Substandard and falsified medical products
- Substandard and falsified 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.
- Substandard and falsified 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 substandard and falsified medical products.
- Both generic and innovator medicines can be falsified, ranging from 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.
- An estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
- Substandard and falsified medical products contribute to antimicrobial resistance and drug-resistant infections.
What are substandard and falsified 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 substandard and falsified medical products have been toxic in nature with either fatal levels of the wrong active ingredient or other toxic chemicals.
Substandard and falsified medical products are often produced in very poor and unhygienic conditions by unqualified personnel, and contain unknown impurities and are sometimes contaminated with bacteria.
Substandard and falsified 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, and can lead to serious health consequences including death.
Substandard also called "out of specification", these are authorized medical products that fail to meet either their quality standards or specifications, or both.
Unregistered/unlicensed medical products that have not undergone evaluation and/or approval by the National or Regional Regulatory Authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.
Falsified medical products that deliberately/fraudulently misrepresent their identity, composition or source.
Identifying a substandard or falsified 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 manufacture 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;
- discussing with your pharmacist, doctor or other healthcare professional as soon as possible if you suspect the product is not working properly or you have suffered an adverse reaction; and
- reporting suspicious medical products to your National Medicines Regulatory Authority.
Substandard and falsified medical products and the Internet
Unregulated websites, social media platforms, and smartphone applications can also be direct conduits of substandard and falsified medical products. Risks to consumers are significantly increased when obtaining medical products from unlicensed and unregulated sources.
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?
Who is at risk?
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 substandard and falsified 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 limited to 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 substandard and falsified 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 substandard and falsified medical products. However, it is in low- and middle-income countries and those in areas of conflict, or civil unrest, where health systems are weak or non-existent that bear the greatest burden of substandard and falsified medical products.
Substandard and falsified medical products are most likely to reach patients in situations where there is constrained access to quality and safe medical products, poor governance and weak technical capacity.
An estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
WHO Member State Mechanism
The Member State Mechanism is the global platform where countries can convene, coordinate, decide and organize actions to address substandard and falsified 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 between Member States and WHO to prevent and control substandard and falsified medical products and associated activities.
WHO Surveillance and Monitoring System
In 2013, WHO launched the Global Surveillance and Monitoring System to encourage countries to report incidents of substandard and falsified medical products in a structured and systematic format, to help develop a more accurate and validated assessment of the problem. The system:
- provides technical support in emergencies, links incidents between countries and regions, and issues WHO medical product alerts; and
- gathers a validated body of evidence to more accurately demonstrate the scope, scale and harm caused by substandard and falsified medical products and identify the vulnerabilities, weaknesses and trends.
As of November 2017, WHO had issued 20 global medical product alerts and numerous regional warnings, and has provided technical support in over 100 cases.
WHO has trained a global network of over 550 regulatory staff in 141 Member States to report substandard and falsified medical products to the WHO Global Surveillance and Monitoring System. WHO also works with 18 of the largest international procurement agencies.
The structured reporting system allows for a fast response to emergencies and the issue of alerts in the most serious cases. It also facilitates in-depth analyses of the medical products most at risk, the vulnerabilities and weaknesses in health systems, the harm caused to public health and the need for investment, training and stronger regulations and standards.