Reducing Medication Harms: Thoughts and Strategies.

Abstract

In 1960, Alphonse Chapanis turned his attention from engineering to healthcare. He dedicated himself to studying medication errors, having identified seven sources of errors with potential harm to the patient, including medicine omitted, or given to the wrong patient, at the wrong dose, as an unintended extra dose, by the wrong route, at the wrong time, or as the wrong drug entirely.[1] Sixty years later, many of these errors are still often detected in clinical practice.Drug safety is not a static concept. Over the years, the (wrong) perception that medicines were safe when made available to the population has changed, causing some therapeutic catastrophes, like the thalidomide tragedy in the 1960s. Damage caused by medication can be considered as the “dark side” of drug therapy. Whenever a decision is made to use medications for a particular patient, it is intended that the benefit outweigh the inherent risk. For that, it is necessary to be aware of all types of harm that can be inflicted on patients, so that strategies can be adopted to minimize it. This editorial will focus on three strategies for (1) medication errors, (2) adverse drug reactions (ADR), and (3) look-alike-sound-alike (LASA) medicines.Medication errors are defined as any preventable incident that can cause harm to the patient or lead to inappropriate use of medicines, when these are under the control of healthcare professionals or patients. These incidents can be related to professional practices, to the products themselves, or to the processes, and include failures in prescription, communication, labelling, packaging, denomination, preparation, distribution, dispensing, administration, education, monitoring, and use of medicines.[2] In other words, a medication error will be any preventable incident that occurs by action or omission at any stage of the medication use process and that may or may not cause harm to the patient. The definition of error contains the following two important aspects to highlight: the first is its avoidable character, which implies the need to implement prevention strategies; the second is that not all errors cause harm to the patient.[3] It is, therefore, essential that health institutions maintain a culture of safety that is not punitive, that allows keeping updated records of errors, and implementing strategies for their minimization.The work performed by Al Mardawi et al.[4] published in the present issue of Global Journal on Quality and Safety in Healthcare suggests an abbreviated root cause analysis to reduce preventable harm events due to medication errors. This approach, which is less time consuming than the traditional root cause analysis, significantly reduced medication error recurrence. However, as a limitation, authors only applied their approach to medication errors that caused less serious harm and excluded errors due to human cause alone, which limits generalizability of the concept.ADRs are very important and responsible for a significant burden in healthcare services. An ADR is a harmful effect suspected to be caused by a drug,[5] as it is assumed that it is an inherent risk of drug utilization. Even so, some ADRs are preventable, and healthcare providers should be aware of potential harm to patients. Some authors have suggested that ADRs are responsible for approximately 5 to 10% of hospitalizations worldwide, being frequently predictable and possibly avoidable reactions. Furthermore, it has been shown that approximately 25% of the ambulatory patients suffer from ADRs, 13% of which are reported as serious.[6]Other pharmacoepidemiologic data have suggested, for example, that in United States hospitals the incidence of serious and fatal ADRs was relevant, with evaluations of 6.7 and 0.32%, respectively, making ADR between the fourth and sixth leading causes of death.[7] In the European Union, ADRs represent approximately 6.5% of hospitalizations and 197,000 deaths per year.[8]Although some ADRs are unpredictable, such as like penicillin anaphylaxis, many are preventable with adequate foresight and monitoring. Preventability usually refers to when the drug treatment plan is inconsistent with current evidence-based practice or is unrealistic when taking known circumstances into account.[9] There are two generic approaches that can be taken to avoid medication harms, as follows:Prior knowledge of the patient's clinical condition can provide information about their susceptibilities and thus reduce the risk of future ADRs. A patient's medication history will identify any previous ADRs and therefore preclude re-exposure to the drug. New areas like pharmacogenetics have allowed the development of new personalized therapeutic strategies, considering susceptibilities by population subgroups, and even individual ones. No doubt that a set of new tools with high scientific robustness are changing the way that ADRs are predicted, prevented, detected, and managed. Error prevention can be planned by means of retroactive and proactive tools; however, it is necessary to consider, the approaches used to detect errors are likely to be different in research and routine care, given the available resources.The existence of confusing drug names is one of the most common causes of medication error and is of concern worldwide. The first LASA list was published in 1973 by Teplitsky,[10] constituting the first major alert to this problem of medication errors. Contributing to this confusion are orthography/illegible handwriting, similar packaging or labelling, dosage forms, incomplete knowledge of drug names, newly available products, and the failure of manufactures and regulatory authorities to recognize the potential for error and to conduct rigorous risk assessments. In addition, manufacturers and regulatory authorities do not always recognize the potential for inherent error. Large investments are not always available to conduct rigorous risk assessments, both for commercial brands and for the international nonproprietary name (INN), before the designations are approved.[11] The World Health Organization has also devoted itself to this problem—through the International Nonproprietary Names Expert Group—to develop INN for pharmaceutical medicinal substances for worldwide acceptance. However, there are still many cases where drugs of the same brand name are marketed in different countries, with different active substances.Health professionals and organizations must always bear in mind the fundamental principle of healthcare, primum non nocere. Patient safety and well-being must be the first goal in every setting to build safer systems, learn from errors, and reduce the human and financial burden.