DRAP Guidelines on National Pharmacovigilance System: Safety Communication and Risk Minimization

Table of content

The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of healthcare products, has published a new revision of the guidelines on the national pharmacovigilance system. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. 

At the same time, the authority reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.

Safety Communication

According to the guidance, safety communication refers to strategies used to inform stakeholders (patients, healthcare professionals, and the public) about the risks, safe usage, and updates regarding therapeutic goods. 

Its primary goals are:

• Promoting the rational, safe, and effective use of therapeutic goods.
• Preventing harm from adverse reactions and minimizing risks.
• Protecting public health.

Safety communication includes various forms of information, such as statutory details in prescribing information (e.g., summaries of product characteristics [SmPC], safety specifications, and package leaflets).

CIOMS Definition (2010): Signals represent new or potentially causal associations, or novel aspects of known relationships, between an intervention and an event. These signals warrant verification for further action.

Content of Safety Communication

As further explained by the authority, effective safety communication must include:

• New, significant safety information.
• Reasons for issuing the communication.
• Recommendations for healthcare professionals and patients.
• Changes to product information (e.g., SmPC or package leaflets).
• Additional guidance for therapeutic good usage.
• References to relevant literature.
• Reminders about adverse drug reaction (ADR) reporting protocols.

Characteristics of Effective Communication:

• Timely dissemination.
• Targeting appropriate audiences.
• Use of suitable language and communication channels.
• Clarity and accuracy.
• Contribution to risk minimization and trust-building.

Responsibilities of NPC, DRAP

The National Pharmacovigilance Centre (NPC) under the Drug Regulatory Authority of Pakistan plays a central role in safety communication. 

Its responsibilities include:

• Issuing therapeutic goods safety alerts, advisories, newsletters, or public updates via various platforms (websites, social media, email, or printed materials).
• Collaborating with stakeholders such as the World Health Organization (WHO) for global and regional safety updates.
• Recommending risk minimization actions and regulatory changes, such as adding contraindications, adjusting dosages, or revising indications.
• Ensuring consistency and accuracy in safety-related information published by other stakeholders.

Target Audiences for Safety Communication

Under the general rule, primary audiences of safety communication include:  

• Healthcare Professionals (HCPs): Their role is crucial in ensuring therapeutic goods are used safely. HCPs rely on accurate safety information to mitigate risks and provide informed care to patients.
• Patients and Consumers: Direct access to safety information builds confidence in the regulatory system and helps patients use therapeutic goods appropriately.

Additional Audiences:

• Media organizations, which serve as amplifiers to reach broader audiences.
• Healthcare professional organizations, which act as intermediaries for disseminating safety updates.

Means of Safety Communication

Communication Channels Used by NPC-DRAP:

1. Direct Healthcare Professional Communication (DHPC): Personalized letters to healthcare professionals detailing urgent safety concerns and actions required.
2. Documents in Lay Language: Simplified information, such as FAQs, to help patients and the public understand safety concerns and regulatory decisions.
3. Press Communication: Includes press releases and briefings, ensuring consistent and accurate dissemination of information through media outlets.
4. Website Updates: A key platform for up-to-date safety alerts, newsletters, and pharmacovigilance system updates.
5. Social Media and Online Tools: Platforms like Facebook, Twitter, and LinkedIn are leveraged for rapid dissemination while maintaining accuracy.
6. Therapeutic Goods Safety Alerts: Issued for newly detected safety concerns, these alerts are shared on websites and other platforms.
7. Newsletters: Periodic publications that summarize updates on safety and regulatory statuses, serving both local and global audiences.
8. Inter- and Intra-Country Communication: Collaborations with provincial centres, regional regulatory bodies, and global organizations like WHO to ensure timely sharing of safety concerns.
9. Advisories: Recommendations tailored to address safety, quality, and availability issues, disseminated after regulatory approval.
10. Public Enquiries: Responses to public questions via channels like the Pakistan Citizen’s Portal, ensuring informed and relevant guidance.

Risk Minimization Measures

Risk minimization measures are proactive steps to reduce the occurrence or severity of adverse reactions linked to therapeutic goods. These measures optimize safe and effective use across the life cycle of a product.

Objectives of risk minimization measures usually include:  

• Improve the risk-benefit balance by minimizing adverse events.
• Promote targeted patient selection and tailored therapeutic approaches.
• Provide necessary information to healthcare professionals and patients.

Types of Risk Minimization Measures

The document also describes the key measures to be considered by the parties involved in operations with healthcare products allowed for marketing and use in the country in order to minimize the risks.

1. Routine Risk Minimization Measures:  

Applicable to all therapeutic goods and involve:

• Detailed prescribing information (e.g., SmPC, package leaflets).
• Appropriate labeling.
• Pack sizes and legal statuses.
• Special or restricted medical prescriptions.

2. Additional Risk Minimization Measures:  

Required when routine measures are insufficient and may include:

• Educational Programs: For healthcare professionals and patients.
• Patient Alert Cards: Reminders about specific risks.
• Controlled Access Programs: Monitoring drug distribution and access.
• Pregnancy Prevention Programs: For teratogenic drugs.
• Direct Healthcare Professional Communication (DHPC): Immediate and direct guidance.

Key Considerations for Effective Safety Communication

The document also outlines the key success factors for safety communication:

• Reaching the appropriate audiences (HCPs, patients, media).
• Timeliness and accuracy in dissemination.
• Clarity in the language and recommendations provided.
• Accessibility through multiple platforms (websites, social media, printed materials).

At the same time, there are certain challenges to be taken into consideration, such as:  

• Managing public perception and media influence on safety concerns.
• Addressing misinformation or incomplete information in media reports.

A well-implemented safety communication strategy builds trust in the pharmacovigilance system, fosters rational use of therapeutic goods, and enhances patient safety.

Conclusion

In summary, safety communication and risk minimization measures form the cornerstone of an effective pharmacovigilance system. Through strategic dissemination of accurate and timely information, NPC-DRAP ensures healthcare professionals, patients, and the public are equipped to make informed decisions, thereby safeguarding public health. Effective communication, combined with robust risk minimization strategies, promotes trust in regulatory systems and the safe use of therapeutic goods in Pakistan.

Source

https://www.dra.gov.pk/wp-content/uploads/2024/10/NPVG-guidelines-reviewed-final-10-10-24.pdf

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