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Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

ABSTRACT: Background: Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer, but no studies have assessed the impact of these warnings by risk of fracture strata. Aim: The aim of this work is to assess changes in the utilization of osteoporosis drugs in the region of Valencia (Spain) after safety warnings from regulatory agencies and cost-sharing changes, according to patient socio-demographic and risk of fracture characteristics. Patients and Methods: We constructed a monthly series of osteoporosis drug consumption for 2009-2015 from the ESOSVAL cohort (n = 11,035; women: 48%; mean age: 65 years old) and used interrupted time series and segmented linear regression models to assess changes in osteoporosis drug utilization while controlling for previous levels and trends after three natural intervention dates: the issue of the Spanish Agency for Drugs and Medical Products (AEMPS) Osteonecrosis Jaw Warning (Sept 2009), the AEMPS Atypical femur Fracture Warning (Apr 2011), and the modification of the cost-sharing scheme (Jul 2012). Results: The AEMPS Osteonecrosis Jaw Warning was not associated with a decline in the consumption of osteoporosis drugs, while the warning on atypical fracture (a downward trend of 0.11% fewer people treated each month) and the increase in the cost-sharing scheme (immediate change level of -1.07% in the proportion of people treated) were associated with a strong decline in the proportion of patients treated, so that by the end of 2015 osteoporosis drug consumption was around half that of 2009. The relative decline was similar in people with both a high and low risk of fracture. Conclusion: The AEMPS Atypical femur Fracture Warning of Apr 2010 was associated with a significant decrease in the number of people treated, reinforced by the increase in the pharmaceutical cost-sharing in 2012. Decreases in treatment affected patients both at a low and higher risk of fracture.

SUBMITTER: Hurtado-Navarro I

PROVIDER: S-EPMC6635591 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

Hurtado-Navarro Isabel I García-Sempere Aníbal A Rodríguez-Bernal Clara C Sanfélix-Genovés José J Peiró Salvador S Sanfélix-Gimeno Gabriel G

Frontiers in pharmacology 20190710

<b>Background:</b> Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer, but no studies have assessed the impact of these warnings by risk of fracture strata. <b>Aim:</b> The aim of this work is to assess changes in the utilization of osteoporosis drugs in the region of Valenc ...[more]

PMID: 31354484

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Project description:Inappropriate prescribing of antiosteoporotic medications has been observed; however, the joint study of both overuse and underuse has barely been attempted. Spain, with its high utilization rates, constitutes a good example to assess differences in over and under use according to diverse highly-influential osteoporosis guidelines (HIOG) worldwide. We used data of a population-based cross-sectional study including 824 post-menopausal women ≥50 years old living in the city of Valencia, Spain and aimed to estimate the percentage of women eligible for treatment, and the proportion of overuse and underuse of antiosteoporotic treatment according to HIOG. The prevalence of antiosteoporotic treatment in postmenopausal women ≥ 50 in Valencia was 20.9% (95%CI:17.6-24.4). The type of antiosteoporotic drugs prescribed varied greatly depending on the medical specialty responsible of the initial prescription. When applying the HIOG, the percentage of women 50 and over who should be treated varied from less than 9% to over 44%. In real terms, from the approximately eight million women of 50 years old and over in Spain, the number eligible for treatment would range from 0.7 to 3.8 million, depending on the guideline used. A huge proportion of inappropriate treatments was found when applying these guidelines to the Spanish population, combining a high overuse (42-78% depending on the guideline used) and underuse (7-41%). In conclusion, we found that the pharmacological management of osteoporosis in women of 50 and over in this population combines an important overuse and, to a lesser extent, underuse, although the level of inappropriateness varied strikingly depending on the CPG used. It seems urgent to reduce treatment overuse without neglecting underuse, as is urgent an attempt to reach wider agreement worldwide regarding osteoporosis management, in order to facilitate appropriate treatment and development of policies to reduce effectively treatment inappropriateness.

Project description:BackgroundData sharing is commonly seen as beneficial for science but is not yet common practice. Research funding agencies are known to play a key role in promoting data sharing, but German funders' data sharing policies appear to lag behind in international comparison. This study aims to answer the question of how German data sharing experts inside and outside funding agencies perceive and evaluate German funders' data sharing policies and overall efforts to promote data sharing.MethodsThis study is based on sixteen guided expert interviews with representatives of German funders and German research data experts from stakeholder organisations, who shared their perceptions of German' funders efforts to promote data sharing. By applying the method of qualitative content analysis to our interview data, we categorise and describe noteworthy aspects of the German data sharing policy landscape and illustrate our findings with interview passages.ResultsWe present our findings in five sections to distinguish our interviewees' perceptions on a) the status quo of German funders' data sharing policies, b) the role of funders in promoting data sharing, c) current and potential measures by funders to promote data sharing, d) general barriers to those measures, and e) the implementation of more binding data sharing requirements.Discussion and conclusionAlthough funders are perceived to be important promoters and facilitators of data sharing throughout our interviews, only few German funding agencies have data sharing policies in place. Several interviewees stated that funders could do more, for example by providing incentives for data sharing or by introducing more concrete policies. Our interviews suggest the academic freedom of grantees is widely perceived as an obstacle for German funders in introducing mandatory data sharing requirements. However, some interviewees stated that stricter data sharing requirements could be justified if data sharing is a part of good scientific practice.

Project description:BackgroundSince 1962, enterovirus D68 (EV-D68) has been implicated in multiple outbreaks and sporadic cases of respiratory infection worldwide, but especially in the USA and Europe with an increasing frequency between 2010 and 2014. We describe the detection, associated clinical features and molecular characterization of EV-D68 in central and southern Viet Nam between 2009 and 2015.MethodsEnterovirus/rhinovirus PCR positive respiratory or CSF samples taken from children and adults with respiratory/central nervous system infections in Viet Nam were tested by an EV-D68 specific PCR. The included samples were derived from 3 different observational studies conducted at referral hospitals across central and southern Viet Nam between 2009 and 2015. Whole-genome sequencing was carried out using a MiSeq based approach. Phylogenetic reconstruction and estimation of evolutionary rate and recombination were carried out in BEAST and Recombination Detection Program, respectively.ResultsEV-D68 was detected in 21/625 (3.4%) enterovirus/rhinovirus PCR positive respiratory samples but in none of the 15 CSF. All the EV-D68 patients were young children (age range: 11.8 - 24.5 months) and had moderate respiratory infections. Phylogenetic analysis suggested that the Vietnamese sequences clustered with those from Asian countries, of which 9 fell in the B1 clade, and the remaining sequence was identified within the A2 clade. One intra sub-clade recombination event was detected, representing the second reported recombination within EV-D68. The evolutionary rate of EV-D68 was estimated to be 5.12E -3 substitutions/site/year. Phylogenetic analysis indicated that the virus was imported into Viet Nam in 2008.ConclusionsWe have demonstrated for the first time EV-D68 has been circulating at low levels in Viet Nam since 2008, associated with moderate acute respiratory infection in children. EV-D68 in Viet Nam is most closely related to Asian viruses, and clusters separately from recent US and European viruses that were suggested to be associated with acute flaccid paralysis.

Project description:UnlabelledLong-term persistence with anti-osteoporosis drugs and determinants for discontinuation among fracture patients were examined. Persistence was 75.0 and 45.3 % after 1 and 5 years, respectively. Those aged ≥80 years were at increased risk of early discontinuation. Within 1 year after discontinuation, 24.3 % restarted therapy, yet 47.0 % persisted for 1 year.IntroductionThe risk of osteoporotic fracture can effectively be reduced with use of anti-osteoporosis drugs. However, little is known about persistence with these drugs after fracture where subsequent fracture risk is high. The aims were to determine long-term persistence with anti-osteoporosis drugs among fracture patients, including its determinants, and to describe restart and subsequent persistence.MethodsA cohort study was conducted within the Dutch PHARMO Database Network. Patients aged ≥50 years (n = 961) who received anti-osteoporosis drugs within 1 year after fracture, but not in the preceding year, were included (2002-2011). Persistence (defined as the proportion on treatment) and the proportion restarting after discontinuation were estimated using Kaplan-Meier analyses. Time-dependent Cox regression was used to identify determinants of non-persistence including age, sex, initial dosage regime, fracture type, comorbidities, and drug use.ResultsPersistence with anti-osteoporosis drugs was 75.0 % (95 % confidence interval (CI) 72.0-77.7) and 45.3 % (95 % CI 40.4-50.0) after 1 and 5 years, respectively. A significant determinant of non-persistence was age ≥80 years (reference 50-59 years: adjusted hazard ratio [adj. HR] 1.65; 95 % CI 1.15-2.38). This effect was not constant over time (≤360 days following initiation: adj. HR 2.07; 95 % CI 1.27-3.37; >360 days: adj. HR 1.08; 95 % CI 0.62-1.88). Within 1 year after discontinuation, 24.3 % (95 % CI 20.1-29.2) restarted therapy, yet 47.0 % persisted for 1 year.ConclusionsThis study identified suboptimal persistence with anti-osteoporosis drugs among fracture patients. Major target groups for measures aimed to improve persistence may be those aged >80 years and those restarting therapy.

Dataset Information

Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

Publications

Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

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