SUPPORT TO THE DEVELOPMENT OF THE PHARMACEUTICAL SECTOR IN FYR MACEDONIA

Director of the Centre for International Health at Boston University, WHO consultant...6 National Drug Policy draft produced by the working group...7 Adoption workshop...7 Lessons lea

SUPPORT TO THE DEVELOPMENT OF THE

PHARMACEUTICAL SECTOR

IN FYR MACEDONIA

END OF MISSION REPORT

Simona Chorliet Pharmaceutical Adviser

May 2001

WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR EUROPE

HUMANITARIAN ASSISTANCE OFFICE SKOPJE, FYR MACEDONIA

Table of contents

I BACKGROUND INFORMATION 4

II OBJECTIVES AND ACTIVITIES 4

III EXPECTED RESULTS 4

I REALISATIONS 5

1 N ATIONAL D RUG P OLICY (NDP) DEVELOPMENT

5 Launch meeting 5

Designation of working groups’ members 5

Stages and timetable 5

Collaboration with the International Project Unit / World Bank 6

Support from Prof Richard Laing, Assoc Director of the Centre for International Health at Boston University, WHO consultant 6

National Drug Policy draft produced by the working group 7

Adoption workshop 7

Lessons learned 7

2 D RUG SUPPLY

8 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 9

Workshop on practical diabetology 10

Training of trainers on asthma patient education 10

Patient information publications 10

3 R ATIONAL D RUG U SE

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

4 N ATIONAL D RUG I NFORMATION C ENTRE (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

5 G EOGRAPHICAL 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

6 S UPPORT TO THE DRUG REGULATORY AUTHORITY

17 II FURTHER ACTIVITIES / PERSPECTIVES 17

3 N ATIONAL D RUG P OLICY DEVELOPMENT

17 3 D RUG SUPPLY

17 4 R ATIONAL D RUG U SE

17

5 N ATIONAL D RUG I NFORMATION C ENTRE

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

1 National Drug Policy (NDP) development

 L AUNCH 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

 D ESIGNATION 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

 S TAGES 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

 C OLLABORATION WITH THE I NTERNATIONAL P ROJECT U NIT / W ORLD

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

 S UPPORT FROM P ROF R ICHARD L AING , A SSOC D IRECTOR OF THE

C ENTRE FOR I NTERNATIONAL H EALTH AT B OSTON U NIVERSITY , 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 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

 N ATIONAL D RUG P OLICY 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

 A DOPTION 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

 L ESSONS 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

2 Drug supply

 A GREEMENT WITH M INISTRY OF H EALTH 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

 I NFORMATION COLLECTION ON MONTHLY CONSUMPTION : OFFICIAL DATA FROM THE H EALTH I NSURANCE F UND

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

 I DENTIFICATION 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

 D ECISION 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

 P URCHASE 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 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

 I DENTIFICATION 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

 T HERAPEUTIC P ATIENT E DUCATION 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

 W ORKSHOP 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

 T RAINING 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 world-wide 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

 P ATIENT 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