Essential medicines and health products

WHO Global Surveillance and Monitoring System

The Global Surveillance and Monitoring System for SSFFC medical products was launched in West Africa in July 2013. Since then over 400 regulatory personnel from 126 Member States have been trained in its use and almost 1400 SSFFC medical products have been reported.

Objectives

Its objective is to work with Member States in improving the quantity, quality and analysis of accurate data concerning SSFFC 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 SSFFC medical products
  • Assess more accurately the scope, scale and harm caused by SSFFC 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 SSFFC 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 SSFFC medical products are submitted to the WHO via an electronic rapid alert form, currently available in English, French, Spanish and Portuguese languages.

The system was piloted by 10 Member States in 2012/13 following a workshop held in the Philippines, and deployment commenced in Mid 2013 at a regional training workshop held in Nigeria. Since then a further 12 Regional workshops and 4 National workshops have been held. In 2017, additional workshops will be carried out.

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. At the conclusion of the workshop the participants will become the nominated focal point for their respective Regulatory Authority.

Member State Participation in Regional Training Workshops
(member states shaded in blue have participated in a workshop; dark blue indicates where the workshops were held)

How the system works

Some Member States submit reports of suspected SSFFC medical products and others submit reports of validated SSFFC 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 SSFFC 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 analyst will close a case by classifying the reported medical product in one of the following categories;

  • Falsified
  • Substandard
  • Not registered
  • Other
  • Not known

This classification will only be conducted where sufficient information exists to make a determination beyond reasonable doubt. The classification allows cases within each category to be compared and analysed in much more detail than previously and for that information to be disseminated to Member States. This analysis provides policy makers with detailed information identifying the emerging trends quickly, better informing post market surveillance and more focused investment for capacity building and regulatory strengthening.

Current regional reporting levels

Updated - March 2017

The system aims to facilitate a more accurate assessment of the scope, scale and socio-economic harm caused by SSFFC medical products and to contribute and assist in the work of the Member State Mechanism on SSFFC medical products.

Reported medical products by therapeutic category

Updated - March 2017

Next Steps

During 2016 all trained focal points will be able to search the database through a secure link to check if a suspected SSFFC medical product has already been reported to WHO, report products through a secure web portal and access photograph libraries of confirmed SSFFC medical products. Further regional workshops are planned in Singapore and Indonesia.

Advice on reporting a suspected SSFFC medical product

If you suspect that you have an SSFFC 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: rapidalert@who.int

WHO Medical Product Alerts

When a report of an SSFFC 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.

Related links

National focal points registration: WHO global surveillance and monitoring system on SSFFC medical products

Login and password to register have been sent by WHO to the Heads of National Medicines Agencies or contact: rapidalert@who.int