Cost avoidance related to a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly.

Aim: Estimate cost avoidance of pharmacist recommendations for participants enrolled in the Program of All-inclusive Care for the Elderly. Materials & methods: Convenience sample of 200 pharmacogenomics consultations from the PHARM-GENOME-PACE study. Genetic variants, drug-gene interactions, drug-drug-gene interactions and phenoconversions were interrogated. Cost avoidance was estimated and adjusted for inflation. Results: In total, 165 participants had at least one actionable drug-gene pair totaling 429 drug-gene pairs, of which 158 (36.8%) were clinically actionable. Most (70.5%) pharmacists' recommendations were accepted. Estimated cost avoidance was $233,945 when all recommendations were included but conservatively $162,031 based on acceptance rates. Overall mean cost avoidance per actionable drug-gene pair was $1063 or $1983 per participant. Conclusion: Pharmacist-led pharmacogenomics services added to the traditional medication review can avoid substantial costs for payers. Clinical trial registration number: NCT03257605.

Association of a Novel Medication Risk Score with Adverse Drug Events and Other Pertinent Outcomes Among Participants of the Programs of All-Inclusive Care for the Elderly.

Preventable adverse drug events (ADEs) represent a significant public health challenge for the older adult population, since they are associated with higher medical expenditures and more hospitalizations and emergency department (ED) visits. This study examines whether a novel medication risk prediction tool, the MedWise Risk Score™ (MRS), is associated with ADEs and other pertinent outcomes in participants of the Programs of All-Inclusive Care for the Elderly (PACE). Unlike other risk predictors, this tool produces actionable information that pharmacists can easily use to reduce ADE risk. This was a retrospective cross-sectional study that analyzed administrative medical claims data of 1965 PACE participants in 2018. To detect ADEs, we identified all claims that had ADE-related International Classification of Diseases and Health Related Problems, 10th revision (ICD-10) codes. Using logistic and linear regression models, we examined the association between the MRS and a variety of outcomes, including the number of PACE participants with an ADE, total medical expenditures, ED visits, hospitalizations, and hospital length of stay. We found significant associations for every outcome. Specifically, every point increase in the MRS corresponded to an 8.6% increase in the odds of having one or more ADEs per year (OR = 1.086, 95% CI: 1.060, 1.113), $1037 USD in additional annual medical spending (adjusted R2 of 0.739; p < 0.001), 3.2 additional ED visits per 100 participants per year (adjusted R2 of 0.568; p < 0.001), and 2.1 additional hospitalizations per 100 participants per year (adjusted R2 of 0.804; p < 0.001). Therefore, the MRS can risk stratify PACE participants and predict a host of important and relevant outcomes pertaining to medication-related morbidity.

Precision medication: An illustrative case series guiding the clinical application of multi-drug interactions and pharmacogenomics.

Precision medication entails selecting the precise medication, dose, and timing of administration. Multi-drug interactions and genetics significantly affect precision medication. In this article, we present two simulated cases for real-world applications of precision medication. Clinicians may need to acquire additional skills to apply the principles illustrated by these cases.

Prescriber-Initiated Engagement of Pharmacists for Information and Intervention in Programs of All-Inclusive Care for the Elderly.

Little is known about the types of drug information inquiries (DIIs) prescribers caring for older adults ask pharmacists during routine practice. The objective of this research was to analyze the types of DIIs prescribing clinicians of Programs of All-Inclusive Care for the Elderly (PACE) made to clinical pharmacists during routine patient care. This was a retrospective analysis of documented pharmacists' encounters with PACE prescribers between March through December, 2018. DIIs were classified using a developed taxonomy that describes prescribers' motivations for consulting with pharmacists and their drug information needs. Prescribers made 414 DIIs during the study period. Medication safety concerns motivated the majority of prescribers' inquiries (223, 53.9%). Inquiries received frequently involved modifying drug therapy (94, 22.7%), identifying or resolving adverse drug events (75, 18.1%), selecting or adjusting doses (61, 14.7%), selecting new drug therapies (57, 13.8%), and identifying or resolving drug interactions (52, 12.6%). Central nervous system medications (e.g., antidepressants and opioids), were involved in 38.6% (n = 160) of all DIIs. When answering DIIs, pharmacists made 389 recommendations. Start alternative medications (18.0%), start new medications (16.7%), and change doses (12.1%) were the most frequent recommendations rendered. Prescribers implemented at least 79.3% (n = 268) of recommendations based on pharmacy records (n = 338 verifiable recommendations). During clinical practice, PACE prescribers commonly ask pharmacists a variety of DIIs, largely related to medication safety concerns. In response to these DIIs, pharmacists provide medication management recommendations, which are largely implemented by prescribers.

Medication-related problems encountered in the Program of All-Inclusive Care for the Elderly: An observational study.

OBJECTIVE: To evaluate pharmacist-encountered medication-related problems (MRPs) among the participants of the Program of All-Inclusive Care for the Elderly (PACE). DESIGN: This was a retrospective analysis of proprietary pharmacy records detailing pharmacist encounters with PACE clinical staff. SETTING AND PARTICIPANTS: A national provider of pharmacy services to more than 75 PACE organizations. In total, 1057 PACE participants at 69 PACE sites across the United States with documented pharmacist encounters between March and May 2018. OUTCOME MEASURES: MRPs were classified using the Hepler-Strand taxonomy, and pharmacists' recommendations made to prescribers to resolve these MRPs were classified using a modified Hoth taxonomy. In addition, pharmacists' communication methods and prescribers' responses were analyzed. RESULTS: Overall, 2004 MRPs were encountered. The most frequent MRPs identified were related to medication safety concerns, including drug interactions (720, 35.9%), adverse drug reactions (ADRs, 356, 17.8%), high doses (270, 13.5%), and unindicated drugs (252, 12.6%). Drug interactions frequently involved competitive inhibition, 3 or more drugs, opioids, anticoagulants, antiplatelets, and antidepressants. Deprescribe medication (561, 24.8%), start alternative therapy (553, 24.4%), change doses (457, 20.2%), and monitor (243, 10.7%) were the top 4 types of recommendations made by pharmacists. Among 1730 responses obtained from PACE prescribers, 78.1% (n = 1351) of pharmacists' recommendations were accepted. Compared with electronic communication, telephonic communication was associated with more acceptance and less prescriber nonresponse (χ2 = 78.5, P < 0.001). CONCLUSION: Pharmacists identified a substantial number of MRPs in PACE, especially those related to medication safety such as drug interactions and ADRs. In this practice setting, significant collaboration occured between pharmacists and PACE prescribers, as evidenced by the rate of prescribers' acceptance of pharmacists' recommendations. Further research is needed to fully evaluate the economic, clinical, and humanistic outcomes associated with pharmacists' encounters in PACE.

Role of Opioid-Involved Drug Interactions in Chronic Pain Management.

The use of opioids for chronic pain management is extraordinarily common despite substantial evidence of only modest benefits, when compared with nonopioid analgesics. Opioid use is also associated with serious risks, including overdose and death. A growing body of evidence suggests that opioids are involved in significant drug interactions that often go unrecognized in clinical practice. Understanding opioid-involved drug interactions is of great practical importance for all health care professionals caring for patients with chronic pain. In this article, we describe the mechanisms of opioid-involved drug interactions and their potential consequences, which have major public health implications. Additionally, this article provides practical strategies to aid health care professionals in avoiding and mitigating opioid-involved drug interactions in order to obtain a favorable balance in the risk-benefit ratio associated with opioid use. These strategies include using osteopathic principles for chronic pain management, separating the times of administration of the opioid(s) from the nonopioid(s) involved in the interaction, changing the opioid(s) adversely affected by the interaction, changing the nonopioid(s) causing the interaction, and partnering with pharmacists in clinical practice.

Genetic variants and interactions from a pharmacist-led pharmacogenomics service for PACE.

Aim: Evaluate results of pharmacogenomics testing for participants enrolled in the Program of All-inclusive Care for the Elderly (PACE). Materials & methods: A convenience sample of 100 participants from the PHARM-GENOME-PACE study. Genetic variants were determined by pharmacogenomics testing. Drug-gene interactions (DGIs), drug-drug-gene interactions (DDGIs) and phenoconversions were interrogated from a clinical decision support system. Results: In total, 146 genetic variants, 169 DGIs and 125 DDGIs were detected. DGIs and DDGIs occurred most commonly with the CYP2D6 gene (36.1 and 39.2%, respectively). There were 280 instances of phenoconversions; majority (62.9%) affecting the CYP3A4 isoenzyme. Conclusion: Prevalence of exposures to DGIs and DDGIs among PACE participants is high. Pharmacists using a clinical decision support system can support PACE practitioners with assessing multidrug simultaneous interactions. Clinical trial registration: NCT03257605.

Implementation of a pharmacist-led pharmacogenomics service for the Program of All-Inclusive Care for the Elderly (PHARM-GENOME-PACE).

OBJECTIVES: To determine the feasibility of implementing a pharmacist-led pharmacogenomics (PGx) service for the Program of All-Inclusive Care for the Elderly (PACE). SETTING: A national centralized pharmacy providing PGx services to community-based PACE centers. PRACTICE DESCRIPTION: Individuals 55 years of age and older enrolled in PACE who underwent PGx testing as part of their medical care (n = 296). PRACTICE INNOVATION: Pharmacist-led PGx testing, interpreting, and consulting. EVALUATION: Implementation processes and roles were ascertained by reviewing policies and procedures for the PGx service and documented observations made by pharmacists providing the service. Genetic variants and drug-gene interactions (DGIs) were determined by interpretations of PGx test results. Types of recommendations provided by pharmacists were ascertained from PGx consultations. Prescribers' acceptance of recommendations were ascertained by documented responses or drug changes made after PGx consultations. RESULTS: Challenges to implementation included lack of systems interoperability, limited access to medical electronic health records, determining prescribers' responses, and knowledge and competency gaps in PGx. Pharmacist roles most essential to overcoming challenges were interpreting and applying PGx data, determining how to disseminate those data to prescribers, advocating for appropriate PGx testing, and educating about the application of test results to clinical practice. Participants frequently used drugs posing DGI risks, with the majority (73.6%) reporting more than 1 interaction. The overwhelming majority (89.0%) of pharmacists' recommendations to mitigate risks were accepted by referring prescribers. CONCLUSION: Implementing a pharmacist-led PGx service for PACE is feasible. Implementation of this service highlights the leadership role of pharmacists in moving PGx from research to practice.

Implementation of a Standardized Medication Therapy Management Plus Approach within Primary Care.

PURPOSE: The purpose of this study was to implement a clinical pharmacist-led medication therapy management (MTM) service within a primary-care setting that is enhanced by 1) a clinical decision support system (CDSS) that includes a unique combination of medication risk mitigation factors, which aids the pharmacist in interpreting the medication profile, and 2) pharmacogenomics (PGx) testing. METHODS: This was a service implementation study, whereby Medicare beneficiaries were eligible if they were patients of Elmwood Family Physicians, a private family, primary care practice with 2 locations in New Jersey, and were on at least 7 medications. Patients had a medication reconciliation completed by a pharmacist and performed a PGx buccal swab. Patient information was run through a CDSS to aid the pharmacist with screening for multidrug interactions and assessing patient's medication-related risks. The output of the CDSS was used to create recommendations and provide a consult to the physicians. Recommendations were followed up by return of the consult. RESULTS: Enrolled patients used a mean (± standard deviation) of 12.1 (± 4.6) medications. The turnaround time for the MTM Plus consults was 11.7 (± 6.2) days. During the consults, the pharmacist identified 138 medication-related problems (MRPs). The most common MRPs were drug-drug interactions (29.0%) and drug-gene interactions (DGIs; 24.6%). CONCLUSION: Implementing a clinical pharmacist-led MTM Plus service in the primary care setting is feasible. This study highlights that DGIs are common in older adults in family practice and indicates that PGx testing identifies additional MRPs that may otherwise go unnoticed in these patients. The experiences we shared can aid other clinicians in establishing successful MTM Plus services. Future studies should also measure the impact of such personalized medicine services on economic, clinical, and humanistic outcomes. This study has been registered with ClinicalTrials.gov (study No. NCT02748148).

Medication Risk Mitigation: Coordinating and Collaborating with Health Care Systems, Universities, and Researchers to Facilitate the Design and Execution of Practice-Based Research.

The high prevalence of inappropriate polypharmacy in geriatric populations is unacceptable. Traditional medication risk mitigation (MRM) strategies have proven to be effective at improving polypharmacy, but these strategies have not consistently translated into positive health outcomes. Enhanced MRM strategies, such as using pharmacogenomics information, are needed, and these strategies need to be tested. A formidable challenge is successfully integrating pharmacogenomic information into clinical practice. As the medication experts on health care teams, pharmacists have a clear role to play in developing, integrating, and assessing enhanced MRM strategies to improve therapeutic outcomes for geriatric patients.

Toward evidence-based prescribing at end of life: a comparative analysis of sustained-release morphine, oxycodone, and transdermal fentanyl, with pain, constipation, and caregiver interaction outcomes in hospice patients.

OBJECTIVE: The primary goal of this investigation was to examine selected outcomes in hospice patients who are prescribed one of three sustained-release opioid preparations. The outcomes examined include: pain score, constipation severity, and ability of the patient to communicate with caregivers. PATIENTS AND SETTINGS: This study included 12,000 terminally ill patients consecutively admitted to hospices and receiving pharmaceutical care services between the period of July 1 and December 31, 2002. DESIGN: We retrospectively examined prescribing patterns of sustained-release morphine, oxycodone, and transdermal fentanyl. We compared individual opioids on the aforementioned outcome markers, as well as patient gender, terminal diagnosis, and median length of stay. RESULTS: Patients prescribed a sustained-release opioid had similar average ratings of pain and constipation severity, regardless of the agent chosen. Patients prescribed transdermal fentanyl were reported to have more difficulty communicating with friends and family when compared with patients prescribed either morphine or oxycodone. On average, patients prescribed transdermal fentanyl had a shorter length of stay on hospice as compared with those receiving morphine or oxycodone. CONCLUSION: There was no difference in observed pain or constipation severity among patients prescribed sustained-release opioid preparations. Patients receiving fentanyl were likely to have been prescribed the medication due to advanced illness and associated dysphagia. Diminished ability to communicate with caregivers and a shorter hospice course would be consistent with this profile. Further investigation is warranted to examine the correlation between a patient's ability to interact with caregivers and pain control achieved.

Are newer, more expensive pharmacotherapy options associated with superior symptom control compared to less costly agents used in a collaborative practice setting?

Innovative approaches to care may be necessary to provide the most effective symptom management to hospice patients. One approach is prescribing newer pharmacotherapy options with the potential to improve symptom management in hospice. Such therapies are sometimes prescribed outside of Food and Drug Administration indications and are typically more costly than older agents used for the same symptoms. Another approach is the collaborative practice (CP) care model, whereby clinical pharmacists are given prescriptive authority according to evidence-based protocols and algorithms within boundaries approved by a physician. The agents typically included in CP protocols are those with wide therapeutic indices and with substantial evidence to support their use. The purpose of this study was to examine both approaches to management of pain, insomnia, and nausea, comparing symptom scores for those patients who received noncollaborative drug therapies (transdermal fentanyl, zolpidem, and ondansetron) to those who received agents under CP (oral sustained-release opioids, temazepam, and prochlorperazine). The object of the study was to investigate outcomes associated with newer drug therapy options as compared to older agents for the management of pain, insomnia, and nausea. A secondary goal is to compare symptom outcomes for patients receiving pharmaceutical care under CP and non-CP models. The study design was retrospective with a cohort. A total of 50 patients were randomly selected for each cohort of the pain and insomnia study arms. Only 45 patients prescribed oral ondansetron met inclusion criteria for the nausea group; 45 patients prescribed prochlorperazine were randomly selected as the comparator group. Patients were compared on their degree of response to the prescribed therapy. Response was classified as complete, partial, no improvement from baseline, worsened, or unknown. A complete response was defined as the symptom score improving to a 0 of 10, regardless of the previous value documented. A partial response was defined as any improvement in score that did not result in a 0 of 10. No improvement from baseline reflected a lack of overall change in score throughout the series of data points collected. A worsened response was any score found to be higher than the score documented at the time of dispense. The unknown category reflects any set of scores that had an "N/A " documented at the time of medication dispense or when documented for both attempts subsequent to dispensing the medication. A complete response was present in 14 of 50 (28 [corrected] percent) of the patients prescribed oral therapy [corrected] as compared with 12 of 50 (24 [corrected] percent) of those prescribed fentanyl [corrected] (p = .82). Responses defined as partial, no improvement over baseline, worsened, and unknown were also comparable between the two cohorts. A complete response was seen in 26 patients prescribed temazepam (52 percent), whereas only 11 (22 percent) of patients initially prescribed zolpidem achieved the same response (p = .0037). Both groups had a similar distribution of partial, no improvement over baseline, and worsened responses. For the nausea arm of the study, a difference was found in the number of complete responses, favoring prochlorperazine (22 of 45, 48.9 percent for prochlorperazine, 12 of 45, 26.7 percent for ondansetron, p = .0504), as well as an increased number of worse responses seen with ondansetron patients (p = .0513); however, neither difference was statistically significant. Newer pharmacotherapy options for the management of pain, insomnia, and nausea were not found to be superior when compared to older agents prescribed under CP.

Initial Selection of Antiemetics in End-of-Life Care: A Retrospecitve Analysis.

The purpose of this study was to compare the relative severity of nausea and vomiting scores before and after initiation of treatnment regimens in end-of-life cancer patients, and secondarily to evaluate the efficacy of a combination antiemetic preparation (ABHR; lorazepam [Ativan], diphenhydramine [Benadryl], haloperidol [Haldol], and metoclopramide [Reglan] in this patient population. A retrospective analysis of antiemetic use was performed through a systematic chart review of patients with an end-of-life diagnosis of lung, pancreatic, or colorectal cancer whose medications were provided through Hospice Pharmacia. Information collected included patient age and sex; terminal diagnosis; pre- and post-antiemetic nausea and vomiting scores; and initial antiemetic choice. A total of 584 patient records were examined, and the most widely used antiemetics used were prochlorperazine, metoclopramide, and ABHR. The most prevalent diagnosis was lung cancer. All of the agents and preparations were determined to be effective as intial therapy for the management of nausea and vomiting in the end-of-life cancer patient; therefore use of these agents as first-line therapy options in this population appears to be justified. ABHR appears to be at least as efficacious as other first-line monotherapy options investigated. Despite a lack of information on the absolute bioavailability of alternative ABHR dosage forms such as suppositories and topical gels, these also appear to be efficacious and therefore are viable options in the treatment of nausea and vomiting in end-of-life cancer patients.

Toward evidence-based prescribing at end of life: a comparative review of temazepam and zolpidem for the treatment of insomnia.

A comparative review of temazepam and zolpidem use in managing insomnia in the hospice patient was undertaken to determine whether treatment with temazepam is a more cost-effective approach for this patient population. A MEDLINE search was conducted to identify pertinent literature, including clinical trials and reviews that involved temazepam or zolpidem. Published data was used as background information and provided in the discussion. This retrospective analysis, conducted from June 2002 through November 2002, focused on the prescribing patterns of temazepam and zolpidem in our hospice practice setting. We examined the reasons for discontinuation of each agent, along with the frequency of therapeutic change from temazepam to zolpidem. The top 10 ICD-9 codes associated with each treatment modality were investigated to determine any prescribing patterns. A total of 4,752 participants were prescribed either temazepam or zolpidem during this six-month period. Of the 4,065 patients prescribed temazepam 9.9 percent had the agent discontinued, whereas, 13.0 percent of those taking zolpidem (n = 687) terminated therapy. Reasons for discontinuation included change in dose, incomplete efficacy, change in patient status, adverse drug reaction, cultural/social issues and "other." Analyses of prescribing patterns and the reasons for termination of each drug therapy were completed and compared with results found in the primary literature. Due to the limited financial resources available for hospice care, our goal is to provide the most clinically appropriate and cost-effective agents for hospice patients. With the lack of data pertaining to the hospice patient, physicians often are faced with challenges in deciding the most appropriate therapy. They may prefer one agent over another based on current medical opinion rather than sound clinical evidence. After review of the primary literature and the prescribing patterns in our setting, there is currently no evidence in our patient population to support that zolpidem is superior to benzodiazepines for the treatment of insomnia.

Methadone and the hospice patient: prescribing trends in the home-care setting.

OBJECTIVE: To identify frequency and utilization patterns of methadone by hospice patients in the home-care setting. PATIENTS AND SETTING: All hospice patients admitted to a North American palliative care specialty pharmacy and dispensed methadone from November 1, 2001 to October 31, 2002 were analyzed. We also analyzed all hospice patients dispensed long-acting opioids during that same time period. DESIGN: A retrospective analysis of the pharmacy database was performed for patients dispensed methadone. Data was compared to the long acting opioid cohort to be able to identify any difference in terminal diagnoses present, and the presence of neuropathic pain in both groups. Methadone daily dosage was also analyzed during this study. RESULTS: Four hundred sixteen hospice patients were dispensed methadone over a twelve-month period of time. For comparison, 21,219 patients were prescribed a long-acting opioid preparation (sustained-release morphine, sustained-release oxycodone, or transdermal fentanyl). The most common terminal diagnosis for both groups was lung carcinoma. The distribution of terminal diagnoses was similar in both groups. The group prescribed methadone was found to have a higher incidence of neuropathic pain (30.5% of patients) when compared to the long-acting opioid group (16.9%). Most patients (61.3%) were prescribed daily methadone doses of 100 mg or less. CONCLUSIONS: Despite its potential clinical and economic benefits, methadone is not commonly prescribed for the hospice patient in the home-care setting. Clinicians may be more aware of the usefulness of methadone in the treatment of neuropathic pain.