Recently The Ministry of health seized counterfeit drug Cialis in Belize. Cialis is a medication used for erectile dysfunction. This medication which should only be used under medical prescription along with a more famous ‘blue pill’ have been found in the market for up to $170.00 / tablet, both of unknown origin. The Ministry of Health issued a release informing the public to report counterfeit medications, specifically Cialis.
Prior to this FDA issued public notices on fentanyl containing counterfeit medication, counterfeit version of Botox, counterfeit cancer medicine and counterfeit versions of many other blockbuster drugs.
At one instance fake drugs killed more than 250,000 children a year where printer ink, paint and arsenic found in some drugs sold to treat life-threatening illnesses (counterfeit vaccines and antibiotics used to treat or prevent acute infections malaria and pneumonia, and diseases such as hepatitis, yellow fever and meningitis).
What is Counterfeit medicine?
Counterfeit drugs have been defined as products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product
Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose.
Counterfeit drugs are illegal and may be harmful to your health.
Counterfeiting a medication occurs where high demand for drugs combines with poor surveillance, quality control and regulations to make it easy for criminal gangs and cartels to infiltrate the market.
High-demand, expensive medications such as various chemotherapeutic drugs, antibiotics, vaccines, erectile dysfunction drugs, weight loss aids, hormones, analgesics, steroids, antihistamines, antivirals, and antianxiety drugs are common counterfeiting targets.
Counterfeit medication makers take advantage of the good reputation of products and brands that the original manufacturer established through its consistently high-quality products. They are only interested in producing what looks like an exact copy, and do not care about the quality and effectiveness of the contents.
Health risks involved with Counterfeit Medicine:
Medicines are used to treat diseases and to promote health. That is not important to counterfeiters. They are not interested in providing patients with a medicine that is equivalent to the original product.
Regulatory authorities have established an elaborate procedure to clinically examine, approve, and follow-up medicines for a reason.
Each and every medicine in the market is approved by regulatory authorities. While developing a drug Pharma companies go through multiple steps to maintain quality and quantity (read article to understand more about drug development process https://allaboutpharmacovigilance.org/4-i-drug-discovery-and-development-process-target-selection-and-validation-phase/).
An individual who receives a counterfeit medicine may risk a number of dangerous health consequences.
The drug may
- contain a different quantity of the original active ingredient or contain the correct active agent, however, either at a dosage that is too high or too low or possess no active agents
- contain totally different active ingredients
- contain toxic ingredients
- bear forged manufacturer’s data on the packaging
- have been completely repackaged or are wrapped in forged packaging, blisters and/or contain falsified patient information
- have been produced under conditions that do not conform with current Good Manufacturing Practice (cGMP)
- have not been transported and stored properly
You may experience unexpected side effects, allergic reactions, or a worsening of a medical condition. Such unexpected effects must be reported immediately to a physician. Even worse, counterfeited medicines can kill.
Ways to identify counterfeit medicines?
Unfortunately, patients, doctors or pharmacists may not be able to distinguish such “medications” from the real ones without a very detailed inspection. If consumers are suspicious, they should contact their doctor, pharmacist or the original manufacturer. Before you take a medicine try to perform below checks to identify whether you are taking fake medicine or original medicine.
1. Visual inspection
Visual inspection as stated by the World Health Organization (WHO) (1999) still remains the first step in identifying potential fake drug irrespective of the analytical methods used. This is because such observation serves as a lead to identifying fake products even in the absence of the knowledge of the physical characteristics of a genuine drug product. You are expected to examine carefully both the package and its content before purchase or use.
a. Visual inspection of the Package
- Examine the package and check if it appears suspicious or different from what you previously know.
- Check if the security seal has been tampered with by looking for breaks or tears in the sealing tape and seals.
- Look for unusual fonts, font sizes, print colour, and spelling errors.
- Check the legibility of the information on both the primary and secondary packages.
- Check if the batch number, expiry date and manufacturer’s address on the secondary package are the same with that on the primary package.
- Check if the manufacturer’s address is traceable, that is, if it contains the exact location of the company and not just the country address.
- Check if the registration number (NAFDAC number as the case is for products marketed or sold in Nigeria) is properly printed or if it appears to be tampered with.
b. Visual inspection of the Dosage form
- Check for differences in the physical appearance (colour uniformity, size, shape, consistency etc.) of the drug. As stated by WHO, commonly encountered physical defects that should be looked out for in tablets include:
- Excessive powder and/or pieces of tablets at the bottom of the container (from abraded, crushed or broken tablets);
- Cracks or chips in the tablets, swelling, mottling, discolouration, fusion of tablets;
- Appearance of crystal on the walls of the container or on the tablet.
- Hardening or softening, cracking, swelling, mottling or discolouration of capsule shell should also be looked out for.
- Also check the organoleptic properties of the dosage form if you have been using the medication.
2. Source
The source of the drug also determines if you are buying a fake drug or not. To avoid counterfeit medicines never buy from market stalls and try to use reputable and accredited pharmacies. Online purchases should only be done through properly accredited sites. 50% of drugs bought online from non-accredited foreign sites were found to be counterfeit medicines.
3. Price
This is another way of identifying fake product. If the price is far cheaper than what is expected, then you have to think twice. However, this may not always be true especially for some products (fake innovator/generic brands) which may be sold at the same price as the genuine one.
4. Allergies / Unexpected Side Effects: Counterfeit drugs most of the time contains inert substances other than the appropriate Active Pharmaceutical Ingredient (API). They may also contain incorrect substances, improper dosage or hazardous substances which do no elicit therapeutic effect. Unusual side effects, allergic reactions, or a worsening of medical condition after taking a medication may be a pointer to identifying a fake drug. The medication should be stopped once any of the above is noticed.
5. Verify Medicines by Online or SMS:
The Mobile Authentication Service (MAS) is one of the methods for testing counterfeit drugs that have given many cell phone users the power to detect fake drugs. It is the world’s first anti-counterfeiting device that uses the SMS platform. This method of identifying fake drugs is very simple to apply and generates immediate results on the identity of drug products.
For example in India to verify medicine: PharmaSecure is working with manufacturers to protect against counterfeits. Unique Identification Code along with a barcode is printed on medicine packages or strips. Consumers can send the unique “Authentication code” by SMS to 9901099010 to receive an authentication message from the pharmaceutical manufacturer to confirm the authenticity of the drug being purchased.
Online Check:
- Go to PharmaSecure website.
- Select your country.
- Enter your Mobile Number and the “Authentication Code” printed on the medicine strips.
- Enter word verification and hit “VERIFY” button.
That is it… Once done, you will get an SMS with result.
Note:
- The Authentication code is different from the Batch Number.
- The Authentication code may not be available on all medicines, except for some expensive medicines.
Most importantly be aware of public notices issued by the regulatory authorities about found counterfeit medications.
Sources:
- http://www.cdc.gov/features/counterfeitdrugs/
- http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/
- Mark D. (2011). Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs. New Jersey: John Wiley and Sons, Inc.
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