US manufacturers must stop shipping prescription drugs in bulk containers, leaving pharmacies to repackage them, as this practice makes the supply chain more vulnerable and leads to medication errors, the Healthcare Compliance Packaging Council (HCPC) has warned.
The HCPC believes pharmacy repackaging is an unnecessary labour-intensive activity, somewhat unique to the US, that can lead to mistakes in the number, strength, or type of drug being dispensed, and also makes it easier to introduce counterfeit product into the Rx supply chain or mix expired drugs with those that are still good.
This makes packaging a major healthcare issue; labelling and packaging were cited as the cause of 33 per cent of errors, including 30 per cent of fatalities, in a study by the US Department of Health and Human Services and Centers for Medicare and Medicaid Services published last month.
Moreover, since pharmacy repackaging inherently requires that Rx drugs be exposed to the atmosphere, there is growing concern that the practice can impair the efficacy of numerous pharmaceutical products.
"A primary part of the HCPC mission is to encourage prescription drug manufacturers to adopt unit dose packaging for the products they sell in the United States," said HCPC executive director Peter Mayberry.
"Manufacturers already use these packages for the exact same products when they sell them virtually everywhere else in the world."
Unit dose is a subset of the unit-of-use packaging universe that includes, among other formats, blister packs commonly used in the United States for nonprescription drugs, and calendar blister packs that are most commonly used in the US for oral contraceptives.
Outside the US however blister packs are employed broadly for both prescription and nonprescription drugs in Europe, Australia, Asia, and Latin America.
The US therefore should catch up, claims the HCPC, citing a recent report by the US Institutes of Medicine which found that a strategy of using calendar blister packs could help large numbers of patients take their medication more reliably and safely and enhance their treatment outcomes.
The HCPC also points to a 2003 survey of state boards of pharmacy, in which two-thirds of respondents believed that unit-of-use packaging would improve efficiency, reduce errors in dispensing, improve patient compliance, and increase opportunities for patient counseling.
While insurance companies and managed care organisations bear the greatest economic burden from pharmaceutical noncompliance, everyone also pays a share in the form of higher taxes, premiums, and lost productivity.
Thus, US drug manufacturers have a responsibility, the HCPC argues, to adopt unit dose packaging for both prescription and over-the-counter medicines.