Association between prescription drugs and all-cause mortality risk in the UK population.

Although most drugs currently approved are meant to treat specific diseases or symptoms, it has been hypothesized that some might bear a beneficial effect on lifespan in healthy older individuals, outside of their specific disease indication. Such drugs include, among others, metformin, SGLT2 inhibitors and rapamycin. Since 2006, the UK biobank has recorded prescription medication and mortality data for over 500'000 participants, aged between 40 and 70 years old. In this work, we examined the impact of the top 406 prescribed medications on overall mortality rates within the general population of the UK. As expected, most drugs were linked to a shorter lifespan, likely due to the life-limiting nature of the diseases they are prescribed to treat. Importantly, a few drugs were associated with increased lifespans, including notably Sildenafil, Atorvastatin, Naproxen and Estradiol. These retrospective results warrant further investigation in randomized controlled trials.

Prescription drug monitoring program in Australia: a qualitative study of stakeholders' experiences and perceptions of a state-wide implementation.

BACKGROUND: Prescription Drug Monitoring Programs (PDMPs) are increasingly implemented across the globe with aims of managing and mitigating risks relating to high-risk prescription medicines. There is limited research focused on identifying strategies or processes for large-scale PDMP implementation. This study aimed to identify strategies perceived as necessary for successful state-wide implementation of a PDMP by exploring the experiences and perceptions of stakeholders responsible for the implementation in New South Wales (NSW), Australia: to identify (1) the drivers of implementation; (2) perceived strategies that worked well; (3) barriers to implementation; and (4) the elements needed for long-term success of SafeScript NSW. METHODS: This study used a qualitative descriptive design. Theoretical frameworks used to design interview questions and guide thematic analysis were the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework and Quadruple Aim framework. Participants were stakeholders responsible for PDMP implementation in NSW. Recruitment and data collection were completed between March and April 2022. Semi-structured interviews were audio-recorded and transcribed. Two researchers independently reviewed transcripts, generated codes from the data, and mapped these to each NASSS domain. They came together multiple times during data analysis to review the codes and grouped them into higher level themes via a discussion and consensus process. Themes were then organised according to the four objectives of the study. RESULTS: Eight interviews were conducted and analysed after which thematic saturation was reached. All participants had a common understanding of the perceived benefits and drivers for PDMP implementation. Participants outlined ten key ingredients for perceived successful state-wide implementation. Strong and iterative engagement with a large number of stakeholder groups was viewed as critical, as was targeting user experience, ongoing monitoring and evaluation. These were facilitated by a phased roll-out strategy. Participants identified some barriers to implementation, particularly around poor usability and user experience of the tool. CONCLUSIONS: This is one of the first studies focused on strategies for what was perceived to be successful state-wide implementation of PDMP. Successful implementation requires significant time and resourcing, with the design and configuration of the technology being only one component of a multi-strategy process. Knowledge and insights gained from this study may be useful for other implementations of similar digital health tools in large-scale jurisdictions.

Biosimilar approval pathways: comparing the roles of five medicines regulators.

Biologics are playing an increasingly important role in health care globally but are placing a substantial burden on payers. The development of biosimilars-drugs that are highly similar to and have no clinically meaningful differences from originator biologics-is critical to improving the affordability and accessibility of these medications. Medicines regulators, however, have had varied success with biosimilars to date. We examined agency guidance documents, peer-reviewed articles, and gray literature related to biosimilars in Australia, Canada, the European Union, the United Kingdom, and the United States to evaluate variations in the approaches to biosimilar approval taken by their respective medicines regulators. We found that the medicines regulators take similar approaches to biosimilar approvals, but that differences in their policies and their jurisdiction's laws regarding testing requirements, indication extrapolation, exclusivities, and substitution may contribute to the varied successes of biosimilars observed. Policies supportive of product-specific guidance, extrapolation, shorter exclusivity periods, and substitution were correlated with greater success in biosimilar approval and uptake. As medicines regulators work to promote biosimilars, understanding the impact of these laws and policies is crucial. Reforms consistent with these policies can create regulatory environments more supportive of biosimilar approvals, promoting access to affordable biologics for patients globally.

Development of pharmacy-based best practices to support safer use and management of prescription opioids based on an e-Delphi methodology.

BACKGROUND: Opioid utilization and related harm have increased in recent decades, notably in Australia, the United States, Canada, and some European countries. For people who are prescribed opioids, pharmacies offer an accessible, regular point-of-contact, providing a unique opportunity to address opioid prescription drugs risks. OBJECTIVE: This project aimed to develop consensus-based, best practice statements for improving the safer use of prescription opioids through community pharmacy settings. METHODS: The e-Delphi technique is used to obtain consensus from experts about issues where conclusive evidence is lacking, using multiple rounds of online participation. The investigator group identified an international group of potential participants with relevant expertise who were invited to the study, and asked to identify other experts for invitation. The e-Delphi process comprised three online rounds, involving (1) statement idea generation, (2) developing statement consensus, and (3) confirming and ranking statements. RESULTS: A diverse group of 42 experts (76 % female, 6 countries) participated, comprising pharmacists (n = 24, 57 %), medical doctors of differing specialties (n = 12, 29 %), and/or researchers (n = 28, 67 %), with a mean of 15 years' professional experience (SD = 8.08). Eighty-five statements were initially developed in Round 1, and 78 were supported with amendments, with suggestions to merge and remove items in Round 2, resulting in 72 final statements which were all endorsed in Round 3. Items spanned seven themes: education, monitoring outcomes and risk, deprescribing and pain management, overdose education and naloxone, opioid agonist treatment, staff education, and overarching practices. Preferred terminology was determined in Round 2 and confirmed in Round 3. CONCLUSIONS: Community pharmacies offer a unique opportunity to support the safer use of prescription opioids. These 72 best practice statements provide practical guidance on specific practices that pharmacists can undertake to support patients' safer use of prescription opioids and prevent or reduce harms from prescribed opioid use.

Implementation of universal screening for substance use in pregnancy in a public healthcare system.

Objective: Screening questionnaires are one option for identification of at-risk substance use and substance use disorder (SUD) during pregnancy. We report the experience of a single institution following universal implementation of a brief screening tool for self-reported substance use at the first prenatal encounter. Study Design: This is a prospective implementation study evaluating screening for substance use in pregnancy in a large safety net healthcare system. Universal screening with the National Institute of Drug Abuse (NIDA) Quick Screen V1.0 was integrated into the electronic medical record (EMR) and administered at the first point of contact with the healthcare system. SUD was identified initially with diagnosis within the EMR by a healthcare provider and was confirmed with toxicology (maternal or neonatal) results corroborating a pattern of substance use and maternal and neonatal ICD-10 codes for SUD. Patients identified with SUD were then classified as moderate or severe SUD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. We measured rates of NIDA implementation across different healthcare settings, evaluated NIDA concordance with ascertainment of SUD, and compared adverse pregnancy outcomes associated with moderate and severe SUD. Results: From July 28, 2021, through June 25, 2022, 14,634 unique pregnant individuals accessed care at ambulatory and acute care sites. Universal implementation of the NIDA Quick Screen identified at-risk substance use in 2146 (14.7%) of those who accessed our system, or 17.1% of 12,550 screened across the system, with greater screen completion in ambulatory over acute care settings. SUD was identified in 256 (1.7%) of 14,634 individuals and moderate or severe SUD was identified in 184 (1.3%). Among those with moderate or severe SUD, 90 (48.9%) were NIDA positive, 22 (12.0%) NIDA negative, and 72 (39.1%) unscreened. Of 94 individuals with NIDA discordance or who were unscreened 76 (81%) accessed initial care through an acute care setting. Of 96 individuals with opioid use disorder, 68 (70.8%) were treated with medication-assisted therapy, and 56 (58.3%) were screened with the NIDA Quick Screen. Among delivered individuals with available outcomes, those with moderate or severe SUD were less likely to seek prenatal care (71 (76%) vs 9852 (98%), <0.001)) and more likely to deliver before 37 weeks, (18 (20%) vs 909 (9%), RR (95% CI) 2.13 (1.40, 3.24)) compared to individuals without SUD. Neonates exposed to moderate or severe SUD were more likely to have birth weight <10th centile for gestational age (20 (22%) vs 1147 (12%), RR (95% CI) 1.92 (1.29, 2.85)) and require admission to the neonatal intensive care unit (NICU) (19 (21%) vs 964 (10%), RR (95%) 1.95 (1.30, 2.93)). Conclusion: Universal screening was implemented across a large public healthcare system at a high rate, with higher rates of implementation in ambulatory settings. NIDA successfully identified at-risk substance use in 17% of the SUD cohort but failed to identify more than 50% of patients with moderate or severe SUD. Patients with moderate and severe SUD accessed care primarily through the emergency department and experienced higher rates of adverse obstetric and neonatal outcomes. Future efforts to identify, engage, and retain this highest-risk group are needed.

Digital Epidemiology of Prescription Drug References on X (Formerly Twitter): Neural Network Topic Modeling and Sentiment Analysis.

BACKGROUND: Data from the social media platform X (formerly Twitter) can provide insights into the types of language that are used when discussing drug use. In past research using latent Dirichlet allocation (LDA), we found that tweets containing "street names" of prescription drugs were difficult to classify due to the similarity to other colloquialisms and lack of clarity over how the terms were used. Conversely, "brand name" references were more amenable to machine-driven categorization. OBJECTIVE: This study sought to use next-generation techniques (beyond LDA) from natural language processing to reprocess X data and automatically cluster groups of tweets into topics to differentiate between street- and brand-name data sets. We also aimed to analyze the differences in emotional valence between the 2 data sets to study the relationship between engagement on social media and sentiment. METHODS: We used the Twitter application programming interface to collect tweets that contained the street and brand name of a prescription drug within the tweet. Using BERTopic in combination with Uniform Manifold Approximation and Projection and k-means, we generated topics for the street-name corpus (n=170,618) and brand-name corpus (n=245,145). Valence Aware Dictionary and Sentiment Reasoner (VADER) scores were used to classify whether tweets within the topics had positive, negative, or neutral sentiments. Two different logistic regression classifiers were used to predict the sentiment label within each corpus. The first model used a tweet's engagement metrics and topic ID to predict the label, while the second model used those features in addition to the top 5000 tweets with the largest term-frequency-inverse document frequency score. RESULTS: Using BERTopic, we identified 40 topics for the street-name data set and 5 topics for the brand-name data set, which we generalized into 8 and 5 topics of discussion, respectively. Four of the general themes of discussion in the brand-name corpus referenced drug use, while 2 themes of discussion in the street-name corpus referenced drug use. From the VADER scores, we found that both corpora were inclined toward positive sentiment. Adding the vectorized tweet text increased the accuracy of our models by around 40% compared with the models that did not incorporate the tweet text in both corpora. CONCLUSIONS: BERTopic was able to classify tweets well. As with LDA, the discussion using brand names was more similar between tweets than the discussion using street names. VADER scores could only be logically applied to the brand-name corpus because of the high prevalence of non-drug-related topics in the street-name data. Brand-name tweets either discussed drugs positively or negatively, with few posts having a neutral emotionality. From our machine learning models, engagement alone was not enough to predict the sentiment label; the added context from the tweets was needed to understand the emotionality of a tweet.

Over the Counter: Self-Care or Self-Harm? A Mixed Method Study Protocol on Prevalence and Determinants of Self-Medication Practices in Wardha.

Background Self-medication (SM), a common practice globally, possesses a dual challenge of being a self-care strategy and a potential source of harm observed across all age groups. The study is being conducted to gauge the prevalence of SM of prescription drugs with their over-the-counter access, thus addressing the delicate balance between self-care and self-harm related to SM. Material and methods This ongoing convergent parallel mixed method study with quantitative and qualitative components will be conducted on a sample size of 180 subjects aged more than 18 years from an urban community. For the quantitative component, a semi-structured questionnaire will assess the prevalence of SM, types of medications used, reasons for self-medicating, and socio-demographic factors influencing these practices. Concurrently, qualitative interviews delve deeper into the beliefs shaping SM practices. Sampling will be purposive to capture diverse perspectives, with data analyzed using statistical tools. Results This study protocol will offer a comprehensive understanding of the prevalence and determinants of SM practices. The quantitative data provide numerical insights into SM trends, while the qualitative findings elucidate the nuanced factors driving individuals' SM choices. Conclusions A multifaceted view of SM practices will be provided, aiding in developing interventions to promote safe and effective self-care while mitigating the risks of self-harm through SM. Anticipated findings can include a widespread prevalence of SM amongst the general urban populace. Significant associations can also be expected to be found with various independent variables. The results will be instrumental in informing public health policies and healthcare practices toward enhancing patient safety and well-being.

The risk of long-term opioid use among immigrants: a national registry-linkage study.

AIMS: We aimed to investigate the association between being an immigrant and long-term prescription opioid use in Norway in 2010-2019. METHODS: Nested case-control study. The cases were all persons 18 years of age or older with long-term opioid use - that is, the use of prescription opioids longer than 3 months (N=215,642). Cases were matched to four controls who filled at least one opioid prescription, but never developed long-term opioid use in the study period (N=862,568) on sex, age and year of starting long-term/short-term opioid use. Being an immigrant was defined as being born outside of Norway to two foreign-born parents and four foreign-born grandparents. Adjusting for socioeconomic variables and clinical confounders, analyses were stratified on three age groups (18-44 years, 45-67 years and ⩾68 years). RESULTS: For the youngest age group, being an immigrant was inversely associated with long-term opioid use (adjusted odds ratio 0.75; 95% confidence interval [0.72-0.77]) compared with being native-born people. For this age group, the odds ratio differed between people born in Africa (0.56 [0.52-0.62]), Central or South America (0.70 [0.62-0.79]), Europe outside the European Union (EU) (0.71 [0.65-0.77]), Asia including Turkey (0.80 [0.77-0.84]) and EU/European Economic Area (EEA) (0.81 [0.77-0.85]). For the middle age group, increased odds were found for immigrants versus natives (1.05 [1.02-1.08]) in particular for those born in North America (1.26 [1.13-1.40]) and the EU/EEA (1.13 [1.09-1.18]). There was no association in the oldest group. CONCLUSIONS: Compared with native-born people, immigrants had lower odds of long-term opioid use among younger adults, higher odds among middle-aged and similar odds among older adults.

Prescription and nonprescription drug misuse and abuse in community pharmacies in Iraq: a cross-sectional survey.

BACKGROUND: There is little known regarding prescription and nonprescription medicine nonmedical use (abuse and misuse) in Iraq, with limited treatment. Pharmacists could be a valuable source of information in the absence of any national monitoring system. AIMS: This study aimed to explore Iraqi community pharmacists' perspectives on prescription and nonprescription medicine abuse/misuse, including motives for use and how often they encounter people whom they think are misusing or abusing medicines. METHODS: A cross-sectional survey was undertaken between November 2020 and February 2021. Community pharmacists in Iraq were asked to complete a prepiloted self-administered questionnaire, distributed through online social media platforms. RESULTS: 300 pharmacists completed the questionnaire. The most commonly reported nonprescription drugs suspected of abuse/misuse were cough and cold medications (n = 80, 26.6%), topical corticosteroids (n = 54, 17.9%), and allergy products (n = 33, 11%). The most common reported prescription drugs suspected of abuse/misuse were systemic antibiotics (n = 111, 36.9%), gabapentinoids (n = 56, 18.6%), and moderate-weak opioids (n = 34, 11.3%). The most commonly method used by pharmacists to limit access to such drugs was responding that the requested medication was unavailable (n = 273, 51.7%), followed by advising on risks (n = 152, 33.2%). CONCLUSIONS: Prescription/nonprescription medicine abuse and misuse are suspected in community pharmacies in Iraq. Current methods for controlling the problem are likely to be ineffective in the absence of prescription drug enforcement. Pharmacists could have a more proactive role in managing this issue, networking with other pharmacists, and referring suspected users to support.

Medication Management Strategies to Support Medication Adherence: Interview Study With Older Adults.

BACKGROUND: Home medication management has been insufficiently studied, including the factors that impact the development and effectiveness of adherence strategies under both routine and anomalous circumstances. Older adults are a particularly important population to study due to the greater likelihood of taking medication in combination with the desire to "age in place." OBJECTIVE: This interview study aims to understand how older adults develop medication management strategies, identify when and why such strategies succeed or fail, learn more about how older adults think about their medication, and explore interventions that increase medication adherence. METHODS: This study used a qualitative, semistructured interview design to elicit older adults' experiences with home medication management. Overall, 22 participants aged ≥50 years taking 1 to 3 prescription medications were recruited and interviewed. Interview responses were recorded, and thematic, qualitative analysis was performed by reviewing recordings and identifying recurring patterns and themes. Responses were systematically coded, which not only facilitated the identification of these themes but also allowed us to quantify the prevalence of behaviors and perceptions, providing a robust understanding of medication management and medication adherence. RESULTS: Participants reported developing home medication management strategies on their own, with none of the participants receiving guidance from health care providers and 59% (13/22) of the participants using trial and error. The strategies developed by study participants were all unique and generally encompassed prescription medication and vitamins or supplements, with no demarcation between what was prescribed or recommended by a physician and what they selected independently. Participants thought about their medications by their chemical name (10/22, 45%), by the appearance of the pill (8/22, 36%), by the medication's purpose (2/22, 9%), or by the medication's generic name (2/22, 9%). Pill cases (17/22, 77%) were more popular than prescription bottles (5/22, 23%) for storage of daily medication. Most participants (19/22, 86%) stored their pill cases or prescription bottles in visible locations in the home, and those using pill cases varied in their refill routines. Participants used ≥2 routines or objects as triggers to take their medication. Nonadherence was associated with a disruption to their routine. Finally, only 14% (3/22) of the participants used a time-based reminder or alarm, and none of the participants used a medication adherence device or app. CONCLUSIONS: Participants in our study varied considerably in their home medication management strategies and developed unique routines to remember to take their medication as well as to refill their pill cases. To reduce trial and error in establishing a strategy, there are opportunities for physicians and pharmacists to provide adherence guidance to older adults. To minimize the impact of disruptions on adherence, there are opportunities to develop more durable strategies and to design aids to medication adherence that leverage established daily routines.

Diagnosing and managing prescription opioid use disorder in patients prescribed opioids for chronic pain in Australian general practice settings: a qualitative study using the theory of Planned Behaviour.

BACKGROUND: Chronic pain is a debilitating and common health issue. General Practitioners (GPs) often prescribe opioids to treat chronic pain, despite limited evidence of benefit and increasing evidence of harms, including prescription Opioid Use Disorder (pOUD). Australian GPs are worried about the harms of long-term opioids, but few are involved in the treatment of pOUD. There is little research on GPs' experiences diagnosing and managing pOUD in their chronic pain patients. METHODS: This qualitative research used semi-structured interviews and a case study to investigate GPs' experiences through the lens of the Theory of Planned Behaviour (TPB). TPB describes three factors, an individual's perceived beliefs/attitudes, perceived social norms and perceived behavioural controls. Participants were interviewed via an online video conferencing platform. Interviews were transcribed verbatim and thematically analysed. RESULTS: Twenty-four GPs took part. Participants were aware of the complex presentations for chronic pain patients and concerned about long-term opioid use. Their approach was holistic, but they had limited understanding of pOUD diagnosis and suggested that pOUD had only one treatment: Opioid Agonist Treatment (OAT). Participants felt uncomfortable prescribing opioids and were fearful of difficult, conflictual conversations with patients about the possibility of pOUD. This led to avoidance and negative attitudes towards diagnosing pOUD. There were few positive social norms, few colleagues diagnosed or managed pOUD. Participants reported that their colleagues only offered positive support as this would allow them to avoid managing pOUD themselves, while patients and other staff were often unsupportive. Negative behavioural controls were common with low levels of knowledge, skill, professional supports, inadequate time and remuneration described by many participants. They felt OAT was not core general practice and required specialist management. This dichotomous approach was reflected in their views that the health system only supported treatment for chronic pain or pOUD, not both conditions. CONCLUSIONS: Negative beliefs, negative social norms and negative behavioural controls decreased individual behavioural intention for this group of GPs. Diagnosing and managing pOUD in chronic pain patients prescribed opioids was perceived as difficult and unsupported. Interventions to change behaviour must address negative perceptions in order to lead to more positive intentions to engage in the management of pOUD.

Relationships of self-reported opioid and benzodiazepine use with health-related quality of life among adults with spinal cord injury.

BACKGROUND: There is limited understanding of the relationships between prescription opioid and benzodiazepine use and indices of health-related quality of life (HRQOL) among those with spinal cord injuries (SCI). OBJECTIVE: To identify the relationships between self-reported prescription opioid and benzodiazepine use and two indicators of HRQOL, number of days in poor physical health and poor mental health in the past 30 days among adults with SCI. METHODS: A cross-sectional cohort study of 918 adults with chronic (>1 year), traumatic SCI living in the Southeastern United States was conducted. Participants completed a self-report assessment (SRA). RESULTS: In the preliminary model, both opioid and benzodiazepine use were associated with a greater number of days in poor physical health and poor mental health in the past month. After controlling for health conditions (pain intensity, spasticity, anxiety and perceived sleep insufficiency), opioid use was associated with 2.04 (CI = 0.69; 3.39) additional poor physical health days in the past 30 days, and benzodiazepine use was associated with 2.18 (CI = 0.70; 3.64) additional days of poor mental health. Age was associated with greater number of poor physical health days and fewer poor mental health days. Lower income was associated with poor mental health days. Most of the health conditions were significantly related to the number of past month poor physical and mental health days. CONCLUSIONS: Opioid and benzodiazepine use are associated with poor physical and mental HRQOL, even after controlling for health conditions. Treatment strategies should consider potential unanticipated negative consequences of pharmacological interventions.

Efficacy of transdermal buprenorphine patch for managing withdrawal symptoms in patients with cancer physically dependent on prescription opioids.

BACKGROUND: The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. METHODS: This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety. RESULTS: Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms. CONCLUSION: TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable.

The impact of different strategies for modeling associations between medications at low doses and health outcomes: a simulation study and practical application to postpartum opioid use.

Pharmacoepidemiological studies commonly examine the association between drug dose and adverse health outcomes. In situations where no safe dose exists, the choice of modeling strategy can lead to identification of an apparent safe low dose range in the presence of a non-linear relationship or due to the modeling strategy forcing a linear relationship through a dose of 0. We conducted a simulation study to assess the performance of several regression approaches to model the drug dose-response curve at low doses in a setting where no safe range exists, including the use of a (1) linear dose term, (2) categorical dose term, and (3) natural cubic spline terms. Additionally, we introduce and apply an expansion of prior work related to modeling dose-response curves at low and infrequently used doses in the setting of no safe dose ("spike-at-zero" and "slab-and-spline"). Furthermore, we demonstrate and empirically assess the use of these regression strategies in a practical scenario examining the association between the dose of the initial postpartum opioid prescribed after vaginal delivery and the subsequent total dose of opioids prescribed in the entire postpartum period among a cohort of opioid-naïve women with a vaginal delivery enrolled in a State Medicaid program (2007-2014).

Interventional Pharmacoepidemiology: Design and evaluation of interventions to improve prescribing.

Despite the value of modern therapeutics, many obstacles prevent their optimal use. Overuse, underuse and misuse are common, resulting in morbidity and mortality impacting billions of individuals across the world. Pharmacoepidemiology provides important insights into drug utilization, safety and effectiveness in large populations, and it is an important method to identify opportunities to improve the value of therapeutics in clinical practice. However, for these opportunities to be realized, interventions to improve prescribing must be developed, evaluated and implemented in the real world. We provide an overview of this process, focusing especially on how such interventions can be designed and deployed to maximize scalability, adoption and impact. Prescribing represents a complex behavior with barriers and enablers, and interventions to improve prescribing will be most successful when developed, piloted and refined to maximize provider and patient acceptability. Carefully developed evaluations of interventions are also critical, and varied methods are available to empirically evaluate the intended and potential unintended consequences of interventions. With illustrative examples from the peer-reviewed literature, we provide readers with an overview of approaches to the essential and growing field of interventional pharmacoepidemiology.

Oncology drug pricing: potential Medicare savings on cancer-directed and supportive care medications through the Mark Cuban cost plus drug model.

Prescription drug costs within oncology remain a challenge for many patients with cancer. The Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022, aiming to provide transparently priced medications at reduced costs. In this study, we sought to describe the potential impact of MCCPDC on Medicare Part-D oncology spending related to cancer-directed (n = 7) and supportive care (n = 26) drugs. We extracted data for drug-specific Part-D claims and spending for 2021. Using 90-count purchases from MCCPDC, we found potential Part-D savings of $857.8 million (91% savings) across the 7 cancer-directed drugs and $28.7 million (67% savings) across 21/26 (5/26 did not demonstrate savings) supportive care drugs. Collectively, our findings support that alternative purchasing models like MCCPDC may promote substantial health care savings.

Administering injectable medications prescribed in the anticipation of the end of life in the community: A mixed-methods observational study.

BACKGROUND: The prescription of injectable anticipatory medications ahead of possible need for last-days-of-life symptom relief is established community practice internationally. Healthcare teams and policy makers view anticipatory medication as having a key role in optimising effective and timely symptom control. However, how these medications are subsequently administered (used) is unclear and warrants detailed investigation to inform interdisciplinary practice and guidance. OBJECTIVE: To identify the frequency, timing and recorded circumstances of the administration of injectable end-of-life anticipatory medications prescribed for patients living at home and in residential care. DESIGN: A retrospective mixed-methods observational study using general practitioner (family doctor) and community nursing held clinical records. SETTING(S): Community-based care in two English counties. PARTICIPANTS: 167 deceased adult patients (aged 18+) registered with eleven general practitioner practices and two associated community nursing services. These were patients prescribed anticipatory medications, identified from the 30 most recent deaths per practice. Patients died between 1 March 2017 and 25 September 2019, from any cause except trauma, sudden death or suicide. METHODS: Patient characteristics, anticipatory medication discussions, recorded administration contexts and decision-making, medication details, recorded symptom control and comfort at death were collected from clinical records. Data analysis combined quantitative and qualitative analyses in a mixed methods approach. RESULTS: Anticipatory medications were administered to 59.9 % (100/167) patients, commenced between 0 and 586 days before death (median 3 days). Their usage was similar for patients who died from cancer and non-cancer conditions. Anticipatory medications were almost universally started and titrated by visiting nurses. Eleven patients had medications started between 59 days and 586 days before death for recorded reversible non-end-of-life care conditions. Only 5 % (5/100) of patient records contained detailed accounts of patient participation in decisions to start medications: four were recorded as being reluctant to commence medications but agreed to trial injections to relieve symptoms. Crucially, there was recurrent under-recording of the effectiveness of injectable medications and patient comfort. CONCLUSIONS: Prescribed medications were commonly administered by visiting community nurses to help manage last-days-of-life symptoms. However, patient records infrequently referred to the effectiveness of administered medication and perceived patient comfort. Most recorded references to patient and family preferences for involvement in anticipatory medication decision-making and their experiences of care were brief and perfunctory. More detailed information should be routinely recorded in clinical records to enable assessment of the appropriate and effective use of anticipatory medicines and how inter-professional collaboration and services could be developed to provide adequate twenty-four-hour cover. TWEETABLE ABSTRACT: Effectiveness of injectable end-of-life symptom control medications and patient comfort often under-recorded @Ben_Bowers__ @PELi_Cam @TheQNI.

Changes in the Appropriateness of US Outpatient Antibiotic Prescribing After the COVID-19 Outbreak: An Interrupted Time Series Analysis of 2016-2021 Data.

BACKGROUND: No national study has evaluated changes in the appropriateness of US outpatient antibiotic prescribing across all conditions and age groups after the coronavirus disease 2019 (COVID-19) outbreak in March 2020. METHODS: This was an interrupted time series analysis of Optum's de-identified Clinformatics Data Mart Database, a national commercial and Medicare Advantage claims database. Analyses included prescriptions for antibiotics dispensed to children and adults enrolled during each month during 2017-2021. For each prescription, we applied our previously developed antibiotic appropriateness classification scheme to International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes on medical claims occurring on or during the 3 days prior to dispensing. Outcomes included the monthly proportion of antibiotic prescriptions that were inappropriate and the monthly proportion of enrollees with ≥1 inappropriate prescription. Using segmented regression models, we assessed for level and slope changes in outcomes in March 2020. RESULTS: Analyses included 37 566 581 enrollees, of whom 19 154 059 (51.0%) were female. The proportion of enrollees with ≥1 inappropriate prescription decreased in March 2020 (level decrease: -0.80 percentage points [95% confidence interval {CI}, -1.09% to -.51%]) and subsequently increased (slope increase: 0.02 percentage points per month [95% CI, .01%-.03%]), partly because overall antibiotic dispensing rebounded and partly because the proportion of antibiotic prescriptions that were inappropriate increased (slope increase: 0.11 percentage points per month [95% CI, .04%-.18%]). In December 2021, the proportion of enrollees with ≥1 inappropriate prescription equaled the corresponding proportion in December 2019. CONCLUSIONS: Despite an initial decline, the proportion of enrollees exposed to inappropriate antibiotics returned to baseline levels by December 2021. Findings underscore the continued importance of outpatient antibiotic stewardship initiatives.