The field of Pharmacovigilance focuses on quality of a drug, adverse effects associated with it, and medication errors, impacting the health care system. According to the definition put forward by WHO, pharmacovigilance can be defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem”.
For the uninitiated, pharmacovigilance is the constant process which involves identification and monitoring of the safe use of pharmaceutical products. The process thus helps minimize the risk of possible harm coming to the patients. As a part of their duty, Pharma Companies are compelled to conduct a pharmacovigilance and comprehensive drug safety audit to see if the proposed product is compliant with FDA guidance, and worldwide laws and regulations.
This article discusses few challenges to Pharmacovigilance –
1. Inconsistent reporting of the adverse effects
The biggest challenge of pharmacovigilance is the inconsistent reporting of the adverse effects. It is important to understand that adverse effects associated to a drug or a medical device may occur not only during a visit to the Healthcare Center, but even after a few hours after the drug adminstration. Patients often fail to remember or notice adverse events experienced and this leads to inconsistent reporting. There are other cases where the patients feel anxious and report discomfort as adverse events. Such wrong reporting leads to incorrect conclusions which further result in the withdrawal or suspension of drugs.
2. Challenges of spontaneous reporting
Patients or drug companies may voluntarily come forward to report adverse events, but under-reporting impact the post-marketing databases. It may also be observed that medical staff neglect reporting and avoid reporting the symptoms which they feel are not serious. This can sometimes lead to delay in the focus towards potential serious adverse events (which might differ from patient to patient) that require immediate action. When the effects of a drug or medical device are not reported spontaneously, then there may be a problem while marketing and distribution.
Another major problem in pharmacovigilance is due to miscoding and misreporting of the adverse events. The field of pharmacovigilance is all about formulations, dosage, time and length of the exposure to adverse effects, and when these elements aren’t reported properly, it becomes difficult to manage and analyze the data. This may also result in false alarms for adverse effents that are non-existent.
3. Priority of efficacy over safety
Smaller or new age drug companies tend to focus more on efficacy over safety during clinical trials and this results in the compromise in drug quality. It is important for such companies to understand that drug development depends on the balance between efficacy and safety.
4. Limitations in Published case reports
The best way to alert about the adverse effects of drugs or medical devices is by publishing detailed reports in medical journals. This is an efficient way to convey suspected adverse effects and drug hazards. However, only a small number of such cases are published, and the reports published regarding them are poorly documented. There are a few cases where there are delays in reports indicating the publication and occurrence of adverse events.
Pharmacovigilance as a career path offers bright future. The field has a lot of demand and it is evolving by the day. Hyderabad, the city known for being professional hub, hosts several pharmacovigilance training centers in its heart land – Ameerpet. For people looking for the best pharmacovigilance training center in Hyderabad, Joshi Medicode is the right place to get trained.
Along with the best pharmacovigilance training, Joshi Medicode also offers medical coding and billing courses including ICD-10 and Clinical SAS courses.