Pharmacovigilance Overview, Regulations, Guidelines, and Goals

What is Pharmacovigilance (PV)?

The World Health Organization (WHO) defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.

Pharmacovigilance is a medical discipline that is crucial in preventing medicine-related adverse effects in humans, promoting patient safety, and the rational use of medicines.

After a medicine is authorized for use, it may be used by a large number of patients, for a long period, and with other medicines. Some side effects may arise in such situations. So, the safety of medicines must be monitored throughout their use in healthcare practice. Hence the need for a pharmacovigilance system. The supervision of a drug from clinical trials and after is called pharmacovigilance. It is the process of standing guard of a medicine.

There are three big parts to Pharmacovigilance.

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

Investigating
After receiving a report, comes the investigation to get the complete picture of the information as possible through detailed examination about medical history, medical conditions, medications, treatment, and response to the treatment.

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

What is a PV system?

It is a system used by an organization to accomplish its legal tasks and responsibilities about PV that monitors the authorized medicine's safety and detects changes to risk-benefit balance.

The Scope of Pharmacovigilance

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

Products covered by Pharmacovigilance include

• Medicines
• Herbals
• Biologics
• Medical devices
• Blood products
• Vaccines
• Traditional and complementary substances

Pharmacovigilance Goals

The goal of Pharmacovigilance is to enable 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
It refers to collecting and managing raw data about patient safety for transforming it into useful information

Describing the Data It refers to organizing and providing meaningful, valuable, and relevant data for improved patient safety.

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

Decision
It refers to supporting improved practices by healthcare professionals and patients to ensure informed and sound therapeutic decisions.

Regulatory Authorities and Their Expectations

Each country has a respective drug regulatory authority.

The European Medicines Agency (EMA)

The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.

• EMA's Regulatory Information
• EMA's Marketing Authorization
• Module IV - Pharmacovigilance audits (Rev 1)
• Module V - Risk management (Rev 2)

The US Food and Drug Administration (US FDA)

The US FDA is responsible for ensuring that medicinal products including biological, vaccines and over the counter (OTC) drugs and medical devices are safe and effective for human use.

The Federal Food, Drug and Cosmetic Act (FDCA) and the FDA Code of Federal Regulations (CFR) Title 21 outlines the requirements for drugs and medical devices. These are divided into several subchapters which are to be adhered to at a federal level and individual state levels.

• FDA's Guidance document on GVP
• FDA's Misconceptions about ADR reporting
• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

In 2014, the EMA and US FDA formed a "cluster" relationship aimed at sharing data, research and coordination of other activities. Such a collaborative process for information sharing is noteworthy.

Health Canada

In 2004, the Canadian Health officials implemented GVP. The Health Products and Food Branch Inspectorate outline several requirements about adverse event reporting of adverse drug reactions and post-approval expectations when conducting inspections.

• Health Canada's GVP Guidelines
• Health Canada's Risk Classification and GVP

International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.

Pharmacovigilance Webinars and Seminars

FDA and MHRA Pharmacovigilance Inspection Readiness and Management

This webinar provides pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and quality and compliance groups in the pharmaceutical industry would benefit from development tips discussed in this session as well.

Scheduling and Conduct of Good Pharmacovigilance Practice Audits

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

This two-day workshop conference will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan.

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