May 16, 2012

Drug Shortages Raise Issues About Federal Regulations

Horsham, PA—Is a federal requirement that pharmacists strictly adhere to manufacturer labels for injectable drugs contributing to drug shortages? How often are hospital pharmacists throwing away drugs they know to be safe and that can't be easily replaced?

A survey of 715 hospital pharmacists and managers, fielded by the Horsham, Pennsylvania-based Institute for Safe Medication Practices (ISMP), sought to answer those questions. Almost all respondents, 97%, said valuable drugs are wasted because of the rules requiring strict adherence to manufacturer's directions even though evidence-based compendia information recommends longer beyond-use dating.
The Centers for Medicare & Medicaid Services (CMS) requires pharmacists to be compliant with FDA-approved labels and avoid the use of expired drugs, despite scientific evidence to the contrary, the ISMP notes. The group says it has called on CMS to review policies involving stability and beyond-use dating of medicines.
In the survey, just half of all respondents said they always follow the manufacturers'  directions on issues such as drug storage, dilution, compounding, stability, and beyond-use dating. The majority of survey participants said they at least sometimes follow national compendia recommendations when those conflict with manufacturers' directions.
One reason is that the manufacturers' directions can be incomplete; in fact, only 2% of respondents found them to be always sufficient for determining storage, stability, compatibility, and beyond-use dating after dilution when making an admixture from a single-dose vial, multiple-dose vial, or ampul.
ISMP points out that "since pharmacists can't rely on drug companies to continually test new parameters for drug storage, stability, and beyond-use dating, or to quickly update the package insert to reflect new findings, they do rely on up-to-date compendia to inform best practices on these matters."

In another issue created by persistent drug shortages, pharmacists are being urged to carefully monitor the use of single-dose/single-use vials to make sure they are not being used for multiple patients.

The national Centers of Disease Control (CDC) said in a recent statement that it strongly opposes the practice, insisting that adhering to single-use requirements "protects patients from life-threatening infections that occur when medications get contaminated from unsafe use."

The one exception, CDC said, is where "shortages of some essential medications may warrant implementation of meticulously applied practice and quality standards to subdivide contents of single-dose/single-use vials, as stated in United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding—Sterile Preparations."

CDC said it felt the need to restate its position because of concerns over whether single-use products contribute to drug shortages and increased medical costs to health care providers. Its response was that drug shortages are a "result of manufacturing, shipping, and other issues unrelated to the above guidelines."

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