Post on 07-Jun-2020
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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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