Pharmacovigilance is a mix of two words Pharma which denotes the Pharmaceutical or drug industry and vigilance which refers to the state of being careful or watchful for possible danger.
It is concerned with the safety and efficacy of a drug. As it touches the entire drug lifecycle from preclinical development to post-market surveillance, it can be considered as a fundamental function to drug development.
Dealing with an adverse event
An adverse event refers to the reaction occurring in a patient’s body due the possible side effect of a drug. A side effect can be life-threatening which can cause incapacity, permanent damage or even the death of a patient.
Pharmacovigilance plays a crucial role in determining which adverse events are caused by a drug and which side effects are considered acceptable with respect to the potential cure for a patient.
If a drug used to treat headache can cause palpitations, the risk would be considered too great and the benefit unsubstantial to justify the drug treatment.
Areas covered by Pharmacovigilance
Though a huge discipline, pharmacovigilance can be divided into three sub-sections:
This is the area associated with the collection and recording of information about preclinical and clinical trial development. Typical jobs of life science professionals involve drug safety operations.
Besides gathering evidence of adverse events, the operational part includes creation of a standard operating procedure, literature screening, case study reports and required regulatory reporting.
It involves data analysis and focuses more on risk management and signal detection. Professionals in this area can assist in the creation and review of reports relating to safety update for drugs in clinical research and periodic risk benefit evaluation reports.
This area is concerned with development of a robust system for housing safety data. This safety data is collated with the focus on staying in line with the changing rules and regulations for business/health authorities.
Importance of Pharmacovigilance
Pharmacovigilance is unarguably the most essential function of drug development. Developing, manufacturing, and commercializing a drug requires strict adherence to regulations. These regulations focus on the patient’s safety and drug efficacy.
- Patient safety
Drug safety ensures that a patient’s well being is safeguarded through the lifecycle of drug development. Drugs are continuously monitored for patient side effects, and any new data is collected & reported to health authorities. While other areas focus on improving a patient’s life, no other area has such a focus when it comes to patient safety.
- Authority and responsibility
Continuous vigil means that the leadership team of a drug safety department has the authority and responsibility to recommend that a drug development process is stopped or an already approved drug is pulled out of the market. These professionals are also known as Qualified persons for Pharmacovigilance and again go on to demonstrate the central role of drug safety.
Keep the Pharma company moving
Pharmacovigilance keeps the wheels of the Pharma industry moving. Drug safety influences health and has the capability to influence the business of Pharma companies.
The future of Pharmacovigilance
Pharma companies have historically controlled the information about drugs and their range. However, adoption of sensors, wearables and digital services has weakened this control.
Incorporating digital technology offers Pharma companies the opportunity to deliver efficiency, speed and quality of the pharmacovigilance process. The combination of patient generated health data and machine learning models offers the chance to generate accurate insights and improve drug safety & efficacy.
Pharma companies can exploit this opportunity with the right offshore partner to manage the significant pharmacovigilance shift, changes in legislation and safety of user data.
Pharmacovigilance will continue to play an influential part in new drug development and forms the core of the life science mission. As the world battles with pandemic and rising lifestyle diseases, the role of pharmacovigilance is bound to play a crucial oversight role.Contact Us