Differences in the information about procedures after cold chain disruption provided by pharmaceutical industry to hospital and community pharmacies.

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.

Information provided by generic and brand-name pharmaceutical manufacturers in response to a request.

AIM: To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies. SETTING: Community pharmacy in Spain. METHOD: A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded. MAIN OUTCOME MEASURES: The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies. RESULTS: About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P < 0.005). We received 369 (65.5% of 533) replies after the first request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312). CONCLUSION: Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.