Side effect management assessment

Chapter 36 Common side effect management Preparation Assessment Management Take-home message References Further reading... 

Control of Plant and Process Modifications Many accidents have occurred because plant or process modifications had unforeseen and unsafe side effects (Sanders, Management of Change in Chemical Plants Learning from Ca.se Histories, Butterworth-Heinemann, 1993). No such modifications shoiild therefore be made until they have been authorized by a professionally quahfied person who has made a systematic attempt to identify and assess the consequences of the proposal, by hazard and operability study or a similar technique. When the modification is complete, the person who authorized it... 

Whereas some drug studies have been done in children with normal IQ who have conduct disorder, there are very few studies involving children with MR and disruptive behavior problems. We are not aware of any studies of psychostimulants primarily to manage conduct problems in children with MR. However, most studies of children with both MR and ADHD have observed improvements on subscales assessing conduct problems, especially as rated by teachers (Aman et al., 1991, Aman et al., 1993). Given the low toxicity and well-tolerated side effects of the stimulants, they should at least be considered for treating conduct disorder in children and adolescents with MR, especially if they have ADHD. 

In severe pain, the administration of an opioid analgesic is usually considered a primary part of the overall management plan. Determining the route of administration (oral, parenteral, neuraxial), duration of drug action, ceiling effect (maximal intrinsic activity), duration of therapy, potential for unwanted side effects, and the patient s past experience with opioids should all be addressed. One of the principal errors made by physicians in this setting is a failure to adequately assess a patient s pain and to match its severity with an appropriate level of therapy. Just as important is the principle that following delivery of the therapeutic plan, its effectiveness must be reevaluated and the plan modified if necessary if the response was excessive or inadequate. 

Therapeutic drug management (TDM) of most antidepressants is not widely available or widely utilized, for any clinical indication. The primary benefits of TDM in the management of antidepressant therapy could include assessment of patient compliance, detection of drug-drug interactions or altered pharmacokinetics, and evaluating the concentration relationship of individual patient response and/or thresholds for dose-related side effects. Of all the classes of antidepressant drugs, TDM of TCAs is most common. 

In my mind, the problem of performing quantitative risk assessment translates to the problem of building good quantitative descriptions or models of the effects and exposure processes Involved In the particular risk problem of Interest. While very Important In the policy process of risk management, the human perception and valuation processes Illustrated on the right hand side of Figure 1 are not part of quantitative risk assessments as It Is usually defined and practiced. 

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