Nepal. Pharmaceuticals in Health Care Delivery. Mission Report September Kathleen A Holloway

Transcription

1 Nepal Pharmaceuticals in Health Care Delivery Mission Report September th October 2011 Kathleen A Holloway Regional Advisor in Essential Drugs and Other Medicines World Health Organization, Regional Office for South East Asia, New Delhi 1

2 Contents Programme Agenda Acronyms... 5 Executive Summary Terms of Reference Background Medicines Supply.. 10 Insurance Medicines Selection and consumption.. 14 Medicines use Medicines Regulation Medicine Policy and health system issues Workshop Conclusions and Recommendations References.. 37 Annex 1: Persons met during the mission Annex 2: Participants in the workshop.. 41 Annex 3: Consultant s slide presentation given in workshop 42 2

3 Programme Agenda Monday, Sept 19 th Morning: Afternoon: Lazimpat). Tuesday, Sept 20 th Morning: Afternoon: Dept Drug Administration; Nepal Pharmaceutical Council; Nepal Pharmaceutical Association; Chief Pharmacist MOHP; Private pharmacy (Xeno in Dept Pharmacology, Institute of Medicine, Kathmandu; OPD Pharmacy in Tribhuvan University Teaching hospital; Sitalpaila sub-health Post (sub-hp) and Ramkot Health Post (Kathmandu district). Wednesday, Sept 21 st Morning: Logistics Management Division; Primary Health Care Revitalization Division; Afternoon: Kathmandu to Biratnagar. Thursday, Sept 22 nd Morning: Afternoon: Friday, Sept 23 rd Morning: Afternoon: District Public Health Office Morang district; Eastern Regional Store; Rangeli District Hospital (Morang); Mangalbare Primary Health Care Centre (Morang). Yangsila sub-hp and Kerabadi HP (Morang); Private pharmacy (Biratnagar). Saturday, Sept 24 th Free Sunday, Sept 25 th Morning: Afternoon: Monday, Sept 26 th Morning: Afternoon: Tuesday, Sept 27 th Morning: Afternoon: District Public Health Office Sunsari district; Inuruwa district hospital; Baklauri HP (Sunsari). B.P.Koirala Institute of Medicine, Dharan; Dept Drug Administration (DDA), Eastern Region Branch. Sitagang HP and Amahibelha sub-hp (Sunsari); Saajha Swasthya Sewa Branch in Biratnagar Wednesday, Sept 28 th Biratnagar - Kathmandu Thursday, Sept 29 th Morning: Afternoon: Thimi HP (Baktapur district in Kathmandu valley) Nepal Medical Council 3

4 Friday, Sept 30 th : Morning: Afternoon: Workshop for national stakeholders Presentation of findings by Dr. K.A.Holloway; Plenary discussion of findings and group work; Presentation of group work; Plenary discussion of group work; Development of recommendations. 4

5 Acronyms ABC ADR AHW ANM BPKIHS CDP CPD CME DDA DHS DIC DHO DPHO DRA DTC EDL EML HA HQ HP HPIC IPD IOM LMD LMIS MO MOHP MRA MTC NGO NCDA NDP NEML NMC NMA NPC NPA NRs OPD OTC RUM SOP STG TOR TUTH VDC VEN WHO ABC analysis method for measuring drug consumption Adverse Drug Reaction Auxiliary Health Worker Auxiliary Nurse Midwife BP Koirala Institute of Health Sciences Community Drug Program Continuing professional development Continuing medical education Department of Drug Administration Department of Health Services Drug Information Centre District Health Officer (doctor) District Public Health Office Drug Regulatory Authority Drug and Therapeutic Committees Essential Drug List Essential Medicines List Health Assistant Headquarters Health Post Health Post in Charge Inpatient department Institute of Medicine, Kathmandu Logistics Management Division Logistics Drug Management Inventory System Medical Officer (doctor) Ministry of Health and Population Medicines Regulatory Authority Medicines and Therapeutic Committee Non-governmental organization Nepal Chemists and Druggists Association National Drug Policy Nepal Essential Medicines List Nepal Medical Council Nepal Medical Association Nepal Pharmacy Council Nepal Pharmacy Association Nepalese Rupees Outpatient department Over-the-counter Rational use of medicines Standard Operating Procedures Standard Treatment Guidelines Terms of Reference Tribhuvan University Teaching Hospital Village Development Committee Vital Essential Non-Essential method for classifying drug importance World Health Organization 5

6 Executive summary A visit was made to Nepal during September 19-30, The programme was arranged in agreement with the MOHP. The TOR were to undertake a situational analysis of the pharmaceutical situation, focusing on health care delivery, and to conduct a 1-day workshop with stakeholders to discuss the findings and develop a roadmap for national action. Visits were made to public health facilities and private pharmacies in the Central and Eastern Regions, the major MOHP departments (including the Department of Drug Administration), the clinical pharmacology department in the Institute of Medicine, 2 university teaching hospitals, the Nepal Medical Council and Association and the Nepal Pharmacy Council and Association. It was found that Nepal has an extensive health care system in difficult terrain with trained health care personnel. However, there are a number of serious problems in the pharmaceutical sector concerning drug supply, selection, use, regulation, policy, information and coordination, as highlighted below, but there are sufficient resources and capacity to address many of the problems. Drug Supply and selection Medicines are supplied by the Logistics Management Division (LMD), MOHP, to all public district facilities. A 'push' system is used from the central level down to the district and, in theory, a 'pull' system from the primary care facility to the district. In practice, a 'push' system is used also from district to primary care facility. A recent drug supply had been received by most health facilities so there were few stock-outs observed although some of them mentioned that stock-outs were frequent and that they had to make emergency orders and collect more medicines from the district centre every 2 weeks. Dumping of short-dated medicines was observed in some facilities and one facility had a large quantity of expired medicines. Good quantification of drugs is needed but currently not possible due to a poor manual inventory control system in the district public health offices. There is a national Essential Medicines List (NEML) 2002, updated in 2011 (although only available on the web). Due to budgetary constraints the LMD is able to supply less than half the drugs on the NEML and has developed its own much shorter lists by level of facility. Referral hospitals do not receive drugs from the LMD but generally charge all patients for drugs. Government referral hospitals contract a private pharmacy to provide outpatient pharmacy services on the premises. Many non-eml drugs are stocked. It was recommended that the electronic logistic management inventory system operating centrally be extended down to the level of the district to improve stock control and quantification and that the LMD publish an ABC analysis of consumption data annually. It was also recommended that each district and each referral hospital employ a pharmacist to manage drug supply, distribution and quantification and to monitor adherence to the NEML. Drug use INRUD Nepal and other NGOs have undertaken a number of surveys on medicine use. The consultant observed prescribing that was similar to what has been previously published. High use of antibiotics for upper respiratory tract infection was observed in district level facilities. In tertiary facilities there was high use of non-eml drugs and 6

7 prescribing by brand name. National standard treatment guidelines for primary care are outdated and none exist for hospitals. Few prescribers were using any guidelines or other source of independent drug information. However, prescribers in the private sector and in tertiary hospitals were receiving pharmaceutical representatives on a daily basis. While, prescribing principles are taught at undergraduate pre-clinical level, this knowledge is later undermined by clinical studies and later work. Continuing professional development (CPD) is adhoc and not followed by many prescribers and does not include much on rational use of medicines. Most health postin-charges must visit the district centre monthly and visits are made by district level supervisors but such visits are concerned with administrative matters or the various MOHP projects but not with general prescribing or drug management. One new initiative on peer review of prescriptions is being piloted in 10 districts but full implementation has yet to start. Few hospitals have functional DTCs or undertake any prescription audit. It was recommended that a unit dedicated to regular monitoring of medicines use and implementing strategies to improve use be created within the MOHP. Other interventions recommended include: strengthening Drug and Therapeutic Committees (DTCs) in all hospitals and requiring them to monitor drug consumption and report annually to MOHP; distributing updated guidelines and incorporating them into undergraduate and Continuing Professional Development (CPD) curricula; and developing public education programs on medicines use to be delivered through the village health workers and female community health volunteers attached to primary health care facilities. Drug Regulation The Department of Drug Administration (DDA) manages a pharmaceutical sector of 10,316 registered products, 15,000 registered drug retail shops and about 100 manufacturers. There is a severe manpower shortage in the DDA, severely limiting the its ability to inspect all the registered drug outlets. Dispensing in many private pharmacy shops is done by unqualified persons contrary to regulations and prescription-only drugs are often sold without prescription. Many retail shops are staffed by paramedical workers who have failed to find jobs in the public sector and the DDA in collaboration with the Nepal Pharmacy Association has conducted a retailer training for them. There are many brands for the same active pharmaceutical ingredient available on the market so making inspection and supervision more difficult. The DDA is managing an active pharmacovigilance program but is unable to monitor pharmaceutical drug promotion due to resource constraints. The DDA has its own drug testing laboratory and tests more than 1000 samples per year but does not have the capacity to do all the testing that it feels is necessary. Drug registration is done manually and the problem of too many brands was recognized. However, the DDA has difficulty to refuse registration of new brands of molecules already existing on the market as government does not like to dissuade private manufacturing companies (all of whom request to market new products of existing molecules) from coming into Nepal. It was recommended that the manpower shortage be rectified as a matter of urgency, that the Standard Operating Procedures (SOPs) be revised for the various procedures and committees, that an electronic drug registration system be instituted and that staff be further trained on dossier evaluation for registration and that a unit be established to monitor drug promotion activities. 7

8 Coordination Many functions such as monitoring of medicines use, coordinating CPD, supporting DTCs, ensuring adherence to the NEML, updating guidelines and ensuring their distribution and incorporation into CPD and undergraduate curricula, public education on medicines use are not undertaken by any MOHP department. The National Drug Policy document, while comprehensive, is not implemented in many aspects and is currently being updated. It was recommended that multidisciplinary mandated independent statutory committee reporting directly to the Minister of Health be established and that an executive unit, possibly a Division of Pharmaceutical Services, be established to carry out the recommendations of the statutory committee. It was also recommended that within the MOHP executive division there be a unit dedicated to monitoring medicines use and coordinating the implementation of strategies to improve use. 8

9 Terms of Reference The objectives were: (1) to meet senior officials of the Nepal Ministry of Health and Population (MOHP). (2) to undertake a rapid situational analysis of the pharmaceutical situation - with a focus on health care delivery and use of medicines. (3) to conduct a 1-day workshop with national stakeholders to validate the findings of the situational analysis and to develop recommendations for future use by MOHP, WHO and stakeholders in planning. Background This mission was undertaken to conduct a national situational analysis with regard to the pharmaceutical sector in order to aid MOHP in planning future action and also to plan for future WHO technical support. The regional strategy to promote rational use of medicines (RUM), updated at the regional meeting of July 2010, recommends undertaking a situational analysis in order to plan for a more coordinated integrated approach to improving the use of medicines. This mission was undertaken during September, 2011, for this purpose. During the situational analysis, a checklist/tool developed in HQ/WHO and now being revised in the region was used. This tool allows the systematic collection of information. The persons met during the fact finding mission can be seen in annex 1. An integral part of this mission was a 1-day workshop with 31 stakeholders that was held at the end of the mission to discuss and validate the findings and to form a road map for action. The participants of the workshop can be seen in annex 2. Nepal has an extensive health care delivery system in difficult terrain. Part of this health delivery system includes delivery of medicines, free to the patient, in the public sector. However, government has insufficient funds to supply all the essential medicines to health facilities and is currently supplying less than half those approved for use. In addition, there have been concerns about irrational use of medicines and the supply system since stock-outs have been reported in some facilities and dumping (over-supply) in other facilities. For these reasons, the situational analysis was undertaken. It is hoped that the recommendations made will be incorporated into future plans of action. The words medicine and drug are used interchangeably in this report. 9

10 Medicines Supply Drugs are procured and distributed by the Logistics Management Division (LMD) of the Department of Health Services (DHS) within the MOHP. It is the policy that medicines are dispensed free of charge to patients in the public sector at district level i.e. at district hospitals, primary health care centres (PHCs), health posts (HPs) and sub-health posts (sub-hps). In addition, a budget is provided to districts to undertake local purchase according to government guidelines. Of all public purchase, 70% is done centrally, 10% at regional level (to maintain a buffer stock) and 20% at district level. The central budget allocation has been estimated for each health facility and district according to population and past usage. Usage is based on patient attendance at health facilities, a certain amount being granted per patient attending NRs 5/person at sub-hp, NRs10/person at HP, NRs 15/person at PHCs and hospitals, and NRs 100/inpatient in district hospitals. However, a survey recently found that the drug budget allocation in 2011 varied between NRs 7-76/- per illness episode in different districts and that supply was influenced by more pressure from the district to the region to supply drugs (Chhetri and Deva 2010). Secondary and tertiary level hospitals undertake all their own drug procurement and generally charge patients for drugs. In Tribhuvan University Teaching Hospital (TUTH), the hospital runs its own pharmacy for outpatient and inpatient use. In BP Koirala Institute of Health Science (BPKIHS), Dharan, the teaching hospital runs its own inpatient pharmacy but has subcontracted its outpatient pharmacy services to a private pharmacy that operates within the hospital compound. Both charge all patients for drugs, whether inpatient or outpatient. Distribution Medicines are distributed from the centre to the 5 regional warehouses and from these warehouses to the district warehouses. Most medicines are delivered to the regional warehouses with district allocation already decided. From the district warehouses, drugs are distributed to hospitals and health facilities about 3 times per year. Prior to 2007, a community drug program (CDP) was in operation whereby patients were charged for drugs at cost price and at this time most of the drugs on the national essential medicines list (NEML) were supplied to health facilities. However, since the policy was changed to distribute drugs free of charge, less than half the drugs on the national list of essential medicines have been supplied to health facilities as government has insufficient funds to cover all medicines. Thus, according the NEML 2002, the numbers of drugs listed are 205 for district hospital, 195 for PHC, 93 for HP and 54 for sub-hp. However, the number of drugs currently supplied by the LMD is 40 for district hospital, 35 for PHC and HP and 25 for sub-hp. Districts are using their local budgets to procure drugs not supplied by the LMD. Some health facilities are still operating the Community Drug Program in collaboration with the local Village Development Committee (VDC) and in these facilities patients receive drugs supplied centrally by the LMD free of charge but must pay for drugs purchased locally through the CDP. In one sub-hp, the CDP had stopped but there was a 5 Lakh balance left only which was currently frozen and unused. It was generally observed that some drugs that are neither on the LMD list nor on the 2002 NEML for the concerned category of health facility are currently supplied to 10

11 facilities. For example, ciprofloxacin and ranitidine tablets, chloramphenicol syrup and metoclopramide injection are supplied to sub-hps. Tinidazole and doxcycline are supplied to some HPs. Ampicillin and ceftriaxone injections and ofloxacin, acyclofenac and levocetrizine are supplied to districts. Other non-eml medicines are also arriving from various sources in HPs e.g. acyclovir, azithromycin, cefixime, amoxicillin/cloxacillin combination and ibuprofen/paracetamol combination products. Procurement Central procurement is done by international tender. With the exception of the national TB control program, the LMD procures on behalf of all the vertical disease control programs. There is one procurement plan per item and from this year 3 year instead of 1 year bidding has been started for all items. Two procurement advisors review all procurement plans prepared by the LMD and then the plans are discussed first with the Director General of Health Services (DGHS) and finally approval is sought from the World Bank. It appears that all procurement is decided within the LMD with the input of a Legal Advisor and a representative of Ministry of Finance. This lack of a wider outside membership in procurement decisions means that the procurement system is open to undue influence from various sources when choosing bids. However, the chief of LMD mentioned that they are currently developing an e- bidding system which would make the system more transparent and less open to biased influences. At district level, procurement is generally decided by the district health officer and district public health officer, based upon the previous year s consumption. In the TUTH teaching hospital procurement is based on the hospital formulary agreed by the DTC and with the input of the chief pharmacist of the hospital. The BPKIHS Teaching Hospital (Dharan) has only an inpatient pharmacy in the charge of an administrator with no health background (the pharmacy for outpatients having been contracted out to the private sector). The administrator of the inpatient pharmacy mentioned that procurement was very difficult because new government rules required them to accept the lowest bid which was sometimes in conflict with what the doctors wanted and also in conflict with which suppliers they felt were the most reliable. There were no criteria for judging the reliability of suppliers. Judging quality of products was done by a committee of doctors and administrators, without any input from a pharmacist, on the basis of personal experiences. Since pharmacists are generally not employed at district level, technical input into district procurement is also limited. It was mentioned that there are regulations currently being drawn up that require that all hospitals with more than 25 beds to employ a pharmacist to manage drug procurement and distribution. Quantification Quantification is based on last year s consumption and LMD consolidates information that is sent from the districts together with data supplied by the vertical disease control programs (who do their own quantification). A commodities forecasting meeting is held to agree quantities for purchase. The LMD has an electronic logistics drug management inventory system (LMIS) into which 3 staff type in data received every 3 months from each health facility in the various districts. If inaccurate information is received from the health facilities, the LMIS will also contain 11

12 inaccurate information. Unfortunately the LMIS contains no information on costs so no ABC analysis based on the value of drugs, e.g. top 20 drugs by value or the % of the drug budget spent on antibiotics, can be done. Such information would only be available from the procurement unit and this could not be supplied on request. Since there is no LMIS system or any pharmacists in the districts to supervise drug distribution, it is likely that some of the data supplied by health facilities to LMD with regard to drug stocks is inaccurate. This would lead to inaccurate central quantification estimates and forecasting. Most district staff had not received any training in stock management and there appeared to be no consistent method used by health workers for calculating the stock needed. The PHC Revitalization Division in DHS has, with the help of a USAID-funded project, undertaken a quantification exercise for all health facilities for a much larger list of drugs than currently supplied by the LMD for free distribution. It is not clear how this quantification has been done or whether the drugs outside of the current LMD list will be purchased. Furthermore, it is not clear whether the PHC Revitalization list will be consistent with the new NEML (by facility type) currently under development. Stock management The distribution system is a push system from central level to region and from region to district level, but is supposed to be a pull system from health facility to district level. However, many health workers stated that in fact a push system operated from district to health facility also. On visiting the health facilities, there was some evidence of inefficient drug distribution. At the time of the visit, most health facilities had just received their 4- monthly drug supplies so there were very few stock-outs of drugs. Nevertheless, some facilities, particularly in the Eastern region, stated that the stocks that they had recently received would only last 1-2 months and that they regularly (every 2 weeks) had to visit the DPHO to get fresh supplies themselves. Visiting the DPHO was relatively easy for the health facilities visited during this mission as all were in the Tarai. However, such frequent visits may not be possible for health facilities in the Hill or Mountainous districts. All facilities visited, in both the central and Eastern regions, complained of dumping over-supply of some drugs that they had not requested from the district public health office particularly with regard to drugs coming centrally from the LMD. In one health facility in Kathmandu, three large sacks and one big carton of expired drugs, including many antibiotics, was observed. Apparently this quantity of expired drugs had accumulated over one year and it had not been possible to redistribute despite many requests to the DPHO. In a sub-hp in the Eastern Region, a large new consignment of drugs was observed in boxes piled on the ground in the middle of the store despite there already being quite a large amount of stock on the shelves remaining from the prior consignment. Such dumping and stock-out has also been observed by others (Chhetri and Deva 2010). In one district it was mentioned that redistribution of short-dated drugs between health posts and sub-hp was relatively easy and often done in order to avoid expiry. However, in another district, it was 12

13 stated that VDCs were unhappy for their HP to send back drugs that had been allocated to them even though there was a risk of expiry. A further problem mentioned was that previously health facilities had been given the leeway to dispose of NRs 5000/- worth of expired drugs annually but that this had recently been stopped so resulting in health facilities saying that they had dispensed these drugs rather than that they had expired. Possible Solutions 1. Extension of the electronic logistics drug management inventory system (LMIS) from the central level at LMD to the regional stores, the district public health offices and district hospitals in order to: improve stock management and quantification; enable monitoring of drug consumption in the public sector. 2. Make it a requirement for the LMD, regions and districts to undertake monitoring of consumption, using ABC and other analyses, and publish their data annually. 3. LMD to undertake the following activities: Development of storage and distribution guidelines; Operation of a system of prequalification for all suppliers in procurement; Allocation of 3% procurement budget to be used for monitoring the quality of procured drugs; Training of district and hospital staff on ABC analysis of annual drug consumption. 4. Appoint a pharmacist to every district public health office/district hospital to manage drug procurement and to supervise stock management and quantification and to train health workers in these issues. 5. Require all secondary or tertiary level hospitals to employ a pharmacist to: manage drug procurement, quantification and distribution; act as the secretary to the hospital Drug and Therapeutics Committee (DTC); monitor drug consumption and undertake prescription audit and to report the results to the DTC. Insurance Generally, there is no health insurance in Nepal. A few local insurance schemes are or have been in existence. One such scheme was Lalitpur Insurance Scheme run for many years by the United Mission to Nepal. However, the consultant was unable to verify the status of this scheme during the current visit. In one PHC (Mangalbare) visited, where they were still operating the CDP, they had also initiated a local insurance scheme, run by an insurance committee with representatives from each of the local VDCs. They have two schemes. In the nonreferral scheme the premium is NRs 600/- per family (covering 6 members) per year, covering local treatment at the PHC up to NRs 6,000/- per person per year. In the 13

14 referral scheme, the premium is NRs 1,400/- per family (covering 6 members) per year, covering treatment locally in the PHC and referral to Biratnagar zonal hospital up to NRs 20,000 per person per year. Within each scheme, the benefits are divided up into maximum amounts for ambulance, drugs, inpatient fees etc. Two staff are employed by the PHC to manage the insurance system and staff in Biratanagar zonal hospital are instructed to receive the insured patients. So far 716 families are insured. In the BP Koirala Institute of Health Science, they operated their own insurance scheme for the staff. The premium paid by each staff member for each member of his/her family is according to his/her salary. For example, professional staff must pay NRs 1200/person/year, which covers 90% of all in-patient costs but not any outpatient costs. There is a maximum limit of NRs 5000/- for in-patient medicines. Medicines Selection and Consumption Nepal published its 3 rd revision of a National Essential Medicines List (NEML) subdivided by level of facility in 2002 in both hard and soft form. This year (2011), the Department of Drug Administration has just revised the NEML and published the 4 th revision (5 th edition), containing 321 essential medicines and vaccines (including supplementary anti-neoplastic agents) on its website A hard copy has not yet been published and the version on the website has no index and no information on how it was prepared as is found in the 2002 edition. The revised list has not yet been sub-divided by level of facility and it is intended that the PHC Revitalization Division of the DHS will do this. Thus, currently, the 2011 NEML is not in a format that can be used by districts. The 3 rd edition published in 2002 was prepared by an Expert committee of about 17 core members with input from a further 31 experts. The selection criteria used are not publicly available. The development of the NEML was coordinated by the DDA with WHO and other partner support. The Logistics Management Division (LMD) procures a subset of 40 drugs from the 2002 NEML, for use in primary care at the district level and districts have a small budget to procure other drugs from the NEML not supplied by LMD. Unfortunately, it was not possible to get any consumption figures from districts or the central level. Secondary and tertiary hospitals do their own procurement or contract it out to the private sector and do their own selection. TUTH had about 4000 products in its own outpatient pharmacy, all these products having been chosen by the DTC. By contrast, the BPKIHS Teaching Hospital in Dharan had contracted out outpatient pharmacy services to the private sector and this pharmacy had about 10,000 products virtually every product that is registered on the market and these products had not been chosen by their DTC. It would appear that specialist doctors are able to prescribe whatever brand they like but patients must pay. Table 1 shows the top 20 drugs used for outpatients over a 2-month period in the two teaching hospitals. It was found that in TUTH the top 20 items (11% of items) consumed 60% of the budget and that in BPKIHS Teaching Hospital the top 63 items (0.5% of items) consumed 2% of the budget. Of the top 20 drugs in TUTH 40% were non-eml drugs. Of the top 63 items in BPKIHS Teaching Hospital 22% were non- EML drugs. In TUTH, 15% of the budget was spent on antibiotics. However, many 14

15 patients may have got medicines from other private pharmacies within the hospital compound. In BPKIHS Teaching Hospital it was not possible to identify all 10,000 items so it was not possible to do a proper ABC analysis on a generic named basis or estimate the % of the budget spent on antibiotics. Table 1: Top 20 drugs consumed by outpatients in two teaching hospitals SN Tribhuvan Univ. Teaching Hospital BPKIHS Teaching Hospital 1 Omeprazole 20mg 14,804 Calcium (6 brands) 23,625 2 Dutesteride Alzuzocin* 14,780 Ferrous/Folic (3 brands) 15,853 3 Calcium 14,770 Atropine Sulphate inj 19,344 4 Atovorstatin 10mg 14,065 Ranitidine (2 brands) 10,309 5 GSB Ear Drops 13,556 Normal saline 9,948 6 Clarithromycin 500mg* 9,767 Pantoprazole* (4 brands) 9,390 7 Normal saline 9,351 Amoxycillin (2 brands) 6,680 8 Azithromycin 250mg 8,524 Paracetamol+Ibuprofen* 6,741 9 Metformin 500mg 8,024 Lithium (2 brands) 5, Amoxycillin 500mg 7,953 Ibuprofen tabs 5, Losarten* 50mg 7,869 Metronidazole 400mg 5, Ceftriaxone 1gm 7,319 Distilled water 5ml 5, Metoprolol 50mg* 7,234 Diclofenac tabs (2 brands) 4, Pantoprazole 40mg* 6,448 Ringer Lactate 500ml 3, Chloral hydrate* 6,407 Paracetamol 500mg 3, Iron 5,823 Oxytocin injection 3, Vitamin B Complex 5,877 Dextrose/normal saline 500ml 3, Optiray 300mg/100ml* 5,362 Acyclofenac tabs* 3, Ciprofloxacin 500mg 5,333 Metronidazole injection 2, Clopidrogel 75mg* 4,883 5% Dextrose 500ml 2,748 Subtotal 178,149 Subtotal 151,587 Total - all items (175) 295,139 Total - all items (>10,000) 12,030,266 * non-neml drugs A prescription audit (see section on rational use) found that the proportion of prescribed drugs belonging to the NEML was 55% in tertiary hospitals, 72% in districts hospitals and 92% in HPs and sub-hps. It was not possible in the time available to measure this in retail shops, where prescribing was exclusively by brand name. These results show that the NEML is followed by the districts and primary care facilities to a large extent but not so much by the specialist hospital doctors. In particular the very large number of medicines in the pharmacies of the two tertiary referral hospitals visited indicated that doctors generally did not use the NEML especially in the private sector. A further issue is the fact that, currently, the LMD drug list is itself not following entirely following the NEML. For example, ciprofloxacin eye and ear drops, both on the LMD list, are not on the 2002 NEML although they are on the recently webpublished 2011 NEML. Also metoclopramide injection, though on the LMD list, is not on the 2002 NEML for use at sub-hp. Whether it will be added for use at the sub- 15

16 HP in the new 2011 NEML, once classification of drugs for use by different level of facility has been done, remains to be seen. In addition, districts are purchasing some drugs that are not on the NEML e.g. ofloxacin, ampicillin inj, acyclofenac, levocetrizine, ceftriaxone. Some drugs classified for use at higher level facilities are being supplied to lower level facilities e.g. ranitidine supply to HPs and sub-hps. If there is laxity by government in following the NEML, it is difficult to convince prescribers and DTCs to follow it. Possible solutions 1. Ensure consistency between the NEML and other lists such as that used by LMD and the PHC Revitalization Division. 2. Require stricter adherence to the NEML by all levels of the public health sector: Referral hospitals should develop their own formularies from within the NEML, monitor adherence and justify the quantity of non-eml drugs used (which should not normally be more than 10-20% of the budget). DTCs or specialist boards, established by specialist associations, could provide guidance on what specialist non-eml drugs are reasonable to purchase. All districts should follow strictly the NEML with regard to purchases once the PHC Revitalization Division has categorized the NEML by level of prescriber. 3. Continue to regularly update the NEML, publish the selection criteria, widely disseminate it to all facilities and include it into pre-service and in-service training curricula in order to further sensitize doctors to the utility of following the NEML. Medicines Use There have been a number of studies of drug use in health facilities done in the last 10 years in Nepal. Table 2 summarizes the baseline data from these studies. In addition some of these studies and others have been done in association with interventions to improve the use of medicines. It has been found that a fee per drug item as compared to a fee per prescription (covering all drugs in whatever quantity) is associated with 15% better compliance to guidelines and 30% reduced drug costs (Holloway et al 2001). A fee per unit (tab/capsule) as compared to a fee per drug item (covering a full course) has been found to be associated 5-7% increase in under-dosage with antibiotics due to patients buying less tablets/capsules for less money (Holloway et al 2008). A community-based intervention involving schools and mothers groups resulted in a 9% improvement in the treatment of childhood pneumonia within the community (Holloway et al 2009). Introduction of standard treatment guidelines plus health worker training was found to reduce the unnecessary use of antibiotics in viral upper respiratory tract infection and acute viral diarrhoea by more than 50% (Kafle et al 2006). Another study also implemented guidelines and undertook health worker training and managed to improve compliance with standard treatment guidelines by 15% (Shrestha et al 2006). A recent intervention involving health worker training, peer review and self-monitoring in the districts resulted in a reduction of antibiotic use in acute diarrhoea by 75% and in viral upper respiratory tract infection by 12% and an increase in the use of ORS in acute diarrhoea by 77% and an increase in the 16

17 use of the correct antibiotics for pneumonia by 14% (Kafle et al 2009). Unlike the former studies, the latter study used a pre-post design without a control group so the actual impact of the intervention may be different from that described. Table 2: Summary of baseline drug use in primary care in Nepal as reported in studies conducted from 2000 onwards Reference Kafle et al BNMT Shankar et al 2003 Karkee et al 2004 WHO 2006 Shrestha et al 2006 Holloway et al 2008 Av. no. drug/px % Px with ABs % Px with INJs % generic drugs % EML drugs % diarrh given ABs % diarrh given ORS % pneumonias given correct AB % viral URTI given ABs % Px with VITs % Px compliant with STGs Px=prescription; AB=antibiotic; INJ=injection; EML=Essential Medicines List; ORS=oral rehydration solution; VIT=vitamin; URTI=upper respiratory infection; STG=Standard Treatment Guideline; Kafle et al 2009 The consultant undertook a rapid prescribing survey in the outpatient departments in 13 public facilities (serving mostly acute patients) and 3 private pharmacies (serving acute and chronic patients). In each facility 30 prescriptions at the pharmacy or 30 patient encounters from the OPD register were examined. In two large private pharmacies 30 patient bills from computerized records were examined and in the government pharmacy 30 prescriptions brought to the pharmacy for dispensing were examined. In some facilities, where data was obtained from the OPD register, diagnosis could be matched against treatment and an assessment of the treatment of ARI and diarrhoea was done. The two private pharmacies' data concerned mainly private outpatient prescription data and thus injection usage was zero. However, the 17

18 government pharmacy was serving the hospital and at the time of the survey only patients from the emergency room were attending - hence the high injection use. The lower rates of antibiotic use seen in the tertiary referral hospitals and retail shops reflect the higher proportion of chronic cases and lower proportion of acute cases as compared to what is seen in primary health care. The results are shown in table 3. Table 3: Prescribing survey undertaken by the consultant Drug use indicator Referral hospital N=2 District hospital and PHC* N=4 HP and Sub-HP N=7 Private Drug Retailer** N=3 Av. no. drug / Px % Px with antibiotics 21% 49% 54% 21% % Px with injections 7% 7% 2% 0-66% % Px with vitamins 5% 12% 12% 9% % drugs by generic name 42% 65% 77% 0-68% % EML drugs 55% 72% 92% - % URTI cases given ABs - 74% 72% - % drugs dispensed 89% 60% 90% 99% Av.cost/Px (NRs) * A district hospital has about 15 beds and Primary Health Care Centre about 5 beds. ** One drug retailer was a government owned pharmacy, Saaja Swasthya Sewa, which is run on a for-profit basis but tries to keep prices lower for patients buying at cost price. It can be clearly seen, by comparing tables 2 and 3, that the prescribing found in the consultant survey is similar to what has been found in other baseline surveys in district level public facilities. The average number of drugs per patient and the % of patients receiving injections in the public sector OPD are very reasonable and indicate that there is no polypharmacy or over-use of injections in district-level OPD facilities. However, antibiotic use was high. Half or more of patients received antibiotics and more than 70% of cases of upper respiratory tract infection cases received antibiotics in district-level public facilities. Although few cases of acute diarrhoea were treated with antibiotics, 81% received metronidazole. Generic prescribing and prescription of EML drugs decreases with increasing level of health facility - highest use being seen in HPs/sub-HPs and lowest use in tertiary referral hospitals. District hospitals had the lowest % of drugs dispensed, not because of stock-out, but simply because they were prescribing more non-eml drugs which were not supplied. By contrast the tertiary referral hospitals were able to arrange for their own or a contracted private pharmacy to stock the non-eml drugs that doctors wanted to prescribe. There was an enormous difference in the average drug cost per prescription between the two teaching hospitals surveyed. The TUTH with its own hospital pharmacy had very much lower prices than the BPKIHS Teaching Hospital with its contracted-out private pharmacy. In most of the public facilities visited, doctors and paramedical prescribers were seeing about 50 patients per day. Some private pharmacies have side clinics with a doctor or paramedical prescriber seeing patients. One doctor said that he saw 3-4 patients an evening. In other pharmacies, auxiliary health workers said that they saw about patients per day and one AHW who owned his own shop saw 50 patients 18

19 per day. Thus most prescribers should not be constrained by overly short consultations from making proper diagnoses. Dispensing was generally done by a paramedical staff that may have to dispense medicines to patients per day. It was observed that the patient-dispenser contact time was often less than one minute, so allowing little time to give patients proper instruction on how to take their medicines. There was no labeling apart from writing the number of tablets and the frequency per day on the strip packaging. Standard Treatment Guidelines (STG) There is a national Standard Treatment Guideline, aimed at primary care, published in However, few prescribers in district-level facilities were using it or other sources of independent drug information. There is a plan by the PHC Revitalization unit to update the national STGs for primary care. There are no national standard treatment guidelines for hospital care. There is a national formulary published in Few doctors had seen the national STGs, EML or Formulary. Education and Information Undergraduate education Prescribing principles, including the Guide to Good Prescribing, are taught to undergraduate pre-clinical level medical students in sufficient detail. However, what they learn is likely to be undermined by their clinical studies and later work with senior consultants. In the Institute of Medicine it was mentioned that a prescribing practical has been attached to the end of every clinical attachment. However, it was mentioned that more prescribing skills and clinical pharmacology teaching is needed during the clinical as well as the pre-clinical training. While some treatment protocols are included in undergraduate training, these protocols are not followed in the clinical setting. Continuing Professional Development Continuing Professional Development (CDP) is organized with the teaching hospitals for in-service staff. The MOHP vertical disease control programs run refresher training for district level staff from time to time. However, for general prescribing outside of teaching hospitals, CPD is adhoc and not mandatory, neither is it followed by many prescribers, nor does it include much on prescribing or rational use of medicines. It was mentioned that for doctors most CPD consists only of lectures accompanied by dinners sponsored by the pharmaceutical industry. In some cases the NMA organizes general meetings. However, most lectures are organized by the specialist societies. While CPD is adhoc or minimal for many prescribers, daily visits by pharmaceutical representatives are common in the private sector and also in public sector hospitals. In BPKIHS Teaching Hospital, they have a rule that no pharmaceutical representatives should visit staff before 12pm but it was said that they cannot enforce this. Almost all respondents mentioned that there is too much pressure and too many promotional activities from the pharmaceutical industry. The Nepal Pharmacy Association mentioned that they were running workshops on Good Pharmacy Practice, Good Distribution Practices and Chromatography for drug quality testing in laboratories. 19

20 Nepal Medical Council The NMC mentioned that currently they are not working towards any compulsory CME programs but that they are thinking of starting a voluntary CME scheme, where doctors will be given credit for undertaking CME. The NMC is mainly concerned with running a licensing exam for all newly qualified doctors and registering those that pass. Since many doctors have trained abroad in institutions that they feel are of inferior quality, they are obliged to run the exam and not rely on the university qualification. The high court has obliged them not to distinguish between Nepalis from home institutions versus those from foreign institutions so all newly qualified doctors must take the exam, which is a computerized MCQ test. It was mentioned that 98% of students from Nepali universities pass the exam. Out of 180 MCQ questions in this exam, 20 questions are allocated for each major specialty such as medicine and surgery and 10 questions for pharmacology. The licensing exam fee is NRs.2500/- and the fee for life registration is 1200/- for Nepalis and NRs 2500/- for foreigners. In addition students must pay an entrance fee of NRs 3000/-. In this way the NMC gains its income. It is planned to introduce 10 yearly re-registration. It was mentioned that one Nepali graduate of a foreign institution had failed the exam ninety times and that the NMC wanted to prevent this by starting an entrance exam for all students to take even before starting medical studies if they wanted to return to practice in Nepal after graduation. This would prevent unsuitable student going abroad for studies, even if using their own funds. The NMC also sets standards for the MBBS degree programme for institutions in Nepal (NMC 2010). Independent Drug Information Sources of independent drug information are few. Some teaching hospitals were receiving journals and producing newsletters but this is not generally the cases elsewhere. There is no Drug Information Centre (DIC) run by MOHP. However, there are DICs run by the university hospitals TUTH and BPKIHS. The Department of Drug Administration (DDA) produces the Nepal Drug Bulletin 3 times per year available on the DDA website (see drug regulation). However, hard copies seemed few and many health workers are unable to access the web. The Drug Information Network of Nepal (DINON) used to bring the various institutions providing drug information together, but it had become inactive during the past 2 years. Public Education There have been some small studies undertaken by NGOs, particularly INRUD Nepal, on public education with regard to use of medicines. Such studies have focused on groups such as school children, mothers and journalists. District-level facilities, such as HPs and sub-hps have Village Health Workers and Community Health Volunteers attached to them and these health workers have undertaken a lot of public education with regard to maternal child health, treatment of childhood illness, vaccination and so on. In BPKIHS it was mentioned that community education on medicine use has been undertaken by nurses. However, in general, the topics taught by Village Health Workers and Community Health Volunteers are decided by MOHP and so far these workers have not generally been used to spread messages on the proper use of medicines to the community, although many people felt this would be good to do as patient demand for drugs is high. Relevant messages could include don t take antibiotics without seeing a health worker first or medicines are not needed for simple coughs and colds or ask your doctor whether your child really needs more than 2 medicines. 20

21 Supervision and training for district level staff Most district health facility-in-charges go to the district public health office once per month for a meeting. Generally, these meetings are concerned with drug stock, meeting targets, filling in the Health Management Information System forms. It was observed that in the OPD register, where details of every patient, their diagnosis and treatment, should be written, doctors were not completing the information on drug treatment. In fact, the OPD register is only used for morbidity information by MOHP. However, drug treatment was recorded in this register by most paramedical prescribers (HAs, AHWs and ANMs) and so this data could be used to monitor prescribing habits and inform training and supervision. The DPHO sends a supervisor to each health facility under its jurisdiction with varying frequency. Some health facilities said they were visited every 1-3 months but one more remote sub-hp said that visits were once very 6 months. Visits to more remote HPs in the hill districts may be even less frequent. During these visits, only management issues are generally reviewed, such as the attendance register, reports, targets, stock, etc. Sometimes there is supervision on behalf of the vertical disease control programs of MOHP e.g. TB, malaria. However, no health worker mentioned ever receiving supervision of drug use. Recently, INRUD in collaboration with the PHC Revitalization Division in the MOHP, had undertaken a training of more than 5000 health workers on rational use of medicines in all districts. However, this is a one-off training so its impact may be limited. In addition, INRUD has developed a peer-review and self-monitoring intervention for use by districts. In this intervention, all HPs keep carbon copies of every prescription and health workers use them to analyse each other s prescriptions. The analysis has focused on the use in children of antibiotics in pneumonia and nonpneumonia, the use of antibiotics and ORS in acute diarrhoea and the use of antibiotics and benzyl benzoate in scabies. The impact in a pilot study district was very effective and described by Kafle et al (2009) as previously mentioned above. Now the intervention has been expanded to 10 more districts but the impact has not been measured. One HP-in-Charge mentioned that he had been involved in this program for one 2-day meeting which he felt had been useful. However, he mentioned that the meetings should have been every 4 months and covered more topics but that no meetings had been held for the past year ever since the first meeting. A PHC-in-Charge mentioned that the program was supposed to be starting but that no meetings had yet taken place. Health workers clearly felt the need for more training and support with regard to prescribing as shown by the following comments: HP-in-Charge (2 years training) For children under 5 years with pneumonia I must give amoxycillin according to the IMCI guidelines. Since we are short of amoxycillin and have short-dated chloramphenicol syrup, I am prescribing chloramphenicol syrup to children of more than 5 years with pneumonia in order to use up the stock. Sub-HP Peon (no training) When doctor saab is not here I do dressings and give out cetamol. For young children I give cotrim. 21