Approximately 90 million adults in the US struggle to understand and correctly act upon common standard drug warnings on prescription bottles, according to estimates from The Institute of Medicine. Many adults are, therefore, at risk of either not receiving the full therapeutic benefits of their prescription (through under dosing), or experiencing unpleasant side effects (through over dosing). 

A new study from Northwestern University Feinberg School of Medicine (IL, USA) suggests that simplifying both the language and icons used on standard warning labels for prescription medicine can significantly help patients to understand how to take their medication correctly. Many of the words and icons in use have been so for decades without any evidence to support patient comprehension. Michael Wolfe, Associate Professor of medicine and learning sciences at Feinberg, and lead author of the study said in a recent press release: “The study shows the value of a clear message…. A lot of the current warnings were phrased very abstractly and were confusing. For example, we changed ‘For external use only’ to ‘Use only on your skin.’ We moved from the intangible to the concise.” 

In addition, the researchers also recommend limiting the number of warnings to two so that only the most important are printed: the study indicated that if there are too many warnings patients tend to ignore them. Wolfe advised in a press release: “We need to figure out which are the most important warnings and only put those on the label.  Otherwise you risk the message never reaching the patient…. The more warnings you put on a label, the more you distract them from essential instructions and precautions that ensure they safely use the medicine.” 

Furthermore, the study also discovered that patients with low literacy were at greatest risk of misunderstanding instructions and, therefore, more liable to misuse medications. The researchers and patients of the study worked with graphic designers to create new icons that captured the mental images of what the warnings meant. For example, “A current and widely used icon of a pregnant woman resembles an olive,” Wolf said in a press release. “For most people that probably doesn’t convey pregnancy. The new design of a silhouette of a pregnant woman with a bump on her stomach was more easily recognizable to patients.” 

Work is already underway to revamp the content of prescription warning labels as Wolfe and colleagues from Emory, Harvard and Louisiana State universities have teamed up with the US Pharmacopeia to create a drug labelling task force.

 Simplifying language, particularly warnings on prescription bottles, is definitely a positive move, but I will be interested to learn how feasible it will be to whittle the warnings down to the recommended limit of two. How will the drugs companies fare in this age of compensation?

This is the key message from Alliance of Liberals and Democrats for Europe MEP Antonyia Parvanova at the recent European Parliament event ”How can the supply chain protect patients against counterfeit medicines in the EU?” organized by the European Generic medicines Association (EGA).

“Costly technology should only be considered as a secondary line of defense if all the other measures are proven to fail…it is tough criminal sanctioning and not barcoding that is going to stop counterfeiters,” stressed Parvanova in a press release issue by the EGA.

According to the Council of Europe it is “preparing a convention to combat counterfeit and illegal medicines and healthcare products, including those being offered on the web.” The convention aims to criminalize offenses and protect victims. The scope of the convention will include manufacturing, supply, offering to supply, trafficking of counterfeit medicinal products, and falsification of documents.

Although drug counterfeiting is on the increase, Greg Perry, EGA director general, advised that patients must not be alarmed because very few medicines infiltrate legal supply chains thanks to the control measures already in place at borders. Also, counterfeiters only seem to be targeting branded drugs—a market that is far more lucrative than generics; for example, the industry is witnessing a rise in fake flu drugs as counterfeiters attempt to cash in on public fears surrounding the H1N1 swine flu epidemic.

Yet, during a presentation at CPhI Worldwide earlier this year, Guy Villax, EFCG board member advised that EU generics containing ‘falsified APIs’ (or not from the approved, labeled source) could be as high as 30%.

Clearly, whatever the figures are, counterfeiting of drugs, branded or generic, is a real threat to patients and requires immediate and effective action on a global scale. What that solution is, I don’t know.

I wonder how much sanctions will really deter criminals. Will harder penalties stop people engaging in such activites or will they just encourage them to be more creative and more determined not to get caught?

Despite the hard talk and promises to clamp down on criminals working in the fake drug arena, pharma companies continue to innovate anticounterfeiting technology; for example, Colorcon and ARmark Authentication Technologies have recently announced in a press release their alliance in the development and introduction of mark On-Dose ID, an “authentication technology that incorporates microscopic covert micro-tags into the immediate-release film coatings of solid oral dosage forms.”

As internet sales of fake drugs continue to rise at an alarming rate, more needs to be done to ‘educate’ the public of the danger of buying pharmaceuticals online, which is a tall challenge in today’s tough economic climate—accessible and cheap products are extremely alluring!

Perhaps there is no one solution and the way to safeguard patients from counterfeit medicines is a multipronged approach. If the policy makers take a harder line with criminals, pharma companies continue to design anticounterfeit technologies that are difficult to replicate, and the public allow themselves to take heed of the advice being given, perhaps the fake drugs market will ebb, and patient confidence and safety will rise.

Just looking at some of the comments from various online Twitterers, I have come across “Fake drugs making me feel alright,” “Had to drive across Birmingham today with three bags of fake drugs. So glad I wasn’t pulled over!” and “Stop buying fakes off websites then… Get them from your local drug dealer instead, they must be better from him/her” reinforces one fact: if there’s a market for counterfeit drugs, criminals will continue to feed the demand.