research and Development: Tropical Diseases Research Centre (TDRC), University of Zambia (UNZA), National Council for Scientific Research (NCSR), The Ministry of Health (MOH) and private organisations Very few local institutions offered training in research There was little collaboration between researchers and end users such as policy makers, practitioners and consumers No local pharmaceutical manufacturer had within their operations Research and Development department or unit to co-ordinate research in various areas because the operations were very small The laboratories available had no adequate analytical equipment for carrying out sustainable research 29

30. Research and Development Collaborative research to mentor and develop capacity have been done with institutions engaged in pharmaceutical services (CIDRZ, JSI, FHI, ZAMBART, UTH-UNZA-Briton Link, Howard University, University of Maryland, Vanderbilt University, University of North Carolina, etc .) The universities are also getting involved in research and publication of findings in peer reviewed journals More institutional review boards have been set up to over see research activities which report their activities to the National Health Research Authority Career pharmaceutical personnel are encouraged to be involved in research and development to promote locally generated evidence based practices 30

31. Traditional Medicines There was no implementable government policy on the promotion of traditional medicines in Zambia There was no regulation to control the use of traditional medicines by the different categories of traditional healers and no co-ordination between traditional medicine and allopathic medicine N o research structure that was currently carrying out documentation and evaluation of traditional medicines identifying the therapeutic/active ingredients and working out dosages and toxicity Traditional/herbal Medicine Bill is in the pipeline and will seek to align Indigenous Knowledge and practices into well documented and patenting of remedies for protection of practitioners Research into natural medicines is receiving a lot of support and funding 31

32. International Co-operation The Health Reform under implementation in Zambia had received broad donor response from Sida , DGIS, World bank, Unicef , WHO and others and pointed to the need for coordination and concerted efforts. In relation to drugs, donor support was demonstrated in providing funds for the procurement of essential drugs for Primary Health Care, provincial and district capacity building, Human resource development and research Institutional cooperation had also been established with IHCAR, and other collaborative arrangements were being developed The Swedish support had shifted from long-term technical assistance to institutional collaboration hence mobilising the wide international network of specific expertise in IHCAR to be involved in the work Thus both long and short term technical assistance could be provided where there was little local staff available 32

33. International Co-operation International cooperation in drug related areas included: participation in the WHO Certification Scheme on pharmaceuticals; participation in International Conference for Drug Regulatory Authorities (ICDRA); WHO Drug Information System; participation in the Comparative National Policy Analysis Project and participation in the SEAMRAC initiative Other international involvements were being developed Cooperating partners have continued to support the pharmaceutical sector; programme driven activities in quantification, procurement, distribution, storage and service delivery point Drug budget support – HIV/AIDS, Tuberculosis, Malaria and other communicable diseases, Essential medicines and operational research activities 33

34. Integration of National Drug Policies into the National Health Strategy and Plan (2021-2026) Medicines and medical supplies play a critical role in the provision of curative and preventive services and, as such, the Ministry of Health continue focusing on ensuring availability of adequate, quality, safe, efficacious and affordable essential medicines and medical supplies at all levels of health care. Below is the goal, objectives and strategic interventions for the strategic plan period. These strategies will be implemented by the Ministry of Health ( MoH ), statutory agencies and strategic cooperating partners 34

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38. Thank you 38