Mid-term report
July 2000
support to the development of the
phARMACEUTICAL SECTOR IN FYR MACEDONIA
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. Its geographical situation in the Balkans is responsible for the fact that the country has experienced all major movements and changes in the region. The flow of refugees coming from Kosovo during last year crisis provoked a certain misbalance and mobilised substantial funds from the international community.
The health sector in FYROM has been facing budgetary and organisational problems over the last year. This in combination with the refugee crisis and the remaining number of about 20 000 refugees, (some of them in Collective Centres some of them in host families) has led to address quality problems in the health care services and particularly access to essential drugs.
All these events and the present 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:
Ø National Drug Policy development
Ø Project drug purchase
Ø Improving of prescribing and use of medicines
Ø Independent drug information
III. Expected results
Ø Improved availability of essential drugs in the health services through the distribution of medicines purchased via the project
Ø Improvement of the drug supply and reimbursement system that will enhance access to the population
Ø A comprehensive National Drug Policy will be developed and in process of implementation
Ø Sources of independent drug information available and used by health professionals
Ø Improved prescribing and use of drugs
IV. Realisations
1. National Drug Policy (NDP) development
Ø National Drug Policy launch meeting with the participation of 130 health professionals
The NDP launching meeting took place on 3rd of February 2000 in Skopje. It was organised by the Ministry of Health with technical assistance and support of WHO. Over 130 professionals from FYR of Macedonia as well as about 20 international representatives and observers have participated in the meeting and demonstrated an active interest in NDP formulation and implementation process.
Ø Formation of the working groups (one main and 4 subgroups) for the policy development
The Minister of Health appointed the members of the working groups developing the draft National Drug Policy document. Four groups were formed working on the main elements of the policy – legislation and regulations, Rational Drug Use (RDU) and drug selection, drug supply and economics and human resource development.
Ø Agreement on ToR of group members, timetable, working plan and participation conditions
The terms of reference for the members of the working groups were prepared by WHO and IPU (World Bank financed project). The timetable, working plan and participation conditions were discussed and agreed upon with the working groups’ members. Due to the fact that summer holidays were scheduled over a long period, the timetable had to be readjusted. (Annex 1)
Ø Collection and distribution of reference documents and NDP examples to all the groups members
The basic WHO documents on National Drug Policy development as well as several countries’ examples of National Drug Policy documents were provided to the working groups. It had been stressed upon however the necessity to elaborate a national policy, adapted to the needs and realities in the country.
Ø On-going NDP formulation in working groups
All the groups have produced the first drafts, more or less elaborated. The results of this preliminary work were used as basis of discussion with our consultant and will be further developed.
Ø The visit of Prof. Richard Laing, Assoc. Director of the Centre for International Health at Boston University, 12 – 20 May 2000
WHO pharmaceuticals programme invited Prof. Richard Laing to assist in the National Drug Policy development process. Numerous meetings were held with the four 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 representatives of the national commission on health policy to discuss the link between the health and drug policies. Another mission in Skopje is programmed by Prof. Laing in October.
2. Drug supply
Ø 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 $500.000 from Danida grant for drug purchase will be used for insulin as strongly requested by the MoH and with the rest asthma drugs will be procured. Drug procurement will be accompanied by training of health professionals and monitoring of the distribution and dispensing.
Ø Information collection on monthly insulin consumption : official data from the Health Insurance Fund (March 2000)
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.
Ø 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 point in the Health Care Centre Skopje were visited. After discussion with our counterpart for diabetes, the distribution points were selected. (Annex 2)
Ø Purchase order
The product specifications, quantities and specific requirements have been transmitted to WHO procurement office in Headquarters in order to proceed with the restricted tender for the drugs purchase. (Annex 3)
Ø Identification of existing asthma and diabetes patients’ education programmes and further education needs
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 Pulmology Department, Clinical centre Skopje.
Ø 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. 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. The workshop was held in Skopje on 28-29 June 2000. (Annex 4)
Ø 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. The booklets will be distributed to the patients having already received training throughout the country.
Two diabetes patient information brochures were prepared by the Diabetes clinic and will also be published through the project. The titles of the brochures are “Nutrition and diabetes” and “Foot care”.
3. Rational Drug Use
The World Bank health sector transition project has a Pharmaceuticals component. Most of the activities on Rational Drug Use are co-ordinated or planned in collaboration with this project.
a) Selection and review of medicines to be distributed and used in the public sector
Ø Lobbying for the adoption of the last revision of the positive list and the essential drugs list
WHO has been actively involved in the technical preparation of the Essential Drugs List and the Positive list (reimbursable drugs). Unfortunately, due to frequent changes in the Ministry of Health and other obstacles, the lists had not been endorsed several months or even years (for the Essential Drugs List) after the technical commissions had finished their work. A lot of efforts had been deployed for demonstrating the importance of the adoption of the lists, and finally the Ministry of Health officially endorsed them in June 2000.
Ø 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 in October, with presentation of experiences from other countries will launch the process. The development of the draft by a focus group, its circulation and adoption should be realised before the end of the year.
b) 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 will then be used to help with the process of implementing a rational prescribing policy and identify priority areas for action. The study objectives are: 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:
Ø Visits to 20 PHC facilities selected randomly throughout the country
Ø Data collection on 600 GP – patient encounters
Ø Processing and analysis of the data in respect with the pre-established prescribing and facility indicators.
c) Training activities
Ø Rational Drug Prescribing
Several meetings with World Bank consultants and IPU representatives have taken place during last months. The objective of these meetings was 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 prescribing will take place starting from October 2000 and then a total of 192 Primary Health Care physicians from Skopje, Tetovo and Kumanovo will be trained through the programme. It will be organised in collaboration with the Pittsburgh University, the Pharmacy Faculty in Skopje, the IPU and WHO.
Ø 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 will start in September this year.
4. National Drug Information Centre (NDIC)
Ø 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).
Ø 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.
Ø 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 costs per treatment, in order to improve prescription, rationalise drug use, decrease expenses for drugs and reduce self-medication problems.
Ø 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: