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How to Manage Risk When Investigating Counterfeit Pharmaceuticals

When drug companies work together with law enforcement, regulatory agencies and health care providers, they can reduce the risk of damage to both their reputations and their patients due to counterfeit pharmaceuticals.

Posted by Ann Snook on May 21st, 2019

The World Health Organization (WHO) estimates that 1 in 10 medical products in low- and middle-income countries is falsified or substandard. But they aren’t the only ones affected. Counterfeit pharmaceuticals and substandard medicines are found in every country as both generic and name brand drugs.

Effective quality control and thorough investigations are critical to manage risk and protect both the public and pharmaceutical companies’ reputations.


Use this free template to ensure your investigation reports are thorough, accurate and consistent. 


Types of Substandard Medicines


Substandard medicines fail to meet quality standards or specifications. This category includes drugs that have degraded due to being stored improperly or for too long.

Unregistered or unlicensed drugs have not undergone evaluation or approval by the regulatory authority where they are marketed and sold.

Falsified drugs (sometimes known as counterfeit pharmaceuticals) deliberately disguise their true source, composition or identity. These may contain no active ingredient, the wrong active ingredient or the wrong amount of the active ingredient. They often contain fillers like potato or corn starch or chalk.

Because falsified drugs are often produced in unsanitary, unregulated conditions, they may contain dangerous bacteria. They can also be toxic, containing dangerous chemicals or too much of an active ingredient for the patient’s body to handle.


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Identifying Counterfeit Pharmaceuticals


Criminals work hard to make their counterfeit and substandard drugs look real. As a result, they can be hard to identify. Investigators, doctors and patients should look for:

  • packaging that contains spelling or grammar mistakes
  • packaging that looks torn or dirty
  • mismatched expiration dates on the inner and outer packaging
  • an odd smell or appearance


Fraudsters will often sell their counterfeit pharmaceuticals via unregulated websites and social media platforms. They offer prescription-only medicines without a prescription and sell their goods for suspiciously low prices.

Pharmaceutical companies need to find and investigate these websites quickly in order to protect both the public and their brands. Your reputation could suffer if criminals are selling substandard medicines and passing them off as your company’s products.


Negative Effects of Counterfeit Pharmaceuticals


In 2008, 84 Nigerian children died from acute kidney failure after using a teething syrup that contained an industrial solvent called diethylene glycol. In addition to poisoning patients, as in this case, falsified and substandard medicines have other health, economic and socioeconomic impacts.

Patients who take ineffective drugs may experience disease progression, untreated disease and even death. Substandard medicines also contribute to breeding superbugs and antimicrobial and antimalarial resistance.

When pharmaceuticals don’t work as they should, doctors may become confused and order more tests and medicines, putting a strain on the health system as well as out-of-pocket payers. Patients may also lose productivity and income due to prolonged illness and having to pay for medicine that doesn’t work.

Falsified drugs can cause patients to lose faith in the health system and in pharmaceutical companies. This can lead them to buy drugs illegally, which are even more likely to be fake. Drug manufacturers’ reputations and sales may also suffer when counterfeit pharmaceuticals are on the market.


Read how one company used powerful case management software to capture and track large volumes of data for counterfeit investigations here.


Managing Risk Through Investigations


In December 2014, 1,000 people in the Democratic Republic of the Congo were treated for what they thought was meningitis. However, healthcare workers eventually figured out that all of the patients had taken what they thought was diazepam (the generic form of Valium) but turned out to contain an antipsychotic drug that causes involuntary muscle spasms, which led to their stiff necks.

Outbreaks like this can be avoided if drug companies, regulatory authorities and health care providers work together towards stronger pharmaceutical quality control. One way to manage risk is to share knowledge of these incidents around the world. Knowing that a specific falsified drug is out there can help health care teams detect them in patients faster and reduce their adverse health effects.

These regulatory bodies should also raise awareness about counterfeit pharmaceuticals to help patients make safer choices. Urging people to avoid buying their drugs online and teaching them how to inspect pharmaceuticals before using them can reduce the negative effects of falsified medicines.

Some pharmaceutical companies have started including scratch-off labels on their products to help verify them. Customers text the package’s code to the company and receive a response saying if it is counterfeit. They can then buy the product (if it is real) or report the fake.

Committing to pharmaceutical quality control best practices means keeping up with training employees, replacing old equipment and maintaining a sterile production environment. Pharmaceutical companies should also perform regular audits of their supply chains to ensure no substandard medicines get through.

Complying with US Food and Drug Administration (FDA) regulations protects potential patients as well as your company’s reputation and bottom line. According to the Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, pharmaceutical companies’ security departments, when they work with law enforcement and regulatory agencies, “gather 80 per cent of the evidence for criminal prosecution” in counterfeit pharmaceutical investigations.


RELATED: Pharmaceutical Fraud: What is Off-Label Marketing?


Case management software helps pharmaceutical companies capture and investigate customer complaints and concerns. With the ability to analyze trends, identify areas of risk and create reports almost instantly, you can manage the risks associated with counterfeit pharmaceuticals.


Ann Snook
Ann Snook

Marketing Writer

Ann is a marketing writer at i-Sight Software. She writes about issues related to investigations of fraud, employee misconduct, corporate security, Title IX, ethics & compliance and more.

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