Reporting ADRs companies

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. 

The practice of ADR reporting by companies has many complexities that I have not discussed and which are best learned on-the-job... 

Despite the anecdotal nature and sometimes poor documentation, publication of case reports in journals remains one of the most useful primary sources of information on ADRs. ADR reports in the literature can be identified in several different ways. Prepublication manuscripts describing a spontaneous case report or an event from a clinical trial are sometimes provided by authors to the manufacturer of the drug and the regulatory authority in that country. Pharmaceutical companies are required to be aware of the literature as to the safety of their approved therapeutic products, and are assumed (by law) to be cognizant of such. 

Published responses from pharmaceuhcal companies to ADR reports follow a similar pattern, usually containing some of the following forms of denial ... 

In the early 1960s, drug companies began to lobby for government indemnity for the vaccines they developed, tested, and produced. Because so many people are vaccinated at one time, particularly school-age children, ADRs from a vaccine can carry considerable liability. As more diseases have become vaccine-preventable, more ADRs have been reported. In 1974, impetus for indemnity increased when the courts upheld a jury verdict of 200,000 for a child who developed polio from the Sabin live-polio vaccine. ... 

The company has a legal obligation to report all suspected serious ADRs occurring in the European Union to the Licensing Authority within 15 days of the receipt from any health professional. Serious and unexpected suspected ADRs are required to be reported from outside the EU within 15 days of receipt from health professionals. All other ADRs should be reported in the periodic safety updates. 

What company action is taken on reports of suspected ADRs ... 

All reports on suspected ADRs are co-ordinated and assessed in the company s Medical Department and/or Pharmacovigilance Unit. As much relevant information as possible is obtained from the doctor concerned to enable physicians and scientists to assess the case and determine whether the reaction was caused by the product. A special company ADR card which is often similar to the CSM yellow card may be sent to the doctor to be completed with the required details. 

Pharmaceutical companies are now required to report all serious suspected ADRs to the CSM within 15 calendar days of receipt of the original information by the representative or other appropriate employee. Companies are also now obliged to submit reports received from all health professionals... 

A yellow card system exists which can be used by physicians, dentists cind pharmacists to report the adverse drug reactions (ADRs) that their patients are experiencing. Companies can also voluntarily communicate ADRs. Post-marketing surveillance in Belgium is regulated by the following laws ... 

I-III studies ADRs notified to the company during clinical studies. If the product has been marketed, then all postmarketing experience should be assessed. Expert reports are not a promotion platform for the product but an assessment of the data generated, an explanation of the results and an interpretation. An expert report should not normally exceed 25 pages of A4. The expert reports should also make clear whether or not the studies submitted have been conducted according to GLP standards and whether the clinical studies have been conducted to GCP principles and in accord with the Declaration of Helsinki. A statement of the enviromental effects of the product is also necessary. 

Use suspected ADR when a health professional or investigator indicates that a drug may have been responsible for an event in an individual case. A vahd case submitted as a spontaneous report to a company or regulatory authority is a suspected ADR by definition. 

Prior to authorisation, in relation to products being investigated in clinical trials, ADR reporting requirements are different. The key principles here are that serious and unexpected (as defined by absence from the investigator s brochure) suspected ADRs SUSARs should be expedited, and that such reports should be unblinded for this purpose. Steps should be taken to ensure that personnel directly involved in the trial remain blinded. Companies are required to submit SUSARs both to regulatory authorities and the ethics committee(s) that approved the trial. They must also ensure that all investigators are kept informed about SUSARs so as to meet the key objective of protecting the safety of trial subjects. 

In general, such studies will measure events rather than suspected ADRs but any serious events which are suspected by investigators to be drug-related should be submitted to regulatory authorities as an expedited report. Regulatory guidelines indicate that companies planning such studies should submit a protocol for... 

At the time of writing, there were 84 national schemes which collaborate with the programme and provide their spontaneous ADR reports to the WHO at least four times per year. The data are entered onto a database which is an international reference source accessible to national authorities and pharmaceutical companies. By mid-2008 this database held around 3.7 million case reports. 

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