A Beginner’s Guide to Adverse Event Reporting in Pharmacovigilance

Pharmacovigilance (PV) is a vital aspect of healthcare, and adverse event reporting is a critical component of it. Adverse drug reactions (ADRs) are increasingly common and significantly cause morbidity and mortality. Adverse drug reactions are a well-recognized public health problem and a major cause of death and hospitalization in developed countries. The safety of a new drug can only be established once it has been on the market for several years. Therefore keeping drug reactions under surveillance through PV systems is indispensable. However, underreporting is a significant issue that undermines the effectiveness of spontaneous reports. This article will provide a beginner’s guide to adverse event reporting in pharmacovigilance, including what it is, who can report, how to report, and why it’s essential.

What is Adverse Event Reporting?

Adverse event reporting refers to the collection and analysis of information on undesirable medical occurrences associated with the use of a particular drug. These events may or may not be caused by the drug. Still, it’s important to report them so that potential safety issues can be identified and appropriate measures taken to ensure patient safety. Reporting ADRs is the cornerstone of detecting uncommon ADRs once the drugs are on the market. In many countries, ADR reporting is regulated by national regulatory agencies, and various methods are employed to report ADRs.

What is an Adverse Drug Reaction (ADR)?

An Adverse Drug Reaction (ADR) is an unintended and harmful response to a medication or drug. It can occur at the recommended drug dose or when a drug is taken improperly or in combination with other medicines. Historically, ADRs have been classified as type A or type B. Type A reactions, associated with high morbidity and low mortality, are predictable from the known pharmacology of a drug. Type B reactions, associated with low morbidity and high mortality, are idiosyncratic or novel responses that cannot be predicted from the known pharmacology of a drug. Additional classes have been developed for ADRs that do not fit into the type A and B categories. These include type C (continuing), type D (delayed use), and type E (end of use) reactions. Age, gender, disease states, pregnancy, ethnicity, and polypharmacy influence ADR susceptibility.

Who Can Report Adverse Events?

Reporting adverse events in PV is not limited to healthcare professionals. Patients, caregivers, or anyone with knowledge of an adverse event associated with a drug can report it. In fact, anyone who knows an adverse event associated with a drug can report it. Additionally, drug manufacturers are obligated to report any adverse events they become aware of, regardless of whether or not the event was reported by someone else. Therefore, adverse event reporting is a collaborative effort involving multiple stakeholders, all aiming to ensure patient safety.

How to Report Adverse Events?

Adverse events can be reported to national PV centers or the drug manufacturer. In many countries, there are also online reporting systems available. For example, Canada was the first country to implement a patient reporting system in 1965. Denmark is the first EU Member State to introduce direct patient reports since 2003. In the United Kingdom, the Yellow Card scheme is a pharmacovigilance program managed by the Medicines and Healthcare Products Regulatory Agency (MHRA). The Yellow Card scheme plays a crucial role in continuously monitoring drug safety in the UK. Including as much relevant information as possible when reporting an adverse event is essential. This includes patient demographics, drug name, dosage, event details, and appropriate laboratory or diagnostic data.

Why is Adverse Event Reporting Important?

Adverse event reporting is essential to patient safety. It helps identify potential safety issues with drugs and allows for implementing appropriate measures to ensure patient safety. It also contributes to the ongoing monitoring of the safety of drugs already on the market.

What Happens After an Adverse Event is Reported?

Pharmacovigilance experts analyze the reported adverse event information to determine if further investigation is necessary. If deemed necessary, the drug manufacturer may need to take action, such as updating the drug’s label or issuing a recall.

Conclusion

Adverse event reporting plays a crucial role in PV, which is responsible for monitoring and ensuring the safety of drugs. As PV experts, we regularly discover ADR case reports through our DrugCard platform, providing valuable insights into drug safety. However, it’s important to note that anyone can report an adverse event, and providing as much relevant information as possible is essential. Reporting adverse events can identify potential safety issues with drugs and enable appropriate measures to ensure patient safety. By adhering to the guidelines outlined in this article, you can make a valuable contribution to the ongoing monitoring of drug safety, and help ensure that patients receive the safest and most effective treatments possible.