World self-medication industry
The world federation promoting better health through responsible self-medication
NGO in official relations with the World Health Organization

New paper on reclassification

Reclassification is an important work area for WSMI. Reclassifying or switching medicines with established safety profiles from prescription to non-prescription aims to increase timely and convenient consumer access to medicines, reduce under treatment and enhance self-management. In a recent study, Dr Nathalie Gauld of the University of Auckland, New-Zealand, and her international co-authors examined why nine countries vary in increasing public access to medicines with established safety profiles.
The study, entitled “why does increasing public access to medicines differ between countries – qualitative comparison of nine countries’”, and published in the Journal of Health Services Research & Policy in August 2015, is based on interviews with 80 key informants from the United-States (US), Japan, UK, Australia, the Netherlands, Denmark, Canada, Singapore and New Zealand.
The study highlights that each country have a unique mix of enablers and barriers to reclassification. Enablers include government policy (particularly in UK), pharmacist-only scheduling (particularly in Australia and New Zealand) and large market size (particularly in the US and Europe). Local barriers include limited market potential in small countries, the cost of a reclassification (particularly in the US), competition from distributors of generic medicines, committee inconsistency and consumer behaviour.
The study concludes that different factors limit or enable reclassification, affecting consumer access to medicines in different countries. The difference in consumer access between countries suggests that the health system in some countries could be unnecessarily burdened by conditions that may reasonably be self-managed or pharmacist-managed instead. For countries attempting to reduce barriers to reclassification, solutions may include garnering government support for reclassification, support and flexibility from the medicines regulator, having a pharmacy-only and/or pharmacist-only category, providing market exclusivity, ensuring best practice in pharmacy, and minimizing the cost and delays of reclassification.
The paper is available at
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