Article

Monitoring for adverse drug reactions

University of Birmingham, Birmingham, England, United Kingdom
British Journal of Clinical Pharmacology (Impact Factor: 3.69). 05/2006; 61(4):371-8. DOI: 10.1111/j.1365-2125.2006.02596.x
Source: PubMed

ABSTRACT Monitoring describes the prospective supervision, observation, and testing of an ongoing process. The result of monitoring provides reassurance that the goal has been or will be achieved, or suggests changes that will allow it to be achieved. In therapeutics, most thought has been given to Therapeutic Drug Monitoring, that is, monitoring of drug concentrations to achieve benefit or avoid harm, or both. Patients and their clinicians can also monitor the progress of a disease, and adjust treatment accordingly, for example, to achieve optimum glycaemic control. Very little consideration has been given to the development of effective schemes for monitoring for the occurrence of adverse effects, such as biochemical or haematological disturbance. Significant harm may go undetected in controlled clinical trials. Even where harm is detected, published details of trials are usually insufficient to allow a practical monitoring scheme to be introduced. The result is that information available to prescribers, such as the Summary of Product Characteristics, frequently provides advice that is incomplete or impossible to follow. We discuss here the elements of logical schemes for monitoring for adverse drug reactions, and the possible contributions that computerized decision support can make. We should require evidence that if a monitoring scheme is proposed, it can be put into practice, will prove effective, and is affordable.

Download full-text

Full-text

Available from: Jamie J Coleman, Jun 16, 2015
1 Follower
 · 
169 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: AIM: This paper reports on the development of an instrument for nurse-led medication monitoring, the West Wales Adverse Drug Reaction profile for respiratory medicines, as part of a strategy to reduce avoidable adverse drug reactions. BACKGROUND: Preventable adverse drug reactions account for 3.7% hospital admissions. Nurse-led medication monitoring may reduce drug-related harm. However, development of medication monitoring strategies is not reported elsewhere. METHODS: The profile was developed by: (1) cognitive interviews (n = 4), (2) the content validity index (n = 10) involving academics, clinicians and service users prescribed respiratory medicines, (3) inter-rater reliability (n = 48) and clinical gains in a nurse-led outpatient clinic. RESULTS: Cognitive interviews prompted more profile changes than either the content validity index or inter-rater reliability testing. Cohen's κ for inter-rater reliability for each item ranged from 0.73-1.00 (good to complete agreement). The profile identified previously unsuspected problems in all participants, including muscular weakness, skin and mouth problems. CONCLUSIONS: The West Wales Adverse Drug Reaction profile was valid and reliable, and helped to detect and ameliorate drug-related harm. IMPLICATIONS FOR NURSING MANAGEMENT: The West Wales Adverse Drug Reaction profile offers opportunities to improve care. Medication monitoring provides the structure to concurrently monitor known adverse drug reactions. Practice-based adverse drug reaction profiles benefit from cognitive, content validity and inter-rater reliability testing.
    Journal of Nursing Management 05/2013; DOI:10.1111/jonm.12067 · 1.14 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: PurposeThe monitoring of serum electrolyte and creatinine concentrations in patients treated with antihypertensive therapy is recommended. We wished to examine the relationship between laboratory monitoring and adverse patient outcomes.Methods We carried out a retrospective cohort study using the General Practice Research Database (GPRD). Patients aged 18 years or older with newly diagnosed hypertension and prescribed a single antihypertensive agent were included. Monitoring was defined as any laboratory test for serum electrolyte and creatinine (or urea) concentrations within 6 months of starting treatment.ResultsWe identified 74 096 patients who were newly diagnosed with hypertension and prescribed a single antihypertensive agent. Twenty six thousand nine hundred forty six (36.4%) patients had any biochemical laboratory measurement within 6 months. Three hundred ten patients (0.4%) died, 1451 (2%) were admitted to hospital at least once and 29 749 (40.2%) discontinued their first course of antihypertensive treatment within 6 months. Patients were more likely to be admitted to hospital if their biochemistry had been monitored after beginning treatment (adjusted hazard ratio (HR) 1.37; 95%CI 1.21–1.55). They were also marginally more likely to discontinue treatment (adjusted HR 1.04; 95%CI 1.02–1.07). They were not significantly more likely to die (adjusted HR 1.21; 95%CI 0.87–1.67).Conclusions Biochemical testing at baseline and monitoring after starting treatment is often omitted in newly diagnosed hypertensive patients. Those patients who are monitored are more likely to be admitted to hospital and to discontinue initial antihypertensive therapy, but not to die. Many biochemical adverse drug reactions are found only by laboratory monitoring. Copyright © 2010 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 01/2010; 19(5):482 - 489. DOI:10.1002/pds.1935 · 3.17 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Monitoring drug treatment is important to assess the therapeutic effects and to prevent adverse drug reactions. Unfortunately, the clinical evidence for monitoring is often missing. To attain evidence-based laboratory monitoring and to improve patient safety it is mandatory for the clinical chemist to develop effective and rational methods for monitoring. The legal source for this evidence-based information is the drug label. We analysed frequency, nature, and applicability of instructions on laboratory monitoring described in 200 drug labels. The applicability of instructions was assessed with an adapted Systematic Information for Monitoring score. Seven items of information were evaluated: why to monitor, what to monitor (essential), when to start or stop monitoring, how frequently to monitor, critical value (essential) and how to respond (essential). Each item scored one point when information was described specifically, otherwise the score was zero. Instructions were applicable if all three essential items scored. In 131 drug labels, 566 instructions on laboratory monitoring were identified, an average of 2.8 per drug label. Kidney, liver, electrolyte, and drug monitoring were important biomarker categories (71%). The median applicability score was 2.1 (0-6) and 95 (17%) instructions were applicable. Six determinants were associated with applicable instructions: kidney (OR 7.0; 95% CI 4.4-11.3), creatine phosphokinase (4.5; 1.5-13.6), drug selection (6.8; 4.0-11.7), dose adjustments (2.4; 1.5-3.7), year on the market 2000-2007 (2.6; 1.1-6.1) and statins (4.8; 2.5-9.0). Drug labels frequently describe instructions on laboratory monitoring, but these are ambiguous and incomplete and clinical applicability for the professional is limited.
    Clinical Chemistry and Laboratory Medicine 01/2012; 50(8):1351-8. DOI:10.1515/cclm-2011-0753 · 2.96 Impact Factor