Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 245
Filtrar
2.
JAMA Netw Open ; 3(3): e200274, 2020 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-32119095

RESUMO

Importance: Although there are many pharmacologic alternatives to opioids, it is unclear whether the structure of Medicare Part D formularies discourages use of the alternatives. Objectives: To quantify the coverage of opioid alternatives and prevalence of prior authorization, step therapy, quantity limits, and tier placement for these drugs, and test whether these formulary exclusions and restrictions are associated with increased opioid prescribing to older adults at the county level. Design, Setting, and Participants: County fixed-effect models were estimated using a panel of counties across the 50 US states and the District of Columbia over calendar years 2015 and 2016. Data analysis was conducted from July 1 to September 23, 2019. The sample included 2721 counties in 2015 and 2671 counties in 2016 with sufficient data on Medicare Part D formulary design and opioid prescribing. Main Outcomes and Measures: County-level opioid prescribing rate (number of opioid claims divided by the number of overall claims) and counts of excluded opioid alternatives and opioid alternatives with prior authorization, step therapy, quantity limits, and high-tier placements. Results: A total of 30 nonopioid analgesics were examined across 28 997 Medicare plans in 2015 and 30 390 plans in 2016. Medicare plans did not cover a mean of 7% of these drugs (interquartile range, 10%; lower to upper limit, 0%-23%). Among covered nonopioids, prior authorization and step therapy were uncommon, with fewer than 5% affected by prior authorization and 0% by step therapy. However, 13% of covered nonopioids had quantity limits (interquartile range, 10%; lower to upper limit, 0%-31%) and 22% were in high-cost tiers (interquartile range, 38%; lower to upper limit, 0%-50%). Increases in the number of nonopioids excluded on Medicare plans in a county were associated with increased opioid prescribing (effect size relative to mean, 2.2%-3.7%; P = .004). Conversely, increases in the number of opioids not covered on Medicare plans in a county was found to be associated with decreased opioid prescribing (effect size relative to mean, 0.8%-1.5%; P = .02). None of the utilization management strategies (prior authorization, step therapy, and quantity limits) examined or high-cost tier placements of nonopioids were associated with increased opioid prescribing. Conclusions and Relevance: Lack of Medicare coverage for pharmacologic alternatives to opioids may be associated with increased opioid prescribing.

3.
Clin Trials ; : 1740774520907609, 2020 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-32114790

RESUMO

BACKGROUND: Pivotal clinical trials provide critical evidence to regulators regarding a product's suitability for marketing approval. The objectives of this study are (1) to characterize select features of trials for oncology products approved by the U.S. Food and Drug Administration between 2015 and 2017; and (2) to quantify the costs of these trials and how such costs varied based on trial characteristics. METHODS: We identified novel oncology therapeutic drugs, and their respective pivotal trials, approved between 2015 and 2017 using annual summary reports from the Food and Drug Administration. Cost estimates for each pivotal trial were calculated using IQVIA's CostPro, a clinical trial cost estimating tool based on executed contracts between pharmaceutical manufacturers and contract research organizations. Measures of drug and trial characteristics included trial design, end point, patient enrollment, and regulatory pathway. We also performed sensitivity analyses that varied assumptions regarding how efficiently each trial was conducted. RESULTS: A total of 39 pivotal clinical trials provided the basis for Food and Drug Administration approval of 30 new oncology drugs from 2015 to 2017. Among these trials, primary end points were objective response rate in 20 (51.3%), progression-free survival in 13 (33.3%), and overall survival in 6 (15.4%). Twenty trials (51.3%) were single-arm studies. The median estimated cost of oncology pivotal trials was $31.7 million (interquartile range = $17.0-$60.4 million). Trials with objective response rate as primary end point had a median estimate of $17.7 million (interquartile range = $11.9-$27.1 million), compared with trials examining progression-free survival ($42.3 million, interquartile range = $34.6-$101.2 million) or overall survival ($79.4 million, interquartile range = $56.9-$97.7 million) (p < 0.001). Estimated costs for single-arm trials ($17.7 million, interquartile range = $11.9-$23.7 million) were less than for trials with a placebo-controlled ($56.7 million, interquartile range = $40.9-$103.9 million) or active control arm ($67.6 million, IQR = $35.5-$93.5 million) (p < 0.001). CONCLUSIONS: Relative to the estimated costs of drug development, the costs of these oncology pivotal trials were modest, with trials that produced more valuable scientific information costing more than their counterparts.

4.
JAMA Intern Med ; 2020 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-32150237

RESUMO

Importance: It is uncertain whether and when angiotensin-converting enzyme inhibitor (ACE-I) and angiotensin II receptor blocker (ARB) treatment should be discontinued in individuals with low estimated glomerular filtration rate (eGFR). Objective: To investigate the association of ACE-I or ARB therapy discontinuation after eGFR decreases to below 30 mL/min/1.73 m2 with the risk of mortality, major adverse cardiovascular events (MACE), and end-stage kidney disease (ESKD). Design, Setting, and Participants: This retrospective, propensity score-matched cohort study included 3909 patients from an integrated health care system that served rural areas of central and northeastern Pennsylvania. Patients who initiated ACE-I or ARB therapy from January 1, 2004, to December 31, 2018, and had an eGFR decrease to below 30 mL/min/1.73 m2 during therapy were enrolled, with follow-up until January 25, 2019. Exposures: Individuals were classified based on whether they discontinued ACE-I or ARB therapy within 6 months after an eGFR decrease to below 30 mL/min/1.73 m2. Main Outcomes and Measures: The association between ACE-I or ARB therapy discontinuation and mortality during the subsequent 5 years was assessed using multivariable Cox proportional hazards regression models, adjusting for patient characteristics at the time of the eGFR decrease in a propensity score-matched sample. Secondary outcomes included MACE and ESKD. Results: Of the 3909 individuals receiving ACE-I or ARB treatment who experienced an eGFR decrease to below 30 mL/min/1.73 m2 (2406 [61.6%] female; mean [SD] age, 73.7 [12.6] years), 1235 discontinued ACE-I or ARB therapy within 6 months after the eGFR decrease and 2674 did not discontinue therapy. A total of 434 patients (35.1%) who discontinued ACE-I or ARB therapy and 786 (29.4%) who did not discontinue therapy died during a median follow-up of 2.9 years (interquartile range, 1.3-5.0 years). In the propensity score-matched sample of 2410 individuals, ACE-I or ARB therapy discontinuation was associated with a higher risk of mortality (hazard ratio [HR], 1.39; 95% CI, 1.20-1.60]) and MACE (HR, 1.37; 95% CI, 1.20-1.56), but no statistically significant difference in the risk of ESKD was found (HR, 1.19; 95% CI, 0.86-1.65). Conclusions and Relevance: The findings suggest that continuing ACE-I or ARB therapy in patients with declining kidney function may be associated with cardiovascular benefit without excessive harm of ESKD.

6.
Ann Rheum Dis ; 79(2): 285-291, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31672774

RESUMO

OBJECTIVE: To examine whether initiation of interleukin (IL)-17, IL-12/23 or tumour necrosis factor (TNF) inhibitor is associated with an increased risk of serious infection among real-world psoriasis (PsO) or psoriatic arthritis (PsA) patients. METHODS: We assembled a retrospective cohort of commercially insured adults in the USA diagnosed with PsO or PsA between 2015 and 2018. Exposure was dispensation for IL-17 (ixekizumab or secukinumab), IL-12/23 (ustekinumab) or TNF (adalimumab, certolizumab pegol, etanercept, golimumab and infliximab). The outcome was infection requiring hospitalisation after biologic initiation. Incidence rates (IRs) per 100 person-years were computed, and hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression models, adjusted for inverse probability of treatment-weighted propensity scores. RESULTS: A total of 11 560 new treatment episodes were included. Overall, 190 serious infections (2% of treatment episodes) were identified in 9264 person-years of follow-up. Class-specific IRs were similar among IL-17 and TNF, yet significantly lower for IL-12/23. After adjustment for propensity scores, there was no increased risk with IL-17 compared with either TNF (HR=0.89, 95% CI 0.48 to 1.66) or IL-12/23 (HR=1.12, 95% CI 0.62 to 2.03). By contrast, IL-23/23 were associated with a lower risk of infections than TNF (HR=0.59, 95% CI 0.39 to 0.90). CONCLUSIONS: Relative to TNF and IL-17, IL-12/23 inhibitors were associated with a reduced risk of serious infection in biologic-naïve patients with PsO or PsA. In biologic-experienced individuals, there was no difference in infection risk across TNF, IL-17 or IL-12/23 inhibitors.

7.
Pain Med ; 21(2): 308-316, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30865779

RESUMO

OBJECTIVE: To describe current state-level policies in the United States, January 1, 2007-June 1, 2017, limiting high morphine equivalent daily dose (MEDD) prescribing. METHODS: State-level MEDD threshold policies were reviewed using LexisNexis and Westlaw Next for legislative acts and using Google for nonlegislative state-level policies. The websites of each state's Medicaid agency, health department, prescription drug monitoring program, workers' compensation board, medical board, and pharmacy board were reviewed to identify additional policies. The final policy list was checked against existing policy compilations and academic literature and through contact with state health agency representatives. Policies were independently double-coded on the categories: state, agency/organization, policy type, effective date, threshold level, and policy exceptions. RESULTS: Currently, 22 states have at least one type of MEDD policy, most commonly guidelines (14 states), followed by prior authorizations (four states), rules/regulations (four states), legislative acts (three states), claim denials (two states), and alert systems/automatic patient reports (two states). Thresholds range widely (30-300 mg MEDD), with higher thresholds generally corresponding to more restrictive policies (e.g., claim denial) and lower thresholds corresponding to less restrictive policies (e.g., guidelines). The majority of policies exclude some groups of opioid users, most commonly patients with terminal illnesses or acute pain. CONCLUSIONS: MEDD policies have gained popularity in recent years, but considerable variation in threshold levels and policy structure point to a lack of consensus. This work provides a foundation for future evaluation of MEDD policies and may inform states considering adopting such policies.

8.
JAMA Intern Med ; 2019 Dec 30.
Artigo em Inglês | MEDLINE | ID: mdl-31886822

RESUMO

Importance: Extended-release/long-acting (ER/LA) opioids have caused substantial morbidity and mortality in the United States, yet little is known about the efforts of the US Food and Drug Administration (FDA) and drug manufacturers to reduce adverse outcomes associated with inappropriate prescribing or use. This review of 9739 pages of FDA documents obtained through a Freedom of Information Act request aimed to investigate whether the FDA and ER/LA manufacturers were able to assess the effectiveness of the ER/LA Risk Evaluation and Mitigation Strategy (REMS) program by evaluating manufacturer REMS assessments and FDA oversight of these assessments. Observations: The REMS program was implemented largely as planned. The FDA's goal was for 60% of ER/LA prescribers to take REMS-adherent continuing education (CE) between 2012 and 2016; 27.6% (88 316 of 320 000) of prescribers had done so by 2016. Audits of REMS programs indicated close adherence to FDA content guidelines except for financial disclosures. Nonrepresentative cross-sectional surveys of self-selected prescribers suggested modestly greater ER/LA knowledge among CE completers than noncompleters, and claims-based surveillance indicated slowly declining ER/LA prescribing, although the contribution of the REMS to these trends could not be assessed. The effectiveness of the REMS program for reducing adverse outcomes also could not be assessed because the analyses used nonrepresentative samples, lacked adequate controls for confounding, and did not link prescribing or clinical outcomes to prescribers' receipt of CE training. Although the FDA had requested studies tracking adverse outcomes as a function of CE training, the FDA concluded that these studies had not been performed as of the 60-month report in 2017. Conclusions and Relevance: Five years after initiation, the FDA and ER/LA manufacturers could not conclude whether the ER/LA REMS had reduced inappropriate prescribing or improved patient outcomes. Alternative observational study designs would have allowed for more rigorous estimates of the program's effectiveness.

9.
PLoS One ; 14(11): e0225109, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31714946

RESUMO

Despite the importance of pharmacopeial standards, little is known regarding their effect on drug competition. Such information is of particular relevance given the rising costs of prescription drugs and the focus of policy-makers and other stakeholders on addressing these costs. We examined 982 prescription drugs approved by U.S Food and Drug Administration since 1982 to examine the association between U.S. Pharmacopeia (USP) standards, generic entry and prescription costs. The presence of a USP drug product monograph was not associated with the time to the third generic entrant or with the likelihood of having a generic competitor. However, on average, drugs with USP drug product monographs had approximately fifty percent more generic manufacturers in the U.S. than their counterparts after accounting for factors such as market volume, age, route of administration and vintage. This greater competition was associated with an approximate savings of $6.22 billion in 2016, suggesting that USP drug product monographs may play an important role in promoting pharmaceutical competition and reducing prescription drug costs.

11.
Clin J Am Soc Nephrol ; 14(11): 1581-1589, 2019 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-31582462

RESUMO

BACKGROUND AND OBJECTIVES: Most opioids undergo kidney excretion. The goal of this study was to evaluate opioid-associated risks of death and hospitalization across the range of eGFR. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The study population included adult primary care patients in Geisinger Health (Danville, PA) between 2008 and 2017. People receiving their first opioid prescription were propensity matched to people receiving NSAIDS (and, in sensitivity analysis, gabapentinoids) and the risk of death and hospitalization were compared, classifying opioid medication exposure as time-varying daily oral morphine milligram equivalents (MMEs) across time-varying eGFR. RESULTS: The propensity-matched cohort included 46,246 patients prescribed either opioids or NSAIDs between 2008 and 2017 (mean [SD] age, 54 [16] years; 56% female; 3% of black race). Prescriptions for 1-59 and ≥60 MMEs were associated with higher risk of death (HR, 1.70; 95% CI, 1.41 to 2.05 for 1-59 MMEs; HR, 2.25; 95% CI, 1.82 to 2.79 for ≥60 MMEs) and hospitalization (HR, 1.38; 95% CI, 1.30 to 1.46 for 1-59 MMEs; HR, 1.68; 95% CI, 1.56 to 1.81 for ≥60 MMEs) compared with NSAID prescriptions, when evaluated at eGFR 80 ml/min per 1.73 m2. The relative risk of death associated with ≥60 MMEs was higher at lower GFR (e.g., eGFR, 40 ml/min per 1.73 m2; HR, 3.94; 95% CI, 2.70 to 5.75; P for interaction, 0.01). When gabapentinoids were used as the comparison medication, only ≥60 MMEs were significantly associated with higher risk of death (HR, 2.72; 95% CI, 1.71 to 4.34), although both 1-59 and ≥60 MMEs were associated with risk of hospitalization (HR, 1.22; 95% CI, 1.04 to 1.43 for 1-59 MMEs; HR, 1.54; 95% CI, 1.28 to 1.86 for ≥60 MMEs). CONCLUSIONS: The receipt of prescription opioids was associated with a higher risk of death and hospitalization compared with other pain medications, particularly with higher doses and at lower eGFR.

12.
Mayo Clin Proc ; 94(11): 2220-2229, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31619367

RESUMO

OBJECTIVE: To assess the patterns of angiotensin converting enzyme inhibitors and angiotensin receptor blockers (ACE-I/ARB) discontinuation in the setting of chronic kidney disease (CKD) progression in real-world clinical practice. PATIENTS AND METHODS: We identified incident ACE-I/ARB users with a baseline estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73 m2 and without end-stage renal disease in the Geisinger Health System between January 1, 2004, and December 31, 2015. We investigated the associations of CKD stage, hospitalizations with and without acute kidney injury (AKI), serum potassium, bicarbonate level, thiazide, and loop diuretic use with ACE-I/ARB discontinuation. RESULTS: Among the 53,912 ACE-I/ARB users, the mean age was 59.9 years, and 50.6% were female. More than half of users discontinued ACE-I/ARB within 5 years of therapy initiation. The risk of ACE-I/ARB discontinuation increased with more advanced CKD stage. For example, patients who initiated ACE-I/ARB with CKD stage G4 (eGFR: 15-29 mL/min/1.73 m2) were 2.09-fold (95% CI, 1.87-2.34) more likely to discontinue therapy than those with eGFR ≥ 90 mL/min/1.73 m2. Potassium level greater than 5.3 mEq/L, systolic blood pressure ≤ 90 mm Hg, bicarbonate level < 22 mmol/L, and intervening hospitalization-particularly AKI-related-were also strong risk factors for ACE-I/ARB discontinuation. Thiazide diuretic use was associated with lower risk, whereas loop diuretic use was associated with higher risk of discontinuation. CONCLUSION: In a real-world cohort, discontinuation of ACE-I/ARB was common, particularly in patients with lower eGFR. Hyperkalemia, hypotension, low bicarbonate level, and hospitalization (AKI-related, in particular) were associated with a higher risk of ACE-I/ARB discontinuation. Additional studies are needed to evaluate the risk-benefit balance of discontinuing ACE-I/ARB in the setting of CKD progression.


Assuntos
Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Adesão à Medicação , Insuficiência Renal Crônica/tratamento farmacológico , Idoso , Antagonistas de Receptores de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Progressão da Doença , Feminino , Taxa de Filtração Glomerular , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/fisiopatologia , Fatores de Risco
13.
Am J Health Syst Pharm ; 76(18): 1403-1412, 2019 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-31505561

RESUMO

PURPOSE: Millions of Americans who undergo surgical procedures receive opioid prescriptions as they return home. While some derive great benefit from these medicines, others experience adverse events, convert to chronic opioid use, or have unused medicines that serve as a reservoir for potential nonmedical use. Our aim was to investigate concepts and methods relevant to optimal opioid prescribing and pain treatment in the perioperative period. METHODS: We reviewed existing literature for trials on factors that influence opioid prescribing and optimization of pain treatment for surgical procedures and generated a conceptual framework to guide future quality, safety, and research efforts. RESULTS: Opioid prescribing and pain treatment after discharge from surgery broadly consist of 3 key interacting perspectives, including those of the patient, the perioperative team, and, serving in an essential role for all patients, the pharmacist. Systems-based factors, ranging from the organizational environment's ability to provide multimodal analgesia and participation in enhanced recovery after surgery programs to other healthcare system and macro-level trends, shape these interactions and influence opioid-related safety outcomes. CONCLUSIONS: The severity and persistence of the opioid crisis underscore the urgent need for interventions to improve postoperative prescription opioid use in the United States. Such interventions are likely to be most effective, with the fewest unintended consequences, if based on sound evidence and built on multidisciplinary efforts that include pharmacists, nurses, surgeons, anesthesiologists, and the patient. Future studies have the potential to identify the optimal amount to prescribe, improve patient-focused safety and quality outcomes, and help curb the oversupply of opioids that contributes to the most pressing public health crisis of our time.


Assuntos
Analgésicos Opioides/uso terapêutico , Prescrições de Medicamentos/normas , Manejo da Dor/métodos , Dor Pós-Operatória/tratamento farmacológico , Procedimentos Cirúrgicos Operatórios/efeitos adversos , /normas , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Humanos , Conduta do Tratamento Medicamentoso/organização & administração , Conduta do Tratamento Medicamentoso/normas , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/etiologia , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Manejo da Dor/normas , Dor Pós-Operatória/etiologia , Equipe de Assistência ao Paciente/organização & administração , Equipe de Assistência ao Paciente/normas , Alta do Paciente , Segurança do Paciente , Assistência Perioperatória/métodos , Assistência Perioperatória/normas , Farmacêuticos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Estados Unidos/epidemiologia
14.
Med Care ; 57(9): 667-672, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31404013

RESUMO

BACKGROUND: Although buprenorphine is an evidence-based treatment for opioid use disorder (OUD), it is unknown whether buprenorphine use may affect patients' adherence to treatments for chronic, unrelated conditions. OBJECTIVES: To quantify the effect of buprenorphine treatment on patient adherence to 5 therapeutic classes: (1) antilipids; (2) antipsychotics; (3) antiepileptics; (4) antidiabetics; and (5) antidepressants. RESEARCH DESIGN: This was a retrospective cohort study. SUBJECTS: We started with 12,719 commercially ensured individuals with a diagnosis of OUD and the buprenorphine initiation between January 2011 and June 2015 using Truven Health's MarketScan data. Individuals using any of the 5 therapeutic classes of interest were included. MEASURES: Within the 180-day period post buprenorphine initiation, we derived 2 daily indicators: having buprenorphine and having chronic medication on hand for each therapeutic class of interest. We applied logistic regression to assess the association between these 2 daily indicators, adjusting for demographics, morbidity, and baseline adherence. RESULTS: Across the 5 therapeutic classes, the probability with a given treatment on hand was always higher on days when buprenorphine was on hand. After adjustment for demographics, morbidity, and baseline adherence, buprenorphine was associated with a greater odds of adherence to antilipids [odds ratio (OR), 1.27; 95% confidence interval (CI), 1.04-1.54], antiepileptics (OR, 1.22; CI, 1.10-1.36) and antidepressants (OR, 1.42; CI, 1.32-1.60). CONCLUSIONS: Using buprenorphine to treat OUD may increase adherence to treatments for chronic unrelated conditions, a finding of particular importance given high rates of mental illness and other comorbidities among many individuals with OUD.


Assuntos
Analgésicos Opioides/uso terapêutico , Buprenorfina/uso terapêutico , Doença Crônica/psicologia , Adesão à Medicação/psicologia , Tratamento de Substituição de Opiáceos/psicologia , Transtornos Relacionados ao Uso de Opioides/psicologia , Adulto , Doença Crônica/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Estudos Retrospectivos
15.
Health Serv Res ; 54(5): 1045-1054, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31372990

RESUMO

OBJECTIVE: To estimate the impact of implementing prescription drug monitoring program (PDMP) best practices on prescription opioid use. DATA SOURCES: 2007-2012 Medicare claims for noncancer pain patients, and PDMP attributes from the Prescription Drug Abuse Policy System. STUDY DESIGN: We derived PDMP composite scores using the number of best practices adopted by states (range: 0-14), classifying states as either no PDMP, low strength (0 < score < median), or high strength (score ≥ median). Using generalized linear models, we quantified the association between the PDMP score category and opioid use measures-overall and stratified by disability/age. Sensitivity analyses assessed the general Medicare sample regardless of pain diagnoses, individual PDMP characteristics, and compared GEE model findings to models with state fixed effects. PRINCIPAL FINDINGS: Compared to non-PDMP states, strong PDMP states had lower opioid cumulative doses (-296 mg; 95% CI: -512, -132), days supplied (-7.84; 95% CI: -10.6, -5.04), prescription fill rates (0.97; 95% CI: 0.95, 0.98), and mean daily doses (-2.31 mg; 95% CI: -3.14, -1.48) but greater prevalence of high opioid doses in disabled adults, whereas there was little or no change in older adults. Findings in states with weak PDMPs were substantively similar to those of strong PDMPs. Results from sensitivity analyses were mostly consistent with main findings except there was a null relationship with mean daily doses and high doses in models with state fixed effects. CONCLUSIONS: Comprehensive or minimal adoption of PDMP best practices was associated with mostly comparable effects on Medicare beneficiaries' opioid use; however, these effects were concentrated among nonelderly disabled adults.


Assuntos
Analgésicos Opioides/normas , Analgésicos Opioides/uso terapêutico , Uso de Medicamentos/estatística & dados numéricos , Medicare/estatística & dados numéricos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Dor/tratamento farmacológico , Guias de Prática Clínica como Assunto , Programas de Monitoramento de Prescrição de Medicamentos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Estados Unidos
17.
JAMA Netw Open ; 2(6): e195388, 2019 06 05.
Artigo em Inglês | MEDLINE | ID: mdl-31173125

RESUMO

Importance: Despite the increasingly important role of pharmacies in the implementation of naloxone access laws, there is limited information on the impact of such laws at the local level. Objective: To evaluate the availability (with or without a prescription) and cost of naloxone nasal spray at pharmacies in Philadelphia, Pennsylvania, following a statewide standing order enacted in Pennsylvania in August 2015 to allow pharmacies to dispense naloxone without a prescription. Design, Setting, and Participants: A survey study was conducted by telephone of all pharmacies in Philadelphia between February and August 2017. Pharmacies were geocoded and linked with the American Community Survey (2011-2015) to obtain information on the demographic characteristics of census tracts and the Medical Examiner's Office of the Philadelphia Department of Public Health to derive information on the number of opioid overdose deaths per 100 000 people for each planning district. Data were analyzed from March 2018 to February 2019. Main Outcomes and Measures: Availability and out-of-pocket cost of naloxone nasal spray (with or without a prescription) at Philadelphia pharmacies overall and by pharmacy and neighborhood characteristics. Results: Of 454 eligible pharmacies, 418 were surveyed (92.1% response rate). One in 3 pharmacies (34.2%) had naloxone nasal spray in stock; of these, 61.5% indicated it was available without a prescription. There were significant differences in the availability of naloxone by pharmacy type and neighborhood characteristics. Naloxone was both more likely to be in stock (45.9% vs 27.8%; difference, 18.0%; 95% CI, 8.3%-27.8%; P < .001) and available without a prescription (80.6% vs 42.2%; difference, 38.4%; 95% CI, 23.0%-53.8%; P < .001) in chain stores than in independent stores. Naloxone was also less likely to be available in planning districts with very elevated rates of opioid overdose death (≥50 per 100 000 people) compared with those with lower rates (31.1% vs 38.5%). The median (interquartile range) out-of-pocket cost among pharmacies offering naloxone without a prescription was $145 ($119-$150); costs were greatest in independent pharmacies and planning districts with elevated rates of opioid overdose death. Conclusions and Relevance: Despite the implementation of a statewide standing order in Pennsylvania more than 3 years prior to this study, only one-third of Philadelphia pharmacies carried naloxone nasal spray and many also required a physician's prescription. Efforts to strengthen the implementation of naloxone access laws and better ensure naloxone supply at local pharmacies are warranted, especially in localities with the highest rates of overdose death.


Assuntos
Naloxona/administração & dosagem , Antagonistas de Entorpecentes/administração & dosagem , Farmácias/estatística & dados numéricos , Administração por Inalação , Honorários Farmacêuticos , Gastos em Saúde/estatística & dados numéricos , Humanos , Naloxona/economia , Naloxona/provisão & distribução , Antagonistas de Entorpecentes/economia , Antagonistas de Entorpecentes/provisão & distribução , Sprays Nasais , Medicamentos sem Prescrição/administração & dosagem , Medicamentos sem Prescrição/economia , Medicamentos sem Prescrição/provisão & distribução , Transtornos Relacionados ao Uso de Opioides/economia , Transtornos Relacionados ao Uso de Opioides/reabilitação , Farmácias/economia , Philadelphia , Medicamentos sob Prescrição/administração & dosagem , Medicamentos sob Prescrição/economia , Medicamentos sob Prescrição/provisão & distribução
18.
Prev Med ; 126: 105744, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31173803

RESUMO

There was an increase in the number and coverage of state and local clean indoor air laws in the US during the past fifteen years. These laws coincided with increases in federal, state, and local cigarette excise taxes. In light of these changes, the objective of this study was to examine the association between clean indoor air laws, cigarette excise taxes and smoking patterns between 2003 and 2011. Using data on 62,165 adult participants in the 2003 and 2010/2011 Current Population Survey-Tobacco Use Supplement who reported smoking cigarettes in the past year, we examined the association of state and county workplace, bar, and restaurant clean indoor air laws and cigarette excise taxes with quitting and current every-day smoking. Between 2003 and 2011, quitting increased and daily smoking among those who continued to smoke decreased significantly. Participants living in states and counties with higher excise taxes and more comprehensive clean indoor air laws had a higher likelihood of quitting and lower likelihood of everyday smoking. Based on the assumption of no uncontrolled confounding, changes in taxes and laws accounted for 64.8% of the increase in smoking cessation and all of the reduction in everyday smoking. Implementation of state and county-level clean indoor air laws and cigarette taxes appears to have achieved the intended goal of encouraging smokers to either quit or reduce their frequency of smoking.

19.
Am J Surg ; 218(5): 818-827, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31023548

RESUMO

BACKGROUND: The consequences of opioids-including post-surgical prescriptions-remain a critical public health issue. We sought to determine how procedure type and subspecialty group influence new opioid use after procedures. METHODS: We analyzed 2011-2015 IBM MarketScan Research Databases to identify opioid-naïve adults prescribed opioids for single surgical procedures. We defined new opioid continuation (primary outcome) a priori as receipt of prescription opioids between 90 and 180 days after the procedure. RESULTS: Among 912,882 individuals, new opioid continuation was higher for non-operating room compared to operating room procedures (13.1% versus 9.2%; aOR 1.61; 95% CI 1.59-1.64) and higher for subspecialties including colorectal surgery (aOR 1.35; 95% CI 1.26-1.43) and cardiovascular surgery (aOR 1.30; 95% CI 1.12-1.50) compared to urology as a referent. New opioid continuation was also associated with perioperative opioid prescription dosage, days' supply, preoperative receipt, and multiple prescriptions. CONCLUSIONS: Opioids prescriptions associated with non-operating room surgical exposures appear to confer higher risk regarding conversion to new long-term opioid use.

20.
JAMA Netw Open ; 2(4): e192606, 2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-31002324

RESUMO

Importance: It is unknown whether and how pharmacy closures alter medication adherence. Objective: To examine the association between pharmacy closures and adherence to statins, ß-blockers, and oral anticoagulants among adults 50 years or older in the United States. Design, Setting, and Participants: In this retrospective cohort study, comparative interrupted time series analyses were performed using a nationally representative 5% random sample of anonymized, longitudinal, individual-level pharmacy claims from IQVIA LRx LifeLink. Analyses included all prescription claims for individuals followed up between January 1, 2011, and December 31, 2016. Separate cohorts were derived for users of statins, ß-blockers, and oral anticoagulants. The differential association of pharmacy closure was examined as a function of baseline adherence, pharmacy, and individual characteristics. Main Outcomes and Measures: Difference in monthly adherence, measured as proportion of days covered, during 12-month baseline and follow-up periods among patients using a pharmacy that subsequently closed (closure cohort) compared with their counterparts (control cohort). Results: Among 3 089 803 individuals filling at least 1 statin prescription between January 1, 2011, and December 31, 2016 (mean [SD] age, 66.3 [9.3] years; 52.0% female), 3.0% (n = 92 287) filled at a pharmacy that subsequently closed. Before closure, monthly adherence was similar in the closure and control cohorts (mean [SD], 70.5% [26.7%] vs 70.7% [26.5%]). In multivariable models, individuals filling at pharmacies that closed experienced an immediate and significant decline (on average, an absolute change of -5.90%; 95% CI, -6.12% to -5.69%) in statin adherence during the first 3 months after closure compared with their counterparts. This difference persisted over 12 months of follow-up. A similar decline in adherence was observed when examining cohorts using ß-blockers (-5.71%; 95% CI, -5.96% to -5.46%) or oral anticoagulants (-5.63%; 95% CI, -6.24% to -5.01%). The mean association of pharmacy closure with adherence was greater among individuals using independent pharmacies (-7.89%; 95% CI, -8.32% to -7.47%) or living in neighborhoods with fewer pharmacies (-7.98%; 95% CI, -8.50% to -7.47%) compared with their counterparts. Conclusions and Relevance: Pharmacy closures are associated with persistent, clinically significant declines in adherence to cardiovascular medications among older adults in the United States. Efforts to reduce nonadherence to prescription medications should consider the role of pharmacy closures, especially among patients at highest risk.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Doenças Cardiovasculares/tratamento farmacológico , Acesso aos Serviços de Saúde/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos , Farmácias/provisão & distribução , Idoso , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Análise de Séries Temporais Interrompida , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA