Drug Utilization Research Group, Yerevan, Armenia: Public Pharmaceutical Sector in Armenia: Policy Analysis and Management Reform

The main results (presented according to the objectives stated):

1. The set of indicators was developed for detailed assessment of the public pharmaceutical sector.
2. Data were collected according to this set of indicators. These data were analysed, conclusions and recommendations were developed. The main data received are presented in the Attachment 1.
3. Policy paper was developed. The main strategies recommended were discussed at the Seminar where the main stakeholders were invited: representatives from the Ministry of Health (MoH), the Yerevan City Administration, medical establishments (ME), National Institute of Health (NIH), the pharmaceutical association, international organizations and so forth.
4. Drafts of three regulation documents were developed, discussed by the partners and then with representatives of the Ministry of Health. These drafts were presented and discussed at the special Seminar where the main interested parties were presented. Then the drafts were presented to the MoH.
5. Curriculum for post-graduate education Course “Managing Drug Supply” for pharmacists was developed and approved by the Educational-Methodological Commission at the National Institute of Health. Teaching materials related to these curricula were prepared, including the Manual “Basic pharmacoeconomics”.
6. Curricula for continuing education Course “Managing Drug Supply at Hospital Level” for hospital pharmacists and Heads of medical establishments was approved by the Educational-Methodological Commission at the NIH. Teaching materials were prepared, including the Manual “Drug and Therapeutic Committees”  (the title of this Manual was changed as “Managing Formulary Process”, what was the planned title of the Manual, covers only one of the functions of Drug and Therapeutic Committees, but the Manual finally prepared involves more issues which are important for managing drug supply at ME).
7. Study was implemented in order to define a gap between knowledge on drug management, necessary for effective managing drug supply, and a real possession of information by civil servants involved in this area.  Curriculum for short in-service training for civil servants and other professionals involved in the area of drug management was developed and approved.
8. Due to the fact that the MoH staffs is extremely busy, according to the request of the Head of the Department at MoH, 5-day in service training has been divided into 10 days Course and rescheduled in the way - day per week.

In addition to the objectives planned, according to the request of the officials from MoH some drafts of regulation documents were studied and an expert opinion was presented; also some information related to experience of drug management in other countries, asked by MoH, was founded and presented. Also the situation, related to implementation of the new Regulation approved by the Decree of the Minister of Health in 2005 for prescribing at policlinics free medicines, was studied and the results were presented to MoH and Yerevan City Administration.

Summary of the main conclusions made on the basis of the results received from studying the situation:

1.      Many approaches and strategies important for effective drug management are known in the public pharmaceutical sector and at the public ME in Armenia, however they are used not to an enough extent to solve the problems exist. In particular, Essential Medicines List (EML) and Standard treatment guidelines (STG) are available at many ME; and administrators at ME stated that many physicians follow them. However, at the majority ME medicines from the EML consist of less than 35% of all the medicines available.

2.      Procurement practice implemented at centralized and decentralized level does not comply with some important operating principles of the Good procurement practice recommended by WHO.

3.      Although the majority of ME representatives believe that the reforms undertaken have led to positive results, it was found that the number of ME, where there is a Drug and Therapeutic Committee, was decreased.

4.      During the last three years the situation on drug financing and drug reimbursement is improved.

5.      There is a lack of data related to drug supply at ME.

6.      There is a need in periodical assessment of the public pharmaceutical sector in Armenia in order to define existing problems and develop evidence–based recommendations.

The main strategies recommended by the policy paper developed:

Regulation strategies

-         To approve regulation document on good medicines procurement

-         To approve regulation document on Drug and Therapeutic Committees

-         To include appropriate points in the draft of the Law “On medicines” currently considered at the National Assembly.

 Managerial strategies

-         To create the National Drug and Therapeutic Committee at the MoH

-         To organize Drug and Therapeutic Committees at all Armenian ME – public and private, and to introduce there a formulary system

-         To develop and introduce a new procedure for EML review what would allow to consider suggestions from ME and physicians.

Educational strategies

-         To improve knowledge of local professionals in the area of drug management

-         To introduce a new Course for preparing clinical pharmacists with good knowledge of drug management at ME level.

Outcomes

Conclusions and recommendations on improving managing drug supply, made on the basis of collecting and analysing the detailed data on functionality of the public pharmaceutical sector, were presented to attention of the main stakeholders during meetings, seminars and round-tables. Representatives of the both MoH and ME were very interested in the results as many data have been collected and analysed for the first time. It was shown that only less than half of medicines prescribed at policlinics for free and with privileges supply to patients are from the EML. It is quite a low level, as according to the new Decree of the Minister of Health, the medicines prescribed to patients, who are from the special List and for whom medicines should be provided free or with privileges, have to be mainly from the latest National EML approved.

Data collected were very important  as they allowed to find out the most urgent problems in the public pharmaceutical sector, approaches and strategies used by ME in the area of drug management, their strong and week sites, their expectations and complains related to the issue studied. The detailed results were presented to the MoH, Yerevan City Administration and, up to request, to representatives of some international organizations, which are currently implementing projects in Armenia, in particular, the Rational Pharmaceutical Management Plus Program at MSH, NOVA (USA project).

On the basis of the comprehensive study results the evidence-based policy paper was developed with recommendations on the public pharmaceutical sector management improvement. It has been discussed and presented to the MoH. In addition to policy paper covering the main strategies, a set of concrete measures and activities important for improving managing drug supply were developed and presented.

Separate recommendations on improving drug management at newly organized public medical establishments were developed and considered. Also a set of problems, requests and suggestions from representatives of ME was analysed and presented for the attention of MoH and Yerevan City Administration.

Tree drafts of regulation documents for the most important areas of managing drug supply were developed for the MoH and are currently there under consideration.

These drafts are:

1)      Draft of the Decree of the Minister of Health approving “Specialities of medicines procurement”

2)      Draft of the Decree of the Minister of Health approving “Regulation on the National Drug and Therapeutic Committee at MoH and a Drug and Therapeutic Committee at ME”

3)   Draft of a regulation document on Distributing Drug Donation.

According to the opinion of the Deputy Minister, they are very important and urgently needed as the draft of the new Law “On medicines” is currently under consideration at the National Assembly and it is expected that it will be approved in February. After that sub legislative documents will be necessary as soon as possible, and MoH is planning to implement this work during half of year. Thus, they are very interested to have ready drafts of important regulation documents, in particular the drafts mentioned above, at this stage.

Three special curricula on drug management issues prepared were introduced at the National Institute of Health and DURG. Training based on these curricula was already implemented. In addition, during seminars organized some stakeholders have informed about their interest to these curricula. They were interested especially in training in the area of Drug and Therapeutic committees. Detailed Training manuals on drug management issues (Drug and Therapeutic Committees; Basics of Pharmacoeconomics) as well as other training materials were prepared on the basis of review of the latest publications. 

Impact

The results of data collected have allowed developing recommendations which are able to improve the current situation with managing drug supply in the public pharmaceutical sector. For example, during the final seminar the Deputy Minister already promised to consider suggestions receiving from ME related to involving some other medicines in the national EML as many physicians are complaining that the EML is covering not all the necessary pharmaceuticals. Many other recommendations developed were also considered as quite urgent and are under special attention of the appropriate Departments of MoH and Yerevan City Administration.

Meetings, seminars and workshops organized with different stakeholders and some journalist have led to rising awareness of officials and professionals and the public on the issues of drug management. The agreement has been achieved with a local leading newspaper that a special interview with a representative of DURG as well as some special articles will be published with presenting the results of this study and recommendations developed. This will lead to rising awareness of the public.

Approval of presented document on medicines procurement will lead to both a more efficient centralized drug purchasing, in particular to selection of more effective and safe medicines of an appropriate quality at the lowest cost at the MoH level, and also to a better procurement practice at the level of ME. It was stressed also by some of ME representatives during discussion related to problems on drug procurement at the seminar. Approval of Rules on the Drug and Therapeutic Committees will improve drug management in hospital settings where there are still many problems which can be solved by organizing such a Committee, in particular DTC is able to play a crucial role in a more rational drug selection, adverse effects monitoring and so forth. Approval of sub-legislation document on Donations will allow improving the situation with distribution which is the most problematic area for managing by the MoH what was underlined by their representative.

The capacity of the Pharmacy Department at the National Institute of Health and Drug Utilization Research Group to support the building of a more effective public pharmaceutical sector in Armenia has been certainly strengthen: curricula and teaching materials were approved and promoted. A lot of information was collected and will be used in further studies and activity. Many contacts were established with ME and other stakeholders in Health care sector. Very good working contacts were established between all three partners: DURG, NIH and Dr. Frazzica Rosa Pina from the Centre for Training and Research in Public Health (CEFPAS), Italy.

II.

In fact we did not have any serious difficulties in implementing project, as we always have met understanding from all the organizations we contacted to. First of all, MoH, Yerevan City Administration and National Institute of Health have been showing support at all stages of work. Then, the Yerevan City Administration provided us by a supporting letter to many ME which also have been showing readiness to provide necessary data and/or information.

The reasons of not having real difficulties are the following:

• urgency and actuality of issues related to drug management in Armenia and appropriate interest of MoH, Yerevan City Administration, ME and other organizations to the results of project
• human factor, as all the three officials we contact – Deputy Minister of Health, the Head of Department at MoH and the Head of Department at Yerevan City Administration were very interested in the results and in improving drug management at the public pharmaceutical sector.

It is important to stress that success of the project is caused by a good working partnership between officials from MoH, Yerevan City Administration and our team consisting of representatives of NGO DURG, National Institute of Health  and a high level expert from the Public Health Administration Teaching Institution Dr. Frazzica. Each of partners has brought a lot of efforts to implement own part of responsibilities and the project in whole. Thus, DURG was mainly responsible for implementing studies and developing policy recommendations, representatives of National Institute of Health – for developing curricula and training, officials - for administrative support. Furthermore, during the implementation regular meetings took place and much more support, information and suggestions were provided by each party. Yerevan City Administration has became more involved in studying situation, the Head of Department at the Ministry of Health was asking for more expert opinion on some additional issues. During the last Seminar the Deputy Minister stressed that developing evidence-based drafts of sub legislative documents by representatives of NGO together with representatives of NIH on very urgent and important issues is a very effective and right way of work because the staff of the MoH is too overload by official work and needs expect support including receiving drafts of policy and regulation documents preparing by leading professionals, who have time and capacity for that, for further consideration. Preparedness to continue a working partnership in future was mentioned by all parties.