WORLD HEALTH ORGANIZATION
REGIONAL OFFICE FOR EUROPE
HUMANITARIAN ASSISTANCE OFFICE
SKOPJE, FYR MACEDONIA
SUPPORT TO THE DEVELOPMENT OF THE
PHARMACEUTICAL SECTOR
IN FYR MACEDONIA
END OF MISSION REPORT
Simona Chorliet
Pharmaceutical Adviser
May 2001
WHO Humanitarian Assistance Office  Mirka Ginova 17 Skopje, FYR Macedonia
Tel +389 2 362-879 / 364-299 / 364-599 Fax +363 710  [email protected]
Table of contents
I.
BACKGROUND INFORMATION ....................................................................................................3
II.
OBJECTIVES AND ACTIVITIES ....................................................................................................3
III.
EXPECTED RESULTS .......................................................................................................................3
I.
REALISATIONS .................................................................................................................................4
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6.
II.
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NATIONAL DRUG POLICY (NDP) DEVELOPMENT ...............................................................................4
Launch meeting ............................................................................................................................4
Designation of working groups’ members ....................................................................................4
Stages and timetable .....................................................................................................................4
Collaboration with the International Project Unit / World Bank .................................................5
Support from Prof. Richard Laing ................................................................................................5
National Drug Policy draft produced by the working group ........................................................6
Adoption workshop .......................................................................................................................6
Lessons learned ............................................................................................................................6
DRUG SUPPLY ....................................................................................................................................7
Agreement with Ministry of Health on drug purchase items ........................................................7
Information collection on monthly consumption ..........................................................................7
Identification of distribution points for insulin in the country ......................................................7
Decision on distribution points for peak-flow meters and inhalers ..............................................7
Purchase order .............................................................................................................................7
Identification of existing asthma and diabetes patients’ education programmes .........................8
Therapeutic Patient Education workshop ....................................................................................8
Workshop on practical diabetology ..............................................................................................9
Training of trainers on asthma patient education ........................................................................9
Patient information publications ..................................................................................................9
RATIONAL DRUG USE ......................................................................................................................10
Selection and review of medicines to be distributed and used in the public sector ....................10
Drug use survey conducted in primary health care facilities .....................................................11
Survey on drug consumption ......................................................................................................11
Training activities .......................................................................................................................11
NATIONAL DRUG INFORMATION CENTRE (NDIC) ...........................................................................12
Background ................................................................................................................................12
Weak points to overcome ............................................................................................................12
Opportunities ..............................................................................................................................12
Assessment of the NDIC activities by WHO consultants ............................................................13
Recommendations for the centre’s development and better performance ..................................13
Increased WHO support .............................................................................................................13
Collaboration with the World Bank pharmaceuticals project ....................................................14
GEOGRAPHICAL AND FINANCIAL ACCESSIBILITY: PUBLIC AND PRIVATE SECTORS ............................14
Assessment of the pharmaceutical sector reform possible impact ..............................................14
Advice on WTO membership/TRIPS application implications in the pharmaceutical sector .....14
Collective centres drug supply assessment .................................................................................15
SUPPORT TO THE DRUG REGULATORY AUTHORITY ...........................................................................15
FURTHER ACTIVITIES / PERSPECTIVES ................................................................................15
3.
3.
4.
5.
NATIONAL DRUG POLICY DEVELOPMENT ........................................................................................15
DRUG SUPPLY ..................................................................................................................................15
RATIONAL DRUG USE ......................................................................................................................15
NATIONAL DRUG INFORMATION CENTRE ........................................................................................16
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I.
Background information
FYR Macedonia has gone through many political and social changes during the last few
years. The political life of the country was characterised by frequent government
reconstruction and governing party changes. Because of its geographical situation in the
Balkans the country has experienced all major movements and changes in the region. The
flow of refugees coming from Kosovo during 1999 crisis provoked a certain misbalance
and mobilised substantial funds from the international community. The situation had just
started to normalise and the first results from ambitious projects became visible, when
armed groups threatened the stability of FYR Macedonia. New mobilisation from the
local and the international communities is still needed to overcome this new even more
serious for the country crisis.
The health sector in FYR Macedonia has been facing budgetary and organisational
problems over the last years. The refugee crisis and the remaining number of about
20 000 refugees since the Kosovo crisis, (some of them in Collective Centres some of
them in host families) are an additional burden to the sector. The situation was aggravated
by the recent internal displacement of people. All these reasons have led to address
quality problems in the health care services and particularly access to essential drugs.
The understanding of the need for changes and the strong political will gave an impetus
to the reform process undertaken in the country. The pharmaceutical sector is also going
through a significant reorganisation. WHO supports the Ministry of Health in this process
through the present pharmaceutical project.
II. Objectives and activities
To assist the health care system improve the access to and use of essential drugs, and with
that the delivery of essential health care services to the whole population, especially for
the vulnerable groups.
The activities are organised in the following main fields:
 National Drug Policy development
 Project drug purchase
 Improving of prescribing and use of medicines
 Independent drug information
III. Expected results
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Improved availability of essential drugs in the health services through the
distribution of medicines purchased via the project
Improvement of the drug supply and reimbursement system that will enhance
access to the population
Development of a comprehensive National Drug Policy
Sources of independent drug information available and used by health
professionals
Improved prescribing and use of drugs
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I.
Realisations
1. National Drug Policy (NDP) development
 LAUNCH MEETING
The launch meeting of the NDP process took place on 3rd of February 2000 in Skopje.
This one-day meeting was organised by the Ministry of Health with technical assistance
and support from WHO. Over 130 professionals from FYR Macedonia as well as about
20 international representatives and observers participated in the meeting and
demonstrated an active interest in the NDP formulating and implementing process. The
morning session consisted of presentations by international experts on the essence of a
NDP and some other countries’ experiences in this field, followed by questions. Prof.
Richard Laing, Assoc. Director of the Centre for International Health at Boston
University, made a presentation on what is and why a National Drug Policy. Assoc. Prof.
Genka Petrova, Faculty of Pharmacy, Sofia, presented the Bulgarian experience. Dr
Andrew Herxheimer presented UK experiences in drug policy. The afternoon session was
organised in working groups’ discussions and contributions. The five working groups’
facilitators presented the results of the work. The meeting ended with closing remarks
and recommendations for further work.
 DESIGNATION OF WORKING GROUPS’ MEMBERS
The Minister of Health appointed 14 working group members. They are distinguished
personalities and key people in the development of the pharmaceutical sector. During the
first meetings, the participants received WHO documents on NDP development and
several examples of NDP documents of other countries. The discussions concerned
mostly what the process should be, the framework and size of the document and
identification of some priority problems to be addressed. After several meetings of the
whole group, the work was divided in five sub-groups developing the following topics:
I.
Legislative and regulatory framework
II-a. Choice of drugs
II-b. Rational drug use, drug information and information systems
III.
Supply and economic strategies for drugs
IV.
Human resources development, monitoring and evaluation
The first division in fact had produced four groups. The part to be developed by the
second group proved to be quite large and the issues distinct. There was also a
concentration of strong personalities in this group, which was rendering the process more
difficult. Our consultant, Prof. Richard Laing, suggested the sub-division of the group.
This proved to be the right thing to do as the work was highly facilitated afterwards.
 STAGES AND TIMETABLE
The working groups’ members organised their activities according to the following main
stages:
 Description and analysis of the situation, strengths and priority problems
 Fixing of goal and objectives
 Developing the main strategies in each group
 Indicators for monitoring and evaluation
 1st consolidated draft of each working group
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 2nd draft - a common document from all the groups' drafts
 Circulation of the draft
 Revision
 Adoption workshop
 Final document after circulation of the draft and revision
Initially the duration of the development process was supposed to be of three to six
months starting from March 2000. We expected in fact to have a draft for circulation no
later than September 2000. Technical and administrative problems provoked a certain
delay. Essential for the smooth development process was the signing of contracts with
clear terms of reference and the appointment of co-ordinators for each group. Besides, the
main policy issues proved to be complex and controversial in the beginning. It became
obvious that time is needed for the ideas to get organised and for solutions to crystallise.
 COLLABORATION
BANK
WITH THE
INTERNATIONAL PROJECT UNIT / WORLD
A fruitful collaboration was established with the International Project Unit – especially
the pharmaceutical component of the WB financed project, that supported some of the
activities in the development process.
 SUPPORT FROM PROF. RICHARD LAING, ASSOC. DIRECTOR OF THE CENTRE
FOR INTERNATIONAL HEALTH AT BOSTON UNIVERSITY, WHO CONSULTANT
12 – 20 May 2000
WHO EURO/PHA and WHO’s Humanitarian Assistance Office in Skopje,
pharmaceuticals programme, invited once again Prof. Richard Laing to assist in the
National Drug Policy development process. Numerous meetings were held with the
different working groups’ members as well as a round table presentation on the “Role of
Hospital Drug and Therapeutics Committees in Rational Drug Use”. These discussions
with the persons involved in the policy development and some other professionals
contributed to a better understanding of the structure and the contents of the document.
Working group members agreed to produce an analysis of the present situation strengths
and priority problems, including priority objectives, strategies and indicators for
monitoring implementation. At the last meeting of all the working groups, members
showed a great determination to develop a Macedonian National Drug Policy adapted to
the country’s realities, needs and existing human and financial resources. Particular
attention in Prof. Laing’s programme was given to drug selection and supply, rational
drug use, pharmacy and medical education programmes, continuous medical education. A
separate meeting was held with the Minister of Health and the national commission on
health policy to discuss the link between health and drug policy.
9 – 13 October 2000
The third visit of Prof. Richard Laing took place in the beginning of October and had for
objective to assist the working groups in passing to the next phase of the process, i.e.
combine the different drafts and produce a common harmonised document. The
individual work with each group and the common meeting of all groups, permitted to
compare the progress, give specific advise and suggest to the groups exchange of the
revised drafts and harmonisation the common document. Concrete indications on the
future activities and phases were suggested. Another presentation on Drug and
Therapeutics Committees was requested in the main hospital in Kumanovo, a town
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situated 50km to the NE from Skopje. Following the presentation and the discussion, the
representatives of the hospital decided to form a Drug and Therapeutics Committee as a
pilot experience in FYR Macedonia. During this visit Assoc. Prof. Brenda Waning,
public health pharmacist, accompanied Prof. Richard Laing. Her academic background
and professional experience were also very helpful in providing examples of options
taken in other countries.
17 – 25 March
In the framework of the faculty exchange between the Faculty of Pharmacy in Skopje and
the Massachusetts College of Pharmacy in Boston, two members of the working groups
visited Boston. Their presence in Boston was used to discuss the combined draft of the
National Drug Policy with Prof. Richard Laing. He provided again valuable comments
and suggestions.
The contribution of Prof. Richard Laing in the National Drug Policy development is
highly appreciated by all parties. His personality and huge international experience were
a precious advantage in this process for the country. Hopefully, Prof. Laing will also be
able to assist the implementation, monitoring and evaluation process.
 NATIONAL DRUG POLICY DRAFT PRODUCED BY THE WORKING GROUP
During the first half of April 2001 the working group finalised the national drug policy
draft. It was distributed to the participants in the launch meeting and other stakeholders
for examination and comments. No written suggestions were submitted before the
workshop. The stakeholders preferred presenting their remarks at the plenary and
working group discussions during the adoption workshop.
 ADOPTION WORKSHOP
The adoption workshop of the National Drug Policy was held on 16 May 2001. It
represented a final discussion on a document that has been developed over the past year
and aimed at achieving a general agreement on its contents.
The contributions expressed during the different sessions were constructive and
supported by well-founded arguments. The draft received a positive appreciation and
some of its parts were praised as remarkably comprehensive and precise. The level of the
whole document was qualified as highly professional.
The draft has been finalised and the remarks and suggestions that are relevant and
adopted by consensus have been incorporated in it.
 LESSONS LEARNED
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National Drug Policy development process is at least as important as the product
Receiving support from internationally recognised personalities in specific fields
is extremely important when working on difficult issues
Confidence building is one of the major factors for success
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2. Drug supply
 AGREEMENT WITH MINISTRY OF HEALTH ON DRUG PURCHASE ITEMS
Following several months of discussions with the Ministry of Health on the choice of the
drugs to be procured and the corresponding modalities, finally an agreement was
achieved. Half of the budget for drug purchase are to be used for insulin as strongly
requested by the MoH and with the rest asthma drugs are to be procured. Drug
procurement should be accompanied by training of health professionals and monitoring
of the distribution and dispensing.
 INFORMATION COLLECTION ON MONTHLY
FROM THE HEALTH INSURANCE FUND
CONSUMPTION: OFFICIAL DATA
The next step was the assessment of the number of registered patients and monthly
consumption of the drugs and most used types of insulin. For that purpose, the Health
Insurance Fund was asked to provide official data and we received the information about
monthly distribution of insulin though with a certain delay. Obtaining the number of
diabetes (insulin dependent) and asthma patients was not an easy task. There is no official
national register, however an improvement in the registration process has been achieved,
especially for diabetes patients. Quantities to be purchased of the inhalers and peak-flow
meters for asthma patients were calculated on the estimated use of these products for the
same period of time, as they are not used yet on a regular basis.
 IDENTIFICATION OF DISTRIBUTION POINTS FOR INSULIN IN THE COUNTRY
Information was collected on the present organisation of insulin dispensing in the
country. All diabetes centres in Skopje and the biggest insulin distribution points in the
Health Care Centre Skopje were visited. After discussion with our counterpart for
diabetes, the distribution points were selected.
 DECISION ON DISTRIBUTION POINTS FOR PEAK-FLOW METERS AND INHALERS
During discussions with our counterpart for asthma, Prof. Dokic, it was decided that
peak-flow meters would be distributed to asthma patients through the health services and
beclometasone and salbutamol inhalers through selected pharmacies of the public
network. The concrete modalities of the distribution were elaborated together with the
pharmaceutical department in the Ministry of Health and the head of the city pharmacies.
Distribution timing is organised to coincide with patient education training of health
professionals linked specifically to the use of these products.
 PURCHASE ORDER
The product specifications, quantities and specific requirements have been transmitted to
WHO supply services in Headquarters in order to proceed with the restricted tender for
the drugs purchase.
The peak-flow meters were procured quite quickly through HQ supply services.
Upon the insistence of the Ministry of Health WHO Humanitarian Assistance Office in
Skopje had agreed to purchase human pen insulin. The supplier had to offer: 1. Human
insulin (the only one used in the past 10 years in the country) 2. Pen insulin (In FYROM
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practically all patients are on pen insulin) 3. Preferably registered products in the country
(two companies, Eli Lilly and Novo Nordisk have already registered the requested types
of insulin). Regarding the selection of suppliers, all three known to us manufacturers of
this kind of insulin were approached: Novo Nordisk, Eli Lilly, Aventis HMR
Aventis HMR did not provide an offer because of the recent reorganisation of HMR
Interphar following the creation of Aventis. We received offers from the two other
manufacturers: Novo Nordisk and Eli Lilly. Both companies met the conditions given by
WHO Humanitarian Assistance Office. Eli Lilly price was much higher than that of Novo
Nordisk for the same products and conditions. As Novo Nordisk insulin offered a better
price than Eli Lilly we decided to order the insulin from this company.
Concerning beclomethasone and salbutamol inhalers for asthma patients, we succeeded in
obtaining a good offer from GlaxoWellcome, the only supplier that has valid registration
for these medicines in FYR Macedonia. Having in mind that this is a purchase of drugs
for humanitarian aid, special low prices were offered. We have been in contact during the
past months with other suppliers of these products, but they all refused to start a
registration procedure. The Ministry of Health does not wish to issue an import
authorisation for non-registered drugs if they will be distributed in outpatient settings.
These drugs are purchased for primary health care, so we had to procure registered drugs.
 IDENTIFICATION
OF EXISTING ASTHMA AND DIABETES
EDUCATION PROGRAMMES AND FURTHER EDUCATION NEEDS
PATIENTS’
In order to identify the training needs meetings were organised with the WHO
counterparts for Diabetes and Asthma. WHO counterpart for diabetes is a Professor in the
Endocrinology Department, Clinical centre Skopje. WHO counterpart for asthma is the
Director of the Department for Pulmonary Diseases, Clinical centre Skopje. A very
fruitful collaboration was established with the team of the Clinic of Endocrinology
resulting in the organisation of workshops and in printing of booklets for patient
education. The activities in asthma patient education were more difficult to organise but
however some concrete results were achieved.
 THERAPEUTIC PATIENT EDUCATION WORKSHOP
A workshop entitled "Therapeutic Education of Diabetic Patients in FYR Macedonia”
was organised by the Ministry of Health, WHO Liaison and Humanitarian Assistance
Offices and was attended by 51 participants from all over the country: doctors, nurses,
dieticians, psychologists, members of the patients associations. The workshop was held in
Skopje on 28-29 June 2000. Prof. Dr. Aldo Maldonato, president of the Diabetes
Education Study Group (DESG) one of the 15 study groups members of the European
Association for the Study of Diabetes (EASD), was invited as a lecturer. At the workshop
different aspects of the patient education were discussed in order to define the role of
each member of the diabetes team, to create inventories of the problems, needs, and ideas
coming from the daily practice of the various medical professionals with diabetic
patients. Participants were involved in experiential learning (how does it feel to be blind
or in a wheelchair) in order to better understand and help their patients. Participants
agreed at the end that the complexity of the educational and psychological approach to
patient education requires a wide range of knowledge, skills and professional teamwork.
For understanding the effects of our actions and words on patients in educational
programs the help of education and psychology specialists is fundamental. Such
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understanding will help in more effective future implementation of training programs for
patients and medical teams. This might help not only therapy of diabetes but also the
therapy of other chronic diseases, such as obesity, arterial hypertension, asthma, etc.
 WORKSHOP ON PRACTICAL DIABETOLOGY
Inspired by the previous workshop, the team of the Clinic of Endocrinology organised in
collaboration with our project a workshop on practical diabetology targeting health
professionals’ teams formed for diabetes patient education. It took place on 30 November
– 1 December 2000 with the participation of 20 physicians and 16 nurses from 12
medical centres. About 30% of the time were dedicated to lectures and 70% to practical
exercises. A metaplan approach was used to discuss issues like how to motivate the
creation of patient education teams in all centres for diabetes in the country, how to
improve awareness of diabetes in the general population, etc. Experimental learning was
used again (blindness, obesity, leg amputation), self-care in diabetes (self-control, foot
care, planning a one-day menu). This workshop was also welcomed with enthusiasm by
the participants and plans for further activities were suggested.
 TRAINING OF TRAINERS ON ASTHMA PATIENT EDUCATION
Two consultants from the UK, Frankie Brown and Linda Pearce, senior trainers at the UK
National Asthma and Respiratory Training Centre (NARTC), worked with a team of local
trainers from Monday 13th November – Friday 17th November 2000. The selected trainers
were physicians and pharmacists. The UK consultants provided an update on what worldwide are considered to be accepted pathways for care in asthma. The local trainers in turn
were able to share experiences. The inclusion of the pharmacists was reported to have
been stimulation to both the doctors and the consultants.
 PATIENT INFORMATION PUBLICATIONS
No asthma patient information booklets were available in the country. Following
consultations with WHO National Counterpart for asthma Dr. Dejan Dokic the translation
and publication in Macedonian of the GINA’s (Global Initiative for Asthma) booklet
“What you and your family can do about asthma” was decided. A pre-test was made, the
translated material was given to a group of asthma patients for reading and comments.
After the positive reaction of the patients, 5000 copies of the booklet were printed. At the
promotion of the booklet that took place on 27th of October 2000, 150 people were
present, among them a lot of asthma patients. At the same occasion, a newly formed
asthma patient association was publicly announced. It was stressed that this association
will act as a non-governmental and non-political organisation aiming at improving the
quality of life of the asthma patients in the country. The booklets are being now
distributed to the patients having already received training throughout the country.
Two diabetes patient information brochures were prepared by the Diabetes clinic and
were also published within the project. The titles of the brochures are “Nutrition and
diabetes” and “Foot care”. They were received with great satisfaction by diabetes
patients.
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3. Rational Drug Use
Most of the activities on Rational Drug Use are co-ordinated or planned in collaboration
with the World Bank health sector transition project’s pharmaceutical component.
 SELECTION
AND REVIEW OF MEDICINES TO BE DISTRIBUTED AND USED IN
THE PUBLIC SECTOR
a) Promotion of the essential drugs concept
Even if the essential drugs concept appears very straightforward to people that have
adopted it a long time ago, this is not the case when for some reasons health professionals
and decision makers are not willing to understand and accept it. Often suspicion is
encountered in terms of dramatically limiting the choice of the prescribers and the
patients and of opposing personal interest in some cases. Misunderstandings derive also
from a partial understanding of the concept. Quite a few persons, for example, insisted
that malaria drugs have to be included in the Macedonian Essential Drugs List because
even if rare such cases might still occur.
Discussions in groups, personal encounters, publishing of printed materials, articles in the
health bulletin, etc. have been used to explain and promote the concept. We have the
feeling that it gains more and more supporters and will gradually obtain general
acceptance. It is already a cornerstone of the National Drug Policy.
b) New revision of the positive list
WHO representative was appointed by the Minister of Health as a member of the Positive
(reimbursement) list commission. The currently used list has been created several years
ago, is presented by brand names and is questionable from the selection point of view.
Another commission had been appointed to review this list and finalised its technical
preparation beginning of November 1999. This list was not adopted because of pressure
on the Ministry of Health from the pharmaceutical companies and other factors. A lot of
efforts had been deployed by WHO for demonstrating the importance of the adoption of
the lists. Finally the Ministry of Health appointed a new commission to review once again
the list. The commission finished the technical work and we have been assured that the
list will soon be adopted.
c) Formulary development
The necessity of developing a national drug formulary has been recognised by all the
actors in the health sector in Macedonia. The preliminary discussions of WHO with the
International Project Unit (IPU – World Bank), the Ministry of Health, the Faculty of
Pharmacy and the University of Pittsburgh, have contributed to defining the strategy for
organising the formulary development process. A workshop took place in October 2000
in order to obtain wide support for it and to launch the process. It was rather a
disappointment for the organisers because the opinions were very diverging and many
participants did not have a practical approach to the task. The development of the draft by
a focus group, its circulation and adoption are the following steps. There is still hope that
this initiative will be realised even if the first steps were difficult.
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 DRUG USE SURVEY CONDUCTED IN PRIMARY HEALTH CARE FACILITIES
A drug use regional survey providing a picture of current prescribing habits was carried
out in 5 “territories”: Kosovo, FYR Macedonia, Albania, Serbia and Montenegro. This
'hard' evidence is very useful in helping with the process of implementing a rational
prescribing policy and identifying priority areas for action. The study objectives were: to
describe current drug use practices in a representative sample of primary care facilities in
a standardised, reproducible manner and to compare results in the participating countries.
Training of data collectors was organised in a workshop in Skopje, 8-9 March 2000. The
drug use survey was conducted in primary health care facilities in FYR Macedonia,
including:
 Visits to 20 PHC facilities selected randomly throughout the country
 Data collection on 600 GP – patient encounters
 Processing and analysis of the data in respect with the pre-established prescribing
and facility indicators.
This survey demonstrated that a number of prescribing problems exist within the primary
health care system of Macedonia. While polypharmacy was not a major problem, drugs
selection could easily be improved. This survey demonstrated the need for standard
treatment guidelines, continuing education for primary care providers and drug utilisation
review of prescribers.
A similar survey of specialists may be necessary as some of the apparently irrational
prescribing may result from primary health care providers following the advice of
specialists.
The revision of the reimbursement (positive) list to take account of optimum prescribing
practises will be a useful intervention.
 SURVEY ON DRUG CONSUMPTION
In order to complete the drug use survey that provided data on prescription patterns, a
survey on drug consumption is being realised in collaboration between the Faculty of
Pharmacy and WHO with the participation of the pharmacy students.
Existing data on drug consumption is highly insufficient. It is possible to exploit some
partial information on drugs from the reimbursement list through the Health Insurance
Fund database, but still access to the data is not straightforward and continuous and it
does not cover drugs paid out of pocket.
Simplicity, cost-effectiveness and relevance to the local health care system were key
considerations in elaborating the study design and the questionnaire.
Apart from the expected benefit of finding out what the drug consumption pattern in the
country is, another important aim is the educational aspect and awareness building in the
students on drug use issues.
 TRAINING ACTIVITIES
a) Rational Drug Prescribing
Discussions with World Bank consultants and IPU representatives have taken place with
the objective to improve collaboration with the World Bank project on rational drug use.
The common exploitation of an existing prescription database has been considered in
order to obtain evidence on current habits. Training for trainers on rational drug
11
prescribing has started in Boston. A total of 192 Primary Health Care physicians from
Skopje, Tetovo and Kumanovo will be trained through the programme. It is organised in
collaboration with the Pittsburgh University, the Pharmacy Faculty in Skopje, the IPU
and WHO.
b) Introduction of a module on Rational Pharmacotherapy in undergraduate
pharmacology course in the Medical Faculty.
Three assistant professors from the clinical pharmacology followed the Groningen
summer course for rational drug prescribing. They prepared a new module to be
introduced in the undergraduate curricula using their experience and materials received
during the course. The training for medical students on rational pharmacotherapy is
supposed to start in next semester.
4. National Drug Information Centre (NDIC)
 BACKGROUND
The need for a professional institution for analysis, evaluation, integration and
distribution of objective information on drugs was met with the establishment of the
NDIC in 1997. This Centre is placed within the Pharmacy Faculty. Ministry of Health,
World Bank and WHO supported the establishment of the Centre as follows: WHO
supported the NDIC with financial and technical assistance and WB supported the Centre
financially providing technical equipment, literature and training activities. The work of
the Centre is managed by Managerial board, composed of professors from the Medical
and Pharmacy faculties and other leading experts from the Clinical Centre. The president
of the Board is Prof. Suturkova (Dean of Pharmacy faculty).

WEAK POINTS TO OVERCOME
The first years of the existence of the NDIC were difficult. The number of received
inquiries for 1998 was 32 and for 1999 only 17. In two years only two issues of the Drug
Information Bulletin were published. The first issue consisted of a monograph on ACE
inhibitors and the second one, was about sildenafil (“Viagra”). The relations with other
national institutions were not very strong.
 OPPORTUNITIES
WHO supports the Centre in order to provide information on different aspects of the
drugs especially for doctors from primary health care services who play the role of “gate
keepers” in the health care system. With the services they provide they cover
approximately 80% of all diseases in the general population. Their access to independent
information on drugs is limited. Information is mainly provided by drug companies
representatives and old registers for drugs, published even more than ten years ago. There
is a need of well-informed physicians on drugs and on costs per treatment, in order to
improve prescription, rationalise drug use, decrease expenses for drugs and reduce selfmedication problems.
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 ASSESSMENT OF THE NDIC ACTIVITIES BY WHO CONSULTANTS
Two WHO consultants, Mr. Tim Donaldson, expert for Drug information centres and Mr.
Andrew Fenton, pharmaceutical advisor to the GPs on rational drug prescribing, visited
FYR of Macedonia from 7th to 10th of February, 2000. Their visit was aimed at analysing
the work of the National Drug Information Centre (NDIC) considering:
 current activities of the centre in provision of drug information to the health
professionals;
 present state of the development of the centre;
 links with other parties of both the pharmaceutical sector and the health sector
in general in the country;
 services provided for health workers through education on drug information
and training;
 plans for future development.
 RECOMMENDATIONS
FOR THE CENTRE’S DEVELOPMENT AND BETTER
PERFORMANCE
The consultants identified a certain number of weak points in the National Drug
Information Centre’s functioning and gave clear recommendations on the way the
centre’s activity should be improved. The management board of the centre and the staff
accepted the critics and made considerable efforts to implement the recommendations.
The results were:
 Improved motivation and engagement on behalf of the centre’s personnel
 Increased number of information requests during the past year
 New projects for the NDIC, for example the creation of a Web site providing
online information on registered drugs, national formulary, drug interactions
and drug information bulletin
 INCREASED WHO SUPPORT
Following the positive attitude and development, WHO increased the support especially
in:
 Ongoing promotion of the centre to PHC practitioners in Skopje pilot region
 Preparation and publishing of the third, fourth, fifth and sixth edition of the
drug information bulletin “Infofarm”
 Provision of eight faxes for each Polyclinic Centre in Skopje, in order to
improve their communication with the NDIC and enable information flow
 Self assessment of the services provided by the NDIC
 Identifying further needs for information of the health professionals and feed
back information
 Preparation of the seventh issue of the drug information bulletin “Infofarm”
 Conduction of survey on generics acceptance and the concept of essential
drugs
 Establishing links of the National Drug Information Centre with other drug
bulletin publishing institutions, the special interest group (SIG) on drug
information that co-ordinates a lot of information centres in Europe and the
International Society of Drug Bulletins.
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
COLLABORATION WITH THE WORLD BANK PHARMACEUTICALS PROJECT IN THE
FURTHER DEVELOPMENT OF THE CENTRE
Additional assistance for the centre was obtained by the International Project Unit / WB
project – pharmaceutical component. Representatives of the Faculty of Pharmacy, the
National Drug Information Centre, the International Project Unit and WHO prepared an
analysis of the equipment and documentation needs of the centre, improving the
information system, the creation of a web-site and other specific issues. The proposal
received financial support from the WB and the functionality of the centre was further
improved.
Another common initiative with the WB financed project was the faculty exchange
between the Faculty of Pharmacy in Skopje and the Massachusetts College of Pharmacy
in Boston, with an accent to establishing professional links and support for the National
Drug Information Centre. Two representatives of the Faculty of Pharmacy, members of
the managing board of the centre visited Boston in Mars 2001 and one representative
from the Massachusetts College of Pharmacy in Boston visited Skopje in April 2001.
Both visits had rich programs of presentations, lectures, round tables and plans for future
collaboration.
5. Geographical and financial accessibility: public and
private sectors
 TECHNICAL
SUPPORT TO THE MOH BY A WHO EXPERT FOR THE
ASSESSMENT OF THE PHARMACEUTICAL SECTOR REFORM POSSIBLE IMPACT
ON DRUG QUALITY, ACCESS AND USE
In relation to the negotiations of the Government with the IMF and especially concerning
public administration reduction, the Ministry of Health (MoH) considered the
privatisation of state pharmacies. WHO received a request from the Ministry to assist the
process in providing expertise and advice. A WHO expert worked for several days in
June 2000 with the MoH, the Health Insurance Fund, wholesalers, state pharmacies and
other actors in the pharmaceutical sector on the analysis of the possible options and
modalities and in order to provide recommendations. WHO pharmaceuticals team
provided the necessary background information, organised and participated in the
discussions.
 ADVICE ON WTO MEMBERSHIP/TRIPS APPLICATION IMPLICATIONS IN THE
PHARMACEUTICAL SECTOR
In preparation of the future membership of FYR Macedonia in WTO, the Law on
intellectual property rights is under revision. The Ministry of Health is represented in this
process by one of its legal advisers, Ms Snezana Cicevalieva. We received a request from
the Ministry to support them with information and advice on the implications for the
health sector and specifically on pharmaceuticals. All WHO related publications and a
summary on the basic issues have been handed out to the Ministry’s legal and
pharmaceutical departments. Several discussions based on analysis and recommendations
with the legal adviser and other key persons took place.
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 COLLECTIVE CENTRES DRUG SUPPLY ASSESSMENT
In the period from 8th- 14th of February 2000, members of WHO pharmaceutical team
visited all the Collective Centres in Skopje Area and the two Collective Centres in Struga.
The purpose of this visit was to get acquainted with drug dispensing organisation and
drugs availability. The general drug supply situation is satisfactory. The only exception
was Radusa Collective Centre.
6. Support to the drug regulatory authority
Close collaboration was established with the pharmaceutical department of the Ministry
of Health and finally also with the new Assistant Minister for pharmaceuticals (third in
six months). A study tours was organised for the Assistant Minister for pharmaceuticals,
M-r Bistra Angelovska to Bulgaria in view of the coming creation of a Drug Agency and
related to the pharmaceutical sector reform in the country. Steady links have thus been
established with the Drug Agency and the department of drug policy in the Ministry of
Health of Bulgaria.
II. Further activities / perspectives
Even if frequent changes of our counterparts, important events in the health sector (ex.
project of privatisation of Primary Health Care) and other difficulties have somehow
slowed down certain activities, we have succeeded in mobilising the efforts for the
implementation of the project and in achieving its goals.
3. National Drug Policy development
A widely accepted National Drug Policy document is now available. The official
endorsement of the document has to be obtained. The action plans need to be quickly
developed and the persons responsible for the implementation of the national drug policy
to be designated. Constant monitoring and timely evaluation should be insured based on
the indicators included in the document.
3. Drug supply
The following activities will be realised until the end of the year:




Co-ordination of the distribution, monitoring and evaluation of the drug use
Continue the patient education training for specialists, GPs, nurses and
pharmacists
Publishing of four more diabetes patient information leaflets in collaboration with
experts from the Diabetes Clinic and local patients associations.
Continue the distribution of the asthma patient information booklet.
4. Rational Drug Use


Finalise the organisation and host the regional Balkan course on promoting
rational drug use.
Continue with the formulary development
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5. National Drug Information Centre
Continuing support to on-going activities:




Amelioration of the information provision quality in the drug info bulletins.
Further support to the preparation of the Drug information bulletin Infofarm
Promotion of the centre for Primary Health Care physicians in throughout country
Continue the development of the web site of the NDIC.
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