Clinical therapeutics

A new model of prescription to nonprescription reclassification: the calcipotriol case study.

PMID 22578311


Medicines reclassification from prescription to nonprescription (switch) has slowed in some countries, including the United States. New thinking may be necessary to drive this area, including third-party reclassification and better use of the pharmacist, collaborative care, or innovative technologies. The goal of this study was to describe a recent, successful, third-party reclassification of topical calcipotriol, a treatment for psoriasis, including the process, challenges, and solutions. This case study used multiple sources of information, including an application to the Medicines Classification Committee (MCC) in New Zealand, the response letter from the MCC, published minutes of the relevant MCC meeting, and interview data. A heuristic qualitative approach was used that embraces the involvement and experiences of the lead researcher. The third-party reclassification of topical calcipotriol generated challenges, mainly due to initial manufacturer opposition. The greatest hurdle was an inability to change the label. However, requiring mandatory pharmacist consultation, with supply under specified conditions, overcame the barriers. Such conditions included supply only to adults with mild to moderate psoriasis, limits on weekly usage and pack size supplied, and the use of a collaborative care approach requiring previous physician diagnosis and advising the physician of usage. An algorithm for supply was developed. The flexibility of the MCC, an advisory committee, and the medicines regulator, both in considering a third-party approach and in allowing an exemption to prescription supply under specific conditions, was vital to the success of the reclassification. Third-party reclassification may be possible in some countries, particularly where supply can be limited to pharmacists only. A flexible approach may be needed from the committee and regulator to assist such reclassification. Given the multiple beneficiaries of reclassification, removing reliance on the pharmaceutical companies to drive reclassification and/or using new models of supply may provide impetus to the reclassification arena.

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Calcipotriol hydrate, ≥98% (HPLC)
C27H40O3 · xH2O