Is putting labels on the inside of medication bottles a dangerous practice?

When François Bayzelon picked up a prescription from his pharmacy a few years ago, he was alarmed to see that the thermal label detailing the medication content was placed inside the bottle itself. Now retired, he is the founder and former CEO of ETI Converting Equipment, a Longueuil, Que.-based company that designs machines used in manufacturing self-adhesive thermal labels. When he raised concerns with his pharmacy about the health risks the label might pose, he felt he wasn’t taken seriously. “A self-adhesive label, as its name suggests, is made to be stuck on. It is always designed to be placed outside,” he said. According to a recent study from McGill University, Bayzelon’s concerns were well-founded. The researchers discovered that the chemical compounds of certain thermal labels penetrate the plastic film that covers food (and other items), resulting in contamination. They published their results in the Environmental Science and Technology journal. Read: ISMP analysis highlights errors that can happen with look-alike high-alert medications When La Presse reported the news, it raised questions among several pharmacists about thermal label practices, in particular on the Facebook page 'Pharmaciens et pharmacistes du Québec (OPQ member),' which has more than 9,000 members. These labels—commonly used on food packaging, postal parcels and prescription drug bottles—contain many chemical components including Bisphenol S (BPS), which has replaced Bisphenol A (BPA), an industrial chemical substance considered dangerous because it's an endocrine disruptor. “We are increasingly realizing that, from a toxicological point of view, the effects of the two components carry risks which are similar, and are both endocrine disruptors,” said Stéphane Bayen, study co-author. “We have to stop replacing one chemical substance with another without having fully tested it and being sure that it is safe for the consumer and not potentially more toxic.” The European Chemicals Agency also opened a consultation last year to study BPS and examine the possibility of adding it to the list of so-called “extremely worrying” substances. In Quebec, these thermal labels are in direct contact with medications. “Is there a reason to put this label inside the bottle? If it is simply to save time, there is no point in doing this, compared to the potential risks of contact with an ingested element,” the researcher said. Read: 10 ways to make repackaged APIs safer: ISMP Bayzelon says that none of the components of the label, be it paper, glue, silicone or even ink, is approved as being safe for direct food contact. “The yellow or white backing paper on which the label is stuck is in contact for months with the thermal paper when it is wrapped around the reel. However, it is this contaminated part that directly affects the drugs. It's appalling," he said. He added that this part is made to be thrown away after the sticker has been peeled off to stick it on a surface, and that it is even indicated on the technical data sheet of the product. As these labels are not intended for laboratory use, they are not subject to the same high standards of hygiene. “Reels of labels go under counters, where there is dust, as they are never supposed to come into contact with food,” said Bayzelon. “It's just in pharmacies that we do that. Putting the labels in the bottle is like taking the pills, putting them on the ground and putting them back in the containers.” More research needed While we know BPS migrates into food, we do not know if this is the case with medications, says Bayen. It is also not known how much of it could have adverse health effects, nor what duration of exposure is more critical or whether certain forms of medications are more vulnerable to contamination (i.e., dry tablets, capsules, etc.). “It is not impossible that the toxic components enter the medicine. The mechanisms are complex and we do not yet know enough about them,” she says. “Why do it when we have no proof that it is safe?” This article has been translated from French and originally appeared on our sister site Profession Santé.

Is putting labels on the inside of medication bottles a dangerous practice?

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