Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin

Raguideau, F.; Mezzarobba, M.; Zureik, Mahmoud; Weill, Alain; Ricordeau, P.; Alla, François

doi:10.1002/pds.3763

Cited by 28 publications

(39 citation statements)

References 23 publications

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“…Over the years, multiple initiatives have been taken to try to prevent women from becoming pregnant while on retinoids. Few have been judged satisfactory [17]. It is thus logical to incorporate the prescription of oral retinoids into a REMS with ETASU.…”

Section: Discussionmentioning

confidence: 99%

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Boudes¹

2017

Drugs R D

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Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug safety. We conducted a literature search and a survey of relevant websites (FDA, manufacturers, and REMSs). ETASU characteristics were summarized. REMS risks were compared with labeled risks, including black box warnings. Forty-two programs were analyzed. Seven incorporated drugs of the same class. Most drugs (57%) were indicated for an orphan disease. A single risk was mentioned in 24 REMSs, and multiple risks in 18. Embryo-fetal toxicity and abuse or misuse were the most frequent risks. All risks were identified during clinical development but some were hypothetical. Thirty-six drugs had a black box warning. REMS risks and black box risks differed for 11 drugs. A drug with multiple indications could have a REMS for one of them but not for another. Most REMSs required prescriber training and certification, half required dispenser certification and patient enrolment. REMSs were revised multiple times and only three (7%) were discontinued. No data were available to establish whether REMSs were effective in improving drug safety. Some REMSs were deemed inefficient. REMSs with ETASU continue to be implemented but their impact on improving drug safety is still not documented. Hence, one of the main requirements of the FDA Amendments Act of 2007 is not being addressed. In addition, REMSs are complex and their logic is inconsistent; we recommend a thorough re-evaluation of the REMS program.

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Section: Discussionmentioning

confidence: 99%

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Boudes¹

2017

Drugs R D

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“…We retrospectively used the French Health Insurance Information System (SNIIRAM), which has been validated [3, 20–22, 31, 37] and used in many studies [4–6, 9, 15, 28, 31, 32, 48, 49, 58, 59]. In France, health insurance is compulsory and it comprehensively covers the entire French population.…”

Section: Methodsmentioning

confidence: 99%

Exchangeable Femoral Neck (Dual-Modular) THA Prostheses Have Poorer Survivorship Than Other Designs: A Nationwide Cohort of 324,108 Patients

Colas

Allalou

Poichotte

et al. 2017

Clinical Orthopaedics &Amp; Related Research

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BackgroundExchangeable neck stems, defined as those with a dual taper (that is, a modular junction between the femoral head and the femoral neck and an additional junction between the neck and the stem body), were introduced in THA to improve restoration of joint biomechanics (restoring anteversion, offset, and limb length) and reduce the risk of dislocation. However exchangeable necks have been reported to result in adverse effects such as stem fractures and acute local tissue reaction. Whether they result in a net improvement to or impairment of reconstructive survivorship remains controversial.Questions/Purposes(1) To compare the prosthetic survivorship and all-cause revision risk of exchangeable femoral neck THAs versus fixed neck THAs, taking known prosthetic revision risk factors into account; and (2) to compare the cause-specific revision risk of exchangeable femoral neck THAs versus fixed neck THAs, adjusting for known prosthetic risk factors.MethodsUsing French national health-insurance databases, we identified all French patients older than 40 years who underwent primary THA from 2009 through 2012. To ensure accuracy of the data, we considered only beneficiaries of the general insurance scheme (approximately 77% of the population). Characteristics of the prosthesis and the patients receiving an exchangeable femoral neck THA were compared with those receiving a fixed femoral neck THA (defined as femoral stem with only the head being exchangeable). Revision was the event of interest. Followup started on the date the THA was performed, until the patient experienced revision, died, was lost to followup, or until the followup period ended (December 31, 2014), whichever came first. Competing risk THA survivorship was calculated and compared (purpose 1), as were cause-specific Cox regression models (purpose 2). The study cohort included 324,108 individuals with a mean age of 77 years. A total of 24% underwent THA for acute trauma, and 3% of the group received an exchangeable neck THA. During the median 45-month followup (mean, 42 months; minimum, 1 day; maximum, 6 years), 11,968 individuals underwent prosthetic revision.ResultsThe cumulative revision incidence was 6.5% (95% CI, 5.8%–7.3%) for exchangeable neck THAs versus 4.7% (95% CI, 4.6%–4.8%) for fixed neck THAs (p < 0.001). After controlling for potential confounding variables including age, sex, comorbidities, indication for THA, cementation, bearing surface, and the characteristics of the center where the implantation was performed, we found that the exchangeable femoral neck THA was associated with an increased hazard ratio (HR) of revision of 1.26 (95% CI, 1.14–1.38; p < 0.001) compared with the fixed neck THA. When dealing with cause-specific revision, exchangeable neck THAs had a higher incidence of revision for implant failure or periprosthetic fracture, and for mechanical complications; adjusted HRs were, respectively, 1.68 (95% CI, 1.24–2.27; p < 0.001) and 1.27 (95% CI, 1.13–1.43; p < 0.001), for exchangeable neck THAs compared with fixed ones.C...

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“…A nationwide and retrospective cohort study was carried out using a French national health insurance database (SNIIRAM) 25, 26, 27, 28, 29, 30, 31. This database contains anonymous individual data on all reimbursements for patient health expenditure, including medicinal products and outpatient medical and nursing care, prescribed or provided by healthcare professionals.…”

Section: Methodsmentioning

confidence: 99%

Short‐Term Risk of Bleeding During Heparin Bridging at Initiation of Vitamin K Antagonist Therapy in More Than 90 000 Patients With Nonvalvular Atrial Fibrillation Managed in Outpatient Care

Bouillon¹,

Bertrand²,

Boudali³

et al. 2016

JAHA

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BackgroundSeveral studies have recently examined the risks of bleeding and of ischemic stroke and systemic embolism associated with perioperative heparin bridging anticoagulation in patients with nonvalvular atrial fibrillation. However, few studies have investigated bridging risks during vitamin K antagonist initiation in outpatient settings.Methods and ResultsA retrospective cohort study was conducted on individuals starting oral anticoagulation between January 2010 and November 2014 for nonvalvular atrial fibrillation managed in outpatient care and identified from French healthcare insurance. Bleeding and ischemic stroke and systemic embolism events were identified from the hospitalization database. Adjusted hazard ratios with 95% CI were estimated using Cox models during the first and 2 following months of anticoagulation. Of 90 826 individuals, 30% had bridging therapy. A total of 318 (0.35%) cases of bleeding and 151 (0.17%) ischemic stroke and systemic embolism cases were identified during the first month of follow‐up and 231 (0.31%) and 122 (0.16%) during the 2 following months, respectively. At 1 month of follow‐up, the incidence of bleeding was higher in the bridged group compared with the nonbridged group (0.47% versus 0.30%; P<0.001), and this increased risk persisted after adjustment for covariates (hazard ratio=1.60; 95% CI, 1.28–2.01). This difference disappeared after the first month of treatment (0.93; 0.70–1.23). No significant difference in the occurrence of ischemic stroke and systemic embolism was observed either at 1 month of follow‐up or later.ConclusionsAt vitamin K antagonist initiation for nonvalvular atrial fibrillation managed in ambulatory settings, bridging therapy is associated with a higher risk of bleeding and a similar risk of arterial thromboembolism compared with no bridging therapy.

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Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin

Abstract: This study highlights poor compliance with acitretin PPP recommendations in France. Physicians and pharmacists must more rigorously apply the acitretin PPP recommendations, and patients must be better informed about acitretin's risk of teratogenicity.

Cited by 28 publications

References 23 publications

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Exchangeable Femoral Neck (Dual-Modular) THA Prostheses Have Poorer Survivorship Than Other Designs: A Nationwide Cohort of 324,108 Patients

Short‐Term Risk of Bleeding During Heparin Bridging at Initiation of Vitamin K Antagonist Therapy in More Than 90 000 Patients With Nonvalvular Atrial Fibrillation Managed in Outpatient Care

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