Pharmacists' perspectives on opioid stewardship challenges.

OBJECTIVE: Pharmacists are in a distinctive position to champion opioid stewardship principles in communications with prescribers and patients. This effort is focused on elucidating perceived barriers to uphold these principles observed in pharmacy practice. DESIGN: Qualitative research study. SETTING: A healthcare system, consisting of inpatient and outpatient settings across several United States (US) states in both rural and academic settings. PARTICIPANTS: Twenty-six pharmacists who represented the study setting in the sole healthcare system. INTERVENTIONS: Five virtual focus groups were conducted with the 26 pharmacists from inpatient and outpatient settings across four states in both rural and academic settings. Trained moderators conducted 1-hour focus group meetings that consisted of a mix of poll and discussion questions. MAIN OUTCOME MEASURE: Participant questions were related to awareness, knowledge, and system issues affecting opioid stewardship. RESULTS: All pharmacists reported their routine follow-up with prescribers when questions or concerns arise but noted workload as a barrier to meticulous review of opioid prescriptions. Participants highlighted best practices, including transparency on the rationale for guideline exceptions to improve the management of after-hours concerns. Suggestions were integration of guidelines into prescriber and pharmacist order review workflows and a more visible prescriber review of prescription drug monitoring programs. CONCLUSIONS: Improvements in communication and transparency of information related to opioid prescribing between pharmacists and prescribers would enhance opioid stewardship. Integration of opioid guidelines into opioid ordering and review would improve efficiency, guideline adherence, and, most importantly, patient care.

Incorporation of pharmacist pre-surgical calls to improve medication history completion rates.

BACKGROUND: The accuracy and timeliness of documenting a medication history is an important aspect to ensure appropriate medication reconciliation during transitions of care. Surgical patients often have their medication history recorded just moments before surgery which may be rushed, incomplete or missed entirely. Between January and May 2020, 76.7% of surgical patients admitted to our institution had a medication history completed by a pharmacist prior to surgery. OBJECTIVE: The objective of this work is to improve the pharmacist medication history completion rates for pre-surgical patients before surgery by integrating pharmacist-led medication histories into the pre-operative pathway. METHODS: Through interdisciplinary collaboration, the pre-operative pathway for surgical patients was evaluated for opportunities to complete medication histories days prior to their scheduled procedure. Plan-Do-Study-Act (PDSA) cycles were utilized to make incremental improvements in practice. INTERVENTIONS: Through an iterative process, the pathway for cardiovascular surgery (CVS) patients was modified to include a scheduled pharmacist phone appointment in the days leading up to their surgical procedure. Utilizing these phone appointments, pharmacists complete patient medication history reviews and share a feedback loop to cardiovascular and peri-operative health care providers. RESULTS: The iterative PDSA cycles revealed challenges to completing pre-surgical medication history calls without advance notice. Patient responsiveness to pre-surgical medication history calls improved with the incorporation of scheduled phone appointments. Between January 18 and May 31, 2021, pharmacists completed 359 of 376 scheduled CVS appointments (95.5%), improving the medication history completion rates for cardiovascular surgery patients from 84.8 to 93.0% (p = 0.000025). The completion rate for all surgical patients also improved from 76.7 to 85.1% (p < 0.00001). CONCLUSIONS: Incorporating scheduled pharmacist medication history appointments as a part of the pre-operative pathway was shown to expand the capacity for pharmacists to complete medication histories for patients prior to surgery. By reducing pharmacist workload on the morning of surgery, fewer patients were admitted to surgery without having their medication history reviewed by pharmacy. Future investigation should be considered to evaluate the impact on patient outcomes.

Emergence of restless legs syndrome during opioid discontinuation.

STUDY OBJECTIVES: The development of restless legs syndrome (RLS) has been rarely reported during and following opioid withdrawal. We aimed to determine the presence and severity of RLS symptoms during and after supervised opioid tapering. METHODS: Ninety-seven adults enrolled in the Mayo Clinic Pain Rehabilitation Center who underwent supervised prescription opioid tapering were prospectively recruited. RLS presence and severity was assessed with the Cambridge-Hopkins Questionnaire 13 and International Restless Legs Syndrome Study Group Rating Severity Scale at admission, midpoint, and dismissal from the program as well as 2 weeks, 4 weeks, and 3 months after completion. Frequency and severity of RLS symptoms were compared between admission and each time point. RESULTS: Average age of the cohort was 52.6 ± 13.3 years with a morphine milligram equivalent dose for the cohort of 45.6 ± 48.3 mg. Frequency of RLS symptoms increased from 28% at admission to peak frequency of 41% at 2 weeks following discharge from the Mayo Pain Rehabilitation Clinic (P = .01), returning to near baseline frequency 3 months after opioid discontinuation. International Restless Legs Syndrome Study Group Rating Severity Scale increased from baseline and then remained relatively stable at each time point following admission. Thirty-five (36.1%) participants developed de novo symptoms of RLS during their opioid taper, with those being exposed to higher morphine milligram equivalent doses having higher risk of developing RLS. CONCLUSIONS: Moderately severe symptoms of RLS, as assessed by survey, occur commonly in individuals undergoing opioid tapering, particularly if exposed to higher doses. In many cases, symptoms appear to be self-limited, although a minority develop persistent symptoms. Our results may have implications for successful opioid tapering, but future confirmatory studies with structured clinician interview are needed to establish that these symptoms truly represent restless legs syndrome given the potential for RLS-mimicking symptoms in individuals with chronic pain syndromes. CITATION: McCarter SJ, Labott JR, Mazumder MK, et al. Emergence of restless legs syndrome during opioid discontinuation. J Clin Sleep Med. 2023;19(4):741-748.

Why we still prescribe so many opioids: A qualitative study on -barriers and facilitators to prescribing guideline implementation.

INTRODUCTION: Opioid prescribing occurs within almost every healthcare setting. Implementation of safe, effective opioid stewardship programs represents a critical but daunting challenge for medical leaders. This study sought to understand the barriers and aids to the routine use of clinical guidelines for opioid prescribing among healthcare professionals and to identify areas in need of additional education for prescribing providers, pharmacists, and nurses. METHODS: Data collection and analysis in 2018-2019 employed a team of two trained facilitators who conducted 20 focus groups using a structured facilitation guide to explore operational, interpersonal, and patient care-related barriers to best practice adherence. Each professional group was interviewed separately, with similar care settings assigned together. Invitation to participate was based on a sampling methodology representing emergency, medical specialty, primary care, and surgical practice settings. RESULTS: Key concerns among all groups reflected the inadequacy of available tools for staff to appropriately assess and treat patients' pain. Tools and technology to support safe opioid prescribing were also cited as a barrier by all three professional groups. All groups noted that prescribers tend to rely upon default settings within the electronic medical record when issuing prescriptions. Both pharmacists and prescribers cited time and scheduling as a barrier to adherence. CONCLUSIONS: In spite of significant regulatory and public policy efforts to address the opioid crisis, healthcare organizations face significant challenges to improve adherence to best practice prescribing guidelines. These findings highlight several facilitators for change which could boost opioid stewardship initiatives to focus on critical systems' factors for improvement.

Pain catastrophizing as a treatment process variable in cognitive behavioural therapy for adults with chronic pain.

BACKGROUND: Interdisciplinary cognitive behavioural therapy (CBT) for chronic pain is effective at improving function, mood and pain interference among individuals with disabling chronic pain. Traditionally, CBT assumes that cognitive change is an active therapeutic ingredient in the determination of treatment outcome. Pain catastrophizing, a cognitive response style that views the experience of pain as uncontrollable, permanent and destructive, has been identified as an important maladaptive cognition which contributes to difficulties with the management of chronic pain. Consequently, pain catastrophizing is commonly targeted in CBT for chronic pain. OBJECTIVES: To examine change trajectories in pain catastrophizing during treatment and assess the relevance of these trajectories to outcomes at posttreatment. METHODS: Participants included individuals with chronic pain (N = 463) who completed a 3-week program of interdisciplinary CBT. Pain catastrophizing was assessed weekly over the 3 weeks of treatment and latent growth curve modelling was used to identify trajectories of change. RESULTS: Findings indicated the presence of two classes of linear change, one with a significant negative slope in pain catastrophizing (i.e. improved class) and the other with a non-significant slope (i.e. unchanged class). Next, latent growth mixture modelling examined treatment outcome in relation to class membership. These results indicated that individuals in the 'improved' PCS class had significantly greater improvement in pain interference and mood, as well as physical and mental quality of life compared to the 'unchanged' class. CONCLUSIONS: Implications for our findings, in relation to the CBT model, are discussed.

Prevalence of Opioid-Induced Adrenal Insufficiency in Patients Taking Chronic Opioids.

CONTEXT: Chronic opioid use may lead to adrenal insufficiency because of central suppression of the hypothalamic-pituitary-adrenal axis. However, the prevalence of opioid-induced adrenal insufficiency (OIAI) is unclear. OBJECTIVE: To determine the prevalence of OIAI and to identify predictors for the development of OIAI in patients taking opioids for chronic pain. DESIGN: Cross-sectional study, 2016-2018. SETTING: Referral center. PATIENTS: Adult patients taking chronic opioids admitted to the Pain Rehabilitation Center. MAIN OUTCOME MEASURE: Diagnosis of OIAI was considered if positive case detection (cortisol < 10 mcg/dL, ACTH < 15 pg/mL, and dehydroepiandrosterone sulfate < 25 mcg/dL), and confirmed after endocrine evaluation. Daily morphine milligram equivalent (MME) was calculated. RESULTS: In 102 patients (median age, 53 years [range, 22-83], 67% women), median daily MME was 60 mg (3-840), and median opioid therapy duration was 60 months (3-360). Abnormal case detection testing was found in 11 (10.8%) patients, and diagnosis of OIAI was made in 9 (9%). Patients with OIAI were on a higher daily MME (median, 140 [20-392] mg vs 57 [3-840] mg, P = 0.1), and demonstrated a 4 times higher cumulative opioid exposure (median of 13,440 vs 3120 mg*months, P = 0.03). No patient taking  20 mg); however, specificity of MME cutoff >20 mg was only 19%. After opioid discontinuation, 6/7 patients recovered adrenal function. CONCLUSION: The prevalence of OIAI was 9%, with MME cumulative exposure being the only predictor for OIAI development. Patients on MME of 20 mg/day and above should be monitored for OIAI.

Provision of a Drug Deactivation System for Unused Opioid Disposal at Surgical Dismissal: Opportunity to Reduce Community Opioid Supply.

OBJECTIVE: To determine the impact of a drug deactivation system to post-surgical patients on the rate of opioid prescription disposal. PATIENTS AND METHODS: Two hundred post-operative patients discharged after inpatient surgery at a large academic medical center. This study was conducted August 20, 2018, through November 30, 2018. Patients were provided with a drug deactivation system (DDS) and instruction sheet along with their opioid prescription. Three to 4 weeks after dismissal, patients were surveyed about quantity of opioids remaining, use of DDS or other disposal methods, and satisfaction with DDS if used. RESULTS: One hundred forty-nine of 200 (74.5%) patients were surveyed. One hundred six reported leftover opioids and 29 (27.3%) had disposed of these medications. By the time of survey, 23 (21.2%) participants with leftover opioids had used the DDS to destroy their remaining supply and an additional 33 (31.1%) participants reported plans to use the disposal bag on a future date. Of the 23 participants who used the DDS, 22 (96.0%) reported that they were very satisfied with the disposal process. CONCLUSION: Participants are willing to use a DDS and are satisfied with the process; however, additional education is needed to ensure timely disposal.

The System Is Broken: A Qualitative Assessment of Opioid Prescribing Practices After Spine Surgery.

OBJECTIVE: To elucidate factors that influence opioid prescribing behaviors of key stakeholders after major spine surgery, with a focus on barriers to optimized prescribing. METHODS: In-person semi-structured interviews were performed with 20 surgical and medical professionals (January 23, 2019 to June 11, 2019) at a large academic medical center, including resident physicians, midlevel providers, attending physicians, and clinical pharmacists. Interviews centered on perceptions of postoperative prescribing practices were coded and analyzed using a qualitative inductive approach. RESULTS: Several unique themes emerged. First, wide interprovider variation exists in the perceived role of opioid prescribing guidelines. Second, there are important relationships between clinical experience, time constraints, and postoperative opioid prescribing. Third, opioid tapering is a major area of inconsistency. Fourth, there are serious challenges in managing analgesic expectations, particularly in those with chronic pain. Finally, there is currently no process to facilitate the hand-off or transition of opioid prescribing responsibility between surgical and primary care teams, which represents a major area for practice optimization efforts. CONCLUSION: Despite increased focus on postoperative opioid prescribing, there remain numerous areas for improvement. The development of tools and processes to address critical gaps in postoperative prescribing will be essential for our efforts to reduce long-term opioid use after major spine surgery and improve patient care.

Treatment Effectiveness and Medication Use Reduction for Older Adults in Interdisciplinary Pain Rehabilitation.

OBJECTIVE: To examine the effectiveness of an interdisciplinary pain rehabilitation program (IPRP) that incorporates medication tapering on improving pain-related and performance-based outcomes for older adults with chronic noncancer pain and determine the proportion who demonstrated reliable improvement in outcome. PATIENTS AND METHODS: This 2-year retrospective clinical cohort study examined treatment outcomes of 134 older adult patients 65 years or older with chronic noncancer pain who completed a 3-week IPRP with physician-supervised medication tapering between January 1, 2015, and December 31, 2017. Pain, pain catastrophizing, depressive symptoms, and quality of life were assessed at pretreatment, posttreatment, and follow-up. Physical performance and medication use were assessed pre- and posttreatment. Outcomes were examined using a series of repeated-measures analyses of variance, examining effect size and reliable change. RESULTS: Significant treatment effects (P<.001) with large effect sizes were observed for all self-report and physical performance outcome measures at posttreatment and 6-month follow-up (42.5% response rate). There were no significant differences in outcome based on opioid use status at admission. Reliable change analyses revealed that 76.9% (n=103 of 134) evidenced improvement in at least 1 pain-related outcome measure at posttreatment, and 87.7% (n=50 of 57), at follow-up. Patients also had significant reductions (P<.01) in medications at posttreatment (opioids, benzodiazepines, sedative-hypnotics, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, and anticonvulsants). CONCLUSION: Older adults with chronic noncancer pain demonstrated improved pain-related outcomes, physical performance, and decreased medication use following IPRP treatment. Results support the effectiveness of IPRPs in enhancing the physical and emotional functioning of older adults with chronic pain while also facilitating the reduction of medications that place them at risk for adverse events.

Association Between Spine Surgery and Availability of Opioid Medication.

Importance: Prolonged prescribing of opioids after spine surgery is often perceived as a negative outcome, but successful opioid reduction may occur despite continued prescribing. Improved characterization of opioid availability before and after surgery is necessary to identify these successes. Objective: To evaluate the association between spine surgery and modification of opioid availability postoperatively by using consistent definitions to classify opioid availability before and after surgery. Design, Setting, and Participants: This population-based cohort study included 2223 adults (age ≥18 years) who underwent spine surgery in Olmsted County, Minnesota, from January 1, 2005, through December 31, 2016. Data were analyzed from April 1, 2019, to December 1, 2019. Exposures: Preoperative opioid availability based on prescription data in the 180 days before surgery in accordance with Consortium to Study Opioid Risks and Trends (CONSORT) definitions. Main Outcomes and Measures: Successful modification of opioid availability, defined as an improvement in CONSORT status postoperatively (assessed from 181 to 365 days after surgery) compared with preoperative status, or continued absence of opioid availability for patients with no preoperative availability. Multivariable logistic regression was used to assess the association between preoperative opioid availability and successful modification by 1 year after undergoing surgery. Results: Of 2223 patients included in the study, 1214 were male (54.6%), with a median age of 55 years (interquartile range, 43-68) years. Patients were classified as having no (778 [35.0%]), short-term (1118 [50.3%]), episodic (227 [10.2%]), or long-term (100 [4.5%]) preoperative opioid availability. Of the 2148 patients (96.6%) who were alive at 1 year, postoperative opioid availability was classified as no (1583 [73.7%]), short-term (398 [18.5%]), episodic (104 [4.8%]), and long-term (63 [2.9%]). A total of 1672 patients (77.8%) had successful modification of opioid availability, with success of 83.0% for those with no preoperative availability, 74.9% for those with short-term preoperative availability, 79.8% for those with episodic preoperative availability, and 64.4% for those with long-term preoperative opioid availability. In multivariable analysis, success was significantly associated with preoperative opioid availability (odds ratio [OR] for short term, 0.61 [95% CI, 0.48-0.77]; OR for episodic, 0.95 [95% CI, 0.64-1.40]; OR long term, 0.49 [95% CI, 0.30-0.82]; P < .001 overall vs no availability). Conclusions and Relevance: In this study, when following standardized CONSORT definitions, 4 of 5 adults undergoing spine surgery in a population-based cohort met the criteria for a successful pattern of postoperative opioid prescribing. Similar methods to objectively assess changes in opioid prescribing may be clinically useful in other perioperative settings.

Examining the effectiveness of pain rehabilitation on chronic pain and post-traumatic symptoms.

Patients with co-morbid chronic pain and post-traumatic stress disorder (PTSD) pose significant treatment challenges. This study evaluated the effectiveness of an interdisciplinary pain rehabilitation program (IPRP) in improving pain and PTSD outcomes, as well as reducing medication use. In addition, the mediating effect of pain catastrophizing, which is theorized to underlie the pain and PTSD comorbidity, was examined. Participants included 83 completers of an IPRP with chronic pain and a provisional PTSD diagnosis. Significant improvements were found for pain outcomes, PTSD symptomatology, depressive symptoms, physical performance, and medication use (i.e., opioids and benzodiazepines). At discharge, 86.7% of participants reliably improved in at least one key measure of functioning and 50.6% demonstrated reliable improvement in PTSD symptomatology. Change in pain catastrophizing mediated improvements in pain interference and PTSD symptomatology. Results support the potential utility of an interdisciplinary pain treatment approach in the treatment of patients with comorbid pain and PTSD.

The professional sabbatical: A systematic review and considerations for the health-system pharmacist.

BACKGROUND: Sabbaticals are considered a professional development experience meant to foster growth and revitalize careers. The personal accounts of sabbaticals among medical professionals indicate high value from this experience. Benefits seen at the institutional and individual level include, but are not limited to, reduced burnout and increased job retention. Staffing issues, determining eligibility, and justifying time utilized may be just some barriers to implementing a sabbatical program accessible to the health-system pharmacist. In the literature, there is a dearth of information related to sabbaticals granted to the health-system pharmacist. However, many published experiences of nurses and physicians exist. OBJECTIVES: A systematic review was performed to synthesize a qualitative yet evidence-based summary of information regarding sabbaticals. The primary aim of this review was to assess the reported benefits and prohibitive factors of taking a sabbatical as it may apply to the health-system pharmacist. METHODS: Three hundred twenty-eight English-language articles were identified through searching Ovid Medline, PsycINFO, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL and Scopus from database inception through December 6, 2019. RESULTS: A total of 172 articles consisting of studies, descriptions of institutional processes, individual accounts, editorials and letters to the editor, and review articles were included in this systematic review. Rejuvenation and new perspectives/skills to bring back to practice should be regarded as important benefits by institutional/departmental leadership as well as the benefits of reduced turnover and improved job satisfaction. Numerous barriers to completing a sabbatical can be overcome with proper planning. CONCLUSION: This review provides limited insight into benefits and barriers to taking sabbaticals and serves as a basis for health-system pharmacy departments to consider initiating a program if one is not currently in place. Mini-sabbaticals may allow the health-system pharmacist to take a professional time away. Corollaries are drawn between a longitudinal pharmacy research award granted at Mayo Clinic - Rochester and ideas are provided for clinical or educational sabbaticals. It is clear that health-system pharmacy-specific information is lacking, and pharmacy department leadership should be encouraged to continue to share experiences of sabbaticals and outcomes.

An Institutional Approach to Managing the Opioid Crisis.

The opioid crisis is a major concern of most health care institutions, including our large academic center. In this article, an organized approach to managing the epidemic institutionally is discussed. An Opioid Stewardship Program was instituted at our tertiary-care center with multiple sites and states of practice, which included diverse membership and expertise. Charges of the program included reviewing current practice, workflows, and external and internal guidelines and evaluating and standardizing prescribing practices. The development of an Opioid Stewardship Program resulted in: (1) an understanding of our diverse prescribing practices and the formation of patient- and procedure-specific guidelines to manage them, (2) education tools for our patients and providers, and (3) workflows and practice advisories within the electronic health record to support appropriate prescribing and monitoring of patients. This ongoing work continues to evolve in response to the needs of our patients, changing regulatory environments, and our improved understanding of our practices.

A Practical Approach for the Management of the Mixed Opioid Agonist-Antagonist Buprenorphine During Acute Pain and Surgery.

The use of buprenorphine, a mixed opioid agonist-antagonist, for the management of chronic pain and/or opioid use disorder is increasing. As such, medical providers will more frequently encounter patients on this therapy. In this paper, we synthesize existing knowledge (derived through keyword searches using MEDLINE databases) in a novel conceptual framework for patients on buprenorphine presenting with acute pain or for those requiring surgical or invasive procedures. This framework is based on three unique domains: the patient, the features of the acute pain insult, and the environment. We discuss important considerations regarding the unique aspects of buprenorphine formulations and dosing, and we describe the importance of multidisciplinary planning and multimodal analgesic strategies. We also highlight important differences in management strategies based upon the presence or absence of opioid use disorder. All medical providers must be prepared to guide the patient on buprenorphine safely through the acute care episode, which includes adequate treatment of acute pain and avoidance of iatrogenic harm, including both short-term complications (eg, respiratory depression) and long-term complications (eg, relapse to opioid use).

Implementation of a pharmacogenomics education program for pharmacists.

PURPOSE: The development, implementation, and evaluation of a pharmacogenomics education program for pharmacists in a large, integrated multicampus health system are described. SUMMARY: Pharmacogenomics has been described as tailoring medications to each patient's unique genetic sequence with the goals of minimizing harmful effects and optimizing therapeutic effects. Pharmacists are uniquely trained to lead the implementation of pharmacogenomics in clinical care. After assessment of pharmacists' comfort with pharmacogenomics, different approaches were explored to develop, pilot test, and disseminate pharmacogenomics education across a multicampus academic medical center. Limited success with large-audience, single-lecture didactic education led to development and delivery of targeted, competency-based online modules using the institution's academic virtual learning environment and course management system. Implementation steps included (1) collaboration with the Mayo Clinic Center for Individualized Medicine to create an interprofessional development team and project charter, (2) galvanizing pharmacy leadership support across multiple campuses, (3) development of competency-based interactive modules, and (4) assessment of the quality of and learner satisfaction with the modules. Significant improvements in competency scores were observed with each module and across the multiple campuses. Satisfaction with the education program was assessed at the end of a 4-module series. CONCLUSION: A pharmacogenomics educational program targeting pharmacists was developed through interprofessional collaboration and provided a novel opportunity to construct an educational infrastructure to support enterprise health-system campuses with limited educational resources.

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status.

Chronic pain is a major public health concern, and widespread use of prescription opioids for chronic pain has contributed to the escalating problem of opioid use disorder. Interdisciplinary pain rehabilitation programs (IPRPs) can be highly effective in discontinuing opioids in patients with chronic pain while also improving functional status. This study sought to examine self-report and performance-based functional outcomes of 2 cohorts of patients enrolled in a 3-week IPRP: patients engaged in interdisciplinary pain treatment and physician-supervised opioid taper versus nonopioid users engaged in interdisciplinary treatment. Immediate and long-term treatment outcomes were assessed using a series of 2 (group: opioid use, no opioid use) × 2 (period: pretreatment, post-treatment) and 2 (group: opioid use, no opioid use) × 2 (period: pretreatment, 6 months post-treatment) mixed model analyses of variance. Group × Period interactions were nonsignificant whereas period effects were significant for all outcomes in directions indicating improvement (Ps < .001) at discharge from the program and at 6 months, irrespective of opioid use status. Results support the assertion that IPRPs lead to significant improvements in subjective as well as objective indices of function, irrespective of opioid use status. Implications for our findings are discussed. PERSPECTIVE: This article provides support for the effectiveness of interdisciplinary, rehabilitative models of care in improving physical and emotional functioning of patients with chronic pain while simultaneously discontinuing opioid use. The reach of this work is substantial, because opioid dependency and chronic pain are public health problems in the United States.

A Lack of Systemic Absorption Following the Repeated Application of Topical Quetiapine in Healthy Adults.

In the absence of suitable oral or intravenous access for medication administration and when the intramuscular medications are undesirable, alternative routes for drug delivery may be considered. Antipsychotics administered via an inhaled, intranasal, rectal, or topical route have been described in the literature. Topically administered antipsychotics have been previously reported to produce negligible systemic absorption despite being used in clinical practice for nausea and behavioral symptoms associated with dementia. Additionally, the American Academy of Hospice and Palliative Medicine recommends against the use of topical medications that lack supporting literature. Three studies have assessed the systemic absorption of different antipsychotics after administration of only a single, topically applied dose. To evaluate whether the repeated administration of a topically applied antipsychotic may result in detectable serum levels in an accumulating fashion, a pharmacokinetic study was conducted. Five healthy, adult participants consented to receive extemporaneously prepared topical quetiapine in Lipoderm every 4 hours for a total of 5 doses. Blood samples were drawn at baseline and hours 2, 4, 8, 12, 16, and 24, and serum quetiapine concentrations were measured using high-performance liquid chromatography. Quetiapine was undetectable in every sample from 3 participants. Two participants had minimally detectable serum quetiapine levels no sooner than hour 12 of the study period. Extemporaneously prepared quetiapine in Lipoderm resulted in nonexistent or minimal serum level following repeated topical administration. The use of topically applied quetiapine should still be questioned.

Comparison of Bioavailability of Single-Dose Extended-Release Venlafaxine Capsules in Obese Patients Before and After Gastric Bypass Surgery.

STUDY OBJECTIVE: The extended-release (ER) form of venlafaxine is preferred because of improved patient adherence, but the immediate-release (IR) form is frequently used after Roux-en-Y gastric bypass (RYGB) surgery because of concerns for malabsorption. The objective of this study was to determine whether a statistically significant and predictable change in the bioavailability of venlafaxine ER capsules occurs after RYGB. DESIGN: Prospective nonblinded single-dose pharmacokinetic study. SETTING: Clinical research unit at a large tertiary care medical practice. PATIENTS: Ten adult pre-bariatric surgery patients who met the criteria for noncomplicated RYGB were enrolled and served as their own controls. INTERVENTIONS: Patients were administered one venlafaxine ER 75-mg capsule at two visits-the first visit at least 1 week before undergoing RYGB and the second visit 3-4 months after RYGB. Blood samples were collected at predetermined intervals over 48 hours after each dose, and the pharmacokinetics of venlafaxine were measured. MEASUREMENTS AND MAIN RESULTS: Plasma levels of venlafaxine and its primary metabolite, O-desmethylvenlafaxine (ODV), were compared at baseline and 3-4 months after RYGB. The areas under the serum concentration-time curves from 0-24 hours (AUC0-24 ) for venlafaxine (mean ± SD 734 ± 602 vs 630 ± 553 ng·hr/ml, p=0.22) and ODV (mean ± SD 894 ± 899 vs 1083 ± 972 ng·hr/ml, p=0.07) were similar before and after RYGB. Using a bioequivalence approach, differences in pre-RYGB and post-RYGB values of AUC0-24 , peak serum concentration, and time to peak serum concentration were not statistically significant for either venlafaxine or ODV. CONCLUSION: This study suggests that RYGB does not significantly alter the amount of venlafaxine or its active metabolite, ODV, absorbed from a venlafaxine ER capsule or the time over which it is absorbed.

Medical cannabis use among patients with chronic pain in an interdisciplinary pain rehabilitation program: Characterization and treatment outcomes.

INTRODUCTION: Cannabis is increasingly being used in the treatment of chronic pain. However, there is a lack of available research in the population of patients with chronic pain who are using cannabis. The current study examines clinical and treatment characteristics for patients who are admitted to a 3-week outpatient interdisciplinary chronic pain rehabilitation program. METHOD: Participants (N=48) included patients with a positive urine drug screen for 9-carboxy-tetrahydrocannabinol (THC(+); n=24) and a matched comparison sample of patients with a negative screen (THC(-); n=24). Participants were matched for age, gender, race, education, and current prescription opioid use. Measures of pain, functioning, and quality of life were completed at admission and discharge. Medical chart review was conducted to assess medication and substance use history. RESULTS: Participants with a positive screen for THC were more likely to report a past history of illicit substance use, alcohol abuse, and current tobacco use. Cannabis use was not associated with a significantly lower morphine equivalence level for participants using prescription opioids (n=14). Both groups of participants reported significant improvement in pain severity, pain interference, depressive symptoms, and pain catastrophizing. There were no group- or treatment-related differences in these outcome variables. DISCUSSION: Results provide preliminary evidence that patients with chronic pain using cannabis may benefit from an interdisciplinary chronic pain program. Patients with chronic pain using cannabis may be at higher risk for substance-related negative outcomes, although more research is needed to understand this relationship.