Improving adverse drug reaction reporting through interdepartmental partnerships in Iran 

Background
Adverse drug reactions (ADRs), a major global health problem, are unintended responses to a drug that occur at commonly used doses. An ADR refers to any unexpected and undesirable event at the time a drug is used, whether or not it’s associated with the administration of the drug.
 

ADR reporting is critical in managing the condition because they are potentially life threatening. Only severe adverse reactions need to be reported for well-established drugs; however, all ADRs, including minor ones, should be reported for new drugs. Pharmacovigilance systems are critical in assessing, monitoring and preventing ADRs.
ADR is prevalent among hospitalized Iranian patients. Pourseyed et al¹. found that 11.75% of hospitalised patients over a 15-week period in the internal medicine wards in Iran experienced at least one ADR. Also, Izadpanah et al². indicated in their study that injectable drugs were found to have more adverse effects in hospitalised patients, and anti-infective agents were the top drugs causing ADRs.
 

The knowledge of ADR reporting in Iran is still low, as it is in many other low- and middle-income countries; however, the trend of ADR reporting has increased over the past 19 years.
 

An organisation or manufacturer creates an established best practice through research to set guidelines or benchmarks for other organisations to follow. We used JBI methodology for evidence implementation and JBI audit criteria for an evidence implementation project aimed to evaluate the current practice and implement best practice related to the detection and reporting of ADR in Sina hospital, affiliated with Tabriz University of Medical Science, Tabriz, Iran.
 

A partnership to promote ADRs through clinical audit
The research centre for evidence-based medicine established a group, which included the treatment vice-chancellor of Tabriz University of Medical Sciences and Quality Improvement Unit of Sina Hospital, to improve the detection and reporting of ADRs in the hospital.
 

Because these three departments have a common goal to increase the quality of services and evidence-based practice, they collaborated to improve the ADR reporting process, each with their own unique role to play. The treatment vice-chancellor provided the most up-to-date standards to identify gaps between current practice and best practice recommendations, the research centre took over the project's leadership, and the quality improvement unit became responsible for the project implementation.
 

A clinical audit was undertaken using the JBI Practical Application of Clinical Evidence System (JBI PACES) tool. Seven audit criteria representing the best practice recommendations for detection and reporting of ADRs were used. A baseline audit was conducted, followed by the implementation of multiple strategies. The project was finalised with a follow-up audit to evaluate the changes in practice.
 

The results of this implementation project showed that the compliance rate of all criteria improved, including:

• the compliance degree of obtaining full medical history at admission (from 70% to 87%)
• documentation of the following information for adverse drug reactions (from 39% to 70%) 
• initial checking of the patient’s drug allergy status (from 70% to 78%) 
• using multifaceted strategies to promote ADR reporting (from 48% to 74%)
• training of healthcare professionals (from 61% to 87%) 
• accessibility of reporting systems (from 70% to 83%)
• accuracy in ADR reporting (from 87% to 91%).

To achieve these improvements, five barriers to compliance with best practice were identified, and educational strategies such as pamphlets, workshops and conferences were formulated and implemented to overcome these barriers.
Educational programs can facilitate the implementation of evidence into practice regarding ADR reporting if carried out with proper planning and interdepartmental partnership. 
 

Conclusions and learnings
The key successes of this partnership can be attributed to:

• involving high-level stakeholders (decision-makers) during the project's implementation, which sped up and facilitated the process
• having partners with similar goals
• cooperation of the process owners during the project to effectively identify defects and barriers
• the involvement of process owners in identifying and removing barriers to motivate them to participate in the project implementation.

Authors

Amin Talebpour¹, Neda Kabiri¹, Sakineh Hajebrahimi¹.
 

1. Iranian EBM Centre: A JBI Centre of Excellence

References
1. Pourseyed S, Fattahi F, Pourpak Z, Gholami K, Shariatpanahi SS, Moin A, et al. Adverse drug reactions in patients in an Iranian department of internal medicine. Pharmacoepidemiology and Drug Safety. 2009;18(2):104-10.

2. Izadpanah F, Amini M, Asadollahpour A, Esfahani Z, M Y. Adverse Drug Reactions in Mazandaran Province, Iran, 2004-2018. Journal of Mazandaran University of Medical Sciences. 2020;30(185):96-103.
 

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