After counterfeit Avastin surfaced in February, the Institute for Safe Medication Practices (ISMP) reminded nurses, pharmacists, and doctors to remain vigilant when procuring and dispensing medications. Packaging and labeling play key roles in that vigilance. But do you give these professionals enough clues to go by?
In its March 8 newsletter, ISMP pointed readers to resources published by the Partnership for Safe Medicines (PSM). These include LEADER’s Guides for Doctors, Nurses, and Pharmacists, with LEADER being an acronym for the steps each professional could take when handling and dispensing drugs. For instance, the “E” in LEADER stands for “Evaluate suspect medicines,” and each guide stresses the importance of “evaluating products, packaging, and labeling.”
Also, doctors are also encouraged to “Dispense free samples,” because “sample packs can help patients establish a ‘baseline’ of a medicine’s characteristics, including its appearance, taste, texture, reactions, and packaging.”
PSM’s point about sample packaging is a good one, since samples can help patients become familiar with the product and packaging. “Examine the medicine’s packaging and look for differences in paper, printing, color and fonts (i.e., is it the same size, raised print, embossed, etc.),” the physician’s LEADER guide reads. “Physicians directing patients to keep a ‘drug diary’ with these characteristics can help keep the patient as part of the safety team and the last barrier to harm. In fact, recent cases of counterfeits were detected by patients.”
Trouble is, not all prescriptions are preceded by a sample package. And according to the Joint Commission, some organizations have stepped away from offering drug samples, moving instead to “starter prescriptions” dispensed by pharmacies.
But even if there is a sample package, subsequent prescriptions or refills may not be dispensed in branded packaging. Instead, pharmacies most likely will be repackaging refills into standard pharmacy vials that offer patients and doctors very few cues to drug authenticity.
In fact, many of the following packaging and labeling clues that PSM implores physicians to look for simply do not exist with pharmacy repackaging:
• Be properly sealed.
• Contain a package insert.
• Have a container and closure that protects the drug from the outside environment for the duration
of its shelf life.
• Have the appropriate container and closure for the drug inside.
• Have smudge-proof ink on the package insert or packaging.
• Have seals or sealing tabs over the product openings.
• Display an authentic logo or hologram (if applicable) that changes color when viewed from different
• Have a package insert that is printed on the same colored and quality paper as the original.
But should manufacturers issue samples for EVERY drug, including generic drugs? Absolutely not. Not only would drug manufacturers’ own costs increase, doctors’ offices and clinics would be overwhelmed by the sheer inventory volumes.
Instead, pharmacy repackaging should be strongly reconsidered. For physicians and patients to become detectives in their own right, they need actual packaging tools they can use to detect counterfeits.
Drug manufacturers can provide many of those tools through carefully designed packaging and labeling and communicate the basics of those tools through Web sites, patient educational materials, and yes, when appropriate, sample packages.