Adverse drug reactions information

Preparing Food and Drug Administration (FDA)-required information, such as New Drug Applications. Collecting, collating, and using adverse drug reaction information. 

State Food and Drug Administration. Chinese Adverse Drug Reaction Information Bulletin 2005 8. [Lian Bi Zhi injection and acute kidney damage.] http //www. sda.gov.cnAVS01/CL0078/11280.html. 

Educating the Patient and Family The nurse explains die therapeutic regimen and adverse drug reactions to the patient and family. The type of information included in the teaching plan will depend on the drug and the reason for its use. It is important to emphasize die importance of following the recom-... 

Notification by sponsor and/or investigator, where applicable to regulatory authorities and IRBs/IECs of unexpected serious adverse drug reactions and other safety information... 

Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator s brochure for an unapproved investigational medicinal product). 

Any dosage-form can produce adverse drug reactions. Hence, a regular feed back of relevant information on such adverse reactions from the medical practitioners to the appropriate regulatory authorities and the concerned manufacturers would not only help to intensify better safety measures but also widen the scope to improve drug-design by meticulous research scientists all over the world. 

Article 102 includes a provision that requires Member States to share information collected through their pharmacovigilance system with other Member States and the EMEA. The central database EudraVigilance has been developed to allow Member States and the EMEA to share information on adverse drug reactions once all Member States have populated it. 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

The standard conditions of registration require the sponsor to inform the TGA of any adverse drug reactions and safety alerts related to their product of which they become aware. 

The ABPI Code of Practice, in line with European Directive 75/319/EEC, calls for an efficient transfer of information on adverse drug reactions. In the case of defective medicines, an ABPI Batch Recall of Pharmaceutical Products system is in operation. In the ABPI Expanded Syllabus, batch recall is referred to in the Pharmaceutical Technology section and adverse drug reactions in the Pharmacology and Classification of Medicines and the Pharmaceutical Industry and the NHS sections. 

There is a 24 hour Freephone service available to all parts of the UK for advice and information on suspected adverse drug reactions contact the National Yellow Card Information Service at the MCA on 0800 731 6789. 

Lee A, editor Adverse Drug Reactions. Similar information to that of Davie s. 

---