 Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
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- HIV/AIDS patients’ knowledge, attitude, and practice toward
anti-retroviral therapy medications’ adverse effects and associated
factors in Tikur Anbessa Specialized Hospital
Authors: Zenebe Negash, Yohannes Yibeltal, Akeberegn Gorems Ayele
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:Adverse effects (AEs) have been reported with all antiretroviral therapy (ART) medications, and it was among the most common cause for switching or terminating therapy and drug non-adherence. Even though AEs of ART medications are common and to be expected, little study has been conducted on the understanding of patients on the AEs. Therefore, this study aimed to assess patients’ knowledge, attitude, and practice (KAP) toward ART medications’ AEs and associated factors.Methods:A cross-sectional study design was applied using an interviewer-administered questionnaire from June to September 2021 on human immunodeficiency virus/acquired immunodeficiency syndrome patients on follow-up at Tikur Anbessa Specialized Hospital, Ethiopia. Data was gathered, cleaned, and analyzed using SPSS version 23. Logistic regression analysis was performed to assess the relationship between the independent variable and patients’ knowledge and attitude about the AEs of ART medication. A p-value of 0.05 was used to determine the statistical significance.Results:About 230 people were enrolled in this study, with 51.3% of them female. Study participants had a mean age of 36 years (standard deviation = 14.19). Of 230 participants, 67.8% had received advice on the AEs of ART medications. Poor knowledge and attitude were observed among 47.8 and 51.3% of respondents, respectively. Prior AEs experience, lack of experiencing opportunistic infection, and lack of counseling about ART medications’ AEs were associated with poor knowledge, whereas female gender and a lack of counseling regarding ART medications’ AEs were associated with a negative attitude (p
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-09-01T11:46:41Z
DOI: 10.1177/20420986231194752
Issue No: Vol. 14 (2023)
- Clinical relevance of potential self-medication drug interactions in
antineoplastic and immune-modulating therapy among online pharmacy
customers
Authors: Florian Schindler, Timo Schinkoethe, Sven Mahner, Thomas Kolben, Rachel Wuerstlein, Carsten Culmsee, Nadia Harbeck, Tanja K. Eggersmann
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:Modern oral antineoplastic and immune-modulating drugs offer an array of therapeutic advantages, and yet pose challenges in daily use for patients, physicians and pharmacists. In contrast to intravenous administration, these drugs are not subject to direct medical control. Recently, we have seen a huge rise in sales of non-prescription over-the-counter (OTC) medicines via the internet without any advice from a healthcare professional.Objectives:The aim of this study was to investigate whether the risk of known potential drug-drug interactions between modern oral antineoplastic and immune-modulating drugs and OTC drugs differs between sales in traditional community pharmacies versus online pharmacies.Design:Real-life sales data from community and online pharmacies were used as basis for the analysis.Methods:We determined the most frequently purchased antineoplastic and immune-modulating drug-substances in 14 local community pharmacies within the Munich area, Germany and identified the OTC substance groups that could potentially cause interactions with oncological therapies. Using sales data from 11 local community pharmacies and three online pharmacies, we investigated whether OTC purchases differed between the two sales channels.Results:We identified 10 relevant OTC substance classes and detected significant variations in patients’ preferred sales channels between the drug classes. Certain OTC drugs, which seem to be bought more often over the internet, pose risks during antineoplastic and immune-modulating therapy.Conclusion:Patients should therefore be proactively made aware of the corresponding risks in order not to jeopardize the activity of the antineoplastic and immune-modulating drugs and thus the success of their therapy.Plain language summaryComparing Community and Online Pharmacies: Investigating Potential Interactions Between Cancer and Immune-Modulating Drugs with Over-the-Counter Medications, and the Importance of Patient Awareness and Healthcare Professional Guidance in Minimizing Adverse Effects and Maintaining Treatment EfficacyModern anticancer and immune-modulating drugs have the advantage of often being taken orally, but they present other challenges in daily use. Unlike intravenously administered drugs, these are usually not administered by a physician but taken by the patient at home. In these cases, patients may be more likely to buy and take self-medicating drugs over-the-counter (OTC) without consulting a healthcare professional.This study aimed to investigate whether there is a different risk of drug interactions between cancer or immune-modulating drugs and OTC drugs when bought in a community pharmacy versus an online pharmacy. Therefore, we looked at the most common cancer and immune-modulating drugs purchased in 14 local community pharmacies in Munich and identified which OTC drugs could cause problems when used simultaneously. Additionally, we analyzed the sales data from 11 local and 3 online pharmacies to determine if people were more likely to buy different OTC drugs from the two types of pharmacies.As a result, this study showed 10 relevant OTC drug types that potentially cause problems and influence effectiveness when used with cancer or immune-modulating drugs. Furthermore, we observed that some of these OTC drugs were purchased more often online than in community pharmacies and thus are more distant from the control of a physician or pharmacist.It is therefore essential for patients to be aware of the risks associated with easily accessible OTC drugs in combination with their cancer or immune-modulating medication, as serious side effects or decreased efficacy may develop. Patients should remember to consult their doctor or pharmacist if there is any uncertainty about potential drug interactions. At the same time, healthcare professionals should proactively draw their patients’ attention to these potential risks, especially when purchasing online.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-08-24T10:54:36Z
DOI: 10.1177/20420986231188845
Issue No: Vol. 14 (2023)
- Enhancing self-medication practices in the era of infodemic: the role of
pharmacovigilance
Authors: Carlos-Alberto Calderon-Ospina
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-08-23T12:10:32Z
DOI: 10.1177/20420986231194754
Issue No: Vol. 14 (2023)
- Hospital admissions attributed to adverse drug reactions in tertiary care
in Uganda: burden and contributing factors
Authors: Lillian Asio, Marble Nasasira, Ronald Kiguba
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:Adverse drug reactions (ADRs) contribute to the burden of disease globally and of particular concern are ADR-related hospital admissions.Objectives:This study sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission among inpatients in Uganda.Design:We conducted a cross-sectional secondary analysis of data from a prospective cohort study of adult inpatients aged 18 years and older at Uganda’s Mulago National Referral Hospital from November 2013 to April 2014.Methods:We reviewed clinical charts to identify inpatients with an ADR as one of the admitting diagnoses and, if so, whether or not the hospital admission was primarily attributed to the ADR. Logistic regression was used to determine factors associated with hospital admissions primarily attributed to ADRs.Results:Among 762 inpatients, 14% had ADRs at hospital admission and 7% were primarily hospitalized due to ADRs. A total of 235 ADRs occurred among all inpatients and 57% of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were attributed to antiretroviral drugs. HIV infection [aOR (adjusted odds ratio) = 2.97, 95% confidence interval (CI): 1.30–6.77], use of antiretroviral therapy (aOR = 5.46, 95% CI: 2.56–11.68), self-medication (aOR = 2.27, 95% CI: 1.14–4.55) and higher number of drugs used (aOR = 1.13, 95% CI: 1.01–1.26) were independently associated with hospital admissions attributed to ADRs.Conclusion:Antiretroviral drugs were often implicated in ADR-related hospital admissions. HIV infection (whether managed by antiretroviral therapy or not), self-medication and high pill burden were associated with hospital admissions attributable to ADRs. The high HIV burden in Sub-Saharan Africa increases the risk of ADR-related hospitalization implying the need for emphasis on early detection, monitoring and appropriate management of ADRs associated with hospital admission in people living with HIV.Plain language summaryPrevalence and contributing factors of hospital admissions attributed to adverse drug reactions in UgandaIntroduction: Adverse drug reactions (ADRs) are a big problem in many parts of the world and of particular concern is a situation where patients are admitted primarily because of an ADR. We sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission in Uganda.Methods: We analysed data collected from a prospective cohort study of adult inpatients aged 18 years and older at Uganda’s Mulago National Referral Hospital from November 2013 to April 2014. We reviewed clinical charts to identify inpatients in whom an ADR was one of the admitting diagnoses and, if so, whether or not the ADR was the primary diagnosis linked to hospital admission. We used statistical tests to assess for contributing factors of hospital admissions attributable to ADRs.Results: Among 762 inpatients, 108 had ADRs at admission and 56 were primarily admitted due to ADRs. A total of 235 ADRs occurred among all inpatients and 135 of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were linked to antiretroviral drugs. HIV infection, use of antiretroviral therapy, self-medication and higher number of drugs used were associated with hospital admissions primarily attributed to ADRs.Conclusion: To prevent hospital admissions attributed to ADRs, patients need to be warned against self-medication, health workers and patients need to be reminded of the importance of early detection, monitoring and appropriate management of ADRs among the HIV-infected (whether managed by ART or not) and those patients taking many drugs.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-07-29T12:18:55Z
DOI: 10.1177/20420986231188842
Issue No: Vol. 14 (2023)
- Funding and financial sustainability of pharmacovigilance: suggested
models for funding pharmacovigilance in resource-limited African countries
Authors: Ambrose O. Isah, Abimbola O. Opadeyi, Henry Tumwijukye, Frank Cobelens, Diede Smith, Margareth Ndomondo-Sigonda, Linda Harmark, Paul Tanui, Edine Tiemersma, Blandina T. Mmbaga, Gugu Mahlangu, Stephen A. Ayinbuomwan, Rachida Soulaymani, Jayesh M. Pandit
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used.Objectives:The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa.Methods/processes:The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out.Results:The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions.Conclusion:In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa.Plain language summaryFunding models for pharmacovigilance in resource-limited African countriesAn important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings following their entry into the WHO Programme of International Drug Monitoring is the lack of adequate funds to establish a functional National Pharmacovigilance System. This article provides an overview of various potential sources of funds in these settings and how they can be harnessed to fund PV.We undertook a review of PV financing in developed settings and carried out a landscape study of funding of PV in some African countries, as well as having an in-depth understanding of the PV system and the organisational structure. The nexus between the regulatory agencies and National Pharmacovigilance Centre was noted.We took into account the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework for the different African countries. We also identified the prevalent and potential sources of funds for PV. Consultative meetings, webinars and interviews with experts in PV were carried out as well.We discovered that most of the PV facilities were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing.We have now proposed funding models that may lead to increased revenue for PV in these countries as well as suggesting that a legal framework be provided to guarantee sustainability and address the nexus between the regulatory agencies and the PV outfits to ensure an appropriate share of resources and blocking diversions.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-07-24T10:48:23Z
DOI: 10.1177/20420986231188836
Issue No: Vol. 14 (2023)
- Flow rate accuracy of infusion devices within healthcare settings: a
systematic review
Authors: Opeyemi Atanda, Jonathan West, Tom Stables, Chris Johnson, Robert Merrifield, James Kinross
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:One in five patients admitted to the hospital treated with intravenous (IV) fluid therapy suffer complications due to inappropriate administration. Errors have been reported in 13–84% of the preparation and administration of IV medications. The safe delivery of IV fluids requires precise rate administration.Objectives:This systematic review aims to determine the accuracy of infusion sets and devices and examine the factors that affect the flow rate accuracy of devices.Data Sources and Methods:Six databases (CINAHL, MEDLINE PubMed, EMBASE, Web of Science and Cochrane Database of systematic reviews) were systematically searched. Search terms included infusion pumps, infusion devices, flow rate accuracy, fluid administration rate, gravity-led infusion set and fluid balance. Studies were included if they examined infusion devices’ flow rate accuracy and drop rates for fluids or non-oncological drugs. Findings were tabulated and synthesised qualitatively. The quality of the studies was examined based on the design of the studies due to their heterogeneity.Results:Eight studies were included: Four studies were conducted on human subjects in the hospital environment; studies recruited 182 participants between the ages of 18 and 94 years. Two studies examined flow rate accuracy in recruited patients across 509 observations and 2387 drip hours. No trials prospectively assessed the accuracy of infusion pumps in the clinical domain, and no studies were reported on patient safety outcomes. Four studies examined the impact of mechanical and physiological factors on the flow rate accuracies of infusion devices. Height and back pressure simulated vibrating conditions, the viscosity of IV fluid and the positions of patients were reported to have a significant impact on infusion volume and flow rates of infusion devices. Additionally, giving sets that vary from the manufacturer’s specifications are reported to increase error percent by 10–20%.Conclusion:Infusion devices are an important source of error in administering IV fluids. Yet, there needs to be more prospective trial data to support their clinical accuracy and the impact on patient outcomes. Future flow variability and accuracy studies should capture their impact on patient safety and clinical outcomes.Plain language summaryAre the flow rate of infusion devices accurate in fluid administration'Background/Why was this study done'Nearly all patients in healthcare settings undergo treatment with fluid therapy that is administered through a vein. Inaccurate intravenous fluid administration causes patient harm. However, very little information in the literature explains how precisely intravenous fluid is administered.What did the researchers do'We reviewed the literature on flow rate accuracies of specific infusion devices and examined the factors that affect the flow rate accuracies of intravenous fluid administered to patients.What did the researchers find'We found that the flow rate accuracies of infusion devices vary greatly, and they are often affected by physiological and mechanical factors. However, the precise impact of this on patients’ clinical outcomes is not often reported, representing a significant knowledge gap.What do the findings mean'We conclude that there is an urgent need to improve the reporting and precision of intravenous fluid rate administration and to understand how this impacts patient safety and clinical outcomes.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-07-21T09:00:08Z
DOI: 10.1177/20420986231188602
Issue No: Vol. 14 (2023)
- Safety monitoring of oral iron supplements in pregnant women with anemia:
a multi-center observational clinical study
Authors: Chang Liu, Qianqian Zhang, Peiye Hui, Yan Wang, Guohui Li, Guangchao Cao, Zicheng Xue, Jing Zhang, Heng Zhang, Xin Huang, Jiyong Wu, Fusehng Sun, Meixing Yan
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Aims:To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world.Methods:A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31 June 2021; follow-up and adverse reactions were recorded. They were divided into six groups according to the treatment drugs.Results:The overall adverse reaction rate was 15.4%, and the main adverse reaction site was the digestive system. The incidence of all kinds of oral iron adverse reactions from high to low in order: compound ferrous sulfate and folic acid tablets (21.88%); iron proteinsuccinylate oral solution (20.90%); ferrous succinate tablets (19.76%); ferrous succinate sustained-release tablets (18.00%); iron polysaccharide complex capsule (12.06%); and iron dextran oral solution (6.94%). It was found that there was a significant difference in the incidence of adverse reactions among the six drugs (p
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-06-24T11:38:07Z
DOI: 10.1177/20420986231181335
Issue No: Vol. 14 (2023)
- Survival outcomes of beta-blocker usage in HER2-positive advanced breast
cancer patients: a retrospective cohort study
Authors: Hui-Hsia Hsieh, Tien-Yuan Wu, Chi-Hua Chen, Yu-Hung Kuo, Mann-Jen Hour
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:Clinical trials investigating the effects of beta-blockers (BBs) on cancer are underway. Evidence from preclinical research suggests that BBs could serve as anticancer agents and immune boosters. There is conflicting evidence regarding the effect of BB use on clinical outcomes in patients with breast cancer.Objectives:The study aimed to determine whether BB use is associated with progression-free survival (PFS) and overall survival (OS) in patients receiving anti-human epidermal growth factor receptor 2 (HER2) treatment for advanced breast cancer.Design:Retrospective hospital-based study.Methods:The participants enrolled were breast cancer patients with advanced HER2-positive status who initiated trastuzumab monotherapy or concomitant therapy with trastuzumab and any dose of BB. The patients were enrolled between January 2012 and May 2021 and divided into three groups based on whether they received a BB or not in the therapeutic regimen: BB−/trastuzumab+, BB+ (non-selective)/trastuzumab+, and BB+ (selective)/trastuzumab+. PFS and OS were the primary and secondary endpoints, respectively.Results:The estimated median PFS in the BB−/trastuzumab+, BB+ (non-selective)/trastuzumab+, and BB+ (selective)/trastuzumab+ groups was 51.93, 21.50, and 20.77 months, respectively. The corresponding OS was 56.70, 29.10, and 27.17 months. The intergroup differences in these durations were significant. Both PFS [adjusted hazard ratio (HR): 2.21, 95% confidence interval (CI): 1.56–3.12; p
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-06-21T12:10:43Z
DOI: 10.1177/20420986231181338
Issue No: Vol. 14 (2023)
- Joint use of population pharmacokinetics and machine learning for
optimizing antiepileptic treatment in pediatric population
Authors: Ivana Damnjanović, Nastia Tsyplakova, Nikola Stefanović, Tatjana Tošić, Aleksandra Catić-Đorđević, Vangelis Karalis
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Purpose:Unpredictable drug efficacy and safety of combined antiepileptic therapy is a major challenge during pharmacotherapy decisions in everyday clinical practice. The aim of this study was to describe the pharmacokinetics of valproic acid (VA), lamotrigine (LTG), and levetiracetam (LEV) in a pediatric population using nonlinear mixed-effect modeling, while machine learning (ML) algorithms were applied to identify any relationships among the plasma levels of the three medications and patients’ characteristics, as well as to develop a predictive model for epileptic seizures.Methods:The study included 71 pediatric patients of both genders, aged 2–18 years, on combined antiepileptic therapy. Population pharmacokinetic (PopPK) models were developed separately for VA, LTG, and LEV. Based on the estimated pharmacokinetic parameters and the patients’ characteristics, three ML approaches were applied (principal component analysis, factor analysis of mixed data, and random forest). PopPK models and ML models were developed, allowing for greater insight into the treatment of children on antiepileptic treatment.Results:Results from the PopPK model showed that the kinetics of LEV, LTG, and VA were best described by a one compartment model with first-order absorption and elimination kinetics. Reliance on random forest model is a compelling vision that shows high prediction ability for all cases. The main factor that can affect antiepileptic activity is antiepileptic drug levels, followed by body weight, while gender is irrelevant. According to our study, children’s age is positively associated with LTG levels, negatively with LEV and without the influence of VA.Conclusion:The application of PopPK and ML models may be useful to improve epilepsy management in vulnerable pediatric population during the period of growth and development.Plain language summaryPharmacokinetics and machine learning in epilepsy : Nowadays, combined antiepileptic therapy is the best option for a number of pediatric patients. Furthermore, there are no standard procedures in the therapy management of this complex treatment. Besides therapeutic monitoring, the population pharmacokinetic (PopPK) approach and machine learning (ML) are useful sources of information regarding the optimization of therapy. The aim of this study was to describe the pharmacokinetics of valproic acid (VA), lamotrigine (LTG), and levetiracetam (LEV) in a pediatric population using nonlinear mixed-effect modeling, while ML algorithms were applied to identify any relationships among the plasma levels of the three medications and patients’ characteristics. The study included 71 pediatric patients of both genders, aged 2–18 years, on combined antiepileptic therapy. Population pharmacokinetic (PopPK) models were developed separately for VA, LTG, and LEV. Based on the estimated pharmacokinetic parameters and the patients’ characteristics, three ML approaches were applied (principal component analysis, factor analysis of mixed data, and random forest). According to our study, children’s age is positively associated with LTG levels, negatively with LEV and without influence from VA. However, the gender of patients has no influence on drug plasma concentration. Findings demonstrated that the application of PopPK and ML models may be useful to improve epilepsy management in vulnerable pediatric population during the period of growth and development.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-06-21T11:22:45Z
DOI: 10.1177/20420986231181337
Issue No: Vol. 14 (2023)
- Assessing adverse drug reaction reports for antidiabetic medications
approved by the food and drug administration between 2012 and 2017: a
pharmacovigilance study
Authors: Britney A. Stottlemyer, Michael C. McDermott, Mackenzie R. Minogue, Matthew P. Gray, Richard D. Boyce, Sandra L. Kane-Gill
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Objective:Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS).Research Design and Methods:A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class.Results:127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports.Conclusion:Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.Plain language summaryAdverse drug reactions reported for antidiabetic medicationsIntroduction: This study investigated the trends in voluntary reporting of adverse drug reactions for recently approved antidiabetic medications.Methods: Data from the FDA Adverse Events Reporting System were evaluated. The top 10 adverse drug reactions were compared between antidiabetic medications in the same therapeutic class.Results: We identified 127,525 adverse drug reaction reports for the newer approved antidiabetic medications. For SGLT-2 inhibitors, empagliflozin was associated with greater reports of blood glucose increase, nausea, and dizziness; weight decreased was reported more often for dapagliflozin; and diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis were reported more commonly for canagliflozin. Assessing GLP-1 receptor agonists, the odds of gastrointestinal adverse drug reactions being reported was greater for dulaglutide and semaglutide. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports.Conclusion: Medication safety studies using a large publicly available dataset allows an essential opportunity to evaluate the safety profile of antidiabetic drugs in the real-world setting. Additional research is needed to determine if the reported safety concerns for recently approved antidiabetic medications to determine causality.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-06-12T12:36:37Z
DOI: 10.1177/20420986231181334
Issue No: Vol. 14 (2023)
- Risk of lower limb amputation in diabetic patients using SGLT2 inhibitors
versus DPP4 inhibitors or GLP-1 agonists: a meta-analysis of 2 million
patients
Authors: Yang Lu, Caiyun Guo
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:The objective of this review was to assess the risk of lower limb amputation (LLA) in type 2 diabetic patients based on the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) versus dipeptidyl peptidase 4 inhibitors (DPP4i) or glucagon-like peptide-1 receptor agonists (GLP1a).Methods:PubMed, CENTRAL, Scopus, Web of Science, and Embase were referenced for articles published up to 5 February 2023. All types of studies comparing the drugs for LLA risk and reporting hazard ratios (HR) were included.Results:Thirteen studies with 2,095,033 patients were included. Meta-analysis of eight studies comparing SGLT2i with Dipeptidyl peptidase inhibitors (DPPi) showed that there was no difference in the risk of LLA between the two drug groups (HR: 0.98 95% CI: 0.73, 1.31 I2 = 89%). The outcomes were unchanged on sensitivity analysis. Another pooled analysis of six studies found no significant difference in the risk of LLA between SGLT2i and GLP1a users (HR: 1.26; 95% CI: 0.99, 1.60; I2 = 69%). The exclusion of a single study showed an increased risk of LLA with SGLT2i (HR: 1.35; 95% CI: 1.14, 1.60; I2 = 14%).Conclusion:The current updated meta-analysis found no significant difference in the risk of LLA between SGLT2i and DPP4i users. A tendency of increased risk of LLA was noted with SGLT2i as compared to GLP1a. Further studies shall increase the robustness of current findings.Plain language summaryRisk of lower limb amputation with SGLT2 inhibitors in comparison with DPP4 inhibitors or GLP-1 agonists among diabetic patientsDiabetic foot leading to lower limb amputation (LLA) is a common complication of diabetes mellitus (DM). We compared the risk of LLA in DM patients taking either sodium-glucose cotransporter 2 inhibitors (SGLT2i) or dipeptidyl peptidase 4 inhibitors (DPP4i) / glucagon-like peptide-1 receptor agonists (GLP1a). We searched the available literature for published studies comparing the risk of LLA with SGLT2i versus DPP4i or GLP1a. Individual study data were combined to generate a comprehensive result. We could find 13 studies with data from approximately 2 million patients. After combining the data, we noted no difference in the risk of LLA between patients using SGLT2i versus DPPi or GLP1a. Nevertheless, when data from a single study was removed from the combined analysis, we noted an increased risk of LLA with SGLT2i in comparison with GLP1a users. To conclude, our study, which is a comprehensive literature review, found that there is no difference in the risk of LLA between SGLT2i and DPP4i users. A tendency of increased risk of LLA was seen with SGLT2i as compared to GLP1a, which requires further research.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-06-10T10:49:23Z
DOI: 10.1177/20420986231178126
Issue No: Vol. 14 (2023)
- Serious neurological adverse events following immunization against
SARS-CoV-2: a narrative review of the literature
Authors: Sara Eslait-Olaciregui, Kevin Llinás-Caballero, David Patiño-Manjarrés, Thomas Urbina-Ariza, Juan Fernando Cediel-Becerra, Camilo Alberto Domínguez-Domínguez
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Amid the coronavirus disease 2019 (COVID-19) pandemic, massive immunization campaigns became the most promising public health measure. During clinical trials, certain neurological adverse effects following immunization (AEFIs) were observed; however, acceptable safety profiles lead to emergency authorization for the distribution and use of the vaccines. To contribute to pharmacovigilance and lessen the potential negative impact that vaccine hesitancy would have on immunization programs, we conducted a review of the scientific literature concerning the epidemiological data, clinical presentation, and potential mechanisms of these neurological AEFIs. There is some epidemiological evidence linking COVID-19 vaccines to cerebral venous sinus thrombosis, arterial ischemic stroke, convulsive disorder, Guillain–Barré syndrome, facial nerve palsy, and other neurological conditions. Cerebral venous sinus thrombosis has been associated with a thrombotic thrombocytopenia induced by the vaccine, similar to that induced by heparin, which suggests similar pathogenic mechanisms (likely involving antibodies against platelet factor 4, a chemokine released from activated platelets). Arterial ischemic stroke is another thrombotic condition observed among some COVID-19 vaccine recipients. Vaccine-induced convulsive disorder might be the result of structural abnormalities potentially caused by the vaccine or autoimmune mechanisms. Guillain–Barré syndrome and facial nerve palsy may also be linked to the immunization event, possibly due to immune mechanisms such as uncontrolled cytokine release, autoantibody production, or bystander effect. However, these events are mostly uncommon and the evidence for the association with the vaccine is not conclusive. Furthermore, the potential pathophysiological mechanisms remain largely unknown. Nevertheless, neurological AEFIs can be serious, life-threatening or even fatal. In sum, COVID-19 vaccines are generally safe and the risk of neurological AEFIs does not outweigh the benefits of immunization. However, early diagnosis and treatment of neurological AEFIs are of utmost importance, and both health professionals and the public should be aware of these conditions.Plain language summaryA review of undesired effects involving the nervous system following the administration of COVID-19 vaccinesAmong the range of complications that can occur after a vaccine, some of them can affect the nervous system and its vasculature. This narrative review aims to evaluate some serious neurological conditions following COVID-19 vaccination. We searched biomedical journal databases where physicians around the globe reported different complications after the administration of different COVID-19 vaccines. Besides reports of cases in individual patients or small groups, we reviewed studies that included bigger groups of patients (e.g. vaccinated versus non-vaccinated) and compared the occurrence of these events between them. We found that after the administration of a certain type of vaccine (e.g. ChAdOx1-S/Oxford, AstraZeneca vaccine), serious neurological complications were rare, with abnormal clot formation involving cerebral blood vessels being one of the most important among them. Nonetheless, other conditions have been observed after the administration of the vaccines; however, it is not certain yet if the vaccines are the actual cause of these complications.There are some hypotheses that could explain why these adverse reactions take place after a vaccine. For instance, an abnormal immune response to the vaccine leads to the production of antibodies (i.e. proteins made by the immune system in response to the presence of a foreign substance). These antibodies trigger a response that could eventually result in clot formation. Besides, the immune response can also produce other adverse effects, including convulsive disorder, Guillain–Barré syndrome, and facial nerve palsy.Scientific evidence suggests that vaccines are safe overall. While mild complications, such as pain at the site of injection or bruising might occur, more serious events remain rare. Furthermore, the complications derived from COVID-19 are far more likely in non-vaccinated individuals than the complications associated with the vaccine. Thus, vaccination continues to be the safest and most effective strategy to control the ongoing pandemic. However, both health professionals and the public should be aware of the possibility of serious neurological adverse reactions occurring after vaccination to allow early diagnosis and treatment.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-05-22T05:28:14Z
DOI: 10.1177/20420986231165674
Issue No: Vol. 14 (2023)
- Development and psychometric assessment of self-reported patient
medication safety scale (SR-PMSS)
Authors: Ning Qin, Yinglong Duan, Shuangjiao Shi, Xiao Li, Haoqi Liu, Feng Zheng, Zhuqing Zhong, Guliang Xiang
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Objectives:Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, few tools have been developed to assess patient medication safety. This study aimed to develop and validate the self-reported patient medication safety scale (SR-PMSS).Methods:We developed SR-PMSS guided by the Donabedian Structure-Process-Outcome framework and used psychometric methods to test its validity and reliability.Results:A total of 501 patients with an average age of 56.81 ± 14.47 were enrolled in this study. The SR-PMSS consisted of 21 items and 5 factors. The content validity was good with item-level content validity index (CVI) > 0.78, average scale-level CVI (S-CVI) > 0.9, and universal agreement S-CVI > 0.8. Exploratory factor analysis extracted a five-factor solution with eigenvalues > 0.1, explaining 67.766% of the variance. Confirmatory factor analysis showed good model fit, acceptable convergent validity, and discriminant validity. The Cronbach’s α coefficient for SR-PMSS was 0.929, the split-half reliability coefficient was 0.855, and the test–retest reliability coefficient was 0.978.Conclusions:The SR-PMSS was a valid and reliable instrument with good reliability and validity to evaluate the level of patient medication safety. The target users of the SR-PMSS are all people who are taking or have used prescription medications. The SR-PMSS can be used by healthcare providers in clinical practice and research to identify patients at risk for medication use and intervene with them to reduce adverse medication events and provide support for patient safety management.Plain Language SummarySR-PMSS – a self-reported tool to assess patient medication safetyMedication therapy was the most common and frequent treatment method to prevent and cure diseases. Medication safety issues may occur in the process of medication use. Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, there are few tools to assess patient medication safety currently, and most of them focused on medication safety related to hospitals or healthcare workers. We developed the self-reported patient medication safety scale (SR-PMSS) guided by the Donabedian Structure-Process-Outcome framework. Then, we conducted a two-round expert consultation, clarity verification, and item simplification to determine the final version of the scale. The SR-PMSS consisted of 21 items and 5 factors and it had good validity and reliability. The target users of the SR-PMSS are all people who are taking or have used prescription medications. Healthcare providers can use the SR-PMSS in clinical practice and research to identify patients at risk for medication use and intervene with them to reduce adverse medication events and provide support for patient safety management.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-03-27T10:45:07Z
DOI: 10.1177/20420986231152934
Issue No: Vol. 14 (2023)
- Developing and piloting a cross-sectoral hospital pharmacist intervention
for patients in transition between hospital and general practice
Authors: Charlotte Arp Sørensen, Linda Jeffery, Jannik Falhof, Philipp Harbig, Klaus Roelsgaard, Solveig Gram, Charlotte Olesen
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:Healthcare is challenged by a rapidly growing group of patients with multi-morbidity and polypharmacy. Increasing activity and specialization puts pressure on healthcare sectors. Medication errors in cross-sectoral transition of patients are often seen. The aim of the study was to explore drug-related problems (DRPs) in the transition of patients between sectors and to develop and pilot-test a cross-sectoral hospital pharmacist intervention to overcome some of these problems.Methods:DRPs in cross-sectoral transitions were explored from four perspectives; the literature, the primary and secondary healthcare sector and the patients. An intervention was developed from the findings through co-creation between pharmacists, doctors and a nurse. The intervention was piloted and evaluated from data on the included patients and the activities performed.Results:DRPs in transitions from general practice (GP) to hospital were caused by inadequate focus on updating the Shared Medication Record (SMR). For patients being discharged, DRPs were described with multiple facets; for example, missing information on medication changes, lacking patient involvement and problems with dose-dispensed medicine or electronic prescriptions. An intervention with a pharmacist in a shared employment between Hospital Pharmacy and GP was developed and piloted. The intervention included medication reconciliation and updating SMR for patients referred to hospital; and medication review, overview of medication changes and follow-up telephone calls for patients discharged from hospital. The intervention identified and solved several DRPs; in this way, medication errors were avoided. Access to health records in both sectors was important in the identification and resolution of DRPs.Conclusion:DRPs in cross-sectoral transitions are multifaceted and the experiences depend on the point of view. The cross-sectoral hospital pharmacist intervention identified and solved several DRPs and medication errors were avoided. The intervention made sense to both healthcare sectors and patients. Shared employment and unique access to health records in both sectors showed to be of importance in the identification and resolution of DRPs.Plain language summaryDevelopment and pilot-test of a pharmacist intervention for patients in transition between hospital and general practiceBackground: Healthcare is challenged by a rapidly growing group of patients with multiple chronic diseases treated with several drugs at the same time. The aim of the study was to explore drug-related problems in the transition of patients between the hospital and patients’ general practitioner and to develop and pilot-test a pharmacist intervention to overcome some of these problems.Methods: Drug-related problems in patient transitions were explored from the perspectives of the hospital, the general practitioner, the patients and the literature. An intervention was developed from the findings by pharmacists, doctors and a nurse. The intervention was pilot-tested and evaluated from the descriptions of the included patients and activities performed.Results: Drug-related problems in transitions from general practice to hospital were caused by inadequate focus on updating the Shared Medication Record.For patients being discharged, drug-related problems were related to for examplemissing information on medication changessparse involvement of the patient in their own treatmentproblems with medicine dispensed on a dose dispensing machine at the local pharmacy.An intervention with a pharmacist in a shared employment between Hospital Pharmacy and general practice was developed and piloted. The intervention includedtalking to the patient about their medication and updating the Shared Medication Record for patients referred to hospitalmedication review, overview of medication changes and follow-up telephone calls for patients discharged from hospital to general practice.The intervention identified and solved several drug-related problems. Access to health records in both the general practice and at the hospital was important in the identification of drug-related problems.Conclusions: Drug-related problems in cross-sectoral transitions are multifaceted. The pharmacist intervention identified and solved several drug-related problems. The intervention made sense to the general practitioner, hospital and patients. Shared employment and unique access to health records in both the general practice and at the hospital showed to be of importance in the identification of drug-related problems.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-03-18T11:02:27Z
DOI: 10.1177/20420986231159221
Issue No: Vol. 14 (2023)
- Impact of risk communication on patient’s safety during the pandemic
Authors: Heyde-Patricia Zuluaga-Arias, Mayada Alkhakany, Manal M. Younus, Houda Sefiani, Angela Caro-Rojas, Sameh Al-Zubiedi, Wafi F. Albalawi, Thamir M. Alshammari
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
More than 2 years has passed since the pandemic was declared in 2019 due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was later declared to be the pathogen causing coronavirus disease 2019 (COVID-19). During this time, many healthcare systems faced numerous challenges to control the high morbidity and mortality of the disease. Unlike previous pandemics, the actions against this pandemic started quickly on both the global and country levels. These actions were, scientifically, to study the virus as well as transmission process and to develop medications and vaccines against it. Also, we had to protect people from transmission by knowing how best to apply precautionary methods. However, there were some unexpected negative consequences of the pandemic and one of those the World Health Organization (WHO) called ‘infodemic’. This term infodemic refers to the manipulation of a population’s behavior in the assessment of information (or, more accurately, lack of assessment) related to the use of medications, particularly vaccines. Unfortunately, even with positive development in science, there was limited and often contradictory amount of information on the safety and efficacy profile of drugs and vaccines. Therefore, this made it harder for public health agencies to determine the impact of the incidence of adverse reactions and events associated with interventions such as vaccines. Hence, risk communication needs to be emphasized during any pandemic, as ignoring risk communications to different stakeholders could undermine all well-intended therapeutic interventions. Given this, it is important that the different stakeholders involved (health authorities, societies, healthcare professionals, etc.) assess the different behavioral patterns within their respective populations and propose appropriate strategies to act. Such an approach complement having risk management and communication plans for this and future pandemics. The aim of this article is to explore how information management, risk management, and risk communication during the pandemic can provide valuable lessons for the future.Plain language summaryImpact of risk communication on patient’s safety during the pandemicMore than 2 years have gone by since the pandemic was declared in 2019 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Many challenges have been confronted by the healthcare system during this time to control the high impact of this disease. This pandemic, unlike others that humanity has faced, is characterized by a special feature: today, we have an enormous amount of information only a click away. This situation has been of great benefit to humanity and has allowed the development of science; nevertheless, misinformation (infodemics) has been a major problem, which has revealed the behavior of the population regarding the evaluation of information (or better, lack of assessment) related to the use of medications and particularly of vaccines. Given this, it is important that the different people involved (health authorities, societies, healthcare professionals, etc.) assess the behavior and propose appropriate strategies to act and have plans for this and future pandemics. This article intends to explore from the authors’ perspective how information management, risk management, and risk communication during the pandemic can provide valuable lessons for the future.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-03-17T11:34:20Z
DOI: 10.1177/20420986231159752
Issue No: Vol. 14 (2023)
- Analysis of the nature and contributory factors of medication safety
incidents following hospital discharge using National Reporting and
Learning System (NRLS) data from England and Wales: a multi-method study
Authors: Fatema A. Alqenae, Douglas Steinke, Andrew Carson-Stevens, Richard N. Keers
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Introduction:Improving medication safety during transition of care is an international healthcare priority. While existing research reveals that medication-related incidents and associated harms may be common following hospital discharge, there is limited information about their nature and contributory factors at a national level which is crucial to inform improvement strategy.Aim:To characterise the nature and contributory factors of medication-related incidents during transition of care from secondary to primary care.Method:A retrospective analysis of medication incidents reported to the National Reporting and Learning System (NRLS) in England and Wales between 2015 and 2019. Descriptive analysis identified the frequency and nature of incidents and content analysis of free text data, coded using the Patient Safety Research Group (PISA) classification, examined the contributory factors and outcome of incidents.Results:A total of 1121 medication-related incident reports underwent analysis. Most incidents involved patients over 65 years old (55%, n = 626/1121). More than one in 10 (12.6%, n = 142/1121) incidents were associated with patient harm. The drug monitoring (17%) and administration stages (15%) were associated with a higher proportion of harmful incidents than any other drug use stages. Common medication classes associated with incidents were the cardiovascular (n = 734) and central nervous (n = 273) systems. Among 408 incidents reporting 467 contributory factors, the most common contributory factors were organisation factors (82%, n = 383/467) (mostly related to continuity of care which is the delivery of a seamless service through integration, co-ordination, and the sharing of information between different providers), followed by staff factors (16%, n = 75/467).Conclusion:Medication incidents after hospital discharge are associated with patient harm. Several targets were identified for future research that could support the development of remedial interventions, including commonly observed medication classes, older adults, increase patient engagement, and improve shared care agreement for medication monitoring post hospital discharge.Plain language summaryStudy using reports about unsafe or substandard care mainly written by healthcare professionals to better understand the type and causes of medication safety problems following hospital dischargeWhy was the study done' The safe use of medicines after hospital discharge has been highlighted by the World Health Organization as an important target for improvement in patient care. Yet, the type of medication problems which occur, and their causes are poorly understood across England and Wales, which may hamper our efforts to create ways to improve care as they may not be based on what we know causes the problem in the first place.What did the researchers do' The research team studied medication safety incident reports collected across England and Wales over a 5-year period to better understand what kind of medication safety problems occur after hospital discharge and why they happen, so we can find ways to prevent them from happening in future.What did the researchers find' The total number of incident reports studied was 1121, and the majority (n = 626) involved older people. More than one in ten of these incidents caused harm to patients. The most common medications involved in the medication safety incidents were for cardiovascular diseases such as high blood pressure, conditions such as mental illness, pain and neurological conditions (e.g., epilepsy) and other illnesses such as diabetes. The most common causes of these incidents were because of the organisation rules, such as information sharing, followed by staff issues, such as not following protocols, individual mistakes and not having the right skills for the task.What do the findings mean' This study has identified some important targets that can be a focus of future efforts to improve the safe use of medicines after hospital discharge. These include concentrating attention on medication for the cardiovascular and central nervous systems (e.g., via incorporating them in prescribing safety indicators and pharmaceutical prioritisation tools), staff skill mix (e.g., embedding clinical pharmacist roles at key parts of the care pathway where greatest risk is suspected), and implementation of electronic interventions to improve timely communication of medication and other information between healthcare providers.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-03-16T12:46:41Z
DOI: 10.1177/20420986231154365
Issue No: Vol. 14 (2023)
- Association between proton pump inhibitors and rhabdomyolysis risk: a
post-marketing surveillance using FDA adverse event reporting system
(FAERS) database
Authors: Ali F. Altebainawi, Lulwa A. Alfaraj, Amjad A. Alharbi, Fadwa F. Alkhuraisi, Thamir M. Alshammari
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:This research aims to explore and compare the signals of rhabdomyolysis from the use of Proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods:Rhabdomyolysis and related terms submitted between 2013 and 2021 were retrieved from the FAERS database. The data were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Empirical Bayes Geometric Mean (EBGM) and the information component (IC). The signals of rhabdomyolysis associated with PPIs use were detected in both 3-Hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) utilizers and non-utilizers.Results:A total of 7,963,090 reports were retrieved and analyzed. Fifty-seven reports linked PPIs to rhabdomyolysis out of 3670 reports from other drugs (non-statin included). The association of rhabdomyolysis and PPIs was significant in both statins included, and non-statin-included reports, although with varying degrees of association. The ROR was 2.5 (95% confidence interval [CI] 1.9–3.2) for PPIs in non-statin-included reports and 2 (95% CI: 1.5–2.6) for PPIs in statin-included reports.Conclusion:Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports compared to statin-included reports.Plain Language SummaryPlain language summaryProton Pump Inhibitors and rhabdomyolysis riskBackground: The FDA created the FDA Adverse Event Reporting System (FAERS) database to support post-marketing surveillance programs. The FAERS is a computerized database with more than nine million adverse event reports, including all reports from 1969 to the present. This research aims to explore and compare the signals of rhabdomyolysis from the use of proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.Research design and methods: We retrieved rhabdomyolysis and related terms submitted between 2013 and 2021 from the FAERS database. Then, we analyzed the data that we found. We detected the signals of rhabdomyolysis associated with PPIs use in both statins utilizers and non-utilizers.Results: We retrieved and analyzed a total of 7,963,090 reports. We found 57 reports linked PPIs to rhabdomyolysis out of 3670 reports from other drugs (non-statin included). The association of rhabdomyolysis and PPIs was significant in both statins included, and non-statin-included reports, although with varying degrees of association.Conclusion: Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports than in statin-included reports.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-02-28T05:47:41Z
DOI: 10.1177/20420986231154075
Issue No: Vol. 14 (2023)
- Patient-centered pharmacovigilance: priority actions from the inherited
bleeding disorders community
Authors: Fiona Robinson, Sonji Wilkes, Nathan Schaefer, Miriam Goldstein, Michelle Rice, Johanna Gray, Sharon Meyers, Leonard A. Valentino
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Pharmacovigilance, the science and practice of monitoring the effects of medicinals and their safety, is the responsibility of all stakeholders involved in the development, manufacture, regulation, distribution, prescription, and use of drugs and devices. The patient is the stakeholder most impacted by and the greatest source of information on safety issues. It is rare, however, for the patient to take a central role and exert leadership in the design and execution of pharmacovigilance. Patient organizations in the inherited bleeding disorders community are among the most established and empowered, particularly in the rare disorders. In this review, two of the largest bleeding disorders patient organizations, Hemophilia Federation of America (HFA) and National Hemophilia Foundation (NHF), offer insights into the priority actions required of all stakeholders to improve pharmacovigilance. The recent and ongoing increase in incidents raising safety concerns and a therapeutic landscape on the cusp of unprecedented expansion heighten the urgency of a recommitment to the primacy of patient safety and well-being in drug development and distribution.Plain Language SummaryPatients at the center of product safetyEvery medical device and therapeutic product has potential benefits and harms. The pharmaceutical and biomedical companies that develop them must demonstrate that they are effective, and the safety risks are limited or manageable, for regulators to approve them for use and sale. After the product has been approved and people are using it in their daily lives, it is important to continue to collect information about any negative side effects or adverse events; this is called pharmacovigilance. Regulators, like the United States (US) Food and Drug Administration, the companies that sell and distribute the products, and healthcare professionals who prescribe them are all required to participate in collecting, reporting, analyzing, and communicating this information. The people with the most firsthand knowledge of the benefits and harms of the drug or device are the patients who use them. They have an important responsibility to learn how to recognize adverse events, how to report them, and to stay informed of any news about the product from the other partners in the pharmacovigilance network. Those partners have a crucial responsibility to provide clear, easy-to-understand information to patients about any new safety concerns that come to light. The community of people with inherited bleeding disorders has recently encountered problems with poor communication of product safety issues, prompting two large US patient organizations, National Hemophilia Foundation and Hemophilia Federation of America, to hold a Safety Summit with all the pharmacovigilance network partners. Together they developed recommendations to improve the collection and communication of information about product safety so that patients can make well-informed, timely decisions about their use of drugs and devices. This article presents these recommendations in the context of how pharmacovigilance is supposed to work and some of the challenges encountered by the community.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-02-25T10:16:52Z
DOI: 10.1177/20420986221146418
Issue No: Vol. 14 (2023)
- Development of a checklist for the assessment of pharmacovigilance
guidelines in Southern Africa: a document review
Authors: Nokuthula L. Makhene, Hanlie Steyn, Martine Vorster, Martie S. Lubbe, Johanita R. Burger
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Introduction:National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV guidelines in Southern African Development Community (SADC) countries, this study aimed to create a checklist that may be used to assess the rigour of PV guidelines in this region and provide guidance for the National Medicines Regulatory Agency (NMRA) authors.Methods:A document analysis was performed based on harmonised international guidelines (n = 22) that prescribed methods of PV regulation to identify themes and items to incorporate into a checklist. The contextualisation of the checklist to the African pharmaceutical environment was accomplished by referencing peer-reviewed journal articles (n = 7). The checklist was subjected to face and content validation by non-experts and PV experts.Results:The document review yielded 5 themes, 18 sub-themes, and 73 items structured into the checklist. Themes encompassed PV systems, definitions, individual case safety reporting, aggregate reporting, and risk management. Under PV systems, aspects of the quality management system were outlined, that is, the legal basis for PV, a description of the marketing authorisation holder’s (MAH’s) PV system, archiving of data, contracting of PV tasks, and the duties of the person responsible for the MAH’s PV obligations. Definitions of the key terms and major stakeholders were identified. Reporting of individual case safety reports (ICSRs) was explicated by considering the criteria for reporting, categories of reportable information, expedited reporting requirements, reporting timelines, and ICSR reporting format. Aggregate report submission during the development and post-marketing phases was addressed. Risk management encompassed signal detection, re-evaluation of the benefit-risk ratio, the safety decision-making process, risk management planning, risk minimisation and safety communication.Conclusion:The developed checklist can contribute towards assisting SADC NMRAs to formulate national PV guidelines that reflect current international practice, with local context incorporated.Plain Language SummaryDeveloping a checklist for the evaluation of medicine safety guidelines in Southern AfricaIntroduction: In Southern African Development Community (SADC) countries, the guidelines for medicine safety [pharmacovigilance (PV)] that marketing authorisation holders (MAHs) and healthcare professionals need to adhere to, are not aligned. We saw the need to develop a checklist that can be used to evaluate these guidelines.Methods: We studied international documents issued by the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Council for International Organizations of Medical Sciences (CIOMS) and the European Medicines Agency (EMA). On the organisational websites, we obtained 22 documents and identified 73 checklist items. All the items were arranged under 5 themes and 18 sub-themes to create the checklist. We adapted the checklist to the local context by using seven journal articles addressing PV concerns in Africa. Experts checked the content and usability of the checklist.Results: The themes were PV systems, definitions, individual case safety reporting (ICSR), combined reporting and risk management. PV systems had six sub-themes: legal structure, description of the MAH’s PV system, contractual agreements, information storage, the qualified person responsible for PV (QPPV) and where the QPPV is located. We included the definitions of keywords and role-players. The ICSR theme had five sub-themes, i.e. criteria for reporting, categories of reportable information, expedited reporting, reporting timelines, and reporting format. Submission of summary reports comprised an overview of the safety profile of a medicine once it is approved by regulators, as well as during clinical trials. Risk management included signal detection, re-evaluation of the benefit-risk ratio, safety decision-making process, risk management planning, risk minimisation, and safety communication. The checklist is applied by allocating yes/no scoring per item.Conclusion: The checklist may be used by regulators within SADC to assess their PV guidelines for alignment with international standards and suitability to the local environment.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-01-24T11:13:16Z
DOI: 10.1177/20420986221143272
Issue No: Vol. 14 (2023)
- The 6th European Pharmacovigilance Congress: speaker abstracts
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-01-20T02:03:40Z
DOI: 10.1177/20420986221144584
Issue No: Vol. 14 (2023)
- Therapy of women with multiple sclerosis: an analysis of the use of drugs
that may have adverse effects on the unborn child in the event of
(unplanned) pregnancy
Authors: Marie-Celine Haker, Niklas Frahm, Michael Hecker, Silvan Elias Langhorst, Pegah Mashhadiakbar, Jane Louisa Debus, Barbara Streckenbach, Julia Baldt, Felicita Heidler, Uwe Klaus Zettl
Abstract: Therapeutic Advances in Drug Safety, Volume 14, Issue , January-December 2023.
Background:Although effective contraception is strongly recommended during the therapy of women with multiple sclerosis (MS) with some immunomodulatory drugs, unplanned pregnancies still occur. Adequate medication management is essential to avoid foetal harm in the event of an unplanned pregnancy.Objective:The aim was to screen for medications used in women of childbearing age with MS that may pose a risk of side effects on foetal development.Methods:Sociodemographic, clinical and medication data were collected from 212 women with MS by structured interviews, clinical examinations and medical records. Using the databases from Embryotox, Reprotox, the Therapeutic Goods Administration and on the German summaries of product characteristics, we assessed whether the taken drugs were potentially harmful regarding the foetal development.Results:The majority of patients (93.4%) were taking one or more drugs for which a possible harmful effect on the foetus is indicated in at least one of the four databases used. This proportion was even higher in patients who used hormonal contraceptives (birth control pills or vaginal rings) (PwCo, n = 101), but it was also quite high in patients who did not use such contraceptives (Pw/oCo, n = 111) (98.0% and 89.2%, respectively). PwCo were significantly more likely to take five or more medications with potential foetal risk according to at least one database than Pw/oCo (31.7% versus 6.3%). PwCo were also more severely disabled (average Expanded Disability Status Scale score: 2.8 versus 2.3) and more frequently had comorbidities (68.3% versus 54.1%) than Pw/oCo.Conclusion:Data on the most commonly used drugs in MS therapy were gathered to study the risk of possible drug effects on foetal development in female MS patients of childbearing age. We found that the majority of drugs used by patients with MS are rated as having a potential risk of interfering with normal foetal development. More effective contraception and special pregnancy information programmes regarding the therapy management during pregnancy should be implemented to reduce potential risks to mother and child.Plain Language SummaryUse of drugs not recommended during pregnancy by women with multiple sclerosisIntroduction: Patients with multiple sclerosis (MS) often have to take different drugs simultaneously. During the therapy with some immunomodulatory drugs, effective contraception is strongly recommended. Nevertheless, unplanned pregnancies occur regularly in women with MS.Methods: Here, we investigated whether the 212 patients included in this study were taking drugs with known possibility of harm to the development of an unborn child. This was done using four different drug databases.Results: A subset of 111 patients was not taking hormonal contraceptives (birth control pills or vaginal rings). Of those, 99 patients were taking at least one drug that is not recommended during pregnancy according to at least one of the four databases. Most of the medications taken have the potential to affect normal foetal development.Conclusion: To ensure safe use of medications, the patients should be reminded of the importance of effective contraception.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2023-01-12T06:54:45Z
DOI: 10.1177/20420986221143830
Issue No: Vol. 14 (2023)
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