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Authors: Moravcevic N, Chiperi A Presenter Name: Natasa Moravcevic Institution: WHO Regional Office for Europe, WHO country Office Serbia and Montenegro Title: Drug Prescribing Habits in Primary Health Care Facilities and Availability of Drugs in Private and State Pharmacies in the Republic of Serbia Abstract: Problem Statement: Irrational drug prescribing presents a major problem in the Republic of Serbia. The availability of drugs and pricing are not consistent. A study on drug prescribing habits in primary health care was conducted in 2000, and confirmed the situation. It also provided significant indicators for improving the situation. Nevertheless, the situation remains almost the same in 2003. Objectives: To assess current drug use practices in a representative sample of primary health care facilities, and compare the results with the previous study; show the availability of drugs in pharmacies; and compare the prices regulated by the law, international reference prices and prices found in selected pharmacies. Design: Cross-sectional study with comparison. Setting and Population: 10 state Primary Health Centers and 10 state Health Stations in Serbia randomly selected, using patient records and interviews; the first 30 patients that visited a health facility on October 6; 20 state pharmacies; and 20 private pharmacies chosen by two phase cluster sampling method, using interviews. Intervention: The study had three phases. Preparation and training of interviewers (completed in October 2003); data were collected in the last week of October; and data processing and analysis were finalized in November 2003. Outcome Measures: Average number of drugs prescribed per encounter; % of prescribed drugs from different groups; order of frequency of most frequently established diagnoses; years of experience and gender of general practitioners; prescription made at the recommendation (finding of specialists) versus prescriptions decided solely by the general practitioner (GP); practices of advising patients; availability of independent information on drugs; information on medical waste treatment; % of international median price of selected essential drugs in private pharmacies; average difference coefficient between minimum and maximum prices of the selected drugs in private pharmacies; average percentage of the selected drugs available in pharmacies. Results: Primary health care doctors serve older age groups with characteristic pathology, and their prescribing trends are still not rational but vary from the earlier study. Doctors do not have sufficient information, training and documentation on new drugs and treatments. Availability of drugs both in private and state pharmacies is inadequate. Prices vary too much considering the fact that prices for locally manufactured drugs are regulated by the law. Conclusions: The situation turned out to be worse than expected. Enforcement of concrete activities is necessary. The Study pointed out the need for additional studies that could provide important information for authorities and further actions. Study Funding: WHO Regular Country Budget for Serbia and Montenegro – Biennial Collaborative Agreement 2002-2003, WHO Country Office, Serbia and Montenegro (Belgrade) BACKGROUND Republic of Serbia is the part of Serbia and Montenegro (former FR Yugoslavia) The population of Serbia is 7,478,820 (2002 census) The economy has begun to recover but political stability is not assured yet Increasing inequality, decreasing purchasing power, high unemployment Average monthly salary about 176 Euros Life expectancy 69 years for men and 74.46 for women Cardiovascular diseases, cancers, and injuries responsible for 80% of the total mortality burden Very low availability of essential medicines in private and public sector in last decade Study on prescribing habits in primary health care conducted in 2000 by WHO Office in Belgrade Study showed high level of irrational drug prescribing and gave significant indicators for improvement Since 2000 various activities undertaken – new prescription form, formulary, clinical guidelines for some diseases Limited public resources for improvement of the situation OBJECTIVES The objectives of the Study were: To describe current drug use practices in a representative sample of primary care facilities in a standardized, reproducible manner, To compare results with the 2000 Study, To show the availability of medicines in public pharmacies, To compare the prices of medicines regulated by law, international prices and prices found in pharmacies. It was expected that Study will help us: To show that undertaken steps were useful, To realize weak points in prescribing habits, To confirm that availability of medicines is sufficient at least in private pharmacies, To prove that locally manufactured medicines have consistent prices, To indicate further activities for improvement. METHODS The Study was a follow-up of the 2000 Study with additional part concerning availability and pricing The type of Study was cross sectional survey of representative sample Sampling units were primary health care facility and pharmacy: 20 primary health facilities (10 Primary Health Centers and 10 linked Health Stations) with 30 patient encounters in each – the first 30 files of patients that visited one GP on October 6th, 2003. 20 state pharmacies within those centers plus 20 private pharmacies randomly selected Simple random sampling was used for health facilities and combined two-phase cluster sampling for pharmacies There were exclusion criteria: Specialist primary health care doctors – immunization, pediatrics, gynecology and obstetrics, occupational health Foreign doctors employed by international organizations Patients under 16 METHODS 6 students from Faculty of Pharmacy were engaged and trained for data collection – groups of two students visited each facility Students were supervised by authors of the Study Data processing and analysis were done in EPI INFO according to validated questionnaires Questionnaires were created based on the number of indicators considering: Data on doctors Data on patients Diagnoses Prescribed drugs – groups of drugs, different forms of drugs Available literature Treatment of medical waste Generic substitution (local and foreign) Availability Prices Inspection visits RESULTS There is a high number of patients elder than 61 Surprising number of female GPs All GPs have some kind of professional literature: Drug register (89,2% mainly old edition) Reimbursable drug list (94,6 %) Treatment protocols (43%) – at the moment exist only for 4 diseases Professional magazines (30%) Advertising material (20%) Patient age Patient gender more than 61 years female 54,33 % 54,33 45,67 (60*) % (40*) % GP age male GP gender male female 0-5 years 10-15 years More than 15 5,41 % 94,59 % 27,03 % 24,32 % 48,65 % RESULTS Morbidity of the sampled patients and top 10 diagnosed diseases # code International Classification of Diseases % 1 I Diseases of the circulatory system (I10-17.2%; I25-2.97%; I20-2.73%; I49-2.73%) 32.70 2 J Diseases of the respiratory system (J02-4.99%; J42-2.38%) 15.81 3 M Diseases of the musculoskeletal system and connective tissue (M544.64%) 9.87 4 E Endocrine, nutritional and metabolic diseases (E11-4.52%; E14-3.21%) 9.75 5 F Mental and behavioral disorders 7.25 6 K Diseases of digestive system (K262.26%) 6.54 7 N Diseases of genito-urinary system 3.92 8 S Injury, poisoning and certain other consequences of external causes 3.09 9 G Diseases of the nervous system 2.73 10 H Diseases of the eye and adnexa 2.50 RESULTS Average # of diagnosis per patient 1-2 diagnosis per patient 3 diagnosis 4-5 diagnosis per patient per patient 2000 2003 2000 2003 2000 2003 2000 1.252 1.402 86.67 % 91.83 % 4.8% 6.5% 1.1% 1.34% 2003 All medicines are prescribed as brands; practice of generic prescribing is not in place yet There are insufficient information and lack of training in generic prescribing In 13,2% cases GPs prescribe drugs according to specialist recommendation In 34,2% of cases GPs verbally recommend: vitamin C, diet, hydration, resting Total # Total of # of patients drugs 600/ 1800* 1398/ 3497* Average 0 drugs drugs prescr. per (%) patient 2.33/ 1.94* 3/ 18.4* 1-3 drugs prescr. 4-6 drugs prescr. 7 and more drugs prescr. 77.67/ 67.88* 18/ 13.3* 1.33/ 1.01* RESULTS Most prescribed medicines (presented as generics) 2000 Study # 2003 Study % # % 1 Diazepam 8.07 1 Diazepam 7.87 2 Diclofenac sodium 6.21 2 Diclofenac sodium 6.29 3 Captopril 4.06 3 Enalapril 5.36 4 Indapamide 3.95 4 Bromazepam 3.58 5 Ibuprofen 3.00 5 Ibuprofen 3.15 6 Nifedipine 2.89 6 Ranitidine 2.86 7 Ranitidine 2.37 7 Amoxicillin 2.79 8 Verapamil 2.26 8 Verapamil 2.72 9 Cotrimoxasole 2.14 9 Cephalexin 2.58 10 Aminophylline 1.80 10 Aminophylline 2.36 RESULTS 81.62% (84.11% in 2000) of prescribed drugs were oral 13.45% (14.33% in 2000) were prescribed injections Cardio-vascular diseases – the most prescribed were ACE inhibitors, Ca antagonists and diuretics Benzodiazepins are less prescribed than in 2000 Most prescribed antibiotics are amoxicillin, cephalexin and cotrimoxasole 9.73% oral antibiotics and 2.07% injections (better than in 2000 – 12.22/4.67) Other significantly prescribed groups: Analgesics Vitamins Steroids H2-blockers Beta-blockers Antidiabetics RESULTS Availability of drugs and pricing 10 out of 18 studied medicines were taken for analysis (cephalexin, gentamycine, ibuprofen, nimesulid, alprazolam, fluoxetin, dexamethasone, methylprednisolone, enalapril, verapamil) All chosen medicines are in reimbursable list and have marketing authorization Availability is not satisfactory especially in private pharmacies Price ranges are too high considering the regulated prices for domestic manufacturers Prices are compared with median prices from International Drug Price Indicator Guide (2002 edition) and medicines in Serbian market is much more expensive Conclusions: Drug pricing system needs to be adapted Control mechanism for prices in pharmacies need to be enforced The reimbursable list needs to be reviewed Training and strengthening of pharmacists awareness is necessary CONCLUSIONS The situation is slightly different than in 2000 Rational drug prescribing promotion for professionals is necessary Introduction of generic prescribing is needed Introduction of new clinical guidelines and adequate promotion of new and existing guidelines Public and patient education would be useful – there is a pressure on professionals since in last decade practice of self-medication was intensified Preventive health care system has to be strengthen as well as health promotion Efficient control mechanisms for pricing and prescribing have to be developed