Reporting ADRs

Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADR to herbal remedies and conventional OTC medicines. Br J Clin Pharmacol 45 496-500, 1998. 

Another problem in detecting and reporting ADRs has been the discovery of instances of proven inveshgafor fraud, which can vary from bewildered igi deliberafe dishonesty ... 

Some choose nof to report ADRs — either because it requires too much effort or because they are deliberately attemphng to defraud. 

Note It is as well to inform doctors who report ADRs to medical representatives that the company is legally obliged to report the ADR to the CSM in 15 calendar days, and that a rapid reply would be appreciated if further information is required. 

Most drug labels report incidence for ADRs in categories such as common, frequent, infrequent, rare, or not known. These clinical incidence data were entered into the BioPrint database in text-based groups defined below. Although some drug labels report ADRs with continuous clinical incidence data from 0% to 100%, this data was also entered according to the text-based bins ... 

Adverse drug reactions constitute a major morbidity, causing deaths in some cases. About 6% of all hospital admissions are related to ADRs and about half of these are avoidable. There is also a substantial diagnostic problem since there is a limited way in which the body may respond patho-physiologically. This means that ADRs often masquerade as other diseases. Commonly reported ADRs are given in Table 1. 

The MA holder has to keep records on all severe ADRs that en-e reported to him by a healthcare professional in Belgium or outside the European Union. Within 15 days he or she has to report ADRs to the Minister (pharmaceutical inspection). It is recommended to use the CIOMS document to indicate the clinical data it also has to be indicated whether the ADR is already mentioned in the approved leeiflet. For products approved by the central procedure, these data have to be reported immediately to the EMEA within 15 days. 

Pharmacy Monitoring System. This is a similar system, collecting ADRs related to non-prescription drugs, by designated pharmacies. Around 2800 pharmacies report ADRs to the MHLW. 

Manufacturers (and wholesalers) should also report ADRs to the MHLW, according to the Law. 

Healthcare professionals may report ADRs by telephone 1800 FDA 1088 Fax 800 FDA 0178 or maU Med Watch, 5600 Fishers Lane, Rockville, MD 20852-9787or through the Medwatch internet site www.fda.gov/ medwatch. Medwatch provides feedback to healthcare professionals though the FDA Medical Bulletin and the Medwatch home page (www.fda.gov/ medwatch). In Europe and other countries individual Ministries of Medicine may have a system in place such as Irelands yellow card system. One might also contact The World... 

Studied. Some of the information gathered on spontaneous adverse event reporting (ADRs) was made available to the ICH EC Working Party by Dr M. Papaluca. 

In the past decade there have been major advances in the application of analytical methods to detect to signals from spontaneously reported ADRs (see Chapter 4). The general view is that these tools are now sufficiently well-established to be regarded as an essential component of the method but there are some sceptics. 

For ectasy 3,4-methylenedioxy-N-methylamphetamine, the most commonly reported ADRs occurring in >5% of patienfs using fhe agenf were viral haemorrhagic disease, hypertension, tachycardia, arrhythmias, tachypnoea and hyperthermia [11 ] [12 ] [13 ]. Serotonin syndrome has been associated with the concurrent use of ecstasy and a serotonergic agent [12 ] [13 ]. 

A retrospective cohort study of new atomoxetine users (n = 20,995) showed that the propensity-score adjusted hazard ratio for sudden death/ventricular arrhythmia was 0.41 (95% Cl 0.10-1.75), for stroke 1.30 (95% Cl 0.52-3.29), for myocardial infarction 0.56 (95% CLO.16-2.00) and 0.92 for stroke/myocardial 0.75 infarction (95% CEO.44-1.92) [2 ]. For atomoxetine, the most commonly reported ADRs in >5% of patients using the agent were decreased appetite, weight loss, suicidal thoughts in children, abdominal pain, erectile dysfunction, headache, insomnia, nausea, xerostomia and tachycardia [6 ] [7 j [36 j [37 ]. 

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