Post-marketing surveillance, data

Stergachis A. Record linkage studies for post-marketing surveillance data quahty and vahdity considerations. Drugintell Clin Pharm 1988 22 157. 

Phase III Extended large-scale trials to obtain additional evidence of efficacy and safety, and definition of adverse effects. Humans exposed several hundred to several thousand Phase IV Post-marketing surveillance occurs after the chnical trials programme is complete. It is used to collect adverse event data from a large patient population. Humans exposed 10 000+... 

Protection of patient safety remains a responsibility at service delivery. Post-marketing surveillance systems aim to monitor, collect, and evaluate ADEs to identify long-term or unknown safety issues. Most developing countries lack the resources to make pharmaco-vigilance a priority therefore, international data can help inform national DRA decisions (WHO 2001). 

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). 

Pioglitazone also causes fluid retention, possibly because of increased production of vascular endothelial growth factor (92). The safety profile of monotherapy and combined therapy with pioglitazone has been evaluated in 3500 patients over 2500 patient-years, and some data from post-marketing surveillance were included peripheral edema and hemodilution were common (93). 

Post-marketing surveillance and pharmacovigilance data contain few convincing cases of withdrawal from zopiclone. Most consist of rebound insomnia, but there are a few instances of withdrawal convulsions following high-dose dependence. A review of 25 zopiclone discontinuation studies found rebound effects and withdrawal symptoms to be minimal [35],... 

K.Agm,R.R Wilson, M. Brim, and D. I. MeDennoiLG mDpqwui post-marketing surveillance. Demographic and adverse experience data in 29.075 patients. Spine 9479(1984). 

Duloxetine has recently been marketed as an antidepressant in Europe. It inhibits the re-uptake of serotonin and noradrenaline, with minimal effects on other neurotransmitter mechanisms. It is therefore classified as a serotonin and noradrenaline re-uptake inhibitor (SNRI) and is grouped with venlafaxine. The adverse effect profile of duloxetine appears to be similar to that of the SSRIs and venlafaxine. In placebo-controlled trials the most common adverse effects were nausea (37%), dry mouth (32%), dizziness (22%), somnolence (20%), insomnia (20%), and diarrhea (14%). Sexual dysfunction has also been reported. Current data suggest that, unlike venlafaxine, duloxetine does not increase the blood pressure, but further post-marketing surveillance studies will be needed to confirm this (1). 

Post-marketing surveillance studies must have a formal protocol and a requirement for data collection, and generate a report. 

Post-marketing surveillance studies, pharmacoeconomic studies, non-interventional trials, clinical audit programmes and the like, which have been commissioned, undertaken or provided by companies, must never be promotional in nature and must be conducted primarily with a scientific or educational purpose. This clause does not preclude the use of the data generated from such studies to support claims in promotion. 

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. 

GPMSP standards were enforced in April 1994 after revision of the text published in May 1993. It became a law in 1997, and was further revised in 2000, to add the Early Post-Marketing Surveillance , applying to new drug in the first six months of marketing. These standards specify the rules to be observed by the manufacturer in order to ensure the reliability of the PMS data, mainly the following ... 

In addition to those items previously mentioned, the FDA is also participating in the development and use of international standards to facilitate pharmaceutical development. The goals of the International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use (ICH) is to facilitate the mutual acceptance of data submitted in support of drug marketing applications by the European Union, Japan, and the United States. The ICH has developed a number of guidelines and standards to harmonize post-marketing surveillance efforts on an international level. 

While the evidence from trials with acceptable methodology was considered limited and more trials are called for, both reviews concluded treatment with P. sidoides offered relief from the symptoms of acute respiratory tract infechon, and specifically from acute bronchihs in children. Taking into account additional data from observational studies and post-market surveillance, results support the use of Umckaloabo (EPs 7630) as a possible alternative to antibiotics for the acute treatment of these conditions. Overall safety and a very low incidence of side effects have been confirmed. 

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. 

Manufacturers of cosmetic and other consumer products can use surveillance data both for premarketing analysis of the sensitization potential of possible ingredients (also relevant for staff in the manufacturing process) and for post-marketing surveillance of ingredients of products already on the market. 

FDA s post-market surveillance of medical devices also left much to be desired. Device manufacturers were required by statute to file annual reports with FDA containing detailed data on product performance, and they were obliged to forward immediately any reports that devices had caused death or serious injury. If the companies concluded that their devices were not responsible for adverse events (because, for example, they had been improperly installed by surgeons), they did not have to report them to FDA. Not surprisingly, many device manufacturers gave themselves the benefit of the doubt in deciding... 

As discussed in the chapter on Drug Surveillance, the safety surveillance mission is to implement the systematic review of spontaneous post-marketing data for proactive risk identification and assessment. In general, signal generation is done using clinical trials data, the medical literature, knowledge of class effects and spontaneous reports. 

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