Draft

Research paper

Contents

Introduction

Chapter 1. Methodology

Chapter 2. Armenia. Background Information

Chapter 3. Health Care System

Chapter 4. Pharmaceutical System

4.1 Regulation and Quality Assurance

4.1.1 Regulation

4.1.2 Quality Assurance

4.2 Drug financing

4.3 Selection of medicines

4.4 Supply systems

4.5 Affordability

4.6 Rational Drug Use

4.7 Research

4.8 Human resources

Chapter 5. Pharmaceutical policy

Conclusions and Recommendations

References

Appendixes:

Appendix 1. Definition of terms

Appendix 2. Questionnaires

Appendix 3. Forms for data collection

Introduction

Access to essential medicines is fundamental to human rights.

“The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition”[6].

“Everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services”[22].

“Governments and the international community have an obligation to see the right to health progressively realized, which includes the responsibility for prevention, treatment and control of disease; and the creation of conditions to ensure access to health facilities, goods and services” [20].

“Access to goods and services include – of course – the provision of essential medicines necessary for the prevention and treatment of prevalent diseases” [21].

National Drug Policy

The idea of national drug policy (NDP) has also arisen because of the failure of piecemeal solutions to tackle problems, for example many countries tried in the seventies to solve ineffective drug procurement and distribution without looking at the use of pharmaceuticals. Thus, the second half of the 20th century has seen the idea of a NDP progress from a mere series of reactions to current problems to a positive concept. It is now widely accepted that each country should make a positive effort to achieve optimal availability and use of drugs to patients and consumers. In order for these efforts to be co-ordinate and to support one another, well-designed overall drug policies need to be developed and implemented. At present an increasing number of countries have now formulated and implemented a NDP to resolve the problem faced to ensure the availability, the accessibility and the proper use of safe, effective and low cost drugs of good quality. By 1999, 66 countries had formulated or updated a national drug policy within the previous 10 years, compared with 14 countries in 1989 [9].

It is now widely accepted that every country should try to achieve optimal availability and use of drugs for patients and consumers. For these efforts to be coordinated and to support one another, well-designed overall drug policies need to be developed and implemented.

A national drug policy is needed for many reasons [9]. The most important are:

• to present a formal record of values, aspirations, aims, decisions and medium- to long-term government commitments;
• to define the national goals and objectives for the pharmaceutical sector, and set priorities;
• to identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy;
• to create a forum for national discussions on these issues.

A national drug policy must fit within the framework of a particular health care system, a national health policy and, perhaps, a programme of health sector reform. The goals of the national drug policy should always be consistent with broader health objectives, and policy implementation should help to achieve those broader objectives.

The Republic of Armenia is conducting far-reaching reforms in the field of health and pharmaceutical services from the first days of independence. Certain success has been achieved in the different areas of pharmaceutical service. However, there are still a number of problems in the Pharmaceutical sector that are waiting for their solution. In order to design the suitable recommendation for the current activity it is necessary to implement careful analysis of the existing situation and affecting factors and to study international experience and approaches in this field.

Chapter 1 Methodology

Data were collected through interviews using the following questionnaires:

• Ministry of Health Questionnaire
• The State Statistical Service Questionnaire
• Customs State Committee

Information was obtained from published and unpublished reports.

At community pharmacies data were collected by completing questionnaires and data collection forms (Appendix 3).

At manufacturers information was obtained by interviewing representatives of Administration using Questionnaire and data collection form (Appendix 2). Householders have been interviewed using the Questionnaire (Appendix 2).

Chapter 2 Armenia. Background Information

The Republic of Armenia is a small, mountainous, country, covering 29 800 km² and bordered by Georgia in the north, Azerbaijan in the east, Turkey in the west, and Azerbaijan, Iran and Turkey in the south.

Basic Facts about the Republic of Armenia:

Religion	Armenian Apostolic Church
Official Language	Armenian
Currency	Dram (AMD)

Table 1. The Main Indicators of the Republic of Armenia

Indicators	1997	1998	1999	2000	2001
Population (mln.)	3.8	3.8	3.8	3.8	3.8
Urban population (as % of total)	66.9	66.8	66.7	66.6	66.6
GDP per capita (USD)	429.0	499.0	485.0	503.6	558
Population density (person/km^2)				128
Population growth rate			0.2%	-0.05%
Education index	0.875	0.863	0.853	0.857
Human Development Index		99/174 (HDR 1998)	87/174 (HDR 1999)	93/174 (HDR 2000)	72/162 (HDR 2001)
Human Development Index (HDI) value	0.732	0.736	0.729	0.730
Population with access to:
Health care (%)	80.0	80.5	81.2	81.3
Safe water (%)	85.0	86.0	97.0	92.6
Sanitation (%)	67.0	67.0	69.0	69.1
Average unemployment rate (%)	10.8	9.4	11.2	11.7	9.8

Source: 1. Data for 1997-2000 – [1]

2. Data for 2001 – [17]

Armenia formally declared its independence in September 1991. The head of state is the president. The legislature consists of a National Assembly composed of 131 seats. The legal framework for democratic governance was mainly put in place during these ten years, which however has not turned Armenia yet into a state “ruled by law” in the literal sense.

Economic reforms implemented in Armenia over the last ten years, aimed at the formation of relations, institutions and management systems inherent to a market economy, had a positive impact and efficient solutions were achieved. However, the approaches to such solutions were neither holistic nor coordinated and they were often incomplete and lacked coherence. As a result, even the most timely laws and decisions were limited in terms of their positive impact since various sectors of the economy operate under different and sometimes contradictory regulations. The social reforms implemented in Armenia do not yet adequately address the fundamental social issues of the population. Having a more tactical rather than strategic nature, they were not based on a system of clearly identified priorities and objectives. The government’s efforts aimed at addressing the needs of the vulnerable groups of the population are not sufficient, since especially children, women and the elderly become the first victims of harsh transitional difficulties. The RA government provides free of charge full secondary and 20% of tertiary education. In reality, at both levels of education significant supplementary payments from family budget have become inevitable, which seriously limits the access of insolvent groups to high quality education [1].

After a decade of economic reforms, one of the most challenging issues is the widespread poverty with 55% of the population living under the poverty line. Comparative analysis of data available over the years have revealed positive shifts in the depth and severity of poverty as well as extreme poverty having decreased from 27.7% to 22.9%. However general poverty yet does not show any indication of being reduced [1]. Despite the fact, that average monthly salary is increasing (Figure 1), in 2000, ratio of money income and minimum standard of living was 87% [18].

Figure 1. Average monthly salary and pension

Series1 – Average monthly salary

Saries2 – Average monthly pension

Source: National Statistical Service of the Republic of Armenia

Between 1998-1999 almost 3,250 million people were part of one or another kind of Armenia’s external migration flows. The total number of those who left the country from1991-2000 is estimated approximately at 900 thousand.

Chapter 3. Health Care System

The fundamental transformations in the country drastically affected the health care system, bringing about deterioration of birth and natural growth rates, even at the background of relatively stabilized mortality rates. Diseases that are considered to be provoked by difficult social conditions are on the rise. The same holds true for cardiovascular diseases and heart attacks, especially among women. Cancer is highest in terms of morbidity incidence and second for mortality. Tuberculosis is mainly found among young people. There is also a ten-fold increase in sexually transmitted diseases (STD) [6].

Table 2. The Main Health Indicators of the Republic of Armenia

			1997	1998	1999	2000	2001
Life Expectancy at birth (years)			73.9	74.7	73.2	72.5
One-year-old fully immunized against	Tuberculosis (%) Measles (%)		72.3	94.9	95.0	95.0
			91.5	93.5	94.8	95.0
AIDS cases (per 100,000 people)			1.1	1.1	0.2	0.0
Tuberculosis cases (per 100,000 people) (# of those under dispensary control in the anti-tuberculosis hospitals as of the end of year, per 100,000)			103.1	122.5	138.8	143.5
Malaria cases (per 100,000 people, identified for the first time)			22.2	30.8	16.2	3.7	2.1
Cigarette consumption (per adult per day)			15	16	16	15
The number of people attending per doctor			291	292	301	319
The number of people attending per nurse			143	147	154	172
People with disabilities (as % of total population)			2.66	2.62	2.60	2.73
Adults who smoke (%)		Male Female	70	69	68.8	68.8
			6	6.2	6.6	6.7
Likelihood of dying after age of 65		Male Female	317	322	306	221
			306	285	287	205
Public expenditure on health (as % of total public expenditure)			7.7	7.3	5.8	4.7
Private expenditure on health (as % of total public expenditure)			88.0	87.0	89.0	89.0
Total expenditure on health (as % of GDP)			1.4	1.4	1.37	1.0
Pregnant women aged 15-49 with anemia (%)			12.6	14.8	15.3	15.7
Low birth weight infants (up to 2500 grams, %)			7.9	8.5	8.5	8.2
Maternal mortality rate (per 100,000 live births)			38.8	25.4	32.9	52.5	6.0
Infant mortality rate			15.4	14.7	15.4	15.6	15.8
Under-five mortality rate (per 1000 live births)			19.5	18.4	19.2	19.3	20.0

Due to the economic crisis, the healthcare system works only at half of its capacity. In 2000, hospital bed occupancy amounted to 35% (in case of some regions it is 10-15%). Compared to 1990s, the referrals to polyclinics decreased by 45%, home calls decreased by 53% and the number of emergency ambulance calls decreased by 60%. All this is undoubtedly a result of high prices, insolvency of the population and a decline in the quality of health care rather than an indicator of improved health [1].

Public health spending from the State Budget approved is decreasing (Figure 2). There is a gap between approved and real spending (Figure 2).

Figure 2. Health expenditures per capita from State Budget

Series 1 – Approved expenditures

Series 2 – Real expenditures

Sources: for Series 1 calculation is made on the basis of the State Budget approved

for Series 2 - National Statistical Service of the Republic of Armenia

According to the integrated survey results, implemented at the National Statistical Service [14], 17% of the interviewed population during the recent month (interviewed period) is sick or has injuries, i.e. 39% of the sick mentioned that they got ill one year before, which means that disease has become chronic. Possibility to acquire medical consultations and treatment is more available for non-poor population, because it often directly linked to availability of financial resources. To this end, average value for getting medical consultation or treatment is dram 12177 with the maximum reaching dram 1606380 (USD 3000).

Table 3. Health Indicators in Correlation to the Living Standards

	Sick during recent month (in percent)	Stopped primary activities (in percent)	Consulted with doctor (in percent)
Non-poor	46,06	46,71	55,11
Poor	29,21	29,19	28,67
Very poor	24,73	24,60	16,22

Despite prenatal services bear responsibility for woman’s health and should be free of charge during pregnancy and delivery however, woman incurred expenses both for consultation and delivery. Thus, according to interview data the price paid for consultation fluctuated between dram 1000 and 10000, accompanied with additional other costs related to pregnancy, delivery and other female aspects in the amount of dram 1000-20000 with the maximum price of dram 200000. Only 36% of parents took their children to policlinics in order to obtain postnatal advice or prophylactic testing, including: 46% of non-poor households; 34% of poor and 20% of very poor [16].

Table 4. Medical Institutions Where Medical Consultations Were Mainly Given

	Policlinic	Diagnostic center	Hospital	Private physician
Non-poor	54	56	57	65
Poor	29	38	26	26
Very poor	17	6	17	9

Chapter 4. Pharmaceutical System

History of pharmaceuticals in the Armenia

The Armenian folk medicine has almost 3000 years of history. Memorials of material culture give evidence on a high level of the medical art development in the Ancient Armenia. During the pagan time the goddesses Asthik and Anahit were regarded as sponsors of the medical art. Their temples became the medical centres where sick people collected from all the parts of the country. The priests of this temples having experience in the field of folk medicine helped patients. The first private hospitals were set up in the Armenia in 3rd century A.D. For example, in 260th princess Agvida financed and opened the hospital for lepers near curative sources. In contrast in Western Europe the first hospital for lepers was not organised until 300 years later.

The Armenian folk medicine has included representatives of flora, fauna and materials of inorganic nature. The Ancient authors (Herodotus, Strabo, Xenophon, Tacitus) in their description of Armenia mentioned curative plants of the Armenian flora. For example, Tacitus in his “Annals” noted the medicines which Armenian peasants successfully used for wound treatment. In the first century BC the Armenian king Artashes organised special gardens where curative plants were cultivated. Inorganic remedies were also very popular. Bolus armena was used as anti-inflammatory, anti-allergic, anti-cancer remedies and also for haemorrhages. Ibn-Sina wrote in his “Canon”: “Armenian or Anian bolus act on wound wonderfully... Many people survived during great pestilence (plague) because they observed the rule to drink it in slight wine”. Ibn-Sina also mentioned remedies of animal origin, for example fat, which is collecting on ships wool when it is dragging on herbs: “...it resolves hard tumour and straighten curved bones if to do medicinal bandeau.”

After creating of the Armenian alphabet at the beginning of 5th century the first books in Armenian appeared. There are more than 850 medical manuscripts in the Yerevan Matenadarane Manuscript Library and it is interesting to mention “bjshkaranner” which are origin works in pathology, treatment and medicinal remedies. An example is the famous “Gagik-Hetum” which was written at the beginning of the 11th century and edited in 1294. Mhitar Heratsi, a famous Armenian doctor of the Middle Ages, is the author of “Relief from Fevers” (1184). He mastered a technique of surgical operation and used silk thread for sewing up wounds. He employed mandragora as an anaesthetic, carried out experiments on animals, and was aware of the value of special diets in treating disorders, and the value of music and psychotherapy for the relief of nervous complaints. The distinguished Armenian doctor Amirdovlat Amasiatsi (1416-96) wrote a number of treatises under such titles as “For the Benefit of Medicine” and “Things unnecessary for Ignorants”. He left behind 300 original recipes for drugs and medicines. The famous “Things unnecessary for Ignorants” is an encyclopedic dictionary with terminology in 5 languages: Armenian, Greek, Latin, Arabic and Persian. It includes 3500 names of medicinal plants, animals and minerals with their synonyms. He empirically defined an efficacy of many medicinal plants for treatment of certain groups of diseases.

Over the centuries, Armenian and Greeks between them attained a dominant position in the medical profession throughout the Ottoman Empire, as well as in Persia, Egypt and other countries of the Levant. Stepanos Sharimanian (1766-1830) continued the tradition of design and study of pharmaceuticals developing wrote “Botany or Flora of Armenia” in 1794-1818. Armenian scientists continue this tradition in our days.

Pharmaceutical sector in the Armenian Soviet Socialistic Republic

The Armenian Soviet Socialistic Republic was one of the fifteen republics of the former Soviet Union and the pharmaceutical service of the Armenia was an integral part of the all-union service. It submitted to enactments of the Supreme Council and the Government of the USSR, as well as decrees of a Minister of Health of the USSR. The main legislative document was The Fundamentals of USSR, approved in 1961. In accordance with this document all the citizens of the USSR had the right for free of charge health service.

The functions of Drug Regulatory Authority were implemented by two Main Departments of the Ministry of Health of the USSR: the Department of Inspection and the Department on Introduction of New Medicines and Medical Technology. The latter included the Pharmacological Committee, Pharmacopoeia Committee and some other institutions and was responsible for registration of pharmaceutical products in the USSR. The Pharmacopoeia of USSR, Pharmacopoeia Articles and Temporary Pharmacopoeia Articles were single documents of quality standardisation for all the organisations in the USSR.

Production of medicines was realised at the state plants and factories. The majority of these plants were joined in the system of the Ministry of Medical Production of USSR. The main suppler and distributor of the State was the “Pharmacy” All-union Association which purchased pharmaceuticals from both local manufacturers and foreign companies and distributed them through republic associations. In Armenia there was the “Armpharmacy” Republic Association, which was a structural part of the “Pharmacy” All-union Association and included the majority of pharmacies and warehouses in the Republic. It carried out all the functions related to drug supply including procurement, distribution, small-scale production at the Interhospital pharmacy, a quality control of medicines and inspection of pharmacies. It submitted to the Ministry of Health of the Republic of Armenia. In addition there were hospital pharmacies and a few pharmacies operate in a structure of other ministers. All the pharmaceutical organisations in the country were state.

Prices on the pharmaceutical products were fixed and were the same for all the republics. Special price-lists existed for retail and wholesale prices. Prices were quite low and pharmaceutical products were affordable for the population. The medical and pharmaceutical services at hospitals were free of charge. In spite of some shortage of the most popular medicines a requirement in pharmaceuticals was mostly satisfied.

4.1 Regulation and Quality Assurance

4.1.1 Regulation

A sound legal basis is a necessary condition for ensuring the quality, safety and efficacy of medicines. However, according to a general opinion of local policy-makers and professionals the current legislation in Armenia related to the pharmaceuticals, is not sufficient to ensure the main requirement to medicines and the pharmaceutical sector activity.

The National Assembly passed the first Armenian Law “On medicines” in October 1998. It covers the following areas: terminology, pharmaceutical activity and its licensing, production, labelling, import and export, information, advertisement, destruction, registration, quality assurance, state guarantees of medicines ensuring to population and some others.

However, this documents includes contradictions, unclear and doesn’t cover all the necessary information. “A new draft of a law On Medicines” has been prepared by the Drug Agency and presented to the National assembly about one year ago.

According to the “Law on medicines“, more than 10 regulation documents have to be developed and introduced by the Government and the Ministry of Health. The following normative acts are already enforced:

· Resolution of the Government N 396 of 8.01.1999 on “Social groups of population having the right to get medicines free or with privileges, and the list of diseases”.

· Resolution of the Government N 581 of 20.09.2000 on “Rules on import and export of medicines and pharmaceutical entities in Republic of Armenia”.

· Resolution of the Government N 347 of 25.04.2001 on “Rules on state registration of pharmaceuticals and fees for expert opinions of state registration of pharmaceuticals”.

· Resolution of the Government N 867 of 29.06.2002 on “Rules on Licensing Production of Medicines, Pharmacy Practice, Health Service, Implementation of Medical Professional Education Curricula, as well as on Approve of Licensing Forms for Implementation of Mentioned Activity”.

· Resolution of the Government N 63 of 24.01.2002 on “Rules on Implementation of Clinic Trials of New Medicines in the Republic of Armenia”.

In addition, Decrees of the Minister of Health approving the “List of OTC-drugs” and the first “Armenian State Register” have been enforced in November 2000 and December 2000, correspondingly. In 2001 the Decree of the Minister of Health on “Rules on medicines supply for persons from social groups of population having the right to get medicines free or with privileges, as well as suffering of selected diseases, at the policlinics” and in 2002 Decree N 100 of the Minister of Health of 26.02.2002 on “Rule on prescribing and dispensing medicines” were approved.

The following important areas still not covered by the local norms and standards: pharmacy practice, manufacturing practice, inspection, advertising and drug promotion, labelling.

Drug Regulatory Authority

The drug regulatory authority (DRA) is the agency that develops and implements most of the legislation and regulations on pharmaceuticals. Its main task is to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. This is done by making certain that the manufacture, procurement, import, export, distribution, supply and sale of drugs, product promotion and advertising, and clinical trials are carried out according to specified standards. Several of these functions also contribute to efforts to promote rational drug use [9].

A Drug Regulatory Authority in Armenia is the Drug and Medical Technology Agency (Drug Agency or ADMTA). It was established in 1992. The Agency is responsible for pharmaceuticals and devices registration, professional studies of pharmaceutical organizations (in fact inspections), evaluating materials for issuing licenses for import and export of pharmaceutical products, quality control of medicines, adverse effects monitoring, drug information and some others.

The main departments of the Drug Agency are the following:

• Department of expertise and medicines evaluation
• Expert Department for licensing import and export of pharmaceutical products
• Expert Department on professional study of pharmaceutical institutions
• Department on rational drug use and adverse drug reaction monitoring
• Department on narcotics control
• Information – publishing Department
• Department on pharmacoeconomics analysis.

The special Quality Control Laboratory what was set up in 1994 at the Agency is very well equipped according to the all WHO Recommendations and intended for state quality control of pharmaceuticals. Established in 1997 the National Centre on adverse drug effects monitoring is also a structural element of the ADMTA.

The State Quality Control Laboratory is responsible for:

· Testing medicines at the process of registration (defining quality of products to specifications from dossier)

· Testing quality of imported medicines

· Testing quality of pharmaceuticals produced in Armenia

· Testing quality of products at the professional studies of pharmacies and wholesalers.

The following projects are being pursued by ADMTA within the framework of collaboration with WHO:

• Cost-effective drug management in a group of pilot hospitals, together with improved procurement methods, improved prescribing by better selection and use of guidelines, and a pro-active role of the hospital pharmacies;
• A regional drug reimbursement pilot in the Kotayk marz aimed at improving access to quality drugs for poor groups with relatively high drug costs;
• Improved quality of pharmaceutical services through enforcement of effective regulations;
• Better treatment outcomes through efficient use of various tools and mechanisms for appropriate drug prescribing and use;
• Development of an action plan for national drug policy implementation, needed for coordinated implementation and monitoring and for ensuring more active involvement of different stakeholders at various policy levels.

Registration of medicines

A drug registration system is a very important element of national regulation intended to review of efficacy, safety, quality and products data sheet and labels.

National system of evaluation and registration of medicines was introduced in Armenia in 1992. The following pharmaceutical products should to be registered in Armenia: medicines (including serums, vaccines, veterinary pharmaceuticals, homeopathic drugs), diagnostic products, herbal medicines, dietetic products, baby food, cosmetic products with biologically active ingredients, devices. Registration system in Armenia is based on the evaluation of dossier that includes necessary pharmaceutical, pharmacological and clinical data about medicines. Samples should be analysed in the Quality Control Laboratory of ADMTA. Decision about registration is taking on the basis of assessment of quality, safety and efficacy of product. The registration period is five years, and then medicines have to be revaluated.

According to law on Medicines, only registered in Armenia medicines can be sold by pharmacies and wholesalers. However, according to the data of ADMTA, unregistered medicines are sometimes available on the market [15]. There is a trend of decreasing number of unregistered drugs at pharmacies (Figure 3)

Figure 3 Number of Unregistered medicines on Armenian market

3350 medicines were registered in Armenia on 31 March 2001. The List of registered medicines and it’s 2 Supplements were approved by three Decree of the Minister of Health.

Table 5. Top Ten Countries Registered Medicines in the Republic of Armenia

(on 1.03.2001)

Country	Number of registered medicines
Germany	334
Ukraine	202
Hungary	197
Russia	158
France	140
Great Britain	137
Slovene	134
Armenia	124
Bulgaria	94
Greece	81

Table 6. Top Ten Companies Registered Medicines in Republic of Armenia

(on 1.03.2001)

Producer	Number of registered medicines
KRKA	124
Gedeon Richter	112
Glaxo Wellcome	74
Egis	59
Nycomed	56
Pharmacia Upjohn	41
F. Hoffman-La Roche	39
Arzneimittelwerk Dresden	32
Boehringer Ingelheim	32
Merck, Sharp & Dohme	31

As there are some medicines in Armenia Essential Drugs List, which are still not registered in Armenia, the staff of ADMTA initiated a policy to apply to manufacturers of such medicines offering to register their production in Armenia.

Other measures, like privileges in registration price for medicines from Armenian EDL, seem to be important to stimulate registration and, correspondingly, generic competition on local market.

4.1.2 Quality Assurance

Quality assurance (QA) concerns both the quality of products themselves and all the activities and services that may affect quality.

GMP

One of the main requirements of QA is adherence of Manufacturers to GMP. However, at present only 3 producers in Armenia are considered as complying with GMP. In addition, at present the majority of medicines from other NIS, registered in Armenia, are produced not under the GMP conditions. According to the ADMTA, 2103 of registered medicines were produced by manufacturers, which comply with GMP and 600 – by those, which don’t comply [15].

According to the results of interviewing local producers, the majority of them believe that manufacturers in Armenia have to comply with GMP. They suppose that there is an urgent need in developing an appropriate standard.

GPP

In 1997, Armenia entered a WHO project on the development and implementation of national GPP standards and quality assurance. A national pharmaceutical conference to introduce the GPP concept has been held in Armenia. GPP standards have been elaborated and adopted by ADMTA and implemented in 20 pilot pharmacies in Yerevan. Meanwhile, indicators for monitoring GPP standards have been developed and enforced, allowing for the measurement of pharmacy services effectiveness in relation to drug production, storage, delivery, and quality assurance, as well as for the evaluation of pharmacists interventions as they dispense drugs and respond to patient symptoms [12]. However, Decree of the Minister of Health on pharmacy practice standards was mot registered by the Ministry of Justice and, thus, did not became regulation document Requirements to pharmacy, approved by the Decision of Parliament this year as conditions for licensing, are too short and don’t cover all the necessary standards. Thus, it can be said that pharmacy practice in fact is almost unregulated.

Licensing

System of licensing of production and sale of pharmaceuticals was introduced still in 1991. This system is essential to ensure that all pharmacies and practices used to manufacture, store and distribute pharmaceutical products comply with requirements.

Inspection

Inspection is a necessary tool to safeguard drug quality. Nevertheless, there is no officially approved inspection in Armenia to check pharmaceutical license-holders. Department of Professional Studies at the ADMTA conducts investigation of pharmacies, wholesalers and manufacturers but it is not based on national legislation documents.

Furthermore, there is no legal provision for penal sanctions in place. Thus, no penalty action can be implemented in the event of failure to conform with any provision of the law. The single measure is license withdrawal. In 1993-1997 about 40 community pharmacies were closed due to failure of professional norm [15].

Control on Drug Promotion

Despite the fact that it is widely accepted by professionals that controlling the marketing, presentations and other drug promotion is very important in preventing irrational drug use, there is no appropriate norms and standards.

Quality Control

National Drug Quality Control laboratory at ADMTA is independent and equipped by necessary modern equipment thanks to the grant provided by the Gulnbenkian Foundation.

Table 7. The Number of Tests Implemented and Drugs Failed Quality Control Testing [15]

Year	1997	1998	1999	2000
Tests implemented	1657	2251	1932	2500
Drugs failed testing	48	52	83	73
Percentage of drugs failed testing	2,9	2,3	4,2	2,8

The main indicator, to which products did not comply, was rate of disintegration for tablets (76 cases), then – packaging (21 cases).

Table 8. The Number of Tests Implemented by Categories [15]

Year	1997	1998	1999
Medicines tested at import and professional studies of pharmaceutical institutions	1335	1600	1239
Medicines tested at registration process	322	651	693
Total	1657	2251	1932

In 1998 certificate for import was not issued to 35 medicines due to poor quality (14 cases) [15].

According to the data provided by the ADMTA, in 1996-2000 years twelve counterfeit medicines were founded and withdrawal from the market. Nine of them were produced in Russian Federation (RF). They are Reopoliglucin (RF), Hemodez (RF), Tincture of Valerianae (RF), Tincture of Leonurae (RF), Paste of Teymurov (RF), Oleum Hippophae (RF), Erythromycin (RF), Gentamycin (RF), Diclofenac Natrium (RF), Baralginum (India), Kephzol (India), Kephzol (Spain).

4.2 Drug financing

National expenditures on pharmaceuticals are very different in countries and may vary from 2 USD to 400 USD per capita per year. In Armenia there are no official statistics on spending on medicines. In order to define this indicator the following calculation has been done. Public pharmaceutical expenditures were received by adding data received from the State Budget Approved: money intended for centralized procurement of medicines, serums, vaccines and 20% of money intended for hospitals (20% was used on the basis of experts’ suggestions).

Private spending were calculated on the basis of data received from the State Statistical Service what collect an information only from so called shops (pharmacies) without taking into account small outlets. According to expert’s suggestions, sales from these small outlets make up about additional 20%.

Thus, it can be assumed that pharmaceutical expenditures per capita in 2001 were about 3 USD. If take into account shadow economy in Armenia, what was calculated to be 60,3% in 2000 [1], it can be accepted that rug expenditures in Armenia are about 4 USD, what is extremely low value.

Government funding

The Ministry of Health, according to the Low on the “State Budget” has to spend some part of the yearly approved money on centralized purchasing of medicines in particular for treatment of diabetes and tuberculosis.

Approved pharmaceutical expenditures intended for central procurement of medicines made up 5% of the total budget for health care in 1998, and 4.6% - in 2000 and 2001 and 5.8% - in 2002. In per capita terms pharmaceutical state budget amounted 0.48 USD in 1998, 0.47 USD in 2000 and 0.41 USD in 2001 and 0.44 USD in 2002 (calculated for 3.8 mln. population on the basis of the State Budget approved).

Figure 4 Pharmaceutical expenditures, intended for central procurement, per capita from the State Budget Approved

Source: Calculation is made on the basis of the State Budget approved

Health facilities mainly purchase medicines for their our purposes independently from their own budget. When calculating for 2002, using the data on approved budget for hospitals, public pharmaceutical expenditures of hospitals makes up in per capita terms 0.8 USD. Thus, total public pharmaceutical expenditures in 2002 constituted about 1.24 USD. It is evident, that it is impossible to ensure access to medicines even for vulnerable groups of population.

According to the data obtained from the Ministry of Health, in 2000 drug requirement (by value) in pharmaceuticals, chosen for centralised procurement, was met only by 18.2%. Drug need in pharmaceuticals of different therapeutic groups was met by centralized purchasing: Cytotoxic medicines – 9.9%, Psychotherapeutic drugs – 17.4%, Antidiabetic Agents – 18.3%, Immunosuppresive agents – 36.2%, Vaccines, Serums and pharmaceuticals for treatment of tuberculosis – 0%. Need in drugs for treatment of tuberculosis was partly met (33.3%) thanks to donation provided in scopes of the special program “Prophylactics and treatment of tuberculosis” by the Armenian Red Cross.

Armenia has a very limited public resources, however some increasing government funding on health needs whole and on pharmaceuticals in particular seems to be necessary. It has to be done on the basis of calculating drug requirement, selecting priorities and analysis of the cost-effectiveness of different interventions.

Health Insurance

Despite of the fact that the majority of policy-makers at the Ministry of Health and Government support the idea about introducing compulsory health insurance system, there is still no effective insurance system in operation in Armenia, either statutory or voluntary. Some private companies provide voluntary insurance programmes for a very small part of population.

Donations

Donations still have some input in drug supply, however there is no special regulation documents in this area. As the result, medicines received by humanitarian assistance not always meet real needs.

Sales of pharmaceuticals

Medicines in Armenia can be sold only from pharmacy or pharmacy outlet. 715 enterprises received license for pharmacy practice on 1^st May 2001, however only 368 were acting (Figure 5) as a pharmacy.

Figure 5. Number of Acting Pharmacies

Source: National Statistical Service of the Republic of Armenia

Number of acting pharmacies, as well as sales of pharmaceutical products is slightly increased in 2001 (Figure 5 and 6). Private expenditures per year per capita were 1,78 or with shadow economy – 2,85 USD what is a very low value and cannot provide an access even to essential medicines.

Figure 6. Sales of Pharmaceutical products in Republic of Armenia

Source: National Statistical Service of the Republic of Armenia

Table 9. Sales of Pharmaceuticals in Republic of Armenia by Marzes

Sales of pharmaceuticals, USD
Region	1998	1999	2000	2001
Aragatsotn	11,944.4	49, 69.3	69,966.9	92,987.3
Ararat	394,608.8	377,026.1	360,929.2	417,558.4
Armavir	18,702.2	289,911.3	184,106.2	200,685.5
Gegharkunik	106,486.7	81,298.2	87,276.4	100,251.8
Lori	89,946.7	560,1029	297,747.7	331,631.6
Kotayk	139,995.6	298,768.3	432,816.6	469,882.5
Shirak	621,955.6	502,493.0	348,088.8	313,161.8
Sjunik	126,317.6	99,032.3	95,655.1	128,494.5
Vajots Dzor	25,111.1	39,435.6	35,710.3	20,669.0
Tavush	155,068.2	138,819.2	122,511.4	126,858.2
Yerevan	3,778,419.3	7,511,986.5	2,874,225.0	3,503,269.0
Total:	5,535,222.8	10,048,742.0	4,909,033.6	5,732,454.1

Source: Calculation is based on data received from the National Statistical Service,

Republic of Armenia.

Great differences are observed in sales of pharmaceuticals between different regions of Armenia (Table 9). In 2001, 61.1% of expenditures were made by the population of Yerevan although population of the capital, according to official statistics [1], represents only 32.8% of total population of the country.

4.3 Selection of medicines

The selection of essential drugs is one of the core principles of a national drug policy because it helps to set priorities for all aspects of the pharmaceutical system. By the end of 1999, 156 Member States had an official national essential drugs list, and 127 of the lists had been updated in the previous five years [9].

The Minister of Health approved the first version of Essential Drugs List (EDL) in 1992. It was based on the WHO model EDL, as well as, on the results of comprehensive consultations with local experts. Activity on creation of the first version of Armenian EDL and on its following renewing was implemented by the Drug and Medical Technology Agency. EDL is evaluated on a regular basis. The Minister of Health has approved all the renewed versions, presented by the Drug Agency. The last version was adopted in 2002 (Decree N 16 of 11 January, 2002).

Despite the fact that the Essential Drug Concept was accepted in Armenia in 1992, some medicines from the Armenian EDL are still not registered in the State. According to our calculation, only about 70% of medicines from Armenian EDL are registered in the state on 31 March 2001. Although about 30% drugs from the List are still not authorised, others meet in the State Register as many different products, even more than ten (Ranitidine, Diclofenac, etc.).

On the basis of the Armenian EDL the first National Formulary (NF) was created and published in 1997. Furthermore standard treatment guidelines (STGs), including medicines from the EDL, were developed and approved by the Minister of Health.

Nevertheless, many physicians and pharmacists are still have not heard about these documents and the majority of them do not use them in their practice. The results of our studies have shown that NF is not available at the majority community pharmacies and physician’s working place.

Although all interviewed representatives of local manufacturers are sure that Armenia is able to produce the majority of essential drugs, only 20% of locally produced medicines are from the Armenian EDL.

It was calculated that only 60% of medicines purchased by the Ministry of Health (centralized procurement) were from Armenian EDL.

Thus, it can be said that at this stage promotion of the essential drugs concept is one of the most important tasks, as it would lead to more rational prescribing and use, as well as cost effective spending.

Developing a regulation document on selection criteria and selection process as well as a special essential drugs programme seems to be the first step of wide introducing essential drugs concept in Armenia.

4.4 Supply systems

Analysis of the situation shows that the majority medicines sold are imported from other countries. According to the data received from the National Statistical Service, in 2001 sales of locally produced medicines totals 1,997,989 USD or less than 30% of sold medicines

Import of Pharmaceutical Products

Since 1995 import of pharmaceutical products varies significantly with a sharp decrease in 1998 and 1999 (Figure 7). Then, in 2000 the total import sharply increased and made up 41.7 mln. USD (CIF prices). The reason of this increase was, probably, a sharp increase of sales in 1999, what could stimulate importers in 2000. Interviewing key experts of the Ministry of Health has allowed to define that an import of pharmaceutical products received, as donation by the Ministry of Health in 2000 was equal 15.8 mln. USD. Figure of total import of pharmaceutical products, received as humanitarian assistance by the state in whole, is definitely higher as donations are often received directly by separate clinics. Another factor what could have impact on import is a further export of imported products to other countries. Thus, we suppose that it will be wrong to assume that the medicines on 36 mln. USD has been sold in state during 2000.

Figure 7. Import of Pharmaceutical Products per Year

Source: 1. For 1995, 1997, and 1998: Statistical Yearbook of Sough Caucasus. Armenia, Azerbaijan, Georgia.

2. Foreign Trade of the Republic of Armenia.

Valuable decrease of import was observed in 2001 (by 30.6%). This fact has been predicted. According to the decision of the National Assembly of 28^th December 2000, VAT was introduced for pharmaceuticals since 1^st January 2001. Before this medicines were free of this kind of tax.

Local Manufacture

According to the opinion of experts, in Armenia there are resources to develop local manufacture. Analysis of number of producers and volume of production during 1997-2001 confirms this opinion (Figure 8).

Figure 8. Pharmaceutical Manufacture in Republic of Armenia

Significant increase is also observed in 2001 for local sales of pharmaceutical product manufactured in Armenia (Figure 9).

Figure 9. Sales of Local Manufacturers production in Armenia

Taking into account that prices of locally produced medicines are visibly lower than imported generics, developing pharmaceutical production in Armenia has to be a serious concern of policy-makers interested in increasing access to pharmaceuticals.

Good Pharmaceutical Procurement

Analysis of the situation on pharmaceutical procurement in public sector show that it does not comply with many of operational principles for good pharmaceutical procurement. Thus, management is not enough efficient and transparent, financing is not reliable, order quantities are not based on a reliable estimate of actual need.

Another serious problem is a large amount of expired drugs on the territory of RA. The special survey has been conducted in all organizations, government departments and regional medical control departments of the RA. The survey covered 11 regions. The researches showed that the accumulation of expired drugs has been caused by the 1998 earthquake in Spitak, which was followed by combat situations and refugees’ migration to the RA, collapse of the USSR and acute fall f peoples’ social welfare. It was discovered that the RA has about 70 tons of expired drugs, most of them are powders – 73%. The results were grouped according to regions, which revealed that 40% of expired drugs is stored in Yerevan. A procedure on expired drugs destruction has been worked out []. Draft of regulation document has been presented to the Ministry of Justice more than one year ago and it is still there waiting for approval.

4.5 Affordability

Affordability of medicines is one of the main objectives of NDP.

Some indicators were calculated in order to assess affordability of medicines in Armenia. Average retail price of standard treatment of pneumonia, out of the average retail price of a basket of food (WHO indicators) makes up 600%. If compare the cost of pneumonia treatment with an average nominal monthly pension (42.1 USD for 2000) or average monthly pension (8,1 USD for 2000) it can said that many people in Armenia are not able to cover expenses need for a single case of pneumonia or will be forced to cut spending even for food. To check a hypothesis about a low affordability of medicines a small survey of householders (N=130) was carried out. The results show that 28,3% of householders are pure (average monthly expenses per capita are lower than 23 USD) and 15,2% - very poor (average monthly expenses per capita are lower than 14 USD).

At the moment of interview any one was not sick at the 28,3% householders, 23% of peoples were chronically sick and constantly need medicines. Respondents complained that many medicines necessary for chronicle illnesses are not affordable and they are not able to get treatment. 38,3% of householders mentioned that they had problems with affordability of medicines during the last year. It was interesting, that medicines are not affordable not only for poor and very poor population, but also for non pure. The comparison shows that in the group of non pure householders complaints on unaffordable prices, but mainly are able to buy them, while in group of very poor the majority of householders are not able to buy pharmaceuticals they need due unaffordable prices (Figure 10).

Figure 10. Unaffordability of medicines for population (% of householders who completely or partly are not able to purchase medicines needed, by groups)

1 - Medicines are affordable

2 - Medicines are unaffordable

1 - Medicines are affordable 1 - Medicines are affordable

2 - Medicines are unaffordable 2 - Medicines are unaffordable

The main reason of such a situation is a hard socio-economic situation in Armenia. However, it has to be mentioned that strategies to increase affordability are not implemented: no pricing policy in place, prescribing is irrational reimbursement system doesn’t work, good procurement practice principles are not used.

In accordance with reform measures, the population covered by the basic package is to receive free pharmaceuticals when treated as inpatients but hospitals have to cover the cost of drugs from the fixed case payment. This is intended to encourage hospitals to monitor and limit physicians’ prescribing. In practice, however, state funds have been insufficient to fully cover inpatient pharmaceutical requirements, with the result that even patients identified to be in the vulnerable groups often must pay out-of-pocket. It is estimated that as much as 80% of inpatient drugs are purchased privately by patients.

Thus, it is evident that urgent measures are necessary to increase access to patient to medicines, especially for poor population.

4.6 Rational Drug Use

Rational drug use requires that patients receive medications appropriate to their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest possible cost to them and their community. Rational drug use promotes quality of care and cost-effective therapy. It helps to ensure that drugs are used only when they are needed, and that people understand what the medicines are for and how to use them. Policies to promote rational drug use need to address the prescribers, dispensers and consumers of drugs as well as manufacturers and sellers, and traditional healers. All these actors have an important influence on how drugs are used. A variety of strategies and interventions are needed to influence drug use [9].

Although a few studies were carried out to define drug utilization it can be concluded that there are a numerous problems in this area.

The results of survey done in 1996 [15] show that duration of sickness depends on rationality of prescribing.

Figure 11. Dependence of disease duration on rational pharmacotherapy

The results of our survey, intended to define sources of decision-making on drug purchasing, show that the majority of medicines are bought without prescription including not OTC-medicines in particular antibiotics (Gentamycin). Purchasing drugs, patients in some cases base on an advise of pharmacists, also on an information, received from friends and so forth.

Many strategies have been implemented to improve the situation, in particular according to the Degree of the Minister of Health Drugs and Therapeutic committees have been introduced in 20 medical Institutions, hospital formularies were developed in 5 hospitals of Yerevan, special issue have been included in curricula of physicians and pharmacists at under and post educational level.

However, still many strategies have to be developed and introduced to get real achievements. The most important are: creating at least one Information Center, promoting public education, control on drug promotion and sale of prescription medicines.

4.7 Research

Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy. It is an essential tool in assessing the drug policy’s impact on national health service systems and delivery, in studying the economics of drug supply, in identifying problems related to prescribing and dispensing, and in understanding the socio-cultural aspects of drug use.

However, only a few research have been implemented in the state due to a lack of time and resources. As the result, necessary information is still not available in Armenia. In particular, there is no data on drug consumption, which have to be basis for estimating drug requirements and assessing rationality drug use.

4.8 Human resources

Human resources development includes the policies and strategies chosen to ensure that there are enough trained and motivated personnel available to implement the components of the national drug policy. Lack of motivation and appropriate expertise has been a decisive factor in the failure to achieve national drug policy objectives.

Intensive reforms have been implemented in the area of pharmaceutical education during the last 10 years of Independence. The new Pharmacy Department and the Faculty was created at the National Institute of Health continuing education of pharmacists and pharmacy technicians.

However, according to the new Law “On Licensing” approved in 2000, licensing system for Health care professional, including pharmacists was abrogated. As the results, professionals stopped to apply to continuing education courses (it was a Licensing system requirements).

Chapter 5. Pharmaceutical policy

In 1992, after the proclamation of independence, the Republic of Armenia started to formulate its own pharmaceutical policy. Recommendation of the WHO as well as local conditions have been taken into account for policy developing. It was concluded that under the conditions of a transition time and changed socio-economic situation it is rational a new policy to be based on the Essential Drugs concept. As the result, in 1992 the first version of Armenian Essential Drugs List (EDL) and some corresponding strategies were approved by a special Decree of the Minister of Health. In 1993 the “Concept of Pharmacy Development Program”, the first official document on pharmaceutical policy in Armenia, was adopted by the Ministry of Economy on behalf of the Government. This document covered the main objectives, tasks, principles of pharmaceutical sector development, as well as strategies for each component of policy. However, this concept, like other policy documents approved at the same time, has not get a further development and a program, based on it, has not been formulated. The next drug policy development was the “Document of Armenian National Drug Policy”, approved by the Common Meeting of the Armenian Drug Administration and representatives of the WHO Regional Office for Europe in 1995. Thus, the situation in Armenia was significantly changed and there is an evident need in a new policy development.

Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy, however at present there is no mechanism approved for monitoring drug policy progress and outcome.

Conclusions and Recommendations

References

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2. Barsegyan S., Sahakyan A., Aleksandryan A., Vardanyan M. The Issue of Expired Drugs’ Destruction in the Republic of Armenia. Abstracts, 60^th International Congress of FIP, 2000, p. 77.

3. Bennett S, Quick JD, Velásquez G. Public–private roles in the pharmaceutical sector. Implications for equitable access and rational drug use. Health Economics and Drugs, EDM Series No.5. Geneva: World Health Organization; 1997. WHO/DAP/97.12.

4. Brudon-Jakobowicz P, Rainhorn J-D, Reich MR. Indicators for monitoring national drug policies. A practical manual. 2nd ed. Geneva: World Health Organization; 1999. WHO/ EDM/PAR/99.3.

5. Brudon-Jakobowicz P. Comparative analysis of national drug policies. EDM Research Series No.25. Geneva: World Health Organization; 1997. WHO/DAP/97.6.

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7. Foreign Trade of the Republic of Armenia. National Statistical Service of the Republic of Armenia, Yerevan. 2002.

8. Health Care System in Transition. Armenia. European Observatory on Health Care System, 2001.

9. How to Develop and Implement a National Drug Policy, 2nd ed. Geneva: World Health Organization, 2001.

10. Kazarian I., Melikyan M. Aspects of Pharmaceutical policy in the Republic of Armenia. eurohealth, Vol. 4, N 6, Special issue, Winter, 1998/1999, p. 84-86.

11. MSH/RPM. Rapid pharmaceutical management assessment: an indicator-based approach. Washington D.C.: Management Sciences for Health, Rapid Pharmaceutical Management Project; 1995.

12. Nikogosian H. High Quality of Pharmaceutical Practice in Armenia.

13. Poverty and food security (Based on 2001 first quarter data), Statistical Bulletin, Yerevan, 2002.

14. Quick JD, Rankin JR, Laing RO, O’Connor RW, Hogerzeil HV, Dukes MNG, Garnett A. Managing Drug Supply. West Hartford, Kumarian Press, 1997: Chapters 10–12.

15. Report on Working Meeting “Progress in implementation of National Drug Policy in Armenia during 1994-2000”. Yerevan, 2001.

16. Social Snapshot and Poverty in the Republic of Armenia, Yerevan, National Statistical Service, 2001.

17. Socio-economic situation of the Republic of Armenia in January-December 2001, Yerevan. 2002.

18. Statistical Yearbook of South Caucasus, Armenia, Azerbaijan, Georgia, 2002.

19. The TRIPS Agreement and Access to essential Medicines. Unpublished Report, PO DURG. Yerevan, 2001.

20. United Nations Economic and Social Council. Committee on Economic, Social and Cultural Rights. 22nd session, Geneva 25 April – 12 May 2000. Substantive issues arising in the implementation of the International Covenant on Economic, Social and Cultural Rights. General Comment No. 14.

21. United Nations Economic and Social Council. International Covenant on Economic, Social and Cultural Rights. Adopted 16 December 1966.

22. Universal Declaration of Human Rights. Adopted by the General Assembly of the United Nations on 10 December 1948.

23. WHO Medicines web site at: http://www.who.int/medicines

24. WHO. Contribution to updating the WHO guidelines for developing national drug policies. Report of the WHO Expert Committee on National Drug Policies. Geneva: World Health Organization; 1995. WHO/DAP/95.9.

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26. WHO. How to investigate drug use in health facilities. Selected drug use indicators. EDM Research Series No.7. Geneva: World Health Organization; 1993. WHO/DAP/93.1.

27. WHO. National drug regulatory legislation: guiding principles for small drug regulatory authorities. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fifth Report. WHO Technical Report Series No.885, Annex 8. Geneva: World Health Organization; 1999.

28. WHO. The use of essential drugs. Ninth report of the WHO Expert Committee (including the 11th WHO Model List of Essential Drugs). WHO Technical Report Series No.895. Geneva: World Health Organization; 2000. The List is also available on the WHO Medicines web site: http://www.who.int/medicines/edl.html

Appendix 1

Definition of terms

Objective: Is the end result a programme seeks to achieve.

Plan: Document that contains a group of programmes/projects and strategies explicitly expressed in order to attain an objective or a group of objectives.

Policy: Declaration of intent in which the Government commits itself, on the basis of a number of values and principles, to achieve a number of objectives to resolve specific problems of the sector by implementing appropriate strategies. Any policy should set the goals, objectives and strategies required to resolve the major problems identified in the sector.

Policy: Policy is the bringing together the resources of government – money and authority - into the service of political objectives and by those resources influence the behavior of institutions, organizations, and individuals.

Problem: Gap between the actual and the desired situation.

Strategy: Is an approach or a way to achieve an objective and to eliminate obstacles or to bypass policy constraints of the internal or external environment that may impede or block the achievement a policy.

A National Drug Policy (NDP) is a guide for action, containing the goals set by the government for the pharmaceutical sector and the main strategies and approaches for attainting them. It provides a framework to coordinate activities of pharmaceutical sector participants: the public and private sectors, nongovernmental organizations (NGOs), donors, and other interested parties.

Appendix 2

Questionnaire

for interviewing householders

Name, Surname __________________________________________________________

Address_________________________________________________Tel._____________

Date___________________Interviewer________________________________________

Profession of responder ___________________________________________________

Number of family members ________ person. Family members (note the age): ________________________________________________________________________

________________________________________________________________________

Average monthly expenditures for family ___________ dram; per one person __________ dram

Information (points 1-10) is collected weekly - 4 times:

1. Was any member of family sick during the last week (name, age)? ______________

________________________________________________________________________

2. If Yes, mention disease or symptom (also note chronic diseases) _________________

________________________________________________________________________

3. What kind of treatment they got? __________________________________________

_____________________________________________________________________________

4. Did he/she get something else (other medicines)? ____________________________________

_____________________________________________________________________________

5. Who did advise to use this remedy (You, other members of family, neighbors, pharmacists, physicians, others)? _____________________________________________________________

6. Where did you buy medicine(s) or get a treatment (at pharmacy, at hospital, etc.)?

_____________________________________________________________________________

7. Please, characterize effect from treatment (nothing, getting better, full treatment, etc.) ______

_____________________________________________________________________________

8. The cost of all drugs, which were bought for the members of the family during the last week __________________________________________________________________________________________________________________________________________________________9. Percentage of expenditures on medicines of total family expenditures during the last week

_____________________________________________________________________________

10. Medicines, which were got free of charge by members of family during the last week _____________________________________________________________________________

_____________________________________________________________________________

11. Medicines, which were prescribed to family members but were not bought due to a lack of money (including medicines necessary for chronic diseases) _____________________________

_____________________________________________________________________________

12. What medicines and at what cost were necessary for members of family during the last month (note in details)? Who prescribed and for what conditions? Are they bought? If No, please, note why? If there is a case when medicines were not bought due to a lack of money? If Yes, what medicines? ___________________________________________________________

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Form Pharmacy 3. Generic substitution and antibiotics distribution (Gentamycin)

N	Pharmacy	Substitution was done			Substitution			Antibiotic was sold		Note
		Yes/No	Medicine asked (Name, form and strength)	Medicine offered for substitution (Name, form and strength)	Equivalent (Yes/No)	Non-equivalent (Yes/No)	Therapeutically equivalent (Yes/No)	Yes/No	With prescription (Yes/No)