Since pharmaceutical services are of prime importance and play a key role in health system, improving quality services have always been one of policymakers′ main priorities in pharmaceutical sector. Ensuring the quality and safety of medicines, on-time provision of medicines, observing patients′ affordability, and improving rational use of medicines are all among the goals of this system. Policy making in pharmaceutical system necessitates providing scientific evidence drawn from the present conditions and the impacts of previous decisions. The evaluation of pharmaceutical system highlights the effectiveness of previous policies and their positive and negative consequences as well as the need for adopting new policies (
1).
Due to the vital role of medicines in controlling burden of diseases and in decreasing their mortality rates, it should be noted that this aim can be achieved when medicines are available to all walks of life. High prices of medicines and their unavailability in pharmacies are the factors which can deteriorate patients′ health. Access generally means medicines are physically available in pharmacies and affordable for all citizens (
2). Likewise, according to the laws of health systems in most countries, people are entitled to have access to essential medicines, and governments are to fulfill this aim (
3). According to the world health organization (WHO)′s reports, around one-third of people in the world do not have assured access to essential medicines (
4); that fifty percent of them live in Africa and Asia (
5). In addition, according to WHO recommendations, to warrantee patients’ safety and promote community health level, it is necessary to evaluate pharmaceutical service providers in terms of “quality” (
6). Quality is defined as “being free from defects, deficiencies, and significant variations” in service provision (
7). As a result, quality, as a commitment to national or international standards, can promote health indicators, increase health system reliability, and enhance patients’ trust to pharmaceutical service providers. Furthermore, in the past decades, development of rational use of medicines was continuously one of the major priorities in pharmaceutical policy-making. According to the WHO′s report more than fifty percent of medicines are prescribed, dispensed, and sold irrationally (
8). Economic losses on patients and health system, occurrence of adverse drug reactions, increased medicine resistance, prolonged illness or finally death can be the consequences and harms of irrational use of medicines (
9). Rational use of medicines is defined as ″patients should receive medications commensurate with their clinical needs, in appropriate dosage that meet their individual requirements, for an adequate period of time, and at lowest cost to them and their community″ (
10). Physicians and other health sectors’ professions, therefore, play the main role in the development of rational use of medicines. The average number of medicines per prescription, the percentage of antibiotics and injectable medicines in prescriptions, medicines prescribed by generic name, and prescription based on essential medicines list as well as standard therapeutic guidelines (STGs) are the main criteria to evaluate rational use of medicines (
6).
This study aims to evaluate the performance of Iran′s pharmaceutical service providers to patients in terms of access to key medicines which were selected by research team according to WHO’s recommended list and national clinical practices, quality of drugs, and the status of rational use of medicines accordance with the WHO instructions. Despite the WHO′s advice concerning conducting such periodical evaluations, in Iran, some thinly scattered studies were carried out in each of these dimensions past few years (
11,
12), yet the present study covers all the indicators related to these three dimensions all inclusively. The results of this study can indicate whether the aims of pharmaceutical system have been fulfilled or not and can clearly reveal the existing gaps to the policy-makers.
Methods
Study design
This research has been carried out based on the level II of “WHO′s operational package for assessing, monitoring and evaluating country pharmaceutical situations” (
6). Dimensions and indicators investigated in this study are provided in
Table 1. In the primary stage of designing study, the checklists had been exactly extracted from WHO guideline (by adjusting some items such as the list of key medicines). However, due to lack of IT capacity in Iran PHFs, missing of medicines’ shortage history recording, and lack of diseases diagnosis records in prescriptions, three survey forms (about average stock out duration, availability of standard treatment guidelines, and tracer cases treated according to recommended treatment protocols) were excluded in this survey. Similarly, three forms which are related to wholesalers’ data were omitted since they are not directly related to the aims of this study, analyzing service providers to end-users. Based on this instruction for evaluating these indicators, eleven separate checklists were developed and were scrutinized and certified by nine pharmaceutical sector experts, in terms of translation, content, and face validity. The experts, with minimum five-years experiences in pharmaceutical policy and management, were invited for face to face interview to validate checklists.
In order to investigate the affordability of medicines, standard treatments of diseases, including diabetes, asthma, hypertension, hyperlipidemia, pulmonary, and out-patient pneumonia were examined. By dividing the patients′ payment for a course of pharmacotherapy or the needed medicines for a one-month treatment of chronic diseases into the daily wage of the lowest paid unskilled government worker (LPGW), the affordability of such periods have been calculated (
13). Should the result of such division be less than one (≤1), the purchase of medicines for a treatment period can be affordable. In 2018, the minimum daily wage in Iran was 380000 Rials (9 USD; exchange rate 42000 Rials). Regarding the indicator of geographic accessibility to pharmacies, the percentage of patients who get to a pharmacy by walking within maximum thirty minutes was investigated.
In order to compare the price of essential medicines, median price ratio (MPR) was considered, which is gained by comparing the price of each medicine with its international price. According to Health Action International (HAI) (14), the source utilized as a reference for exchange rates was the websites of “World Bank”, “IMF”, and “Central Bank of Iran”. According to these references, each U.S dollar was equal to 42000 Iranian Rials. By dividing the price of a given medicine in Iran into its reference price, MPR can be gained. This indicator should be less than 1.5 and 2 in public and private sector, respectively (
15).
Concerning the quality, as WHO guideline recommends, the existence of expired medicines in pharmacies and observing the standards of storing medicines were considered as evaluation indicators. Standards concerning storing medicines based on the WHO guideline are: controlling the pharmacy temperature and appropriate thermal insulation, proper ventilation, not being exposed to direct sunlight, controlled humidity of the pharmacy, having air-conditioner and temperature log-sheets, sorting of medicines based on the expiry dates, having pest control program, not manipulation of tablets/capsules by naked hands, and not storing medicines directly on the floor. Since there is no list of essential medicines in Iran, a list of key medicines was prepared so that some indicators such as availability of medicines, the percentage of expired medicines, and the price of key medicines could be provided. The list of key medicines was developed considering the list of 15 medicines recommended by WHO, expanding to 25 medicines based on clinical expert opinion. The 25 selected medicines are prescribed in primary and secondary health care levels for common diseases and such medicines are expected to be always available in pharmacies. In this study, only the lowest price of generic (LPG) medicines have been taken into account, not the brand or brand-generic ones. To clear more, the list of selected medicines was presented in
Table 2.
Sampling and Data Collection
To carry out this research, 30 public pharmacies and 30 private pharmacies from five cities were selected. According to the data provided by Iran Central Bank, Tehran, as the most privileged, and Zahedan, as the least privileged cities were selected. Then, based on clustered sampling technique, to cover different geographic regions, three more cities, namely Mashhad, Yazd, and Tabriz, were randomly chosen. The research sample included pharmacies and pharmaceutical centers which provided out-patient services in public (general) levels and had a specific place to dispense medicines to the patients. Therefore, specialized services were excluded. The first medical service-providers were the biggest out-patient pharmacies belonging to public hospitals in each city. The second samples were the smallest pharmaceutical service-providers in one of health centers located in the least privileged part of the city. These centers were selected by vice-chancellor for food and drug in medical universities of each province. Four more pharmacies were selected randomly in different parts of the cities. Pharmacies belonging to universities, social security organization, charities, and the armed forces were assumed as public ones. Having selected public pharmacies, the researchers chose the nearest private centers to the selected public pharmacies as the samples of private sectors.
In data collection phase, some appointments were made with pharmacy managers so that data collectors could collect the necessary information. Furthermore, As the WHO guidelines recommend, both retrospective and prospective methods were employed in patients sampling. For example, to measure some indicators related to rational use of medicines, prospective sampling was randomly carried out from among thirty patients who referred to the pharmacy. In order to achieve comparable data from different cities, uniformity in data collection was necessary. Therefore, data collectors were provided with some information, such as key medicines list, treatment guidelines, checklists, official letter of introduction to the local health authorities, and identification card. According to the WHO guideline, the selected patients were suffering from common diseases such as non-bacterial diarrhea, mild/moderate (outpatient) pneumonia, non-pneumonia acute respiratory tract infection, diabetes, asthma, and hyperlipidemia. It is worth mentioning that patients who referred for prenatal and postnatal care, the elderly and the children′s healthcare, and specialized counseling were excluded due to the difference in their treatments. The data were collected from April to November 2018.
Data Analysis
During the data gathering process, the non-qualified data were modified and the biased data were deleted. SPSS 24 was employed to analyze the data. Depending on proving data normality based on the Kolmogorov-smirnov test, Independent sample t-test and one-way ANOVA test were performed to test significant differences among various sectors with P-value <0.05 or <0.1.