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Bhutan

Pharmaceuticals in Health Care

Delivery

Mission Report 8 - 22 June 2011

31st July 2011

Kathleen A Holloway

Regional Advisor in Essential Drugs and Other Medicines

World Health Organization,

Regional Office for South East Asia, New Delhi

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Contents

Programme Agenda ……………………………………………………….…....……. 3

Acronyms ………………………………………………………………….....……… 5

Executive Summary …………………………………………….…………...….…… 6

Terms of Reference ……………………………………………………….…...….…. 9

Background …………………………………………………………….……..…..…. 9

Medicines Supply ……………………………………………………….……...…... 10

Medicines Selection and consumption ………………………………….……..…… 16

Medicines use ……………………………………………………………….….…... 18

Medicines Regulation ………………………………………………………....……. 25

Medicines Policy and Coordination ………………………..……….………..…….. 27

Workshop ……………………………………………………………….……..…… 32

Recommendations …………………………………………………………....…….. 33

References ……………………………………………………………….…….…… 37

Annex 1: Persons met during the mission ……………….………….………...……. 38

Annex 2: Participants in the workshop ……………………………………….…….. 40

Annex 3: Consultant’s slide presentation given in workshop ……………………… 41

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Programme Agenda

Wednesday, June 8th

Arrive Bhutan, Paro Airport

Paro - Thimphu

Thursday, June 9th

(Thimphu)

Morning: Briefing by WR and planning the program

Honorable Secretary of Health, MOH, Bhutan

Afternoon: Acting Director, Department Medical Services, MOH

Essential Medicines and Technology Division (EMTD) and

Essential Drug Program (EDP) unit

Friday, June 10th

(Thimphu)

Morning: Royal Institute of Health Sciences (RIHS)

Afternoon: Drugs, Vaccines and Equipment Division (DVED)

Drug Regulatory Authority (DRA)

Saturday, June 11th

(Thimphu) Morning: Jigme Dorji Wangchuk National Referral Hospital

Chairman of the National Drug Committee (NDC)

Afternoon: City Health Care Pharmacy (private), Thimhpu

City Pharmacy, Thimpu (private)

Sunday, June 12th

Thimphu - Bumthang

Monday, June 13th

(Bumthang)

Morning: Bumthang District Hospital

Afternoon: Tang Primary health care centre (BHU), Bumthang district

Tuesday, June 14th

(Trongsa) Morning: Bumthang - Trongsa

Trongsa district hospital

Afternoon: Tashiling BHU, Trongsa district

Wednesday, June 15th

(national holiday)

Trongsa - Gelephu

Thursday, June 16th

(Gelephu) Morning: Gelephu regional referral hospital

Afternoon: Gelephu - Thimphu

Friday, June 17th

(Gedu and Phuentsholing)

Morning: Thimphu - Gedu

Gedu Hospital

Afternoon: Gedu - Phuentsholing

Medical Supply Depot (MSD)

Namsey Dental Clinic and Pharmacy (private)

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Saturday, June 18th

(Phuentsholing)

Morning: Phuentsholing Hospital

Afternoon: Phuentsholing - Thimphu

Sunday, June 19th

(Thimphu)

Morning: Telephone interview with Drug Controller DRA

Preparation for workshop

Afternoon: Preparation for workshop

Monday, June 20th

(Thimphu) Morning: Director General, Department of Medical Services

Chief Program Officer EMTD and EDP staff

Officiating Chief Procurement Officer, DVED

Afternoon: Presentation of findings by Dr. K.A.Holloway

Plenary discussion of findings and development of

recommendations

Tuesday, June 21st (Thimphu)

Morning: Debriefing with EMTD and EDP staff

Debriefing with WHO - Dr Nani Nair (WR)

Afternoon: Thimphu - Paro

Wednesday, June 22nd

Departed from Bhutan (Paro Airport)

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Acronyms

ABC ABC analysis – method for measuring drug consumption

ADR Adverse Drug Reaction

BHU Basic Health Unit (primary care)

BMHC Bhutan Medical and Health Council

BNF Bhutan National Formulary

CHU Community Health Unit

CPD Continuing professional development

CME Continuing medical education

CMS Central Medical Store

DHO District Health Office

DIC Drug Information Centre

DIGPY Bhutan's Electronic drug inventory system

DMS Department Medical Services

DRA Drug Regulatory Authority

DTC Drug and Therapeutic Committees

DVED Drugs, Vaccines and Equipment Division

EDL Essential Drug List

EDP Essential Drug Program

EML Essential Medicines List

EMTD Essential Medicines and Technology Department

HC Health Centre

HQ Headquarters

INRUD International Network for the Rational Use of Drugs

IPD Inpatient department

JDWNRH Jigme Dorji Wangchuk National Referral Hospital

MIC Medicine Information Centre

MOH Ministry of Health

MRA Medicines Regulatory Authority

MSD Medicines Supply Depot

MTC Medicines and Therapeutic Committee

NDC National Drugs Committee

NGO Non-governmental organization

NDP National Drug Policy

NMP National Medicines Policy

NOL No objection letter

OPD Outpatient department

ORS Oral Rehydration Solution

OTC Over-the-counter

RIHS Royal Institute of Health Sciences

RUM Rational use of medicines

SOP Standard Operating Procedures

STG Standard Treatment Guidelines

TOR Terms of Reference

VEN Vital Essential Non-Essential – method for classifying drug importance

WHO World Health Organization

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Executive summary

A visit was made to Bhutan during 8 – 22 June, 2011. The programme was arranged

in agreement with the MOH with the TOR to undertake a situational analysis of the

pharmaceutical situation with a focus on drug supply and use and to conduct a half-

day workshop with stakeholders to discuss the findings and develop a roadmap for

national action. Visits were made to public health facilities in Thimphu, Trongsa,

Bumthang, Gelephu and Phuentsholing, the major MOH departments, the Medicines

Supply Depot, private importers/wholesalers and retailers and the Royal Institute of

Health Sciences. It was found that Bhutan has an extensive health care system, with

substantial infrastructure, trained health care personnel and good health indicators, but

that there are a number of serious problems in the pharmaceutical sector concerning

drug supply, selection, use and coordination, as highlighted below. However, there are

sufficient resources and capacity to address the problems.

Medicines Supply

Nearly all drug use in Bhutan is in the public sector where all drugs belong to the

national Essential Drug List (EDL) and are dispensed free of charge to patients. All

drugs are procured through international tendering annually and must be imported

from India. In the past one year there have been complaints of frequent stock-outs.

Health facility visits during the mission revealed that most stock-outs concerned drugs

used in the referral hospitals. In the districts, there had been good redistribution of

drugs such that few patients had suffered from lack of drugs. The main reason for the

stock-outs was that many of the drugs ordered during the last annual procurement had

not been delivered more than 6 months past the due date - due to several reasons.

Firstly, the quantification process was changed introducing a new formula based on

15 months average consumption rather than 26 months. Also more district people

were involved. However, the changed formula could not be used due to lack of

training and supervision and underestimated quantities were finally ordered late.

Secondly, 2011 was the first year when the DRA's new rule to import only registered

drugs came into force. The procurement committee gave tenders to suppliers of

unregistered products (because the unregistered drugs were much cheaper than the

registered ones) on the promise that the suppliers would get them registered - but

unfortunately many of them defaulted so requiring a second tendering process.

Thirdly, the procurement process was changed, whereby an attempt was made to do

tendering over 3 years and by lot. Unfortunately, many suppliers could not offer bids

on this basis. Finally, storage at the Medicines Supply Depot (MSD) were inadequate.

It is recommended to strengthen the drug quantification process by investing in the

DIGPY electronic drug management system and in training and supervision of staff

on drug management. It is also recommended to strengthen the procurement system

by (1) only giving tenders for registered products (whether normal registration or

temporary registration in the case of low-volume / high-price products which no

manufacturers or their agents wish to register), (2) not limiting tendering to 3-year

periods or by lot, and (3) strengthening the pre-procurement evaluation process of

products and supplier performance. In addition, it is recommended to upgrade the

storage and distribution conditions at the MSD in Phuntsholing. All these actions will

require recruitment of extra staff within the Drugs, Vaccines and Equipment Division

(DVED), MSD and Essential Medicines and Technology Division (EMTD).

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Medicines Selection and Consumption

Bhutan has a national EDL which is followed but there is constant pressure to add

drugs to the list, which is slowly growing. A sizeable amount is also spent annually on

non-EDL drugs prescribed outside the country and for which the chief pharmacist in

the national referral hospital must judge whether they are appropriate or not and

whether generic substitution can be undertaken. Drug consumption data was

unavailable except to senior DVED staff and had not really been used to make

judgments about consumption and where to focus effort to improve drugs use.

It is recommended that: (1) the DVED publish annually consumption data to inform

decision-making with regard to drug policy and strategies to promote rational use of

medicines; (2) the National Drug Committee publish criteria for the selection of

medicines, and (3) that a permanent sub-committee be established to judge all non-

EDL drugs prescribed abroad and whether they could be generically substituted.

Medicines use

There was a dearth of published information on medicine use. The consultant found

polypharmacy, moderate use of antibiotics and high use of vitamins. Most drugs were

prescribed by generic name and belonged to the EDL. Antibiotics were reported to be

the most consumed class of medicine but antibiotic use was moderate in most Basic

Health Units (BHUs) and hospitals. By contrast, use of paracetamol, vitamin C and

vitamin B Complex seemed high. There are national standard treatment guidelines for

BHUs and they are used extensively by paramedical prescribers but not by doctors. A

Drug & Therapeutics Committee only existed in the national referral hospital

(JDWNRH) but it had not met for the past year. Continuing professional development

(CPD) is fairly regular, run mostly by the MOH vertical programs, but it does not

cover prescribing issues. The Community Health Units (CHUs) are very active in

carrying out maternal child health programs and giving health education messages,

but up until now, they have not given any education on the use of medicines.

It is recommended that the Essential Drug Program (EDP) be strengthened in order

to give dedicated attention to regular monitoring of medicines use and implementing

strategies to improve use. Other interventions recommended include: (1) establishing

Drug and Therapeutic Committees (DTCs) in all hospitals with a requirement for

them to monitor medicines use and undertake strategies to improve medicines and

report annually to MOH; (2) incorporating the National Standard Treatment

Guidelines, the National EDL, the National Formulary and prescribing audit and

feedback into the Continuing Professional Development curricula and into the

orientation package for new doctors; (3) developing public education programs on

medicines use to be delivered through the existing Community Health Units.

Medicines Regulation

The Drug Regulatory Authority is independent of the MOH and is governed by the

Medicines Board, constituted by Parliament and chaired by the Minister of Health.

The DRA regulates a sector that comprises 1406 registered products, 9 wholesalers,

38 retail pharmacies, according to the Drug Act of 2003 and comprehensive set of

rules and regulation published in 2008. There are SOPs for all procedures and

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inspection and licensing procedures are well established. Antibiotics were not freely

available without prescription after a recent initiative to enforce the drug schedules.

Pharmacovigilance and monitoring of drug promotion were being undertaken but

there had been little activity. The regulation stating that all imported drugs must be

registered, though initiated some years previously came into force in 2011. Since half

of the drugs on the EDL were not registered, this had created a problem for the

government annual procurement of drugs, particularly low-volume / high-cost drugs

that no manufacturers (or their agents) wished to monitor, due to the small market and

time and money involved in preparing the dossier and paying the fee for registration.

It is recommended to continue to enforce the regulations with rigor and to use the

existing regulation for temporary registration for those low-volume / high-cost drugs

which are facing difficulty to become registered.

Medicine Policy and Coordination

Bhutan has benefited from a strong Essential Drug Program (EDP) for many years

and this unit was responsible for much informal coordination between different

stakeholders, particularly, the Drugs, Vaccines and Equipment Division (DVED), the

Drug Regulatory Authority (DRA) and the Department of Medical Services (DMS) as

well as other players. The EDP was responsible for implementing much of the

national Drug Policy (2007). However, the EDP has suffered from decreased support

in recent years so resulting in reduced coordination and reduced training and

supervision in the health facilities on drug management. The recent strengthening of

the EDP may improve the situation but extra staff would be needed. The current

democratization process with the requirement for more transparency resulted in

changes in the processes of drug quantification and procurement that the DVED has

found difficult to manage with their current staff shortage. In particular, the

requirement for lower cost drugs conflicted with the requirement to procure only

registered drugs which were often more expensive. The Bhutan Medicine Rules and

Regulation (2008) actually allows for temporary registration of drugs needed by

government for public health purposes but this rule is only lately being applied. All

these difficulties resulted in delayed drug supply and stock-outs. In addition, the

Royal Institute of Health Sciences (RIHS) and the various vertical programs within

the MOH could have played a role in training and supervision of health workers on

drug management but they have not been involved. The Health Council of Bhutan has

introduced anew credit system for continuing medical education (CME) or CPD but it

does not cover prescribing (except for specific diseases). Although all these actors

may play a positive synergistic role in managing medicines, there is no forum to bring

them together. In such circumstances, one risks duplication of effort or no effort with

regard to training and supervision in drug management.

It is recommended that a coordinating mechanism under the MOH be established

whereby the EDP/EMTD, DVED, MSD, DRA, RIHS and Bhutan Medical & Health

Council can be brought together to resolve issues; this forum could be chaired by the

Health Secretary and would be different from the Medicines Board (for the DRA) or

the National Drug Committee (for selection of the EDL). It was further recommended

that the EDP be strengthened and dedicated to monitoring medicines use and

coordinating the implementation of strategies to improve medicines use and

implement the national drug policy.

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Terms of Reference

The objectives were:

(1) to meet senior officials of the Bhutan Ministry of Health (MOH);

(2) to conduct a rapid assessment of the pharmaceutical situation - with a focus on

drug supply and rational use of medicines, in liaison with a national

counterpart from the MOH;

(3) to report on the findings in a workshop to government officials and other

stakeholders and develop recommendations for future action.

Background

This mission was undertaken to conduct a national situational analysis with regard to

the pharmaceutical sector in order to aid MOH 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 8 - 21 June, 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 half-day workshop with 30 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.

Bhutan is now a middle-income country with a well developed health care delivery

system with trained staff and relatively good health statistics (MOH 2010). All

medicines are imported and virtually all medicines supply is within the public sector,

the private sector being extremely small and mostly confined to the border area with

India and Thimpu. All medicines and treatment are provided free of charge to the

patients, all costs being borne by the government. There is virtually no health

insurance. The increasing consumption of, and demand for, medicines, together with

irrational use of medicines and changes in the process of estimating need and

medicines procurement in the last year has resulted in frequent stock-outs and lack of

drug availability in public health facilities. This is of particular concern to the

government whose policy is to provide essential medicines free of cost to all the

population through the public sector health 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.

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Medicines Supply

Almost all medicines are imported by and used in the public sector, the private sector

being extremely small, limited to a few drug retail shops in border towns with India

and to the capital city, Thimpu. Most of the country has no private sector whatever.

The Drugs, Vaccines and Equipment Division (DVED) in the Department of Medical

Services (DMS) in Thimphu procures all the public sector medicines and also

estimates the quantities to be procured and where they are to be distributed. The

Medical Supply Depot (MSD) in Phuentsholing on the border with India receives all

procured medicines and distributes them to facilities throughout Bhutan as determined

by the DVED. The DVED imported 79.67 million NU (1.89 million USD) worth of

drugs in 2010 and 81.49 million NU (1.94 million USD) in 2009. Virtually all the

drugs were purchased from the Indian market, mostly through Indian and Bhutanese

wholesalers, and not directly from the manufacturers.

Until 2009-10, drug supply and stock levels in health facilities had been good. In the

last 1-2 years, in part due to the new democratization process in the country, a number

of changes have occurred which have resulted in the system failing in part, so

resulting in drug stock-outs. The problems concern drug inventory management and

quantification and drug procurement and the support of EDP in both these functions.

While there are many media reports on the problem, the degree of severity is unsure.

Drug availability

The DVED mentioned that from the 2010 annual tendering process for procurement,

82 drug items had not yet arrived – due to supplier default for 49 products and lack of

any supplier bid for 33 products. Over half of these drugs are not registered. The

consulate general in Calcutta has undertaken a 2nd

tendering process and a further 62

items were expected on 17th

June. There would remain 21 items still not ordered - 7

vital, 7 essential and 7 non-essential items.

Table 1 shows the stock-out situation as found by the consultant in 8 government

facilities. It can be seen that many of the drugs out of stock are used only in the

referral hospitals, the stock availability being good in BHUs and district hospitals.

Some drugs were out of stock in nearly all the facilities e.g. hydrochlorothiazide,

since they were absent also from MSD. However, other drugs were only absent in

some facilities and not in others e.g. ORS and Tetanus Toxoid injection were absent

in JDWNRH but not elsewhere. In the districts there is a good system of mobilizing

drugs through the District Health Office (DHO) so that excess stocks in one facility

may be transferred to other facilities where there is a stock-out. However, this system

did not seem to work for referral hospitals which only exchanged drugs between

themselves occasionally, usually through requests to DVED or MSD.

Some drug stock-outs could be managed by substituting other appropriate drugs e.g.

hydrocortisone cream for triamcinolone cream, chlormaphenicol applicaps or eye

ointment for chloramphenical eye drops, half or quarter of prednisolone 20 mg tabs

for prednisolone 5mg tabs, other antibiotics in place of doxcycline, erythromycin or

cephalexin. Some out-of-stock items are rarely used, e.g. Dextrose 25% injection, so

their absence was not missed.

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Table 1: Out-of-Stock Items

Facility Type No.Items

Out-of-

Stock

Out-of-stock items

(Formulation is tab/capsule unless otherwise indicated)

National

Referral

Hospital,

JDWNRH

N=1

77 Amitriptyline, Amlodipine, Atropine eye ointment, Anti-D(Rh) inj,

Betahistine dihydrochloride, Bromonidine eye drop, Buvicaine inj,

Calcium lactate, Carboprost inj, Carvedolil, Cephalexin, Cetirizine,

Chloramphenicol inj, Chlorpeniramine, Chlorpromazine,

Cinnarizine, Clotrimazole cream & pessaries, Dicylomine,

Doxycline, Enalapril, Ephedrine tab & inj, Ergotamine,

Ethionamide, Ethyl chloride spray, Fluoroscein strip, Fluphenazine

inj, Folic acid, Frusemide, Gentamicin inj, Haloperiodol inj,

Hepatitis B vacc, Homatropine eye drop, Hydrallazine,

Hydrocortisone eye ointment & inj, Hydrogen peroxide solution,

Isoniazid, Isosorbide dinitrate, Ketakonazole, Ketamine inj,

Levadopa, Lignocaine+adrenaline inj, Lignocaine spray,

Lorazepam, Mefenamic acid, Metoclopramide,

Neomycin+bacitracin eye ointment, Nitrofurazone, Ofloxacin,

Omnipaque inj, Omniscan inj, ORS, Phenytoin, Pioglitazone,

Pralidoxime, Prednisolone, Procainamide, Pyrazinamide, Quinine,

Sodium valproate, Sodium stibogluconate, Co-trimoxazole inj,

Sstreptokinase inj, Tetanus toxoid inj, Tetracycline eye ointment,

Theophylline+Etophyllin, Tramadol inj, Triamcinolone cream,

Vincristine inj, Dextrose 25% inj, 3FDC, 4FDC, Spirit

Sub-referral

hospitals

N=2

10-12 Adrenaline inj, Amitriptyline, Atovastatin, Cephalexin, Cetirizine,

Cinnarizine, Clotrimazole cream, Deriphyllin, Diazepam,

Dicylomine, Doxycycline, Enalapril, Erythomycin, Folic acid,

Gentamicin inj, Glibenclamide, Hydrochlorthiazide, Metformin,

Metoclopramide, Prednisolone, Phenytoin,

District

hospitals

N=3

4-7 Adrenaline inj, Ceftriaxone inj, Chloramphenicol eye drops eye

ointment and inj, Dextrose 25% inj, Diazepam, Glibenclamide,

Hydrochlorothiazide, Phenytoin, Phenobarbitone, Triamcinolone

ointment

BHUs

N=2

1-3 Hydrochlorothiazide, Metoclopramide, Gamma benzene

hydrochloride, Haemorrhoid ointment

Overall, it seems that relatively few patients have suffered due to drug stock-outs and

then mainly in the referral hospitals. In Gelephu hospital, a record was kept of how

many patients were denied one or more drugs due to a stock-out, this being 295

patients out of a total of 3072 outpatients, i.e. 9.6% of outpatients, in the first 2 weeks

of June 2011.

Drug Supply Management and Quantification

There is an electronic drug inventory management system, DIGPY, which extends

down from DVED to hospital and central district level. Staff send data from DIGPY

to the DVED and also fill in a 6-monthly reporting from and send to DVED. Until

recently, this system has been successfully used to manage drug supply. However,

recently the DIGPY system has not always been maintained in health facilities and

there has been no IT support so that some computers in facilities are not working.

There has also been a lack of staff training and even many senior staff were not able

to export and analyse data for management purposes (e.g. ABC analysis, consumption

and quantification of need).

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Drug quantification of needs in the health facilities has been taught to all the staff

over many years and was based on the formula:

Annual requirement

= Last year's average monthly consumption x 26 months - balance in stock

(including any supplies that are in the pipeline from MSD.

During 2009-2010, the quantification process was changed in order to provide more

transparency and with the assumption that the 26-month quantification formula may

be overestimating need. Initially the formula was changed to from 26 months to 15

months and other factors were incorporated into the formula, for example, the number

of months of stock-out in the previous year. The chief of DVED mentioned that some

facilities were requesting too many medicines in consideration of the local population,

for example, paracetamol and vitamins, and that he had managed to save 18 million

NU in 2010 by cutting down on their requests and that this was another reason behind

the desire to change the formula. While these changes were theoretically good for

efficiency, such changes cannot be introduced without widespread and repeated

training and supervision. Thus, for logistical reasons, the new formula was

abandoned, but the attempt to introduce it resulted in staff confusion and delay in the

quantification process. This, in turn, resulted in a delay in procurement.

It was noticed during the facility visits that a number of staff were no longer

following the old quantification formula and were consistently under-estimating need

according to the formula. The issue of over-consumption of some medicines, such as

paracetamol, noticed by the chief of DVED was also noticed by the WHO consultant

and may be better addressed by measures to promote more rational use of medicines

rather than by changing the quantification formula (see section on rational use of

medicines). In some health facilities, drug storage was cramped and sub-optimal.

The Medicines Supply Depot (MSD) in Phuntsholing has long been in need of an

upgrade and the chief has been lobbying for this for some years. Currently the store is

lodged in the old hospital, a new hospital having been built in the town. The store is

cramped with insufficient shelving and no loading facilities. It was noticed in the

current store that there was a lack of shelving with up to a dozen or more boxes being

stacked one on top of the other, which could cause product damage in the lower

boxes. Furthermore, many boxes were resting on the ground and not on pallets, which

could further result in damage due to damp and lack of aeration. Some new pallets to

raise boxes off the floor had recently arrived so this problem may be eased. The MOH

has already agreed to build a new store on the existing site and the store will be

temporarily re-housed in two nearby warehouses. Architectural plans have been

completed and a government budget of 54 million NU identified for this. However, a

budget for equipment has not been identified and no new staff posts have been

allocated. It was mentioned that there was a need for 3 fork-lift trucks, 6 movable

trolleys, 10 computers and extensive shelving and also staff training in stock

management and the use of DIGPY.

Drug procurement

Procurement is based on an international tendering process that has involved many

trusted and known suppliers who have been able to deliver reliably over the years. All

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bids are reviewed by a small pre-evaluation committee of 3 pharmacists (from DVED,

the national referral hospital and previously EDP) which collects information on

supplier performance and product specification and presents their findings to the

procurement committee. The latter then decide upon which suppliers will win bids to

supply various items. According to agreed criteria, all suppliers should have a 70%

performance rating based on the timeliness, completeness and quality of past drug

supplies. Until 2010, there was no requirement to register all the drugs for

importation.

A number of changes were introduced into the procurement process in 2010 as a

result of recommendations from the audit commission and the new transparency anti-

corruption initiative. These were as follows:

• Two regular Indian suppliers were found to have supplied overly-expensive and

faulty equipment and were suspended - this resulting in having to try out new

untested suppliers.

• The evaluation committee could not follow their own supplier performance

criteria because of insufficient numbers of suppliers qualifying so less experienced

suppliers won some bids. Three new Bhutanese suppliers defaulted on their bids.

It was mentioned by one member of the selection committee that the quality of

many bids was poor and that much time was wasted in clarifying specifications in

communication with the concerned suppliers.

• The regulation of only importing registered products came into force for the first

time and resulted in many suppliers defaulting on their bids because they could

not get their products registered contrary to their promises at the time of tendering.

• The tender award committee decided to accept bids for non-registered produced

on the promise that they would be registered because some registered products

were very much more expensive than non-registered ones. For example,

nitroglycerine cost 53NU/tablet for the unregistered product and 200 NU/tablet for

the registered one. The DVED chief mentioned that at the time the International

Drug Price was 82 NU and the Indian reference price was 63 NU and that

procurement of registered products would have cost an extra 32 million NU in

2010. He further mentioned that Nitrogylcerine had cost 12 NU/tablet in 2009,

14.8 in 2008 and 16.2 in 2007 and that there was no good reason for registered

product costing 200 NU/tablet. Since, the suppliers of non-registered products did

manage to register about half of the products, the procurement of these rather than

already registered ones had saved 16 million NU from procurement costs in 2010.

• Special temporary registration with reduced requirements, though in the

regulations, has only recently been enacted for registering low volume/high cost

products that manufacturers and their agents (wholesalers) are reluctant to register

because of the small market. If only a few people require a drug, the supplier will

not make a return on the outlay of 1500 Nu (+ 150 Nu processing fee) for each

item for a 3-year registration period. This resulted in no suppliers bidding for

some products and thus non-supply. While the DRA regulations do allow for

temporary registration for such products it is not clear whether this regulation is

being fully used or whether products are now being imported with registration

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exemption. It was mentioned that products are now being imported without

discussion of the DRA Medicines Board.

• In order to attract more suppliers to register and supply products, tendering in lots

(groups of drugs) and for 3 years was tried as opposed to annual tendering by line

item. While some people felt that this had merit and did attract more suppliers,

others felt that:

o The 3-year period dissuaded many suppliers from bidding because they felt

unable to quote realistic prices over 3 years in the changing market and that

other suppliers lost bids because they quoted higher prices to cover 3 years.

o The lot system did not work because many suppliers were excluded since they

could only supply 1-2 items quoted and not all of the drugs in the lot.

Monitoring and Evaluation

The Essential Drug Program (EDP) has undertaken monitoring and evaluation of drug

supply and management. The EDP is also responsible for implementing the national

drug policy, developing, updating and implementing the Essential Drug List, national

standard treatment guidelines (STGs) and also for training and monitoring on drug use

as well as management. For many years the EDP was very strong and the envy of

many countries in the region. It used to be based within the DVED, where it worked

together with DVED staff to organize regular training and supervision for health

facility staff in drug management, quantification and drug use. Furthermore, EDP

staff also assisted in collecting information on supplier and product details for the pre-

evaluation process in procurement.

In order to give the EDP more independence, it was detached from DVED in 2008 to

be a unit in the DMS. However, sufficient staff were not provided and there was

usually only one pharmacist till 2009 and in 2010 only one Pharmacy Technician.

While, there had only been 1-2 staff previously in the EDP, it had not mattered when

it had been within the DVED structure since collaboration between EDP and DVED

staff had been easy, particularly with regard to training and supervising district staff in

drug management. However, once the EDP was physically separated from DVED,

this collaboration became more difficult - so resulting in reduced, or for some areas

absent, training and supervision of district staff in drug management. The roles of

DVED and EDP in training and supervision of drug management at health facilities

are now unclear since there is the potential for duplication or absence (of training and

monitoring). Thus, it was found in a recent survey by the newly revived EDP early in

2011, and also by the WHO consultant in June 2011, that in some facilities, routine

drug stock management activities were not being undertaken e.g. updating the DIGPY

system, sending the 6-monthly reporting form on stock levels to DVED, or using the

correct quantification formula. This has resulted in senior DVED staff not being able

to trust DIGPY data and having to redo all quantification estimates coming from the

districts manually - so taking staff time away from other activities such as training and

supervision. Furthermore, the some drug stores were not being managed properly.

In early 2011 the EMTD was strengthened from one to several staff members. The

Essential Medicines and Technology Division (EMTD) now has 2 units - one being

the EDP and the other being a new unit for health technology assessment. The EDP

now has two program officers with pharmacy qualifications (diploma) and the Health

15

Technology Assessment unit has one officer for laboratories and one for bio-

informatics. A doctor is the overall in charge of the division.

Human Resources

The DVED, MSD and EDP all mentioned the lack of human resources as contributing

to the current problem of drug stock-outs. It was mentioned that there are simply not

enough staff to undertake the necessary training and supervision for drug management

in districts nor enough staff to undertake thorough data collection on products and

suppliers in the pre-evaluation stage of drug procurement. The MSD complained that

they had insufficient staff to manage the store at Phuentsholing.

The DVED chief mentioned that they currently had 8 staff in total centrally, but that

1-2 staff were needed per Dzongkag (district) and 12 staff centrally were needed. The

EMTD chief mentioned that the current staffing of one diploma pharmacist and one

pharmacy technician in EDP was insufficient and that a pharmacist plus an extra

pharmacy technician were needed. The MSD also felt that they needed at least one

pharmacist and extra pharmacy technicians.

Possible Solutions

1. Strengthen the EDP/EMTD, DVED & MSD and their collaboration:

• Need at least one pharmacist per division to oversee all activities;

• Need collaboration on training and supervision of district staff in order to

avoid duplication of effort and to ensure that harmonised messages are given;

2. Strengthen the electronic drug management system, initially the DIGBY system,

which requires some full-time IT input in order to train all staff and sort out all

computer problems in health facilities;

3. Do not limit tendering to a 3-year period or by lot (groups of drugs are chosen for

tendering):

• tendering annually by line item and not by lot is the easiest option for

suppliers so if tendering by 3-year period or lot is done then the effect of this

type of tendering should be carefully monitored;

4. For unregistered low volume/high price products:

• Various suppliers could be invited to bid for a “lot” that included all the high-

cost / low-volume items to be supplied on a special registration basis and then

one bidder chosen; such a "lot" consisting of many of these items may be more

attractive to a supplier than a single item of this type;

5. If there is only one supplier for a registered product and the procurement

committee thinks the price is too high, DVED should investigate international

prices and also the price in the DRA proforma invoice for importation;

6. Only give tenders to suppliers of registered drugs (whether the products be fully

registered or are registered on a special temporary basis):

16

• provided the products are of a reasonable price based on comparison with

international and Indian prices and

• provided that the supplier meets all the supplier performance criteria;

7. DVED should do a full pre-qualification assessment of the product and a

performance assessment of all suppliers to present to the procurement committee:

• there should be adequate pharmaceutical technical expertise present in

meeting to advise members on technical issues

8. Strengthen the storage facilities in Phuntsholing in terms of the premises,

equipment, staffing numbers and training;

9. DRA to consider extending registration of products from 3 to 5 years so as to ease

the financial outlay and effort of wholesalers to get products registered (see

regulation also).

10. As far as possible, introduce changes to the procurement and supply processes in a

systematic controlled way, preferably one change at a time and monitoring closely

the effect of the change(s);

11. WHO to consider investigating the possibility of a SEAR drug facility for small

countries.

Medicines Selection and Consumption

Bhutan has a national Essential Drug List (EDL), which was updated at the 17th

National Drug Committee Meeting held in February 2011 (EMTD/MOH 2011). At

this meeting 22 drugs were added, 3 deleted, 20 extended and 1 changed in strength.

The list now contains 383 chemical entities, plus a further 20 intensive care drugs, all

of which are assigned to one or more of 4 different levels of facility (BHU, district

hospital, regional hospital and JDWNRH) and all of which are classified as vital,

essential or non-essential. The list was developed by the National Drug Committee

that included 16 different specialists from Bhutan, 12 from JDWNRH, 3 from district

hospitals and the Director Dept Public Health. It was coordinated by Member

Secretariat of 3 persons in EMTD. It was mentioned that there is always pressure to

add new drugs to the list particularly as there are many foreign doctors working and

all Bhutanese doctors are trained abroad so that a certain amount of filtering must be

done for all new drugs being considered for addition to the list. This was done by a

small group consisting of the Chair of the Committee, EMTD, the JDWNRH

pharmacist and district representative doctors. After this filtering, for all remaining

drugs being considered for addition to the list, evidence was then collected and

presented to the Committee. There are no published criteria for selection.

On review of the EDL, it is not always clear why all drugs are needed and some drugs

are very expensive. For example:

• Why does one need fentanyl patches which are very expensive when one has

oral morphine?

17

• Why have tramadol injection as well as morphine, pethidine and injectable

fentanyl?

• Why have lamotrigene when there are already many other anti-epileptics?

• While there are many psychotherapeutic drugs, lithium and carbamazepine

used for bipolar disorders are not listed.

• Also some drugs are listed by brand name and this should be avoided.

WHO undertook a detailed review of the 2009 EDL, a copy of which was shared with

the Bhutan MOH in March 2011. The EDL is followed by government procurement

and by all public health facilities. Since the private sector is limited to some retail and

wholesale pharmacies in Thimpu and the border with India, there are very few non-

EDL drugs in Bhutan. Monitoring of drug consumption and ABC analysis had not

been done on a routine basis so that most people were unaware of what the total drug

consumption in Bhutan has been. Only senior staff DVED had been monitoring

consumption and could provide some data of drug consumption in terms of quantity

and cost in the past few years. Even they had not done detailed analysis comparing

consumption by district or by therapeutic group or per capita. Based on the data

provided by DVED, the top 23 drugs, consuming 51% of the budget in 2009-2010,

are shown in table 2. Further analysis by the consultant revealed that in 2009-2010,

antibiotics accounted for 27.8% of the budget.

Table 2: Top 22 drugs consumed by cost in 2009-2010

S.No. Drug Name Total Amount % of total

1 Amoxycillin 250mg tab 7,964,780 10%

2 Antirabies vaccine 3,050,000 3.8%

3 Vitamin C tab 2,716,532 3.4%

4 Ferrous Sulphate+Folic Acid 2,230,740 2.8%

5 Sterile disposable syringe kit 2,160,000 2.7%

6 Human albumin 20% 100 ml inj 2,017,800 2.5%

7 Methylcellulose 0.3% eye drops 1,930,500 2.4%

8 Cotrimoxazole 480mg tab 1,771,640 2.2%

9 Antacid 1,735,020 2.2%

10 Paracetamol 500mg tab 1,671,560 2.1%

11 Chloramphenicol 1% eye applicaps 1,634,528 2.0%

12 Ibuprofen 1,584,450 2.0%

13 Envelopes plastic dispensing 1,345,685 1.7%

14 ORS 1 litre 1,321,450 1.7%

15 Cyclosporin 100mg cap 1,192,800 1.5%

16 Ampicillin 500mg inj 1,043,739 1.3%

17 Retinol 200,000 U cap 1,007,172 1.3%

18 Erythropoetin 2000 U inj 963,000 1.2%

19 Sodium Chloride 0.9% inj (540ml) 951,660 1.2%

20 Compound solution sodium lactate inj 944,460 1.2%

21 Ranitidine 150mg tab 902,700 1.1%

22 Erythromycin 250mg tab 882,378 1.1%

23 All other drug items not listed above 38,652,842 48.5%

Total All drugs 79,675,436 100%

18

This data shows which drugs are consuming most of the budget and monitoring can

be directed to looking at whether these drugs are being consumed appropriately. If

such data were published annually, policy makers and prescribers may be sensitized

on the consumption and cost of drugs. This may then be taken into account in when

planning activities with regard to the selection and use of medicines. DVED may also

find it useful when deciding upon drug requests from the districts. For example, per

capita drug consumption can inform DVED whether certain drug requests from

districts are reasonable or overly high due to excessive per capita consumption (see

section on use of medicines). Extraction of such consumption data could more easily

be done and other comparisons made such as per capita consumption if the electronic

drug management system, DIGPY, were kept up to date.

Another problem that was mentioned is the amount of non-EDL drugs prescribed

from outside the country and for which approval is requested for importation and/or

reimbursement by government. Currently, these prescriptions are received by the

chief pharmacist of the national referral hospital (JDWNRH), who must refer the

matter to senior consultant doctors if he is in doubt about the necessity or expense of a

drug. There may be considerable pressure to accept all requests. A permanent sub-

committee, made up of the chief pharmacist and various doctors, to decide all such

requests, may be a better option for this problem.

Possible solutions

1. DVED to estimate and publish consumption data annually, in terms of quantity

and cost and to include comparison of consumption by district (Dzongkhag), by

therapeutic class and by per capita;

2. Invest in an electronic drug inventory system, DIGPY to start with, to get up-to-

date consumption data;

3. Train staff in drug consumption analysis - DVED and EMTD may work together

on this;

4. To improve the selection of essential drugs by:

• Developing, in consultation with prescribers, written published criteria for

selecting drugs for the national EDL.

• Establishing a permanent sub-committee to judge all out-of-list requests

coming from outside the country and whether cheaper generic drugs could be

substituted.

Medicines Use

There was little information concerning medicines use. No published studies were

found in the international literature but 1 past survey was found in WHO archives

(Myint UH 1999). This survey, done in 3 hospitals and 1 BHU, showed that: the

average number of drugs per prescription was 2.39; the % patients receiving an

antibiotic was 51%, vitamins 29%, injections 10%; that the % of drugs prescribed by

generic name was 76% and belonging to the EDL 93%; and that 80% of patients were

19

treated in accordance with STGs. More recently, in 2010-2011, EMTD/EDP has

started prescription monitoring in all district hospitals and BHUs. Pharmacy

technicians are required to collect every 11th

prescription randomly every month until

they have achieved 30 prescriptions and to record the number of items prescribed,

whether they include antibiotics, injections, steroids and whether the drugs are

prescribed by generic name, belong to the EDL and are dispensed. In addition they

record the prescriber type and, sometimes, diagnosis. Overall, analysis had not yet

been done by the MOH. However, the consultant analyzed a sample of data from 8

facilities over several months in 2010-2011 and found that that the average number of

drugs prescribed per patient was 3.15 in hospitals and 2.85 in BHUs and that the % of

patients prescribed an antibiotic was 40% in hospitals and 48% in BHUs. In two of

the 8 facilities, diagnosis was recorded and it was found that 27% of patients suffering

from ARI (non-pneumonia) were treated with antibiotics and that 34% of acute

diarrhoea cases were treated with antibiotics. This would indicate some degree of

inappropriate antibiotic use.

The consultant undertook a rapid survey of outpatient prescribing in 8 public facilities

and in 3 private facilities during the mission. Data in the public sector was collected

by examining the prescriptions as they were presented in the health facility outpatient

pharmacies and in the private retail pharmacies by examining carbon copy patient

bills. Care was taken in hospitals to include only new primary health care type cases,

which can be assessed using INRUD indicators, and to exclude discharged inpatients

and chronic specialist cases. At least 30 patient prescriptions were examined per

facility. The results are shown in table 3.

Table 3: Primary care drug use indicators in facilities visited during the mission

Drug use indicator Referral

hospital

(n=2)

District

hospital

(n=3)

BHU

(PHC)

(n=2)

Private

retailer

(n=3)

Average number drugs per prescription 2.63 2.51 1.9 1.52

% prescriptions containing antibiotics 31 33 34 17

% prescriptions containing injections - - 8.2 0

% prescriptions containing vitamins 28 42 29 17

% drugs prescribed by generic name 77 92 100 22

% prescribed drugs belonging to EDL 96 97 100 53

% prescribed drugs dispensed 85 93 97 -

Average drug cost per prescription (NU) - - - 163.67

Table 3 shows that the average number of drugs increases with higher level of facility

i.e. more drugs were prescribed per patient in referral hospitals compared to district

ones compared to BHUs. One might expect this since higher level facilities see more

complex cases. However, care was taken to include only acute new cases, mostly with

PHC type conditions, so complexity of case is not the only reason for higher

prescribing in higher level facilities. In addition, while generic prescribing was high in

all facilities it was lowest in the national referral hospital. Vitamin use was high in all

facility types and was mostly irrational. Often it was prescribed in addition to several

other medicines so its use as a placebo was not justified. Medicines use in the private

retail pharmacies showed low prescribing of EDL drugs and by generic name – which

20

is an indication of what may happen should the private sector expand in Bhutan.

Interestingly patients were prepared to pay about 164 NU on average.

About one third of patients received antibiotics, which is lower than many other

countries of the region. Nevertheless, an analysis of a subset of 35 prescriptions (26

ARI and 9 diarrhoea prescriptions) showed that on average 54% of ARI (non-

pneumonia) cases received antibiotics and 44% of acute diarrhoea cases received

anibiotics – which does indicate some irrational use of antibiotics.

It was noticed that many prescriptions contained paracetamol, vitamin C and vitamin

B Complex in addition to the “main” drugs such as antacid and/or ranitidine for peptic

ulcer or an antibiotic for cough. Many doctors felt that this was not polypharmacy as

these drugs were just “placebo”. They did not appreciate that patients may not take

the antibiotic or ranitidine correctly because they are taking so many other medicines

nor the fact that these extra medicines were being wasted. Furthermore, it was noticed

that large amounts of Paracetamol and Ferrous Sulphate+Folic Acid were being

issued to village health workers and also quite large amounts of Paracetamol to

schools and religious institutions. However, this use was not being monitored. On

estimating total consumption in some BHUs with well defined catchment populations

it was found that the annual per capita consumption of the population was 13-60

paracetamol 500mg tabs, 5-45 vitamin B Complex tabs, 4-18 Vitamin C tabs and 7-34

Ferrous Sulphate+Folic Acid tabs. These are large amounts indicating irrational use

and warrant investigation. The chief of DVED said that he had similarly noticed this

high per capita consumption and that there had been 46 cases of paracetamol

poisoning in Thimpu in the period 2006-2010. He mentioned that this was also one of

the reasons that he wanted to change the system of quantification. The amounts spent

on these drugs in 2010 was Paracetamol 9,331,000 Nu, Vitamin C 2,700,000Nu,

Vitamin B Complex 514,736Nu and Ferrous Sulphate+Folic Acid 2,230,740Nu, a

total of 14,776,476Nu (33,502 USD) much of which was probably wasted.

A number of methodological issues concerning prescribing surveys were noted.

Firstly, for all drug use indicators, apart from treatment of ARI and diarrhoea,

prescribing appeared to be worse according to the MOH survey as compared to the

consultant survey. This was because in some facilities, pharmacy technicians were not

selecting prescriptions randomly but rather the ones they thought had problems. While

selecting such problematic prescriptions is fine for photocopying and later use for

teaching purposes, they cannot be used for general surveys as they give an impression

of worse prescribing than is actually the case. Secondly, it was noticed that many

patients receiving injections do not come to the dispensary but go directly to the

injection room. Therefore the % of patients receiving injections cannot be measured at

the dispensary in hospitals (although in BHUs it can be measured since the same

health worker often prescribes and gives injections). Thirdly, the % of prescribed

drugs dispensed cannot be measured in retrospect from the dispensing register in most

facilities because non-dispensed drugs are not recorded. Only in Gelephu were they

recording non-dispensed drugs. This means that the % of drugs dispensed can only be

measured by examining prescriptions as they come to the dispensary – which is more

time consuming that retrospective analysis of the dispensing register.

The number of patients a prescriber sees per day may affect the quality and length of

the consultation and ultimately how medicines are prescribed. On average doctors saw

21

about 50 patients a day, assistant clinical officers about 70-100 per day, health

assistants in hospitals 80-120 per day and health assistants in BHUs 10-30 per day.

Thus, very short consultation time was a problem for all prescribers in hospitals, more

for the ACOs and HAs than for the doctors. However, in the BHUs, prescribers had

sufficient time to give quality consultation. Patient-dispenser interaction time was

often only 1-2 minutes or less and often discussion between dispenser and patient was

minimal. Most drugs were dispensed in small plastic bags, on which the name of the

drug and how to take it were written.

Standard Treatment Guidelines and other sources of independent information

There are a national EDL, national STGs for BHUs (EDP/MOH 2007) and a national

formularly (EMTD/MOH), all of which are regularly updated. Many HAs and ACOs

were using the standard treatment guideline for the BHU. However, few doctors were

using any Standard Treatment Guidelines (STGs). Some used their old text books

from medical school but there were few up-to-date sources of independent drug

information. There is a Bhutanese national formulary (2007) now being updated and

renamed as the Bhutan Essential Drugs Formulary (2011). However, few people were

using the latest version as it is no longer being distributed free of charge by the

EMTD. Instead it is being charged for by the Drug Regulatory Authority.

Unfortunately, few health workers or facilities were buying it even though the charge

is fairly nominal at around 60Nu.

Apart from the national EDL, STGs for BHUs and formulary, sources of independent

drug information are quite few. Some doctors were getting prescribing information

on-line. There is no Drug Information Centre (DIC) run by MOH, although the

pharmacist in Thimpu hospital (JDWNRH) mentioned that he answers queries from

doctors mostly in JDWNRH. Although there are a few drug representative visits to

prescribers in Thimpu and the border towns such as Gelephu and Phuntsholing, this is

not a problem in the rest of the country, it not being worthwhile for drug companies to

send drug representatives to these areas.

Prescriber Education

The Royal Institute of Health Sciences (RIHS) trains nurses, pharmacy technicians

and paramedical staff such as Health Assistants (HAs) and Assistant Clinical Officer

(ACOs), who do all the prescribing in BHUs and much of the prescribing in district

hospitals also. In addition, they run courses for BSc public health and BSc Nursing

and management courses for District Health Officers. The RIHS does teach

prescribing skills and use of the EDL and STGs to HAs and ACOs (who are HAs who

have received one extra year's training). In addition they train other medical

technicians covering areas such as physiotherapy, operating theatre, X-ray, laboratory,

orthopaedics, dental, eye, ear-nose-throat. About 25 HAs, 15 nurses and 60

technicians (including pharmacy technicians) graduate per year. Even so, many

people felt that there was still a shortage of health workers. Recently, other cadres of

health worker such as Auxiliary Nurse Midwives (ANM), who are mostly involved in

maternal child health (MCH), have been upgraded to HAs. While staff with an ANM

background are generally assigned to MCH duties they are sometimes being required

to prescribe as the HAs - even though they have not actually been trained to prescribe

as have HAs. This may have some negative consequences for prescribing.

22

It was mentioned that the RIHS was only involved in undergraduate training and not

in post-graduate training or CME, the latter being mostly arranged by the vertical

programs within the MOH and, thus, not generally covering prescribing. Sometimes

they are involved in a special training such as a recent training course conducted with

the DRA to train health workers who were running pharmacy shops. There is

currently no medical school although they hope to start one.

Since there is no medical school in Bhutan, all doctors are trained abroad. While most

doctors are of Bhutanese nationality, having been trained abroad mostly with

government sponsorship, there are a number of expatriates mostly from India,

Myanmar and Bangladesh. Some young doctors mentioned that it was difficult

starting work in Bhutan as they were not familiar with the EDL and clinical guidelines

and it took some time to adjust since the prescribing is quite different in the countries

of study or origin. There is a 3-day orientation program for new doctors to explain

about working in Bhutan and it was felt that perhaps this should be extended to have

more time on prescribing, the EDL and clinical guidelines. In some cases of senior

expatriate specialists, there has been a serious problem in adjusting to the use of the

national EDL. MOH accepts some expatriate doctors on the basis of an inter-

governmental agreement, e.g. with Myanmar, and does not select the doctors

themselves. In one case, it was mentioned that a doctor from Myanmar was very

seriously overprescribing medicines and antibiotics in a way that local staff felt to be

totally inappropriate but were unable to stop and so the problem was referred up to the

Director General, Medical Services.

Continuing Professional Development (CDP) or continuing medical education (CME)

consists of several workshops a year for most health professionals. Most health

workers mentioned that they are receiving training regularly several times per year,

mostly from the vertical programs within the MOH. Some health workers in very

remote health workers may be having difficulty to attend sufficient sessions of CME.

Likewise, gynaecologists and surgeons who are in short supply and need specific

replacement also have difficulty to leave the hospital for CME. Since there is no

medical school or faculty in Bhutan, it has been difficult to organize CME on subjects

outside of the MOH vertical programs, particularly with regard to general prescribing.

The Bhutanese Health Council have developed a new accreditation system whereby

all health workers must gain 30 continuing medical education credits in 5 years, 6 per

year, to get re-licensed. Each 3 hour session of training counts for 1 credit if a

participant or 2 credits if a resource person. The scheme started in 2006 and this year,

2011, is the first year when all health staff will have to show to the Council that they

have got 30 credits in order to get re-licensed. It is not certain what will happen at the

end of the year if a staff member has not got the required number of credits. A number

of specialist doctors mentioned that they are building up credits by acting as resource

persons but are often not attending educational sessions as participants in their own

areas of expertise. Recently, some seminars were held with doctors concerning the

drafting of new antibiotic guidelines and the irrational use of antibiotics was

discussed. However, overall, very few of the CME session have included anything on

rational prescribing.

23

Drug and Therapeutic Committees (DTC) and Quality Assurance

There is a National Drug Committee for the selection of drugs and a National

Medicines Board to oversee the DRA. However, there is no national DTC that

oversees all aspects of drug utilization in the health care system. The JDWNRH has a

DTC but it had not met in the past one year and really its only function is to stop the

use of very expensive non-EDL drugs. It was mentioned that senior physicians did not

have time to sit on the DTC to do the monitoring and training activities needed. One

physician mentioned that he had to see 80 patients per day, many of which were

routine. If the hospital employed sufficient other health professionals this would free

up his time to do more monitoring and quality assurance activities. Other hospitals did

not have a DTC, but did mention having staff meetings from time to time.

Recently, all hospitals have been required by MOH to establish a Hospital

Administration and Management Transformation Committee (HAMT). This

committee discusses general issues concerning quality of care and is required to send

an HAMT report every 2 weeks to the MOH. In this report are details about staff

availability, non-availability of drugs, equipment and reagents, use of equipment,

mortality, patient waiting times, delay in discharge of inpatients, infection control,

hygiene, bed occupancy and the number of long stay inpatients. However, there is

nothing on drug us - consumption or prescribing. Currently different parts of MOH

are requesting both the HAMT information and prescription audit data but it might be

easier and more useful for the hospitals to include the prescription audit information

in the HAMT form for 2 reasons. Firstly, the HAMT committee is headed by a senior

doctor for whom it would be useful to know the prescribing data and act on it.

Secondly, the HAMT committee analyses its own data and is learning from this about

what corrective action to take locally. However, the prescription data collected by the

pharmacy technician is not analysed locally but sent to MOH for analysis which is not

only time-consuming for MOH staff but also results in very infrequent or no

feedback to staff about their prescribing.

Public Education

All health personnel mentioned patient demand as a major reason for irrational use of

medicines. However, few public education programs on medicine use have ever been

conducted. All MOH hospitals have a Community Health Unit (CHU) which

undertakes a number of routine services including childhood vaccination, cervical

smears, family planning and antenatal care. In addition they may spread specific

public health messages, e.g. hygiene, according requests by the MOH vertical

programs. Similarly, all BHUs have outreach programs that go to various villages to

run such programs regularly every week or month.

The topics taught in the community have mainly centred on MCH or other subjects

generally decided by the vertical MOH programs. While these units have not been

used to spread messages on the proper use of medicines to the community, many

people felt this would be good to do as patient demand for drugs is high.

24

Possible Solutions

1. Monitor drug consumption through the DIGPY database in order to undertake:

• ABC analysis in association with VEN analysis (are the drugs that consume

the most budget vital and essential?) to determine which drugs are the most

consumed by quantity and value and whether they are essential or not;

• Compare consumption at primary care versus hospital or between districts

regions.

2. Prescription audit and feedback targeting the gross areas of potential misuse as

identified through monitoring of consumption (described above).

3. Annual reports (ideally as a statutory requirement) by all Hospitals and District

Health Offices of drug consumption analysis and prescription audit in all the

health facilities under their jurisdiction - with analysis by the MOH of all the

reports sent to them.

4. Continue to regularly update and implement the STGs and National Formulary:

• disseminate to all prescribers - doctors, HAs and ACOs – free of charge

• incorporate into the CPD curricula of all prescribers (doctors, HAs and ACOs)

and the orientation package for new doctors.

5. Mandate all hospitals to establish a DTC, the DTC having an obligation to

monitor drug use, coordinate CPD in their institutions and to report annually to

MOH.

• Reporting on drug use could be incorporated into the current HAMT reporting

system established in all hospitals but reporting on drug use should also be

done by DHOs on behalf of the BHUs in the district:

• Reporting by health facilities on quality of care issues and drug use will enable

both local staff and MOH to know what is and is not going on and what needs

to be done. However, such a system does require capacity in the MOH to

review these reports.

6. Encourage the Bhutan Health Council together with the RIHS to develop:

• an orientation package for new doctors - to incorporate rational use concepts

such as the national EDL, prescription audit and feedback, ethics and CPD,

and

• a CPD program for doctors, HAs and ACOs incorporating rational use

concepts.

7. Establish a National Drug Information Centre within the JDWNRH where

prescribers could telephone from all over Bhutan could get drug information.

8. Disseminate to the public of core pharmaceutical messages through the already

existing government Community Health Units and the media. e.g. does my child

need more than one drug?

25

Medicines Regulation

There is currently a comprehensive Medicines Act in force since 2003. In addition,

the Bhutan Drug Regulatory Authority published a 1st edition of Medicines Rules and

Regulations in 2005 and a 2nd

edition in 2008. The DRA is independent of the MOH

and is governed by the Medicines Board, which is constituted by Parliament, and

where the Minister of Health is the Chairman and there is representation from the

Ministry of Agriculture, the Medical and Health Council, the Ministry of Trade and

Industries and the Bhutan Chamber of Commerce and where the Drug Controller is

the Member Secretary. The Bhutan DRA has a website http://dra.gov.bt . The DRA

regulates a sector that comprises 1406 registered products, 9 wholesalers, 38 retail

pharmacies and no manufacturers for a population of approximately 700 000 people.

Staffing in the DRA comprises 4 BPharm pharmacists, 1 diploma pharmacist, 7

pharmacy technicians and 9 other general staff. Of the 4 pharmacists, one is the Drug

Controller, two work on drug registration and 1 on good manufacturing practice.

There are 7 inspectors.

Regulation of outlets and drug schedules

All pharmacies must be registered with the DRA and there must be a licensed

dispenser present in the pharmacy at all times. Recently the DRA together with the

RIHS ran a course and exam to license health workers who were currently running the

few pharmacy shops in the country. The DRA regularly inspects (at least annually)

the retailer and wholesale pharmacies using a standard procedure for inspection.

There is a regulation stipulating drug schedules and which drugs can and cannot be

sold without prescription. Previously, many prescription-only drugs were freely

available without prescription (except for controlled drugs). However, recently the

regulations have been enforced such that antibiotics were not available over-the-

counter at least in Thimpu. In the border areas, enforcement is more difficult.

Drug Promotion, Pharmacovigilance and Drug Quality

A few staff manage all the activities outside of inspection and drug registration, since

the DRA is small. Drug promotion is rare in Bhutan due to the small market. In most

of the country, visits by drug representatives do not occur. In the large border towns

and in Thimpu, drug representatives are known to visit and give out free samples of

unregistered drugs to doctors. Monitoring of advertising is done and twice illegal

advertising of traditional medicine occurred and was stopped.

A Pharmacovigilance unit has just been set up in the DRA. However, so far there is

no database and it was not clear how many, if any, ADRs had been reported.

However, it was mentioned that they would like to become an Associate Member of

Pharmacovigilance Monitoring Centre run by the WHO Collaborating Centre in

Uppsala, Sweden. For this, 20 ADRs must be reported by the DRA.

There is no drug testing laboratory in Bhutan so the DRA send samples, collected by

the inspectors, regularly to a laboratory run by a WHO Collaborating Centre in

26

Thailand. In the last 2 years, 149 samples have been tested of which 9 failed to meet

quality standards.

Drug registration

The Medicines Board is responsible for deciding upon which drugs may be registered

and is advised by the Drug Technical Advisory Committee (DTAC). The membership

of this committee is defined and includes the Chairman of the National Drugs

Committee (selects the EDL), the Chairman of the National Veterinary Drug

Committee, the principal pharmacist in the Dept of Health Services and a qualified

doctor, veterinary surgeon and pharmacist as nominated by the respective Ministries.

There are written criteria and SOPs for undertaking registration. The registration fee

is - 1500Nu with an extra 150Nu processing fee for each item but the income goes

straight to the MOF and is not kept by the DRA. From the DRA perspective the fee is

quite small, particularly since the fees are much higher in other countries. However,

the market in Bhutan is very small and there is little incentive for manufacturers or

their representatives (wholesalers) to register products. Some product sales may not

cover the time taken to collect the dossiers of documents for registration purposes or

the fees. Therefore many felt that the fee was too high. Registration lasts 3 years and

must then be renewed.

There are many unregistered drugs in Bhutan, many of them hospital drugs for use

only in hospitals. Due to the small market, many manufacturers do not feel it worth

their while to get their products registered for use in Bhutan. The DRA had given an

order in 2008 that by 2011 all drugs imported into the country must be registered.

Unfortunately, for half of the drugs on the EDL there are no registered products. This,

in turn, has made it very difficult for the wholesalers to import the medicines with

serious results for the government supply which has been disrupted. For some

products the government contract for supply had gone to a supplier of an unregistered

product rather than a registered one due to much lower prices. This problem may be

rectified to some extent in future tenders by the DVED action to control prices and

charge defaulting suppliers the difference between the prices they quoted and what

another supplier delivering the drugs is actually charging. However, for other high-

cost / low-volume drugs where no manufacturer or agent can be found to register a

product, the government is now enacting a fast-track process for importing such

drugs. In Bhutan Medicine Rules and Regulation (2008), there is provision for

temporary registration when requested by relevant government agencies, especially

for products required in emergencies, disease outbreaks or specific patient needs.

It was mentioned that it is only now - when the regulation on drug registration has

come into force - that the number of registered products has increased. While it is

important to encourage the registration of products for which there is no alternative

product already registered, caution should be exerted in not allowing an excessive

number of “me-too” products to be registered. In other words, 5 different products of

the same chemical entity in a particular formulation are sufficient to ensure a

competitive supply of registered products. Having 20-30 products of the same

chemical entity is unnecessary and would add considerably to the work of the DRA.

Another problem that emerged was that when a wholesaler had gone to the trouble of

registering drugs, he not only did not necessarily get the government contract (which

27

constitutes the majority of sales in Bhutan where the private sector is minimal) but in

at least one case, he did not have sole import rights. One wholesaler in Thimpu had

found other retailers selling his product and apparently there was no means of

correcting the situation.

Possible Solutions

1. Train existing staff on dossier evaluation for drug registration.

2. Improve the process of drug registration by:

• reviewing the criteria for fast-track drug registration for low-volume / high-

cost products so as to ensure that all EDL drugs can have temporary

registration and be imported;

• applying all the registration procedures (normal and fast track) with rigor (as

too many exemptions would weaken the DRA);

• possibly extending the registration period to 5 years instead of 3;

3. Continue to strictly comply with all drug regulations.

4. DRA should provide an incentive to wholesalers to register drugs by ensuring that

only they have the right to import, assuming that they are not defaulting on

supply.

Medicine Policies and Coordination

There is an extensive public health care system in which patients can receive good

health care free of charge. The various medicine policies that may impact on drug use

and are in place are shown in table 4. This data was compiled from information found

during the mission and as reported by the Country Pharmaceutical Profile sent by

MOH to WHO Geneva in 2011.

28

Table 4: Medicine Policies in place in Bhutan according to the WHO

Pharmaceutical Country Profiles Survey in 2011

Drug Policy State of implementation

National Medicines Policy Official document published and endorsed in 2007.

Monitoring the use of

medicines

Some recent monitoring by EMTD/EDP in 2011 but very

little prior to this

Essential Medicines List National EDL 2011 exists and is followed by the

government sector

Standard Treatment

Guidelines

National STGs for Basic Health Units 2007 is used in all

the BHUs and by paramedical staff

Formulary Bhutan National Formulary 2009 was distributed free and

was widely available but 2011 version was not freely

available at it is being charged for by DRA

Generic Policies Generic prescribing encouraged and also generic

substitution occurs in the public sector with the

concurrence of prescribers

Regulation of promotion

of medicines

Government regulation exists but very little drug

promotion actually occurs

Monitoring of ADRs No national pharmacovigilance centre but the DRA does it.

No information on ADRs reported.

Payment for medicines All medicines are provided free of charge to patients in the

public sector.

Health Insurance Very few people have health insurance as government care

is available to all

Revenue from medicines Never used to pay salaries in the public sector

Medicine Pricing policies No strict pricing policies used in either the public or

private sectors

Undergraduate medical

training

There is no medical training but the national EML, STG

and prescribing are part of the paramedical curricula

Continuing medical

education

Vertical MOH programs organize CME but very little

CME includes prescribing

Medicines Information

Centre

No national medicines information centre

Public education on

medicines use

No public education campaigns on medicines use done in

the past 2 years

Drug and Therapeutic

Committees (DTCs)

Only the JDWNRH has a DTC which has not met for 1

year. No other hospitals had DTCs though they have

HAMT committees for general quality of care issues

National Strategy for

containing antimicrobial

resistance

No national strategy but antibiotics now infrequently

available over-the-counter without prescription

29

Coordination and Management

A national medicines policy (NMP) document was first published in 1987 and revised

in 2007 (DMS/MOH 2007). The primary aim of the NMP is to ensure that primary

care services are extended to those living in the most remote part of the nation and

specifically:

i. To ensure the accessibility, availability and affordability of essential drugs to

all citizens

ii. To ensure the safety, efficacy and quality of drugs;

iii. To promote good dispensing practices, prescribing practices and rational use

of drugs;

iv. To promote efficient supply management system;

v. To promote the development of local pharmaceutical industry and local

production of essential drugs.

There has been sustained effort to implement points (i) to (iv) over the years. The

current problems in drug supply and use are only so visible because of past effort.

Point (v) on local manufacture has not been implemented for allopathic drugs but may

be quite difficult to do due to the relatively small amounts actually needed.

There are two main reasons why Bhutan has been relatively successful at

implementing its National Drug Policy. Firstly, there has been, and is, political will to

achieve Gross National Happiness and implement the NDP. Secondly, the Essential

Drugs Program was established and has been responsible for implementation of the

national EDL, STGs, Formulary, training on rational use of medicines and supply

management.

In past years, the EDP had substantial external support but this has been diminishing

for a number of years and stopped completely in 2008. Up until 2008, the EDP though

a small unit, was situated in the DVED (drug supply). This allowed the EDP 1-2 staff

members to work together with DVED staff on drug management and supervision

issues, as well as development of EDL, STGs and Formulary. The EDP also helped

DVED in collating details on supplier performance and products specifications for use

in the procurement process. However, in 2008, it was decided to move the EDP from

the DVED to a new division the EMTD, in order to be more independent of DVED.

However, only 1 staff member was posted in the EDP until April 2011. Once the EDP

was no longer situated on the same premises as DVED it made it more difficult for 1

staff member to work on issues of drug supply and use, and thus much training and

supervision of health workers was stopped. Since April 2011, the EDP has been

revived and it is now one of the units in the Essential Medicines and Technology

Division (EMTD), the other unit being on technology. There is now a doctor heading

the EMTD and 1 pharmacy technician and 1 diploma pharmacist in the EDP. While

this represents a doubling of staff, the EMTD chief still stated that a pharmacist plus

an extra pharmacy technician were needed if they were to take up former supervision

on drug management. The chief of the DVED also mentioned that extra staff were

needed if proper training and supervision of drug management were to be achieved –

specifically 1-2 staff were needed per dzongkhag (district) and 12 staff centrally. With

regard to supervision drug supply and management, the division of responsibilities

concerning supervision of drug management between DVED and EDP are not clear.

30

It was found that there were about 7 checklists to examine various aspects of drug

management including physical conditions, storage procedures, ledgers, ordering

supplies, receiving supplies, dispensing procedures, availability of drugs. In addition

there was a prescription audit form, a form for assessing the health facility and lab

services and the Hospital Administration and Management Transformation (HAMT)

form. Only the HAMT form and the prescription audit form were seen in use. While

the prescription audit form was clearly being collected by the EDP and the HAMT

form was being sent to the DMS, it was not clear who was filling in the 7 checklists

on drug management. At the health facilities, a logbook of visits is kept. However,

many of the visits were for MOH vertical programs or visits of local or foreign

dignitaries and very few were on drug management.

The number of forms and registers that health staff must fill in is large. In one BHU,

more than a dozen registers (Outpatients, Laboratory, Injections, Oral Rehydration

Solution, Compounding, Birth, Family Planning, Sexually Transmitted Infections,

School Health, Drug and Vaccine stocks, Equipment Stocks, Patient admissions, IEC

activities, Chronic Diseases, Antenatal Care, Mental Care, Child Health, Malaria)

were identified. In the same BHU another dozen forms were also identified (IMCI, 6-

monthly Drug Stock, Reproductive health, HIV/AIDS, TB, ARI, Diarrhoea, Leprosy,

Malaria, Nutrition, Salt Analysis, Morbidity, Household Survey). Likewise, hospitals

have a very large number of registers and forms to fill in – many being the same as in

the BHU. However, in addition they must fill in forms on drug and non-drug supply,

staff management, mortality, morbidity, waiting times, utilization of equipment,

infection control, hygiene, bed occupancy, HAMT, etc. All these forms are sent to

MOH to compile health statistics and also to oversee the various vertical programs.

The quantity of forms that must be filled requires a large amount of staff time – and

some of the forms are not analysed locally in which case their local use is limited. It

may be useful if review all these forms to see which are really necessary and how

some of the paperwork could be reduced. The forms that are filled in, at least for

medicines, should be reviewed locally as well as centrally so that local action can be

taken. Despite all these forms, indicators of drug use and availability are not included

in the general health management information system.

Promoting rational use of medicines and implementing national drug policy requires

coordination between the various stakeholders. At present, the DG Medical Services

holds a weekly meeting for staff in his department – including the EMTD and the

DVED. However, the DRA, RIHS and the Health Council of Bhutan are not included

and clearly there is a need to bring together all concerned stakeholders when planning

how to implement national drug policy. If such a forum existed, apparently conflicting

results of different departments’ actions, e.g. DVED and DRA, could possibly be

avoided and quicker solutions found.

Possible Solutions

1. Institute a coordinating mechanism under the MOH whereby the EDP, DVED,

MSD, DRA, RIHS and Health Council can be brought together to resolve issues;

this forum could be chaired by the Health Secretary and would be different from

the Medicines Board (for the DRA) or the National Drug Committee (for selection

of the EDL);

31

2. Liaise with the Human Resources Division (HRD of MoH) to increase the number

of pharmacist posts in the EDP, DVED, MSD;

3. Continue to implement the NMP and to comply with the drug regulations;

4. Strengthen the EDP so that it can take full responsibility for promoting rational

use of drugs, including coordination of the following components - EML, STGs,

DTCs, monitor use, CPD, DIC, public education;

5. Liaise with Royal Institute of Health Sciences could provide students to collect

prescription and other information needed by MOH as part of their research

studies;

6. Liaise with the Bhutan Medical & Health Council to include prescribing and/or

drug management, as relevant, in the credit system for continuing Medical

Education for relicensing.

32

Workshop

At the end of the mission, a half-day workshop was held on June 20th

with 30 national

stakeholders to discuss the consultant’s findings and to develop recommendations.

The participants in the workshop can be seen in annex 2. The consultant’s

presentation at the workshop can be seen in annex 3.

Objectives of workshop • Review the WHO fact finding results

• Identify the main priority problems to be addressed

• Formulate recommendations to resolve / address the problems

• Facilitate the development of plans to:

– implement recommendations, and

– incorporate recommendations into the national health plan for sustained

implementation and follow up

Agenda

• Presentation of the findings by the WHO consultant with discussion of the

findings and identification of main problems and possible solutions

• Plenary discussion and finalization of recommendations

– Road map for MOH, stakeholders and WHO to follow

Unfortunately there was insufficient time for group work as originally planned. This

meant that there was less involvement of more junior staff in the discussion.

Nevertheless, there was a lively discussion and the stakeholders agreed with the many

of the consultant’s findings and most of the consultant’s recommendations. During the

workshop, recommendations were agreed by consensus in plenary discussion.

Following the workshop, the recommendations were edited (for language and

coherence) and circulated to all the stakeholders. The following conclusions and

recommendations were agreed by all stakeholders and incorporate all comments from

the workshop participants.

33

Recommendations

A. Medicines Supply

1. Strengthen the EDP/EMTD, DVED & MSD and their collaboration:

• Need at least one pharmacist per division to oversee all activities;

• Need collaboration on training and supervision of district staff in order to

avoid duplication of effort and to ensure that harmonised messages are given.

2. Strengthen the electronic drug management system, initially the DIGBY system,

which requires some full-time IT input in order to train all staff and sort out all

computer problems in health facilities.

3. Do not limit tendering to a 3-year period or by lot (groups of drugs are chosen for

tendering):

• tendering annually by line item and not by lot is the easiest option for

suppliers - if tendering by 3 year period or lot is done then the effect of this

type of tendering should be carefully monitored.

4. For unregistered low volume/high price products:

• Various suppliers could be invited to bid for a “lot” that included all the high-

cost / low-volume items to be supplied on a special registration basis and then

one bidder chosen; such a "lot" consisting of many of these items may be more

attractive to a supplier than a single item of this type.

5. If there is only one supplier for a registered product and the procurement

committee thinks the price is too high, DVED should investigate international

prices and also the price in the DRA proforma invoice for importation.

6. Only give tenders to suppliers of registered drugs (whether the products be fully

registered or are registered on a special basis):

• provided the products are of a reasonable price based on comparison with

international and Indian prices and

• provided that the supplier meets all the supplier performance criteria.

7. DVED should do a full pre-qualification assessment of the product and a

performance assessment of all suppliers to present to the procurement committee:

• there should be adequate pharmaceutical technical expertise present in

meeting to advise members on technical issues.

8. Strengthen the storage facilities in Phuntsholing in terms of the premises,

equipment, staffing numbers and training.

9. DRA should consider extending registration of products from 3 to 5 years so as to

ease the financial outlay and effort of wholesalers to get products registered (see

regulation also).

34

10. As far as possible, introduce changes to the procurement and supply processes in a

systematic controlled way, preferably one change at a time and monitoring closely

the effect of the change(s).

11. WHO to consider investigating the possibility of a SEAR drug facility for small

countries.

B. Medicines Selection and Consumption

12. DVED To estimate and publish consumption data annually, in terms of quantity

and cost and to include comparison of consumption by district (Dzongkhag), by

therapeutic class and by per capita.

13. Invest in an electronic drug inventory system, DIGPY to start with, to get up-to-

date consumption data.

14. Train staff in drug consumption analysis - DVED and EMTD may work together

on this.

15. To improve the selection of essential drugs by:

• developing, in consultation with prescribers, written published criteria for

selecting drugs for the national EDL;

• Establishing a permanent sun-committee to judge all out-of-list requests

coming from outside the country and whether cheaper generic drugs could be

substituted.

C. Medicines Use

17. Monitoring of drug consumption through the DIGPY database in order to

undertake:

• ABC analysis in association with VEN analysis (are the drugs consuming the

most budget vital and essential?) to determine whether which drugs are the

most consumed by quantity and value and whether they are essential or not;

• Comparison of consumption at primary care versus hospital or between

districts regions.

18. Prescription audit and feedback targeting the gross areas of potential misuse as

identified through monitoring of consumption (described above).

19. Annual reports (ideally as a statutory requirement) by all Hospitals and District

Health Offices of drug consumption analysis and prescription audit in all the

health facilities under their jurisdiction - with analysis by the MOH of all the

reports sent to them.

20. Continue to regularly update and implement the STGs and National Formulary:

• disseminate to all prescribers - doctors, HAs and ACOs – free of charge;

• incorporate into the CPD curricula of all prescribers (doctors, HAs and ACOs)

and the orientation package for new doctors.

35

21. Mandate all hospitals to establish a DTC, the DTC having an obligation to

monitor drug use, coordinate CPD in their institutions and to report annually to

MOH:

• Reporting on drug use could be incorporated into the current HAMT reporting

system established in all hospitals but reporting on drug use should also be

done by DHOs on behalf of the BHUs in the district;

• Reporting by health facilities on quality of care issues and drug use will enable

both local staff and MOH to know what is and is not going on and what needs

to be done. However, such as system does require capacity in the MOH to

review these reports.

22. Encourage the Bhutan Medical & Health Council together with the RIHS to

develop:

• an orientation package for new doctors - to incorporate rational use concepts

such as the national EML, prescription audit and feedback, ethics and CPD,

and

• a CPD program for doctors, HAs and ACOs incorporating rational use

concepts.

23. Establish a National Drug Information Centre within the JDWNRH where

prescribers could telephone from all over Bhutan could get drug information.

24. Disseminate to the public of core pharmaceutical messages through the already

existing government Community Health Units and the media. e.g. does my child

need more than one drug?

D. Medicines Regulation

25. Train existing staff on dossier evaluation for drug registration.

26. Improve the process of drug registration by:

• reviewing the criteria for fast-track drug registration for low-volume / high-

cost so as to ensure that all EDL drugs can have temporary registration and be

imported;

• applying all the registration procedures (normal and fast track) with rigor (as

too many exemptions would weaken the DRA);

• possibly extending the registration period to 5 years instead of 3.

27. Continue to strictly comply with all drug regulations.

28. DRA should provide an incentive to wholesalers to register drugs by ensuring that

only they have the right to import, assuming that they are not defaulting on

supply.

36

E. Medicines Policy and Coordination

29. Institute a coordinating mechanism under the MOH whereby the EDP, DVED,

MSD, DRA, RIHS and Health Council can be brought together to resolve issues;

this forum could be chaired by the Health Secretary and would be different from

the Medicines Board (for the DRA) or the National Drug Committee (for selection

of the EDL).

30. Liaise with the HRD of MoH for Human Resources to increase the number of

pharmacist posts in the EDP, DVED, MSD.

31. Continue to implement the NMP and to comply with the drug regulations.

32. Strengthen the EDP so that it can take full responsibility for promoting rational

use of drugs, including coordination of the following components - EML, STGs,

DTCs, monitor use, CPD, DIC, public education.

33. Liaise with Royal Institute of Health Sciences could provide students to collect

prescription and other information needed by MOH as part of their research

studies.

34. Liaise with the Bhutan Health Council to include prescribing and/or drug

management, as relevant, in the credit system for continuing Medical Education

for relicensing.

37

References

Myint UH, Strengthening Rational Use of Drugs in Bhutan ,World Health

Organization, Regional Office for South-East Asia, New Delhi, 1999.

DMS/MOH, National Drug Policy 2007, Department of Medical Services, Ministry

of Health, Bhutan, 2007.

EMTD/MOH, Bhutan Essential Drugs List 2011, Essential Medicines and

Technology Division, Department of Medical Services, Ministry of Health, Bhutan,

2011.

EDP/MOH, Standard Treatment Guidelines: Basic Health Unit, Essential Drug

Program, Department of Medical Services, MOH, 2007

EDP/MOH Bhutan National Formulary 2007, Essential Drug Program, Department

of Medical Services, MOH, 2007.

DRA Bhutan Essential Drugs Formulary 2011, Essential Drug Program, Department

of Medical Services, MOH, 2011.

EDP/MOH, National Antibiotic Guideline: promoting rational use of antibiotics, 1st

Edition, Essential Drug Program, Department of Medical Services, MOH, 2007.

DRA, Bhutan Medicine Rules and Regulation 2005, Drug Regulatory Authority,

Bhutan, 2008.

DRA, Guideline: application for registration of medicinal products, Drug Regulatory

Authority, Bhutan, 2008.

The medicines act of the Kingdom of Bhutan 2003. Government of Bhutan.

Annual Report 2010. Royal University of Bhutan.

WHO, Country Cooperation Strategy 2009-13, World Health Organisation, Bhutan.

2010.

38

Annex 1: Persons met and places visited during the situational

analysis:

22 Mr. Amin Tashi Pharmacist, JDWNRH

23 Ms Kamala Pradhan Owner, City Health Care Pharmacy (private),

Thimphu

24 Mr Bhakta Bahadur

Rai

Pharmacy Technician, City Health Care

Pharmacy (private), Thimphu

25 Mr Prem Singh

Lepcha

Owner, City Pharmacy (private) Thimphu

26 Mr Kinzang

Namgyal

District Health Officer, Bumthang

27 Mr. Sonam Tenzin Pharmacy Technician, Bumthang Hospital

28 Dr Tandin Zangpo District Medical Officer, Bumthang Hospital

SN Name Institution

1 Dr. Gado Tshering Secretary of Health

2 Dr. Dorji Wangchuk Director General, Department of Medical

Services (DMS)

3 Mr Ngawang Dorji Officiating Director General, DMS

4 Dr Karma Lhazeen Chief Program Officer Essential Medicines and

Technology Division (EMTD)

5 Mr Som Bahadur

Darjee

Program Officer, Essential Drug Program(EDP),

EMTD

6 Mr Kaka Tshering Program Officer, (EDP), EMTD

7 Ms. Deepika

Adhikari

PO, Bio Informatics Engineer, EMTD

8 Mr. Sonam Dorji Drug Controller, Drug Regulatory Authority

(DRA)

9 Mr. Choki Dorji Regulatory Officer for registration, DRA

10 Mr. Sangpo Senior regulatory officer for licensing, DRA

11 Mr. Tandin Dorji Officiating Chief Procurement Officer, DVED

12 Ms.Saraswati

Darjee

Procurement Officer (in charge of distribution),

DVED

13 Mr. Chakchu

Tshering

Sr. Procurement Officer, MSD

14 Mr. Pema Wangdi Assistant Procurement Officer, DVED

15 Mr. Pema

Wangchuk

Assistant Procurement Officer, DVED

16 Dr. Chencho Dorji Director, Royal Institute of Health Sciences

(RIHS)

17 Dr Tashi Wangdi Chairman, National Drug Committee, Head of

Dept. of Medicine, JDWNRH, Thimpu

18 Dr Pakila Dukpa Officiating Medical Superintendant, JDWNRH

19 Dr Ngawang Tenzin Medical Director, JDWNRH

20 Mr Thupten

Tshering

Officiating Chief Pharmacist, JDWNRH

21 Mr. Ratnalal

Sharma

Clinical Officer, JDWNRH

39

29 Mr Tandin Tshering Health Assistant,

Bumthang Hospital

30 Mr Kinlay Dorjee Health Assistant, Tang BHU, Bumthang District

31 Mr Nechen Dorji Officiating District Health Officer, Trongsa

District

32 Dr Tashi Wangchuk District Medical Officer, Trongsa Hospital

33 Ms. Rinchen Pema Pharmacy Technician, Trongsa Hospital

34 Mr. Chophel Pharmacy Technician, Trongsa Hospital

35 Dr G M Rai Officiating Medical Superintendant, Gelephu

Hospital

36 Mr. Pema Dorji Administrative Officer, Gelephu Hospital

37 Dr Sonam

Yangchen

Medical Specialist, Gelephu Hospital

38 Dr Tshering

Wangden

Gynaecologist, Gelephu Hospital

39 Tek Bdr. Chhetri Diploma in Pharmacist Gelephu Hospital

40 Ms. Pema Lhamo Diploma Pharmacist, Gedu Hospital

41 Mr. Pasang Sherpa Pharmacy Technician, Gedu Hospital

42 Dr. Birendra

Pradhan

Medical Officer, Gedu Hospital, Chukha dist

43 Mr Sonam Dorji Owner, Namsey Dental Clinic and Pharmacy

44 Mr Shiva Kumar

Sharma

Pharmacy Technician, Namsey Dental Clinic

and Pharmacy, Phuentsholing

45 Mr Namgyal Dorjee Administrative Officer, Phuentsholing Hospital

46 Dr Chandra Rai Dental Surgeon, Phuentsholing Hospital

47 Mr. Jigme Pharmacy Technician, Phuentsholing Hospital

48 Ms. Sonam Yanzom Assistant Clinical Officer, Phuentsholing

Hospital

49 Ms. Manusika Rai Sr. Pharmacist, Former EDP Program Manager

40

Annex 2: Participants of Workshop on Medicines Supply and

Rational Use -Thimpu, Bhutan, 20 June 2011

Name Institution

1. Dr. Dorji Wangchuk Director General, Dept Medical Services

2. Ms. Pem Zam Sr. PO, RH, Dept of Public Health

3. Ms. Tshering Norbu Pharmacy Technician, JDWNRH

4. Dr. Kunzang Jigme RIHS

5. Ms. Norbu HA, JDWNRH

6. Dr. Kunzang

Gyeltshen

Ophthalmologist, JDWNRH

7. Dr. D.S. Mothey Radiologist , JDWNRH

8. Dr. D. K. Nirola Psychiatrist, JDWNRH

9. Dr. Jampel Tshering Anesthesiologist, JDWNRH

10. Mr. Thupten Tshering Pharmacist, JDWNRH

11. Mr. Ganga Prasad Rai PO, Health Care & Diagnostic Division

12. Ms. Roma Karki PO, Dept of Public Health

13. Ms. Karma Wangdi PO, Dept of Public Health

14. Ms. Khina Maya PO, Dept of Public Health

15. Dr Chencho Dorji Director, RIHS

16. Ms. Pema Yangchen Nutritionist, Dept of Public Health

17. Mr. Tandin Dorji Officiating Chief Procurement Officer, DVED

18. Mr. Pema Wangchuk Procurement Officer, DVED

19. Ms. Saraswati Darjee Procurement Officer, DVED

20. Mr. Sangpo Sr. Regulatory Officer, DRA

21. Mr. Choki Dorji Pharmacist, DRA

22. Mr. Kunzang Dorji DRA

23. Ms. Ngawang Dema Senior Regulatory Officer, DRA

24. Dr. Singye Dorji Owner, Ngangpa Pharmacy & Medical

Equipment

25. Ms. Sonam P Dorjee Owner, Karma Tshongkhang

26. Dr Karma Lhazeen CPO, EMTD

27. Mr. Som Bahadur

Darjee

PO, EMTD

28. Mr. Kaka PO, EDP,EMTD

29. Mr. Sonam Wangda PO (Lab), EMTD

30. Ms. Deepika Adhikari PO (Bio-informatics Engineer) EMTD

41

Annex 3: Slide presentation given by consultant to stakeholders in

the 1-day workshop

Medicines supply and use in Bhutan:WHO mission: 8-22 June 2011

Dr Kathleen Holloway

Regional Advisor in Medicines, WHO/SEARO

Background• Current problems in the pharmaceutical sector

– Increasing demand for medicines but limited budget

– Frequent stock-outs and emergency orders

– Problem of EDL drugs that are not-registered

– Poly-pharmacy and irrational use of medicines

• Need for national action plan to address the

problems

– WHO fact finding mission, 8-22 June, 2011

– Workshop to develop recommendations for national

plan of action, incorporated into national health plan

Objectives of the workshop

• Review the WHO fact finding results

• Identify the main priority problems to be

addressed

• Formulate recommendations to resolve / address the problems

• Develop plan to:

– implement recommendations, and

– incorporate recommendations into the national health plan for sustained implementation and follow up

Agenda of the workshop

• Presentation by WHO with discussion of findings, identification of main problems and possible solutions

• Group work to discuss solutions and develop recommendations to implement solutions

– include practical steps and the human and financial resources needed

• Presentation of group work with plenary

discussion and finalization of recommendations

– Road map for MOH, stakeholders and WHO to follow

Mission 9-22 June, 2011 9 June: Orientation in WHO and MOH, including WR, Health

secretary, EMTD, EDP, Acting DGMS

10 June: DVED, DRA, RIHS;11 June: Thimpu referral hosp (JDWRH), Chair National

Drug Committee, 2 private wholesaler/retailers;

12 June: Thimpu - Bumtang

13 June: Bumtang District hosp & DHO, Tang BHU

14 June: Trongsar District Hosp & DHO, Tashiling BHU;15 June: Trongsar - Gelephu

16 June: Gelephu referral hospital; return to Thimpu

17 June: Thimpu – Phuntsholing, visiting Gedu hospital, Phuntsholing MSD, 1 private wholesaler/retailer

18 June: Phuntsholing referral hospital; return to Thimpu

20 June: Workshop21 June: Debriefing to senior officials & WR

Mission findings

• Extensive health care system, with substantial infrastructure, trained health care personnel and

good health indicators, but…

• Serious problems in the pharmaceutical sector

concerning:

– Drug supply and use, information and coordination,

but…

• Sufficient resources and capacity to address the

problems

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Drug availability: stock-outs

• Complaints about stock-outs from all public facilities

• DVED: 86 items still out of stock due to non-delivery, non-quotation

• Thimpu hosp: 77 items

• Sub-referral hospitals: 10 – 12 items

• District hospitals: 4 – 7 items

• BHUs: 1-3 items

• Some items are rarely used, some can be substituted (eye ointment for drops) and others are available in

other facilities (TT and ORS)

Drug supply problems: inventory control

• Sub-optimal inventory control– electronic DIGBY system hosps but not BHUs but not being

used properly in many institutions and not being fully utilisedanywhere, so manual system is still used

– under-estimation of requirement in facilities due to change in forecasting formula based on last year’s average monthly consumption

• 26 months consumption (minus the balance) was changed to 15 months in quantification exercise

– delay in estimating requirement due to new procedures to involve the districts more fully

– Reduced monitoring of stock management: 6-monthly stock reporting often not done

• Insufficient staff in DVED and EDP with only 1 pharmacist between them - so monitoring and training very reduced

– Frequent emergency orders and buying drugs on the free market

• BUT– good redistribution in districts despite manual inventory systems

and inadequate storage facilities in Phuntsholing

Drug supply problems: delayed procurement

• Sub-optimal drug procurement– Lot tendering tried but abandoned as suppliers could not bid– New requirement for 3 year tendering excluded many suppliers who

felt they could not bid a competitive price or who bid a higher price to cover 3 years and were not selected by the committee

– Allowed suppliers to win bids with unregistered products relying on their unfulfilled promise to register these products – even though other suppliers bid with registered products

– Some high price, low-volume products on the EDL are not registered and no manufacturer or wholesaler can be found to register them

• DVED and DRA disagree as to the number of such products• No incentive for wholesalers to act as agents for registration

– 2 previously reliable drug suppliers suspended following corruption scandal of supplying expensive poor functioning equipment

– Gave contracts to 3 new Bhutani wholesalers in order to encourage Bhutanese wholesale industry but these 3 new suppliers defaulted

– Insufficient staff in DVED (with only 1 pharmacist who is chief)

Drug Supply: suggested solutions

• Strengthen the EDP, DVED & MSD and their collaboration– Need more pharmacists to do regular training on stock management

• Strengthen the DIGBY system which requires full-time IT input

• Do annual tendering by item and not by lot

• For unregistered low volume/high price products

– Appoint 1 agent in India to supply them on a special license basis

• If there is only one supplier for a registered product and the procurement committee thinks the price is too high, DVED can investigate international prices and also the price in the DRA proforma invoice for importation

• Only give tenders to suppliers of registered drugs that also meet all the supplier performance criteria

• DVED should do a full pre-qualification assessment to present to the procurement committee and have 2 pharmacists present in meeting

• Give incentive to wholesalers to register drugs by ensuring that only they have the right to import

• Do not introduce more than one procurement, quantification or regulatory change at any one time

• Strengthen the storage facilities in Phuntsholing

Drug selection and consumption• National EDL 2009 and new one formed in 2011

• 403 drugs on the EDL– List is different according to the type of health facility and also

classified by Vital, Essential and Non-Essential

– Drugs are added but few are deleted

• MSD follows the EDL so most patients are prescribed EDL since there is very limited private retail market

• National Formulary updated but not present in all hospitals since DRA charging for it

• ABC analysis not done so top 10 medicines by cost and quantity could not be identified by DVED or any facility

• ABC analysis to identify large volume and high cost drugs is essential for identifying drugs whose use should be monitored more closely

Possible solutions for selection• MSD/DEVD should produce an annual report on

consumption– In terms of quantity and cost for each line item– Comparison by therapeutic class, health facility and district can be

done to identify high cost line items and high consuming facilities where monitoring can be concentrated

• Electronic inventory management system for all hospitals– Better estimation / forecasting of drug need– ABC analysis for feedback to prescribers

– Can easily be done if the DIGBY system was kept up to date

• Improve collaboration between DVED, MSD and EDP

• Stricter adherence to EML – For prescriptions of patients receiving specialised treatment in

Calcutta– permanent sub-committee could judge all such out-of-list requests

and whether cheaper generic drugs could be substituted

• Provide National Formulary free to all facilities or all prescribers

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Drug use• No international publications on drug use found

• BHU prescribers using the national STGs but not the hospitals doctors and very few other sources of independent drug information

• Daily pharmaceutical representative only visiting doctors regularly in Phuntsholing hospital

• Prescribing principles taught to HAs but all doctors receive their undergraduate studies abroad

• CPD undertaken by all prescribers– New system whereby every health worker will need 30 credits

every 5 years and also by 2012 in order to get re-licensed but

– does not include much on rational use of medicines

• Overcrowding in some hospitals resulting in prescribersseeing 100 patients day with very short consultation times so leading to polypharmacy

Drug use indicator survey

163.67---Av.cost/Px (NU)

-97%93%85%% drugs dispensed

53%100%97%96%% EDL drugs

22%100%92%77%% generic drugs

17%29%42%28%% patients with VITs

0%8.2%--% patients with INJs

17%34%33%31%% patients with ABs

1.521.92.512.63Av.no.drugs/patient

Retailer

n=2

BHU

n=2

District hosp

n=3

Referral hosp

n=3

Drug use indicator

Issues on the prescription surveys

• WHO survey showed better drug use than MOH survey because

– MOH prescription selection was not random and the worst prescriptions

were selected

• Cannot mix chronic and acute cases in prescription survey in

hospitals because

– Chronic case prescriptions have more items and fewer antibiotics than

acute case prescriptions

• Injection rate, % drugs dispensed cannot be measured from the dispensing book because injections and non-dispensed items are

not recorded

• Must give regular feedback to prescribers

• Phuntsholing is the only hospital receiving drug representatives and

therefore had:

– slightly lower rates of prescribing generic and EDL drugs and in

consequence a slightly lower rate of prescribed drugs dispensed

Cost of irrational prescribing

• Many prescriptions have:– Paracetamol, vit B Complex and Vit C as placebo as well as a

"main" drug

• Most prescribers define polypharmacy define as 5+ drugs or more than 1 AB– Paracetamol, vit B Complex and Vit C "do not count"

• No. tablets issued per head of population in 4 areas– Paracetamol 500mg: 13-316

– B complex: 5-45

– Vitamin C: 4-18

– Ferrous Sulphate: 7-34

• VHWs dispense some of these drugs & they are not supervised

• Cost of paracetamol, vit B Co and Vit C per year in 2010 was:

Possible solutions for improving use

• Monitoring drug use– ABC analysis, prescription audit in the facilities as well as by MOH

• Standard Treatment Guidelines and Formulary– Disseminate to every doctor and incorporate into CPD

• Establish DTCs– to monitor drug use, encourage CPD, and report annually on activities to

MOH– Could be incorporated into the Hospital Administration & Management

Transformation Committee and drug use indicators could be incorporated into the HAMT reporting format

• Continuing professional development (CPD)– Bhutan Medical Council credit system should include incorporation of

prescription audit and feedback into CPD– Extend orientation course for all new doctors – to include EML, STGs

• Public Education– Core pharmaceutical messages e.g. does my child need more than one

drug? through the Maternal Child Health units attached to every hospital and media

• Establish Drug Information Centre

Drug regulation

• New DRA

• Comprehensive set of rules and regulations first published in 2005 and revised in 2008

• 4 pharmacists

• Managing well

• Trying to be strict over drug registration

– Will ultimately result in safer medicines but will require political support and should remain independent

– Too many exemptions will weaken the DRA

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National Drug Policy• National Drug Policy published in 2007

• Comprehensive set of policies to be implemented mainly by DVED and EDP

• Mentions development of human resources but DVED and EDP too weak to implement NDP

• Many parts of the NDP implemented e.g. EDL, Formulary, STGs, formation of DRA, but ….– Human resources are reduced not improved

– EDP was reduced in capacity – 1 staff member – until recently

– Storage facilities in MSD inadequate

– DTCs not established in hospitals and monitoring of drug use not done

– NDP indicators are not incorporated into the HMIS

– Drug Information Centre not established

Coordination and management

• Under MOH, there are 3 departments

– Dept Medical Services, Secretariat for Human Resources & the Dept Public Health

• Under Dept Medical Services, there are 6 divisions

including EMTD and DVED

• Under EMTD, there is EDP & a similar unit for equipment

– EDP is relatively low in the hierarchy

• The DRA is independent of the MOH and reports to the

Bhutan Medicines Board

• While independence between the different "drug"

departments is necessary,

– communication, and collaboration are sub-optimal

Possible solutions for coordinating structure

and national policy

• Strengthen the following units / departments all of which

require pharmacists

– EDP, DVED, MSD

• Institute a coordinating mechanism under the MOH

whereby the EDP, DVED, MSD and DRA can be brought together to resolve issues

– Possibly through the Medicines Board of which the Secretary is

the chairman

• Liaise with the Secretariat for Human Resources to

increase the number of pharmacist posts in the EDP,

DVED, MSD

• Continue to implement the NDP and to support a strong DRA

Group work

• Each group to draft recommendations with practical steps including

– Who will do it

– How many staff

– Budget

• Groups

– Drug supply: procurement, storage & distribution

– Drug selection & promoting rational drug use

– National structure, drug regulation and policy

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