In this study, a descriptive, explanatory, and prescriptive objectives methodology has been designed to describe the consequences, stakeholders, interests, and networks involved in the NDP; to help explain how and why a particular decision was reached in the past; and to assist decision-makers in managing the politics of formulation or implementation.
To identify strengths and weaknesses of pharmaceutical policy formation and implementation in Iran, four standard questionnaires that were designed by WHO (Action Program on Essential Drugs) was used (see table for more information). Questionnaires contained four categories of drug policy indicators including background information, structural indicators, process indicators, and outcome indicators. The indicators serve two purposes in the research: assessment of the implementation of NDP by measuring progress in key components (structural and process indicators) and evaluation of the outcomes of NDP (outcome indicators) [11
WHO standardized NDP indicators
Background information provides data on the demographic, economic, health and pharmaceutical contexts in which drug policy is being implemented. The information is quantitative data, at a single point in time, which was readily available at the central level. Background information was obtained from Iran statistics center [12
], Iran central bank [13
], population report of UNICEF [14
], health status report of Iran [15
], Iran drug statistics annual report [16
] and the ministry of health.
Structural indicators provide qualitative information to assess the pharmaceutical system's capacity to achieve its policy objectives. Questions on structural indicators were answered as yes or no based on available information. Process indicators provide quantitative information on the processes by which a NDP is implemented. They assess the degree to which activities are being effectively implemented and the progress over time.
Outcome indicators were used to measure the results achieved and the changes that can be attributed to the implementation of a NDP. They measure the effects of implementation on the overall objectives of NDP including availability and affordability of essential drugs, drug quality, and the rational use of drugs. Outcome indicators were obtained from available information.
In this study, information on structural and process indicators of drug allocation in the health budget and public sector financing policy, public sector procurement procedures, public sector distribution and logistics indicators were collected from the ministry of health, Iran drug statistics annual report [16
], drug regulatory affairs, and management and planning organization of Iran. The information of structural and process indicators of drug pricing policy in Iran were collected from ministry of health and drug regulatory affairs information resources. Because of epidemiologic transition and lack of exact prevalence of new pattern of diseases [15
] and their standard treatment guidelines in Iran, calculation of the value of the basket of drugs was impossible.
Structural and process indicators of drug allocation in information, continuing education on drug use and rational use of drugs were obtained from Iran drug and poison information center, and rational drug use (RDU)/prescribing auditing committee [17
Selection of drugs for adding to list is performed in IDSC by considering of efficacy and safety, rationality in use, accessibility, and affordability altogether. To assess the agreement between decisions of drug selecting committee and standardized NDP indicators in the last 5 years (1998–2002), an additional weighted questionnaire was designed based on the questions that should be answered about any drug during decision in IDSC. Questionnaire mostly included questions about the history and documentations on efficacy and safety of drugs and also pharmacoeconomics assessment of drugs that are usually provided by applicants. In addition, information related to above fields that are usually obtained from reliable and independent sources by expert team of the secretary of IDSC were included. Additional questions were about identification of applicants and history of clinical trials especially in Iran, approval record of drug by international agencies like FDA, existence of drug standard treatment guidelines (STGs), potential to be produced by local factories, the supportive coverage umbrella like subsidization and insurance, and also price of the nominated drug. This information was designed in a 29-question form with yes/no pattern. The ideal point for questionnaire could be acquiesced with all positive answers except one. Final decision for a new molecule to be added to NDL is performed in IDSC with ten members who are selected and authorized by minister of health. Therefore, questionnaire was weighted by nominal group technique and by 10 members of IDSC who had mostly participated during last 5 years in IDSC meetings. The relation between each question and four indicators of NDP including: "efficacy and safety", "affordability", "availability and accessibility" and "rationality in use" have been asked and in case of each positive relation, the member of IDSC was asked to give a score from 1–5 for that indicator and for negative answer we considered the score of zero for it. Related to the point which obtained from the IDSC's opinion, any "yes" answer for each question could acquire scores in the range of +1 to +5 and the answer "no" got score 0 for each indicator. Fifty-nine drugs during 1998–2002 have been approved by IDSC's members. Their weighted questionnaire was filled out for each medicine separately and the results were reported by means of percentage of agreement.
Distribution of decision makers' point of view is available in related scattergram for interested readers (see additional file 1