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Pharmacovigilance basically targets safety of medicine. Pharmacists play crucial roles in health systems in maintaining the rational and safe use of medicines since they are drug experts who are specifically trained in this field.

Pharmaceutical drugs are a valuable part of patient care throughout the world. For doctors to adequately care for their patients, drug safety must be monitored and reported from initial testing to everyday use.

The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analysing which side effects are worth the risk to patients compared with how effective they are at treating a disease.

This is the world of pharmacovigilance.

The scope of BGM’s Pharmacovigilance processes includes but is not limited to:

  • Adverse Event Reporting
  • Individual Case Safety Reporting
  • Coding of Averse Events Reporting
  • Seriousness Determination Reporting
  • Risk Management
  • Causality Assessment
  • Risk Management Plans
  • Risk/benefit profile of drugs
OUR RESEARCH

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation).

Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.

Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.

In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority such as SAPRHA.

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.

BGM Pharmaceuticals conducts comprehensive drug safety and pharmacovigilance audits to assess our compliance with local laws, regulations, guidance and legislation.

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. … Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems.

The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analysing which side effects are worth the risk to patients compared with how effective they are at treating a disease.

Both refer to the same function – of gathering and reporting adverse drug reactions. The main difference between ‘Drug Safety’ and ‘Pharmacovigilance‘ lies in the value of the data generated. … The Pharmacovigilance model takes drug safety to another level.