The US, the largest pharmaceutical market in the world, remains one of the only countries still repackaging drugs in pharmacy while the majority of the world has adopted unit dose blister packaging filled by the manufacturer or a regulated packager for the delivery of pharmaceuticals to patients.
1) Serialized unit dose packaging that does not require repackaging at the pharmacy would allow better tracking of doses dispensed which would give better visibility to abusive prescribing and dispensing practices.
The US’ antiquated method of repackaging Opioids and other Class II narcotics in pharmacy not only increases the opportunity for theft and diversion but facilitates prescription fraud due to reduced control and visibility of drugs during distribution. Serialized unit dose packaging would allow better tracking of doses dispensed which would give better visibility to abusive prescribing and dispensing practices. Product reaching the street could be tracked back to the patient, pharmacy and prescribing physician which means patterns of abuse are easier to spot for law enforcement, FDA and DEA.
2) Unit dose packaging can complement and support the CDC’s recommended 3, 5 and 7 day prescriptions for new patient, short term use
The smaller dosing quantities (3-7 days for acute care) now recommended by the CDC and a number of states1, eliminating the blanket 30 day prescription, can best be accomplished with pre-counted, pre-packed unit dose blisters, which would also include the original, unique serialization code. The packages can be modified to contain space for recording the time the dose was taken or include smart technology that will communicate with caregivers.
3) Reduction in filling errors or introduction of counterfeit drugs
In addition to providing increased visibility and security in the supply chain, elimination of repackaging in pharmacy also reduces the opportunity for filling errors and the introduction of counterfeit drugs.2 The US accepted practice of bulk packaging in larger bottles (500 or 1,000 count) forces repackaging product in the pharmacy. Bulk packaging is less expensive for the pharmaceutical manufacturer, yet these same manufacturers pack in blisters everywhere else in the world.
While changing the packaging form itself would not aid in directly preventing addiction, unit of use compliance packaging would provide better visibility into current distribution problems and allow for better controls, benefiting those pursuing a reduction in addictions. This packaging form will also aid in the roll out of the Drug Supply Chain Security Act, signed into law in November 2013 by allowing serialized packages to reach patients. The DSCSA will require the serialization and tracking of original manufacturer pharmaceutical packaging as it moves through the supply chain from the manufacturer to the pharmacy.3 The current law does not continue monitoring through the pharmacy since it allows repackaging into standard vials and bottle for patient distribution.
It is this last step of repackaging, with the subsequent loss of a unique serialization code, that opens the door for problems or, rather, a continuation of the poor controls we have today. The serialized containers required by DSCSA can be tracked as they move through the supply chain giving visibility into where they are, who sold them, and who bought them. The current pharmacy practice ends the ability to track those containers once drugs are repacked into non-traceable pharmacy vials.
The FDA and others concerned about the opioid epidemic are taking a closer look at how packaging can help inhibit abuse.