Adverse events communication

Corrections or removals of devices from the market may be necessitated either as a consequence of adverse event reports or the discovery of manufacturing or other defects that pose a risk to public health. The manufacturer must submit a report to the FDA within 10 days of initiating such corrections or removals. This should provide information on the identity and number of devices concerned, the reasons for doing so, and the communication of the action. The manufacturer must also maintain records of other corrections or removals that need not be reported. 

Humans should use computers to do functional work for them in the most efficient manner possible. However, we must not delude ourselves into thinking that the mere use of a computer to analyze adverse events will magically analyze these events in a systematic, efficient way. Computers do not automatically produce coherent, auditable results that can be subsequently reproduced with ease. Computers must be actively programmed through an iterative process involving tight communication between analysts and software developers until these processes are totally functional. 

Watchful waiting and safety-net antibiotic prescriptions are approaches being used more frequently to attenuate microbial resistance and avoid unnecessary adverse events and costs of antibiotics. Observation is practiced extensively in Europe and involves monitoring for 48 to 72 hours after diagnosing AOM to see if spontaneous resolution will occur. Observation or delayed antibiotic therapy should be considered only in otherwise healthy children without recurrent disease (Fig. 69-1) and only if proper follow-up and good communication exist between clinicians and the parent/caregiver.4,5,16... 

Drug adverse events will always remain part of modern medicine and the potential for another thalidomide disaster cannot be totally dismissed. The prevention of a future disaster lies, not in simply increasing the number of regulatory hurdles but in the ability to communicate and control unexpected events and where necessary make rapid withdrawal from the market. 

Safety/Health and Environmental Affairs are often interwoven in practice, especially where process emissions, chemical exposure, and waste disposal can impact on public health. Many, if not most, companies with chemical synthesis plants in populated areas work with local communities to foster good relations sometimes via open house days or in the creation of action plans to deal with adverse events which may occur in plant operation. The presentation on Environment (Chapter 5) addresses the canon that has developed to deal with exposure to chemicals, with the impact of spills and emissions on all life forms and with waste recycle, treatment, and disposal. 

The AD 2000 West Midlands Donepezil Trial was based on 565 community-resident patients with mild to moderate Alzheimer s disease who took donepezil 5 or 10 mg/day for 12 weeks(31). The results suggested that donepezil is not cost-effective, with benefits below minimally relevant thresholds. Common adverse events and those contributing to withdrawal of medication could have major impact on quality of life and costs, but were not measured or reported. 

In a multicenter, parallel-group, double-bhnd trial in 420 evaluable patients aged 6 months to 16 years with community-acquired pneumonia, the therapeutic effect of azithromycin (once-daily for 5 days) was similar to that of co-amoxiclav in children under 5 years and to that of erythromycin tds for 10 days. Treatment-related adverse events occurred in 11% of those given azithromycin and 31% in the comparator group (8). 

Abnormal taste developed in 17 of 175 patients treated with clarithromycin 250 mg bd for 10 days for community-acquired pneumonia, compared with 3 of 167 patients treated with sparfloxacin (18). Mild to moderate gastrointestinal disturbances were the most common adverse events and were reported in 13 and 11% respectively. 

A review of the data generated in the last 4 years has amply described the continued efforts of the scientific community to monitor and understand true measles vaccine-associated adverse events (6). The rapidity and clarity of this same community s debunking of the spurious associations with Crohn s disease and autism suggests that those charged with vaccination programs have learned from past mistakes. 

In a prospective, uncontrolled, unbhnded, phase III trial in 254 patients with community-acquired pneumonia diagnosed by culture or serologically, moxifloxacin (400 mg/day orally for 10 days) produced a bacteriological response of 91% (9). Drug-related adverse events were reported in 33% of patients nausea (9%), diarrhea (6%), and dizziness (4%) were the most common adverse events. 

Stokes SL, Atkinson WL, Becher JA, Williams WW. Vaccination against orthopoxvirus infection and adverse events among laboratory personnel, United States, 1983-1991. Personal communication, 1992. 

A critical examination (4) of a report (5) of several children whose chronic bowel and behavioral abnormalities were linked to measles, mumps, and rubella (MMR) immunization can be used as an example to underline Halsey s comments. Without effective and credible systems for the detection of vaccine-associated adverse events through pharmacovigilance, for distinguishing causal reactions from coincidental reactions by pharmacoepidemiological or other studies, and for risk communication, vaccine safety concerns may confuse the media and the public. 

Adverse events after immunization—the need for improved research, surveillance, and communication... 

Among the many new developments in the communication of adverse events, the increasing role of the Internet should be mentioned. Many national bodies (for example the FDA, Rockville, Maryland, USA, www.fda.gov, or the CDC, Atlanta, Georgia, USA, www.vaers.org) and intergovernmental health authorities... 

Besides the medicine adverse event monitoring, a medicine quality defect reporting system is operated as part of the post-marketing surveillance in Hungary (Bayer 1984, Paal 1988). All phcirmacists working for medicine supply companies or in community and hospital pharmacies have the obligation to report suspected medicine qucility defects to the NIP. These reports are evaluated in close collabo-... 

In the United Kingdom, regulation is derived from the Medicines Act of 1968, which provides a comprehensive system of licensing affecting most aspects of the sale of medicinal products. It also contains provisions on related matters, such as pharmacovigilance and the requirements for the reporting of adverse events (AEs). The Medicines Act encompasses measures contained in European Community Directives, including the first on the control of medicines, introduced in 1965. The Medicines Act led to the creation of various... 

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