WHO Global Surveillance and Monitoring System
The Global Surveillance and Monitoring System for SF medical products was launched in July 2013.
Objectives
Its objective is to work with Member States in improving the quantity, quality and analysis of accurate data concerning SF medical products, and to use that data in the better prevention, detection and response to those products, in order to protect public health.
- Improve reporting of SF medical products
- Assess more accurately the scope, scale and harm caused by SF medical products
- Provide immediate co-ordination and technical support in emergencies
- Issue medical products rapid alerts
- Gather and analyse a detailed body of validated evidence for Member States to enable evidence based policy making and investment
- Strengthen regional and national regulatory capacities to prevent, detect and respond to SF medical products
Following consultations with Member States, and building on the experience of an existing regional rapid alert system operating in the Western Pacific Region, WHO designed a global reporting system.
The system is designed for use by trained focal points in National Medicine Regulatory Authorities. Reports of SF medical products are submitted to the WHO via an electronic rapid alert form, currently available in English, French, Spanish and Portuguese languages.
Workshops
Workshops are usually held over 3 days and comprise of at least 4 exercises relating to real and recent incidents. The attendees are drawn from National Regulatory Authorities and usually represent inspectorates, enforcement Units, pharmacovigilance centres and quality Control laboratories. Participants are asked to complete the exercises and at the conclusion of each one to submit a report to the WHO system.
In Lagos, Nigeria from 17-19 April 2018, WHO conducted an African regional workshop for the officially nominated focal points on the Global Surveillance and Monitoring System (GSMS) for substandard and falsified (SF) medical products. Attended by participants from 38 African countries, the workshop focused on training the regulatory focal points on the tools to enable strengthened prevention, detection and response to SF medical products, with focused attention on the use of and reporting to the GSMS and risk-based communication campaigns and post market surveillance in-countries. At the end of the workshop, focal points from the participating Member States were better equipped with the knowledge and skills to handle incidents of SF medical products in collaboration with WHO, regional networks, and other partners, including the World Customs Organization and United States Pharmacopeia.
How the system works
Some Member States submit reports of suspected SF medical products and others submit reports of validated SF medical products.
When a report is received at WHO it is automatically uploaded in to a secure WHO database, and immediately compared against all reports. Any matches are identified and details shared with the reporting Member State.
WHO will contact the reporting focal point within 72 hours for further details and where requested provide technical support. In emergencies this may take the form of facilitating urgent laboratory analysis or in extreme and complex cases deploying experts in the field.
Emergencies
When a report is received which indicates adverse reactions in patients WHO will contact the originator of the report within 24 hours. If the report does not indicate adverse reactions WHO will respond within 72 hours.
On receipt of a report the system will immediately link it to other known similar cases. This can be useful in putting National focal points in touch with each other, who may be able to share information and laboratory testing results.
WHO will request some further information and will provide technical assistance to Member States wherever possible and where a serious incident is ongoing. This assistance may take the form of facilitating access to a specialist laboratory through to on the ground assistance in investigating the root cause of the issue.
In cases that represent a serious threat to public health and have the potential for a wide geographic impact, WHO will consult with the reporting focal point, and assess the need for the issue of a medical product alert.
Data Analysis
In all cases data analysts at WHO will work with the focal point to gather as much information about the SF medical product as possible, in order to validate the information. The analysts are seeking to identify the medical products most at risk, vulnerabilities in supply chains and weaknesses in capacity and health systems.
The data analysis equips policy makers and regulators with detailed information identifying the emerging trends quickly, better informing post market surveillance and more focused investment for capacity building and regulatory strengthening.
The system aims to facilitate a more accurate assessment of the scope, scale and socio-economic harm caused by SF medical products and to contribute and assist in the work of the Member State Mechanism on SF medical products.
Progress to Date
Starting in 2016, all trained focal points are able to search the WHO database through a secure link to check if a suspected SF medical product has already been reported to WHO, report products through a secure web portal and access photograph libraries of confirmed SF medical products.
In November 2017, the WHO Director General launched two documents on the subject of substandard and falsified medical products.
Advice on reporting a suspected SF medical product
If you suspect that you have an SF medical product or have suffered an adverse reaction which you believe was caused by a medical product you should consult a pharmacist or medical doctor and report the case to your National Medicines Regulatory Authority. The WHO global surveillance and monitoring system receive reports from trained focal points in the National Drug Regulatory Authorities and International procurement agencies who if necessary will forward your report to the WHO.
In emergencies please contact: [email protected]
WHO Medical Product Alerts
When a report of an SF medical product is received, WHO will seek to validate the report. In cases where there is a significant threat to public health, a wider geographic risk or where steps have not been taken to reduce the risks to patients, WHO will consider issuing a public medical products alert.