The Skirmish Against Counterfeit Drugs and Medical Devices

A Fake drug is a drug product which is not what it purports to be. It is any drug product which is formulated or made to appear to be better than it really is. The term can also refer to a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging.

The deadly consequences of using counterfeit medicine are well understood to be a challenge to the integrity of public health systems round the globe, and also a threat to our individual health and welfare. The issue of fake drug has persisted despite all efforts by regulatory bodies towards compliance with standards.

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It is widely acknowledged that counterfeiting medical devices is a very real and constant threat to patient safety. With the forthcoming implementation of the EU Medical Device Regulation in 2020, there is an increase in demand for more information about product origin. This impending law will have a significant impact throughout the healthcare industry, affecting operations from one end of the supply chain to the other, from manufacturing to distribution.

Anti-counterfeit measures protect both the manufacturer and the end user. In the life sciences industry and particularly, medical devices, a counterfeit item, when used, puts the patient at risk and impacts the manufacturer through potential damage to reputation, cost of removing these counterfeit goods out of the supply chain and additional effort to prevent further issues occurring. So, it is crucial that medical device manufacturers ensure their packaging, labeling, and supply chain is tight and precisely tracked to the point of use.

What is a counterfeit medicine?

There are two types of fake medicines: products that imitate genuine medicines, and products that make false claims about their ingredients.

A counterfeit medicine could have:

•           no active ingredient

•           substandard ingredients

•           undeclared ingredients

•           illegal or dangerous ingredients

•           incorrect dosage (too much, too little or variation in dose across tablets)

•           contaminants from unhygienic manufacture.

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

You should

1.         Examine the package and check if it appears suspicious or different from what you previously know.

2.         Check if the security seal has been tampered with by looking for breaks or tears in the sealing tape and seals.

3.         Look for unusual fonts, font sizes, print colour, and spelling errors.

4.         Check the legibility of the information on both the primary and secondary packages.

5.         Check if the batch number, expiry date and manufacturer’s address on the secondary package are the same with that on the primary package.

6.         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.

7.         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

At this stage, you are meant to:

1.         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:

a.         Excessive powder and/or pieces of tablets at the bottom of the container (from abraded, crushed or broken tablets);

b.         Cracks or chips in the tablets, swelling, mottling, discolouration, fusion of tablets;

c.         Appearance of crystal on the walls of the container or on the tablet.

d.         Hardening or softening, cracking, swelling, mottling or discolouration of capsule shell should also be looked out for.

2.         Also check the organoleptic properties of the dosage form if you have been using the medication.

How can I assure my medical device at the point of use or point of receipt is the right one?

Manufacturers have both passive and active methods of clarification and protection.

The Passive Method

Passive methods apply to the packaging. Medical devices usually have three levels of packaging: The primary packaging (pouch), which then goes into a secondary box (product box) and finally packaged into a shipper where there will be multiple products stored in one package.

To avoid counterfeiting, manufacturers can apply deterrents to each of these items of packaging. Whether that be a hologram, UV identification code, 2-D barcode with unique numbering/serialization or hidden text printed using security or magnetic ink. These are not intended as end-user checks but as deterrents to the counterfeiter. A trained person can quickly establish if the product is authentic and can take things further by referencing the unique numbers used in the security marking via an authentication site.

The Active Method

The active method takes the passive method one step further, using various technologies to avert counterfeiting. A unique serial number or reference number (URN) is a randomized number printed onto the product’s packaging and as it’s unique, it can be used to define exactly who manufactured the item, where it was manufactured and the country of origin. This type of serialization at the item level is vital in the fight against counterfeiting. Web-based “labeling and data management” solutions can support you in delivering secure printing for mass serialization to protect the product and the consumer. Serialization not only gives the ability to authenticate the product as genuine, but also offers the ability to track product movement throughout the supply chain, improve efficiency and most importantly, protect the end user.

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How common are counterfeit medicines?

Any product can be counterfeit, from dermal fillers to leukaemia medicine. In countries that have strong medicines regulation, fake medicines are rarer, especially when bought from reputable retailers such as registered pharmacies. A pharmacist found to deal in counterfeits could have their registration as a pharmacist cancelled.

You are more likely to encounter a counterfeit medicine if you try to buy a medicine online. Some websites look like they are Australian, but are actually located and distributing goods from overseas. According to the World Health Organisation, a number of medicines sold online are fake.

Health risks of counterfeits

All unapproved therapeutic goods pose a risk, and counterfeit goods have a much greater risk. Anyone that is willing to break the law to take your money could also be willing to cheat you or risk your health.

A fraudulent medicine may fail to treat the disease, which can be fatal if the medicine is intended to treat a life-threatening condition. Each year, more than 250,000 children die because of fake and substandard pneumonia and malaria medicines alone.

Fake medicines can cause unexpected adverse reactions if they have undeclared ingredients or contaminants. Moreover, in the case of diluted antibiotics, understrength medicines contribute to antimicrobial resistance.

Unexpected side effect

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.

How to spot a fake

The quickest way to spot a bogus medicine is to compare it with an authentic medicine. Medicines are manufactured with precision, so any variation in size, weight, colour, quality or embossing could indicate a forgery. When you take a counterfeit medicine, you may also get the sense that something is “off”, such as an unexpected reaction.

Don’t take the risk

Counterfeit medicines can be hard to identify. Lower your risk by buying your medicine from a registered pharmacy. If you do buy your medicines online, make sure it is through a pharmacist registered. Be alert to anything suspicious about your medicine, and talk to your doctor or pharmacist if you have concerns about a product.

Conclusion

Organizations need to make sure that they put into practice the correct systems and processes that can support them in meeting global standards and country-specific requirements now and in the future. Implementing a fit-for-purpose validated labeling solution with in-built serialization capabilities, which can provide very high volumes of unique, secured and “intelligent” serial numbers for this process would therefore be vital.

Control your label, its design, and the data to reduce risk. If you don’t have control of these three things, it’s likely that counterfeiting can creep in. Keeping up with counterfeiters in the life sciences industry is no easy task, but patients’ lives depend on it. There are a thousand and one counterfeit, gray and substandard drugs in the market today; and the negative impacts of these drugs know no boundaries. Drugs are poisons and care must be taken to avoid fake ones. The tips discussed in this article will not only help reduce your chances of purchasing, using and suffering the untoward effects of fake drug product but will also save you some money. You can contribute your quota in fighting the war against counterfeit drugs by sharing this information. Let me know your thoughts in the comment section.

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