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January 14, 2026
Approximately 5 minutes
Medsafe Safety Communications for Medicines and Medical Devices
Medsafe Safety Communications for Medicines and Medical Devices
1. Purpose of Safety Communications
Medsafe uses safety communications to promptly share important new safety information about medicines and medical devices with healthcare professionals, consumers, and other stakeholders. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp These communications help ensure safe and effective use by highlighting emerging risks, changes in benefit-risk balance, or recommended actions to mitigate harm. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
2. Types of Safety Communications
Medsafe issues several types of safety communications:
- Alerts — Urgent notifications about serious safety issues requiring immediate attention or action.
- Dear Healthcare Professional (DHCP) letters — Targeted communications sent directly to prescribers, pharmacists, and other healthcare providers detailing specific risks, updated prescribing information, or management recommendations.
- Consumer Medicine Information (CMI) updates — Revised patient information reflecting new safety data or advice.
- Prescriber Updates — Periodic newsletters or summaries providing broader safety information for healthcare professionals.
- Medicine and Device Safety Communications — General announcements or summaries of international safety signals relevant to New Zealand.
Each communication includes a date, reference number, and details on the affected product(s) and recommended actions. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
3. Content and Distribution
Safety communications typically include:
- Description of the safety issue or emerging signal
- Affected products (including brand names, active ingredients, or device types)
- Evidence or source of the concern (e.g., adverse event reports, international regulatory actions)
- Recommended actions for healthcare professionals and/or patients
- Contact information for further questions
Communications are published on the Medsafe website and may be emailed to healthcare professionals or distributed through professional networks. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
4. Triggers for Communications
Medsafe issues communications based on:
- New adverse event reports or trends identified through the Centre for Adverse Reactions Monitoring (CARM)
- International safety alerts from regulators such as TGA (Australia), MHRA (UK), FDA (USA), or EMA
- Sponsor notifications of field safety corrective actions or significant risk findings
- Periodic benefit-risk assessments or post-market surveillance data
The decision to communicate depends on the seriousness of the issue, public health impact, and need for risk mitigation. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
5. Stakeholder Responsibilities
Healthcare professionals are expected to:
- Read and act on safety communications relevant to their practice
- Report suspected adverse reactions or device incidents to CARM
- Discuss new safety information with patients when appropriate
Consumers and patients are encouraged to report any concerns and follow updated advice provided in communications. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
6. Access to Communications
All current and archived safety communications are available on the Medsafe website under the Safety Communications section. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp Users can browse by date, product type (medicine or device), or issue category. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
This transparent communication approach supports informed decision-making and contributes to ongoing medicine and medical device safety in New Zealand. https://www.medsafe.govt.nz/safety/SafetyCommunications.asp
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