INTRODUCTION:

In the etymological meaning, counterfeiting is “the fraudulent copy of another’s product without their consent”.

According to the WHO definition, a medical product is counterfeit “when there is a false representation in relation to its identity (e.g. any misleading statement with respect to name, composition, strength, or other elements), its history or source (e.g. any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorization holder).”

This applies to the product, its container or other packaging or labeling information. Counterfeiting can apply to both branded and generic products.¹

May include products without the active ingredient, with an insufficient or excessive quantity of the active ingredient, with the wrong active ingredient, or with fake packaging.

Drug counterfeiting is a significant public health threat and is rapidly increasing with dozens of new cases being reported throughout the world every day. Drug counterfeiters must be prosecuted as such, since their products can have serious effects on patients.

How to identify counterfeit drugs?

Fig 3: Comparison of counterfeit and authentic

Fig 4: Comparison of counterfeit and authentic

The counterfeit tablet (far left) had a pinkish tinge and a rougher surface texture than the authentic. The debossing was poorly rendered, particularly “Pfizer”, and in a narrower font. The counterfeit contained little, or none, of Norvasc’s active pharmaceutical ingredient. ²

Fig 5: Comparison of counterfeit and authentic

Fig 6: Comparison of counterfeit and authentic

India becomes a hub for fake medicines:

In India popular branded drugs of cough syrup, supplements, vitamins and painkillers are looks real, but all of them are fakes. India, the world's largest manufacturer of generic drugs, has become a busy centre for counterfeit and substandard medicines. Stuffed in slick packaging and often labeled with the names of such legitimate companies as GlaxoSmithKline, Pfizer and Novartis, the fake drugs are passed off to Indian consumers and sold in developing nations around the world. Experts say the global fake-drug industry, worth about $90 billion, cause the deaths of almost 1 million people a year and are contributing to a rise in drug resistance.

Estimates vary on the number of these drugs made in India. The Indian government says that 0.4 percent of the country's drugs are counterfeit and that substandard drugs account for about 8 percent. But independent estimates range from 12 to 25 percent. Over the years, drug companies have used holograms or embossed their logo on the packaging to protect their brands, but these have also been counterfeited in India.

One company, MSN Labs, is using a technology developed by U.S.-based start-up firm PharmaSecure that allows consumers to check the authenticity of medicines by sending in a text message of the code written on them.

But many Indian companies are apprehensive of pursuing the cases for fear of bad publicity and possible loss of confidence among consumers.³

Steps to check counterfeiting drugs by Consumers:

This checklist will help you judge whether your medications are safe and provide tips on what to do if you think a drug has been compromised.

Purchase:

Always purchase the drugs from a reputed Pharmacy. Further ensure that the medicine you have been given do correspond with the same name which has been prescribed. Generally these days there is lot of confusion and misjudgment when medicines are given by the pharmacist. There are medicines with similar sounding names, when the basic medicines are different.

Sample:

Request a sample from your physician when you are first prescribed a medication to help you establish a “baseline” of a product’s characteristics, including its appearance, taste, texture, reactions and packaging or show your first purchase to the physician who has prescribed the drug. Please note that manufacturer samples are usually only available for brand name medications and not generic products. Generics may differ in shape or color but still be a safe and effective product. For specific questions on identification of medications, talk to your pharmacist and or Doctor.

Appearance:

Compare the prescription medicine you receive with what it is supposed to look like by taking pictures of the original manufacturer's drug and all associated packaging with the drug you are taking. When comparing packaging, look for differences in paper, printing, color, and fonts (i.e. is it the same size, raised print, embossed, etc.).

Feel:

Take note of the prescription drug’s taste and any associated feelings once you take it. Check about anything unusual happening in your body’s reaction compared to previous experiences, such as a stomach ache or headache.

Evaluate:

Always ask your doctor or pharmacist what you should expect to feel when you take your medicine and when you should expect to begin feeling relief or improvement.

Remember:

Counterfeit drugs can contain not enough, too much or wrong or no active ingredient. They could have the right active ingredient but at the wrong dose.

Doctor:

If your drugs do not seem to have the same taste or if you feel different than usual, immediately write down your symptoms and contact your doctor and pharmacist.

Report:

If you have any concerns about the quality of your drugs, or have confirmed there is a difference in packaging, labelling, or pills, immediately contact the pharmacy where you purchased them. You may also want to contact the FDA and the manufacturer of the medication to report your concerns.⁴

How to deal with counterfeiting?

Counterfeiting of medicines not only lower the pharmaceutical revenues but also poses serious health hazards. To stop counterfeiting of drug following measures can be taken:

1. Purchase medicines by safest ways:

The best way to avoid counterfeit drugs is to purchase prescription medicines from a reputable pharmacy with which you are familiar. Ensure that you take a bill with the batch number written on the bill. This batch number should tally or correspond to the batch number given on your vial or the strip of the drug you have purchased.

If you choose to purchase your medicines online, always see your doctor and get a written prescription first.

Use an online pharmacy certified by the National Association of Boards of Pharmacy (NABP) through its “Verified Internet Pharmacy Practice Sites” (VIPPS™) program. These pharmacies can be located using the VIPPS™ certified pharmacy list available at http://www.nabp.net.

Don’t buy medications from an online pharmacy that isn’t licensed in your country, that offers to write prescriptions, or that sells medications without prescriptions. Remember that if the price of a medicine seems too good to be true, it probably is. ⁵

2. Postcard guidance for patients

As part of a long-term public awareness campaign about counterfeit medication and its dangers, the MHRA and the Royal Pharmaceutical Society of Great Britain (RPSGB) have produced new guidance for patients, which is being issued through pharmacies. The pilot project (launched May 2009) involves every pharmacy in Great Britain distributing 50 copies of the guidance leaflets in patients’ prescription bags.

The guidance has been developed in conjunction with patient groups. The postcard-size leaflet offers practical advice about the safest way to purchase medicines as well as explaining what counterfeit medications are, how to minimise the risk of buying them, and what to do if patients suspect that they have been sold or supplied counterfeits. It particularly focuses on the increased risks involved with obtaining medication online. ⁶

3. Drugs carry barcode

The government has made it mandatory for drug makers to carry a barcode on every product exported out of the country to put an end to allegations overseas that some local firms ship out counterfeit medicines.

Industry experts said that new rules will increase the cost of exports for Indian medicines and will impose a cumbersome compliance process.

A barcode is a machine-readable data, which contains information about the product including details about the manufacturer. It will allow authorities to track each and every medicine exported out of the country.

The drug control authorities at the ports can also retain a sample of the drug for its reference and tracking.

Role of Pharmacist:

1. Minimize the risk of and exposure to counterfeit medical products

Pharmacist always knows that with whom they are doing business with reputed and authorized firm.

He should stay informed

Purchase and sale only safeguard products

Destroy empty packages/containers

2. Be vigilant

Inspect the product and packaging whether it is counterfeit or safe.

Should have knowledge about the high risk products

Consider counterfeits if:

New/unusual side effects observe about any medication

Lack of therapeutic effect found

Products tastes/smell is abnormal

Patient experiences pain, burning, redness at injection site

3. Counseling patients about counterfeit medical products

Encourage patients to shop only at licensed pharmacies maintenance of patient medication records, health promotion, and patient medication. A pharmacist cannot give medications to those without prescriptions unless the medications are legally sold over the counter. Provides an advice and information on the use and effects of medications

Tell you patient if you dispense a drug that may look different from their previously dispensed drug. If paying for meds is a problem, counsel on assistance program and generics, rather than buying online.⁷

Conclusion:

Counterfeit products have no therapeutic effect, at worst the patient can die from it and these are prove to be dangerous to public health because they are not produced under safe manufacturing procedure and also they are not inspected by regulatory authorities. Local drug maker says such allegation of counterfeit drugs is attempts by international drug makers to scuttle competition from generic companies. Counterfeiting of medicines not only lower the pharmaceutical revenues but also poses serious health hazards.

Pharmacist has wide range of responsibilities like counseling patients about counterfeit medical products, inspect the product and packaging whether it is counterfeit or safe and also minimize the risk of and exposure to counterfeit medical products

REFERENCES:

1. http://www.who.int/impact/activities/lisbon_ppt/en/index.html/ Principles and Elements for National Legislation against Counterfeit Medical Products

2. Pfizer Global Security, Counterfeit Pharmaceuticals: A Serious Threat to Patient safety, Pfizer Inc, 2007:

3. http://www.pfizer.com/files/products/CounterfeitBrochure.pdf.

4. http://www.safemedicinesindia.in/patients1.php

5. Examination and Assessment of Prescription Drug Importation from Foreign Sources to the United States, April 2005, Giuliani Partners.

6. https://www.gov.uk/drug-safety-update/counterfeit-medicines-what-pharmacists-should-know

7. FDA Efforts: Counterfeit Drugs Ilisa B.G. Bernstein, Pharm. D., J.D.

Received on 21.07.2016 Accepted on 23.08.2016

Asian J. Pharm. Tech. 2016; 6(4): 273-276.

DOI: 10.5958/2231-5713.2016.00039.8