Therapeutic Advances in Drug Safety最新文献

Self-medication (SM) is a global and growing phenomenon. It represents a public health problem due to antibiotic resistance, risk of adverse drug reactions, drug-drug interactions, disease masking, and increased morbidity. There is not a consensus on the definition of SM. The definitions found in different studies make it difficult to address this problem from a theoretical perspective and therefore find an adequate solution to this public health problem. The aim of this article is to search the medical literature to characterize the current understanding of SM in the medical community. We conducted a scoping review of definitions of SM by searching on PubMed - Medline, Embase, and LILACS using the following combination of keywords: 'self-prescription' or 'self prescription', 'self-medication' or 'self medication', or 'automedication' and 'definition' or 'explanation'. The search was limited to articles containing the definition of SM, with no limit on language or year. Duplicate studies and those that did not mention the definition of SM were excluded from the final review. A total of 65 studies were included in the final selection. We found a vast heterogeneity in the definition of SM. Most articles based their definition of SM on the process of obtaining the drug, the nonparticipation of a specific health professional, the source of the medication, and the reason for SM. Other interesting concepts such as self-care, nonadherence to a prescription, reuse of stored drugs, and sharing and lending medicines were also considered forms of SM by other authors, however. This study highlights the need to reach a consensus regarding the definition of SM to adequately propose strategies to address this global health problem. This study shows the diverse concepts that need to be included in a future definition of SM.

Plain language summary: Definition of self-medication: a review with systematic methodology Self-medication (SM) is a global and growing phenomenon that represents a public health problem due to antibiotic resistance, risk of dangerous side effects, interactions between drugs, and disease masking. Currently, there is not a consensus on the definition of SM, which makes it difficult to address this problem and therefore find an adequate solution. Making a standard definition would allow the development of programs focused on addressing drug-related problems associated with self-medication behavior. The purpose of this article is to search the medical literature to define the current understanding of SM in the medical community. We included a total of 65 studies and found a great variance in the definition of SM. Most articles based their definition of SM on the process of obtaining the drug, the nonparticipation of a specific health professional, the source of the medication, and the reason for SM. Other interesting concepts such as self-care, not following a prescription, reuse of stored drugs, and sharing

Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the safety and effectiveness of pharmaceuticals is extremely important. Pharmacovigilance is a key component of drug safety regulatory processes and is paramount for ensuring the safety profile of medications used to treat patients. All participants in the healthcare system, including healthcare providers and consumers, should understand and meaningfully engage in the pharmacovigilance process; healthcare providers should integrate pharmacovigilance into everyday practice, inviting feedback from patients. This narrative review aims to give an overview of the main topics underlying pharmacovigilance and drug safety in pharmaceutical research phase after the authorization of a drug in the United States. The US Food and Drug Administration guidance and post-approval regulatory actions are considered from an industry perspective.

Plain language summary: Regulatory processes that ensure the safety of drugs is monitored Government agencies regulate the safe use of medicinal products. By determining and enforcing pharmacovigilance, the monitoring of drugs for potential risks, they safeguard the welfare of consumers of medicines. Comprehensive, documented methods for evaluating the safety of a drug during its development and its subsequent use allow identification of any risks associated with the drug's use throughout its lifetime. The comprehensive identification of safety issues associated with a drug is improved when all parties involved in the development and use of drugs participate in the pharmacovigilance process. For example, clinicians should regularly ask their patients if they are experiencing any issues with their treatment, and patients should be encouraged to report problems they encounter with a particular medication to their healthcare provider. This narrative review provides an overview of the main topics underlying pharmacovigilance and drug safety after approval of a drug in the United States. Guidelines and actions from the US Food and Drug Administration are considered from an industry perspective.

Introduction: Many older adults are affected by multimorbidity and subsequent polypharmacy which is associated with adverse outcomes. This is especially relevant for frail older patients. Polypharmacy may be reduced via deprescribing. As part of the complex intervention in the COFRAIL study, we developed a deprescribing manual to be used by general practitioners (GPs) in family conferences, in which GPs, patients and caregivers jointly discuss treatments.

Methods: We selected indications with a high prevalence in older adults in primary care (e.g. diabetes mellitus, hypertension) and conducted a literature search to identify deprescribing criteria for these indications. We additionally reviewed clinical practice guidelines. Based on the extracted information, we created a deprescribing manual which was then piloted in an expert workshop and in family conferences with volunteer patients according to the inclusion and exclusion criteria of the study protocol.

Results: Initially, 13 indications/topics were selected. The literature search identified deprescribing guides, reviews and clinical trials as well as lists of potentially inappropriate medication and systematic reviews on the risk and benefits of specific drugs and drug classes in older patients. After piloting and revisions, the deprescribing manual now covers 11 indications/topics. In each chapter, patient- and medication-related deprescribing criteria, monitoring and communication strategies, and information about concerns related to the use of specific drugs in older patients are provided.

Discussion: We found varying deprescribing strategies in the literature, which we consolidated in our deprescribing manual. Whether this approach leads to successful deprescribing in family conferences is being investigated in the cluster-randomised controlled COFRAIL study.

Plain language summary: Development of a manual to help doctors to identify which medications can be withdrawn Many older adults suffer from chronic diseases and take multiple medications concurrently. This can lead to side effects and other undesired events. We developed a manual to help doctors identify which medications can be withdrawn, so that they can discuss this with their patients. This manual was used in the COFRAIL study where doctors, patients and caregivers met in family conferences to discuss their preferences and decide together how future treatments should be handled. The manual contains information on common medications, symptoms and diseases in older patients such as diabetes and high blood pressure. Before the manual was used in the study, it was tested by volunteer patients and their doctors and caregivers to make sure that it is user-friendly.

The COVID-19 pandemic, caused by a novel type of coronavirus, continues to infect people, increasing morbidity and mortality across the globe. Measures to slow the transmission of the virus have had limited impact, and people, businesses, and economies have suffered. The disease has disproportionally impacted elderly and individuals with certain pre-existing conditions and has highlighted health and social inequities in some racial and ethnic minority groups. The majority of those who contract the disease recover completely, but some experience long-lasting complications. Vaccines have the potential to end the pandemic, and through the intense collaboration of scientists in government and private sectors, more than 200 COVID-19 candidate vaccines have been or are being developed, using known platforms and previous experiences with severe acute respiratory syndrome (SARS), at unprecedented speed. The expectations for vaccine safety and quality in the setting of accelerated development are the same as during non-emergency times; however, challenges inherent with the circumstances of the pandemic situation provide opportunities to improve clinical trial conduct and strengthen pharmacovigilance systems. We have reviewed and analyzed existing PV guidelines and recommendations throughout the lifecycle of vaccine development with a focus on developing a global/worldwide effort for post-marketing vaccine safety surveillance.

Plain language summary: The Important Role of Pharmacovigilance in Accelerated COVID-19 Vaccine Development This is an extensive review that intends to address important aspects of COVID-19 vaccines' accelerated development and safety surveillance. It is focused on regulatory requirements for long-term safety monitoring, practical applications, and current global efforts in developing robust pharmacovigilance systems for post-authorization surveillance.Notably, different perspectives of authors from industry, academic institutions, and contract research organizations involved in drug safety were incorporated to reflect on various regulatory requirements and new developments in vaccine safety. All co-authors are current members of International Society of Pharmacovigilance (ISoP).

Pharmacovigilance (PV) came suddenly into the spotlight when several new vaccines, developed as a response to the COVID-19 pandemic, received emergency authorisation and were rolled out on a large scale in late 2020. The vaccines underwent stringent clinical trials and evaluation from regulatory authorities, but with the use of novel technology and an anticipated rapid and vast deployment of the vaccines, the importance of a well-functioning international post marketing safety surveillance system was stressed. International PV stakeholders were faced with several challenges due to the extent of the global vaccination campaign. The unprecedented volume of reports of suspected adverse events following immunization has led to the development and use of new tools. Furthermore, the collaboration between various PV stakeholders was encouraged and strengthened. PV rose to the challenges posed by the currently ongoing global COVID-19 vaccination campaign and successful adaptations were made in a short period of time. However, the pandemic has not ended yet, the vaccination campaign is far from being completed, and further challenges are anticipated. Advances made during the pandemic will be important to strengthen PV in future and ensure to advance medicines' safety together.

Plain language summary: Global safety monitoring of the COVID-19 vaccines: challenges, preparations, and outlooks Pharmacovigilance (PV) is the umbrella term for all sciences and activities relating to the detection, assessment, understanding, and prevention of adverse effects relating to medicines or vaccines. PV came into the spotlight when several new vaccines were authorised and rolled out as a response to the COVID-19 pandemic.The anticipated extent of the global vaccine rollout stressed the importance of a well-functioning safety surveillance system and international collaborations between patients, health care workers, vaccine producers, regulatory authorities, and PV centres.The identification and communication of potential safety concerns showed that adaptations to PV processes made in a short period of time as well as international collaborations were successful. However, it is important to learn from experiences made so far and to make sure the positive advances are maintained in the future to advance medicines' safety together.

Background: There has been a rising prevalence of polypharmacy among people living with HIV (PLWH). Uncertainty however remains regarding the exact estimates of polypharmacy among these cohorts of patients.

Methods: We conducted a systematic search of PubMed; EMBASE, CROI, Cochrane Database of Systematic Reviews; Science Citation Index and Database of Abstracts of Reviews of Effects for studies between 1 January 2000 and 30 June 2021 that reported on the prevalence of polypharmacy (ingestion of > 5 non-ART medications) among PLWH on antiretroviral therapy regimen (ART). Prevalence of polypharmacy among HIV-positive patients on ART with Clopper-Pearson 95% confidence intervals were presented. The heterogeneity between studies was evaluated using $I^2$ and ${\tau }^2$ statistics.

Results: One hundred ninety-seven studies were initially identified, 23 met the inclusion criteria enrolling 55,988 PLWH, of which 76.7% [95% confidence interval (CI): 76.4-77.1] were male. The overall pooled prevalence of polypharmacy among PLWH was 33% (95% CI: 25-42%) (I ² = 100%, τ² = 0.9170, p < 0.0001). Prevalence of polypharmacy is higher in the Americas (44%, 95% CI: 27-63%) (I ² = 100%, τ² = 1.0886, p < 0.01) than Europe (29%, 95% CI: 20-40%) (I ² = 100%, τ² = 0.7944, p < 0.01).

Conclusion: The pooled prevalence estimates from this synthesis established that polypharmacy is a significant and rising problem among PLWH. The exact interventions that are likely to significantly mitigate its effect remain uncertain and will need exploration by future prospective and systematic studies.

Registration: PROSPERO: CRD42020170071.

Plain language summary: Background: In people living with HIV (PLWH), what is the prevalence of polypharmacy and is this influenced by sociodemographic factors?Methods and Results: In this systematic review and meta-analysis of 23 studies comprising 55,988 participants, we have for the first time found an estimated polypharmacy pooled prevalence of 33% among PLWH. There was a relatively higher pooled prevalence of polypharmacy among the America's compared with European cohorts of PLWH.Conclusion: Polypharmacy among PLWH is a rising morbidity that needs urgent intervention both at policy and patient levels of care.

Purpose: Developing effective deprescribing interventions relies on understanding attitudes, beliefs, and communication challenges of those involved in the deprescribing decision-making process, including the patient, the primary care clinician, and the pharmacist. The objective of this study was to assess patients' beliefs and attitudes and identify facilitators of and barriers to deprescribing.

Methods: As part of a larger study, we recruited patients ⩾18 years of age taking ⩾3 chronic medications. Participants were recruited from retail pharmacies associated with the University of Kentucky HealthCare system. They completed an electronic survey that included demographic information, questions about communication with their primary care clinician and pharmacists, and the revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire.

Results: Our analyses included 103 participants (n = 65 identified as female and n = 74 as White/Caucasian) with a mean age of 50.4 years [standard deviation (SD) = 15.5]. Participants reported taking an average of 8.4 daily medications (SD = 6.1). Most participants reported effective communication with clinicians and pharmacists (66.9%) and expressed willingness to stop one of their medications if their clinician said it was possible (83.5%). Predictors of willingness to accept deprescribing were older age [odds ratio (OR) = 2.99, 95% confidence interval (CI) = 1.45-6.2], college/graduate degree (OR = 55.25, 95% CI = 5.74-531.4), perceiving medications as less appropriate (OR = 8.99, 95% CI = 1.1-73.62), and perceived effectiveness of communication with the clinician or pharmacist (OR = 4.56, 95% CI = 0.85-24.35).

Conclusion: Adults taking ⩾3 chronic medications expressed high willingness to accept deprescribing of medications when their doctor said it was possible. Targeted strategies to facilitate communication within the patient-primary care clinician-pharmacist triad that consider patient characteristics such as age and education level may be necessary ingredients for developing successful deprescribing interventions.

Plain language summary: Are patients willing to accept stopping medications? Sometimes, medicines that a patient takes regularly become inappropriate. In other words, the risks of adverse effects might be greater than a medicine's potential benefits. The decision to stop such medicines should involve the patient and consider their preferences. We surveyed a group of patients taking multiple medicines to see how they felt about having those medicines stopped. We also asked patients whether and how much they talk to their primary care clinician and pharmacists about their medicines. To qualify for this study, patients had to be at least 18 years old and to take three or more medicines daily; they also needed to speak English. Participants provided demographic i

Background: Spontaneous reporting systems are the commonest means of reporting adverse drug reactions (ADRs) worldwide. Under-reporting remains a challenge particularly in developing countries among healthcare professionals (HCPs) who are considered the primary stakeholders in the reporting of ADRs. The challenge with studies in countries such as Ghana is that the focus has been on a single professional group or health facility. This study examines the rate of reporting as well as awareness, knowledge, and attitudes toward ADR reporting across professional groups (doctors, nurses, and pharmacist) and selected health facilities (ownership types: government, quasi-government, and private; hierarchy: district, regional, and teaching) in Ghana.

Method: A cross-sectional survey was conducted to select and interview 424 healthcare professionals (HCPs) from 8 hospitals in the Greater Accra and Eastern regions of Ghana on issues of ADR reporting, awareness, knowledge, and attitudes toward ADR reporting. Valid responses from 378 HCPs were obtained and analyzed using frequencies and percentages.

Findings: The results suggest that about 82.8% of the HCPs interviewed have come across an ADR incidence, but only 52.6% of them have reported such incidence, with pharmacist (66.7%) being the most likely to report. The results further suggest that about 85.8% of HCPs are aware of ADR reporting procedures and display positive attitudes toward same. In addition, the knowledge of HCPs on ADR reporting is low with training being a major area of need.

Conclusion: There is the need for healthcare managers and the regulator to pay attention to existing gaps in awareness, attitudes, and most importantly knowledge of HCPs on structures and modalities for ADR reporting.

Plain language summary: Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana Reporting of unpleasant reactions related to the use of medicinal products has been very low in less developed countries. Studies conducted in Ghana to examine the reporting of unpleasant reactions associated with the use of medicinal products have focused mainly on one health facility or health care provider group. This article examines the level of awareness, knowledge, and attitudes toward the reporting of unpleasant reactions to the use of medicinal products.The authors used a quantitative method to examine the level of awareness, knowledge, and attitude toward reporting of unpleasant reactions to medicinal products. The study was conducted in eight hospitals in Greater Accra and Eastern regions of Ghana using a structured questionnaire. Only 378 out of 424 healthcare providers returned the completed questionnaire.The findings of the study show that 213 of the healthcare providers have encountered at least one patient with an unpleasant reaction