Recycling Expensive Medication: Why Not?

Jay M. Pomerantz, MD

Disclosures

Medscape General Medicine. 2004;6(2):4 

In This Article

New Technology for Assuring Safety and Potency of Recycled Medicine

If we have already learned how to recycle everything from newspapers to soda cans and rubber tires, eyeglasses and human organs such as corneas and kidneys, then why not medicines? Medicines would not even have to be remanufactured, just verified. Many tablets or capsules already are packaged individually in tamper-proof wrappings with the name and date of expiration stamped on each one. Such blister packaging is already routine for many over-the-counter medicines and physician samples.

Bar coding of identifying information on the individual pill or capsule wrapper would also be helpful, and we may be closing in on that possibility. The FDA just passed a final rule requiring bar coding on all medication labels (ie, immediate container label and the outside container or wrapper) for all products that might be dispensed in a hospital or other institutional setting.[31] The labels would have to be imprinted with a bar code containing the National Drug Code number that identifies each drug and its dosage form and strength. The requirement would not preclude the inclusion of other information, such as the drug's lot number and expiration date. Bar codes on the medication label would allow for computer scanning at the bedside in hospitals and nursing homes to verify that drug and dosage matched the patient bar code imprinted on patient-specific bracelets -- thereby guarding against medication errors.

Unfortunately, since the FDA did not mandate unit dose packaging along with the bar coding, there is still a possibility of bedside errors. Even more ominously, the additional cost of requiring bar codes may cause a decline in the use of unit dose packaging. So, what looks like a very good safety measure may not be such a clear winner. As far as our discussion of the feasibility of recycling, it is clear that bar coding of each unit dose of medicine would be what would be required.

The FDA is also assessing the extent to which new technologies in development, such as color-shifting inks and images (seen only when the package is turned in a certain way) could defeat unlawful copying and counterfeiting. Micro-bar-code tags, special perfumes, embedded threads, and/or implanted radio frequency chips within an individual tablet or capsule blister package might be utilized to establish authenticity and integrity of medicines.[32] While most of these new approaches have not yet been fully developed, implemented, and tested, they hold the promise of a more secure drug distribution system in the years ahead.[33] Not only do these technologies have the potential to make recycling more feasible than previously thought, they will come about anyhow to counter the growing problem of counterfeit drugs.

Additional new developments in packaging address the many compounds that are moisture sensitive, for which exposure to sustained high temperatures and humidity results in significant degradation. However, when a very moisture sensitive compound (eg, PGE-7762928) is packaged in cold-form aluminum blisters, even harsh conditions -- 6 months at 40° Centigrade and 75% humidity -- results in 100% preservation of physical and chemical stability.[34] Not all blister packaging works as well. In the same study, with a baseline of 82% sustained activity of the compound when unpackaged, there was 84% stability when stored in polyvinyl chloride blisters, 91% in cyclic olefin blisters, 97% in aclar blisters, and 99% in a high-density polyethylene bottle with a foil induction seal. Other studies show that mathematical models can predict moisture uptake by packaged pharmaceutical products during storage under different conditions.[35]

Oxidation is another common way for medicines to lose potency, and there are great complexities in how that may happen, depending up on the compound involved. Still, modern individual dose packaging, either by the manufacturer or wholesaler, can help enormously. Blister packaging, especially in opaque foil blisters, works extremely well. It is even feasible to blister package under nitrogen or argon to reduce the oxygen in the package to begin with.[36] Alternatively, blister packaging with oxygen absorption capacity (eg, self-activated, iron-based oxygen scavengers) could be utilized such that single doses can be maintained under anaerobic conditions.[37] Plastics containing oxygen scavengers have also become available and result in what some have termed "active packaging."[38] Another new tool, high-pressure processing,[39] already useful in protecting food and extending its shelf life, might be used for the stabilization of heat-labile, fragile pharmaceuticals.

As medicines have risen in price, the differential cost for more expensive protective blister packaging becomes a relatively trivial expense. When one is talking about tens of dollars or more for each pill or capsule, a few cents investment is clearly worthwhile to maintain the integrity of a product long enough (even under adverse storage conditions) to be able to reach a needy patient. Either the FDA or Congress might mandate the use of individual tablet/capsule packaging and identification, or wholesalers or large pharmacy chains might do it for all new prescriptions, expensive items, and any items deemed eligible for return credit and recycling.

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