Understanding the Different Methods Used in Pharmacovigilance Practices

Pharmacovigilance is a pharmacological science or activities that monitors the effects of drugs after they have been approved for use, specifically to detect, assess, and understand previously unreported adverse reactions of the drugs. Increase in the incidences of drug consumption on the coattails of high prevalence of acute as well as chronic diseases is leading to rise in the number of drug toxicity cases and adverse drug reactions (ADRs). This has led to surge in the need for pharmacovigilance. Further, pharmaceutical companies are relying on the various outsourcing services of drug monitoring due to stringent safety regulations and risk of high-profile safety issues of the drugs.

Importance of Pharmacovigilance in Drug Development

The field of drug safety has been gaining a great deal of attention lately. Pharmacovigilance is one of the most crucial activities of pharmaceutical industry and it must adhere to strict regulations to develop, manufacture, and commercialize a drug. This process ensures doctors together with patients to have enough information to make a rightful decision in choosing a drug for treatment. Many of the regulations are focused on patients’ safety and added advantages to the patient derived from the drugs. In pharmacovigilance, drugs are continuously being monitored to detect other side effects on the patient and any new data is collected and informed to health authorities on a regular basis. On detection of any adverse drug reactions, development process of the particular drug is stopped or an approved drug is pulled from the market.

Large-scale self-medication by wide range of population across the globe have increased the need for creating awareness and leveraging pharmacovigilance practices for herbal medicines. Due to its natural origin, safety element associated with herbal medicines are often overlooked. However, use of wrong species of medicinal plants by healthcare providers and consumers can have adverse effects and hence requires pharmacovigilance system to monitor the medicines. In addition, interaction with other medicines and contamination of the products with heavy metals, agrochemical residues, pathogenic microorganisms, and others may worsen the quality of the drugs. Therefore, it is important to collect reliable information of these drugs to develop appropriate safety and efficacy guidelines.

Different Reporting Methods Used in Pharmacovigilance

In a recent market intelligence study published by Future Market Insights (FMI), based on the type of reporting methods, pharmacovigilance market is segmented into five different methods.

  • Spontaneous Reporting

It is the primary method for collecting post-marketing information on the safety of drugs which detects the signals of new, rare, and serious adverse drug reactions. Spontaneous reporting is used by pharmaceutical companies to collect information of their drugs. This system monitors all drugs on the market over the entire life cycle at relatively low cost. If a patient suspects that an unfavorable medical condition may have happened due to exposure to a particular drug, he/she can report the condition to a pharmacovigilance center. Spontaneous reporting is the most common method used in pharmacovigilance which cost-effective, easy to establish, covers entire population, and requires least workforce. However, it represents only suspected ADRs and becomes difficult to detect delayed ADRs with high background incidence.

  • Intensified ADR Reporting

Intensive reporting monitors specific medicines during a certain period of time in early post-marketing phase which distinguish from spontaneous reporting. It provides real clinical data without inclusion or exclusion criteria throughout the collection period. Intensified ADR reporting is also used for monitoring medicines with new active substance, biological medicines, and drugs that require additional studies. One of the advantages of this methodology is to identify signal for events that were not necessarily suspected as an ADR of the drug.

  • Targeted Spontaneous Reporting

This method is used to enhance reporting of ADR related to antiretroviral therapy (ART). It focuses on treatment-threatening ADRs to promote change or discontinuation of the treatment.

  • Cohort Event Monitoring

Cohort event monitoring is adopted for new class of medicine, drugs relating to a class of medicine that has previously caused ADRs, and potentially significant adverse event detected during pre- or post-marketing phase. It records all clinical events to enable long-term and widespread use of the drugs. With cohort event monitoring, a pharmaceutical event can detect signals of unrecognized reactions, identify interactions with other medicines and detect risk factors of ADRs.

  • EHR Mining

Also known as electronic health records mining which offers a rich source of ADR data. It makes use of the existing records to enhance the pharmacovigilance system. HER mining is a potentially emerging method for post-marketing drug safety surveillance

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About the Author

Sabyasachi Ghosh

Sabyasachi Ghosh is an experienced market research analyst and consultant, with over six years of experience in end-to-end project management. He has worked at numerous leadership positions and has a vast experience of compiling high-quality market research reports. Sabyasachi is an authoritative voice in the market research sector, and has been cited in top industry publications. He is a travel junkie, and loves to travel far and wide with his friends.

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