In the late 1950s, a drug called thalidomide, given to pregnant women for morning sickness led to thousands of babies being born a serious birth defect called phocomelia (rare congenital deformity in which the hands or feet are attached close to the trunk, the limbs being grossly underdeveloped or absent).
After this incidence the regulatory bodies have founded adverse event reporting system to make sure this tragedy would never be repeated. These system encourage healthcare professionals (clinicians, dentist, pharmacist, nurse and other HCPs) to report serious or unknown adverse drug reactions (ADRs) experienced by patients.
Adverse drug reactions are important causes of hospitalization and mortality worldwide. They decrease patients quality of life and may reduce their confidence in healthcare system.
Potential drug treatments are first tested on paper, in laboratory and eventually in thousands of people. Every drug that goes through this cycle carries some risk. The limitations of clinical trials mean that when a drug is first marketed, much may be known about its efficacy while relatively less may be known about its safety profile. Therefore post-marketing surveillance is essential to help identification of drug safety problems not detected during pre-marketing evaluation. The safety profile of a drug relies on both evidence from clinical trials and postmarketing data.
Collecting adverse events helps to generate a signal regarding any new adverse event associated with a drug and also it helps to judge the health risk associated with it depending on the severity of the event. This may lead to change in reference safety information (updating contraindications, warnings, precautions, use in special populations) and depending on benefit-risk analysis, may also be responsible for withdrawal of drug from market.
Hence it is extremely important to be aware of adverse reporting system among healthcare professionals regarding diagnosis, prevention, and reporting of adverse event reports.
The nurses and physicians are more likely to become aware of adverse events that occur while providing care to a patient in a hospital or clinic setting. However, adverse event reporting by pharmacists is increasingly feasible because of their close work with patients and physicians in the hospital setting where the pharmacist has access to the patient’s medical chart and laboratory results.
When prescribing medication, physicians should inform patients that should they suffer any reaction to a medication, they should inform the prescribing doctor and / or report to national regulatory authorities or to manufacturer.
Pharmacists in clinical settings are able to access patient information that allows them to monitor and report adverse events that occur. In the retail setting, pharmacists may become aware of a potential adverse event while counseling or interacting with patients. These pharmacists have access to patient information and drug therapy regimens, which can contribute greatly to the reporting of an adverse event.
Spontaneous reporting of suspected adverse reactions is particularly useful in identifying rare or delayed reactions. It provides a system whereby the safety of a medicine can be monitored throughout its life cycle. Thus drug safety assessment should be considered an integral part of everyday clinical practice for healthcare professionals. It is essential for healthcare professionals to be aware of the toxicity profile of medicines, to be ever vigilant for the occurrence of unexpected adverse reactions and to report suspected adverse reactions to the Regulatory Authority in order to facilitate timely and accurate detection and assessment of drug safety signals.
If an event happened to one person then it could happen to others too, that’s why it is important to report to protect patient safety. Of particular importance are all suspected reactions to newly authorised products, serious reactions to established products, products undergoing additional monitoring and suspected reactions to vaccines or medicines used in pregnancy.
A barrier to Adverse event reporting is that healthcare providers do not prioritise reporting if they find the problem easily resolved. They fix the problem and forget about it, and no learning occurs. As per many studies it has also been shown that incidents are more likely to be reported if harm results.
Every report counts, One report of adverse event can change drug label/ marketing status of drug.
Quality of adverse event reports is equally important as reporting adverse events. Adverse event reports must include certain data elements like patients age, gender, adverse event terms, date when event occurred, treatment given for event, severity of event (hospitalized or death etc,), suspected medications and reporter details to qualify to be valid for reporting. The minimum required elements of an adverse event report include: (1) a reporter, (2) a patient, (3) an adverse event, and (4) a suspect product.
Education about adverse event reporting is important for pharmacy students so that by the time they become practitioners, they are well acquainted with the relevance and importance of adverse event reporting.
Detailed guidelines on how to report ADR and the required information, is available in country specific guidance documents. Here are few links for spontaneous adverse event reporting system.
Yellow card scheme – UK MHRA
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