According to the World Health Organization definition, pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse reactions or any other drug-related problem .
In 1999, the US Institute of Medicine’s report ‘To err is human’ showed that there were more than one million preventable adverse drug reactions each year in the USA, of which 44 000–98 000 were fatal and 7000 were due to medication errors . Although pharmacovigilance had always been concerned with minimizing the risks of adverse drug reactions and medication errors, in March 2007 the Erice Manifesto formulated a new vision, in which patient safety constitutes one of the main challenges to pharmacovigilance .
Root Cause Analysis
Root cause analysis is a systematic investigation technique that looks beyond the affected individual and seeks to understand the underlying causes and environmental context in which an incident related to a medication error occurred. It is usually applied to serious adverse events or critical incidents, which are also known as sentinel events.
A sentinel event is an unexpected occurrence that involves death or serious physical or psychological injury, or a risk thereof [9, 10]. The phrase ‘or a risk thereof’ includes any process variation a recurrence of which would carry a significant chance of a serious adverse outcome. Such events are called sentinel events because they signal the need for immediate investigation and response, as the term ‘signal’ implies in pharmacovigilance .
There are several methods of conducting root cause analysis, such as the Canadian root cause analysis framework, the Ishikawa or Fishbone Diagram  and the Guidelines for Root Cause Analysis of the Massachusetts Medical Society , but they all have the same goals and the same concepts.
The Moroccan Pharmacovigilance Centre has taken action to prevent medication errors after root cause analysis, using the Massachusetts Medical Society’s method in 30 cases of local reactions to intravenous flucloxacillin, with tissue necrosis leading to amputation in two cases. This method has four steps: describing the event, identifying the proximate cause(s) that led to the effect(s), identifying the contributing factors (or latent errors) that led to the proximate cause(s), and creating an action plan.
Root cause analysis identified the proximate cause and the contributory factors: failure to follow the recommendations of the Summary of Product Characteristics (SPC) and the absence of water for intravenous injection in the drug box .
The duties of pharmacovigilance centres in preventing adverse drug reactions and medication errors include alerting healthcare professionals to the importance of reporting such errors, making them aware of the factors that cause them, encouraging them to develop a safety culture that leads to enhanced awareness, and stressing the need for commitment among healthcare professionals in preventing medication errors and improving patient care.
In some countries the two functions of pharmacovigilance and drug regulation reside in the same organization (for example, the Medicines and Healthcare products Regulatory Agency in the UK). Elsewhere, collaboration between pharmacovigilance centres and regulatory agencies is important. For example, after receiving, detecting, and analyzing notifications of suspected adverse drug reactions, the Moroccan Pharmacovigilance Centre submits these results to the Moroccan Drug Regulatory Directorate , which can submit the findings and proposed solutions to the national commission of pharmacovigilance, which submits the outcome to the Minister of Health for a final decision.
Pharmacovigilance centres can contribute to the detection and prevention of medication errors. Collaboration between poison control centres and pharmacovigilance centres needs to be strengthened, in order to improve the quality of data collected, enhancing patient safety, and bridges need to be built linking pharmacovigilance centres, poison control centres, and organizations dedicated to patient safety, in order to avoid duplication of workload.
--Bencheikh, R., & Benabdallah, G. (2009). Medication errors: pharmacovigilance centres in detection and prevention. British Journal Of Clinical Pharmacology, 67(6), 687-690. doi:10.1111/j.1365-2125.2009.03426.x
Reflection Exercise #6
The preceding section contained information
about root cause analysis and sentinel events. Write three case study examples
regarding how you might use the content of this section in your practice.
Peer-Reviewed Journal Article References:
Halfond, R. W., Wright, C. V., & Bufka, L. F. (2021). The role of harms and burdens in clinical practice guidelines: Lessons learned from the American Psychological Association's guideline development. Clinical Psychology: Science and Practice, 28(1), 19–28.
McKay, D., & Jensen-Doss, A. (2021). Harmful treatments in psychotherapy. Clinical Psychology: Science and Practice, 28(1), 2-4.
Teachman, B. A., White, B. A., & Lilienfeld, S. O. (2021). Identifying harmful therapies: Setting the research agenda. Clinical Psychology: Science and Practice, 28(1), 101–106.
What is a sentinel event? Record the letter of the correct answer the
Excerpts from Bibliography referenced in this article
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13. Massachusetts Medical Society. Patient safety: conducting a root cause analysis of adverse events. Available at
http://www.massmed.org/AM/Template.cfm?Section=Patient_Safety_Conducting_a_Root_Cause_Analysis_of_Adverse_Events (last accessed 28 February 2009).
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Azzouzi AA, Alaoui AAM, Thimou AA, Nejmi MM, Maazouzi WW,Madani NN, Edwards IR, Soulaymani RR. Incidence of adverse drug events and medication errors in Intensive Care Units: a prospective multicenter study. J Patient Saf 2009; 5: 16–22.
18. Royaume de Maroc.Ministère de la Santé. Bonnes pratique de pharmacovigilance. Centre Marocain de Pharmacovigilance, 28 Janvier 2004. Available at http://www.capm.ma/sources_site_capm/pv_site_capm/1_ BONNES%20PRATIQUES%20DE%20PHARMACOVIGILANCE_MAROC.pdf (last accessed 28 February 2009)