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1.
JAMA Dermatol ; 160(5): 535-543, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38568616

ABSTRACT

Importance: Dermatologists prescribe more oral antibiotics per clinician than clinicians in any other specialty. Despite clinical guidelines that recommend limitation of long-term oral antibiotic treatments for acne to less than 3 months, there is little evidence to guide the design and implementation of an antibiotic stewardship program in clinical practice. Objective: To identify salient barriers and facilitators to long-term antibiotic prescriptions for acne treatment. Design, Setting, and Participants: This qualitative study assessed data collected from stakeholders (including dermatologists, infectious disease physicians, dermatology resident physicians, and nonphysician clinicians) via an online survey and semistructured video interviews between March and August 2021. Data analyses were performed from August 12, 2021, to January 20, 2024. Main Outcomes and Measures: Online survey and qualitative video interviews developed with the Theoretical Domains Framework. Thematic analyses were used to identify salient themes on barriers and facilitators to long-term antibiotic prescriptions for acne treatment. Results: Among 30 participants (14 [47%] males and 16 [53%] females) who completed the study requirements and were included in the analysis, knowledge of antibiotic guideline recommendations was high and antibiotic stewardship was believed to be a professional responsibility. Five salient themes were to be affecting long-term antibiotic prescriptions: perceived lack of evidence to justify change in dermatologic practice, difficulty navigating patient demands and satisfaction, discomfort with discussing contraception, iPLEDGE-related barriers, and the absence of an effective system to measure progress on antibiotic stewardship. Conclusions and Relevance: The findings of this qualitative study indicate that multiple salient factors affect long-term antibiotic prescribing practices for acne treatment. These factors should be considered in the design and implementation of any future outpatient antibiotic stewardship program for clinical dermatology.


Subject(s)
Acne Vulgaris , Anti-Bacterial Agents , Antimicrobial Stewardship , Practice Patterns, Physicians' , Humans , Acne Vulgaris/drug therapy , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Female , Male , Practice Patterns, Physicians'/statistics & numerical data , Practice Patterns, Physicians'/standards , Adult , Qualitative Research , Dermatologists/statistics & numerical data , Drug Prescriptions/statistics & numerical data , Drug Prescriptions/standards , Practice Guidelines as Topic , Surveys and Questionnaires , Time Factors
2.
J Am Coll Surg ; 238(6): 1001-1010, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38525970

ABSTRACT

BACKGROUND: Many institutions have developed operation-specific guidelines for opioid prescribing. These guidelines rarely incorporate in-hospital opioid consumption, which is highly correlated with consumption. We compare outcomes of several patient-centered approaches to prescribing that are derived from in-hospital consumption, including several experimental, rule-based prescribing guidelines and our current institutional guideline. STUDY DESIGN: We performed a retrospective, cohort study of all adults undergoing surgery at a single-academic medical center. Several rule-based guidelines, derived from in-hospital consumption (quantity of opioids consumed within 24 hours of discharge), were used to specify the theoretical quantity of opioid prescribed on discharge. The efficacy of the experimental guidelines was compared with 3 references: an approximation of our institution's tailored prescribing guideline; prescribing all patients the typical quantity of opioids consumed for patients undergoing the same operation; and a representative rule-based, tiered framework. For each scenario, we calculated the penalized residual sum of squares (reflecting the composite deviation from actual patient consumption, with 15% penalty for overprescribing) and the proportion of opioids consumed relative to prescribed. RESULTS: A total of 1,048 patients met inclusion criteria. Mean (SD) and median (interquartile range [IQR]) quantity of opioids consumed within 24 hours of discharge were 11.2 (26.9) morphine milligram equivalents and 0 (0 to 15) morphine milligram equivalents. Median (IQR) postdischarge consumption was 16 (0 to 150) morphine milligram equivalents. Our institutional guideline and the previously validated rule-based guideline outperform alternate approaches, with median (IQR) differences in prescribed vs consumed opioids of 0 (-60 to 27.25) and 37.5 (-37.5 to 37.5), respectively, corresponding to penalized residual sum of squares of 39,817,602 and 38,336,895, respectively. CONCLUSIONS: Rather than relying on fixed quantities for defined operations, rule-based guidelines offer a simple yet effective method for tailoring opioid prescribing to in-hospital consumption.


Subject(s)
Analgesics, Opioid , Pain, Postoperative , Patient Discharge , Practice Guidelines as Topic , Practice Patterns, Physicians' , Humans , Analgesics, Opioid/therapeutic use , Pain, Postoperative/drug therapy , Retrospective Studies , Female , Male , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data , Practice Patterns, Physicians'/standards , Adult , Drug Prescriptions/statistics & numerical data , Drug Prescriptions/standards , Aged
3.
JAMA Intern Med ; 184(5): 510-518, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38466269

ABSTRACT

Importance: Although the intention of the 2016 US Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain was not to limit pain treatment for patients with sickle cell disease (SCD), clinicians and patients have recognized the possibility that the guideline may have altered outcomes for this population. However, the outcomes of the 2016 guideline for this patient population are unknown. Objective: To examine changes in opioid prescribing patterns and health outcomes among patients with SCD before and after the release of the 2016 CDC guideline. Design, Setting, and Participants: This retrospective cohort study conducted interrupted time series analysis of claims data from the Merative MarketScan Commercial Database from January 1, 2011, to December 31, 2019. In this population-based study in the US, individuals with SCD who were at least 1 year of age, had no cancer diagnosis, and had pharmacy coverage for the month of measurement were included. The data were analyzed from January 2021 to November 2023. Exposure: The CDC Guideline for Prescribing Opioids for Chronic Pain released in March 2016. Main Outcomes and Measures: The main variables measured in this study included the practice of opioid prescribing among patients with SCD (ie, rate of opioid prescriptions dispensed, mean number of days supplied, mean total morphine milligram equivalents [MME] per patient, and mean daily MME per opioid prescription) and pain-related health outcomes (rates of emergency department visits related to vaso-occlusive crises [VOC] and hospitalizations related to VOC). Results: The cohort included 14 979 patients with SCD (mean [SD] age, 25.9 [16.9] years; 8520 [56.9%] female). Compared with the preguideline trends, the following changes were observed after the guideline was released: significant decreases in the coefficient for change in slope of the opioid dispensing rate (-0.29 [95% CI, -0.39 to -0.20] prescriptions per 100 person-month; P < .001), the number of days supplied per prescription (-0.05 [95% CI, -0.06 to -0.04] days per prescription-month; P < .001), and opioid dosage (-141.0 [95% CI, -219.5 to -62.5] MME per person-month; P = .001; -10.1 [95% CI, -14.6 to -5.6] MME/prescription-month; P < .001). Conversely, a significant increase in VOC-related hospitalizations occurred after the guideline release (0.16 [95% CI, 0.07-0.25] hospitalizations per 100 person-month; P = .001). These changes were observed to a greater extent among adult patients, but pediatric patients experienced similar changes in several measures, even though the guideline focused exclusively on adult patients. Conclusions and Relevance: This retrospective cohort study showed that the 2016 CDC guideline may have had unintended negative outcomes on the patient population living with SCD.


Subject(s)
Analgesics, Opioid , Anemia, Sickle Cell , Centers for Disease Control and Prevention, U.S. , Chronic Pain , Practice Patterns, Physicians' , Humans , Anemia, Sickle Cell/complications , Anemia, Sickle Cell/drug therapy , Analgesics, Opioid/therapeutic use , Female , Male , United States , Adult , Retrospective Studies , Chronic Pain/drug therapy , Practice Patterns, Physicians'/statistics & numerical data , Practice Guidelines as Topic , Adolescent , Young Adult , Middle Aged , Drug Prescriptions/statistics & numerical data , Drug Prescriptions/standards , Child , Pain Management/methods
4.
Br J Clin Pharmacol ; 90(5): 1333-1343, 2024 May.
Article in English | MEDLINE | ID: mdl-38403473

ABSTRACT

AIMS: The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day. METHODS: An a priori descriptive analysis was carried out by using the risk matrix approach. After defining the scope in a multidisciplinary meeting, we determined at each step the failure modes (FMs), their effects (E) and their associated causes (C). A severity score (S) was assigned to all effects and a probability of occurrence (O) to all causes. These S and O indicators, were used to obtain a criticality index (CI) matrix. We assessed the risk control (RC) of each failure in order to define a residual criticality index (rCI) matrix. RESULTS: During risk analysis, 14 FMs were detected, and 61 scenarios were identified considering all possible effects and causes. Nine situations (15%) were highlighted with the maximum CI, 18 (30%) with a medium CI, and 34 (55%) with a negligible CI. Nevertheless, among all these critical situations, only three (5%) had an rCI to process (i.e., missed dose adjustment, multiple prescriptions and abnormal biology data); the others required monitoring only. Clinicians' and pharmacists' knowledge of these critical situations enables them to manage the associated risks. CONCLUSIONS: Advanced prescription of injectable anticancer drugs appears to be a safe practice for patients when combined with risk management. The major risks identified concerned missed dose adjustment, prescription duplication and lack of consideration for abnormal biology data.


Subject(s)
Antineoplastic Agents , Humans , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Risk Assessment , Medication Errors/prevention & control , Medication Errors/statistics & numerical data , Neoplasms/drug therapy , Drug Prescriptions/statistics & numerical data , Drug Prescriptions/standards , Injections , Cancer Care Facilities/statistics & numerical data , Cancer Care Facilities/organization & administration , Healthcare Failure Mode and Effect Analysis , Adult
6.
Rev. esp. quimioter ; 36(5): 470-476, oct. 2023. tab
Article in Spanish | IBECS | ID: ibc-225882

ABSTRACT

Introducción. En 2019, el Comité Europeo para el estudio de la sensibilidad antibiótica modificó las categorías de los test de sensibilidad antibiótica incluyendo el término “sensible con exposición incrementada”. Tras la difusión de protocolos locales recogiendo estas modificaciones, el objetivo de nuestro estudio fue analizar si los prescriptores se han adecuado a los mismos y el posible impacto clínico en los casos de inadecuación. Material y métodos. Estudio observacional y retrospecti vo de los pacientes con infección por pseudomonas aeruginosa y que hayan recibido antibiótico antipseudomónico desde ene ro a octubre de 2021 en un hospital terciario. Resultados. La inadecuación a las recomendaciones de la guía fueron un 57,6% en planta y un 40,4% en UCI (p<0,05). Tanto en planta como en UCI el grupo con más prescripción no ajustada a las recomendaciones de la guía fueron los amino glucósidos (92,9% y 64,9% respectivamente) por utilizar dosis subóptimas, seguido de los carbapenémicos (89,1% y 53,7% respectivamente) por no administrarlo en perfusión extendida. En planta, la tasa de mortalidad durante el ingreso o a los 30 días en el grupo de terapia inadecuada fue de 23,3% vs 11,5% en los que recibieron los tratamientos de forma adecuada (OR: 2,34; IC 95% 1,14-4,82); en UCI no hubo diferencias estadísti camente significativas. Conclusiones. Los resultados muestran la necesidad de implementar medidas para garantizar una mejor difusión y co nocimiento de los conceptos claves en el manejo de los antibió ticos, con el objetivo de garantizar exposiciones incrementadas y poder ofrecer una mejor cobertura de la infección, así como de evitar la amplificación de cepas resistente (AU)


Introduction. In 2019, the European Committee for the Study of Antibiotic Susceptibility modified the categories of antibiotic susceptibility tests to include the term “susceptible with increased exposure”. Following the dissemination of local protocols reflecting these modifications, the aim of our study was to analyse whether prescribers have adapted to them and the clinical impact in cases of inadequacy. Material and methods. Observational and retrospective study of patients with infection who received antipseudomonal antibiotics from January to October 2021 in a tertiary hospital.Results. Non adherence to the guideline recommendations was 57.6% in the ward and 40.4% in the ICU (p<0.05). In both the ward and ICU, the group with the most prescriptions not by the guideline ecommendations were aminoglycosides (92.9% and 64.9% respectively) for using suboptimal doses, followed by carbapenems (89.1% and 53.7% respectively) for not administering an extended infusion. On the ward, the mortality rate during admission or at 30 days in the inadequate therapy group was 23.3% vs 11.5% in those who received adequate treatment (OR: 2.34; 95% CI 1.14-4.82); in ICU there were no statistically significant differences.Conclusions. The results show the need to implement measures to ensure better dissemination and knowledge of key concepts in antibiotic management, to ensure increased exposures, and to be able to provide better infection coverage, as well as to avoid amplifying resistant strains (AU)


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , Drug Resistance, Bacterial , Anti-Bacterial Agents/administration & dosage , Pseudomonas aeruginosa/drug effects , Pseudomonas Infections/drug therapy , Drug Prescriptions/standards , Professional Staff Committees , Retrospective Studies
7.
J Surg Oncol ; 128(8): 1235-1242, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37653689

ABSTRACT

BACKGROUND: The lack of evidence-based guidelines for postoperative opioid prescriptions following breast reconstruction contributes to a wide variation in prescribing practices and increases potential for misuse and abuse. METHODS: Between August and December 2019, women who underwent outpatient breast reconstruction were surveyed 7-10 days before (n = 97) and after (n = 101) implementing a standardized opioid prescription reduction initiative. We compared postoperative opioid use, pain control, and refills in both groups. Patient reported outcomes were compared using the BREAST-Q physical wellbeing of the chest domain and a novel symptom Recovery Tracker. RESULTS: Before changes in prescriptions, patients were prescribed a median of 30 pills and consumed three pills (interquartile range [IQR: 1,9]). After standardization, patients were prescribed eight pills and consumed three pills (IQR: 1,6). There was no evidence of a difference in the proportion of patients experiencing moderate to very severe pain on the Recovery Tracker or in the early BREAST-Q physical wellbeing of the chest scores (p = 0.8 and 0.3, respectively). CONCLUSION: Standardizing and reducing opioid prescriptions for patients undergoing reconstructive breast surgery is feasible and can significantly decrease the number of excess pills prescribed. The was no adverse impact on early physical wellbeing, although larger studies are needed to obtain further data.


Subject(s)
Analgesics, Opioid , Mammaplasty , Pain, Postoperative , Plastic Surgery Procedures , Female , Humans , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/adverse effects , Mammaplasty/adverse effects , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control , Pain, Postoperative/diagnosis , Plastic Surgery Procedures/adverse effects , Practice Patterns, Physicians' , Drug Prescriptions/standards , Drug Prescriptions/statistics & numerical data
8.
J Pain Symptom Manage ; 66(3): e431-e435, 2023 09.
Article in English | MEDLINE | ID: mdl-37356595

ABSTRACT

Pain is one of the most common symptoms experienced by patients living with cancer. Guidelines recommend opioids as the mainstay in the management of cancer-related pain. However, the opioid epidemic has resulted in policymakers recommending limitations on opioid prescribing which led to community pharmacies implementing various parameters. These restrictions have created barriers for patients with cancer-related pain attempting to fill opioid prescriptions from their community pharmacies. Additionally, in the setting of the opioid epidemic, there have been reports of systemic bias within community pharmacies, leading to experiences with embarrassment and shame for patients with cancer-related pain. This case series presents specific examples of community pharmacies declining to fill opioid prescriptions for patients with cancer-related pain and associated patient suffering.


Subject(s)
Analgesics, Opioid , Cancer Pain , Drug Prescriptions , Pharmacies , Pharmacy , Adult , Female , Humans , Male , Middle Aged , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/therapeutic use , Bias , Cancer Pain/drug therapy , Cancer Pain/psychology , Drug Prescriptions/standards , Drug Prescriptions/statistics & numerical data , Embarrassment , Opioid Epidemic/prevention & control , Pain , Pharmacists , Shame , Pharmacy/methods
9.
Brain Nerve ; 75(5): 658-662, 2023 May.
Article in Japanese | MEDLINE | ID: mdl-37194547

ABSTRACT

Older adults are likely to develop adverse drug events owing to age-related changes in pharmacokinetics and polypharmacy. In terms of pharmacokinetics, the drug should be prescribed at a reduced dose, which should be reconsidered and reduced during long-term use. For polypharmacy, "List of drugs to be prescribed with special caution" should be referred and deprescription should be practiced in consideration of the priority of treatment. Because older adults often show reduced ability to manage their medication due to cognitive dysfunction, low visual acuity, and hearing loss, measures should be taken to maintain their adherence.


Subject(s)
Drug Prescriptions , Drug-Related Side Effects and Adverse Reactions , Polypharmacy , Aged , Aged, 80 and over , Humans , Polypharmacy/prevention & control , Drug Prescriptions/standards , Cognitive Dysfunction/psychology , Visually Impaired Persons/psychology , Vision, Low/psychology , Hearing Loss/psychology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Off-Label Use , Age Factors
10.
Rev. ADM ; 80(1): 49-51, ene.-feb. 2023.
Article in Spanish | LILACS | ID: biblio-1512273

ABSTRACT

La receta médica es la materialización del acto médico a través de la cual el profesional de la salud prescribe a su paciente los fármacos necesarios para aliviar su enfermedad. Existen numerosas sustancias o fármacos que, por sus efectos, no pueden ser ofrecidas al público en general si no es mediante la expedición de una receta médica; por tanto, existen numerosas legislaciones y normas que regulan la prescripción médica con el objetivo de tener un control sobre los fármacos prescritos. A su vez, la receta médica debe tener una estructura específica, misma que está establecida por numerosas leyes y reglamentos sanitarios y que interesantemente es ignorada por múltiples médicos u odontólogos. El objetivo del presente artículo es definir el concepto de prescripción médica, así como indagar en todas las leyes y normas vigentes que regulan la prescripción médica en México (AU)


The medical prescription is the materialization of the medical act through which the health professional prescribes to his patient the necessary drugs to alleviate his illness There are numerous substances or drugs that, due to their effects, cannot be offered to the general public, except through the issuance of a medical prescription, and therefore, there are numerous laws that regulate the medical prescription with the aim of having control over prescribed drugs. In turn, the medical prescription must have a specific structure, which is established by numerous health laws and regulations, and which, interestingly enough, is ignored by many doctors and dentists. The aim of this article is to define the concept of medical prescription as well as to investigate all the current laws and regulations that regulate the medical prescription in Mexico (AU)


Subject(s)
Humans , Drug Prescriptions/standards , Forensic Dentistry/legislation & jurisprudence , Legislation, Dental , Mexico
12.
J Perinat Med ; 51(4): 546-549, 2023 May 25.
Article in English | MEDLINE | ID: mdl-36420538

ABSTRACT

OBJECTIVES: To assess the degree to which removal of FDA' Pregnancy Categories (PC) of medications (A, B, C, and D) from labeling, affects the likelihood that providers will prescribe those medications. METHODS: Over a one-year period a convenience sample of providers was recruited into a randomized, survey-based, study. Two versions of the survey were randomly distributed; version 1 presented clinical vignettes, drug information, and PC, while version 2, presented the identical information without the PC. Respondents were asked to estimate their likelihood of prescribing the drug. A mixed linear model was constructed, with likelihood of prescription as the dependent variable, treated as interval-scaled. RESULTS: Out of 169 surveys given out, 162 (96%) were returned. Simple effects analysis showed that the presence of PC letter significantly affected the decision to prescribe category B (p<0.001) and C drugs (p=0.008) but not the A or D. Participants were significantly less likely to prescribe class B and C drugs when the letters were not available for review. These findings remained significant even when controlling for covariates (p=0.001). CONCLUSIONS: When a PC letter is absent on labeling, physicians were less likely to use category B and C drugs, the most common medications prescribed in pregnancy.


Subject(s)
Drug Prescriptions , Pregnancy , Surveys and Questionnaires , Female , Humans , Drug Prescriptions/standards
13.
Article in English | LILACS | ID: biblio-1438287

ABSTRACT

OBJECTIVE: To compare information on the risks of potentially inappropriate medications (PIMs) for older adults in the Beers criteria with data in the package inserts made available by the Brazilian Health Regulatory Agency. METHODS: This is an observational, cross-sectional study that compared information on the package inserts of 33 brand-name drugs in the Brazilian market with specific recommendations for older adults contemplated in the Beers criteria, categorizing them into: complete, incomplete, absent, or discrepant. RESULTS: Among the analyzed package inserts, 21.21% did not present a specific section dedicated to the use of these drugs by older adults and data were scattered throughout the text; 63.64% were classified as incomplete; 33.33% lacked data; and 3.03% had discrepant information. CONCLUSION: The analyzed package inserts presented incomplete data or lacked information characterizing the drugs as PIMs for older adults. This study demonstrated that some package inserts of drugs used in Brazil are not satisfactory, warranting higher caution in the medical community when prescribing these medications and guiding patients


OBJETIVO: Comparar as informações sobre os riscos de medicamentos potencialmente inapropriados (MPIs) para idosos contidas nos critérios Beers com as informações presentes nas bulas para profissionais de saúde disponibilizadas pela Agência Nacional de Vigilância Sanitária no Brasil. METODOLOGIA: Estudo observacional e transversal que comparou informações das bulas para profissionais de saúde de 33 medicamentos de referência no mercado brasileiro com recomendações específicas para idosos contempladas nos critérios Beers e que foram categorizadas em: completas, incompletas, ausentes ou discrepantes. RESULTADOS: Dentre as bulas dos MPIs analisadas, 21,21% não apresentam seção específica destinada ao uso desses medicamentos por idosos, nas quais as informações estão dispersas pelo texto; 63,64% delas foram classificadas como incompletas; 33,33% tinham informações ausentes; e 3,03% com informações discrepantes. CONCLUSÃO: As bulas analisadas apresentaram dados incompletos ou não apresentam qualquer informação que caracterizasse o medicamento como MPI para idosos. Este estudo demonstra que algumas bulas de medicamentos utilizados no Brasil não estão satisfatórias, sugerindo maior cautela à comunidade médica na prescrição e na orientação aos seus pacientes


Subject(s)
Humans , Aged , Drug Prescriptions/standards , Health of the Elderly , Medicine Package Inserts , Brazil , Cross-Sectional Studies , Risk Factors
14.
JAMA ; 328(15): 1499-1500, 2022 10 18.
Article in English | MEDLINE | ID: mdl-36190715

ABSTRACT

This Viewpoint explains how a recent Supreme Court decision clarifies rules for prescribing controlled substances so that patients are not denied appropriate care and physicians are not unjustly prosecuted.


Subject(s)
Controlled Substances , Drug Prescriptions , Government Regulation , Legislation, Drug , Supreme Court Decisions , Controlled Substances/administration & dosage , Jurisprudence , United States , Drug Prescriptions/standards , Federal Government , Legislation, Drug/standards
16.
Londres; NICE; rev; Mar. 11, 2022. tab, ilus.
Non-conventional in English | BIGG - GRADE guidelines | ID: biblio-1379308

ABSTRACT

This guideline sets out an antimicrobial prescribing strategy for acute otitis media (ear infection). It aims to limit antibiotic use and reduce antimicrobial resistance. Acute otitis media can be caused by viruses or bacteria. It lasts for about a week, and most children get better in 3 days without antibiotics. Serious complications are rare. In March 2022, we reviewed the evidence and added a recommendation on eardrops containing an anaesthetic and an analgesic because a licensed preparation is now available in the UK. For more information, see update information.


Subject(s)
Otitis Media/drug therapy , Anti-Infective Agents/therapeutic use , Placebos/therapeutic use , Drug Prescriptions/standards , Tobacco Use Disorder/complications , Drug Resistance, Microbial , Superinfection/prevention & control , Cephalosporins/therapeutic use , Ibuprofen/therapeutic use , Analgesics, Non-Narcotic/therapeutic use , Drug Resistance, Bacterial/drug effects , Amoxicillin/therapeutic use , Acetaminophen/therapeutic use , Anti-Bacterial Agents/therapeutic use
17.
PLoS One ; 17(1): e0262537, 2022.
Article in English | MEDLINE | ID: mdl-35015783

ABSTRACT

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.


Subject(s)
Biological Factors/standards , Biosimilar Pharmaceuticals/standards , Drug Industry/standards , Drug Prescriptions/standards , Drug Substitution/standards , Expert Testimony/methods , Pharmacovigilance , Biological Factors/administration & dosage , Biosimilar Pharmaceuticals/administration & dosage , Drug Approval , Humans , United States , United States Food and Drug Administration
18.
Surgery ; 171(2): 504-510, 2022 02.
Article in English | MEDLINE | ID: mdl-34740455

ABSTRACT

BACKGROUND: Enhanced Recovery After Surgery programs have been shown to effectively reduce opioid prescriptions at discharge after their implementation in several institutions, but little is known regarding the sustainability of this effect. Understanding opioid prescribing patterns after long-term implementation of Enhanced Recovery After Surgery initiatives may help guide further opioid prescription reduction and improvements. Our group aimed to determine whether reductions in opioid prescriptions at discharge are sustained in an Enhanced Recovery After Surgery program for thoracic surgery. METHODS: This retrospective cohort included 2,081 patients undergoing thoracic surgery within a 4-year Enhanced Recovery After Surgery program from March 2016 through April 2020. Our Enhanced Recovery After Surgery protocol included a standardized multimodal analgesic regimen (ie, preoperative gabapentin, tramadol, intercostal nerve block with liposomal bupivacaine, and intraoperative acetaminophen, and ketorolac) and the rest of the interventions recommended by the Enhanced Recovery After Surgery society guidelines. Our primary outcomes were the presence of opioid prescriptions at discharge (hydrocodone, hydromorphone, and oxycodone) and the total opioid amount prescribed (morphine equivalent daily dose). Multilevel generalized linear models were used to account for surgeon variabilities and types of thoracic resection. RESULTS: Over the study period, the rate of opioid prescriptions at discharge reduced from 35% (Mar 2016) to 25% (Apr 2020), and the amount of opioid prescribed declined from 184 ± 321 morphine equivalent daily dose to 94 ± 251 morphine equivalent daily dose. In multilevel generalized linear models, there was a sustained downward trend in opioid prescriptions over the study period (ß -11.8 morphine equivalent daily dose per year, P = .048), which was also directly correlated with the use of minimally invasive surgery (ß -84.9 morphine equivalent daily dose for video-assisted thoracoscopic surgery, P < .001; ß -139.2 morphine equivalent daily dose for robotic-assisted thoracic surgery, P < .001), intraoperative opioid administration (ß -1.4 morphine equivalent daily dose per 1 morphine equivalent dose, P = .026), and the amount of postoperative acetaminophen (ß -18.2 morphine equivalent daily dose per 1 g, P = .026). The sustained reduction of opioid prescriptions at discharge did not impact hospital readmission rates within 30 days (odds ratio 1.17, 95% confidence interval 0.86-1.59, P = .306). Subgroup analysis showed a significant, sustained decrease in hydromorphone (ß -10.9 morphine equivalent daily dose per year, P = .004), but not for hydrocodone prescriptions (ß -5.7 morphine equivalent daily dose per year, P = .168) or oxycodone (ß +4.78 morphine equivalent daily dose per year, P = .183). CONCLUSION: Our Enhanced Recovery After Surgery program for thoracic surgery contributed to a sustained reduction of opioid prescriptions at discharge, which positively correlated with the duration of its implementation and the use of minimally invasive surgical techniques but was negatively impacted by the amount of intraoperative opioid administration.


Subject(s)
Analgesics, Opioid/adverse effects , Enhanced Recovery After Surgery , Pain Management/methods , Pain, Postoperative/therapy , Thoracic Surgical Procedures/adverse effects , Aged , Drug Prescriptions/standards , Drug Prescriptions/statistics & numerical data , Female , Humans , Male , Middle Aged , Opioid Epidemic/prevention & control , Pain Management/standards , Pain Management/statistics & numerical data , Patient Discharge/statistics & numerical data , Practice Patterns, Physicians'/standards , Practice Patterns, Physicians'/statistics & numerical data , Retrospective Studies
19.
Ann N Y Acad Sci ; 1507(1): 99-107, 2022 01.
Article in English | MEDLINE | ID: mdl-34476819

ABSTRACT

Doctors' prescribing behaviors impact both medical expenses and health resources. This study aims to identify the significant determinants of prescribing behaviors of doctors, which could potentially provide theoretical evidence on how to improve prescribing decisions. A multistage, stratified, cluster, random sampling method was employed in this survey. Data were collected from Jiangsu and Shanxi provinces in China in 2018. A total of 444 doctors in public hospitals completed the self-administered questionnaires. A structural equation model based on the theory of planned behavior (TPB) was adopted for analysis. On the basis of the TPB, we constructed a model of doctors' prescribing behaviors, which explained the subjective and objective reasons for irrational prescribing behavior. Behavioral attitude, subjective norms, and perceived behavioral control could positively influence the actual behaviors, of which subjective norms impact prescribing behaviors the most. Employing the TPB helped in identifying determinants of prescribing behaviors from a new perspective. More significant policy changes and government support are required to help improve appropriate prescribing behaviors and ultimately make better prescribing decisions. This study provided a deeper understanding of this complex issue and will inform the development of a theory and evidence-based intervention for future research.


Subject(s)
Drug Prescriptions/economics , Hospitals, Public/economics , Hospitals, Public/trends , Physicians/economics , Physicians/trends , Surveys and Questionnaires , Adult , China/epidemiology , Drug Prescriptions/standards , Female , Humans , Male , Physicians/standards , Socioeconomic Factors
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