CMS rules add to US drug shortages

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CMS rules add to US drug shortages

INICIO/Noticias Farmacéuticas | Posted 23/04/2012 0 Post your comment

Results of a survey carried out by the Institute for Safe Medication Practices (ISMP) and published on 22 March 2012 point to the fact that ‘too strict’ rules from the US Centers for Medicare & Medicaid Services (CMS) have led to waste of medications already in short supply.

The ISMP survey questioned 715 practitioners including pharmacy directors and managers, staff pharmacists, clinical pharmacists and medication safety pharmacists about drug storage, stability and beyond-use dating of injectable drugs.

The problem is that CMS rules insist that ‘outdated, mislabelled, or otherwise unusable drugs and biologicals must not be available for patient use.’ This means that pharmacists must follow the manufacturer’s directions regarding storage, stability and beyond-use dating in the official FDA-approved prescribing information (package insert). However, 1) complete information is often not provided in the official prescribing information and; 2) newer, evidence-based information can sometimes be found in peer-reviewed journals and compendia fully endorsed by national pharmacy organisations.

The results of the survey showed that only half of respondents always followed the manufacturer’s directions regarding drug storage, dilution, compounding, stability, and beyond-use dating. Of those who always followed the manufacturer’s directions, 88% were aware of the CMS regulation requiring this and 80% were aware that national compendia sometimes provide information on storage, stability and beyond-use dating that differs from the manufacturer’s directions.

Sixty-one per cent of respondents had discarded injectable medications according to the package insert, corresponding to more than 100 different medications. More than 80% of the medications reportedly discarded by respondents have been or are currently in short supply, further adding to the drug shortage problem.

Nearly all respondents (97%) felt that the CMS regulation and interpretive guidelines that require strict adherence to the manufacturer’s directions for storage, stability and beyond-use dating increases waste and contributes to drug shortages when evidence-based compendia information recommends a longer beyond-use dating. In fact, 36% reported that following the CMS regulation often results in unnecessary waste and 43% said it always results in waste.

The ISMP has stated that it will be sharing the results of this study with the CMS. ISMP hopes that the study results can be used to inform future changes in CMS policy that might allow pharmacists to use newer evidence-based information about drug storage, stability and beyond-use dating.

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Source: Institute for Safe Medication Practices