Pharmacovigilance (PV) at Roche

Summary

This video from Roche explains the critical process of pharmacovigilance, which ensures the safety of medicines both before and after they are approved for use. Pharmacovigilance involves monitoring, investigating, and communicating potential side effects or adverse events through reports from healthcare providers, patients, and publications. The data is carefully reviewed to assess the risk-benefit balance, with information shared with health authorities and continuously updated in the medication's label. Roche emphasizes its commitment to patient safety through global collaboration and ongoing vigilance in medicine usage.

Takeaways

• 🛡️ Roche prioritizes patient safety and continuously monitors the safety of their medicines post-approval.
• 🤝 Pharmacovigilance is a collaborative process involving Roche, healthcare providers, and health authorities.
• 📚 The European Medicines Agency (EMA) was established in 1995 to ensure the safety and efficacy of medicines.
• 🔍 Roche's pharmacovigilance process includes monitoring, investigating, and communicating about drug safety.
• 👥 Over 2000 people at Roche are dedicated to monitoring adverse events and maintaining patient safety.
• 📝 Reports of adverse events come from various sources including patients, caregivers, pharmacists, and doctors.
• 🔎 Once a report is received, Roche conducts a thorough investigation to understand the situation completely.
• 💬 Communication is key; adverse event reports are shared with health authorities and are accessible through a database.
• 🌐 All personal identification information is removed from reports to protect privacy, in line with local laws.
• 🔄 Roche constantly reviews and assesses reports to determine if the benefit-risk balance of a medicine changes.
• 📋 If a risk is identified, Roche updates the drug's label, also known as the package insert, and communicates this to healthcare providers.

Q & A

What is Roche's top priority regarding medicine?

Roche's top priority is ensuring that when patients take their medicine, they know what to expect from it, with a strong emphasis on safety.

What is pharmacovigilance and how does it relate to Roche?

Pharmacovigilance is the process of continuously monitoring the safety of medicines after they are approved and available for use. Roche partners with healthcare providers and health authorities to ensure the safety of their medicines through this process.

When was the European Medicines Agency (EMA) formed and what is its role?

The EMA was formed in 1995 and its role is to ensure that medicines are safe and effective by reviewing data from clinical trials.

How does a medicine get approved by health authorities like EMA?

A medicine gets approved if the data from clinical trials show that its known benefits outweigh its known risks.

What does the term 'pharmacovigilance' mean?

Pharmacovigilance is derived from the Greek word 'pharmakon' for drugs and the Latin word 'vigilantia' for wakefulness or watchfulness, meaning the process of standing guard over medicine.

What are the three main parts of pharmacovigilance at Roche?

The three main parts of pharmacovigilance at Roche are monitoring, investigating, and communicating.

Who are the sources of reports for Roche's pharmacovigilance team?

Reports can come from healthcare providers, patients, caregivers, pharmacists, doctors, or even publications.

How does Roche maintain confidentiality of the information gathered from adverse event reports?

Roche keeps the information from adverse event reports highly confidential, using it solely to gather information about the medicine.

What happens after an adverse event report is received by Roche?

After receiving a report, Roche conducts an investigation to understand the situation comprehensively, maintaining ongoing communication with reporters for up-to-date information.

How does Roche communicate with health authorities about adverse events?

Roche shares adverse event reports with health authorities, ensuring transparency and accessibility to everyone through databases like EudraVigilance, with all personal identification information removed.

What is the purpose of updating the drug label, also known as the package insert?

The drug label is updated when the balance of benefit to risk changes, providing important information about the medication and any new risks identified.

How does Roche create an ongoing understanding of a drug's safety in the real world?

Roche creates an ongoing understanding by reviewing and assessing all incoming reports globally, looking for patterns and updating the drug's benefit-risk profile accordingly.