Evaluation of the effectiveness of electronic prescription in reducing medical and medical errors (systematic review study).

INTRODUCTION: The use of electronic systems in prescription is considered as the final solution to overcome the many problems of the paper transcription process, especially with the outbreak of Coronavirus needs more attention than before. But despite the many advantages, its implementation faces many challenges and obstacles. Therefore, the present study was conducted to review the effectiveness of computerized physician order entry systems (CPOE) on relative risk reduction on medication error and adverse drug events (ADE). METHOD: This study is one of the systematic review studies that was conducted in 2021. In this study, searching for keywords such as E-Electronic Prescription, Patient safety, Medication Errors prescription, Drug Interactions, orginal articles from 2000 to October-2020 in the valid databases such as ISI web of Science PubMed Embase, Scopus and search engines like google was done. The included studies were based on the main objectives of the study and based on the inclusion criteria after several stages of review and quality evaluation. In fact, the main criteria for selecting articles were studies that compared the rate of medication errors with or without assessing the associated harms (real or potential) before and after the implementation of EMS. RESULTS: Out of 110 selected studies after initial screening, only 16 articles were selected due to their relevance. Among the final studies, there was a significant heterogeneity. Only 6 studies were of good quality. Of the 10 studies prescribing error rates, 9 reported reductions, but variable denominators prevented meta-analysis. Twelve studies provided specific examples of systemic drug errors. 5 cases reported their occurrence slightly. Out of 9 cases that analyzed the effects on drug error rate, 7 cases showed a significant relative reduction between 13 and 99%. Four of the six studies that analyzed the effects on potential ADEs showed a significant relative reduction of between 35 and 98%. Two of the four studies that analyzed the effect of ADEs showed a relative reduction of between 30 and 84%. CONCLUSION: Finally, e-prescribing seems to reduce the risk of medication errors and ADE. However, the studies differed significantly in terms of setting, design, quality and results. More randomized controlled trials (RCTs) are needed to further improve the evidence of health informatics information.

Adverse effects of COVID-19 vaccines and measures to prevent them.

Recently, The Lancet published a study on the effectiveness of COVID-19 vaccines and the waning of immunity with time. The study showed that immune function among vaccinated individuals 8 months after the administration of two doses of COVID-19 vaccine was lower than that among the unvaccinated individuals. According to European Medicines Agency recommendations, frequent COVID-19 booster shots could adversely affect the immune response and may not be feasible. The decrease in immunity can be caused by several factors such as N1-methylpseudouridine, the spike protein, lipid nanoparticles, antibody-dependent enhancement, and the original antigenic stimulus. These clinical alterations may explain the association reported between COVID-19 vaccination and shingles. As a safety measure, further booster vaccinations should be discontinued. In addition, the date of vaccination should be recorded in the medical record of patients. Several practical measures to prevent a decrease in immunity have been reported. These include limiting the use of non-steroidal anti-inflammatory drugs, including acetaminophen to maintain deep body temperature, appropriate use of antibiotics, smoking cessation, stress control, and limiting the use of lipid emulsions, including propofol, which may cause perioperative immunosuppression. In conclusion, COVID-19 vaccination is a major risk factor for infections in critically ill patients.

"Artificial Intelligence" for Pharmacovigilance: Ready for Prime Time?

There is great interest in the application of 'artificial intelligence' (AI) to pharmacovigilance (PV). Although US FDA is broadly exploring the use of AI for PV, we focus on the application of AI to the processing and evaluation of Individual Case Safety Reports (ICSRs) submitted to the FDA Adverse Event Reporting System (FAERS). We describe a general framework for considering the readiness of AI for PV, followed by some examples of the application of AI to ICSR processing and evaluation in industry and FDA. We conclude that AI can usefully be applied to some aspects of ICSR processing and evaluation, but the performance of current AI algorithms requires a 'human-in-the-loop' to ensure good quality. We identify outstanding scientific and policy issues to be addressed before the full potential of AI can be exploited for ICSR processing and evaluation, including approaches to quality assurance of 'human-in-the-loop' AI systems, large-scale, publicly available training datasets, a well-defined and computable 'cognitive framework', a formal sociotechnical framework for applying AI to PV, and development of best practices for applying AI to PV. Practical experience with stepwise implementation of AI for ICSR processing and evaluation will likely provide important lessons that will inform the necessary policy and regulatory framework to facilitate widespread adoption and provide a foundation for further development of AI approaches to other aspects of PV.

Raising awareness about the unintended consequences of hand sanitiser in children.

The use of hand sanitisers is common practice to prevent the spread of coronavirus disease 2019 (COVID-19). However, the safety thereof requires consideration as this may be hazardous in children. Recent studies have shown that the misuse and increased unsupervised availability of alcohol-based hand sanitisers may result in adverse events in children such as skin irritation, dryness, cracking and peeling. Unintentional or intentional ingestion of hand sanitisers in children under the age of 12 years may occur because of the colour, smell and flavour added to it. Consumption of alcohol in children may result in hypoglycaemia, apnoea and acidosis. This allows the invasion of other bacterial and viral infections. Children may also rub their eyes with sanitised hands and cause ocular injury. Therefore, the use of hand sanitisers in general needs to be revised in both children and adults. Other interventions on lowering the risk of adverse events because of misuse of hand sanitiser should be practised more often. These include promoting washing of hands over sanitisers where possible, training children on how to use hand sanitisers and creating awareness of the dangers if ingested or in contact with the eyes.

Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19.

Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds the supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety and immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays the SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004 ). The co-primary outcomes were the short-term tolerability/safety and immunogenicity of CoVLP formulations assessed by neutralizing antibody (NAb) and cellular responses. Secondary outcomes in this ongoing study include safety and immunogenicity assessments up to 12 months after vaccination. Adults (18-55 years, n = 180) were randomized at two sites in Quebec, Canada, to receive two intramuscular doses of CoVLP (3.75 µg, 7.5 µg, and 15 µg) 21 d apart, alone or adjuvanted with AS03 or CpG1018. All formulations were well tolerated, and adverse events after vaccination were generally mild to moderate, transient and highest in the adjuvanted groups. There was no CoVLP dose effect on serum NAbs, but titers increased significantly with both adjuvants. After the second dose, NAbs in the CoVLP + AS03 groups were more than tenfold higher than titers in Coronavirus 2019 convalescent sera. Both spike protein-specific interferon-γ and interleukin-4 cellular responses were also induced. This pre-specified interim analysis supports further evaluation of the CoVLP vaccine candidate.

Drugs in COVID-19 Clinical Trials: Predicting Transporter-Mediated Drug-Drug Interactions Using In Vitro Assays and Real-World Data.

Numerous drugs are currently under accelerated clinical investigation for the treatment of coronavirus disease 2019 (COVID-19); however, well-established safety and efficacy data for these drugs are limited. The goal of this study was to predict the potential of 25 small molecule drugs in clinical trials for COVID-19 to cause clinically relevant drug-drug interactions (DDIs), which could lead to potential adverse drug reactions (ADRs) with the use of concomitant medications. We focused on 11 transporters, which are targets for DDIs. In vitro potency studies in membrane vesicles or HEK293 cells expressing the transporters coupled with DDI risk assessment methods revealed that 20 of the 25 drugs met the criteria from regulatory authorities to trigger consideration of a DDI clinical trial. Analyses of real-world data from electronic health records, including a database representing nearly 120,000 patients with COVID-19, were consistent with several of the drugs causing transporter-mediated DDIs (e.g., sildenafil, chloroquine, and hydroxychloroquine). This study suggests that patients with COVID-19, who are often older and on various concomitant medications, should be carefully monitored for ADRs. Future clinical studies are needed to determine whether the drugs that are predicted to inhibit transporters at clinically relevant concentrations, actually result in DDIs.

Clozapine treatment: Ensuring ongoing monitoring during the COVID-19 pandemic.

The current coronavirus pandemic (COVID-19) has led mental health systems to uncertainty regarding safe continuation of clozapine monitoring protocols. Clozapine is without doubt the only antipsychotic available with repeatedly proven efficacy in treatment resistant schizophrenia.1 Replacing clozapine with an alternative antipsychotic in patients stabilized with clozapine can potentially lead to higher risk of relapse or exacerbation of severity of illness.1 Clozapine, as already known, has a number of side effects, some of which can be serious, thus patients receiving clozapine require ongoing scheduled monitoring. Side effects of clozapine include neutropenia or agranulocytosis, myocarditis, fever, hypersalivation, weight gain and constipation. These side effects can be detected and treated when recognized on time decreasing the possibility of serious consequences making the implementation of an ongoing treatment monitoring protocol for patients on clozapine mandatory.2 Since it was advised for all mental health providers in most countries worldwide to limit non-urgent hospital visits and procedures to reduce the risk of contamination a challenge arose for patients' ability to access health care facilities for their routine clozapine monitoring. Nevertheless, the majority of Mental Health Care Authorities decided to ensure access for all patients on clozapine to their routine monitoring protocol.3,4 To date, no data exist on any potential relationship between antipsychotic use and the risk of contamination with SARS-CoV-2 or the development of severe symptoms of the infection. The literature suggests that patients receiving antipsychotics, especially clozapine, have an increased risk of developing pneumonia, leading to the assumption that patients receiving clozapine are at higher risk to develop COVID-19. 1 Balancing the importance of monitoring continuation against the increased risk for COVID-19, an International Consensus Statement was recently published addressing a monitoring protocol with reduced visits. The Consensus suggested reduced hematologic monitoring frequency of every 3 months with a prescription of 90 days clozapine supply (if safe). The above applies to patients receiving clozapine for at least one year without neutropenia. Τhe risk of neutropenia after 12 months of clozapine treatment falls significantly.4 Based on the above it is suggested to all clozapine clinics to implement a guidance monitoring protocol for all patients on clozapine to ensure safety during the pandemic. Besides hematological monitoring that requires physical contact with healthcare workers it is significant to implement a telemedicine appointment in frequent intervals to monitor symptoms of infection, symptoms of cardiovascular diseases and constipation. Patient should also be advised to regularly monitor one's blood pressure and pulses and ideally be educated on how by a member of the staff. If a patient is detected with any symptoms related to the above an emergency appointment for evaluation should be planned. Overall, since both the consequences and the duration of the pandemic are unknown, mental health services must work jointly to implement a clozapine monitoring plan to ensure safe continuation in such a vulnerable population.

Systemic corticosteroids in coronavirus disease 2019 (COVID-19)-related smell dysfunction: an international view.

The frequent association between coronavirus disease 2019 (COVID-19) and olfactory dysfunction is creating an unprecedented demand for a treatment of the olfactory loss. Systemic corticosteroids have been considered as a therapeutic option. However, based on current literature, we call for caution using these treatments in early COVID-19-related olfactory dysfunction because: (1) evidence supporting their usefulness is weak; (2) the rate of spontaneous recovery of COVID-19-related olfactory dysfunction is high; and (3) corticosteroids have well-known potential adverse effects. We encourage randomized placebo-controlled trials investigating the efficacy of systemic steroids in this indication and strongly emphasize to initially consider smell training, which is supported by a robust evidence base and has no known side effects.

Mechanisms of COVID-19 Entry into the Cell: Potential Therapeutic Approaches Based on Virus Entry Inhibition in COVID-19 Patients with Underlying Diseases.

The Coronavirus disease 2019 (COVID-19) virus spread from Wuhan, China, in 2019 and is spreading rapidly around the world. COVID-19 victims are almost associated with cardiovascular disease, high blood pressure, diabetes, and other underlying diseases. Concerning the high prevalence of these disorders, widespread mortality threatens global society, and its fatality rate may increase with increasing COVID-19 prevalence in countries with older populations. Therefore, evaluating patients' clinical status with severe COVID-19 infection and their medical history can help manage treatment. Currently, one of the considered treatments is angiotensin-converting enzyme 2 (ACE2) inhibition. This study investigated virus entry mechanisms through membrane receptors, their role in the pathogenesis of COVID-19 and underlying diseases, and treatment methods based on the viral entrance inhibition. According to existing studies, inhibition of ACE2 can increase oxidative stress, inflammation, fibrosis and ultimately exacerbate underlying diseases such as cardiovascular disease, kidney disease, diabetes, and hypertension in individuals with COVID-19. The ACE2 inhibition is not suitable for patients with COVID-19 with underlying diseases, but it seems that the recombinant ACE2 solution is more appropriate for inhibiting the virus in these patients if hypotension would be monitored.

Why Are Patients With COVID-19 at Risk for Drug-Drug Interactions?

The goal of this column is to provide information to health care professionals about drug-drug interactions (DDIs) and why DDIs are important to consider in those at serious risk of illness with Coronavirus Disease 2019 (COVID-19). Important considerations discussed in this column include the frequency and complexity of multiple medication use, particularly important for the older patient who often has multiple comorbid illnesses. The column covers the following issues: (1) Why patients at high risk for serious illness from COVID-19 are also at high risk for DDIs. (2) Application of results of pharmacoepidemiological studies to the population at risk for serious COVID-19 illness. (3) Mechanisms underlying DDIs, frequency and potential complexity of DDIs, and how DDIs can present clinically. (4) Methods for preventing or mitigating DDIs. (5) An introduction to the University of Liverpool drug interaction checker as a tool to reduce the risk of adverse DDIs while treating patients for COVID-19. Commentary is also provided on issues related to specific psychiatric and nonpsychiatric medications a patient may be taking. A subsequent column will focus on DDIs between psychiatric medications and emerging COVID-19 treatments, as a detailed discussion of that topic is beyond the scope of this column.

Treating Epilepsy Patients with Investigational Anti-COVID-19 Drugs: Recommendations by the Israeli Chapter of the ILAE.

BACKGROUND: The coronavirus disease-2019 (COVID-19) and its management in patients with epilepsy can be complex. Prescribers should consider potential effects of investigational anti-COVID-19 drugs on seizures, immunomodulation by anti-seizure medications (ASMs), changes in ASM pharmacokinetics, and the potential for drug-drug interactions (DDIs). The goal of the Board of the Israeli League Against Epilepsy (the Israeli Chapter of the International League Against Epilepsy, ILAE) was to summarize the main principles of the pharmacological treatment of COVID-19 in patients with epilepsy. This guide was based on current literature, drug labels, and drug interaction resources. We summarized the available data related to the potential implications of anti-COVID-19 co-medication in patients treated with ASMs. Our recommendations refer to drug selection, dosing, and patient monitoring. Given the limited availability of data, some recommendations are based on general pharmacokinetic or pharmacodynamic principles and might apply to additional future drug combinations as novel treatments emerge. They do not replace evidence-based guidelines, should those become available. Awareness to drug characteristics that increase the risk of interactions can help adjust anti-COVID-19 and ASM treatment for patients with epilepsy.

Role of clinical pharmacists in telemonitoring for patients with Coronavirus Disease 2019 (COVID-19).

WHAT IS KNOWN AND OBJECTIVE: Clinical pharmacists actively participate in patient care via patients' medication use. Yet the setting of Coronavirus Disease 2019 (COVID-19) limits patient contact with healthcare personnel. We aimed to review the services provided and drug-related problems detected using telemonitoring methods to guide clinical pharmacists in providing service in treating COVID-19 patients. COMMENT: At a tertiary care hospital in Thailand, clinical pharmacists provided pharmaceutical care services for COVID-19 patients via telemonitoring using the hospital's computerized physician order entry system. The pharmacists were able to provide therapeutic drug monitoring services, especially for anticoagulants. Many patients were considered special populations, with individualized requirements for drug dosing. Some adverse drug reactions were observed. Drug-related problems were mostly related to medication use in critically ill patients. WHAT IS NEW AND CONCLUSION: Telemonitoring is a viable method for clinical pharmacists to provide pharmaceutical care and meet the challenges posed by treating patients with COVID-19.

A Real-World Evidence Framework for Optimizing Dosing in All Patients With COVID-19.

Potential treatments for coronavirus disease 2019 (COVID-19) are being investigated at unprecedented speed, and successful treatments will rapidly be used in tens or hundreds of thousands of patients. To ensure safe and effective use in all those patents it is essential also to develop, at unprecedented speed, a means to provide frequently updated, optimal dosing information for all patient subgroups. Success will require immediate collaboration between drug developers, academics, and regulators.

Ophthalmic manifestations of coronavirus disease 2019 and ocular side effects of investigational pharmacologic agents.

PURPOSE OF REVIEW: To compile and report the ocular manifestations of coronavirus disease 2019 (COVID-19) infection and summarize the ocular side effects of investigational treatments of this disease. RECENT FINDINGS: Conjunctivitis is by far the most common ocular manifestation of COVID-19 with viral particles being isolated from tears/secretions of infected individuals. Multiple therapeutic options are being explored across a variety of medication classes with diverse ocular side effects. SUMMARY: Eye care professionals must exercise caution, as conjunctivitis may be the presenting or sole finding of an active COVID-19 infection. While no currently studied therapeutic agents have been found to reliably treat COVID-19, early vaccination trials are progressing and show promise. A video abstract is available for a more detailed summary. VIDEO ABSTRACT: http://links.lww.com/COOP/A36.

[Psychopharmacotherapy during the COVID-19 pandemic]. / Psychopharmakotherapie in Zeiten der COVID-19-Pandemie.

In view of the current coronavirus disease 2019 (COVID-19) pandemic, patient care, including that of psychiatric patients, is facing unprecedented challenges. Treatment strategies for mental illness include psychotherapy and psychopharmacological interventions. The latter are associated with a multitude of adverse drug reactions (ADR); however, they may currently represent the preferred treatment due to restrictions regarding patient care (i.e. social distancing). Direct contact to patients may have to be reduced in favor of telephone calls or video conferences, so that new techniques in diagnosing and treating patients have to be established to guarantee patient safety. Patients should be extensively informed about relevant ADRs and physicians should actively ask patients about the timely recognition of ADRs. The use of psychotropic drugs may lead to an increased risk of developing ADRs, which are considered to be particularly unfavorable if they occur simultaneously with an acute infection or may even lead to an increased risk of infection. These include respiratory depression, agranulocytosis, intoxication by inhibition of metabolizing enzymes and venous thromboembolism, each of which may be associated with potentially fatal consequences; however, physicians should simultaneously ensure adequate efficacy of treatment, since the ongoing crisis may lead to a worsening of preexisting mental illnesses and to a surge in first onset of psychiatric disorders.

Barriers to conducting deprescribing in the elderly population amid the COVID-19 pandemic.

Deprescribing aims to reduce polypharmacy, especially in the elderly population, in order to maintain or improve quality of life, reduce harm from medications, and limit healthcare expenditure. Coronavirus disease (COVID-19) is an infectious disease that has led to a pandemic and has changed the lives many throughout the world. The mode of transmission of this virus is from person to person through the transfer of respiratory droplets. Therefore, non-essential healthcare services involving direct patient interactions, including deprescribing, has been on hiatus to reduce spread. Barriers to deprescribing before the pandemic include patient and system related factors, such as resistance to change, patient's knowledge deficit about deprescribing, lack of alternatives for treatment of disease, uncoordinated delivery of health services, prescriber's attitudes and/or experience, limited availability of guidelines for deprescribing, and lack of evidence on preventative therapy. Some of these barriers can be mitigated by using the following interventions:patient education, prioritization of non-pharmacological therapy, incorporation of electronic health record (EHR), continuous prescriber education, and development of research studies on deprescribing. Currently, deprescribing cannot be delivered through in person interactions, so virtual care is a reasonable alternative format. The full incorporation of EHR throughout Canada can add to the success of this strategy. However, there are several challenges of conducting deprescribing virtually in the elderly population. These challenges include, but are not limited, to their inability to use technology, lack of literacy, lack of assistance from others, greater propensity for withdrawal effects, and increased risk of severe consequences, if hospitalized. Virtual care is the future of healthcare and in order to retain the benefits of deprescribing, additional initiatives should be in place to address the challenges that elderly patients may experience in accessing deprescribing virtually. These initiatives should involve teaching elderly patients how to use technology to access health services and with technical support in place to address any concerns.