1. Outcomes of Introducing the Essential Drugs Concept in Armenia Kazaryan I, Melikyan M, Sevikyan A, Vardanyan L Drug Utilization Research Group, ______________________ Drug Utilization Research Group,Armenia

2. Abstract Problem Statement: In Armenia, difficulties caused by the transition time have led to decreasing access to drugs and appearing new problems in the area of rational use. To improve the situation, in 1992 the Ministry of Health (MoH) introduced the Essential Drugs Concept (EDC). Objectives: To assess outcomes of introducing EDC in Armenia for the past 10 years, in particular in the areas of registration, centralized procurement, availability, affordability, prescribing and use. Design: Retrospective study. Study Components: Review of all registered medicines (RM) and all the drugs from the MoH contracts for centralized procurement (1998-2000). In Yerevan, in 2002: interviewing 100 physicians from 10 public hospitals, and 100 from 10 public ambulances; analyzing 300 prescriptions from ambulances and 210 from hospitals; 600 drugs sold and 600 requested in 20 private community pharmacies. Intervention: The MoH approved EDC and Essential Drugs List (EDL) by decree in 1992. Due to efforts of the Agency on drugs and medical technologies, EDL is regularly updated, the National Formulary (NF) was published in 1997, and Standard Treatment Guidelines (STG) for more than 40 diseases were worked out. Through initiative of the Pharmacy Department at the National Institute of Health (NIH), EDC was included in curricula for continuing education of pharmacists (starting in 1994) and post-graduate education of physicians (starting in 1998). Outcome Measures: % of the essential drugs (ED) of the total number of RM and of the total number of medicines centrally purchased by MoH; % of ED of the total number of medicines prescribed by physicians, asked for by patients and sold by private community pharmacies; average % of ED which are available at community pharmacies; % of physicians who know and use EDL, NF and STG in their practices; cost of drugs for some STG and some others. Results: The percentage (%) of drugs in the national EDL, which are registered in Armenia, is increasing (70% in 2001; 82% in 2002), although in 2001 only 27% of all registered medicines were from EDL. The maximum percent, ED amounted to the total number of medicines selected by MoH for annual centralized purchases, was 60% in 2000. Only about half of medicines prescribed by physicians were from the EDL. In average, 56% of the essential drugs were available at community pharmacies studied; only about 6% of ED was founded at all pharmacies. Many essential drugs were not available at specialized hospitals. Essential medicines comprised 30% of all the drugs sold from community pharmacies. Only 20% of all the physicians interviewed use EDL and NF. The average cost of hypertension treatment equals 150 % of an average monthly pension. Conclusions: There is visible progress, however still many efforts are necessary. To achieve desirable objectives a comprehensive approach and specified strategies are necessary that can be realized through adopting a national drug policy, an Essential Drugs Program, and a system of monitoring. Study Funding: Mainly – initiative; partly – by OSI Assistance Foundation.

3. Background The beginning of 1990s Political and economic factors: Declaration of the Independence of Armenia Collapse of the former USSR Transition to a new economic system (from socialist to capitalist) Some of consequences for the pharmaceutical sector: Lack of medicines Liberalization of prices Private unlicensed pharmacy outlets Unregulated import Numerous unknown medicines received as a donation The main problems: Low access to drugs Unknown quality of medicines Irrational use Intervention: To improve the situation, in 1992 the Ministry of Health (MoH) introduced the Essential Drugs Concept (EDC).

4. Intervention development DatesMeasuresInitiator 1992 EDC and the first* Essential Drugs List (EDL) were approved by the Ministry of Health. According to the Decree, public procurement and prescribing should cover medicines mainly from EDL. Agency on drugs and medical technologies (ADMTA) 1994EDC was included in a curricula for continuing education of pharmacists Pharmacy Department at National Institute of Health (NIH ) 1997The National Formulary (NF) was publishedADMTA 1998Law “On Medicines” was passed by the National Assembly. It includes definition of “essential medicines” ADMTA 1998EDC was included in a curricula for post-graduate education of physicians at NIH Pharmacy Department at NIH The end of 1990s Standard Treatment Guidelines (STG) for more than 40 diseases were worked out ADMTA The end of 1990s Seminars on EDC for physicians at hospitalsADMTA * Due to efforts of the ADMTA, EDL is regularly updated.

5. Aim To assess outcomes of introducing EDC in Armenia for the past 10 years, in particular in the areas of registration, centralized procurement, availability, affordability, prescribing and use. Objectives 1. To define what part of and which essential medicines are registered in Armenia. 2. To assess whether centralized procurement of the MoH follows to the principles of the Good procurement practice in the area of medicines selection. 3. To define whether essential medicines are available at the public hospitals and private pharmacies. 4. To assess affordability of treatment cost according to the STG for the most wide- spread diseases. 5. To evaluate prescribing patterns of physicians at public ambulances. 6. To define whether local physicians use EDL, NF and STG in their routine practice. 7. To assess the level of essential medicines use by patients.

6. Methods Study components and outcome measures Areas Study componentsOutcome measures RegistrationReviewing the List of registered medicines (RM) and Essential Drugs List (EDL). The percentage (%) of drugs in the national EDL, which are registered in Armenia; the percentage (%) of the essential drugs (ED) of the total number of RM. Public procurement Analyzing medicines from contracts of Ministry of Health for centralized procurement (1998-2000). The percentage (%) of the essential drugs (ED) of the total number of medicines centrally purchased by Ministry of Health. AvailabilityReviewing collected at 20 community pharmacies (Yerevan, 2002) Questionnaire, what covers all possibly available on market products for all ED. Interviewing heads of 10 hospital pharmacies* (Yerevan, 2001). Average % of ED which are available at community pharmacies; the percentage (%) of ED available at all pharmacies studied. ED not available at specialized hospitals.

7. Affordability Defining cost of medicines, included in some STG at 20 community pharmacies Cost of drugs for some STG; as % of an average monthly pension. Prescribing Interviewing 100 physicians from 10 public hospitals, and 100 physicians from 10 public ambulances (Yerevan, 2002-2003). Analyzing 300 prescriptions from public ambulances (Yerevan, 2003). The percentage (%) of physicians who know and use EDL, NF and STG in their practices. The percentage (%) of ED of the total number of medicines prescribed by physicians. Use Analyzing 600 drugs sold and 600 drugs requested in 20 private community pharmacies. (Yerevan, 2002). The percentage (%) of ED of the total number of medicines asked for by patients and sold by private community pharmacies. * Source: Our unpublished report for the project “The TRIPS and access to essential medicines”, 2001

8. RESULTSRegistration Number of drugs in the national EDL, which are registered in Armenia, of the total number of medicines in EDL (%)

9. Public procurement Number of ED of the total number of medicines selected by the Ministry of Health for annual centralized purchases (%) Antineoplastic agents9.9% Pharmaceuticals for treatment of tuberculosis - Vaccines and Serums- Meeting need in medicines from EDL by the Ministry of Health centralized procurement in 2000:

10. Availability Availability of essential medicines at community pharmacies Note: a National EDL was available at 81% of community pharmacies studied

11. Availability of Essential Drugs at some clinics, 2001 ED, listed by chief pharmacists as valuable for clinic, but mainly not available at clinic Oncology Cyclophosphamide, Methotrexate, Vincristine, Fluorouracil, Tamoxifen, Etoposide, Cefotaxime Cisplatin, Doxorubicin, Metronidazole Doxorubicin, Methotrexate, Vincristine, Vinblastine, Bleomycin, Cisplatin Cardiology Streptokinase, Diltiazem, Aminophylline,Diazepam Captopril, FurosemideFurosemid, Verapamil, Nitrats All fields (children) Ciprofloxacin, Omeprazole Erythromycin, Isoniazid, Cefotaxime, Gentamicin, Ampicillin, Sodium chloride 0.9% Metronidazole, Dexamethasone Psychiatry Diazepam, Thioridazine, Carbamazepine, Phenobarbital Amitriptyline Fluphenazine, Benzobarbital, Chlorpromazine Field of service ED from Questionnaire, valuable for respondent’s clinic, for which need was not met at all ED from Questionnaire, valuable for respondent’s clinic, for which need was met only partly

12. Affordability In 2002 the average cost, according to approved clinical guidelines, of treatment for hypertension (the 3 rd stage), what is a very common condition in Armenia, equaled about 14 USD, that made about 30 % of an average monthly nominal salary or 150 % of an average monthly pension. Use

13. Prescribing

14. Conclusions 1. There is a visible progress in implementing the EDC in Armenia. 2. The problems of access to essential drugs and irrational drug use have persisted. 3. There is a need in a better managing drug supply. Recommendations Recommendations 1. Comprehensive approach and specified strategies are necessary to achieve desirable objectives in the area of access to essential drugs and their rational use. 2. A National Drug Policy, an Essential Drugs Program and a system of monitoring and evaluation can serve as important tools for effective realizing necessary approaches. Adopting these documents seems to be an urgent task. The main strategies for the suggested “Essential Drugs Program”:  Creating the standing committee on ED. Updating EDL on the basis of the evidence-based data and approved clinical guidelines during transparent procedure with attraction of experts and the public. Providing access to EDL for health professionals.  Developing clinical guidelines for treatment of the main diseases and providing their availability to health professionals.  Estimating need of population in ED and introducing a reimbursement system for medicines, list of which is made on the basis of EDL.  Introducing Formulary system in medical establishments.  Developing and introducing regulation on medicines procurement including the demand that medicines for centralized purchases have to be selected from EDL.  Encouragement of local manufacturing ED by involving investments and introducing a system of privileges.  Developing and introducing regulation, providing availability of an approved obligatory assortment of medicines, made on the basis of EDL, at pharmacies.  Inclusion of the EDC in curricula of under- and postgraduate education of health professionals.  Inclusion of necessary knowledge concerning ED in education programs for the population.  Developing and introducing regulation, providing that donations are based on the EDL and the priority is given to vital medicines.