Eleonora M Morais1, Teresa M Salgado2, Isabel Vazquez Gomez3, Andreia M Duarte4, Fernando Fernandez-Llimos5. 1. Research Center in Biosciences & Health Technologies (CBIOS), Lusofona University of Humanities and Technologies, Lisbon, Portugal. 2. Department of Clinical Pharmacy, University of Michigan, College of Pharmacy, Ann Arbor, Michigan, USA. 3. Center for Pharmaceutical Research and Publishing, Redondela, Pontevedra, Spain. 4. Pharmacy Department, Hospital da Luz, Lisbon, Portugal. 5. Faculty of Pharmacy, Department of Social-Pharmacy, Research Institute for Medicines (iMed.ULisboa), University of Lisbon, Lisbon, Portugal.
Abstract
PURPOSE: To compare the response of the pharmaceutical industry to information requests from a hospital pharmacy and a community pharmacy regarding the inadvertent exposure of refrigerated medicines (2-8°C) to out-of-range temperatures. METHODS: A complete list of all authorised medicines labelled for refrigeration was obtained from the Portuguese Medicines Agency. A standard information request regarding cold chain disruption for refrigerated medicines was sent to pharmaceutical companies from a hospital and a community pharmacy in Portugal. For companies who did not provide a response within the first 45 days, a second request was sent and an additional 45 days were allowed before completing data collection. To compare information received from the drug industry with that contained in the official European labelling, the Summaries of Product Characteristics (SmPCs) were retrieved from the regulatory agencies' databases. Response rate, response time and information appropriateness were assessed. RESULTS: A total of 792 medicines marketed by 70 different pharmaceutical companies were included. The hospital pharmacy received 560 (70.7%) responses, with a mean response time of 6.5 days (SD=5.3) for the first request. The community pharmacy obtained a response for 411 (51.9%), with a mean response time of 15.5 days (SD=4.8). More appropriate information was provided to hospital pharmacy requests. SmPCs did not contain complete information regarding the inadvertent exposure of medicines to unrefrigerated conditions. CONCLUSIONS: When enquired about a specific piece of information, the pharmaceutical industry provided quicker, higher quality and more frequent responses to a hospital pharmacy compared with a community pharmacy.
PURPOSE: To compare the response of the pharmaceutical industry to information requests from a hospital pharmacy and a community pharmacy regarding the inadvertent exposure of refrigerated medicines (2-8°C) to out-of-range temperatures. METHODS: A complete list of all authorised medicines labelled for refrigeration was obtained from the Portuguese Medicines Agency. A standard information request regarding cold chain disruption for refrigerated medicines was sent to pharmaceutical companies from a hospital and a community pharmacy in Portugal. For companies who did not provide a response within the first 45 days, a second request was sent and an additional 45 days were allowed before completing data collection. To compare information received from the drug industry with that contained in the official European labelling, the Summaries of Product Characteristics (SmPCs) were retrieved from the regulatory agencies' databases. Response rate, response time and information appropriateness were assessed. RESULTS: A total of 792 medicines marketed by 70 different pharmaceutical companies were included. The hospital pharmacy received 560 (70.7%) responses, with a mean response time of 6.5 days (SD=5.3) for the first request. The community pharmacy obtained a response for 411 (51.9%), with a mean response time of 15.5 days (SD=4.8). More appropriate information was provided to hospital pharmacy requests. SmPCs did not contain complete information regarding the inadvertent exposure of medicines to unrefrigerated conditions. CONCLUSIONS: When enquired about a specific piece of information, the pharmaceutical industry provided quicker, higher quality and more frequent responses to a hospital pharmacy compared with a community pharmacy.
Authors: Joel S Weissman; David Blumenthal; Alvin J Silk; Kinga Zapert; Michael Newman; Robert Leitman Journal: Health Aff (Millwood) Date: 2003 Jan-Jun Impact factor: 6.301