Access to Medicine In Iran Cheraghali AM, Nikfar S, Behmanesh Y, Rahimi V, Habibipour F, Tirdad T, Asadi A, Bahrami A Department of Food and Drugs, Ministry of Health, Tehran, Iran m.cheraghali@bmsu.ac.ir 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Abstract Problem Statement: Iran has adopted a national drug list and a completely generics-based national drug policy (NDP). Local production of pharmaceuticals, price controls, licensing for locally produced and imported pharmaceutical and biological products, and active Good Manufacturing Practice (GMP) inspections are the main characteristics of its NDP. However, evidence of irrational use of drugs, including a high number of drugs per prescription and a high use rate for parenterals and antibiotics, is present in prescibers’ behavior. The Iranian Ministry of Health (MOH) has dedicated resources to monitoring the efficiency of the pharmaceutical sector in terms of rational use of safe drugs. Objectives: To assess the availability and accessibility of essential medicines in the primary health care setting in Iran and propose, based on the results of the evaluation, possible interventions for improvement. Design: Cross-sectional study. Setting and Population: Five regions, according to their geographical distribution and to the local availability of qualified personnel who could conduct the evaluation, were selected. In each province, 20 public health centers (PHC) were randomly chosen. The choice was nevertheless restricted to centers were a pharmacy was operative. Outcome Measures: The study collected data for availability of the drugs cross the country .Results: Results of the study showed that, on average, 92% of the 12 drug items monitored were available in the pharmacies at the PHCs. Good availability is confirmed by the observation that 95% of the drugs prescribed by the physicians are dispensed by the PHC pharmacy. The stock-out duration was less than 1 month, on average. The national average number of drugs per prescription was 3.4, and prescription rates of antibiotics (58%) and parenterals (41%) were high. Conclusions: Although availability and affordability of essential drugs in Iran is very good, rational use of drugs should be emphasized. Study Funding: WHO, Iran MOH 11/23/2018 2nd ICIUM, Cheraghali, Iran

Islamic Republic of Iran Population 66,000,000 Population Growth Rate 1.24 Infant Mortality Rate 28.6 Life Expectancy F:71; M:69 Literacy Rate 81.4% Per Capita GNP 2188 USD Health Expenditure (% GNP) 7.5 Per Capita for Drug 14 USD Health Human Resources (per 1000 population) Physician 1.1 Dentists 0.2 Pharmacist 0.14 Nurses 2.6 Hospital Beds 1.6 11/23/2018 2nd ICIUM, Cheraghali, Iran

Iran National Health Strategy Focus on PHC (Health Centers) Increasing insurance coverage Referral strategy Improving quality of life Population control Eradication of communicable diseases 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Iran NDP Fully generic based NDP Local production of Pharmaceuticals Price control Formulation based national Industry Herbal medicine industry National biological industry High regulation Licensing for all locally produced and imported pharmaceutical and biologicals Active GMP inspection 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Results of Iran NDP >97% (quantitatively) of needs to drugs is locally produced High availability (>90%) High affordability High insurance coverage (>85%) Self sufficiency in Vaccine production Quality produced herbal medicines National quality control system in place Active RUD promotion activities Active PMS and drug information dissemination Efficient drug selection mechanism Generic substitution Centralized drug procurement Centralized drug distribution system 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Methods The methodology of the study followed the instructions presented in the "Operational Package for Monitoring and Assessing the Pharmaceutical Situation in Countries". WHO/EDM developed three levels of indicators and corresponding data collection tools. Level II indicators provide systematic data to describe the degree of attainment of the national medicine policy objectives: access and rational use of quality drugs. This study measures the results of the pharmaceutical policy for proposing plan of action . Choice of the regions to be investigated: Five regions, according to their geographical distribution and to the local availability of qualified personnel who could conduct the evaluation, were selected. The chosen provinces were Fars, Tehran, Kermanshah, Khorasan, Khuzestan Choice of the health structures: In each province 20 Public Health Centres were randomly chosen. The choice was nevertheless restricted to Centres were a pharmacy was operative. Choice of investigators: In each Province a responsible investigator was named. These persons held an introductory meeting in order to prepare the investigation and define the necessary procedures. The actual evaluation was then performed by personnel chosen in the province. Choice of the reference list of drugs: From the “Iran Drug List” 12 drugs which are used mainly in primary health care to treat common disease are selected. Based on Iranian consumption pattern a list of 12 items including ORS, Co-Trimoxazole, Penicillin, Acetaminophen, Ferrous Sulfate, Folic Acid, Mebendazole, Tetracycline (eye ointment), Povidone Iodine, Clotrimazole, Antacid and Pediatric Drop of Multivitamine or Vit. A+D were selected for this survey. Data consolidation and analysis: Data collected on the field during the year 2001, assembled in the provinces and then forwarded to MOH in Tehran for review and consolidation. During a two-day meeting in June 2002, the persons in charge of each region, representatives of MOH and a WHO consultant analysed and discussed these results and developed recommendations for the improvement of the situation of the pharmaceutical sector in Iran. 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Results Affordability for medicines was very good; the very low drug price is the result of an important state support to the national pharmaceutical industries. In Iran the price of the drugs is fixed all over the country and it is the same in public and private settings. A complete treatment of pneumonia costs only 2% of the lowest weekly government salary and for the 85% of the population covered by the health insurance only 30% of the price has to be paid. Compulsory generic prescription and substitution guarantee large use of generic drugs. The stock out duration (i.e. the yearly number of days during which a drug of the list was not available in the pharmacy) was less than a month on average. The very low quantity of expired drugs (only 2 centres had more than one expired drugs on their shelves) and the good quality of their storage (average notation of 8.4 out of 11) are a confirmation of quality storage system for the pharmaceuticals. The national average number of drugs per prescription was 3.4. The prescription of injectables and antibiotics were very high. Apparently patients and physicians still consider that injections are more effective than oral drugs. The availability of National Treatment Guidelines was good all over the country while Iran Drug List was missing in the majority of the health centres of some provinces. 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Results The results of the evaluation of the adherence of prescribing habit to standard treatment guidelines (STG) were disappointing. During the survey it was namely very difficult to link the prescriptions to diagnose because the prescribed treatment was not written in the log-book of the doctor and the prescriptions do not report the diagnose. In 84% of cases drugs which handed over to the patients were adequately labelled. For assessing the knowledge about the dispensed drugs, it was considered necessary that the patient should be able to recognise the drug, indication and use of each drug delivered. On a national basis this happened only for 60 % of the patients. More than one third of the patients were not able to provide this information to the investigators. The survey included the rapid assessment of private pharmacies and regional drug warehouses. Prices for different drugs are the same in public and private pharmacies and so is their affordability. The number of expired drugs was very low in the private outlets (1.2%). The situation in the warehouses was also good, with high drug availability, 94%, average stock out duration (6.6 days per year) and good quality of storage conditions (9.6 out of 11). 11/23/2018 2nd ICIUM, Cheraghali, Iran

Results of Indicators of the pharmaceutical sector in Iran % availability of key drugs 92 % expired drugs 0.7 Average stock out duration (days) 29 % Affordability 2 Adequacy of storage (out of 11) 8.4 Average number of items per prescription 3.4 % antibiotic use 58 % injection use 41 % of prescribed drugs included in the EDL 100 % dispensed prescribed drugs 95 % of drugs adequately labeled 84 % of patients with adequate knowledge about their medicine 60 % of Facilities with STG 91 % of Facilities with Iran Drug List 57 11/23/2018 2nd ICIUM, Cheraghali, Iran

Over prescription of Injectable and Antibiotics by Iran’s Prescribers 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Conclusions The survey confirmed the good availability of essential drugs in the public pharmacies. The management of drugs in these facilities was good, storage quality up to the standards, acceptable stock out duration, and very few expired drugs. Centralised drug procurement and distribution contributed to these achievements. An MOH Drug Information Service is actively providing information concerning the safe and rational use of drugs to health professionals and to the public. The availability of key drugs in the PHC was good. The good availability is confirmed by the observation that 95% of the drugs prescribed by the physician are dispensed by the HC pharmacy. The Iran Drug List should be divided by level of care to guarantee a rational use of the limited resources. The recording procedures for patients diagnose and treatment were inefficient and do not allow a good follow up of the prescribing patterns of the doctors. Patient diagnose must be linked to patient treatment in order to allow an efficient monitoring of the prescribing habit and to provide a reliable national disease pattern map. 11/23/2018 2nd ICIUM, Cheraghali, Iran

2nd ICIUM, Cheraghali, Iran Conclusions The knowledge of the patients concerning the drugs they received must be improved in order to guarantee a more rational use of medicines. To improve the population knowledge, drug information booklets (e.g. explaining the rights of the patients or the rational use of antibiotics and injectables) should be prepared and disseminated. Media campaigns might also be considered. Pharmacists should provide better information to the patients about the drugs they are delivering. Written information should always be provided with all necessary details. Low knowledge of the patients about their drugs indicates that pharmacist do not provide enough information to the patients. The cause of low counselling of the pharmacists should be investigated with some proposal for interventions. It seems use of antibiotic and injectables in Iran is high and standard treatment guidelines are not very well followed by the physicians. Further studies should be undertaken to better understand the reasons for the high rate of antibiotics and injectables prescribed. According to the results of such investigation, appropriate administrative and educational. Subsidisation of the pharmaceutical industry should be targeted in a way that does not cause irrational drug use due to very low price of the drugs. 11/23/2018 2nd ICIUM, Cheraghali, Iran