Barriers to reclassifying drugs identified by researchers

Academics try to understand why medicines cannot be accessed without a prescription in one country but are available over the counter in another. 

Aisle in drugstore with over-the-counter (OTC) medicines

Researchers have investigated the factors that influence the likelihood of reclassification of medicines from prescription-only to being available over-the-counter in an attempt to explain the variation between different countries.

The team explored why nine countries (Japan, the UK, the United States, Australia, the Netherlands, Denmark, Canada, Singapore and New Zealand) differed in their levels of public access to medicines and identified barriers and enablers in each country.

The results, published in the Journal of Health Services Research and Policy

, showed that each country had a unique mix of enablers and barriers. Enablers included government policy, particularly in the UK; pharmacist-only scheduling, particularly in Australia and New Zealand; support from pharmacy organisations and a regulator that provides a facilitative reclassification process; public trust in the pharmacist; and large market size in the United States and Europe.

Barriers included limited market size in small countries; the cost of reclassification, particularly in the United States; medical opposition to reclassification, particularly in Japan; competition from distributors of generic medicines; and consumer behaviour.

Natalie Gauld, from the department of general practice University of Auckland in New Zealand, who led the research, says: “We aimed to provide a comprehensive understanding of why the public cannot access a medicine in one country without a prescription that is available in another. For example, trimethoprim and sildenafil have been switched in New Zealand but not in the other countries examined, and Dutch women had to wait 20 years longer than British women to access non-prescription vaginal antifungals for thrush.

“In the context of ageing populations, burgeoning healthcare costs, and increasing pressure on primary care, we need to understand why this difference happens to help overcome some of the barriers to consumer access to medicines.”

Switching or reclassifying medicines with established safety profiles from prescription to non-prescription aims to increase quick and convenient consumer access to medicines, reduce under-treatment and enhance self-management, the authors write.

“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 minimising the cost and delays of reclassification.”

Paul Rutter, professor of pharmacy practice at the University of Wolverhampton, argued in The BMJ
in July 2015 that the US dichotomy of prescription-only and non-prescription drugs might be simpler than the current UK system, as there is a lack of evidence that oversight by pharmacists has benefits. The new research is “informative and useful”, he says.

“What is apparent is that medical opposition continues to remain strong and data from pharmacy mystery shopper research is used to support their argument,” Rutter says.

The research found that medical and consumer participants worried about privacy in pharmacies and that mystery shopper research had cited “inadequate pharmacy performance” increasing distrust of pharmacists.

“Having a ‘pharmacist-only’ medicine class (as in Australia/New Zealand) was seen positively by some interviewees in deciding to reclassify medicines,” says Rutter. “Pharmacy could build on this and use it as an opportunity to demonstrate their worth and value, but there remains an urgent need for consumer outcomes to be assessed, and this is acknowledged by the authors.”


[1] Gauld N, Bryant L, Emmerton L et al. Why does increasing public access to medicines differ between countries? Qualitative comparison of nine countries. J Health Serv Res Policy 2015. doi:10.1177/1355819615593302.

[2] Rutter P. End pharmacists’ monopoly on selling certain drugs. BMJ 2015;351:h3415.

Last updated
The Pharmaceutical Journal, PJ, 22/29 August 2015, Vol 295, No 7876/7;295(7876/7):DOI:10.1211/PJ.2015.20069131

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