Therapeutic Advances in Drug Safety最新文献

{"title":"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","doi":"10.1177/20420986221143830","DOIUrl":"https://doi.org/10.1177/20420986221143830","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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, <i>n</i> = 101), but it was also quite high in patients who did not use such contraceptives (Pw/oCo, <i>n</i> = 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% <i>versus</i> 6.3%). PwCo were also more severely disabled (average Expanded Disability Status Scale score: 2.8 <i>versus</i> 2.3) and more frequently had comorbidities (68.3% <i>versus</i> 54.1%) than Pw/oCo.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Plain language summary: </strong><b>Use of drugs not recommended during pregnancy by women with multiple sclerosis</b> <b>Introduction:</b> 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.<b>Methods:</b> 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.<b>Results:</b> A subset of 111 patients was not taking hormonal co","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986221143830"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/22/61/10.1177_20420986221143830.PMC10060274.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9241369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of lower limb amputation in diabetic patients using SGLT2 inhibitors <i>versus</i> DPP4 inhibitors or GLP-1 agonists: a meta-analysis of 2 million patients.","authors":"Yang Lu,&nbsp;Caiyun Guo","doi":"10.1177/20420986231178126","DOIUrl":"https://doi.org/10.1177/20420986231178126","url":null,"abstract":"<p><strong>Background: </strong>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) <i>versus</i> dipeptidyl peptidase 4 inhibitors (DPP4i) or glucagon-like peptide-1 receptor agonists (GLP1a).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 <i>I</i>² = 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; <i>I</i>² = 69%). The exclusion of a single study showed an increased risk of LLA with SGLT2i (HR: 1.35; 95% CI: 1.14, 1.60; <i>I</i>² = 14%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231178126"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/22/9e/10.1177_20420986231178126.PMC10272677.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10035951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Flow rate accuracy of infusion devices within healthcare settings: a systematic review.","authors":"Opeyemi Atanda,&nbsp;Jonathan West,&nbsp;Tom Stables,&nbsp;Chris Johnson,&nbsp;Robert Merrifield,&nbsp;James Kinross","doi":"10.1177/20420986231188602","DOIUrl":"https://doi.org/10.1177/20420986231188602","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Data sources and methods: </strong>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.</p><p><strong>Results: </strong>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%.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231188602"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10363896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10353666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serious neurological adverse events following immunization against SARS-CoV-2: a narrative review of the literature.","authors":"Sara Eslait-Olaciregui,&nbsp;Kevin Llinás-Caballero,&nbsp;David Patiño-Manjarrés,&nbsp;Thomas Urbina-Ariza,&nbsp;Juan Fernando Cediel-Becerra,&nbsp;Camilo Alberto Domínguez-Domínguez","doi":"10.1177/20420986231165674","DOIUrl":"https://doi.org/10.1177/20420986231165674","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231165674"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4a/34/10.1177_20420986231165674.PMC10201278.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9888106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries.","authors":"Ambrose O Isah,&nbsp;Abimbola O Opadeyi,&nbsp;Henry Tumwijukye,&nbsp;Frank Cobelens,&nbsp;Diede Smith,&nbsp;Margareth Ndomondo-Sigonda,&nbsp;Linda Harmark,&nbsp;Paul Tanui,&nbsp;Edine Tiemersma,&nbsp;Blandina T Mmbaga,&nbsp;Gugu Mahlangu,&nbsp;Stephen A Ayinbuomwan,&nbsp;Rachida Soulaymani,&nbsp;Jayesh M Pandit","doi":"10.1177/20420986231188836","DOIUrl":"https://doi.org/10.1177/20420986231188836","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods/processes: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231188836"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/32/c0/10.1177_20420986231188836.PMC10387667.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10354753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between proton pump inhibitors and rhabdomyolysis risk: a post-marketing surveillance using FDA adverse event reporting system (FAERS) database.","authors":"Ali F Altebainawi,&nbsp;Lulwa A Alfaraj,&nbsp;Amjad A Alharbi,&nbsp;Fadwa F Alkhuraisi,&nbsp;Thamir M Alshammari","doi":"10.1177/20420986231154075","DOIUrl":"https://doi.org/10.1177/20420986231154075","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports compared to statin-included reports.</p><p><strong>Plain language summary: </strong><b>Plain language summaryProton Pump Inhibitors and rhabdomyolysis risk</b> <b>Background:</b> 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.<b>Research design and methods:</b> 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.<b>Results:</b> 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.<b>Conclusion:</b> Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports than in statin-included reports.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231154075"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2b/1b/10.1177_20420986231154075.PMC9974623.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10846025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Survival outcomes of beta-blocker usage in HER2-positive advanced breast cancer patients: a retrospective cohort study.","authors":"Hui-Hsia Hsieh,&nbsp;Tien-Yuan Wu,&nbsp;Chi-Hua Chen,&nbsp;Yu-Hung Kuo,&nbsp;Mann-Jen Hour","doi":"10.1177/20420986231181338","DOIUrl":"https://doi.org/10.1177/20420986231181338","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Retrospective hospital-based study.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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; <i>p</i> < 0.001]) and OS (adjusted HR: 2.46, 95% CI: 1.69-3.57; <i>p</i> < 0.001) were worse when BBs were used.</p><p><strong>Conclusion: </strong>Our study provides important evidence that BB use potentially has a negative effect on patients with HER2-positive advanced breast cancer. Nevertheless, despite the study's results, cardiovascular disease (CVD) should be appropriately treated in patients with HER2-positive advanced breast cancer. Other types of drugs can be used to treat CVD, but BB use should be avoided. Large real-world database and prospective studies should be conducted to validate the results of this study.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231181338"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/27/88/10.1177_20420986231181338.PMC10288415.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10351982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing and piloting a cross-sectoral hospital pharmacist intervention for patients in transition between hospital and general practice.","authors":"Charlotte Arp Sørensen,&nbsp;Linda Jeffery,&nbsp;Jannik Falhof,&nbsp;Philipp Harbig,&nbsp;Klaus Roelsgaard,&nbsp;Solveig Gram,&nbsp;Charlotte Olesen","doi":"10.1177/20420986231159221","DOIUrl":"https://doi.org/10.1177/20420986231159221","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;Development and pilot-test of a pharmacist intervention for patients in transition between hospital and general practice&lt;/b&gt; &lt;b&gt;Background:&lt;/b&gt; 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.&lt;b&gt;Methods:&lt;/b&gt; Drug-related problems in patient transitions were explored from the perspectives of the ","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231159221"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fd/74/10.1177_20420986231159221.PMC10026123.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9174544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of risk communication on patient's safety during the pandemic.","authors":"Heyde-Patricia Zuluaga-Arias,&nbsp;Mayada Alkhakany,&nbsp;Manal M Younus,&nbsp;Houda Sefiani,&nbsp;Angela Caro-Rojas,&nbsp;Sameh Al-Zubiedi,&nbsp;Wafi F Albalawi,&nbsp;Thamir M Alshammari","doi":"10.1177/20420986231159752","DOIUrl":"https://doi.org/10.1177/20420986231159752","url":null,"abstract":"&lt;p&gt;&lt;p&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;Impact of risk communication on patient's safety during the pandemic&lt;/b&gt; More 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 th","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231159752"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a7/35/10.1177_20420986231159752.PMC10026095.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9174545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing self-medication practices in the era of infodemic: the role of pharmacovigilance.","authors":"Carlos-Alberto Calderon-Ospina","doi":"10.1177/20420986231194754","DOIUrl":"https://doi.org/10.1177/20420986231194754","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the Sage and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). TherapeuTic advances in drug safety","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231194754"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bd/43/10.1177_20420986231194754.PMC10457137.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10106395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}