Good post-marketing Surveillance

Office of Compliance and Standards. In this department, data compliance to good laboratory practice (GLP), good clinical practice (GCP) and good post-marketing surveillance practice (GPMSP) is carefully controlled. Applications are checked to determine if they were prepared according to the Criteria for Reliability of Application Data. 

The Good Post-marketing Surveillance Practice (GPMSP). The postmarketing surveillance (PMS) system is a well established system in Japan for collecting safety data in order to prepare the documentation requested for re-examination which will be described in the section on Postapproval Activities, below. 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

In a post-marketing surveillance study in 27 803 patients with diabetes mellitus (94% type 2), data were reported after 12 weeks. The doses of acarbose were low 4.1% took less than 100 mg/day, 64% 100-250 mg/day, 32% 250-300 mg/day, and 0.1% more than 300 mg/day. Only 2.1% stopped therapy, mainly because of gastrointestinal adverse events. Tolerability appeared to be good and independent of age. Abnormal liver function was reported in 0.01%. The difference between these results and those of many controlled trials may in part be explained by the fact that higher doses have been used in most trials (14). 

Additionally, in Canada, post-marketing surveillance of the voluntary reports reeeived by the manufacturers of fluoxetine, identified 2 cases that showed good evidence, and another 4 cases that showed some, but not strong evidence, of reactions consistent with the serotonin syndrome in patients also taking sumatriptan. Other cases describe a decrease in the efficacy of sumatriptan with fluoxetine, dyskinesias and dystonias with sumatriptan and paroxetine, and twenty possible cases of the serotonin syndrome with sumatriptan and SSRIs. ... 

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