Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products
- SSFFC medical products may cause harm to patients and fail to treat the diseases for which they were intended.
- They lead to loss of confidence in medicines, healthcare providers and health systems.
- They affect every region of the world.
- SSFFC medical products from all main therapeutic categories have been reported to WHO including medicines, vaccines and in vitro diagnostics.
- Anti-malarials and antibiotics are amongst the most commonly reported SSFFC medical products.
- Both Generic and Innovator medicines are falsified including very expensive products for cancer to very inexpensive products for treatment of pain.
- They can be found in illegal street markets, via unregulated websites through to pharmacies, clinics and hospitals.
Scope of the problem
Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products are by their very nature difficult to detect. They are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction, however they often will fail to properly treat the disease or condition for which they were intended.
There are many estimates of the scope and scale of the market in SSFFC medical products but little validated evidence to underpin those estimates. In 2013 WHO launched a global surveillance and monitoring system to encourage Member States to report SSFFC incidents in a structured and systematic format, to help develop a more accurate and validated assessment of the scope, scale and harm caused by this issue. Over 920 medical products have so far been reported representing all main therapeutic categories and representing both innovator and generic medicines.
Contents of SSFFC medical products
Falsified medical products may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient.
They are also found to commonly contain corn starch, potato starch or chalk.
Some SSFFC medical products have been toxic in nature with either fatal levels of the wrong active ingredient or other toxic chemicals.
SSFFC medical products are often produced in very poor and unhygienic conditions by unqualified personnel, and contain unknown impurities and are sometimes contaminated with bacteria.
Identifying an SSFFC medical product
Some falsified medical products are almost visually identical to the genuine product and very difficult to detect. However, many can be identified by:
- examining the packaging for condition, spelling mistakes or grammatical errors;
- checking the manufacturing and expiry dates and ensuring any details on the outer packaging match the dates shown on the inner packaging;
- ensuring the medicine looks correct, is not discoloured, degraded or has an unusual smell; and
- discussing with your pharmacist or doctor as soon as possible if you suspect it is not working properly or you have suffered an adverse reaction.
SSFFC medical products and the Internet
Unregulated websites supplying medicines, particularly those concealing their physical address or landline telephone number are frequently the source of unlicensed, substandard and falsified medical products. Consumers should be cautious of the following:
- spam email advertising medicines
- lack of authenticity; no verification logo or certificate
- spelling mistakes and poor grammar on the packaging
- websites that do not display a physical address or landline
- websites offering prescription only medicines without a prescription
- suspiciously low priced products.
Checklist for medicines purchased online
- Is it exactly the medicine ordered?
- Is it the correct dosage?
- Is the packaging in good condition, clean, with a patient information leaflet and in the language in which it was advertised?
- Does the medicine look, feel and smell as it should?
- Are security seals intact with no signs of tampering?
- Does any customs declaration or postal label declare the contents as medicines?
- Does the batch number and expiry date on the primary internal packaging match the batch number and expiry date on the secondary (external) packaging?
- Have you noticed any unusual activity on your credit card since the purchase?
Falsified medical products are manufactured in many different countries and in all regions. Many countries and the media frequently report successful operations against manufacturers of SSFFC medical products. Some reports refer to large scale manufacturing and others to small back street operations. With the availability of tableting machines, ovens, specialist equipment, ingredients and packaging materials, clandestine manufacturing facilities are quick and easy to assemble.
No countries remain untouched by this issue — from North America and Europe through to Sub Saharan Africa, South East Asia, and Latin America. What was once considered a problem suffered by developing and low income countries has now become an issue for all. With the exponential increase in internet connectivity those engaged in the manufacture, distribution and supply of SSFFC medical products have gained access to a global market place. This extends both to consumers and business forums. A culture of self-diagnosis and self-prescribing has led to the emergence of thousands of unregulated websites providing unsupervised access to SSFFC medical products. However, it is low- and middle-income countries and those in areas of conflict, or civil unrest, with very weak or non-existent health systems that bear the greatest burden of SSFFC medical products.
WHO Member State Mechanism
The Member State Mechanism is the global forum at which countries can convene, coordinate, decide and organise activities to address SSFFC medical products.
It was established in order to protect public health and promote access to affordable, safe, efficacious and quality medical products, through effective collaboration among Member States and WHO to prevent and control substandard / spurious / falsely-labelled / falsified / counterfeit medical products and associated activities.
WHO Surveillance and Monitoring System
The Global Surveillance and Monitoring System for SSFFC medical products was launched in 2013. It is open to all Member States, currently 113 countries and 18 of the largest procurement agencies have been trained to use the system. Its purpose is to:
- provide technical support in emergencies, link incidents between countries and regions, and issue WHO medical product alerts; and
- accumulate a validated body of evidence to more accurately demonstrate the scope, scale, harm caused by SSFFC medical products and identify the vulnerabilities, weaknesses and trends.
The System encourages trained focal points in National Regulatory Agencies and International Procurement Agencies to report incidents involving suspected SSFFC medical products in a systematic and structured way to WHO. These reports permit a fast response to emergencies and the issue of alerts in the most serious cases. It also permits an in-depth analysis of the medical products most at risk, vulnerabilities and weaknesses in health systems, the harm caused to public health and the need for investment, capacity building and regulatory strengthening. All of which assists in developing evidence based policy.