Risk Of ADRs Research Articles

CKD increases risk of antitubercular-related ADRs

CKD increases risk of antitubercular-related ADRs

Diabetes increases risk of ADRs in elderly hospitalised patients

Diabetes increases risk of ADRs in elderly hospitalised patients

CONTROVERSIAL ISSUES OF ANTIBIOTIC THERAPY DURATION IN PATIENTS AFTER INJURIES AND SURGERIES ON MUSCULOSKELETAL SYSTEM

Improvements in surgical techniques and the introduction of minimally invasive osteosynthesis technologies have had a beneficial effect on the patient treatment after injuries and surgeries on the musculoskeletal system. However, the problem of treating infectious complications, especially in elderly patients with high comorbidity, has not lost its relevance.
 The purpose of the paper is to study the effectiveness of antibiotic therapy in elderly patients after injuries and surgeries on the musculoskeletal system in comorbidity.
 Materials and methods. An open prospective cohort study was conducted with a 12-month follow-up period. We examined 53 elderly and senile patients (24 men and 29 women, average age 69.1±7.3) who were hospitalized. The combined endpoint of treatment outcome was assessed. Comorbidity and duration of antibiotic therapy were determined in all patients. The GerontoNet ADR Risk Score was used to assess the risk of drug therapy complications.
 Results. The comorbidity index in elderly patients was 4 (3; 5) points. One third of patients (19 people; 35.9 %) had high comorbidity rates. The average number of antibacterial drugs was 2 (1; 2). Total course of administration was 8 (5; 21) days. Therapy duration less than 7 days was observed in 24 (45.3 %) patients. In 13 (24.5 %) patients, the result exceeded 5 points on the GerontoNet scale. During the observation period, a positive result was achieved in 45 (84.9 %) patients. There was no significant difference in achieving positive results based on the duration of antibiotic therapy (p>0.05).
 Conclusion. The use of long-term systemic antibiotic therapy in elderly patients after injuries and surgeries on the musculoskeletal system does not lead to better results compared to shorter treatment modalities, which help us avoid unwanted side effects and drug interactions, given the high comorbidity of this group of patients.

Pharmacogenetic aspects of efficacy and safety of methotrexate treatment in pediatric acute lymphoblastic leukemia.

To evaluate the role of ABCB1 (C3435T rs1045642, rs1128503, rs2032582, rs4148738), SLCO1B1 T521C rs4149056 genetic polymorphisms in the development of major types of methotrexate (MTX) toxicities and the occurrence of a terminal event (death, relapse) in pediatric АLL. The study included 124 patients diagnosed with pediatric ALL. All patients treated according to the protocols of the German BFM group (2002/2009) with high-dose (1,000, 2,000 and 5,000 mg/m2) methotrexate. MTX-related toxicities, including hematologic, hepatic and renal, were evaluated according to the common terminology criteria for adverse events version 5.0 (CTCAE v.5.0). Real-time PCR method was used to investigate polymorphisms of ABCB1 and SLCO1B1 genes. The study material was peripheral blood. A competitive analysis demonstrated significant relationships between MTX ADRs. The results of the study support the existence of relationships between some ADRs and MTX kinetics. An associative analysis showed association with the development of AEs to methotrexate indicating their clinical significance from different genetic polymorphisms protein-transporters. The available results confirm the associations of the studied genes with the increased risk of high doses MTX toxic ADRs and terminal events. Complementing the existing criteria for pediatric ALL risk groups with pharmacogenetic indicators will allow further individualization of therapy.

Risk prediction models on adverse drug reactions: A review

Background: The risk prediction model has become increasingly popular in recent years in helping clinical decision-making. Existing models cannot be directly applied in Indonesia. Objective: To review the existing prediction models and their limitations. Method: A search related to the prediction of ADR risk was conducted using several journal databases: PubMed, Scopus and Google Scholar. Articles were screened to match specified criteria and further studied. Result: Nine articles met the criteria and were then analysed. Studies were carried out in various countries. The study population include; the elderly (>65 years, three studies), age (≥15 years, three studies), patients with Chronic Kidney Disease (CKD) (≥18 years, one study) and two studies in cancer patients. The outcomes were; ADR (five studies), ADE ( two studies), DRPs (one study), and cardiovascular effects (one study). The methods for determining the predictors of ADRs all used multivariable logistic regression. Conclusion: Each country has different treatment patterns, prescribing practices, traditions and drug distribution, so it is necessary to develop a prediction model for ADRs that is country-specific.

Immune checkpoint inhibitor monotherapy is associated with less cardiac toxicity than combination therapy.

Treatment options for many cancers include immune checkpoint inhibitor (ICI) monotherapy and combination therapy with impressive clinical benefit across cancers. We sought to define the comparative cardiac risks of ICI combination and monotherapy. We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac ADRs (cADRs), such as carditis, heart failure, arrhythmia, myocardial infarction, and valvular dysfunction, related to ICI therapy. To explore possible relationships, we used the reporting odds ratio (ROR) as a proxy of relative risk. A lower bound of a 95% confidence interval of ROR > 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. We found 2278 cADR for ICI monotherapy and 353 for ICI combination therapy. Combination therapy was associated with significantly higher odds of carditis (ROR 6.9, 95% CI: 5.6-8.3) versus ICI monotherapy (ROR 5.0, 95% CI: 4.6-5.4). Carditis in ICI combination therapy was fatal in 23.4% of reported ADRs, compared to 15.8% for ICI monotherapy (P = 0.058). Using validated pharmacovigilance methodology, we found increased odds of carditis for all ICI therapies, with the highest odds for combination therapy. Given the substantial risk of severe ADR and death, clinicians should consider these findings when prescribing checkpoint inhibitors.

Cutaneous adverse drug reactions among people living with human immunodeficiency virus in a tertiary care hospital in Johor, Malaysia.

Cutaneous adverse drug reactions (cADRs) among people living with HIV (PLWH) are common. Data on drug eruptions among PLWH in Malaysia are limited. Thus, our study aimed to determine the clinical patterns of cADRs among PLWH and the risk factors associated with severe cutaneous adverse reactions (SCAR). A cross-sectional study was conducted among PLWH who developed cADRs presenting to our dermatology clinic from June 2020 to December 2020. The Naranjo scale was used for drug causality assessment. A total of 78 PLWH were recruited with a male-to-female ratio of 12:1. The maculopapular eruption was the commonest type of cADRs (75.6%), followed by drug reaction with eosinophilia and systemic symptoms (DRESS) (15.4%). SCAR is defined as a potentially life-threatening, immunologically mediated, drug-induced disease, accounting for 17.9% of the cases. Most of the patients were on antiretroviral therapy (ART) (85.9%), with efavirenz + tenofovir/emtricitabine being the most common combination (80.6%). Efavirenz (51.3%) was the main culprit drug implicated, followed by trimethoprim/sulfamethoxazole (23.1%) and nevirapine (11.5%). CD4 T-cell count <100 cells/μL (p = 0.006) was the independent risk factor for SCAR. Most cases had probable causal relationships with the culprit drugs (84.6%) and were not preventable (93.6%). The commonest cADR seen in PLWH was maculopapular eruption, while efavirenz, trimethoprim/sulfamethoxazole, and nevirapine were the three main implicated drugs. Most of the cases had probable drug causality and were not preventable. PLWH with CD4 count <100 cells/μL were particularly at risk of developing SCAR. Overall, this study showed that immune suppression and polypharmacy as a consequence of opportunistic infection prophylaxis are important factors contributing to the increased risk of ADRs among PLWH.

Nutritional Status and Potentially Inappropriate Medications in Elderly.

(1) Background: The association between polypharmacy and malnutrition has been investigated in several studies; however, few of these specifically deepened the relationship between potentially inappropriate medication and malnutrition. With a descriptive approach, the primary aim of our study was to evaluate the impact of the nutritional status, assessed with the Mini Nutritional Assessment (MNA), on potentially inappropriate medications (PIM), estimated 10-year survival, and the risk of adverse drug reactions in elderly patients; the secondary aim was to evaluate how the Screening Tool of Older People’s Prescriptions (STOPP), Screening Tool to Alert to Right Treatment (START), and BEERS 2019 criteria identify PIM compared to nutritional status. (2) Methods: In this study, 3091 subjects were enrolled, of whom 2748 (71.7%) were women; the median age was 80 years, with an interquartile range between 75 and 85 years of age. The subjects were assessed at the outpatient service for frail older people of the University Hospital of Cagliari. The study population was evaluated for their: MNA, Charlson Comorbidity Index, 10-year survival estimation, BEERS 2019, STOPP and START criteria, and ADR Risk scores. (3) Results: We divided the study population into three groups: MNA1 (MNA score ≥ 24), MNA2 (23.5–17), and MNA3 (<17): the severity of comorbidities, STOPP and START alerts, and BEERS 2019 criteria were significantly worse in both MNA2 and MNA3 compared to MNA1—with the exception of BEERS “non-anti-infective medications that should be avoided or have their dosage reduced with varying levels of kidney function in older adults”. Moreover, the estimated 10-year survival was significantly higher in MNA1 than in MNA2 and MNA3, and also in MNA2 compared to MNA3. Finally, the ADR risk scores were significantly lower in MNA1 than in MNA2 and MNA3. (4) Conclusions: Our study demonstrated the association between nutritional status and PIM checked with the BEERS 2019 criteria, and, for the first time, with the STOPP and START criteria.

Safety of Off-Label Pharmacological Treatment in Pediatric Neuropsychiatric Disorders: A Global Perspective From an Observational Study at an Italian Third Level Children's Hospital.

Background: The acquisition of proper and relevant pediatric clinical data is essential to ensure tolerable and effective pediatric drug therapies. In the field of pharmacological treatment of neuropsychiatric disorders, the lack of sufficient high quality scientific evidence for pediatric age results in the frequent need to prescribe off-label drugs. With the aim of improving knowledge about safety profile of off-label drug prescription in children and adolescent with neurological and/or psychiatric disorders, we realized a multidisciplinary pharmacovigilance study. Materials and methods: An observational retrospective study was conducted to assess the safety of off-label pharmacological therapies in patients aged 0–18 years, admitted to the Neuropsychiatry Unit of the Institute for Maternal and Child Health - IRCCS “Burlo Garofolo” between January 2016 and December 2018. Prescription patterns and adverse drug reactions were evaluated by a multidisciplinary team. Results: Overall, 230 patients were enrolled, 48% boys (N = 111), 52% girls (N = 119), average age of 10 years, and a total of 534 prescriptions was analyzed. 54.5% (N = 125) of patients had epilepsy, 37.5% (N = 86) suffered from psychiatric disorders, 8% (N = 19) had other neurological disorders. The prevalence of off-label prescriptions was 32% and 50% of the study population received at least one off-label drug. A total of 106 ADRs was detected: 57% of ADRs were due to drug-drug interactions, 30% were due to off-label prescriptions, 10% were due to overdose and 3% were due to improper use. No significant association between emerged ADRs and off label prescriptions was found (Fisher’s exact two-tailed test, p = 1.000). There was significant association between increasing number of administrated drugs and risk of ADRs (OR 1.99; IC95% 1.58–2.5; p = 0.000). Psychiatric disorders were associated with at least three times higher risk to be treated with an off-label drug (OR 3.30; IC95% 2.26–4.83; p = 0.000). Conclusions: This study shows that off-label prescribing in neuropsychiatric disorders does not pose a greater risk of ADRs than on-label prescribing and highlights unmet clinical needs in pediatric neuropsychopharmacology. The multidisciplinary approach can provide important contributions to improve therapeutic path of these already complex pathologies by careful monitoring of therapeutic appropriateness and drug interactions.

Comparison of Quality Measures for Detection of Neoplasia at Screening Colonoscopy

The proportion of colonoscopies with at least one adenoma (adenoma detection rate [ADR]) is inversely associated with colorectal cancer (CRC) risk and death. The aim of this study was to examine whether such associations exist for colonoscopy quality measures other than ADR. We used data from the Polish Colorectal Cancer Screening Program collected in 2000-2011. For all endoscopists who performed ≥100 colonoscopies we calculated detection rates of adenomas (ADR), polyps (PDR), and advanced adenomas (≥10 mm/villous component/high-grade dysplasia [AADR]); and number of adenomas per colonoscopy (APC) and per colonoscopy with ≥1 adenoma (APPC). We followed patients until CRC diagnosed before recommended surveillance, death, or December 31, 2019. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) using Cox proportional-hazard models. We used Harrell's C statistic to compare the predictive power of the quality measures. Data on 173,287 patients (median age, 56 years; 37.8% male) and 262 endoscopists were used. During a median follow-up of 10 years and 1,490,683 person-years, we identified 395 CRCs. All quality measures were significantly associated with CRC risk and death. The relative reductions in CRC risk were as follows: for ADR ≥24.9% (reference <12.1%; HR, 0.41; 95% CI, 0.25-0.66), PDR ≥42.7% (reference <19.9%; HR, 0.35; 95% CI, 0.24-0.51), AADR ≥9.1% (reference <4.1%; HR, 0.69; 95% CI, 0.49-0.96), APC ≥0.37 (reference <0.15; HR, 0.35; 95% CI, 0.21-0.58), and APPC ≥1.54 (reference <1.19; HR, 0.54; 95% CI, 0.35-0.83). AADR was the only quality measure with significantly lower predictive power than ADR (Harrell's C, 59.7 vs 63.4; P= .001). Similar relative reductions were observed for CRC death. This large observational study confirmed the inverse association between ADR and CRC risk and death. The PDR and APC quality measures appear to be comparable with ADR.

PPIs or COX-2 inhibitors reduce risk of gastrointestinal ADRs from NSAID + anticoagulant use

PPIs or COX-2 inhibitors reduce risk of gastrointestinal ADRs from NSAID + anticoagulant use

ПЕРСПЕКТИВЫ ПРИМЕНЕНИЯ ИНСТРУМЕНТОВ ПО БОРЬБЕ С ПОЛИПРАГМАЗИЕЙ У БОЛЬНЫХ ПСИХИАТРИЧЕСКОГО ПРОФИЛЯ

The study aimed to evaluate the risk of developing adverse drug reactions in patients aged 65 years and older who received drug treatment for mental disorders. The analysis demonstrated the potential of specific tools for assessing drug therapy appropriateness in a mental health setting. An assessment using «Trigger Tool for Measuring Adverse Drug Events in a Mental Health Setting» and «The GerontoNet ADR Risk Score» showed that more than half of hospitalized elderly patients are at risk of adverse reactions. In the majority of cases, this risk was associated with two major factors characterizing drug therapy in the study group: age and psychopharmacotherapy. These results highlight the importance of careful control over drug therapy safety in patients aged 65 years and older and therapy optimization when a high risk of adverse drug events is identified.

Common osteoporosis drug associated with increased rates of depression and anxiety

Osteoporosis affects over 10 million Americans over 50. Bisphosphonate therapy, mainly alendronate, is amongst the most prescribed treatments for the disease. The use of alendronate and other bisphosphonates has been associated with depressive symptoms in recent case reports. In this study we quantified this association by analyzing over 100,000 adverse events reports from the Food and Drug Administration Adverse Events Reporting System (FAERS) and the World Health Organization’s (WHO) global database for adverse drug reactions, ADRs, VigiAccess. We found that alendronate therapy is significantly associated with depression and anxiety when compared to other first-line osteoporosis treatments. The reported risk of depressive ADRs was found to be over 14-fold greater in patients taking alendronate under the age of 65 and over fourfold greater for patients over 65 compared to the control. Several hypotheses concerning the molecular mechanism of the observed association of alendronate and depressive symptoms were discussed.

The evolution of polypharmacy: appropriate and problematic polypharmacy, choosing the right strategy and tactics

The evolution of polypharmacy, which for many years consisted of quantifying concurrently prescribed drugs, has led to an qualitative description: “appropriate polypharmacy”, which may be beneficial for some patients, and “problematic polypharmacy”, which is harmful. The concept of “appropriate polypharmacy” is to prescribe multiple drugs based on the best evidence, taking into account the patient’s clinical condition and potential drug-drug interactions. With age, the prevalence of geriatric syndromes, comorbidity/multimorbidity, and limitation of life expectancy increase, which reduces the positive benefit/risk ratio for most drugs. The problem with polypharmacy is associated with an increased risk of adverse reactions, drug-drug interactions, and decreased patient compliance. To improve polypharmacy, various methodologies are used to optimize drug use for maximum benefit and least harm. Such interventions include professional patient counseling, the use of additional tools (including Bierce’s criteria, STOPP/START, MAI index, etc.), electronic decision-making systems, educational programs. The effectiveness of interventions to reduce polypharmacy has been evaluated in several Cochrane meta-analyzes (2012, 2014, 2018) and showed a decrease in drug misuse and the risk of ADR, but there was no effect on mortality, and few studies found a decrease in the number of hospitalizations. The deprescribing methodology is especially relevant in the context of problematic polypharmacy and is considered an integral component of the continuum of good prescribing practice, promoted as a strategy to reduce polypharmacy and improve patient outcomes. Among other interventions, deprescribing has the most evidence for its utility in preventing drugrelated complications, improving clinical outcomes, and reducing costs. The International Group for Reducing Inappropriate Medication Use &amp; Polypharmacy (IGRIMUP) in 2018 developed 10 recommendations to reduce polypharmacy and potentially inappropriate drugs. Thus, the concept of “appropriate polypharmacy” is a rational approach to optimizing polypharmacy; it should be promoted to replace existing thresholds.

Evaluation of Drug Prescription Pattern using World Health Organisation Prescribing Indicators in a Tertiary Care Hospital, Bangalore

Aim of the study: To monitor the drug use patterns by using WHO prescribing indicators in a tertiary care hospital and to minimise the irrational prescribing practices by the prescribers. To monitor the drug use patterns by using WHO prescribing indicators in a tertiary care hospital and to minimise the irrational prescribing practices by the prescribers. Materials and Methods: This is a prospective observational study, the patients who were satisfying the inclusion criteria will be enrolled into the study. The patient’s data were collected in specially designed documentation form. The collected data’s were assessed using descriptive statistics. Results: The study was conducted in 143 patients in which the average number of drugs per encounters was 3.5 and the percentage of drugs in the generic name was 37.10% (n=190), and in brand names were 62.89% (n=322). The number of encounters with antibiotics was 61.5% and where as 57.35% of the total drugs prescribed was injections. Most of the medicines prescribed were included in the list of essential medicines of India that is 96.09% and without use of antibiotics 38.46% (n=55). Conclusion: Poly pharmacy leads to drug chances of interactions and risk of ADRs and revealed that most of the patients were prescribed with the poly pharmacy and in brand names. The use of antibiotics was much more in the study, which should be minimize so that antimicrobial resistance can be minimized. Keywords: adverse drug reaction, essential drug list, prescribing indicators

DEPRESCRIBING AND PROGNOSIS IN OLDER PATIENTS WITH ARTERIAL HYPERTENSION AND CHRONIC HEART FAILURE

Objective: Treatment of older patients with arterial hypertension is complicated by comorbidity and frailty syndrome. Deprescribing is a possible option for comorbid patients. The aim of this study was to investigate deprescribing and prognosis in older hypertensive patients with chronic heart failure (CHF). Design and method: 119 older hypertensive patients with CHF (89 males, mean age was 68.9 ± 6.7 years) were studied. Arterial hypertension was defined according to ESC Guidelines for the diagnosis and treatment of arterial hypertension, 2018. Charlson comorbidity index (CCI) was estimated. Comorbidity was regarded as high at index more or equal 6 scores. Quality of life, frailty syndrome, personal characteristics were evaluated. GerontoNet ADR Risk Score was used for predicting ADRs. Follow-up period was 1 year, primary endpoint - all-cause mortality. Results: The CCI was 5.9 ± 1.9 scores. 67 (56.3%) older hypertensive patients with CHF had high comorbidity, 19 (10%) - frailty syndrome. The total number of drugs was 5 [4;7]. According to GerontoNet ADR Risk Score patients had 3 [2;4] scores. Most of patients (92;77.3%) had more than 5 scores (high risk of ADRs). Only 30 (25%) patients had high adherence to drug therapy. Patients with high comorbidity had more scores according to GerontoNet ADR Risk Score, than patients with low comorbidity (4 [3;6]. and 2 [1;4] resp., p = 0.0003). During the follow-up 13 patients died. The deceased patients compared to the surviving patients had a higher level of comorbidity (7.5 ± 1.9 and 5.8 ± 1.9 resp., p = 0.001)) and higher scores according to GerontoNet ADR Risk Score (4 [3;7]. and 3 [2;4] resp., p = 0.0006)). Relative risk of death within 12 months in older hypertension patients with CHF and high risk of adverse drug reactions (more or equal 6 scores according to GerontoNet ADR Risk Score) was 3.85 times (95% CI 1.42 - 10.48) higher risk of death in patients with low risk of ADRs. Conclusions: Older patients with arterial hypertension and CHF are characterized by high comorbidity, polypharmacy and low adherence to treatment. GerontoNet ADR Risk Score may be recommended for assessing prognosis in older hypertensive patients with CHF.

Knowledge, attitude &amp; practice towards self-medication among nursing students in a teaching hospital of north India

Introduction: Self-medication the use of medication by a patient on his own initiative is increasing widely due to easy accessibility and availability of vast knowledge as a source of information about various drugs more so in the youth. This practice is larger in healthcare students and if used irrationally can lead to various adversities including resistance for drugs. Objective: Aim of the study is to assess the prevalence, knowledge, attitudes & practices towards self medication among nursing students in Acharya shri Chander College of medical sciences, Jammu. Materials and Methods: A cross sectional study was conducted among first year, second & third year nursing students using a 16 questions questionnaire comprising of knowledge, attitude & practice related queries. The responses were recorded and assessment was made based on them. Results: The prevalence of self-medication was high in the study population, with most people relying on previous prescriptions as drug source, using self medications for quick relief with risk of ADR being the most common cause of avoidance. Antipyretics were most rampantly used as self medication but there is lack of sufficient knowledge about the same. Though, the responders exhibit positive attitude and yearn to bring about change in the scenario with alteration of certain policies & regulations. Conclusion: There is a rise in the practice of self-medication among nursing students with lack of knowledge but positive attitude towards the same. Keywords: Knowledge, Attitude, Practice, Self-medication, Nursing students.

STOPP-START Medication Review: A Non-Randomized Trial in an Indonesian Tertiary Hospital to Improve Medication Appropriateness and to Reduce the Length of Stay of Older Adults.

Background: Inappropriate prescribing may lead to medication errors among older adults. Pharmacists can curb the occurrences of these errors by conducting medication reviews. Screening Tool of Older Person's Prescriptions (STOPP) or Screening Tool to Alert doctors to Right Treatments (START) may curb the incidence of adverse drug reactions and improve medication appropriateness by providing guides about when particular types of medications should be started or stopped. Objective: This study aimed to evaluate the use of STOPP/START to improve the Adapted Medication Appropriateness Index (MAI), to reduce the risk of ADRs (GerontoNet score), and length of stay (LOS). Setting: Geriatric Inpatient Ward, Sanglah General Hospital, Bali, Indonesia. Method: A non-randomized controlled trial was conducted in older adults (>60 years) who were selected consecutively from inpatient units in a tertiary hospital in Bali, Indonesia. The intervention group received medication reviews by pharmacists in collaboration with physicians to assess its appropriateness with STOPP/START criteria on admission and during their stay at the hospital. The control group obtained standard care. Main Outcome Measures: The outcomes were measured using the Adapted MAI, GerontoNet Score, and LOS. Results: Thirty patients in the intervention group and 33 patients in the control group were included in this study. The adapted MAI was 2.97 (2.25) and 9.94 (6.14) with P < .001. The GerontoNet score was 3.33 (2.28) and 5.18 (2.10) with P = .003, LOS was 7.63 (3.00) days and 14.18 (9.97) days with P = .011, respectively. Conclusion: The use of STOPP/START as a tool for medication review improved medication appropriateness and reduced ADR risk and LOS.

“Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers

SummaryIntroductionCOVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences.MethodsSince March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with “off-label” use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.ResultsIn one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them “serious” (64%), 48 of which proved ≥ 500 ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication.Discussion and conclusion“Off-label” use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.

Screening Tools Used by Clinical Pharmacists to Identify Elderly Patients at Risk of Drug-Related Problems on Hospital Admission: A Systematic Review.

In recent years, a number of studies have examined tools to identify elderly patients who are at increased risk of drug-related problems (DRPs). There has been interest in developing tools to prioritise patients for clinical pharmacist (CP) review. This systematic review (SR) aimed to identify published primary research in this area and critically evaluate the quality of prediction tools to identify elderly patients at increased risk of DRPs and/or likely to need CP intervention. The PubMed, EMBASE, OVID HMIC, Cochrane Library, PsychInfo, CINAHL PLUS, Web of Science and ProQuest databases were searched. Keeping up to date with research and citations, the reference lists of included articles were also searched to identify relevant studies. The studies involved the development, utilisation and/or validation of a prediction tool. The protocol for this SR, CRD42019115673, was registered on PROSPERO. Data were extracted and systematically assessed for quality by considering the four key stages involved in accurate risk prediction models—development, validation, impact and implementation—and following the Checklist for the critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS). Nineteen studies met the inclusion criteria. Variations in study design, participant characteristics and outcomes made meta-analysis unsuitable. The tools varied in complexity. Most studies reported the sensitivity, specificity and/or discriminatory ability of the tool. Only four studies included external validation of the tool(s), namely of the BADRI model and the GerontoNet ADR Risk Score. The BADRI score demonstrated acceptable goodness of fit and good discrimination performance, whilst the GerontoNet ADR Risk Score showed poor reliability in external validation. None of the models met the four key stages required to create a quality risk prediction model. Further research is needed to either refine the tools developed to date or develop new ones that have good performance and have been externally validated before considering the potential impact and implementation of such tools.