IMS Health Research Articles

Economic evaluation of spondyloarthritis: economic impact of diagnostic delay in Italy.

Background and aimSpondyloarthritis (SpA) is a disease that normally affects the axial skeleton. It progressively leads to overall stiffness up to severe postural deformity of rachis and functional impotence. The objective of the study was to quantify, through an economic model, the impact of specialized testing and pharmacological treatments carried out by the National Health Service (NHS) in normal clinical practice, before the patient is diagnosed with SpA in Italy. In line with the analysis objective, the chosen perspective is that of the NHS.MethodThe study was conducted by analyzing the Health Search Database – IMS Health Longitudinal Patient Database, from which newly diagnosed SpA patients were identified over the period 1 January 2007 to 31 December 2013. The use of specialist health care services and pharmacological treatments provided to the patients before the final SpA diagnosis were estimated.ResultsThrough a retrospective analysis of the Health Search Database, 1,084 subjects (aged 25–45 years) were identified. These patients produced an expense of approximately €153,000 in the 3 years prior to a confirmed SpA diagnosis, in terms of specialist check-ups and drugs, presumably not appropriately used due to a lack of diagnosis. If we assume that the Health Search Database is a representative sample of the Italian population, it may be estimated that, in the 3 years prior to SpA diagnosis, over €5.4 million was largely unduly spent in Italy to examine and manage 38,232 newly diagnosed SpA patients, between 2010 and 2013.ConclusionThe costs due to the delay in SpA diagnosis were quantified for the first time in Italy. For this reason, this work represents a contribution for national and regional decision makers to understand the current clinical practice and the economic consequences of a diagnostic delay in the short and medium term.

The incidence of abortion and unintended pregnancy in India, 2015.

SummaryBackgroundReliable information on the incidence of induced abortion in India is lacking. Official statistics and national surveys provide incomplete coverage. Since the early 2000s, medication abortion has become increasingly available, improving the way women obtain abortions. The aim of this study was to estimate the national incidence of abortion and unintended pregnancy for 2015.MethodsNational abortion incidence was estimated through three separate components: abortions (medication and surgical) in facilities (including private sector, public sector, and non-governmental organisations [NGOs]); medication abortions outside facilities; and abortions outside of facilities and with methods other than medication abortion. Facility-based abortions were estimated from the 2015 Health Facilities Survey of 4001 public and private health facilities in six Indian states (Assam, Bihar, Gujarat, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh) and from NGO clinic data. National medication abortion drug sales and distribution data were obtained from IMS Health and six principal NGOs (DKT International, Marie Stopes International, Population Services International, World Health Partners, Parivar Seva Santha, and Janani). We estimated the total number of abortions that are not medication abortions and are not obtained in a health facility setting through an indirect technique based on findings from community-based study findings in two states in 2009, with adjustments to account for the rapid increase in use of medication abortion since 2009. The total number of women of reproductive age and livebirth data were obtained from UN population data, and the proportion of births from unplanned pregnancies and data on contraceptive use and need were obtained from the 2015–16 National Family Health Survey-4.FindingsWe estimate that 15·6 million abortions (14·1 million–17·3 million) occurred in India in 2015. The abortion rate was 47·0 abortions (42·2–52·1) per 1000 women aged 15–49 years. 3·4 million abortions (22%) were obtained in health facilities, 11·5 million (73%) abortions were medication abortions done outside of health facilities, and 0·8 million (5%) abortions were done outside of health facilities using methods other than medication abortion. Overall, 12·7 million (81%) abortions were medication abortions, 2·2 million (14%) abortions were surgical, and 0·8 million (5%) abortions were done through other methods that were probably unsafe. We estimated 48·1 million pregnancies, a rate of 144·7 pregnancies per 1000 women aged 15–49 years, and a rate of 70·1 unintended pregnancies per 1000 women aged 15–49 years. Abortions accounted for one third of all pregnancies, and nearly half of pregnancies were unintended.InterpretationHealth facilities can have a greater role in abortion service provision and provide quality care, including post-abortion contraception. Interventions are needed to expand access to abortion services through better equipping existing facilities, ensuring adequate and continuous supplies of medication abortion drugs, and by increasing the number of trained providers. In view of how many women rely on self-administration of medication abortion drugs, interventions are needed to provide women with accurate information on these drugs and follow-up care when needed. Research is needed to test interventions that improve knowledge and practice in providing medication abortion, and the Indian Government at the national and state level needs to prioritise improving policies and practice to increase access to comprehensive abortion care and quality contraceptive services that prevent unintended pregnancy.FundingGovernment of UK Department for International Development (until 2015), the David and Lucile Packard Foundation, the John D. and Catherine T. MacArthur Foundation, and the Ford Foundation.

The quality of information on the internet relating to top-selling dietary supplements in the Czech Republic.

Background The purchase of dietary supplements (DS) via the Internet is increasing worldwide as well as in the Czech Republic. Objective The aim of the study is to evaluate the quality of information on DS available on the Internet. Setting Czech websites related to dietary supplements. Methods A cross-sectional study was carried out involving the analysis of information placed on the websites related to the 100 top-selling DS in the Czech Republic in 2014, according to IMS Health data. Main outcome measure The following criteria were evaluated: contact for the manufacturer, recommended dosage, information on active substances as well as overall composition, permitted health claims, % of the daily reference intake value (DRIV) for vitamins and minerals, link for online counseling, pregnancy/breastfeeding, allergy information, contraindications, adverse reactions, and supplement-drug interactions (some criteria were evaluated from both points of view). Results A total of 199 web domains and 850 websites were evaluated. From the regulatory point of view, all the criteria were fulfilled by 11.3% of websites. Almost 9% of the websites reported information referring to the treatment, cure, or prevention of a disease. From the clinical point of view, all the criteria were onlymet by one website. Conclusions The quality of information related to DS available on the Internet in the Czech Republic is quite low. The consumers should consult a specialist when using DS purchased online.

Variability in market uptake of psychotropic medications in Europe reflects cultural diversity

BackgroundIn the last 20–30 years, many international studies have found substantial differences in the use of (older) psychotropic medication between European countries. The majority mentioned an important role for attitudes and beliefs towards psychotropic medication. So far, no studies have looked into the effects of cultural diversity on the use of new medications entering the market. As national cultures relate deeply to held values regarding, for example, what is seen as effective versus ineffective or safe versus dangerous, (cultural) diversity in decision making around the role of new medications in clinical practice may already be expected from the first day after market authorization.MethodsThis study examined the relation between cultural diversity, described in Hofstede’s model of cultural dimensions (Power Distance, Individualism, Masculinity, Uncertainty Avoidance, Indulgence and Long-Term Orientation) and utilization of three new psychotropic medications, namely aripiprazole, duloxetine and pregabalin in Europe. Country level sales data of the case study medications were correlated to country-specific scores of Hofstede’s cultural dimensions. IMS Health’s MIDAS database has been used for sales data (converted to Defined Daily Doses/1000 inhabitants/day) for the case study medications from the market authorization date in 2004 until December 2009 for 23 EU member states.ResultsConsumption of the case study medications was seen in all countries. In general, pregabalin was used more often than aripiprazole and duloxetine. In 2 years after market authorization, approximately 80% of all countries have reported use of all three molecules.Correlations between Hofstede dimensions individualism, long-term orientation and indulgence and total use of the case study medications tended to become stronger over time, but they were only statistically significant for indulgence at two years after market authorization (rho = 0.51, p = 0.014) and three years after market authorization (rho = 0.54, p = 0.008). A more detailed analysis showed (slight) variation by molecule.ConclusionsThis study is a first step in including cultural dimensions when explaining cross-national variation in the use of new medications. The results indicate that indulgence, however marginally, is a cultural aspect that relates to the utilization of new psychotropic medications, suggesting that within the cultural context, less regulation of social norms is a main factor in explaining cross-national variation in uptake of these medications.

Patterns and predictors of physician adoption of new cardiovascular drugs

BackgroundLittle is known about physicians’ approaches to adopting new cardiovascular drugs and how adoption varies between drugs of differing novelty. MethodsUsing data on dispensed prescriptions from IMS Health's Xponent™ database, we created a cohort of all primary care physicians (PCPs) and cardiologists in Pennsylvania who regularly prescribed anticoagulants, antihypertensives and statins from 2007 to 2011. We examined prescribing of three new cardiovascular drugs of differing novelty: dabigatran, aliskiren and pitavastatin. Outcomes were rapid adoption of each new drug, defined by early and sustained monthly prescribing detected by group-based trajectory models, by physicians within the first 15 months of marketplace introduction. Results5953 physicians regularly prescribed each drug class. The majority of physicians (63.8%) adopted zero new drugs in the first 15 months, 35.0% rapidly adopted one or two, and 1.2% rapidly adopted all three. Physicians were more likely to rapidly adopt the most novel drug, dabigatran (27.3%), than aliskiren (10.5%) or pitavastatin (8.0%). Physician specialty and sex were the most consistent predictors of adoption. Compared to PCPs, cardiologists were more likely to rapidly adopt dabigatran (Adjusted Odds Ratio 8.90, 95% confidence interval 7.42–10.67; P<0.001) aliskerin (2.05, CI 1.56–2.69; P<0.001) and pitavastatin (3.44, CI 2.60–4.57; P<0.001). Female physicians were less likely to adopt dabigatran (0.71, CI 0.59–0.85; P <0.001) and aliskiren (0.64, CI 0.49–0.83; P <0.001). ConclusionsPhysicians vary in their prescribing of recently-introduced cardiovascular drugs. Though most physicians did not rapidly adopt any new cardiovascular drugs, drug novelty and cardiology training were associated with greater adoption.

To what extent do data from pharmaceutical claims under-estimate opioid analgesic utilisation in Australia?

Although pharmaceutical claims are an essential data source for pharmacoepidemiological studies, these data potentially under-estimate opioid utilisation. Therefore, this study aimed to quantify the extent to which pharmaceutical claims from Australia's national medicines subsidy programs (Pharmaceutical Benefits Scheme [PBS] and Repatriation Schedule of Pharmaceutical Benefits [RPBS]) under-estimate prescription-only and total national opioid utilisation across time and for different opioids. A secondary aim was to examine the impact of the 2012 policy change to record all PBS/RPBS dispensed medicines, irrespective of government subsidy, on the degree of under-estimation. Aggregated data on Australian opioid utilisation were obtained for the 2010 to 2014 calendar years, including all single ingredient and combination opioid analgesic preparations available on prescription or over-the-counter (OTC). Total opioid utilisation (oral morphine equivalent kilogrammes) was quantified using sales data from IMS Health and compared with pharmaceutical claims data from the PBS/RPBS. PBS/RPBS claims data did not account for 12.4% of prescription-only opioid utilisation in 2014 and 19.1% in 2010, and 18.4% to 25.4% of total opioid use when accounting for OTC preparations. Between 2010 and 2014, 5.6% to 5.3% of buprenorphine, 8.1% to 6.3% fentanyl, 17.7% to 10.7% oxycodone, 18.4% to 11.0% tramadol, 38.4% to 21.0% hydromorphone, and 28.6% to 21.0% of prescription-only codeine utilisation were not accounted for in PBS/RPBS claims. Despite increased capture of less expensive (under co-payment) opioid items since 2012, PBS/RPBS claims still under-estimate opioid use in Australia, with varying degrees across opioids. The estimates generated in this study allow us to better understand the degree of under-estimation and account for these in research using Australia's national pharmaceutical claims data.

Economic Analysis And Evaluation Of The Value Of The Parallel Export Of Medicinal Products For Treatment Of Oncological Diseases In Bulgaria, 2016 T. VEKOV 1 AND G. KOLEV2

The aim of the research is to analyze and assess the parallel export of medicines with annual sales of >3 million BGN for treatment of oncological diseases from Bulgaria in the year 2016. Risk assessment for the shortage of life-saving medicinal products. A documentary method and analysis was used to compare the quantity and value of oncological medicinal products sold to distributors in Bulgaria in 2016 and paid by the National Health Insurance Fund (NHIF), reported by two independent sources - IMS Health (IMS) and National Health Insurance Fund (NHIF). The study included products with annual sales of> 3 million BGN. The economic analysis carried out estimated the value of the parallel export of medical products for treatment of cancer from Bulgaria in 2016 at 43.2 million BGN. Products of 5 pharmaceutical manufacturers account for 87.2% of the value of the parallel export: Roche (52.8%) - bevacizumab, trastuzumab, rituximab , erlotinib, pertuzumab, vemurafenib; BMS (14.3%) - dasatinib; Bayer (9.2%) - sorafenib, Novartis (6.2%) - everolimus, nilotinib, pazopanib; Astellas (4.7%) – enzalutamide. Conclusions: This study does not reveal any evidence of either medical product shortage nor limited access to treatment for patients due to lack of access to drug therapy in Bulgaria

Do Characteristics of Patients Influencing the Choice of Pain Treatment by GPS Differ in Osteoarthritis and Cancer? – An Italian Real World Evidence Study

To understand whether patients’ features underneath the choice of pain treatments by Italian GPs differ between osteoarthritis and cancer. Retrospective analysis on Real World Data from IMS Health Italian Longitudinal Patient Database. For both osteoarthritis and cancer, three cohorts of patients have been identified based on anti-inflammatory and antirheumatic (M01) and analgesic (N02) drugs prescriptions recorded during 2016: a) patients receiving a treatment with M01 drugs and not having N02 prescriptions, b) patients receiving a treatment with N02 and not having M01 prescriptions, c) patients treated with both M01 and N02 drugs. Descriptive statistics, Chi-square and t-tests were used to compare demographic and clinical characteristics of the patients in the three cohorts for osteoarthritis and cancer. Patients receiving a treatment with M01 drugs were 32,238 (70%) and 2,496 (31%) for osteoarthritis and cancer, respectively. Patients receiving a treatment with N02 were 8,569 (19%) and 4,450 (55%) for osteoarthritis and cancer, respectively. Patients treated with both M01 and N02 drugs were 5,026 (11%) and 1,107 (14%) for osteoarthritis and cancer, respectively. In osteoarthritis, the highest proportion of men was observed among patients treated with M01 only (33% versus 25% and 25%), while in cancer, higher proportions of men were observed among patients treated with N02 and among those treated with both M01 and N02 (46% and 47% versus 41%). For osteoarthritis, as well as for cancer, the oldest patients were those treated with N02 only, with a mean age of 77 and 71 years, respectively. Both in osteoarthritis and in cancer, patients treated with N02 only and with both N02 and M01 had a more impaired health status. All the comparisons were statistically significant. Despite all the considered patients’ features seem to be correlated with treatment choice, only gender shows opposite effects when comparing osteoarthritis and cancer.

A Retrospective Claims Analysis on Rates of Compliance and Discontinuation Among Canadian Multiple Sclerosis Patients Treated with Disease-Modifying Therapies at 6, 12 and 24-Month Periods

To assess compliance and discontinuation rates with DMTs in Canadian patients with RRMS In this Canadian retrospective claims analysis based on Rx Dynamics® data from IMS Health Canada Inc., compliance and discontinuation rates were collected at 6, 12 and 24-month (cohorts from 2013-2017, rolling 36 months total). Patients had ≥1 prescription filled for each DMT (oral: fingolimod, dimethyl fumarate (DMF), teriflunomide; injectable (BRACE): interferon beta-1a, interferon beta-1b, glatiramer acetate; infusible: natalizumab). A medication possession ratio (MPR) of ≥80% was used to reflect patient compliance to their treatment. Discontinuation rates were calculated based on patients who stopped therapy (60 day window) or who were switched to another DMT. Compliance and discontinuation data was collected after 6 month (n=12543, n=9460 respectively), 12 month (n=7665, n=7234) and 24 month (n=6047, n=6030) periods. The percentage of patients deemed compliant after 6, 12- and 24-months across Canada was higher for fingolimod (75%, 76%, 71% respectively), compared to natalizumab (72%, 73%, 56%), DMF (71%, 68%, 55%), and BRACE (52%, 46%, 35%) and comparable to teriflunomide (76%, 77%, 68%). Patients on fingolimod had the lowest discontinuation rate after 6, 12 and 24-month periods (26%, 25%, 29% respectively) compared to: BRACE (48%, 35%, and 55%); natalizumab (34%, 29%, and 49%) and DMF (31%, 30% and 43%); and similar to teriflunomide (26%, 25%, 31%). The compliance for patients treated with fingolimod remained stable at all time point and was higher than for other DMTs but was comparable to teriflunomide. Unlike other DMTs, the discontinuation rate with fingolimod did not significantly increase over the 24-month period and remained lower than other DMTs and similar to teriflunomide. These findings may inform MS management strategies in Canada which may lead to improved clinical and economic outcomes.

Severe Depression as a Risk Factor for Osteoporosis: A Real World Data Study Conducted in Italy

Depression is a common mental disorder, with more than 300 million people suffering from it. The presence of a relationship between depression and osteoporosis has been shown by a previous real world data study conducted in Italy. The objective of this analysis is to investigate whether the association observed could have been confused by antidepressants use or by time dependent confounders’ presence. This was a retrospective analysis based on data extracted from Italian IMS Health Longitudinal Patient Database. Three cohorts have been defined: the cohort of incident depressed patients, consisting of individuals with a diagnosis of depression (index date) during the period January 2004 - December 2010. The cohort of non-depressed patients, containing subjects with a first contact with the general practitioner (Index date) during the period January 2004 - December 2010, and that were not included in the previous cohort (free from depression). The cohort of depressed patients using antidepressants, identified within the first cohort. Patients of all cohorts must not have an osteoporosis diagnosis or a depression diagnosis during the five years period preceding the Index Date. Extended multivariate Cox models were performed controlling for antidepressants use and for other time dependent confounders. No association was found between depression and osteoporosis during the follow-up period (HR 1.024, p=0.26), while a higher incidence of osteoporosis of about 7% (HR 1.07, p=0.0010) was observed among antidepressants users when compared to non-users. Focusing on patients with antidepressants, the risk of developing osteoporosis increased by 13% for each antidepressant prescribed and by 14% (HR 1.141, p=0.0012) at antidepressant switch. Results from this study suggest that patients receiving a higher number of antidepressants and those needing pharmacological treatment changes have an increased risk of osteoporosis. Thus, this study suggests an association between a severe status of depression and osteoporosis.

Effect of the Disease Management Program on HbA1c Value in Type 2 Diabetes Mellitus Patients: A Retrospective Comparison between Disease Management Programs and Standard Care

Background This retrospective study aims to measure the effect of the disease management program (DMP) for type 2 diabetes mellitus (T2DM) patients on HbA1c value within Germany. Methods This study is based on patient data from the Disease Analyzer panel (IMS Health). An adequate control group was created using 2:1 propensity score matching. After matching, the analysis included 14 759 patients. Of these, 5875 participated in a DMP while 8884 received standard care. The DMP effect was estimated on the basis of the matched data, using an unpaired t-test. In addition, subgroups were considered from the perspective of personalized medicine. Results The reduction in HbA1c values in the DMP group amounted to an average of 1.0 percentage point (baseline HbA1c = 8.1 vs. final HbA1c = 7.1), while the SC group wasable to achieve an average reduction in HbA1c values of0.9 percentage point (baseline HbA1c = 8.1 vs. final HbA1c = 7.2). The DMP group thus achieved an average reduction in HbA1c values that exceeded that of the SC group by only 0.1 percentage point (95 % CI: 0.04 - 0.16). Descriptively, it also became apparent that patients from the DMP group received a greater average number of annual prescriptions and had more HbA1c measurements. The subgroup analysis identified groups of patients who benefit more from DMPs than others. Thus, young patients or patients who are being treated by diabetologists are able to benefit most from a DMP. Furthermore, the baseline HbA1c value has an influence on the DMP effect. Conclusion T2DM patients in the DMP exhibit a significantly higher reduction in HbA1c value. However, it is questionable whether this effect is clinically relevant. Certain groups of patients benefit more from DMPs than others. Nevertheless, further studies are needed in order to better understand the impact of the DMP on HbA1c value and the reasons for the subgroup effects. Such studies should be carried out using a randomized controlled design.

Characteristics of newly diagnosed COPD patients treated with triple inhaled therapy by general practitioners: a real world Italian study

Factors predicting prescriptions of triple therapy were investigated in a large group of general practitioners in Italy. In the population treated by identified general practitioners, a cohort of newly diagnosed chronic obstructive pulmonary disease patients was extracted from IMS Health Longitudinal Database during the period 2010–2013. From the diagnosis, 1-year follow-up was evaluated. Thirty-two thousand forty-six newly diagnosed chronic obstructive pulmonary disease patients were evaluated (57.7% male, mean age 67 years). During 2 years prior to diagnosis less than 13% of patients were requested with a pulmonology evaluation and less than 5% with a spirometry; 65.1% cases were prescribed with a respiratory drug, which in 9.6% of cases was inhaled corticosteroid/long-acting β2-agonist fixed-dose combination. Two thousand and twenty eight patients (6.3% of the newly diagnosed chronic obstructive pulmonary disease patients) were treated with triple therapy during the first year of follow-up, whose 858 (42.3%) starting immediately, and 762 (37.6%) following an initial treatment with inhaled corticosteroid/long-acting β2-agonist fixed-dose combination. Being older, being requested with pulmonologist evaluation or spirometry, being prescribed with a inhaled corticosteroid/long-acting β2-agonist fixed-dose combination at diagnosis resulted independent predictors of triple therapy use.

Unspecified intestinal malabsorption in patients treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers: a retrospective analysis in primary care settings

ABSTRACTObjective: To investigate the possible relationship between the use of Angiotensin II Receptor Blockers (ARBs) or Angiotensin-Converting-Enzyme Inhibitors (ACE-i) and unspecified intestinal malabsorption (IM) within the Italian and German real-life context.Research design and methods: a retrospective cohort of patients with a new unspecified IM diagnosis during the period 1 January 2010–31 December 2013 was extracted from Italian IMS Health Longitudinal Patient Database and German IMS Disease Analyzer. Only patients with at least one prescription of ARB or ACE-i medication during the 6 months preceding the IM diagnosis were included and then followed up for 12 months to assess treatment exposure.Results: After stratification by year and molecule, the proportion of patients experiencing an unspecified IM diagnosis on total patients receiving ARBs or ACE-i ranged from 0% to 0.14%, showing no relevant differences between molecules and no time trends.Conclusions: this study indicates that ACE-i or ARBs were rarely associated to an unspecified IM diagnosis. No relevant difference between each specific ACE-i and ARB was highlighted.

Adherence to Rivaroxaban Compared with Other Oral Anticoagulant Agents Among Patients with Nonvalvular Atrial Fibrillation.

Adherence to oral anticoagulant (OAC) agents is important for patients with nonvalvular atrial fibrillation (NVAF) to prevent potentially severe adverse events. To compare real-world adherence rates and time to discontinuation for rivaroxaban versus other OACs (apixaban, dabigatran, and warfarin) among patients with NVAF using claims-based data. Health care claims from the IMS Health Real-World Data Adjudicated Claims database (July 2012-June 2015) were analyzed. Adherence rate was defined as the percentage of patients with proportion of days covered (PDC) ≥ 0.80 and ≥ 0.90. Discontinuation was defined as a gap of more than 30 days between the end of a dispensing days of supply and the start date of the next fill, if any. Patients were included if they had ≥ 2 dispensings of rivaroxaban, apixaban, dabigatran, or warfarin at least 180 days apart (the first was considered the index date), had > 60 days of supply, had ≥ 6 months of pre-index eligibility, had ≥ 1 atrial fibrillation (AF) diagnosis pre-index or at index date, and had no valvular involvement. A logistic regression model was used to evaluate adherence to OAC therapy, while a Cox model was used to compare time to discontinuation; both models adjusted for baseline confounders. A total of 13,645 rivaroxaban, 6,304 apixaban, 3,360 dabigatran, and 13,366 warfarin patients were identified. A significantly higher proportion of rivaroxaban users (80.1%) was adherent to therapy (PDC ≥ 0.80 at 6 months) versus apixaban (75.8%), dabigatran (69.2%), and warfarin users (64.5%). After adjustment, the proportion of patients adherent to therapy remained significantly higher for rivaroxaban users versus apixaban (absolute difference [AD] = 5.8%), dabigatran (AD = 9.5%), and warfarin users (AD = 13.6%; all P < 0.001). More pronounced differences were found with a PDC ≥0.90. In addition, rivaroxaban users were significantly less likely to discontinue therapy compared with other OACs after adjustments (all P < 0.05). Among NVAF patients, rivaroxaban was associated with significantly higher adherence rates relative to other OACs whether using either a PDC of > 0.80 or > 0.90. Such differences in adherence could translate into improved patient outcomes and lower health care costs. This research was funded by Janssen Scientific Affairs. Ashton, Crivera, and Schein are employees and stockholders of Janssen Scientific Affairs. Laliberté, Germain, Wynant, and Lefebvre are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs in connection with this study. McHorney is an employee of Evidera, a consulting company that received research grants from Janssen Scientific Affairs in connection with this study. Peterson received research grants from Janssen Scientific Affairs in connection with this study. All authors contributed to concept and design. The data were collected by Germain, Wynant, Laliberté, and Lefebvre and interpreted primarily by McHorney and Peterson, with the assistance of Lefebvre, Laliberté, Ashton, Crivera, and Schein. The manuscript was written primarily by Laliberté, Germain, and Lefebvre, with the assistance of Wynant. Revisions were made primarily by Ashton, Crivera, McHorney, Schein, and Peterson.

Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines.

This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing-2016.

The results of the 2016 ASHP national survey of pharmacy practice in hospital settings are presented. A stratified random sample of pharmacy directors at 1,315 general and children's medical-surgical hospitals in the United States were surveyed using a mixed-mode method offering a choice of completing a paper survey or an online survey. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS's hospital database. The survey response rate was 29.8%. Drug policy development by pharmacy and therapeutics committees continues to be an important strategy for improving prescribing. Strict formulary systems are maintained in 63.0% of hospitals, and 89.7% of hospitals use clinical practice guidelines that include medications. Pharmacists have the authority to order laboratory tests in 89.9% of hospitals and order medications in 86.8% of hospitals. Therapeutic interchange policies are used in 89.2% of hospitals. Electronic health records (EHRs) have been implemented partially or completely in most hospitals (99.1%). Computerized prescriber-order-entry systems with clinical decision support are used in 95.6% of hospitals, and 92.6% of hospitals have barcode-assisted medication administration systems. Transitions-of-care programs are increasing in number, with 34.6% of hospitals now offering discharge prescription services. Pharmacists practice in 39.5% of hospital ambulatory or primary care clinics. The most common service offered by pharmacists to outpatients is anticoagulation management (26.0%). When pharmacists practice in ambulatory care clinics, 64.5% have prescribing authority through collaborative practice agreements. Pharmacists continue to expand their role in improving the prescribing of medications in both hospital and outpatient settings. The adoption of EHRs and medication-use technologies has contributed to this growth.

Silencing Peter Does Not Quiet Paul: Constitutional Infirmities in the TCPA's Ineffective Quest to Silence Telemarketers

This article considers the viability of the Telephone Consumer Protection Act (TCPA) in light of recent Supreme Court First Amendment precedent (such as Reed v. Town of Gilbert and Sorrell v. IMS Health) and technological & regulatory developments (such as the FCC’s ongoing consideration of rules that would allow or require prospective callers to implement technologies that obviate many of the TCPA’s concerns). The TCPA is the primary law prohibiting “robocalls” – phone calls made using autodialers or pre-recorded messages without the consent of the call recipient. In recent years robocalls have become one of the primary consumer protection issues facing regulators – with more than 4.1 billion of these calls placed eachmonth, consumer concern about them dominate complaints received by both the FCC and FTC. Simultaneously, as cellphones have become a ubiquitous means by which individuals engage with one another and the public square, the scope of the TCPA has expanded from protection of the privacy of the home (long recognized as Constitutionally permissible) to a more general shield from unwanted communications (generally not Constitutionally permissible). Because the TCPA regulates speech, it has been subject to repeated First Amendment challenges since it was enacted in 1991. Those challenges have consistently been reviewed subject to intermediate scrutiny, under which the statute has consistently survived. Recent developments in First Amendment precedent, however, suggest that such challenges would likely be subject to strict scrutiny today. Moreover, recent technological and regulatory developments suggest that the statute is not sufficiently tailored to survive application of intermediate scrutiny, let alone its stricter cousin. Given the sharp increase in TCPA suits in recent years -- from just 14 suits in 2007 to nearly 5,000 in 2016 – and this legal evolution, this article provides analysis relevant to certainly-forthcoming judicial and regulatory consideration of the TCPA. The TCPA also raises difficult questions beyond the traditional First Amendment analysis. For instance, the government itself regulates many aspects of the architecture of the telephone network. In this role, it has slowed or prevented the adoption of technologies that could dramatically reduce the problems the TCPA seeks to address by curtailing speech in order to (ineffectively) address. And the TCPA is largely premised on the government’s important interest in protecting the sanctuary of the home as a place in which individuals can be free from intrusions from the outside world. But as mobile telephones increasingly displace residential wireline telephones, the TCPA’s effect has grown sub silentio from protecting the sanctuary of the home to protecting the sanctuary of the phone. These issues raise important questions about the government’s power to regulate private speech, particularly in an era of rapid technological change.

Characteristics, resource utilization and safety profile of patients prescribed with neuropathic pain treatments: a real-world evidence study on general practices in Europe – the role of the lidocaine 5% medicated plaster

Objectives: To identify characteristics, resource utilization, and safety profile of patients prescribed with lidocaine 5% medicated plaster, pregabalin, gabapentin, amitriptyline and duloxetine when experiencing pain in the real-world setting of general practitioners (GPs) in Europe.Methods: Retrospective analysis on real world data from IMS Health Longitudinal Patient Database. Patients with at least one prescription of the drugs of interest during 2014 were selected and those with a non-neuropathic pain-related diagnosis were excluded. Patients’ demographic and clinical characteristics, resource utilization data and adverse drug reactions (ADRs) as described in the leaflet were extracted. The association between treatments and ADR occurrence was evaluated applying multivariate logistic models.Results: A total of 70,515 patients were selected from Italy, Germany, the UK, Spain and Belgium. Lidocaine 5% medicated plaster patients were the oldest in Italy, the UK and Spain and the most health impaired in Italy, Spain and Belgium. No relevant differences in the number of co-prescriptions, specialist visits, examinations and hospitalizations were found. Significantly less lidocaine 5% plasters patients experienced ADRs, with odds ratios in favor of lidocaine 5% medicated plasters ranging from 3.41 (p = .036) to 52.33 (p < .001).Conclusions: Evidence from daily clinical practice in GP settings agrees with the findings from more controlled clinical-trial settings, with lidocaine 5% medicated plaster patients showing a better safety profile, but also a comparable level of resource utilization. A possible re-evaluation of the scientific value coming from this retrospective study in building up a diagnostic as well as a therapeutic algorithm is suggested.

Development and validation of a claims-based measure as an indicator for disease status in patients with multiple sclerosis treated with disease-modifying drugs

BackgroundAdministrative healthcare claims data provide a mechanism for assessing and monitoring multiple sclerosis (MS) disease status across large, clinically representative “real-world” populations. The estimation of MS disease status using administrative claims can be a challenge, however, due to a lack of detailed clinical information. Retrospective claims analyses in MS have traditionally used rates of MS relapses to approximate disease status. Healthcare costs may be alternate, broader claims-based indicators of disease activity because costs reflect multiple facets of care of patients with MS, and there is a strong correlation between quality of life of patients with MS and costs of the disease. This study developed, tested, and validated a healthcare cost-based measure to serve as an indicator of overall disease status in patients with MS treated with disease-modifying drugs (DMDs) utilizing administrative claims.MethodsUsing IMS Health Real World Data Adjudicated Claims – US data (January 2006–June 2013), a negative binomial regression predicted annual all-cause medical costs. Coefficients reaching statistical significance (p < 0.05) and increasing costs by ≥5% were selected for inclusion into an MS-specific severity score (scale of 0 to 100). Components of the score included rehabilitation services, altered mental state, pain, disability, stiffness, balance disorder, urinary incontinence, numbness, malaise/fatigue, and infections. Coefficient weights represented each predictor’s contribution. The predictive model was derived using 50% of a random sample and tested/validated using the remaining 50%.ResultsAverage overall predicted annual total medical cost was $11,134 (development sample, n = 11,384, vs. $10,528 actual) and $11,303 (validation sample, n = 11,385, vs. $10,620 actual). The model had consistent bias (approximately +$600 or +6% of actual costs) for both samples. In the validation sample, mean MS disease status scores were 0.24, 8.95, and 21.77 for low, medium, and high tertiles, respectively. Mean costs were most accurately predicted among less severe patients ($5243 predicted vs. $5233 actual cost for lowest tertile).ConclusionThe algorithm developed in this study provides an initial step to helping understand and potentially predict cost changes for a commercially insured MS population.

High Prevalence of Antipsychotic Medication Use in Dementia Patients in German Neuropsychiatric Practices

Background The aim of the present study was to examine inpatients as well as patients living at home with respect tothe frequency of antipsychotic medication use and to determine the factors leading to initial use of antipsychotics following dementia diagnosis. Methods This study included patients aged 60 years and over with an initial diagnosis of all-cause dementia (index date) by German psychiatrists in Disease Analyzer database (IMS Health). The main outcome measure was the proportion of patients who initially received an antipsychotic prescription after the index date. Kaplan-Meier analyses were performed for studying time to initiation of antipsychotic therapy as afunction of age and residence in nursing homes. A Cox proportional hazards regression model was used to estimate the relation between the likelihood of therapy initiation and the predefined demographical/clinical variables. Results 14 915 patients with dementia (mean age 80.3 years, 34.7 % male, 53.3 % residents of nursing homes) were included in this study. Within two years after the index date, 47.7 % patients with dementia were treated with antipsychotics. Residing in nursing homes, private insurance status, higher age, private health insurance, exhibiting mental disorders due to known physiological condition, personality and behavioral disorders due to known physiological condition, vascular dementia, and symptoms and signs involving emotional state were positively associated with therapy initiation. Conclusion The prevalence of antipsychotic drug therapy in dementia patients, particularly in nursing homes, is very high. Further studies including qualitative research are required in order to understand and explain the reasons for this prescribing behavior.