Clinical risk management plan

What sorts of drugs and indications have special clinical hazards and need special risk management programs At the pan-European level, the EMEA now considers risk management plans more or less routinely prior to Marketing Authorization. But in general, the products for which detailed risk management plans will almost always be required are... 

Chang L, Tong K, Ameen V. Ischemic colitis and complications of constipation associated with the use of alosetron under a risk management plan clinical characteristics, outcomes, and incidences. Am J Gastroenterol 2010 105 866-75. 

Nonetheless, hospital-based clinical engineering departments—if adequately staffed and prepared— are often the best suited to the task of managing the equipment-related risks. To do so, however, also requires a thorough, organizational-wide understanding and awareness of each of the model s major elements and—especially—their interactions. Even if the hospital s risk management department is not famihar with Reason s model, they may be a tremendous resource in the development and dissemination of the overall plan. 

The purpose of the safety specification is to explicitly consider the level of safety that has been demonstrated so far. It should identify what is and is not yet known about safety and the latter (i.e. what is not known) should be a major driver of the pharmacovigilance plan. The purpose of that plan is essentially to attempt to find out what is not yet known, largely because of the limitations of clinical trials. Risk minimisation plans are not invariably required - essentially they are needed when there are known or potential risks which cannot simply be managed through routine measures contained in the product information. 

The hospital uses the following risk criteria, at a minimum, for identifying, evaluating, and creating an inventory of equipment to be included in the medical equipment management plan before equipment is used equipment function, physical risks, equipment history, maintenance requirements, and environment of use. Clinical engineering uses the AIMS database to inventory and assist in equipment evaluation and risk stratification. 

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