LEPTOSPIROSIS

 

PHARMACOVIGILANCE: AN OVERVIEW

What is Pharmavovigilance?

It is pharmaceutical science relating to the collection, detection, monitory assessment, and prevention of adverse events with pharmaceutical products. It is also known as Drug safety. The roots of this word PHARMACOVIGILANCE are Pharmacon (Greek word for drug) & Vigilare (Latin word to keep watch).

Pharmacovigilance (PV) mainly focuses on ADR (adverse drug reactions), which identifies any hazards associated with pharmaceutical products and minimizes the risk of any harm to patients.

There are three main topics of Pharmacovigilance –

1. Monitoring
   Keeping track of adverse events from healthcare providers and patients about any new adverse events and potential side effects that emerge.

2. Investigating
   To get the complete picture of the information through detailed examination about medical history, medical conditions, medications, treatment, and response to the treatment.

3. Communicating
   Sharing of adverse events with health authorities and updating of labels when the balance of benefit of risk is changed.

The Scope of Pharmacovigilance (PV)

The WHO includes the following as the scope of Pharmacovigilance

• ADRs or events

• Medication errors

• Counterfeit or substandard medicines

• Lack of efficacy of medicines

• Misuse and/or abuse of medicines

• Interaction between medicines

Pharmacovigilance includes following products –

• Medicines

• Herbals

• Biologics

• Medical devices

• Blood products

• Vaccines

• Traditional and complementary substances

Pharmacovigilance (PV) Goals

The main goal of PV is to promote the safe and effective use of health products, in particular by providing timely information about the safety of health products to patients, health-care professionals, and the public. PV is therefore an activity contributing to the protection of patients and maintaining public health which enables better decisions about therapy for patients and healthcare professionals. It begins with collecting data and transforming that into information that should serve to build better knowledge about therapeutic decisions.

Data collection in PV - to collect and manage raw data about patient safety for transforming it into useful information

Describing the Data - to organize and providing meaningful, valuable, and relevant data for better patient safety.

Explaining the Data - to the understanding of the data through analysis, interpretation, and communication

Decision - to support improved practices by healthcare professionals to ensure informed and sound therapeutic decisions.

Methods of Pharmacovigilance (PV)

1. Passive surveillance

Passive surveillance methods involve the usage of spontaneous adverse event reports voluntarily sent by healthcare professionals or patients to the marketing authorization holder or regulatory authority.

2. Active surveillance

Treatment plan that involves closely watching a patient’s condition but not giving any treatment unless there are changes in test results that show the condition is getting worse.

3. Comparative observational studies

The purpose of a comparative observational study is to determine if there is a difference in measurements between groups of individual subjects. An observational study does not inflict a treatment on the subjects — it observes them as they are.

4. Targeted Clinical studies

Targeted clinical studies are studies in which a pre- specified subgroup of patients, often based on biomarker, is identified (“targeted”) for special attention.

Type of report in Pharmacovigilance

1. Individual Case Safety Report –

One of the fundamental principles of adverse event reporting is the determination of what constitutes an individual case safety report. During the triage phase of a potential adverse event report, it is important to determine if the "four elements" of a valid individual case safety report are present:

• An identifiable patient

• An identifiable reporter

• A suspect drug

• An adverse event

2. Expedited reporting –

An Individual Case Safety Report (ICSR) may involve a serious or non-serious adverse reaction – regardless of expectedness. The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of new, important information on serious reactions. 

3. Clinical trial reporting –

These trials aim to study the drug as administered to patients who already have the disease which the drug may have the potential to treat. The objective is to determine the optimal dose and dosing regimen, one which delivers maximal efficiency alongside acceptable adverse effects.

4. Spontaneous reporting –

Spontaneous reporting is an inexpensive, flexible and very effective method of collecting information whereby health professionals voluntarily submit case reports of ADR; pharmaceutical companies or consumers to the national Pharmacovigilance centers for evaluation in order to mitigate the impact of ADR on society.

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5. Aggregate reporting –

Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product's life cycle (during the pre-marketing and post-marketing phase) to provide a comprehensive view of the drug's safety profile.

Conclusion

Pharmacovigilance is essentially based on the qualitative and quantitative study of spontaneous adverse drug reaction reports, followed by a clinical assessment/judgment with regard to its impact on the overall safety profile of the drug.

Name – Ankita Pai

Qualification – M.Sc

Clinosol ID: 194/1122