Medication incidents and medication errors in Danish healthcare: A descriptive study based on medication incident reports from the Danish Patient Safety Database, 2014–2018

In Denmark, reporting of safety incidents to the nationwide Danish Patient Safety Database (DPSD) is mandatory. Medication incident reports constitute the largest category of safety reports. We aimed to provide numbers and characteristics of medication incidents and MEs reported to DPSD focusing on medication, their severity and the trends therein. This is a cross-sectional study of medication incident reports for individuals ≥18, submitted to DPSD in 2014–2018. We performed analyses on the (1) medication incident and (2) ME levels. Out of 479 814 incident reports, 61.18% (n = 293 536) were related to individuals ≥70 and 44.6% (n = 213 974) to nursing homes. Most of the events were harmless (70.87%, n = 340 047) and 0.8% (n = 3859) had caused severe harm or death. ME-analysis (n = 444 555) revealed that paracetamol and furosemide were the most frequently reported drugs. The most common drugs for severe and fatal MEs were warfarin, methotrexate, potassium chloride, paracetamol and morphine. When the reporting ratio for all MEs and harmful MEs was considered, other drugs than the most frequently reported ones were found to be associated with harm. We found a large proportion of harmless medication incident reports and reports from community healthcare services and identified high-risk medicines associated with harm.     

Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey

Aims

Fatal adverse drug reactions (ADRs) are important causes of death, but data from resource-limited settings are scarce. We determined the proportion of deaths in South African medical inpatients attributable to ADRs, and their preventability, stratified by human immunodeficiency virus (HIV) status.

Methods

We reviewed the folders of all patients who died over a 30 day period in the medical wards of four hospitals. We identified ADR-related deaths (deaths where an ADR was ‘possible’, ‘probable’ or ‘certain’ using WHO-UMC criteria and where the ADR contributed to death). We determined preventability according to previously published criteria.

Results

ADRs contributed to the death of 2.9% of medical admissions and 56 of 357 deaths (16%) were ADR-related. Tenofovir, rifampicin and co-trimoxazole were the most commonly implicated drugs. 43% of ADRs were considered preventable. The following factors were independently associated with ADR-related death: HIV-infected patients on antiretroviral therapy (adjusted odds ratio (aOR) 4.4, 95% confidence interval (CI) 1.6, 12), exposure to more than seven drugs (aOR 2.5, 95% CI 1.3, 4.8) and increasing comorbidity score (aOR 1.3, 95% CI 1.1, 1.7).

Conclusions

In our setting, where HIV and tuberculosis are highly prevalent, fatal in-hospital ADRs were more common than reported in high income settings. Most deaths were attributed to drugs used in managing HIV and tuberculosis. A large proportion of the ADRs were preventable, highlighting the need to strengthen systems for health care worker training and support.     

Factors predicting hospital readmissions related to adverse drug reactions

Objective  To analyse the contribution of adverse drug reactions (ADR) to hospital readmissions. Methods  This was a case–control study in which unscheduled admissions of patients who had been admitted to the hospital during the two previous months were assessed during a 21-month period. The patient was considered a case when the main diagnosis of readmission complied with the World Health Organisation’s definition of an ADR. For each case, two controls were selected from those patients that had been admitted for ADR without readmission (n = 177). Information on drugs and other risk factors was obtained from cases by interview and from controls by clinical record review. Results  There were 26,559 unscheduled admissions of which 81 were readmissions associated with ADR (4.5% of the unscheduled readmissions). There were no statistically significant correlations with sex, age or medical history, with the exception of arterial hypertension. The main drug products causing readmission were acenocoumarol (15, 18.5%), antihypertensive-diuretics (14, 17.3%), anticancer drugs (11, 13.6%) and digoxin (seven, 8.6%). In the multivariate logistic analysis, the variables predicting readmission were acenocoumarol [odds ratio (OR) 12.2, 95% confidence interval (CI) 3.8–38.3, P < 0.0001], a record of diabetes mellitus (OR 2.6, 95% CI 1.3–5.5, P < 0.01), the number of drugs taken at the moment of ADR (OR 1.2, 95% CI 1.1–1.4, P < 0.001) and high blood pressure (OR 0.3, 95% CI 0.2–0.6, P < 0.001) even though the latter was a negative predictor, preventing readmission. Of the 81 readmissions associated with ADR, 28 (34.6%) were preventable. Conclusion  A medical record of diabetes mellitus, polypharmacy and acenocoumarol treatment were risk factors predicting hospital readmission related to ADR.     

Impact of pharmacist and physician collaborations in primary care on reducing readmission to hospital: A systematic review and meta-analysis

BackgroundReadmissions to hospital due to medication-related problems are common and may be preventable. Pharmacists act to optimise use of medicines during care transitions from hospital to community.ObjectiveTo assess the impact of pharmacist-led interventions, which include communication with a primary care physician (PCP) on reducing hospital readmissions.MethodsPubMed, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL and Web of Science were searched for articles published from inception to March 2021 that described interventions involving a pharmacist interacting with a PCP in regards to medication management of patients recently discharged from hospital. The primary outcome was effect on all-cause readmission expressed as Mantel-Haenszel risk ratio (RR) derived from applying a random effects model to pooled data. Sensitivity analysis was also conducted to investigate differences between randomised controlled trials (RCTs) and non-RCTs. The GRADE system was applied in rating the quality of evidence and certainty in the estimates of effect.ResultsIn total, 37 studies were included (16 RCTs and 29 non-RCTs). Compared to control patients, the proportion of intervention patients readmitted at least once was significantly reduced by 13% (RR = 0.87, CI:0.79–0.97, p = 0.01; low to very low certainty of evidence) over follow-up periods of variable duration in all studies combined, and by 22% (RR = 0.78, CI:0.67–0.92; low certainty of evidence) at 30 day follow-up across studies reporting this time point. Analysis of data from RCTs only showed no significant reduction in readmissions (RR = 0.92, CI:0.80–1.06; low certainty of evidence).ConclusionsThe totality of evidence suggests pharmacist-led interventions with PCP communication are effective in reducing readmissions, especially at 30 days follow-up. Future studies need to adopt more rigorous study designs and apply well-defined patient eligibility criteria.     

An evaluation of consumers’ knowledge, perceptions and attitudes regarding generic medicines in Auckland

Objectives The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. Methods A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. Results A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers’ willingness to use generics. Conclusion Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.     

The provision of care provided by the pharmacy workforce in relation to complementary medicines in Australia

BackgroundThe use of complementary medicines (CMs) is prevalent across the world. Some CMs, such as St John's Wort, when taken with specific pharmaceutical medicines, may cause drug-herb interactions. In this context, pharmacists have the opportunity to play an important role in preventing harm to patients.ObjectiveThe aim of this study was to explore real-life pharmacy practice in relation to CMs in New South Wales, Australia.MethodsThe study design involved ‘pseudo-patient’ pharmacy visits while posing as a patient's relative requesting St John's Wort and using a standardized set of questions to document details of the interaction with a range of pharmacy staff.ResultsOf the 110 metropolitan pharmacy visits made, the pharmacy workforce who were involved in assisting the pseudo-patient's request included 51 pharmacists (46.4%), 57 pharmacy assistants (51.8%) and 1 naturopath (0.9%). Advice that may have resulted in harm to the patient, was offered by pharmacists in 11.8% (n = 13) of the encounters, and 20.9% (n = 23) by pharmacy assistants. Conversely, advice that prevented harm was provided by only 17.3% (n = 19) pharmacists and 10.9% (n = 12) pharmacy assistants. History-taking was not attempted by 84 pharmacy staff.ConclusionThe majority of pharmacy staff involved in this study did not manage a request for a CM with known drug-herb interactions in a way that would prevent harm. These findings highlight the need for the pharmacy workforce to engage in education and training in CMs, with a focus on how to consult evidence-based resources regarding interactions in the interest of patient safety.     

Systematic review of drug–drug interactions between rifamycins and anticoagulant and antiplatelet agents and considerations for management

Rifamycins (rifampin, rifabutin, and rifapentine) play an essential role in the treatment of mycobacterial and some nonmycobacterial infections. They also induce the activity of various drug transporting and metabolizing enzymes, which can impact the concentrations and efficacy of substrates. Many anticoagulant and antiplatelet (AC/AP) agents are substrates of these enzymes and have narrow therapeutic indices, leading to risks of thrombosis or bleeding when coadministered with rifamycins. The objective of this systematic review was to evaluate the effects on AC/AP pharmacokinetics, laboratory markers, and clinical safety and efficacy of combined use with rifamycins. A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidance was performed. The PubMed, Embase, and Web of Science databases were queried for English-language reports on combination use of rifamycins and AC/AP agents from database inception through August 2021. The 29 studies identified examined warfarin (n = 17), direct oral anticoagulants (DOACs) (n = 8), and antiplatelet agents (n = 4) combined with rifampin (n = 28) or rifabutin (n = 1). Eleven studies were case reports or small case series; 14 reported on pharmacokinetic or laboratory markers in healthy volunteers. Rifampin-warfarin combinations led to reductions in warfarin area under the curve (AUC) of 15%–74%, with variability by warfarin isomer and study. Warfarin dose increases of up to 3–5 times prerifampin doses were required to maintain coagulation parameters in the therapeutic range. DOAC AUCs were decreased by 20%–67%, with variability by individual agent and with rifampin versus rifabutin. The active metabolite of clopidogrel increased substantially with rifampin coadministration, whereas prasugrel was largely unaffected and ticagrelor saw decreases. Our review suggests most combinations of AC/AP agents and rifampin are problematic. Further studies are required to determine whether rifabutin or rifapentine could be safe alternatives for coadministration with AC/AP drugs.     

Views, attitudes and self-assessed training needs of Scottish community pharmacists to public health practice and competence

Objective To assess the education and training needs of community pharmacists to support the delivery of an expanded public health role. Setting Community pharmacy in Scotland. Method Two focus groups of community pharmacists (n = 4 in each) in geographically distinct regions of Scotland explored issues of public health function, competencies and education and training. Findings from thematic analysis were used to develop a draft postal questionnaire. Following piloting, pharmacist managers from a random sample of 500 community pharmacies in Scotland were contacted by telephone to ascertain the number of pharmacists working in each pharmacy in the following 14-day period. A survey pack containing questionnaires for each identified pharmacist working in the study period was sent by post to the pharmacist manager in each pharmacy. The questionnaire contained items on: demographics; views and attitudes towards: public health; competencies for public health practitioners; and education and training needs. One postal reminder was sent 2 weeks later. Main Outcome Measures Main themes identified from focus group discussions; questionnaire response rate; views and attitudes towards public health competencies and education and training. Results Four hundred and fifteen managers agreed to participate, providing 904 potential participants. The response rate was 25% (223/904). Most (n = 179, 80%) were aware of the term ‘pharmaceutical public health’. While a majority saw the importance of public health to their practice (n = 177, 79%) agreeing/strongly agreeing, they were less comfortable with the term ‘specialist’. Respondents viewed competencies relating to health promotion (n = 192, 86%) more relevant than surveillance (n = 70, 31%), risk management (n = 29, 13%) and strategic developments (n = 12, 5%). Responses indicated a desire for education and training with more than half (n = 121, 54%) agreeing/strongly agreeing that they had a need now, with 69% (n = 153) expressing a future need. Conclusion Results should be interpreted with caution due to the response rate. However, this research highlights the self assessed gap in competence related to pharmaceutical public health for community pharmacists in Scotland.     

Suspected adverse drug events requiring emergency department visits or hospital admissions

Objective: To analyse the contribution of adverse drug events (ADEs) to the overall number of referrals or visits at an emergency department, to determine the proportion of more severe episodes requiring hospital admission and to characterize the different causes of drug-related visits or admissions. Methods: A 1-year prospective collection of data on visits performed at an emergency department. All visits, observed during 1 week every month, were analyzed in order to identify suspected ADEs. The effects of age and sex on the frequency of ADE-related visits and admissions were evaluated. All patients hospitalized because of an ADE were followed up in order to collect information about progress and outcome of the events, which were also assessed in terms of avoidability. Results: Among the 5497 patients who visited the Emergency Department over 1 year, 235 (4.3%) experienced an ADE, 45 of these (19.1%) were subsequently hospitalized, among whom there were five deaths. Dose-related therapeutic failures were the main causes of drug-related admissions (55.6%), whereas adverse drug reactions caused the most frequent drug-related visits to the Emergency Department (63.8%). Although the frequency of drug-drug interactions leading to a visit to the Emergency Department was small (3.8%), this type of event was more severe, because most of these patients were hospitalized. No age/sex effect was observed in the proportion of ADE-related hospital admissions. Twenty-five (1.4% of the total admissions) of the 45 ADE-related admissions were evaluated as preventable, contributing by more than 61% of the overall length of hospital stay. Conclusion: The high proportion of drug therapeutic failures leading to an admission highlights the need for public education, particularly to prevent non-compliance. Received: 14 April 1998 / Accepted in revised form: 5 October 1998