Health systems approach to improving the use of medicines in the S. E. Asian Region. Holloway KA, Weerasuriya K, Abayawardana C, Ahmed S, Rahman F

Transcription

1 Health systems approach to improving the use of medicines in the S. E. Asian Region Holloway KA, Weerasuriya K, Abayawardana C, Ahmed S, Rahman F 1

2 Abstract Problem statement: WHO recommends national programs to improve medicine use, deciding actions on the basis of a situational analysis. However, few low & middle-income countries (LMIC) are doing this. Objectives: To develop (1) a regional strategy & (2) country plans of action based on a national situational analysis. Design: A regional meeting on improving medicines use was held in July Thereafter a situation analysis was done in Sri Lanka and Bangladesh. The process was guided by a checklist, & a subsequent workshop/debriefing meeting held to develop a national roadmap for action. Setting: Pharmaceutical sector in SEAR countries. Study population: Public & private facilities, MOH departments, academia & other stakeholders. Intervention(s): The situation analysis involved visits to the MOH (drug supply, distribution & regulation), public & private facilities, medical/pharmacy association & council, plus academia (clinical pharmacology, pharmacy, medicine) & discussion of the results with stakeholders.. Outcome Measure(s): (1) Major determinants & factors in the pharmaceutical sector impacting on medicines use, (2) Recommendations for action. Results: 9 countries attended a regional meeting in July 2010 where it was recommended that (1) a health systems integrated approach was needed & that this required doing systematic situational analyses, & (2) all MOHs have a unit dedicated to improving medicines use, guided by a multidisciplinary body. Visits were then made, at the invitation of MOH, to Sri Lanka & Bangladesh, to conduct a rapid situational analysis. Both countries have a good health service delivery infrastructure & a recently updated National Medicines Policy although many components are not implemented. Weaknesses in both countries included: insufficient availability of essential drugs in the public sector; lack of an electronic medicine inventory system to monitor consumption; lack of updated national treatment guidelines; & inadequate regulatory systems with severe manpower deficiencies. Regulatory problems included too many brands on the market (>20000), lack of pharmacists in shops to supervise dispensing, lack of an updated Over-the-Counter (OTC) list with the availability of many prescriptiononly medicines OTC, & inadequate monitoring of drug promotional activities. Stakeholders in both countries appreciated the situational analysis findings & how it facilitated planning. Recommendations included: setting up a dedicated MOH unit to monitor medicines use; initiating an electronic drug inventory system & strengthening the drug regulatory authority. Recommendations will be used for MOH & WHO planning for the pharmaceutical sector. Conclusions: A country situational analysis proved extremely useful in understanding the pharmaceutical situation &, in the absence of routine monitoring, necessary to identify a roadmap for action for both public & private sectors. Resource mobilization for this is urgently needed. Funding Source(s): WHO 2

3 Background WHO recommends national programs to improve medicine use, deciding actions on the basis of a situational analysis.but few low and middle-income countries (LMIC) are doing this and there is no standard method for doing national situational analyses. Objectives 1. To develop a regional strategy; 2. To develop country plans of action based on a national situational analysis; 3. To develop a standardised method for doing country situational analysis. 3

4 Methods Regional meeting held in July 2010 Country situational analysis done in Sri Lanka Aug 2010 and Bangladesh Nov 2010 at invitation of MOH National situational analysis consisted of: Negotiation with MOH and WHO Country Office about objectives Use of a draft tool and checklist (RUMRAT) developed in WHO/HQ Working with a national counterpart Visiting at least 2 districts to see public facilities (2 hospitals, 2PHCs) and private facilities (2 pharmacies) Visiting major MOH departments & agencies responsible for drug supply, selection and regulation, insurance, academia especially clinical pharmacology, medical council & association Conducting a 1-day workshop to validate findings and develop, by consensus, a roadmap for future action Writing a report for use by MOH & WHO Country Office in future planning 4

5 Regional Meeting July out of 11 members attended Recent projects to promote rational use of medicines in the different countries presented Special theme discussions on (1) resource mobilisation, (2) scaling up successful interventions and (3) creating an enabling policy environment Concluded that health systems integrated approach needed Recommendations Do systematic country situational analyses to develop roadmap for action to promote rational use of medicines (RUM) All MOHs should have a unit dedicated to improving medicines use, guided by a multidisciplinary body Get a Regional Committee Resolution to endorse the regional strategy 5

6 Sri Lanka (1) Drug Supply Government provides essential medicines in public sector (through MSD) but frequent stock-outs demand is outstripping supply by about 30% and inventory control is poor with no monitoring system for consumption Establish electronic inventory management system for all hospitals under Management Supplies Division (MSD) of MOH Better quantification, monitoring of consumption Drug Selection Government drug supply follows national EML but doctors request non-eml drugs and they are supplied 29% drugs non-eml in 2004 and non-eml drugs cost 29% of budget in 2010 Stricter adherence to EML colleges and specialist boards to provide guidance on reasonable specialist drugs for out-of-eml purchase permanent sub-committee to judge all out-of-list requests 6

7 Sri Lanka (2) Drug use Public PHC Px survey: 3 drugs/patient, 49% patients receive ABs, 23% patients receive vitamins, 63% drugs by generic name typical OPD child with cough & cold receives panadol, piriton, salbutamol, vitamin B Co + AB. Annual cost of panadol, piriton, salbutamol, vitamin B Co in 2009 was SLRs 355,806,110 Private Px survey less generics, less EML drugs, greater cost STGs not used, adhoc continuing professional development (CPD), lack of referral system leading to overcrowding & 1 minute consultations, no Drug and Therapeutic Committees (DTCs) Establish functional hospital DTCs to monitor use & encourage CDP Encourage Sri Lankan Medical Council to develop accreditation based on CPD that includes RUM & STGs, Start public education on drug use through existing MOH health education units attached to every hospital Have a unit in MOH dedicated to monitoring drug use and coordinating strategies to promote RUM 7

8 Regulation Sri Lanka (3) Pharmaceutical sector is larger than it need be, creating more work for an understaffed DRA, which has only 9 pharmacists 3000 pharmacies, 8000 products on market, brands of some drugs some drugs registered without recourse to the advisory committee through no-objection letters; drug promotion aimed at prescribers not monitored; OTC list not updated and Px-only drugs available OTC; pharmacists often not on premises Strengthen the DRA by recruiting more pharmacists and developing SOPs for all procedures Update the OTC list & monitor promotion aimed at prescribers Encourage stricter adherence to the registration process by publishing annually newly registered drugs (1) after approval by the Advisory Committee and (2) without recourse to the Committee Discourage registration of me-too products by increasing the registration fee, reviewing registration criteria and black-listing manufacturers who have provided false documents 8

9 Bangladesh (1) Drug Supply Government provides essential drugs in public sector (through Essential Drugs Corporation Ltd & Central Medical Supply Depot) but only 1/3 drugs available according to a 2009 study and 1/3 patients observed by consultant do not get their drugs in OPD manual inventory control system & no monitoring of consumption Establish electronic inventory management system for all hospitals / districts under control DG Health Services Better quantification, monitoring of consumption Drug Selection Government drug supply follows national EML but this list is aimed at PHC and many hospital drugs are not covered 25% budget is spent on non-eml hospital drugs Revise the national EML to have a hospital component and monitor adherence to the EML Ensure wide specialist representation & publish selection criteria Include in pre- & in-service training & sensitize all doctors 9

10 Bangladesh (2) Drug use Public PHC Px survey: av.no.drugs/patient 3.4 (ref hosp), 2.8 (dist hosp), 2.5 (PHC); % patients getting ABs 74% (ref hosp), 47% (dist hosp), 34% (PHC); one PHC gave vitamins to 59% patients 47% supply to public sector from govt manufacturer is for ABs Private Px survey: av.no.drugs/patient 3.8, av.cost/px 712 BT Many local publications showing irrational use but info not used STGs & National Formulary not used, adhoc CPD, no DTCs, lack of referral system leading to overcrowding & 1 minute consultations Inadequate control of drug promotion (though reps not allowed in public facilities before 1pm), Develop & implement STGs, establish functional DTCs in all hospitals, encourage Bangladesh Medical Council to develop accreditation based on CPD, start public education on drug use through MOH health education units attached to district hospitals Resurrect the "Core Committee for RUM" discussed by MOH in 2008 and establish an executive unit in MOH dedicated to monitoring drug use and carrying out recommendations of the core committee to promote RUM 10

11 Bangladesh (3) Regulation Pharmaceutical sector is larger than it need be, creating more work for a DRA, which has only 370 approved posts but only 135 filled 90,000 pharmacies, 255 manufacturers & 18,687 products on market, 546 brands of amoxycillin, 400 brands of ciprofloxacin Lack of SOPs for many processes and committees Drug registration process influenced by industry so allowing too many me-too products on the market 60 products approved in one Drug Control Committee (DCC) meeting drug promotion inadequately monitored, no updated OTC list and Pxonly drugs available OTC, pharmacists often not on premises Inadequate drug testing laboratory Strengthen the DRA by urgently recruiting more pharmacists and developing SOPs for all procedures Update & disseminate OTC list, assign staff to monitor promotion Discourage registration of me-too products by increasing the registration fee, reviewing registration criteria, ensuring that DCC members are adequately qualified & do not represent industry Upgrade drug testing laboratory 11

12 Rapid Appraisal Tool (RUMRAT) National situational analysis appreciated by MOH & WHO country office Preparation included negotiation of objectives, visits, national counterpart & anything else MOH wants Visits to all the major stakeholders and health facilities essential to gain an holistic understanding of the health system minimum 2 weeks to visit 2 districts Collection of actual data on consumption & prescribing essential as often MOH does not have such information & it highlights the problems Workshop /debriefing with senior MOH officials and other stakeholders very much appreciated Holistic picture provided and findings validated Forum to develop practical solutions provided Important to provide a readable report & follow-up so that the recommendations may be incorporated into future MOH plans Regional meeting & strategy gave required mandate for approaching countries to do the situational analysis Tool developed in HQ provided systematic method for doing a rapid situational analysis but requires revision to make it more user friendly 12

13 Conclusions Similar problems and solutions Serious irrational use of medicines not fully appreciated due to lack of consumption and drug use data develop an electronic inventory management system and undertake prescription audit Pharmaceutical sector larger than required causing increased work for understaffed regulatory authorities Recruit and train staff, improve drug registration and monitoring of drug promotion No MOH unit monitoring & coordinating RUM strategies Establish dedicated unit in MOH to coordinate CPD, DTCs, etc Health education structure not used for public education Public education campaign on drug use through this structure Rapid Appraisal Tool with workshop Allowed a holistic health system assessment and development of a practical roadmap for action by consensus with stakeholders 13