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Medicine Safety & Pharmacovigilance

Many Public Health Programmes (PHPs) involves the direct administration of medicines to large populations and communities for the prophylaxis, treatment and/or eradication of diseases. A large number of patients who will receive the drugs in a systematic manner in these programmes generates the possibility of harm if unmonitored and, at the same time, an opportunity to develop systems for generating valid and valuable data that will assist in decision making. PHPs and Pharmacovigilance (PV) can derive mutual benefits from each other; PV and adverse drug reactions monitoring in PHPs can detect rare adverse events and risk factors in patients and can have a tremendous positive impact on the implementation and success of these programmes; PHPs, on the other hand, can provide an opportunity to introduce PV in countries that lack a system for drug safety monitoring. Safety issues that are specific to various disease-control programmes (HIV/AIDS, Malaria, Tuberculosis, etc) are being addressed through different Projects.

SGT University, Gurugram had organized a workshop on the theme “Medicine Safety & Pharmacovigilance” on 16th January 2019. This seminar was sponsored /supported by the Pharmacovigilance Programme of India (PvPI) Indian Pharmacopoeia Commission (IPC), Govt. of India. More than 200 registered delegates from various Medical and Pharmaceutical institutions of the region participated in the event.

The workshop was inaugurated at the hands of Chief Guest Dr. G N Singh (Director, Indian Pharmacopoeia Commission and Ex-Drugs Controller General of India), Dr. Y K Gupta (Former Dean Academics, AIIMS: National Scientific Coordinator & Advisory PvPI), Dr. Jai Prakash (Senior Principal Scientific Officer, IPC, In Charge PvPI) along with Dr. Sham Lal Singla (Pro-Chancellor – SGT University), Prof. Gurpreet Singh Tuteja (Pro Vice-Chancellor – SGT University), Dr. Kamlesh Kohli (Director, Medical Sciences), Dr. Sansar Chand Sharma (Dean, FMHS) and Dr. Poonam Salwan (Co-coordinator PvPI, AMC, FMHS).

Dr Y K Gupta emphasized the objectives of Pharmacovigilance and PvPI. He expressed the key role of Pharmacovigilance in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects on human. He informed that pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during the development of drugs such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance.

Dr G N Singh illustrated that such type of workshops is aimed to strengthen the Pharmacovigilance system. The core objectives of such events are to cater the current issues and challenges for reporting of adverse drug reactions at ADR monitoring at various level. He mentioned that Pharmacovigilance improves patients care and safety in relation to the use of medicines and also plays a major role in clinical practices and the development of public health policy. He said that continuous monitoring of drug effects, side effects, contraindications and outright harmful effects which could result in a high degree of morbidity, and in some cases, even mortality, are essential to maximize benefits and minimize risks.

Dr Jai Prakash highlighted that no degree of care and caution at the pre-clinical and clinical testing stages can guarantee absolute safety when a drug is marketed and prescribed to large populations across the country and outside. Because clinical trials involve several thousands of patients at most, less common side effects and ADRs are often unknown at the time a drug enters the market. Postmarketing Pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.

Dr Pooja Gupta focused on Materiovigilance & Haemovigilance and the responsibilities of drug regulatory agencies, to monitor ADRs during the drug development phase and later during the lifetime. She said that materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient’s health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines.

Dr Sughir Sarangi elaborated that focused Pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety. It is a challenge to codify and standardize the act of signal detection and risk management in the context of clinical trials and post-marketing Pharmacovigilance.

Dr N C Arora revealed that despite the availability of adverse drug reactions (ADR’s) reporting systems, patient safety net and many databases; Pharmacovigilance needs to be incorporated as part of this electronic database (not isolated) such as electronic prescribing, physician-decision matrix (order-entry) and patient profile systems. The advantage of such a trend is not just an added icon or drop-menu, it is a complete surveillance system that encompasses the essence, value and supportive nature of Pharmacovigilance data blended with patient clinical health outcomes.

Dr Suma highlighted the role of the dentist in Pharmacovigilance. She said that as a large number of dentists are using various drugs during treatment of dental problems. But various studies performed on dentist shows that there is a negligible role of the dentist in Pharmacovigilance programme. She also emphasized that dentists have a good attitude towards the practice of reporting ADR. But unable to report ADR due to lack of knowledge, lack of training of ADR reporting, non-remuneration of reporting, difficult to decide whether ADR has occurred or not.

Dr Vijay Sharma mentioned that pharmacists are not mere preparing or dispensing of drugs. The professional practice reaches far beyond serving a community. Pharmacists have an important responsibility in monitoring the on-going safety of medicines as part of their professional practice. Pharmacists can create a trusted environment by counselling patients to reduce medication errors, improve safety and quality of care. The pharmacist has the potential of reporting ADRs on their own, though his/her clinical experience may vary with respect to that of a physician. The process of Pharmacovigilance program can be a success when effective risk information is communicated back to the health-care workers. Pharmacist role in Pharmacovigilance varies from country to country, but the professional responsibility is the same regardless of jurisdiction.

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