Dataset Information

Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study.

ABSTRACT: INTRODUCTION:Two risk minimization (RM) tools-a healthcare professional frequently asked questions (HCP-FAQs) brochure and a patient/caregiver information brochure (PCIB)-were developed for HCPs and for adolescents (aged???13 years) receiving aripiprazole for bipolar I mania and their caregivers. OBJECTIVES:This study evaluated the effectiveness of these RM tools in improving the awareness and education of HCPs and patients/caregivers. METHOD:The RM tools were distributed to HCPs (identified in agreement with the marketing authorization holder [MAH] and local regulatory authorities), who in turn distributed the PCIBs to patients/caregivers. A web-based survey was then conducted targeting HCPs and patients/caregivers. RESULTS:The response rate was low: 118 of 23,282 invited HCPs and 16 patients/caregivers completed the survey. Overall, 42% (49/118) of HCP respondents were aware of aripiprazole RM tools; of these, 59% (29/49) of HCPs read them at least once and 66% (19/29) of these used the RM tools while discussing the benefit-risk profile of aripiprazole with patients/caregivers. In total, 30 of the 118 HCPs (25%) were aware of the PCIB, and 26 distributed it to their patients/caregivers, whereas seven HCPs advised them to read the brochure. Overall, 15 of the 16 patients/caregivers were aware of the PCIB, and 13 read/referred to it. Of these, 12 found the PCIB useful, and five monitored their weight while receiving aripiprazole and reported potential risks immediately to their HCP. CONCLUSION:The response rate to the survey was low, and the tools displayed limited utility and effectiveness in improving awareness and education in a small number of responders. Therefore, the aripiprazole risk management plan was amended, and the tools were discontinued.

SUBMITTER: Landsberg W

PROVIDER: S-EPMC6061424 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study.

Landsberg Wally W Al-Dakkak Imad I Coppin-Renz Antonia A Geis Uli U Peters-Strickland Timothy T van Heumen Emiel E Rahman Mirza M

Drug safety 20180801 8

<h4>Introduction</h4>Two risk minimization (RM) tools-a healthcare professional frequently asked questions (HCP-FAQs) brochure and a patient/caregiver information brochure (PCIB)-were developed for HCPs and for adolescents (aged ≥ 13 years) receiving aripiprazole for bipolar I mania and their caregivers.<h4>Objectives</h4>This study evaluated the effectiveness of these RM tools in improving the awareness and education of HCPs and patients/caregivers.<h4>Method</h4>The RM tools were distributed t ...[more]

PMID: 29671224

Similar Datasets

Project description:BackgroundA Guide for Healthcare Professionals (HCP Guide) and patient alert card (PAC) for atezolizumab as additional risk minimization measures for physicians were distributed to raise awareness and help in the detection and management of immune-related adverse drug reactions.ObjectivesThe main objective of this study was to assess the receipt, knowledge, and behaviors of physicians regarding the atezolizumab HCP Guide and PAC.MethodsA multi-country, one-wave, observational, cross-sectional, web-based, self-reported physician survey was conducted to assess the level of knowledge of key messages related to immune-related adverse drug reactions summarized in the atezolizumab HCP Guide and PAC among physicians (oncologists, pulmonologists, and urologists) prescribing atezolizumab in six European countries (Denmark, Germany, Italy, Spain, Sweden, and the UK). Responses regarding the receipt, understanding and use of the materials, and knowledge and behavior related to the HCP Guide and PAC are presented as percentages and continuous scores scaled out of 100 points, with corresponding 95% confidence intervals (CIs).ResultsAmong 313 physicians (255 oncologists, 30 pulmonologists, and 28 urologists), 77.4% received the HCP Guide and 74.2% the PAC. The HCP Guide was read by 71.3% of the 267 physicians who received the materials, and the mean usage score was 69.5 (95% CI 66.0-72.9), and 57.1% of physicians had scores ≥ 70. The HCP Guide was completely understood by 85.4% of physicians who had read it. Mean knowledge scores were 63.9 (95% CI 62.1-65.7) and 39.4% of physicians had correct knowledge scores ≥ 70. Mean knowledge scores were 66.8 (95% CI 64.9-68.7) for receipt of both the HCP Guide and PAC, 59.4 (95% CI 55.5-63.4) for one of the materials, and 60.8 (95% CI 55.4-66.2) for having received none of the materials. Mean behavior scores were 78.9 (95% CI 76.8-81.0), and 74.8% of physicians had behavior scores ≥ 70. The mean behavior score was 79.0 (95% CI 76.5-81.5) for those who received both the HCP Guide and PAC, 76.9 (95% CI 72.2-81.5) for receipt of one of the materials, and 81.5 (95% CI 75.0-88.0) for those who received none of the materials.ConclusionsThe study assessed the effectiveness of the atezolizumab additional risk minimization educational materials among physicians in six European countries, using process indicators. The educational materials reached over 70% of target physicians, 57.1% of whom reported using them. Knowledge and behavior related to immune-related adverse drug reactions for atezolizumab were no better in those who received the additional risk minimization educational materials. The results support the safe use of atezolizumab by these physician groups and contributed to the European Medicines Agency permitting removal of the HCP Guide.

Project description:BackgroundSodium oxybate (Xyrem®), approved by the European Medicines Agency (EMA) for narcolepsy with cataplexy, is only available through risk mitigation programs due to potential adverse effects including respiratory and central nervous system depression, neuropsychiatric events, and misuse.ObjectiveWe report findings from a survey evaluating effectiveness of the European Union Xyrem® Risk Management Plan (RMP).Patients and methodsA cross-sectional, online, multiple-choice survey was distributed to randomly selected healthcare professionals (HCPs) from six European countries (April 2016-May 2018). Eligibility criteria: current/potential Xyrem® prescriber and/or sleep disorder specialist; contact information available; on the Xyrem® RMP educational materials mailing list.Primary outcomeproportion of respondents answering each question correctly (< 50% responses correct = unsatisfactory comprehension, 50% to < 70% = satisfactory, ≥ 70% = excellent), with precision assessed using 95% confidence intervals (CIs).ResultsOf the 709 HCPs contacted, 601 did not agree to take part, 108 were screened with 35/108 eligible for inclusion; 31 HCPs completed the survey. Of the 31 respondents, 29 (93.5%; 95% CI 84.4-100.0) reported receiving Xyrem® safety information, commonly from a sales representative, EMA Summary of Product Characteristics (SmPC), or educational meeting; only 9/31 (31.0%; 14.3-50.0) recalled receiving mailed educational materials. The number of HCPs answering dosing-related questions correctly ranged from 24/31 to 31/31. All Xyrem® contraindications were correctly identified by 26/31 (83.9%; 70.0-96.7) respondents. All respondents 'always' or 'sometimes' completed SmPC recommended activities upon treatment initiation. The majority indicated signs of abuses/misuse/diversion (23/31; 74.2%; 58.6-88.0) and criminal use (23/31; 74.2%; 59.4-89.3) should be monitored at follow-up.ConclusionsThese data demonstrate the importance of providing a range of educational materials. However, the low sample size limits interpretation; increased HCP engagement would improve understanding of how best to develop educational materials.European post-authorization study (pas) register numberEUPAS15024.

Project description:BackgroundCyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual deviations in men, and signs of androgenization in women. In 2020, the CPA summary of product characteristics (SmPC) was revised to include an updated special warning and precaution about (1) the risk of meningioma with increasing cumulative dose and (2) contraindication in patients with meningioma or history of meningioma. A Direct Healthcare Professional Communication (DHPC) was distributed. The European Medicine Agency's Pharmacovigilance Risk Assessment Committee requested that marketing authorization holders in Europe conduct a survey to assess physicians' knowledge of the updated key safety information. The primary objective of this study was to measure physicians' awareness (i.e., did they receive and review the revised SmPC and DHPC) and level of knowledge and understanding of the key safety information pertaining to the restricted use of CPA monotherapy because of the risk of meningioma.MethodsThis cross-sectional web-based survey was administered to dermatologists, endocrinologists, gynecologists, urologists, oncologists, psychiatrists, and general practitioners in France, Germany, Poland, Spain, and the Netherlands who had prescribed CPA monotherapy in the previous 12 months to assess awareness of the risk of meningioma associated with CPA monotherapy.ResultsOf the 613 physicians who participated, 85% correctly indicated that CPA monotherapy should be prescribed with the lowest effective dose, 75% correctly indicated that the risk of meningioma increases with increasing cumulative CPA monotherapy doses, and 73% correctly indicated that treatment with CPA-containing products must be stopped permanently if a patient is diagnosed with meningioma. Overall, 40% of physicians reported having received the DHPC, and 42% reported having received the revised SmPC.ConclusionsDespite low recall of receipt of the updated SmPC and DHPC, most physicians surveyed are aware of the meningioma risk and actions to mitigate the risk.

Project description:BackgroundAdditional risk minimization measures (aRMMs) are required for some pharmaceutical products when routine risk minimization measures (i.e., product labeling) are deemed insufficient. Measures often include educational materials, such as paper brochures, leaflets, and/or alert cards that provide information to healthcare professionals and patients on the key risks associated with a product and risk minimization actions to take should particular signs or symptoms arise. Paper-based educational aRMMs have several limitations. They do not present information in an interactive manner, and their update and distribution can be costly and often complex. Measuring how effective they are in achieving their aims can also be difficult. Digital methods offer design and delivery flexibility, easier updating processes, opportunities to increase engagement with important information, as well possibilities for tracking distribution, receipt, and potentially understanding of the materials. Pharmaceutical companies have started to look to digital methods as an option for educational aRMMs, alongside paper materials.ObjectivesResearch into healthcare professionals and patient needs and preferences, as well as the general acceptability of digital educational options is needed to establish a baseline. This was an exploratory study intended to provide initial insights on the acceptability of digital aRMMs and to inform future research directions.MethodsDigital concepts for educational aRMMs, one for healthcare professionals and one for patients, were evaluated with 30 healthcare professionals and 20 patients in six countries through 1:1 Zoom calls, with responses recorded in a structured Qualtrics-based survey. Criteria for selecting the six countries included local familiarity with aRMMs as well as interest in and capability to deliver a potential digital aRMM program by the sponsoring company's affiliate teams. Of the healthcare professionals, 19 were rheumatologists and 11 were dermatologists. 16 patients had rheumatologic (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) conditions and four had atopic dermatitis. These conditions were chosen as they aligned to potential therapeutic areas where the sponsoring company may have the opportunity to use a digital aRMM. Participants were given an overview of the concept as well as the opportunity to interact with it directly via the "control screen" function in Zoom before questions were posed.ResultsThe results demonstrated that the majority of healthcare professionals (87%) and all patients interviewed would prefer website-based or app-based delivery, respectively, of aRMM information instead of, or alongside traditional paper-based approaches, with only 13% of healthcare professionals and no patients expressing a preference for paper-only communication.ConclusionsGiven new options offered by digital technology, its widespread use in many fields, and the importance of patient safety as a topic, there is an imperative for pharmaceutical companies and regulators to work together to establish a way forward for the use of digital options for aRMMs. This study is limited in its generalizability but offers some ideas for future research directions.

Project description:BackgroundThe European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested PAS, commonly observational studies, must be recorded in this register. Multi-database studies (MDS) leveraging secondary data have become an important strategy to conduct PAS in recent years, as reflected by the type of studies registered in the EU PAS register.ObjectivesTo analyse and describe PAS in the EU PAS register, with focus on MDS.MethodsStudies in the EU PAS register from inception to 31st December 2018 were described concerning transparency, regulatory obligations, scope, study type (e.g., observational study, clinical trial, survey, systematic review/meta-analysis), study design, type of data collection and target population. MDS were defined as studies conducted through secondary use of >1 data source not linked at patient-level. Data extraction was carried out independently by 14 centres with expertise in pharmacoepidemiology, using publicly available information in the EU PAS register including study protocol, whenever available, using a standardised data collection form. For validation purposes, a second revision of key fields for a 15% random sample of studies was carried out by a different centre. The inter-rater reliability (IRR) was then calculated. Finally, to identify predictors of primary data collection-based studies/versus those based on secondary use of healthcare databases) or MDS (vs. non-MDS), odds ratios (OR) and 95% confidence intervals (CI) were calculated fitting univariate logistic regression models.ResultsOverall, 1426 studies were identified. Clinical trials (N = 30; 2%), systematic reviews/meta-analyses (N = 16; 1%) and miscellaneous study designs (N = 46; 3%) were much less common than observational studies (N = 1227; 86%). The protocol was available for 63% (N = 360) of 572 observational studies requested by a competent authority. Overall, 36% (N = 446) of observational studies were based fully or partially on primary data collection. Of 757 observational studies based on secondary use of data alone, 282 (37%) were MDS. Drug utilisation was significantly more common as a study scope in MDS compared to non-MDS studies. The overall percentage agreement among collaborating centres that collected the data concerning study variables was highest for study type (93.5%) and lowest for type of secondary data (67.8%).ConclusionsObservational studies were the most common type of studies in the EU PAS register, but 30% used primary data, which is more resource-intensive. Almost half of observational studies using secondary data were MDS. Data recording in the EU PAS register may be improved further, including more widespread availability of study protocols to improve transparency.

Project description:BackgroundApixaban (ELIQUIS®) is a direct oral anticoagulant authorised for multiple indications in the European Economic Area (EEA). Additional risk minimisation measures (aRMMs) to address the risk of bleeding include educational materials comprising a Prescriber Guide and Patient Alert Card.ObjectivesThis study evaluated effectiveness of the apixaban Prescriber Guide and Patient Alert Card in terms of healthcare professional (HCP) and patient knowledge of associated bleeding risk, as well as material distribution, utilisation and behaviour.MethodsThis non-interventional, cross-sectional study included online surveys in ten countries that represented a high proportion of apixaban usage in the EEA. The HCP source population was based on HCP lists used for communications about and distribution of the risk minimisation materials. Patient recruitment took place via HCPs. Study participants included HCPs involved in apixaban treatment and patients treated with apixaban (or their caregivers) for multiple indications. Data collection took place over an 18-month period between August 2015 and February 2017.ResultsSurvey responses from 385 HCPs and 125 patients/caregivers were analysed. HCP knowledge of bleeding risk included early recognition of symptoms requiring immediate contact with an HCP (96.1%), appropriate dosing (83.6%), contraindications (76.1%) and subpopulations at increased risk of bleeding complications (ranging from 63.5 to 85.9%). Patient knowledge included abnormal bleeding as an important side effect (71.2%), communicating risk factors to HCPs (76.8%) and recognition of potential bleeding symptoms ('high' knowledge levels 22.4%, 'moderate' knowledge levels 49.6%). Of 226 (58.7%) HCPs who recalled receiving/obtaining the Prescriber Guide, 97.8% read at least part of it and 74.8% had used it to assist patient discussions. Of 74 (59.2%) patients who were aware of the Patient Alert Card, 89.2% recalled receiving/obtaining a copy. When received, 90.9% of patients read the card at least once and 93.9% kept it with them at least some of the time.ConclusionsHCP and patient respondent knowledge of bleeding risk was satisfactory. Although not optimal, reach of the aRMMs was consistent with other studies. No modifications to aRMM content were required. To increase reach, the Prescriber Guide has been provided in an additional format as a web-based platform whilst the Patient Alert Card was included within product packaging.

Dataset Information

Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study.

Publications

Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets