Monitoring for adverse drug reactions

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.

Development and clinical gains of nurse-led medication monitoring profiles

“…Collaborative team working, with patient involvement, is needed to improve medication monitoring (Coleman et al . , Steinman et al . ).…”

Oversight: a retrospective study of biochemical monitoring in patients beginning antihypertensive drug treatment in primary care

“…Monitoring is a process of checking a system that changes with time, in order to guide changes to the system that will maintain it or improve it [1]. Monitoring of drug treatment can have several effects: improved adherence, better selection of drug therapy and better titration of treatment [2].…”

“…Guidelines recommend that patients with newly diagnosed hypertension should have baseline biochemical tests of renal function and electrolyte concentrations before treatment, monitored again 1 week and 1 month after starting treatment, and at intervals following any dose changes [3–5]. These recommendations are based on the supposition that pre‐treatment testing can discover rare secondary causes of hypertension and identify contraindications to treatment, and that post‐treatment biochemical monitoring can identify changes related to adverse drug reactions (ADRs) before they have caused serious or permanent effects, and so avert them [1, 6]. However, primary evidence for the recommendations is lacking.…”

Influence of Coadministration of Antithrombotic Medicines, Warfarin, and NSAIDs on Heparin Safety: Data from a Prospective Observational Study

“…The comprehensive list of indications for this pharmaceutical category illustrates how frequently these drugs are used in daily medical practice. 8,9 Worldwide heparin utilization trends have shown 10% to 15% yearly growth in the past decade. These medicines were primarily used in the inpatient setting, and heparins consumed up to 10% of the total medication costs in hospitals.…”