Adverse events assessment

Schlagenhauf P, Steffen R, Lobel H, Johnson R, Letz R, Tschopp A, Vranjes N, Bergqvist Y, Ericsson O, Hellgren U, Rombo L, Mannino S, Handschin J, Sturchler D. Mefloquine tolerability during chemoprophylaxis focus on adverse event assessments, stereochemistry and compliance. Trop Med Int Health 1996 l(4) 485-94. 

Sturchler D. Mefloquine tolerability during chemoprophylaxis focus on adverse event assessments, stereochemistry and compliance. Trop Med Int Health 1996 l(4) 485-94. 

Encourage teamwork as a strategy to support staff who work extended work shifts or hours Consider fatigue as a potentially contributing factor when reviewing all adverse events Assess the environment provided for sleep breaks to ensure that it fully protects sleep... 

ADCC. Cetuximab is approved for treatment of metastatic colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN). Interestingly, an adverse event, acneiform rash seems to correlate with a better response to cetuximab, while there is no such correlation with expression levels of EGFR assessed by immunohistochemistry. Further side effects are rare infusion reactions and hypomagnesia. Two other anti-EGFR antibodies approved for clinical use are the fully human antibody panitumumab (Vectibix)... 

The first issue lies in the whole realm of the human disease process itself. Many adverse drug events mimic diseases and vice versa. Is an adverse event really an adverse event, or is it merely a natural occurrence of a disease process that is entirely independent of drug exposure The science of drug safety is often complicated by the lack of objective markers of drug toxicity that can systematically separate a disease process from an adverse drug event process [2]. Clinical trials, often viewed as the gold standard to assess efficacy, are simply too limited in scope to answer safety questions in a systematic way. 

Failure to assess adverse events that occur more than 30 days after the last dose of a drug... 

Failure to assess adverse events occurring outside a scheduled time window... 

Temporal Relationships of Adverse Events. The temporal relationship between duration of product exposure and development of an adverse event is important in assessing causality. But how can data on temporal relationships be systematically summarized in a database containing thousands or even hundreds of thousands of subjects Temporal relationships cannot be clearly elicited if only frequencies of adverse events between treatment and control groups are compared. There can be many disparities in the subjects time of exposure or time at risk. Toxic manifestations of drugs may not occur until several months or even years after the initial exposure to the drug. How do we systematically assess delayed toxicity of a previously prescribed drug from the effect of a newly prescribed drug Such a scenario occurred with reported cases of pancreatitis associated with valproic acid therapy, in which some cases appeared several years after therapy [2]. 

There are a variety of process safety risks one needs to assess with chemical processes. In general, these risks will lead to an evaluation of the potential for the process to have precipitous changes in temperature and or pressure that lead to secondary events such as detonations, explosions, over pressurizations, fires, and so forth. The most cost-effective way of avoiding these sorts of risks is through the adoption of inherent safety principles. Inherent safety principles are very similar to and complementary to pollution prevention principles, where one attempts to use a hierarchy of approaches to avoid and/or reduce the risk of an adverse event. The reader is referred elsewhere to a more complete treatment of this important area of process design. ... 

Control of existing risk factors and the presence of new risk factors for IHD should also be assessed regularly. Routine screening for the presence of metabolic syndrome will help in assessing the control of known major risk factors and identifying new risk factors. If new risk factors are identified and/or the presence of metabolic syndrome is detected, modify the pharmacotherapy regimen, as discussed previously, to control these risk factors and lower the risk of IHD and IHD-related adverse events. 

Re-evaluate the pharmacotherapy regimen at each visit to assess effectiveness, adverse events, and need for drug titration. 

Elicit adverse events of therapy in a non-leading manner and ask the patient to judge their severity. Ask the patient or par-ents/guardians what measures if any were used to ameliorate them. Assess adherence (ask patient or parents/guardians about missed doses do pill counts if the prescription vial is available). 

Develop a follow-up plan to determine whether the patient has achieved a cure, which includes a clinical evaluation of signs/symptoms, repeat blood cultures, and possibly a repeat echocardiogram. The patient also should be assessed for any adverse events. This should be performed usually within a few weeks after the completion of therapy. 

Develop a follow-up plan to assess the resolution of infection once the patient has completed therapy. Assessment of any adverse events also should be conducted at this time. 

Develop a plan to assess the effectiveness of the overall treatment plan, focusing on educating the patient on ways to monitor and track adverse events and/or disease-related symptoms throughout therapy. 

Determine success of the overall treatment plan by obtaining a thorough history of adverse events experienced with the previous chemotherapy/endocrine therapy treatment and objective measures of response to therapy. Assess effects on quality-of-life measures such as physical, psychological, and social function and well-being. 

Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40... 

Patients with short-term or chronic insomnia should be evaluated after 1 week of therapy to assess for drug effectiveness, adverse events, and compliance with nonpharmacologic recommendations. Patients should be instructed to maintain a sleep diary, including a daily recording of awakenings, medications taken, naps, and an index of sleep quality. 

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