MONGOLIA PHARMACEUTICAL SECTOR

ASSESSMENT REPORT

December 2004

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Table of Contents Acknowledgments ……………………………………………………… 2 Abbreviations …………………………………………………………….. 3 Executive Summary………………………………………………………. 4 Country Information ……………………………………………………... 6

Government of Mongolia ………………………………………… 7 Economic Situation ………………………………………………. 7 Demographic and Health situation ………………………………. 8 Health Services ………………………………………………….. 9 Health Workforce ………………………………………………… 10

Pharmaceutical Sector of Mongolia ……………………………………… 11 National Medicines Policy and Drug Regulations ……………… 11 Regulatory Functions …………………………………………….. 13 Ethical Criteria for Medicines Promotion and Advertisement and its control ………………………………………………………

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Drug Registration ………………………………………………… 15 Pharmacy Workforce ……………………………………………. 17 Essential drug selection and its availability ……………………... 18 Pharmaceutical sector …………………………………………… 20

Retailers …………………………………………………. 20 Wholesalers/Importers …………………………………… 21 Manufacturers ……………………………………………. 21

Procurement of medicines ………………………………………. 22 Drug financing ………………………………………………….. 24 Quality assurance of medicines …………………………………. 25 Rational selection and use ………………………………………. 28 Drug and Poison Information Centre 32 Key medicines ………………………………………………….. 32

Reference 37 Annex

1. Methodology of the assessment 2. Summary Form of the assessment 3. Questionnaire on structures and processes of country

pharmaceutical situation

4. Data collection forms

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Acknowledgments This pharmaceutical sector assessment was commissioned by the Pharmacy Department of Directorate of Medical Services and conducted with financial and technical support of the World Health Organization. Staff of the Pharmacy Department conducted the assessment. Special gratitude is extended to Dr Salik Govind, Programme Officer, WR office in Mongolia, for his invaluable guidance and involvement during the preparations, commissioning and completion of the survey. This also refers to Dr Dulamsuren, Director, Directorate of Medical Services, for their support in conducting this assessment. We are also very grateful to Mr T. Namkhainyambuu and Ms. D. Uranchimeg Officers, Department of Health Statistic Department, Directorate of Medical Services for their work in computing and analysing the data presented in the report. This report would not have been completed without their support. Our thanks also go out to the all those health workers at central, aimag and soum level who were involved in this exercise for their time and assistance in availing useful information relating to the assessment. Ms Lkhagvadorj Vanchinsuren Head of Pharmacy Department Directorate of Medical Services (Government Executing Agency) Enkhtaivanii gudamj 13B Ulaanbaatar 210648 Mongolia pharm.dep@mobinet.mn lkhagvadorj@mobinet.mn

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Abbreviations ADR Adverse drug reaction CV Cardiovascular medicine DMS Directorate of Medical Services DPIC Drug and Poison Information Centre DTC Drug Therapeutic Committees EML Essential Medicines List GDP Gross Domestic Product GMP Good Manufacturing Practices IDA International Dispensary Association IV Intravenous injections MEIK Mongolemimpex MDG Millennium Development Goals MNS Mongolian National Standard MNT Mongolian Tugrug (currency) MOH Ministry of Health MSH Management Sciences for Health NMP National Medicines Policy NMPM National Medicines Policy of Mongolia HIF Health Insurance Fund OTC over the counter ORS Oral rehydration salt PD Pharmacy Department RDF Revolving Drug Funds SPIA State Professional Inspection Agency STG Standard Treatment Guidelines UNICEF United Nations Children's Fund WHO World Health Organization The terms of "medicines" and "drugs" are used interchangeably in this report.

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Executive summary This study aims to assess the work of the pharmaceutical sector in Mongolia and progress of implementation of the National Medicines Policy of Mongolia including all its element namely rational selection, quality of medicines, and supply and management system of medicines of the country. The study also has intended to compare main indicators of national medicines policy with those of 1999, recorded at the first assessment of the country's pharmaceutical sector (A methodology of the assessment is attaché herewith -Annex 1). It also has been conducted after the endorsement of the Regional Strategy on Improving Access to Essential Medicines in the Western Pacific Region that was a useful. Most of the recommendations based on the first assessment have been implemented. These are the development and endorsement of the National Medicines Policy, the amendment of the 1998 Law of Medicines, the establishment of Pharmacy Department and initiatives in promoting rational use of medicines both for consumers and health workers. However there is a need for greater efforts to implement the National Medicines Policy in order to ensure that medicines are safe, efficacious and of good quality and properly used by those who need them. Key recommendations: To ensure that medicines are used properly by those who need them:

- Develop and implement a comprehensive rational medicines use strategy and monitor its implementation periodically

- Strengthen implementation of regulations on ethical promotion of pharmaceuticals and promote WHO guidelines on Ethical criteria on medicinal promotion

- Develop and implement a national strategy to contain antimicrobial resistance - Support and guide drug therapeutic committees at hospitals - Update and promote use of essential medicines list and evidence based

standard treatment guidelines in treatment as well as procurement practices - Introduce rational medicines use and problem- based pharmaco-therapy

teaching into the curricula of health care providers To ensure medicines are affordable at all segments of a society:

- Formulate pricing policies, including policies on relevant taxes, mark-ups, and reference pricing

- Implement policies on generic medicines and promote affordable and quality medicines to providers and consumers

- Provide price information on providers and consumers - Promote inter sectoral collaboration in reimbursement schemes and medicines

financing To ensure that medicines are available at all time when needed:

- Encourage training in drug supply management including medicines quantification, costing, procurement, distribution and inventory management of essential medicines

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- Encourage procurement of medicines that are listed in essential medicines list and standard treatment guidelines

To ensure that medicine are of good quality:

- Introduce and implement Good Procurement Practice, Good Storage Practice on Medicinal Products for both public and private sector

- Promote WHO Quality Scheme on Medicinal Product moving in International Commerce

- Develop and implement good manufacturing practices of medicinal products and strengthen inspections in order to cease the production of substandard medicines

- Conduct quality surveys and evaluation of medicines in ensure that counterfeit medicines are not in use and not in the market

Among the key recommendations are the need to develop and implement a comprehensive rational medicines use strategy, formulation of pricing policies, training in drug supply management, establishment of good procurement and good manufacturing practices, follow up actions to combat counterfeit medicines, as well as regular monitoring be strengthening inspections. In order to implement recommendations, it is important to strengthen the pharmacy department /drug regulatory authority and to make the regulatory bodies more effective.

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Pharmaceutical sector works within the context of a country’s health system. It is required to get an understanding of the health status, health system and priority health needs of Mongolian people in any assessment undertaken with a view to improving the work of the pharmaceutical sector. This assessment covers the relevant areas of national medicines policy of Mongolia.

Country information (1)

Mongolia is a vast and landlocked country. The population, which stood at 2504.0 thousand at the end of 2003, is spread across some 1565 thousand square kilometres. It is 2392 km from west to eastern frontier and 1259 km from north to southern frontier. Average altitude is 1580 m above sea level.

Mongolia's population is relatively young, with 32.6% aged under 15 and only 3.5 % aged 65 or over.

The 2000 Population and Housing Census identifies eight main ethnic groups in Mongolia. Roughly 80% of the population is of Khalkh ethnic origins. The next largest group (4.3%) comprises ethnic Kazakhs who have, historically, lived in the extreme west of the country. Since the early 1990s, however, many have migrated to Kazakhstan or moved to Ulaanbaatar. Other ethnic groups are relatively small (none is larger than 70000 people) and sometimes live in very remote areas.

Traditionally, many Mongolians lived as nomadic herders, moving their animals with the seasons, but in recent years urbanization has increased. A growing proportion (currently about one in three) of the population lives in the capital Ulaanbaatar while about 43% live in rural areas. Population density ranges from 180 people per km2 in Ulaanbaatar to just 0.3 people per km2 in the southern Gobi Region of the country. There are just 1900 km of paved roads in the entire country and journey times to and between near by provincial centres may be many hours or days.

The climate of Mongolia is continental with four seasons and it endures long, severe winters, with average temperature as low as -32°C in January. Geography and climate thus combine to present significant difficulties for those who are tasked with planning and delivering health services.

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Government of Mongolia (1)

Mongolia has a parliamentary system of government. The State Great Khural is the elected national parliament. There are two levels of local government, which have gained increasing powers under recent policies of administrative decentralization. The country is divided into 21 aimags (provinces) which together with the autonomous capital region, form a second tier of government.

Aimag population vary and range between 12,500 and 121,500 people. Administrative levels below the aimag level are soums that represent rural districts, which are further divided into baghs (villages).

Economic situation

The main pillar of the economy continues to be the agriculture sector, including livestock, which provided 20.7% of GDP in 2002. The other main sectors in 2002 were trade and services (27.6%), transport and communication (14.0%), manufacturing (9.5%) and mining (8.6%) (1).

During the early years of economic transition, Mongolia experienced a negative growth rate of 9.2% in 1991 and 9.5% in 1992. Since 1994, Mongolia has been experiencing positive economic growth despite recent natural disasters. Real GDP increased by 1% in 2001, by 4% in 2002 and by 5.3% in 2003, primarily as a result of growth in the mining sector. The inflation rate has fallen from 8% in 2000-2001 to 1.6% in 2002, but rose up to 5.0% in 2003 (table 1).

Table 1. Key indicators (2)

2001 2002 2003 Population (million) 2.4 2.4 2.5 GDP growth (%) 1.0 4.0 5.3 Inflation rate (%) 8.0 1.6 5.0 Exchange rate MNT/USD 1098 1110 1166 Exchange rate MNT/EUR 968 1058 1473 Exports (million EUR) 540 495 395 Imports (million EUR) 659 653 507 Budget deficit (%) -4.5 -5.9 -6.0 Official Development Assistance (million EUR) 220 164 NA GDP per capita (USD) 419.0 454.6 469.2 GNI per capita ( thousand USD) 430.9 478.9 494.5

Unemployment is 20%-30% of the workforce. Under-employment is a growing problem in both urban and rural settings. Mongolia is among the countries with the highest donor support per person. In 2001, official development assistance accounted for 20% of GDP and amounts to US$ 84 per person in Mongolia.

Income distribution is becoming more unequal in Mongolia as evidenced by a 42% increase in the Gini-coefficient between 1995 and 2002. According to the Human Development Report, Mongolia 2003 36.0 % of the Mongolian population could, at that time, be classified as "poor" or "very poor" which is at the poverty line at around 25,000 Tugrug /21.4 USD per person per month (15). The number of poor people is

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significantly lower in urban areas (30%) than in rural areas (43%). The depth and severity of poverty are increasing.

The Government of Mongolia is committed to reducing poverty and improving the quality of life and health status of its population. The Poverty Partnership Agreement between the Government of Mongolia and the Asian Development Bank signed on 24 March 2004 adopted the Millennium Development Goals (MDG) as the targets to be achieved under the agreement. These goals and their target dates are shown in table 2.

Table 2. MDG related development targets for achievement by Mongolia by 2015 (2)

Indicator Target Period Infant and child mortality rates reduce by 2/3 1990-2015 Maternal mortality ratios reduce by ¾ 1990-2015 Access to reproductive health services for all who need 2015 Prevalence of TB reduce from 12.5 to 4 per

100.000 people 2000-2015

Access to safe water by the population increase by 48% 2006

Demographic and Health situation

The annual population growth rate between the 1989 and 2000 censuses was 1.4%; a significant reduction from the period varied comparatively little within range of 2.5% to 3.0%. As stated in the Mongolian Statistical Yearbook of 2003, the life expectancy at birth was 63.63 (60.79 years for males and 66.5 years for females) and total fertility rate has fallen from 4.6 in 1989 to 2.0. The population growth rate was 12.7 per 1000 population. Adult literacy rate is 97.8% and the GDP per capita was US$ 469.2.

Official figures indicate that the infant mortality rate fell from a level of 35.4 per 1,000 live births in 1999 (3) 23.49 in 1,000 live births in 2003.(4). Maternal mortality too showed a gradual decline over the years but still remains very high and it is of great concern to health authorities. The leading causes of mortality among infants and adults are shown in the tables 3 and 4.

Table 3. Five leading causes of infant mortality and morbidity (2003) (4)

Infant mortality Infant morbidity( 1000) Certain conditions originating in the prenatal period

39.3 Diseases of the respiratory system 97.8

Diseases of the respiratory system 29.7 Diseases of the digestive system 73.9 Diseases of the digestive system 9.8 Congenital malformations, deformations

and chromosomal abnormalities 24.4

Congenital malformations, deformations and chromosomal abnormalities

7.9 Diseases of the circulatory system 19.6

Skin and subcutaneous tissue disorders 4.3 Skin and subcutaneous tissue disorders 10.6

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Table 4. Five leading causes of adult mortality and morbidity (per 10,000 population), 2003 (4)

Adult mortality Adult morbidity Disease of the circulatory system 24.40 Diseases of the respiratory system 962.16 Neoplasms 12.26 Diseases of the digestive system 713.94 Injury, poisoning and certain other consequences of external causes

8.39 Diseases of the genito- urinary system 649.42

Diseases of the respiratory system 34.18 Diseases of the circulatory system 479.39 Diseases of the digestive system 4.9 Injury, poisoning and certain other

consequences of external causes 335.98

There has been a reduction in deaths attributable to infectious and parasitic diseases and an increase in those due to cancers, diseases of the circulatory system, injuries, poisoning and other external causes.

Particular areas of current concern include (5):

Tuberculosis- which has shown an increasing incidence during the 1990s; Sexually transmitted infection- which are also increasing in incidence; Brucellosis- which has high incidence among both humans and animals; Injuries, poisoning and other external causes- which have seen a rapid

increase in incidence; Hypertension, stroke and rheumatic hearth diseases- which feature

prominently in the growing rates of cardiovascular disease; and Cancers of liver (frequently due to hepatitis B), stomach, lung, oesophagus

and cervix- which together account for four out of every five deaths due to malignancies.

Mongolia faces a number of environmental health risks. They include poor access to safe water and adequate sanitation (especially in rural areas) and air population due to coal burned in energy plants and domestic space heating.

Health services

Factors compounding health system problems include a thin population spread over huge areas, growing expectations by patients, and an extensive health system (26.66 physicians and 73.02 beds per 10 000 population in 2003). Mongolia also faces issues related to cost-effectiveness (a high hospital admission rate of 207 per 1000 population, with average length of stay of 10.6 days in 2002) and the quality of services. At the end of 2002, Mongolia had 536 private hospitals and clinics, of which 136 were hospitals. Most pharmacies are private. Despite the relatively large number of enterprises, the private sector has low purchasing power and a lack of managerial capacity. Most private health enterprises are located in the capital city.

The percentage of GDP spent on health has slightly increased in the last few years, reaching 4.7% in 2002. This has resulted in a per capita health expenditure of US$ 23. The main financing sources are the state budget (64.1% in 2002), health insurance fund (28.5%) and out-of-pocket payments and other sources (7.4%). Donor aid accounted for 15%-20% of all health spending during recent years (table 5).

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Table 5. Public sector health spending by source for 1999-2004 (2) (mln UD)

Sources 1999 2000 2001 2002 2003 2004 I. Government health spending 34.67 43.05 47.00 52.46 54.34 66.55 State budget 24.39 31.77 34.91 35.77 37.70 47.14 % 70.3 73.8 74.3 68.2 69.4 70.8 Health Insurance Fund 8.04 8.78 9.26 12.71 14.48 16.94 % 23.2 20.4 19.7 24.2 26.6 25.5 Out of pocket expenditure 2.24 2.51 2.83 3.98 2.16 2.47 % 6.5 5.8 6.0 7.6 4.0 3.7 % of total government expenditure 10.13 10.91 10.53 8.95 10.12 11.73 % of GDP 3.99 4.60 4.62 4.69 4.57 5.19 II. Donor Financing 11.20 8.37 25.57 8.54 7.61 8.67 Grants (%) 9.87 4.70 20.15 7.22 6.30 6.30 Soft loan (%) 1.33 3.67 5.42 1.32 1.31 2.37 % of GDP 1.29 0.89 2.52 0.76 0.64 0.68 % public sector health spending 24.42 16.28 35.24 14.00 12.28 11.53 Total Public Sector Health Spending 45.87 51.42 72.57 61 61.95 75.22

Social health insurance (introduced in 1994) 80% of the population in 2002, with the state subsidizing the premiums for 73% of those insured. Over 90% of health insurance funds are spent on inpatient care, 7% for outpatient care, and about 2% for operational costs (2).

The Government's plan of action identifies the priority issues as providing good quality primary health services, improving rural health care, developing the private health sector and expanding health insurance coverage. Another important policy document is the state public health policy, approved in November 2001. There is no long-term national health policy, but in 2003 the Ministry of Health started a project with the support of the Government of Japan to develop a health sector master plan for the next 10-15 years. Health legislation and most of the national health programmes have been updated in the last few years.

Health Workforce The total health workforce in 2003 was 32,478, the majority (more than 75%) being females and in the public sector (76 %) comprising 6637 doctors, 821 pharmacists and 1503 pharmacy assistant (see the section "Workforce for NMP).

Overall, there has been a reduction in the total workforce in the last decade from 217 per 10 000 population in 1990 to 132 per 10 000 population in 2002, the reductions being significant in nurses (from 53.7 to 31.7 per 10 000) and mid-level personnel (from 88.8 to 57.3 per 10 000). Although, there was no significant change in the ratio of doctors per population during the period, the ratio of 27 doctors per 10 000 in 2002 is among the highest in the world, and the actual numbers increased from 5682 in 1995 to 6823 in 2002 due to increased enrolment in the four medical schools (6).

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PHARMACEUTICAL SECTOR OF MONGOLIA National Medicines Policy WHO has supported a collaborative programme on essential drugs with the Government of Mongolia since the early 1990. The overall objective of the programme is to support the Government of Mongolia in implementing a national medicines policy based on primary health care approach with an emphasis on the essential medicines concept, including promoting of rational drug use and standard treatment guidelines. The programme also seeks to strengthen the drug supply system in order to overcome dependency on drug donations from abroad. The National Medicines Policy of Mongolia (NMPM) was promulgated by the Parliament in December 2002. The NMPM is the Government 's commitment to achieve priorities on pharmaceutical sector within 10 years of its endorsement and its overall objective is to ensure the availability of good quality, efficacy and safety medicines at affordable prices to those who need them and ensure its rational use (Government Resolution #68, 2002) The NMPM consists of five sections and includes legislation, drug selection, drug production, drug distribution, drug financing, quality assurance of medicines and rational use of medicines. The key strategies are: • Management and coordination related tasks of the NMP to be executed by the designated

ministry of health organization; • The Government of Mongolia will ensure an access of medicines to all population who

need them through effective financing and pricing of essential medicines that would be monitored closely;

• Distribution of medicines will be exercised by accredited supply organizations • An interagency guidelines on medicines donation will be adhered to in case of all

donations and aids; • The Government will support national pharmaceutical industry in terms of increasing

local production and adhering to Good Manufacturing Practice; • Import and local production of patented medicines will be regulated by the Agreement on

Trade Related aspects of Intellectual Property Rights and the 2001 Doha Declaration on public health issues;

• The Government will extend adequate support to drug laboratories, drug quality assurance and strengthening of the inspection agency;

• A national pharmacopoeia will be developed and made available for application; • The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in

International Commerce will be applied to the registration and importation of medicines; • Selection of medicines will be based on the WHO's essential medicines concept. The

essential medicines list and standard treatment guidelines will be reviewed and adopted at least every four years;

• Use of generic names of medicines will be encouraged and the Government will support IEC activities on proper use of medicines among the community and health workers;

• Monitoring of adverse drug reactions will be undertaken and ethical promotion of medicines will be promoted;

• The Government will coordinate and facilitate the implementation of the NMPM and integrate cooperation among international and non-international agencies in order to ensure its effective implementation;

• The implementation of the NMPM will be incorporated into responsibilities and tasks of the Government of Mongolia and local authorities.

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Medicines legislation A Drug Law of Mongolia was first endorsed in 1998 and amended in 2002. The major amendments leading to new legislation were made and are listed below: o The related ministries are responsible for coordinating of the licensing of retail and

wholesale and quality assurance of human and veterinarian medicines; o Importers should have contracts with foreign distribution agency; o The name and amount of medicines, validity as well as name of designated border point

should be written in the license; o Orphan medicines used for rare diseases could be imported without marketing

authorization (registration) and a list of such medicines is ratified by the Minister of Health;

o Medicines imported for personnel usage are regulated in accordance with the Custom Law;

o Medicinal raw materials are registered prior to their usage; o Pharmacies are allowed to dispense medical equipment and devices, disinfectants,

sanitary goods, nutrients, dietary supplements and cosmetics; o Licensing of imports, manufacture and sale of narcotic drugs and psychotropic substances

and its revocation are regulated by the Law on Special Permissions and o Intellectual property rights and patent of new medicines are subject to the related

regulations. One the questionable amendment is that medicinal equipment and devices are regulated by the Health Law and will not come under Drug Law. Thus violations under that area can not be subjected to the Drug Law. Other key legislations in addition to the Drug Law 1998 include the 2002 Narcotics Drug and Psychotropic Substance Control Law, and several regulations, which were promulgated between 1998 and 2004 concerning the following issues: o The border points are designated where medicines can go through (Cabinet Resolution,

1998) o Storage, import and export of Narcotics and Psychotropic Substances (Cabinet

Resolution, 2003) o Requirements for medicines to be registered in the State Registry (Minister of Health,

2004); o Medicines Registration Procedures and Fees (Director of DMS, 2004); o Requirements for development of new medicines to ensure its safety (Minister of Health,

2004); o Storage and Distribution requirements of medicinal products (Minister of Health, 2001); o Manufacturing requirements of medicinal products (Minister of Health, 1998); o List of Essential Medicines, Equipment and Medical Devices (2001, MOH); o Storage, distribution and utilization of narcotics drugs and psychotropic substances

(2004); o Structure and responsibilities of Drug and Therapeutic Committees (2003, DMS); o Requirements for running pharmacy services (MNS, 2003); o National Standard on Good Prescribing Practices (MNS, 2004); o List of prescription only medicines (2001, MOH); o Licensing procedures of manufacturing, importing and wholesaling of medicinal products

(MOH, 2003); o Transportation, manufacture and storage of oxygen and other medical liquids (MOH,

1998) etc

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In addition to the 1961 Single Convention on Narcotic Drugs, the Government of Mongolia has become a signatory to the 1971 Convention on Psychotropic Substances and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances respectively. Regulatory functions In order to ensure that drugs reaching consumers are effective, safe, of good quality and affordable, governments should exert control in several areas through various means. In addition to the Pharmacy Department, which was established in 2003, the Drug Council and the State Professional Inspection Agency, are two other organizations that are involved in the regulation of medicinal products. Besides these two agencies, the Special Licensing Committee is responsible for granting of licenses for manufacturing, importing/wholesale purchase of medicines while the Central Body for Standardization approves technical standards for manufacture and quality control for pharmaceuticals industry (see figure 1. Organizations' chart showing those involved in pharmaceutical regulation). To ensure coordination among those agencies, National Drug Council has been established that consist of representatives of all the relevant ministries and organizations. The National Drug Council has two separate sub- councils (human and veterinary) under its management.

Figure 1. ORGANIZATIONS INVOLVED IN THE REGULATIONS OF PHARMACEUTICAL ACTIVITIES

Government of Mongolia

Ministry Health

State Professional Inspection

Agency

Ministry of Industry

and Trade

Directorate of Medical Services

Health Inspection

Unit

Agency for Standardizatio

n

Pharmacy Department

Drug Inspection Department

Health Department

of Aimag and

Licensing Committee Standardization Committee

Sub Council

Quality Assurance Department

Committee on Special Permission

National Drug Council

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The overall picture of drug regulatory functions within the above-mentioned organizations is presented in the table below. One function namely product registration and licensing of manufacturing and the function of licensing of manufacturing and importation and distribution, two of the four main regulatory functions are being executed by different agencies while control of drug promotion, advertising and price control are not subject to any regulation so far (those without tick). Functions SCHD MOH

(SPC) HAD&C

SPIA STAN PD QA

Licensing of manufacturing √ Licensing of importation √ Licensing of wholesale √ Licensing of retail √ Product assessment and registration √ √ GMP Inspection √ Inspection of distribution channels √ Import control Quality control of products √ Control of medicines promotion& advertising Price control Generic substitution Control of prescribing Technical elements (involvement in the development of standards, norms, guidelines, procedures etc)

√ √ √ √

SCHD- Sub Council of Human Drugs; MOH (SPC)- Special Permission Committee of Ministry of Health; HAD&C- Health Department of Aimag and City; SPIA- State Professional Inspection Agency; STAN- Standardization Agency; PD- Pharmacy Department, DMS; QA- Quality Assurance Department, DMS Ethical criteria for medicines promotion and advertisement and its control Drug promotion/ information can significantly influence the way medicines are used by consumers and providers of medicines. Regulation of drug information and promotion is therefore necessary to prevent the dissemination of inaccurate and misleading information. Accordingly, control of drug promotion and advertising is one of the important functions of Drug regulatory authorities. In Mongolia, there are 1384 newsletters and 320 magazines, 6 televisions and 20 broadcastings were registered by Ministry of Law and Home Affairs. A retrospective analysis of the printed materials in 5 most publicly available news journals and 5 medical journals on drug advertisements show that of total advertisements only 55% are intended for medical practitioners. Contents of information on advertisements intended to both medical practitioners and the general public are shown in the table 6 according to WHO Ethical criteria for medicinal drug promotion 1988 (7).

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Table 6. Contents of information of the advertisements

Content (%) Information on drug advertisement Health providers

Public

The names of the active ingredients using either international nonproprietary names or the approved generic name of the drugs are composed

76.2

The brand name are written on 20.0 27.6 Content of active ingredients per dosage form or regimen are indicated

93.3 88.0

Name of other ingredients to cause problems written 13.3 68.0 Approved therapeutic uses 17.3 Dosage form or regimen 95.2 Warned side effects and major adverse drug reactions 20.2 14 Precautions, contra-indications and warnings 29.8 Major interactions 37.5 11.7 Major indication (s) for use 6.8 Name and address of manufacturer or distributor 40.8/39.4 61.2/51.0 Information are referred to scientific literature as appropriate 21.4 The national TV broadcasts drug advertisements are found to announce a bonus (car, phone etc) for those who purchase medicines exceeding a certain amount, even though the 2003 Law on Advertisement lay restrictions and allows mass media to advertise only over the counter medicines and information intended for promoting rational use of medicines. Drug Registration Imported and locally produced drugs are registered by the Sub- Council of Human Drug (hereafter referred as “drug council”) whose members are specified by the Minister. Currently 1234 products (figure 9) have been registered and it is found that number of registered medicines have been doubled compared to that of 1998 (4). 28 kinds of active pharmaceutical ingredients have been registered. The Pharmacy Department (PD) evaluates and compiles documentation from applicants for drug registration and coordinates work between the Drug Council and the Pharmacy Department. There are 2 pharmacists working in this area and the computer software based MS Access has been used to record all applications. Registration is reviewed every 4 years. If the registration is not reviewed, the products are de-listed. Both registered or de-listed products' name is published in a monthly drug bulletin of the PD and those de-listed manufacturers and suppliers are advised accordingly. Registration checks for expiry are carried out quarterly. Table 7. Registration of essential and generic medicines (8) Number of registered medicines 1234 Percentage of essential medicines 61% Percentage of generic medicines 14.9% (185) Number of countries registered their products 33 Number of applicants (local agents) 76

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During 2002-2004, an average number of newly registered medicines range from 120 to 138, which 13-36 per cent of those were combination medicines. 9- 14 per cent of the newly registered medicines during this period of time were found to be medicines that have been banned in other countries (figure 2). This data shows that registration/ issuing marketing authorization of medicines in Mongolia should be reviewed and revised to comply in line with the National Medicines Policy of Mongolia Figure 2. Number of banned and combination medicines (8)

1827

44

138157

120

1322

11

020406080

100120140160180

2002 2003 2004

combination drugs newly registered drugs banned in other countries drugs

The study has shown that only 74.85 per cent of the key medicines available in the market are registered. It is not possible to state how many per cent of the total medicines registered, are of good quality, safety and efficacy (figure 3) as no analysis has been done on these. Figure 3. Registration status of key medicines in the market

67.7

81.177.7 77.9

70.1

60

65

70

75

80

85

wes

tern

east

ern

north

en

sout

hern

UB

Num

ber o

f med

icin

es

Perc

enta

ge o

f reg

iste

red

med

icin

es

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Beside the above mentioned issue, illegal sale of medicinal products and inappropriate trade is one of the challenging issues facing the implementation of the National Medicines Policy of Mongolia (see the section "quality assurance"). Pharmacy Workforce Number of pharmacy workforce that have been employed by different health organization are shown in the table 8. It is obvious that due to liberalization of the pharmaceutical sector and expansion of the private sector, almost 3/4 of the pharmacists and pharmacy assistants work in private drug outlets. At soum level all of the pharmacies (except 2 out of 243) are in charge of pharmacy assistants. 25-30 pharmacy students are enrolled each year for training at the Health Sciences University of Mongolia. There are 4 colleges to train pharmacy assistants in the country. Table 8. Number of pharmacy workforce employed in Mongolia (4)

Organization Pharmacist Pharmacy assistant

Clinical and specialized hospitals 41 65 Aimag general hospital 44 17 Soum hospital 2 243 Aimag Health Department* 10 2 Medical Universities 20 2 Procurement agencies 102 172 Community pharmacy (private) 554 931 Private owned hospitals 21 25 Others 14 2 Total 821 1503

The population per authorized dispenser in the public sector is 6048.

pharmacy assistant

tertiary and secondary

hospital8%

soum pharmacy

16%

rocurement agency

11%

community pharmacy

63%

private hospital 2%

other 0%

Figure 4. Number of pharmacy workforce recruited in different drug supply organizations

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pharmacist

tertiary and secondary

hospital10%

soum pharmacy1%

procurement agency

12%

community pharmacy

68%

private hospital 3%

other 6%

In the survey of 15 soum pharmacies (1 private, 4 hospital and 10 RDF pharmacies) it was found that these are managed by pharmacy assistant/technician (14) and feldsher (1). While at he aimag level, 7.1% (1) of hospital pharmacies are managed by pharmacists, 71.4%(10) by pharmacy assistants. Neither pharmacist nor pharmacy assistants are available 21.4% of them (Figure 5). The law allows pharmacy assistants to handle only over the counter medicines (OTC). At bagh level feldsher is allowed to handle and dispense a designated number of medicines listed for that level.

Figure 5. Pharmacy workforce at aimag and soum level

0

14

11

10

3

0

5

10

15

pharmacist p technician non pharmacy

num

ber soum

aimag

Essential drug selection and availability The fourth essential medicines list (EML) was approved in 2001 and it includes 319 medicines of different dosages. In a survey conducted to study psychical availability of essential medicines show that the figure varies from 22.2% to 70.0% at soum or primary health care level, 30-60% at aimag (secondary health care) and 29.3- 70% at national (tertiary) levels. The percentage of availability of essential medicines in aimags and soums is shown in the Figure 6.

19

36

49

36

71

5955

5157

39

32

48

2228

4247 49

43

29

62

42

72

35

4347

38

56

73

64

5549

3633

61

42

55 56

40

0

10

20

30

40

50

60

70

80

ARKHBAU

BKHBUL

DARDOR

DUGGOA

GSUHUV

KHEKHO

ORKSEL

SUKTUV UB

UKHUMG

UVSZAV

soum aimag

ARKH- Arkhangai, BAU- Bayan- Ulgii, BKH- Bayankhongor; BUL- Bulgan; DAR-Darkhan; DOR- Dornod; DUG- Dundgovi; GOA- Govi- Altai; GSU- Govi Sumber; HUV-Khuvsgul; KHE- Khentii; KHO- Khovd; ORK- Orkhon; SEL- Selenge; SUK- Sukhbaatar; UB- Ulaanbaatar (by district and tertiary hospitals); UKH- Uvurkhangai; UMG- Umnugovi; ZAV-Zavkhan. Currently, 65% (221 soums) (9) of all the soum pharmacies are supported by a Community and Health Project. The Community and Health Project was started in 1994 by the Ministry of Health in cooperation with UNICEF and supported by a grant from the Nippon Foundation. The project aimed to address the problem of the lack of essential drugs in rural areas by establishing the Revolving Drug Funds (RDF) and to sustain primary health care services through the active participation of communities. UNICEF undertook an assessment of revolving drug funds (RDF) in November 2003 and among its recommendations to the MOH has been to review management of pharmacies dealing with revolving drug funds pharmacies. This support has been the major international project in the pharmacy sector. The programme was quite successful as reported in the first assessment in 1999 and at that time 80 per cent of essential medicines were available (3) at RDF pharmacies. A comparison of availability of essential medicines between RDF and non-RDF pharmacies is shown the figure 7.

Figure 6. Physical availability of essential medicines

Per

cent

age

of a

vaila

ble

esse

ntia

l med

icin

e

20

48.6

43.5

404244464850

avai

labi

liy in

pe

rcen

tage

RDF non RDF

Figure 7. Comparision of the RDF pharmacies with non RDF pharmacies

Pharmaceutical sector The pharmaceutical sector in Mongolia has undergone a gradual transition along with the other related sectors and has to be seen within the context of the country’s history, development and changes in the health sector. The Mongolian pharmaceutical sector celebrated its 80th anniversary in October 2003 and it is becoming more liberalized and decentralized. With the advent of free market economy in 1990s Mongolia saw a rapidly growing in the private pharmaceutical sector. In 2004, there are 29 local manufacturers, 90 wholesalers and 807 pharmacies in the country (including pharmacy branches). Table 9 compares the figures with those in 1999. There were 261 pharmacies in three major cities. Table 9. Number of drug outlets in Mongolia

Pharmaceutical organizations 1999 2004 Manufacturers 25 29 Wholesalers 36 90 Pharmacies 718 807 total 779 926

Retailers Most community pharmacies are privately owned. There is a law laying down criteria and qualifications required for opening a pharmacy and those who dispense medicines must have a license from the health authority. Most community pharmacies (88.2%) are owned by qualified pharmacists. The Drug Law also allows pharmacists to expand its scale of service by opening new branches as long as these outlets fulfil the written requirements. Such branches are allowed to dispense only OTC medicines and they are not obliged be managed by a pharmacist. 75% of those community pharmacies have 1-2 branches and 7% have more than 2 branches.

Injection use is very high among patients and according to WHO, Mongolia is one of the highest users of injectable medicines. In our study, 40 % of soum pharmacies and

21

56.5 % of aimag pharmacies produce solution, which are either for intramuscular or intravenous injections. The latter (for IV use) as recorded at soum pharmacies and aimag pharmacies are 10.5% and 75% respectively. Hospital pharmacies compound intravenous solutions, such as calcium chloride, sodium chloride 0.9; 10%, glucose 5%; novocaine 0.25%; 0.5%; sodium salicylate 10 %; analgin (methamizole) 50%; sodium hydro carbonate 4% in an environment that is low quality and the circumstances far from Good Manufacturing Practices. . According to the Law on Narcotic Drugs, the pharmacies that dispense narcotic drugs and psychotropic substances should obtain permission from the local government and meet requirements including the restrictions to facilitate its safety and misuse. The law allows a district health authority to designate only one pharmacy for dispensing such substances, even tough its demand has been increasing substantially due to requirements of palliative care for increasing number of cancer pains relief. The study shows that most pharmacies store narcotic drugs and psychotropic substances in a safe place as stated in the relevant order, such as locked safe and while 3.8% of aimag community pharmacy does not meet this requirement (Table 10). Table 10. Storage of narcotic drugs and psychotropic substances at pharmacies Special conditions (locked safe) ordinary Aimag hospital pharmacy 100% Aimag community pharmacy 96.2 3.8 Soum hospital 100% Wholesalers/importers There are currently 90 drug wholesalers in Mongolia, almost all of which are based in Ulaanbaatar, except those branches of Mongolemimpex (MEIK). MEIK is a government drug supply organization and 49% of its share was sold in 2004 to private sector. There is a licensing system to regulate who can be a wholesaler, however, the licensing procedures need strengthening to ensure that the medicines are safe and of good quality. The main drug suppliers to pharmacies as well as hospitals are: Monos pharma trade, Nahia, Monpharm and Tavin-Us. Imported drugs, mostly from Russia, and the Eastern European countries, account for almost 90 % of the market share (value). Drug importers do not use the WHO Certification on the Quality of Pharmaceutical Product Moving in International Commerce. Most selling medicines come from "Philco Troge" (India), "Balkanpharma" (Bulgaria), Monos (Mongolia), "Kraspharma" (Russia) and "Nahia" (Mongolia). An inventory control and stock tracking are not in place in any of the wholesalers that have been involved in the study.

22

Manufacturers There are 29 "drug manufacturers" in Mongolia. The state pharmaceutical company was privatised in 2003. Most of the drug manufacturers produce non essential medicines, namely vitamins, general analgesics and herbal medicines. The local manufacturers claim that they are restricted due to lack of investment and adequate government support to the local industry. There is a great need to improve the conditions of these manufacturers in order for them to comply with the written requirements that would in turn support GMP’ implementation. A market value of the domestic manufactured medicines is 4.6 bln MNT (13) The main "western medicines" that are manufactured locally include: 1 Chitamon, cough syrup 7 Dimedrole (diphenhydramine

chloride) 30 mg tablets 2 Ascorbic acid 50 mg tablets 8 Furosemide 40 mg tablets 3 Glutaminic acid 300 mg tablets 9 Indomon (indomethacin) 25 mg

tablets 4 Co- trimixazole 480 mg tablets 10 Paracetamol 500 mg tablets 5 Metronidazole 250 mg tablets 11 Chlorphenamine 4 mg tablets 6 Dibazole 300 mg tablets 12 Choramphenicol 500 mg cap Currently the national guidelines on good manufacturing practices and good distribution and storage practices are under development. Procurement of medicines According to the Law of Procurement, 2000, every government organization should purchase goods, supplies as well as consultancy services by bidding. Type of procurement depends on the amount of budget and at each government administrative level has to establish a bidding committee to evaluate and select suppliers. A joint decree of the Minister of Health and Minister of Finance has been issued to promote good procurement practices with prequalification of suppliers and to also promote essential medicines concept. The order classifies the essential medicines into several packages to allow the suppliers to participate in the biddings under each package. The Essential Medicines list that first was published in 1992 has rarely been referred to and used for government procurement of drugs. The list should be reviewed, printed and distributed and used as basis for government procurement, and also as a guide for reimbursement of insurance claims. Our study shows that a percentage of essential medicines purchased by hospitals ranges from 11.2 % to 65.8% (out of medicines worth of 72.0-628.0 mln MNT) in the 5 hospitals from which data was collected. This figure is still low even considering that most medicines for specialized hospitals are not categorized as essential. There

23

are neither approved essential medicines list nor clinical guidelines that could be used as a guide for selecting of cost effective quality medicines. According to the auditor's report, 2004 (10) the percentage of medicines purchased by open tender ranges from 23% to 87 % at those hospitals. Of those 19.2% were through restricted tender and 63.7% were by negotiated purchase. The most important policy of prequalification should be adhered to in every purchase of medicinal products. Also estimating of drug requirements should be in place to ensure that the medicines are available at all times when they need them. The figure 8 shows a source of medicines at soum and aimag hospitals by different suppliers.

23.5

23.5

11.85.9

35.3 competitive tender

soum pharmacy

UB wholesaler

aimag wholesaler

individual

medicines supplier at aimag hospital

92%

4% 4%

competitive tender UB wholesaleraimad wholesaler

Figure 8. Main suppliers of medicines at soum hospitals

24

29.4 % of the community pharmacies receive supplies delivered directly by the designated suppliers and the others purchase directly from private suppliers due to lack of a proper delivery system by the designated suppliers to those pharmacies. It is also top be noted that quantity of medicines required by these pharmacies is low making it uneconomical for supplier (see figure 9). Figure 9. Type of delivery of consignments

29%

71%

delivery by suppliers

direct purchase fromsuppliers

An average lead-time of medicines to hospitals is presented in the table 11. It shows that a delivery of medicines has taken shorter time during 2003/2004 than it was 1999. This is probably result of procurement of medicines by bidding, increased number of wholesalers of medicines in the country and increased numbers of medicines in the market. Table 11. Average lead time of delivery

2003 (in days) 2004 (in days) 1999 primary health care (soum)

secondary health care (aimag)

primary health care (soum)

secondary health care (aimag)

North na 14 na 15 East na 16 17 16 South 22 4 22 4.5 East

20-60

15 17 20 16 Average 4-22 Drug financing The MOH drug budget in 2004 was 78,631,231.9 MNT and it has been increasing substantially from previous years (Table 12).

25

Table 12. Drug allocation in the health budget (11) Year Drug budget (mln MNT)

Total health expenditure (mln MNT)

1998 5,686.9 1999 6,835.5 2001 9,538.2 54,281,132.7 2002 9.379.7 57,662,218.6 2003 8,871.3 62,299,687.3 2004 10,362.3 78,631,231.9 In our survey we intended to find out an average cost of medicines per inpatient using the medicines budget and number of patient admitted to the hospitals and it ranges from 7974- to 11235 MNT at primary level, 8100- 20472 at secondary level in 2002 while the figure increased to 8919-19839 at primary level and 8103-23609 at secondary level in 2004. However, the cost of medicines purchased by outpatient was 1165 MNT, which has doubled compared to that in 1999. Drugs for cancer, kidney dialysis, some psychiatric illnesses etc (total number of 55 medicines for 15 kinds of disease) are provided free of charge, through the tertiary and secondary hospitals. There is also a reimbursement scheme of medicines cost. The items of reimbursable drugs as well as their prices were reviewed according to the existing list and prices. There were 127 medicines whose prices could be reimbursed by the health insurance fund (HIF) based on prescriptions issued by family doctors (general practitioners). The pharmacist charges a designated per cent of the retail cost at the pharmacy from the customer, and also applies for the retail cost of the medicines through the HIF. 38.2 % of the studied community pharmacies dispense such medicines. They have been facing some problems due to delay of reimbursement (72.7%) and difficulty due to lack of financing (2.9%). Only 9.1% of the pharmacists have not got any problems so far. The accessibility of essential medicines of the community continues to be very low under such circumstances making it difficult for, the patients could not obtain the appropriate medicines for their needs in time. Table 13. Drug Reimbursement Budget from the Health Insurance Fund (16) Year Amount (million MNT) 1998 123.8 1999 142.3 2001 378.6 2002 424.5 2003 381.8 Quality Assurance of Medicines

26

Some samples were taken at the drug supply organizations and were sent for quality control testing at the Central Laboratory at the State Professional Inspection Agency (SPIA). The laboratory is responsible for medicines quality control, also for quality of food, seeds, radiological and microbiological products/materials and tests. The national pharmacopoeia is under development. There are 6 drug inspectors at the national level who are responsible for inspecting manufacturers and wholesalers and 23 inspectors for pharmacy outlets. The number of licensed manufacturers and wholesalers per drug inspector is 6 while the number of pharmacy outlets per district inspector is 35. The main indictors for quality control are shown in the figure 14 (12). Table 14. Main indicators 1999 2003 Oct

2004 Number of inspected drug outlets 355 236 Number of violations investigated in the inspected outlets 857 438 Number of drug outlets that improved the conditions after the inspections

659 341

Number of drug outlets suspended under the existing regulations

0 0

Number of samples collected during the inspection 2604 (3) Number of samples sent for analysis

1843 728

Number of drugs that failed lab analysis 264 116 27 Number of reported counterfeit medicines 24 27 Table 14, presents the numbers available under each indicator. On further analysis it is seen that in 2004, 25 % of all drug outlets (manufacturers, retailers, wholesalers) were inspected and each of them were reported to have 2 violations. 77.8% of violations were significant and needed changes/improvements. None of them have been suspended, even though there were some improvements to be done.

Figure 10.Quality analysis of medicines

26031843

728264 116 27

0

1000

2000

3000

1999 2003 2004

sam

ples

sen

t to

lab

samples substandard

27

Figure 11 Percentage of substandard medicines out of the collected samples in 1999, 2003 and 2004

91%

9%

samples collected substandard

96%

4%

A survey was conducted to gather information on the number of illegal sellers of medicines at one market place and what kind of medicines are most sold at this place named “Narantuul” Trade Centre during one the weekends in November 2004. There were 18 people who were selling medicines and most sold medicines were: vitamin C tablets, paracetamol tablets, co-trimexazole tablets, ampicillin capsules, doxycycline capsules, amoxicillin capsules, aloe injections, benzyl penicillin powder for injection, chloramphenicol capsules and all these in varied dosage forms (see figure 11). The seriousness of the situation is that most of the sales are without any prescriptions from a registered medical practitioner and medicines sold are probably of low quality. An intensified surveillance for counterfeit and substandard medicines will be undertaken with support of WHO specially directed at similar “high risk” places.

94%

6%

2004

1999 2003

The figure 11 shows existence of substandard medicines at selected licensed drug outlets ( pls refer to the section "Drug Registration" and "Key Medicines")

28

Figure 11. Type of medicines sold in a black market

analgesics 20%

vitamins10%

antibiotics 40%

CV medicines10%

others 20%

Rational selection and use The existence of a limited number of medicines is a measure of the country's commitment to rational resource allocation and containing drugs costs by using essential medicines and cost- effective products in the health care system. The fourth EML that was approved in 2001 includes 319 medicines (by different dosage). The medicines that should be available all the time, presented in the list are classified according to level of use, from the 319 varieties of drugs authorized for use in hospitals with specialist physicians to the 56 authorized for use in baugh level by its paramedical workers. Table 15: Number of essential medicines for different levels Level of health service Number of the medicines that should be

available for all time at the relevant levels tertiary hospitals (clinical) 319 secondary (aimag and district hospital) 295 soum hospitals 177 baugh paramedical workers 56 The list needs be reviewed and updated regularly. Action should be taken to use then list as a guide in procurement of medicines and in the education and training of physicians, pharmacists and other health workers. Explicit criteria for drug selection are generally not known widely in the country and there seems to be a general misinformation on selection, use and on the concept of essential drugs, which is the basis for rational drug

29

use. A strong trade name affinity, caused by heavy promotion, has resulted in very limited knowledge and use of non proprietary names of drugs. Updating of curricula, in-service training courses and continuing education in clinical pharmacology and therapeutics, review teaching of clinical pharmacy, and applying new methods of teaching pharmacotherapy should be conducted by universities. One tool to promote rational use of medicines is the National Formulary produced in 2001. Availability of drug information varies across the system. While the national formulary is available in majority of centres, the distribution of essential medicines list and standard treatment guidelines is poor. Action is needed to correct this situation and also to put to use these important documents at all medical institutions at all levels. Distribution pattern is shown in Figure 12.

availability of drug information

12.5

81.3

6.3

25

62.5

4.2 8.417.8

61.8

20.4

0102030405060708090

EML NF STG othersinformation source

perc

enta

ge soum aimag hospitalaimag com.pharmacy

Reporting of adverse drug reaction has been initiated in 2003. However 200 collected reports from health institutions are not being evaluated by the relevant committee of the Drug Council (drug council has 4 committees- pharmacy, pharmacology, ADR monitoring and bio preparation). For a long time the public has been able to buy a large number of prescription drugs over the counter which has led to misuse and overuse of these, in particular, antibiotics and injections. In July 2001, a decree by the Minister of Health announced that measures to be taken to stop this practice. Prescription drug list is approved by the Minister, and distributed to pharmacists and physicians. But progress is poor regarding good prescribing practices . It is required to develop the Mongolian National Standard on Good Prescribing Practices that instructs prescribers to prescribe medicines according to the WHO recommendations and pharmacist to dispense them based on the prescriptions.

EML- essential medicines list NF- national formulary STG- standard treatment guidelines

Figure 12. Availability of drug information

30

72.7 % of prescribers do have a prescription form, the form designated for narcotic drugs and reimbursable medicines. However there are cases where it is available for a short period only and others not have been used even when available (figure 13).

duration of unavailab ility of prescription forms

34%

33%

11%

22%

1 month

1-6 months

6 and more

never used

Key indicators to measure rational use of medicines are average consultancy time on drug information, percentage of essential medicines, injections and antibiotics out of total dispensed medicines etc as shown in Table 16. The indicators show that a rational use of medicines has improved slightly in especially in areas of injection and antibiotic use. ( Table 16 and Figure 14). Table 16 . The comparison of the key indicators 1999 and 2004 Percentage 1999 2004 Average of medicines per patient 2.9 Average consultancy time on drug information NA 119 sec (2’) Medicines from the EML dispensed, out of total number of dispensed

58.9% 59.4% (786\1322)

Injections dispensed, out of total number of dispensed 25.5 12.1% (160) Antibiotics dispensed during the survey 35 15.0% (199) Vitamins dispensed, out of total number of dispensed medicines

25.5 16.1% (213)

Generic medicines 47% 50% (665) Adequately labelled NA 46%

Figure 14. key indicators (1999 and 2003)

0

10

20

30

40

50

60

70

generics antibiotics EM injections vitamins

perc

enta

ge

19992003

Figure 13. Shortage of prescription form

31

Another step forward is the establishment of drug therapeutic committees (DTCs) in every hospital. All tertiary and secondary hospitals have been advised to set up such committees under the guidance of a Director of Directorate of Medical Services (DMS). Terms of references of the committee and its composition were as recommended by WHO. In the survey 95.8% of the hospitals (24) have established DTCs and almost 70% of them organize activities on promoting rational use of medicines among its health workers. 72.2 % of the DTC-s have a budget to subscribe for drug information materials. Training courses on rational drug use organized by medical universities and professional associations have increased substantially as well as health workers’ attendance in these courses. Frequency of attendance was: once- 50.0%, 2-4 times - 34.6% and more than 4 times 15.4%. Attendance of health workers for training is high at primary and secondary levels (figure 15) while more needs to be done to improve attendance at all levels especially at tertiary levels.

involvement of health workers in RUD training

45

67.5

45

61.1

78.9

56.360

85.7

53.8

0

20

40

60

80

100

2002 2003 X\2004

atte

ndan

ce (%

)

tertiary health care org. secondary primary

ABC and VEN analysis's on drug needs in 20 health facilities at primary, secondary and tertiary levels were undertaken to examine annual consumption and expenditure of 394 medicines used in the country and to categorize medicines by their health impact. The cost of all medicines was 6 billion MNT at the hospitals. The most commonly used medicines categorized according to high levels of expenditure incurred are shown in the table 17. Most consumed medicines under high expenditure group were antibiotics for systemic use which account for 1.8 billion MNT and cover 30.2 per cent of the medicines, while drugs for digestion and metabolism were 20.5% and drugs for nervous system disease conditions were 13.3 % of a total of 6 billion MNT.

Figure 15. Attendance of health workers at RUD training

32

Table 17. Most prices consumed 5 medicines N Name, dosage form and

strength of medicine Packing unit

Total quantity consumed in 2003

Total price (MNT)

Percentage out of the total medicines cost

1. Ampicillin, powder for injection 500 mg

vial 1 353 800 338460 250.0 5.68 %

2 Benzylpenicillin, powder for injection 1 mln IU

vial 2 376 000 304 129 920.0 5.1%

3 Ampicillin, powder for injection for

Vial 411 9000 148 284 000.0 2.49

4 Hemodeus , 400 ml solution for infusion

Bottle 44 411 128 791 900.0 2.16

5 Reopholiglucin 400 ml solution for infusion

Bottle 17 705 77 370 850 1.3

The most consumed medicines by quantity on the other hand were non-steroid anti-inflammatory medicines, analgesics, antibiotics and vitamins. They are analgin (2 666 700 tablets); benzylpenicillin (2 376 000 vials), ampicillin, powder for injection 500 mg (1 353 800 vials), ascorbic acid (1292 800 tablets) and paracetamol (1031500 tablets). 65.2 %of the medicines were those in the essential medicines (E- essential) list, 15.9 % of medicines were those used in emergency (V-vital) and 34.7 % were non-essential medicines (N).There are some medicines that could be replaced by more effective, safety medicines now commonly used in other countries while some obsolete medicines could be dropped. This analysis goes to point out the need to initiate a reliable drug quantification method .The latter along with development of an appropriate antimicrobial strategy would help in containment of drug costs and appropriate use of antimicrobials. Drug and Poison Information Centre There is a Drug Information Centre that has been established in 2002, with technical support of WHO and till April 2003 the centre was under the SPIA. However, in September 2003, the Poison Information Centre, which was established also with support of the WHO has been merged to the Drug Information Centre and the new centre is named Drug and Poison Information Centre (DPIC). One pharmacist, one clinical pharmacist, a medical doctor and toxicologist staff the DPIC. The centre responds to requests related to rational use and safety of drug and chemical substances on request and monthly publishes a drug bulletin monthly. All staff is trained on the relevant areas and the centre is supplied with all the necessary equipment and with financial support to produce advocacy materials. Funds for information education campaign is allocated from retention fee of drug registration.

33

The above mentioned drug bulletin was one of most important initiatives of PD and the number of copies increased (400-600 copies) significantly due to increase in demand. It contains information on newly registered medicines in the country, substandard and counterfeit medicinal products, safety of the concerned medicines etc. However, the survey shows that availability of such monthly updated news information is relatively low and in this regard further action should be considered. Key Medicines The following 15 key medicines have been selected from the essential medicines list according to those commonly prescribed be doctors and frequency of use amount the population of Mongolia. 1 Aluminium hydroxide,

suspension 9 Metronidazole, tablet o f 250 mg

2 Amoxacillin, capsule of 250 mg 10 Nifedipine, tablet of 10 mg, 20 mg 3 Atenolol, tablet of 50 mg 11 ORS, powder 4 Carbamazpine, tablet of 200 mg 12 Pancreatin , tablet 5 Co trimoxazole, tablet of 480 mg 13 Paracetamol, tablet of 500 mg 6 Ferrous salt + Folic acid, tablet 14 Phenoxymethylpenicillin, tablet of 250

mg 7 Furosemide, tablet of 40 mg 15 Retinol ( vitamin A) 8 Mebendazole, tablet of 100 mg The study also shows that availability of the key medicines at warehouses in Mongolia has improved slightly compared to that in 1998 (Table 18). Of the medicines that were out of stock ORS powder recorded 150 days. The reason of being out of stock at warehouses and pharmacies is that UNICEF provides ORS free to every IMCI unit of the country. However this should not be an excuse for non availability of this life saving medicine in pharmacies. Table 18. Comparison of an availability of the key medicines at warehouses in Mongolia Year Number of days at least one of key medicines was out of stock 1998 215 2004 30-150 (ORS) A free sale certificate provided by suppliers and quality analysis by the State Professional Inspection Agency assures the quality of medicines. All wholesalers are obliged to possess these documents to show that medicinal products are of good quality. Expired medicines have to be destroyed. However, it was observed a significant number of key medicines with expired shelf life were found lying at shelves of pharmacies and warehouses. Figure 16 shows the scale of existence of such medicines by the regions.

34

2.9

13.4 14

3.6

7.7

02468

101214

perc

enta

ge o

f exp

ired

med

icin

es

Western Northern Southern Eastern UB

Figure 16. Expired medicines at drug outlets by Region

Most of the key medicines available at pharmacies and warehouses were been prescribed/dispensed with their generic names and it ranges from 77.9-96.0% among various regions, the highest being in Western region (figure 17).

9680.4 77.9 85.3 90.3

0

20

40

60

80

100

perc

enta

ge o

f gen

eric

s

Western Northern Southern Eastern UB

Figure 17. Generic key medicines

Table 19. The average cost of one tablet/capsule of each key medicines in 5 regions, Mongolia (MNT) East South West North UB Average 1 Aluminium hydroxide, suspension 2000.0 1800.0 1800.0 2500.0 700.0 1760.0

2 Amoxacillin capsule, 250 mg 60.0 54 45 57.5 50.0 53.3

3 Atenolol, tablet, 50 mg 85.7 68.8 33.3 53.6 33.3 54.94

4 Carbamazpine, tablet, 200 mg 40.0 44.0 40.0 46.0 40.0 41.6

5 Co trimoxazole Tablet, 480 mg 31.0 19.5 31.0 35.0 31.0 29.5

6 Ferrous salt + Folic acid Provided free of charge by a "Reproductive Health" project of United Nations Population Fund

35

7 Furosemide, tablet, 40 mg 30.0 10.0 120.0 120. 12.0 58.4

8 Mebendazole, tablet, 100 mg 133.3 120.0 150.0 200.0 500.0 220.6

9 Metronidazole, tablet 250 mg 30.0 13.3 13.3 16.6 13.3 17.3

10 Nifedipine, tablet, 10 mg, 20 mg 30.0 19.5 30.0 30.0 30.0 27.9

11 ORS, powder 250.0 200.0 300.0 266.6

12 Pancreatin , tablet 9.0 35.0 11.6 8.0 70.0 26.7

13 Paracetamol, tablet, 500 mg 15.0 12.0 10.0 15.0 13.0 13.0

14 Phenoxymethylpenicillin, tablet, 250 mg

40.0 35.0 28.0 50.0 35.0 37.6

15 Retinol ( vitamin A) 40.0 53.3 25.0 20.0 15.0 22.7

Total price of one basket of key medicines

2544.0 2284.8 2337.3 3151.7 1542.6 2630.2

2544 2285 23373152

1543

0

1000

2000

3000

4000

MN

T

east south west north UB

Figure 18. Comparison of the average price of the basket of the key medicines by the regions

The table 19 presents the national average of wholesaler price of the 15 key medicines in the regions while figure 18 shows comparison of average price. It is observed that the price of medicines varied from place to place from a very low to very high levels for the same medicine. For example the price of a tablet of mebendazole found to be 133.3 MNT in one region while the same was 500.0 MNT in another region. The worst case was with furosemide, tablet of 40 mg of which the minimum price is 12.0 MNT to maximum of 120.0 MNT. These figures show the inequity in health service delivery between rural and urban areas, the medicines are less affordable to people in rural areas than urban area and a price monitoring by way of setting up maximum mark up of the medicines should be considered to ensure that essential medicines are affordable to every segment of the society.

36

Table 20. Price comparison of the key medicines 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 International Drug Price –IDA (2003) (14)

172.

5 (ta

b)

18.8

8.05

12.6

5

8.74

2.87

5

5.52

4.7

4.25

5

24.8

4

66.4

7

2.99

13.3

4

11.5

357.

23

Country's average price

1725

53.3

54.9

4

41.6

29.5

1.32

(don

ated

)

58.4

220.

6

17.3

27.9

266.

6

26.7

13.

37.6

22.7

2630

.2

(1- Aluminium hydroxide, suspension; 2- Amoxacillin capsule, 250 mg; 3- Atenolol, tablet, 50 mg; 4- Carbamazpine, tablet, 200 mg; 5- Co trimoxazole Tablet, 480 mg; 6- Ferrous salt + Folic acid; 7- Furosemide, tablet, 40 mg; 8- Mebendazole, tablet, 100 mg; 9- Metronidazole, tablet 250 mg; 10- Nifedipine, tablet, 10 mg, 20 mg; 11- ORS, powder; 12- Pancreatin , tablet; 13- Paracetamol, tablet, 500 mg; 14- Phenoxymethylpenicillin, tablet, 250 mg; 15- vitamin A,50000IU) (1 USD =1150 MNT) Table 20 shows a price comparison of the key medicines (1 tablet/ capsule) with those listed in an International Drug Price Indicator Guide published by Management Sciences for Health (MSH) in 2003. A price of International Dispensary Association has been used as a reference price and it shows that there is a great variation of prices of those in the international and domestic markets, for example a significant price difference of furosemide tablet of 40 mg is observed and its price is 10 times more at country level. The total price of the key medicines at IDA is 357.23 MNT (1 USD=1150 MNT) while it is more than (one item not costed) 2630.2 MNT at our warehouses. It would be pertinent to look at cost effectiveness of purchasing medicines from recognized international medicines organizations, taking into account CIF prices of the medicines. Beside cost effectiveness it would guarantee the quality of medicines (A survey on medicines pricing with support of WHO also has been undertaking by the MOH and for information would be presented there)

37

REFERENCES (1) National Statistic Office, Mongolian Statistical Yearbook 2003 (2) First Draft of the Health Sector Strategic Master Plan, 2004 (3) Ms Margaret Bonner, Ms. V. Lkhagvadorj, Mongolian Pharmaceutical Sector Report,

October 1999 (4) Health Indicator, Directorate of Medical Services, 2003 (5) Country health information profile, 2004, WPRO/ WHO (6) WHO report on Human Resource Development of Mongolia, WRPO/WHO (7) Ms. Ch. Munkhdelger, B. Burmaa, E. Erdenechimeg, MOH, "Ethics of Drugs

Advertisements of Printed Media in Mongolia", 2004 (8) Ms Z. Zuzaan, Personal communication with Ms Lkhagvadorj and List of registered

medicines in Mongolia (9) Alejandro N. Herrin, Sustaining the Gains form the Community and Health Project in

Mongolia; Evaluation Findings and Issues, November 2003 (10) State Property Committee, Auditors' report, 2004 (11) Health Budget Report 1999-2004, MOH http://www.moh.mn (12) State Professional Inspection Agency. Ref: October 2004 (13) Mongolian Drug Suppliers' Association "Em holboo" (14) International Drug Price Indicator Guide, MSH, 2003

http://www.who.int/medicines/organization/par/ipc/drugpriceinfo.shtml (15) Mongolian Human Development Report, 2003 As a guide:

- Indicators for Monitoring National Drug Policies, WHO/EDM/PAR/99.3 - Rapid pharmaceutical Management Assessment: an Indicator- Based Approach

16 Health Insurance Committee, MOH