Mark Davison

Mark Davison is one of the foremost experts on authentication, anti-counterfeiting, and product security. His company (see www.bluespherehealth.com) helps drug companies to get to grips with serialization, epedigree and traceability issues both for legal compliance requirements and to enhance supply chain efficiency. He started his career in the drug industry by joining Beecham in the year that it merged with SmithKline and long before the marriage to Glaxo. After a career in anti-infectives R&D, he moved into the commercial world and sold high-value services such as clinical trials. He got into anti-counterfeiting when he realised the rising magnitude of the global fake drugs problem. After spending the last five years travelling the world trying to help governments and drug companies to control this growing threat, he set up his own company, Blue Sphere Health Ltd, to advise and help corporate and government clients. Many of the things he learned along the way, and many more insights that he researched and learned from others, are in "Pharmaceutical Anti-Counterfeiting". Pharmaceutical scientists, managers and executives represent the majority of Mark's professional clients, but he also has plenty to say for physicians, pharmacists, and the interested public about how to avoid counterfeit drugs.

A Guide to Avoiding Counterfeit Drugs

It is useful to think about practical actions that we can all take, as physicians, pharmacists, patients and members of the public, to reduce the market for fake drugs by becoming better informed and more discerning consumers. What can we all do to spot counterfeit medicines before they cause harm? Are there any steps that almost anyone can take, with no special training or tools?

As with other threats to our safety, the key behavior is vigilance. Many people don't give their medication a second thought, but by being more observant about what drugs look like, where they come from etc, we can help to eliminate at least the more obvious counterfeits.

Here are some of the things to think about when buying and consuming drugs:

Is This Medication Needed?

Many chronic medical conditions are accompanied by internet myths about supposed new cures or new uses for established drugs. The desperate or incautious patient can be lured by online advertising into putting their faith in these untried and off-label drugs, often in conjunction with their existing prescribed medication. For those who suspect they have a serious or embarrassing medical condition but have not consulted a doctor about it, the desire to avoid a diagnosis can be a strong motivator to seek anonymous, unauthorized channels for their medication. The reason for avoiding their physician may be simply shyness or it may be the wish to avoid having something on their medical record that may be a perceived disadvantage in obtaining insurance or employment. The first step in avoiding counterfeits is to seek the advice and endorsement of a qualified medical practitioner for any medication you wish to take, and to buy drugs only from approved channels.

Is The Drug Approved and Available in My Country?

The blunt fact of the matter is that if a patient lives in a developed country and their national regulator has not approved the medication the patient wants (and the drug is therefore not for sale or obtainable locally) there is likely a very good reason. If that patient resides in the United States, they are part of the world's most commercially attractive and profitable medical marketplace. In general, if an American patient's desired drug doesn't appear on the FDA approved drugs database, known as 'Drugs@FDA' then this is a major warning sign. The database lists both approved drugs and approved manufacturers.

Are The Drug Sources and Methods of Purchase Safe?

Some buying behaviors are more risky for patients than others, and buying prescription drugs over the internet is the riskiest of all. There are many reputable internet pharmacies, but unfortunately on a global basis these are in a small minority. The genuine sites are crowded out by a large number of bogus sites, many of which may be controlled by organized crime groups involved with various other illegal activities including money laundering, selling counterfeit products, credit card fraud and identity theft. Unless the website shows a physical location and a phone number which can be fully verified (by making a call to a pharmacist, for example) then it is safer to assume that it is not a genuine site. Patients should also check the site's accreditation. In the USA, the National Association of Boards of Pharmacy (NABP) operates the Verified Internet Pharmacy Practice Sites™ scheme which certifies and approves online pharmacies. Similar schemes operate in some European countries. Buyers should beware, though: counterfeiters will also fake online accreditations. Nothing should be taken at face value and everything should be checked out. A bona fide pharmacy site should also ask for a medical prescription before dispensing. If the patient has not been asked to provide one, then they should ask themselves why not.

The risk of fake drugs is not limited to online pharmacies. Those buying drugs abroad should also take care when in unfamiliar surroundings or when buying unfamiliar brands. Even when getting medication from well-known chain drug stores, a little vigilance never does any harm.

What Does the Packaging Look Like?

The external appearance of a product can give often some important clues to its authenticity, especially if it is an unsophisticated copy or a refilled pack. Does it look as though it has been opened or tampered with? If there is a closure seal, has it been slit or does it look like it might have been replaced (glue residues, ripped area on package)? If there is a plastic shrink sleeve around the neck of the bottle, check that it looks like an original and has not been re-sealed in any way. If it is a liquid product for injection, check the rubber seal for needle holes and look for apparent damage or alteration to the aluminum collar or the flip cap.

Does the package or bottle look scuffed or dirty, like it has been recycled? Genuine pharmaceutical products from legitimate supply channels should normally arrive with the consumer in pretty good shape having been carefully transported. Criminals frequently re-use medical packaging scavenged from waste, or the products may have been stored and transported frequently leading to abrasion.

If the patient has used this drug before, does the product and packaging received this time look exactly the same as previous ones? Look for small differences - different fonts, changes in text size, mis-spellings, color changes, logo not quite right etc. Many counterfeits are very good copies of the original but few are perfect. Patients should check new packaging against previous packs and take the product to a pharmacist if unsure.

Is the manufacturer's label on straight? Genuine drugs are usually machine-labelled by the manufacturer to strict quality controls. If the label is poorly applied or not straight, the product may have been labelled by hand. This may have a simple explanation if the bottle has been made up to order by a busy pharmacist, but if the product was labelled by the manufacturer then this may be a warning sign.

What Does the Product Itself Look Like?

Does the shape and size of the pill look right? Manufacturers are not allowed to change the appearance of their products without a formal regulatory process and therefore it is not done lightly. If the appearance is not the same as the last time the patient received this medication then there could be an innocent explanation (substitution of a generic equivalent product, change by the manufacturer with an accompanying explanatory note etc). However, an unexplained change could indicate either an unidentified quality issue or a counterfeit. In either case, the patient's pharmacist should be informed.

Do the pills (or vials etc) in the consignment all look the same as each other? Genuine drugs are manufactured in bulk by automated, quality-controlled processes and have a consistent appearance. If there is noticeable variation between individual pills or capsules this is a warning sign.

Are the pills cracked or chipped or crumbling? Some counterfeit drugs are made with identical machinery to the original and are therefore very difficult to tell apart. However, often the fakes will be made with a different tablet press and using different bulk materials. These will not have the same physical characteristics as the original machinery and ingredients and often counterfeit drugs are coarse-grained, gritty or crumbly compared to the genuine product.

Has the pill color changed compared to previous prescriptions? Manufacturing of genuine medicines is highly controlled and they should look the same every time. Even subtle changes from the usual appearance, or differences between pills in the same batch, can indicate fake product. If the product is a clear liquid, check for precipitates, cloudiness, or color. If it is a white powder, check for grayness or specks. If there are any features which not usually present then seek advice.

When Taking the Drug:

Does it feel, smell or taste different? Genuine manufacturers' product will usually be consistent, so changes could indicate a counterfeit - especially if there seems to be a strong 'masking' flavor or smell present which was not in previous batches. Sometimes an unusual or unpleasant taste or odor may reflect a quality issue at the manufacturer, rather than a counterfeit. However, this should still be reported to a pharmacist as strange odors and tastes can be an indicator of fungal or bacterial contamination or a tainting of the product during manufacture.

Does the product behave unexpectedly (e.g. dissolve differently)? The differences in manufacturing processes and ingredients between genuine drugs and counterfeits mean that there will almost always be differences in their behavior. The fake drug may dissolve badly or not at all when it should be soluble, or it may crumble on the tongue when it should be swallowed whole. For injectable drugs supplied as powder or freeze-dried, any remaining particulates after reconstitution are a strong indicator of a quality problem or a counterfeit.

After Taking the Drug:

Any unexpected adverse reactions (side effects) should be noted and followed up with a pharmacist or physician. Many drugs have well-known side effect profiles which are explained on the patient information leaflet. However, if the patient has taken the drug before without problems, minor symptoms (headache, nausea, dizziness etc) after starting a new batch of the medication may be a sign of fake or sub-standard drugs. Major adverse events (palpitations, shortness of breath etc) should be followed up with immediate medical consultation. Often, these events are explainable by other factors, but in some cases counterfeit drugs may be to blame. If the patient has any unusual adverse event relating to their medication, they should keep all drug packaging as evidence. It is important that if the patient has bought additional drugs, vitamins, supplements etc off the internet then these should be included in the discussion with the doctor - whether the physician authorized or recommended the product or not. If the patient hides the fact that they are taking something else on top of what their doctor is aware of, it only makes investigating potential counterfeiting or quality incidents harder and could put other people at risk.

Don't get the problem out of proportion - almost all drugs are safe - but take these few precautions to protect yourself from counterfeits.