SUPPORT TO THE DEVELOPMENT OF THE PHARMACEUTICAL SECTOR IN FYR MACEDONIA

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 +389 362-879 / 364-299 / 364-599 Fax +363 710  mgu@who.org.mk Table of contents I BACKGROUND INFORMATION II OBJECTIVES AND ACTIVITIES .4 III EXPECTED RESULTS I REALISATIONS .5 NATIONAL DRUG POLICY (NDP) DEVELOPMENT Launch meeting Designation of working groups’ members Stages and timetable Collaboration with the International Project Unit / World Bank Support from Prof Richard Laing, Assoc Director of the Centre for International Health at Boston University, WHO consultant National Drug Policy draft produced by the working group .7 Adoption workshop Lessons learned DRUG SUPPLY Agreement with Ministry of Health on drug purchase items .8 Information collection on monthly consumption: official data from the Health Insurance Fund .8 Identification of distribution points for insulin in the country .8 Decision on distribution points for peak-flow meters and inhalers .8 Purchase order .8 Identification of existing asthma and diabetes patients’ education programmes and further education needs .9 Therapeutic Patient Education workshop Workshop on practical diabetology 10 Training of trainers on asthma patient education .10 Patient information publications .10 RATIONAL DRUG USE 12 Selection and review of medicines to be distributed and used in the public sector 12 Drug use survey conducted in primary health care facilities 13 Survey on drug consumption 13 Training activities 13 NATIONAL DRUG INFORMATION CENTRE (NDIC) 14 Background 14 Weak points to overcome 14 Opportunities .14 Assessment of the NDIC activities by WHO consultants 15 Recommendations for the centre’s development and better performance 15 Increased WHO support 15 Collaboration with the World Bank pharmaceuticals project in the further development of the centre 16 GEOGRAPHICAL AND FINANCIAL ACCESSIBILITY: PUBLIC AND PRIVATE SECTORS 16 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 16 Advice on WTO membership/TRIPS application implications in the pharmaceutical sector 16 Collective centres drug supply assessment 17 SUPPORT TO THE DRUG REGULATORY AUTHORITY 17 II FURTHER ACTIVITIES / PERSPECTIVES 17 NATIONAL DRUG POLICY DEVELOPMENT DRUG SUPPLY RATIONAL DRUG USE 17 17 17 NATIONAL DRUG INFORMATION CENTRE 18 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      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 I Realisations 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 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  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 – 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 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    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 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: Human insulin (the only one used in the past 10 years in the country) Pen insulin (In FYROM practically all patients are on pen insulin) 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 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 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 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 – 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 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 10 11 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 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 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 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 12  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 “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 13 order to obtain evidence on current habits Training for trainers on rational drug 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 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 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 14  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 15  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 Geographical and financial accessibility: public and private sectors  TECHNICAL SUPPORT TO THE MOH BY A WHO ASSESSMENT OF THE PHARMACEUTICAL SECTOR IMPACT ON DRUG QUALITY, ACCESS AND USE EXPERT FOR THE REFORM POSSIBLE 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 16  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 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 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 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 Rational Drug Use   Finalise the organisation and host the regional Balkan course on promoting rational drug use Continue with the formulary development 17 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 18 ... 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. .. 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... purchase human pen insulin The supplier had to offer: Human insulin (the only one used in the past 10 years in the country) Pen insulin (In FYROM practically all patients are on pen insulin) Preferably