Open AccessUsing community pharmacies to evaluate the safety of a prescription only medicine in an OTC environment: a unique method in Europe
Author(s) -
Gibb I. A.,
Miller K.,
Veltri J. C.,
Page B. A.,
Charlesworth A.,
Kellett N.
Publication year - 2001
Publication title -
international journal of pharmacy practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.42
H-Index - 37
eISSN - 2042-7174
pISSN - 0961-7671
DOI - 10.1111/j.2042-7174.2001.tb01070.x
Subject(s) - medicine , medical prescription , pharmacy , community pharmacy , family medicine , traditional medicine , medical emergency , nursing
Focal points □ Safety data in support of prescription‐only to over‐the‐counter (OTC) switches is usually obtained from clinical studies set in a controlled medical environment, normally general practice, and from pharmacovigilance. Such an approach can make it difficult to generalise a product's safety profile to an OTC user population □ To overcome this difficulty, we developed a method whereby pharmacists enrolled over 7,000 subjects from the community in a comparative study of two products for sore throat – soluble aspirin 500–1,000mg and flurbiprofen 8.75mg lozenges (the latter being a POM in the UK); the study was conducted in 45 community pharmacies throughout the UK □ Pharmacists obtained informed consent from subjects, corroborated subjects' decisions on product suitability and provided study medication; there was no direct physician involvement; follow up data was obtained in a structured telephone follow up interview conducted by nurses in a separate coordinating centre □ Data quality from the pharmacies was high, with a missing data rate of 0.6 % all medication was accounted for □ Pharmacists can generate relevant data to required quality standards, in an environment and population that reflects the OTC setting, thus providing better information to support decisions on potential POM to OTC switches.