Journal of Modern Medical

Introduction
The goal of medicine is to maintain and improve the health level of society and restore it in patients. This goal is realized through a set of factors, including the correct distribution and consumption of medications. Unwanted adverse drug reactions (ADRs) can cause irreparable effects and put great cost burden on the society. There are different methods in different countries in order to voluntarily identify ADRs by the monitoring centers. The process of reporting ADRs in Iran has been officially started since 1998. They are reported by completing and sending a yellow card to the ADR centers in the Ministry of Food and Drug Administration. This process has been facilitated by the design of the national website for registering ADRs. Continuous reporting can identify, collect and evaluate ADRs efficiently and in a timely manner. This study was conducted with the aim of investigating the processes of reporting ADRs in Iran compared to other countries to identify information elements and the need for common data elements to compare with international data.
Methods
This is a descriptive-comparative study that was conducted in 2020 using Delphi technique in three stages. In the first stage, guidelines, forms and websites designed in the countries including U.S., Canada, England, Australia, India, to register ADRs were reviewed. Valid databases such as PubMed, Scopus, Web of Science were searched using the keywords adverse drug reactions, minimum data set, adverse drug events on studies published from 2010 to 2020. In the second stage, based on the comparative tables, a list of the minimum data collection was prepared according to the similarities and differences in the information elements of the selected countries. The proposed national minimum dataset (NMDS) was designed using a five-point Likert scale for the importance of each data element from 1 (very low) to 5 (very high). The validity of the initial NMDS was measured based on the opinions of three experts in health information management and two pharmacists who were familiar with ADR reporting systems. Then, the NMDS was provided to the participants (experts) online. The third step was the validation of the NMDS using the Delphi method by asking the opinions of 15 experts. After scoring by the experts, all the data elements with an importance level >3 were included in the dataset for registering ADRs; the elements that obtained an importance value <2 were removed from the dataset and entered the next Delphi stage.
Results
A total of 109 data elements were identified. Based on the similarities in the selected countries, 45 data elements were put to the survey, of which 33 reached a collective agreement in the first stage of Delphi. Six data elements including the patient’s medical file number, patient’s date of birth, hospital fax or e-mail address, reporter’s address, reporter’s city/country, and access to the drug after consumption, were removed in the first Delphi phase. The six elements of the hospital address, recording the possible cause of the complication, frequency, reason for use, reporter’s telephone/email, and the action taken in case of complications were scored 2-3 in terms of importance, and entered the second stage of Delphi. Then, 39 data elements in 7 groups of patient information (age at the time of the complication, gender, height, weight, pregnancy/lactation, type of underlying disease, allergy, ethnicity/race), hospital information (name of the hospital, address), complication-related information (type of complication, date of onset of the complication, date of recovery, description of the complication, recurrence of the complication, record of the possible cause of the complication, severity of the complication), drug-related information (brand or generic name of drug, manufacturer, Batch No, expiration date, used dosage, routine dosage, frequency (once a day, twice a day), date of starting drug use, date of stopping drug use, simultaneous use of chemical and herbal drugs, reason for drug use), the drug preparation method (buying from a pharmacy, buying on the Internet, taking without a prescription), reporter’s information (first and last name, job, phone/email, date and time of reporting), and others (registration of the patient’s final condition, action taken in case of complications, medical history/history of complications, laboratory tests) were agreed by the experts.
Dissection
Dispersion, large volume of data and lack of timely access to them for health care providers, poor documentation and existence of duplicate information are among the problems of existing information systems. The use of standard data elements with the same definitions as a minimum dataset can increase the understanding and interpretation of data. The ADR data must be uniform and complete in order to obtain meaningful conclusions. In all countries, the voluntary reporting form of ADRs is the most important tool of the monitoring system. This form is a tool for collecting information related to ADRs, which helps to know the causal relationship between the suspected drug and the reactions. Recording insufficient data about ADRs causes inefficiency of reports for regulatory authorities, because no results can be drawn from these data. The difference data in the dataset of the countries, need assessment of the users, and obtaining the opinion of experts are important to design a minimum dataset. A national ADR reporting system was launched in Iran in June 1998. It is expected that a new national ADR system be designed using the minimum dataset proposed in this study and based on the needs of users and standards.

Ethical Considerations
Compliance with ethical guidelines
The study protocol was approved by the Research Ethics Committee of Mashhad University of Medical Sciences (Ethical code: IR.MUMS.REC.1398.056).

Funding
This work has been done with the support of Mashhad University of Medical Sciences. This research is part of a project (Grant Code No. 971701). 

Authors' contributions
Conceptualization: Marziyhe Meraji;  Methodology: Marziyhe Meraji, Haniyeh Bameri, Zahra Ebnehoseini; Investigation: Haniyeh Bameri; Writing-Original Draft: Marziyhe Meraji, Somayeh Fazaeli, Haniyeh Bameri; Writing-Review & Editing: All author; Supervision: Marziyhe Meraji.

Conflicts of interest
The authors declare that they have no competing interests.

Acknowledgements
The authors would like to thank Mashhad University of Medical Sciences for supporting this project.
 
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