Journal of Clinical Medicine Article Detection and Prevention of Medication Errors by the Network of Sentinel Pharmacies in a Southern European Region Anna M. Jambrina 1,2, * , Àlex Santomà 1 , Andrea Rocher 1 , Neus Rams 1 , Glòria Cereza 1,3 , Pilar Rius 4 , Montserrat Gironès 4 , Clara Pareja 1 , Àngels Franch 2,5 and Manel Rabanal 1,2,5 1 Directorate-General for Healthcare Planning and Regulation, Ministry of Health, Government of Catalonia, 08028 Barcelona, Spain 2 Physiology Section, Department of Biochemistry and Physiology, Faculty of Pharmacy and Food Science, University of Barcelona, 08028 Barcelona, Spain 3 Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain 4 Council of the Pharmacist’s Association of Catalonia, 08009 Barcelona, Spain 5 Nutrition and Food Safety Research Institute (INSA-UB), 08921 Santa Coloma de Gramenet, Spain * Correspondence: amjambrina@gencat.cat Abstract: A medication error (ME) is a drug-related problem that has been recognized as a common and serious threat to patient safety. The aim of this study was to detect and analyze ME reports occurring throughout the therapeutic process through the community’s pharmacies in order to improve the efficacy and safety of medications and contribute to the prevention of future MEs. This was a three-year descriptive, observational, and prospective study to detect and analyze the different MEs reported by the Catalan sentinel pharmacies network (Catalan SePhaNet). In total, 1394 notifications of MEs were reported (an incidence rate of 737.34 cases/100,000 inhabitants). MEs were detected more frequently in primary care centers. Most of the MEs reported were caused by an incorrect, incomplete, illegible, or verbal medical prescription (41.3%). Of the global notifications detected, 71.9% did not reach the patient (categories A and B). The drugs most frequently implicated Citation: Jambrina, A.M.; Santomà, in the reported ME cases were beta-lactam antibiotics. In 6.0% of the cases, the ME caused injury to the À.; Rocher, A.; Rams, N.; Cereza, G.; patient (categories E and F). In 72.0% of the global notifications, a pharmacist’s intervention avoided Rius, P.; Gironès, M.; Pareja, C.; the ME. The importance of a community pharmacy and the role of a pharmacist were demonstrated Franch, À.; Rabanal, M. Detection in aspects related to patient and drug safety. and Prevention of Medication Errors by the Network of Sentinel Keywords: adverse drug reaction (ADR); medication error; medication safety; drug-related problems; Pharmacies in a Southern European community pharmacies; health services administration; pharmacoepidemiology Region. J. Clin. Med. 2023, 12, 194. https://doi.org/10.3390/ jcm12010194 Academic Editor: Renke Maas 1. Introduction Received: 7 December 2022 A medication error (ME) is defined as any preventable event that may cause or lead Revised: 22 December 2022 to inappropriate medication use or patient harm while the medication is in control of the Accepted: 23 December 2022 health care professional or patient [1]. Published: 27 December 2022 MEs, together with adverse drug reactions (ADRs), are drug-related problems that have been recognized as common and serious threats to patient safety [2]. In this sense, drug-related problems are important causes of morbidity and mortality, as well as hos- pital admissions and lengthened patient stays, thereby increasing costs for the health Copyright: © 2022 by the authors. care system [3]. Licensee MDPI, Basel, Switzerland. An ME occurs when weak medication systems and/or human factors affect prescrib- This article is an open access article distributed under the terms and ing, transcribing, dispensing, administering, and monitoring practices [4]. MEs can cause conditions of the Creative Commons undesirable adverse drug events, and in some cases, they can lead to life-threatening Attribution (CC BY) license (https:// injuries [5]. Reducing preventable harm in healthcare, as well as the errors that lead to creativecommons.org/licenses/by/ them, has long been recognized as a patient safety priority; recent reports estimate that 5% 4.0/). of patients are exposed to preventable harm during their medical care [6,7]. J. Clin. Med. 2023, 12, 194. https://doi.org/10.3390/jcm12010194 https://www.mdpi.com/journal/jcm J. Clin. Med. 2023, 12, 194 2 of 13 As an important but underappreciated part of the healthcare system, community pharmacies play a vital role in patient safety by ensuring that medications are used safely by patients [8]. At the same time, community pharmacies are the closest health care centers for patients because of their accessibility and geographical capillarity, and they are where pharmacists can take care of most of the low-complexity processes. To this end, in Catalonia, a region of Southern Europe, a network of sentinel pharma- cies (Catalan SePhaNet) has been created and promoted [9]. This network is a new sentinel surveillance model in pharmacy offices that has been integrated into health systems where a community pharmacist is able to participate in shared management scenarios. In this context, community pharmacists collaborate with health administration in the observation, detection, and reporting of events of interest related to the surveillance of medicine pre- scription, dispensing, and administration, as well as in the description of population-level behaviors regarding important health problems. The Catalan SePhaNet works in several lines of performance; one of them is in the detection, notification, and pharmacist inter- vention in cases of suspected ME. The network pharmacies run these activities in order to strengthen the existing voluntary notification system and verify if the actions in terms of prevention of MEs are useful, as well as to increase drug safety [9]. In this sense, community pharmacists can help improve health by acting in certain aspects. On the one hand, they can decrease the probability of ADRs and increase the reporting of low-severity events detected during dispensing. On the other hand, they can promote greater adherence to medication, strengthening and improving the quality of health care. In this study, we detected and analyzed ME reports occurring in the therapeutic process through the Catalan SePhaNet in order to improve the efficacy and safety of medications and contribute to the prevention of future MEs. 2. Materials and Methods We conducted a three-year descriptive, observational, and prospective study (January 2019–December 2021) in order to detect and analyze the different MEs reported by Catalan SePhaNet community pharmacies in Catalonia, Spain. 2.1. Sampling Frame The Catalan SePhaNet, formed by 75 community pharmacies scattered throughout the region, was selected proportionally to a stratification of the population of Catalonia based on criteria of representativeness, ensuring a coverage of approximately 2.5% of the total population of Catalonia being monitored [9]. The inclusion criteria were a patient who attended at the community pharmacy with a foreseeable incident that could result in inappropriate use of the medication or harm [1]. Dual cases—cases involving incomplete information and relating to products which were not drugs—were excluded. The community pharmacist only detected MEs at the time of dispensing the medica- tion during their daily care practice in the pharmacy, without having access to the patient’s medical records. The ADRs corresponding to the severe ME cases were defined by the European Medicine Agency (EMA) as noxious and unintended responses to medicine [10]. The ADRs were reported directly to the Regional Pharmacovigilance Centre. The respon- sible technicians of this Centre recorded the case, analyzed the data, and accessed the patient’s medical history, as required. The community pharmacists were only in charge of detecting the cases, and the evaluations of causality were carried out by professionals from the Regional Pharmacovigilance Centre. Participant pharmacists were trained by expert pharmacists from the Catalan Ministry of Health and the Council of the Pharmacist’s Association of Catalonia. The workshop had a duration of 4 h and was developed in two parts. Initially, a theoretical part was taught to improve the knowledge of the pharmacists in these subjects. Next, real cases of received notifications were used, with the aim of improving the information collected J. Clin. Med. 2023, 12, 194 3 of 13 and the ability to detect cases and acquire the knowledge and skills necessary to carry out the activity. The main topics of this training were the theoretical bases of MEs, their severity, the causes, the places of detection, and the patient harms associated with the ADRs. Several training sessions were performed to maintain a regular exchange of information and resolve questions. 2.2. Data Collection We gathered the data through an anonymous 11-item electronic form filled in by the community pharmacists during their daily care practice whenever a ME was detected. The electronic form filled in was a validated questionnaire (“Notification of medication error”) and was grouped in four different parts: pharmacy identification, ME classification, medication involved in the ME, and pharmacist management. The recorded variables were: • Code and name of sentinel pharmacy • Date of ME detection • Classification of the ME severity (choice between severity categories A to I) according to the Institute for Safe Medication Practices (ISMP) classification [11] • National code of medicinal product • Name of medicinal product • ME origin (choice between pharmacy office, primary care center, hospital, patient residence, nursing home, and other) • Cause of the ME (multiple answer: prescription, verification, dispensing, adminis- tration, similarity of packaging, similar names, incorrect labelling, incorrect dose, incorrect preparation, lack of information, system errors, non-compliance of the pa- tient, therapeutic duplicity, and others) • ME has been avoided (yes or no) • Description of the preventive pharmaceutical action performed • If the ME had caused an injury to the patient and a description of the associated ADR type • Observations (free text field to indicate any relevant aspect during the ME detection) Patient information was obtained anonymously by observation during the interview and neither verbal nor written consents were needed. All confidential information collected was recorded in the applications portal of the Ministry of Health, accessible by username and password through the Drugs and Pharmacy Channel website. Overall, it allowed us to obtain information about the type of ME that occurred most frequently and the involvement of the pharmacist in their prevention. 2.3. Statistical Analysis The variables were categorical and were summarized as numbers of (notified) cases and percentages. We grouped the numbers of notifications by quarters for the statistical analysis. Then we used the Kruskall–Wallis test to find the significant differences between the groups. For the multiple comparison, we applied a Dunn’s test post hoc. For the purposes of this study, we considered a p-value of <0.05 to be statistically significant. All the analyses were conducted with the XLSTAT software (Data Analysis and Statistical Solution for Microsoft Excel, Addinsoft, Paris, France 2017) [12]. 3. Results 3.1. Incidence Data During the study period, 1394 notifications of MEs were reported by Catalan SePhaNet. This represents a three-year cumulative incidence rate of 737.34 cases/100,000 inhabitants. The incidence of ME notifications during the pre-pandemic phase of the SARS-CoV-2 period in 2019 overall (302.05 cases/100,000 inhabitants) was lower than the incidence rate during the pandemic period in 2020 and 2021 (435.30 cases/100,000 inhabitants). No significant differences were observed overall. A more detailed incidence data analysis per quarter (Figure 1) showed differences for the second quarter of 2020 (corresponding to the pandemic lock-down) compared to habitants. The incidence of ME notifications during the pre-pandemic phase of the SARS- CoV-2 period in 2019 overall (302.05 cases/100,000 inhabitants) was lower than the inci- dence rate during the pandemic period in 2020 and 2021 (435.30 cases/100,000 inhabit- ants). No significant differences were observed overall. J. Clin. Med. 2023, 12, 194 A more detailed incidence data analysis per quarter (Figure 1) showed differences 4 of 13 for the second quarter of 2020 (corresponding to the pandemic lock-down) compared to that of 2019 (p < 0.05). Likewise, there was a difference between the fourth quarter of 2021 (corresponding that to theLikewise, of 2019 (p < 0.05). omicron variant outbreak) there was and the a difference same the between quarter of quarter fourth 2019 (p