1. Rational Use of Injections within National Drug Policies World health organisation Essential Drugs and Medicines Policy Safe Injection Global Network Cairo October 2000

2. A National Drug Policy Expresses the goals and objectives set by a government for the pharmaceutical sector and identifies the main strategies for achieving them. –it is the documented framework within which the activities of the pharmaceutical sector are prioritised and coordinated –it should specify the roles of the public and private sectors and all stakeholders and is concerned with efficiency, equity, and sustainability

3. Every country needs a national drug policy because of: (1) medical reasons –25-40% of the world population has no access to drugs –up to 50% of the worlds drugs may be used inappropriately ( 2) cost reasons –drugs are 20-40% of health budgets - antibiotics & injections are most expensive

4. Goals of a national drug policy to set objectives and identify priorities for action and gain government commitment for these

5. Objectives to make essential drugs available and affordable to those who need them to ensure the safety, efficacy and quality of all medicines provided to the public to improve prescribing and dispensing practices and to promote the correct use of medicines by health workers and the public

6. The problem of unsafe inappropriate injections Overuse 5-48% of outpatients received injections in 12 developing countries Inappropriate use 22-80% of injections were found to be unnecessary in 3 developing countries Unsafe use 40% of sterilised needles and syringes in Tanzania showed bacterial contamination

7. The consequences of unsafe inappropriate use Children aged 2years in Zaire averaged 24 injections and HIV seropositivity was associated with injection frequency 39-57% of the population in Moldova received an injection over 1 year and 50% of cases of Hepatitis B were associated with injection use 75% of children with paralytic polio in India received an unnecessary injection just before onset of paralysis

8. Developing a national drug policy Organise the policy process - MOH is the most appropriate lead agency Identify and analyse the problems - involve all stakeholders Set goals and objectives - aimed at the highest priority problems Draft the policy, circulate and revise it Obtain formal endorsement for the policy and launch the policy

9. Implementing a national drug policy Depends on political will, resources, shared values between the NDP and powerful interest groups, economic situation, technical expertise, and committed people Policies often fail due to lack of political will, lack of resources and corruption

10. Comparative analysis of national drug policies, WHO/DAP/97.6 (1) A study in 12 countries (Bulgaria, Chad, Colombia, Guinea, India, Mali, Philippines, Sri Lanka, Thailand, Vietnam, Zambia, Zimbabwe) to evaluate NDP effectiveness. all countries had drug regulatory authorities with mandates which included drug registration and inspection; most countries had established structures, but implementation was not always working, and monitoring and evaluation was rarely done; it was much easier to improve drug availability than to change drug use behaviour;

11. Comparative analysis of national drug policies, WHO/DAP/97.6 (2) generic policies resulted in lower cost of treatment in the public sector; withdrawal of irrational drugs led to less irrational use; good quality assurance led to better acceptance of generics, prescribing, dispensing; good registration had a positive impact on drug use; an appropriate financing system led to better prescribing; procurement through tender led to better drug availability; public sector training led to better prescribing in the public sector as compared to the private sector.

12. Role of national drug policies to reduce unsafe inappropriate injections (1) Government commitment to safer more appropriate injections may be secured through the body responsible for the NDP (national drug authority, MOH). A national task force – a subcommittee of the NDP body - could coordinate an initial assessment of unsafe inappropriate injections and an action plan to improve use The national drug policy can reduce unsafe inappropriate injections by: (1) Selection of appropriate injectable drugs and equipment e.g. public sector EDL, market withdrawal of inappropriate injections

13. Role of national drug policies to reduce unsafe inappropriate injections (2) (2) Increasing availability of appropriate injections and alternatives to injections (3) Reducing inappropriate availability through effective registration of drugs and dispensing outlets (4) Ensuring appropriate training on the use of injections for healthcare workers (5) Encouraging appropriate public education concerning injections (6) Regulation and monitoring of promotional activities and material (7) Establish functional drug and therapeutic committees (8) Identify and eliminate economic incentives that encourage over- use of injections

14. Components of a National Drug Policy (1) Legislations and Regulations –drug regulatory authority –drug registration and licensing –pharmaceutical quality assurance –postmarketing surveillance (drug efficacy and safety) –regulation of prescription and distribution Drug Selection, EDL –criteria (efficacy, safety, quality, cost) and process Supply –Local production, procurement, distribution, storage

15. Components of a National Drug Policy (2) Rational Drug Use by providers & consumers –Objective drug information - formulary, bulletin –Controlled promotional activities Economic strategies for drugs –role of government in the pharmaceutical market –public drug financing mechanism –pricing policies e.g. retailer margins, producer prices Human resource development –role of health professions –HRD development plan –education, pre- & in-service training

16. Successful interventions to reduce unsafe and inappropriate injections (1) Interactional group discussions in Indonesia Hadiyono, Suryawati, et al, SSM, 1996, 42(8):1177-83 RCT of the effect of interactional group discussions, each lasting 1-2 hours and including 6 prescribers and 6 patients over a 4-week period. Data from 100 prescriptions per facility, 3 months pre- and post intervention. % patients prescribed injections Intervention (n = 12) Control (n =12) Pre-intervention69.575.6 Post-intervention42.367.1 Change-27.2%-8.5%

17. Successful interventions to reduce unsafe and inappropriate injections (2) Treatment and Sterility Guidelines in Tanzania Gumodoka et al, TMIH, 1998, 3(4):291-6 Pre-post study on the effect of local development and introduction of guidelines for treatment and sterilisation in 66 health facilities. Indicator of injection usePre-Post-Change % patients prescribed injections23%10%-13% % patients that received avoidable injections16%6%-10% %sterilis. needles contaminated44%22%-22%