Opioid Therapy for Chronic Pain: Overview of the 2017 US Department of Veterans Affairs and US Department of Defense Clinical Practice Guideline.

Description: The US Department of Veterans Affairs (VA) and US Department of Defense (DoD) revised the 2010 clinical practice guideline (CPG) for the management of opioid therapy for chronic pain, considering the specific needs of the VA and DoD and new evidence regarding prescribing opioid medication for non-end-of-life-related chronic pain. This paper summarizes the major recommendations and compares them with the US Centers for Disease Control and Prevention (CDC) guideline for prescribing opioids. Patient Population: This Opioid Therapy CPG was developed for VA-DoD service members, veterans, and their families. Methods: The VA/DoD Evidence-Based Practice Work Group convened a VA/DoD guideline renewal development effort and conformed to the guidelines established by the VA/DoD Joint Executive Council (JEC) and VA/DoD Health Executive Council (HEC). The panel developed questions, searched and evaluated the literature, developed recommendations using GRADE methodology, and developed algorithms. Passage of the CARA Act by Congress compelled consideration and comparison with the CDC opioid therapy guideline mid-development. Results: There were 18 recommendations made. This article focuses on guideline development and key recommendations with CDC comparisons taken from four major areas, including: initiation and continuation of opioids;type, dose, follow-up, and taper of opioids;risk mitigation;acute pain. Conclusions: Guideline development and recommendations are presented. There was substantial overlap with the CDC opioid guideline. Additionally, there were items particularly relevant to the VA-DoD, including risk mitigation, suicide prevention, and preventing opioid use disorder in young patients. Our guideline highlights avoiding opioid therapy longer than 90 days as a critical juncture.

Evaluation of Buprenorphine Rotation in Patients Receiving Long-term Opioids for Chronic Pain: A Systematic Review.

Importance: Individuals with chronic pain who use long-term opioid therapy (LTOT) are at risk of opioid use disorder and other harmful outcomes. Rotation to buprenorphine may be considered, but the outcomes of such rotation in this population have not been systematically reviewed. Objective: To synthesize the evidence on rotation to buprenorphine from full µ-opioid receptor agonists among individuals with chronic pain who were receiving LTOT, including the outcomes of precipitated opioid withdrawal, pain intensity, pain interference, treatment success, adverse events or adverse effects, mental health condition, and health care use. Evidence Review: PubMed, CINAHL, Embase, and PsycInfo were searched from inception through November 3, 2020, for peer-reviewed original English-language research that reported the prespecified outcomes of rotation from prescribed long-term opioids to buprenorphine among individuals with chronic pain. Two independent reviewers extracted data as well as assessed risk of bias and study quality according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Quality of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Findings: A total of 22 studies were analyzed, of which 5 (22.7%) were randomized clinical trials, 7 (31.8%) were case-control or cohort studies, and 10 (45.5%) were uncontrolled pre-post studies, which involved 1616 unique participants (675 female [41.8%] and 941 male [58.2%] individuals). Six of the 22 studies (27.3%) were primary or secondary analyses of a large randomized clinical trial. Participants had diverse pain and opioid use histories. Rationale for buprenorphine rotation included inadequate analgesia, intolerable adverse effects, risky opioid regimens (eg, high dose and/or sedative coprescriptions), and aberrant opioid use. Most protocols were adapted from protocols for initiating treatment in patients with opioid use disorder and used buccal or sublingual buprenorphine. Very low-quality evidence suggested that buprenorphine rotation was associated with maintained or improved analgesia, with a low risk of precipitating opioid withdrawal. Steady-dose buprenorphine was better tolerated than tapered-dose buprenorphine. Adverse effects were manageable, and severe adverse events were rare. Only 2 studies evaluated mental health outcomes, but none evaluated health care use. Limitations included a high risk of bias in most studies. Conclusions and Relevance: In this systematic review, buprenorphine was associated with reduced chronic pain intensity without precipitating opioid withdrawal in individuals with chronic pain who were receiving LTOT. Future studies are necessary to ascertain the ideal starting dose, formulation, and administration frequency of buprenorphine as well as the best approach to buprenorphine rotation.

Patients' use and perception of medication information leaflets.

BACKGROUND: Federal law mandates that at least 95% of patients receive useful written information with new medications. Recent data concerning whether patients read such leaflets are lacking. OBJECTIVES: To evaluate whether patients read non-manufacturer-developed leaflets and assess patients' opinions concerning the understandability and usefulness of these leaflets. METHODS: Patients were surveyed at 32 community pharmacies in the New York City metropolitan area. The main outcome measures were the percentage of patients who read the leaflet provided with new and refilled medications and the perceived understandability and usefulness of the leaflet. Descriptive statistics were used to analyze the results. RESULTS: A total of 307 patients were surveyed. For leaflets provided with new medications, 151 (49.2%), 65 (21.2%), 49 (16.0%), and 42 (13.7%) reported reading the leaflets always, often, seldom, or never, respectively. For refilled medications, 64 (21.6%), 41 (13.9%), 78 (26.4%), and 113 (38.2%) of the 296 respondents reported reading the leaflets always, often, seldom, or never, respectively. Of 267 patients who read the leaflets provided with new or refilled prescriptions at least seldom, 258 (96.6%) responded to the question concerning its understandability and 257 (96.3%) responded to the question concerning its usefulness. One hundred forty-five (56.2%), 89 (34.5%), 22 (8.5%), and 2 (0.8%) reported that the leaflet was very easy, somewhat easy, somewhat difficult, and very difficult to understand, respectively, and 164 (63.8%), 90 (35.0%), and 3 (1.2%) reported that the leaflet was very useful, somewhat useful, and not useful, respectively. CONCLUSIONS: Approximately two-thirds of the patients surveyed reported reading the leaflets provided with new medications at least often. The majority reported the leaflets to be useful and easy to understand. Pharmacists should advocate reading the leaflet and promote it as a useful resource. The leaflet should not replace the pharmacist's obligation to provide verbal counseling.

Overview of Medicare Part D prescription drug benefit: potential implications for patients with psychotic disorders.

PURPOSE: Medicare Part D prescription drug benefits are reviewed. Potential implications for patients with psychotic disorders in relation to Medicare Part D are discussed. SUMMARY: The newly created Medicare Part D provides prescription drug benefits to many individuals formerly without prescription benefits and, possibly, lower-cost benefits to those who previously relied on other benefits. Participating prescription plans use a variety of pharmacy management tools to minimize costs while providing benefit plans that meet Part D requirements for composition and coverage. Patients then have the challenge of choosing a prescription drug plan that will best satisfy their prescriptions needs. CONCLUSION: The rollout of Part D has not been without problems, and although more Medicare participants are receiving prescription drug benefits at a greater savings, there are concerns that Part D may not provide adequate coverage for all patients or for patients requiring certain types of medications, especially some psychotropic medications. Pharmacists have voiced concerns about the Medicare Part D drug plan in regard to both the degree of coverage it provides to enrollees and the difficulty in administering the benefit.

Use of statins and gemfibrozil in patients with type 2 diabetes mellitus and cardiovascular risk factors attending adult day health care centers: an opportunity for pharmacists.

OBJECTIVE: Identify the extent of statin use for primary prevention of macrovascular complications, the extent of statin or gemfibrozil use for the secondary prevention of cardiovascular morbidity and mortality, and the statin doses used in patients with type 2 diabetes and other cardiovascular risk factors. DESIGN: Retrospective chart review. SETTING: Three adult day health care centers in Brooklyn and Queens, New York. PATIENTS: Patients with a diagnosis of type 2 diabetes and either a history of coronary artery disease or at least one other significant cardiovascular risk factor as defined by the American College of Physicians guidelines (i.e., age greater than 55 years, hypertension, left-ventricular hypertrophy, previous cerebrovascular disease, or peripheral arterial disease). MAIN OUTCOME MEASURES: Percentage of patients prescribed a statin for primary prevention of macrovascular complications of type 2 diabetes, percentage of patients prescribed a statin or gemfibrozil for secondary prevention of cardiovascular mortality and morbidity, and the percentage of patients on at least moderate doses of statins. RESULTS: Ninety-three patients were evaluated-51 in the primary-prevention group and 42 in the secondary-prevention group. In the primary-prevention group, 33 (64.7%) patients were prescribed a statin, while in the secondary-prevention group, 26 (61.9%) patients were on statins, a nonsignificant difference (P = 0.8308). No patients were prescribed gemfibrozil. Of all patients prescribed statins, 63.2% were at least on moderate doses. CONCLUSION: This study demonstrates suboptimal treatment with statins in patients with type 2 diabetes and cardiovascular risk factors.

Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.

UNLABELLED: Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. The American Pain Society, with input from the American Society of Anesthesiologists, commissioned an interdisciplinary expert panel to develop a clinical practice guideline to promote evidence-based, effective, and safer postoperative pain management in children and adults. The guideline was subsequently approved by the American Society for Regional Anesthesia. As part of the guideline development process, a systematic review was commissioned on various aspects related to various interventions and management strategies for postoperative pain. After a review of the evidence, the expert panel formulated recommendations that addressed various aspects of postoperative pain management, including preoperative education, perioperative pain management planning, use of different pharmacological and nonpharmacological modalities, organizational policies, and transition to outpatient care. The recommendations are based on the underlying premise that optimal management begins in the preoperative period with an assessment of the patient and development of a plan of care tailored to the individual and the surgical procedure involved. The panel found that evidence supports the use of multimodal regimens in many situations, although the exact components of effective multimodal care will vary depending on the patient, setting, and surgical procedure. Although these guidelines are based on a systematic review of the evidence on management of postoperative pain, the panel identified numerous research gaps. Of 32 recommendations, 4 were assessed as being supported by high-quality evidence, and 11 (in the areas of patient education and perioperative planning, patient assessment, organizational structures and policies, and transitioning to outpatient care) were made on the basis of low-quality evidence. PERSPECTIVE: This guideline, on the basis of a systematic review of the evidence on postoperative pain management, provides recommendations developed by a multidisciplinary expert panel. Safe and effective postoperative pain management should be on the basis of a plan of care tailored to the individual and the surgical procedure involved, and multimodal regimens are recommended in many situations.

Rapid improvement in pain management: the Veterans Health Administration and the institute for healthcare improvement collaborative.

BACKGROUND: Poor pain management persists in health care. Although common practice errors in pain management have been identified and standards and guidelines for pain management have been published, improvement has been modest. With the goal of rapid improvement in pain management, a joint Collaborative (Veterans Health Administration and Institute for Healthcare Improvement) was conducted from May 2000 to January 2001. OBJECTIVE: To improve delivery of pain management to VHA patients and to compare team process and patient report data on key goals from selected study units. METHODS: Charts were reviewed for outcome and process measures. Measures included changes in percentage of patients with (1) moderate to severe pain, (2) documentation of a pain assessment, (3) documentation of a pain care plan, and (4) documentation that the patient received pain education. RESULTS: Seventy teams from 22 Veteran's Integrated Service Networks throughout the U.S. participated. Moderate or severe pain on study units dropped from 24% to 17%; pain assessment increased from 75% to 85%; pain care plans for patients with at least mild pain increased from 58% to 78%; and number of patients provided with pain educational materials increased from 35% to 62%. DISCUSSION: Significant progress toward the target goals was reported during the Collaborative period. This improvement needs to be viewed in the context of a VHA system-wide effort to improve pain management. Data suggest that a program of team formation, goal identification, testing and adaptation of recommended system changes, sharing and feedback of process and outcome information can produce significant change in pain management in a major health care organization.

Current status of pharmacist-operated drug information centers in the United States.

PURPOSE: Pharmacist-operated drug information centers (DICs) in the United States and Puerto Rico were surveyed, and the results were compared with those of similar surveys conducted over the past 30 years. METHODS: In January 2003, surveys were mailed to 151 institutions that were thought to have an organized DIC, defined as a center that regularly accepts a broad scope of requests from health care professionals, regardless of the location or affiliation of those professionals. The survey covered such topics as affiliations, staffing, services, resources, quality assurance, involvement in education, and funding. RESULTS: One hundred nineteen DICs responded (79%), of which 81 met the criteria. Hospitals and medical centers and colleges and schools of pharmacy continued to be the most commonly reported affiliations. The number of DICs declined in the past decade, and the number of DIC pharmacists and other personnel was the lowest reported in the past 30 years. Drug information pharmacists appeared to be better trained than in the past, and a larger percentage had advanced degrees. Services provided by DICs remained consistent with previous findings, except for greater participation in the training and education of pharmacy students and residents. The resource most commonly reported by DICs as useful was Micromedex Healthcare Series, followed by MEDLINE and AHFS Drug Information. The percentage of DICs with formal quality assurance programs did not change significantly in the past decade. Funding sources and fee-for-service activities remained the same. CONCLUSION: The number of DICs has declined steadily since 1986, and the number of drug information pharmacists is at its lowest in 30 years. DIC services continue to be comprehensive. Only half of the DICs surveyed had a formal quality assurance program.

Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain.

The safe and effective prescribing of opioid therapy for chronic pain has become a significant health care priority over the last several years. Substantial research has focused on patient-oriented interventions toward preventing problematic use, but provider and system level factors may be more amenable to quality improvement approaches. Here, we outline administrative data-based metrics that are intended to assess adherence to key practices outlined in the 2010 Department of Veterans Affairs/Department of Defense Clinical Practice Guideline for management of opioid therapy for chronic pain. In addition to the metrics, we discuss their development process, which was done in consultation with experts on chronic opioid therapy.

Update on the status of 89 drug information centers in the United States.

PURPOSE: Previously identified U.S. drug information centers (DICs) were surveyed to determine whether they were still in existence and whether changes had occurred in the DICs since 2003. METHODS: Eighty-nine DICs identified in a 2003 survey were surveyed in April 2008. For DICs still in existence, questions were designed to determine whether there were changes in the mission, time spent on activities, staffing, and drug information questions (number, complexity, and time required to answer) compared with five years earlier. Respondents' projected need for their DIC over the next five years was also surveyed. RESULTS: Seventy-five (84%) of the 89 DICs were still active. The most notable changes in activities were increases in time spent on educating health-professions students (53%), supporting the institution's medication safety program (44%), and providing information-systems support (36%). The majority of respondents (73%) reported no change in the number of employed drug information personnel. The percentages of DICs reporting an increase, decrease, and no change in the number of drug information requests received were 29%, 42%, and 29%, respectively. Seventy percent reported an increase in the number of complex questions, while 53% reported an increase in the time required to answer each question. Ninety-seven percent of respondents projected no change or an increase in the need for their DIC over the next five years. CONCLUSION: Eighty-four percent of the previously identified DICs were still in existence. The most notable changes in these DICs were increases in the number of DICs focusing on educating health-professions students, the complexity of drug information questions, and the amount of time required to answer each request.

Social connectedness and patient recovery after major operations.

BACKGROUND: Social connectedness is thought to play an important role in overall health and well being. We hypothesized that social network size and other measures of social connectedness would predict perceived pain intensity, unpleasantness, and anxiety in veterans recovering after major thoracic or abdominal operations and influence postoperative complications and length of stay. STUDY DESIGN: Six hundred five patients from two Veterans Affairs' medical centers who participated in a randomized controlled trial of massage as adjuvant treatment for postoperative pain were the subjects of this study. Subjects' social networks were assessed by the numbers of friends or relatives an individual had and how frequently contact was made with members of their social network. Subjective outcomes were rated with visual analogue scales for 5 postoperative days. Daily opiate use, postoperative complications, and length of stay were also recorded. RESULTS: Mean (+/-SD) age was 63.8 years (+/-10.2 years) and 98.5% of participants were men. Those reporting a greater social network were older and had lower preoperative pain intensity, unpleasantness, and state and trait anxiety (p < 0.001). Considerably less pain intensity, unpleasantness, and opiate use were associated with increasing social network size during the first 5 postoperative days. After adjusting for preoperative values of pain and anxiety, these relationships were no longer statistically significant. Smaller social network size was associated with the likelihood of length of stay >or= 7 days (p = 0.03). CONCLUSIONS: These findings suggest that the effect of social networks on surgical outcomes can be mediated by their effect on levels of preoperative pain and anxiety. Patients should be screened preoperatively for pain and anxiety because these are strong predictors of a more difficult postoperative recovery.

Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial.

HYPOTHESIS: Adjuvant massage therapy improves pain management and postoperative anxiety among many patients who experience unrelieved postoperative pain. Pharmacologic interventions alone may not address all of the factors involved in the experience of pain. DESIGN: Randomized controlled trial. SETTING: Department of Veterans Affairs hospitals in Ann Arbor, Michigan, and Indianapolis, Indiana. PATIENTS: Six hundred five veterans (mean age, 64 years) undergoing major surgery from February 1, 2003, through January 31, 2005. INTERVENTIONS: Patients were assigned to the following 3 groups: (1) control (routine care), (2) individualized attention from a massage therapist (20 minutes), or (3) back massage by a massage therapist each evening for up to 5 postoperative days. Main Outcome Measure Short- and long-term (> 4 days) pain intensity, pain unpleasantness, and anxiety measured by visual analog scales. RESULTS: Compared with the control group, patients in the massage group experienced short-term (preintervention vs postintervention) decreases in pain intensity (P = .001), pain unpleasantness (P < .001), and anxiety (P = .007). In addition, patients in the massage group experienced a faster rate of decrease in pain intensity (P = .02) and unpleasantness (P = .01) during the first 4 postoperative days compared with the control group. There were no differences in the rates of decrease in long-term anxiety, length of stay, opiate use, or complications across the 3 groups. CONCLUSION: Massage is an effective and safe adjuvant therapy for the relief of acute postoperative pain in patients undergoing major operations.

Drug information education in doctor of pharmacy programs.

OBJECTIVE: To characterize pharmacy program standards and trends in drug information education. METHODS: A questionnaire containing 34 questions addressing general demographic characteristics, organization, and content of drug information education was distributed to 86 colleges and schools of pharmacy in the United States using a Web-based survey system. RESULTS: Sixty colleges responded (73% response rate). All colleges offered a campus-based 6-year first-professional degree PharmD program. Didactic drug information was a required course in over 70% of these schools. Only 51 of the 60 colleges offered an advanced pharmacy practice experience (APPE) in drug information, and 62% of these did so only on an elective basis. CONCLUSION: Although almost all of the PharmD programs in the US include a required course in drug information, the majority do not have a required APPE in this important area.

Availability of and attitudes toward resources on alternative medicine products in the community pharmacy setting.

OBJECTIVE: To examine the availability of resources on dietary supplements in the community pharmacy setting and to assess the attitudes of community pharmacists toward these resources. DESIGN: Cross-sectional study. SETTING: Community pharmacies in New York and New Jersey that serve as experiential sites for senior student pharmacists at the Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University. PARTICIPANTS: Preceptors or full-time pharmacists. INTERVENTION: Mailed survey. MAIN OUTCOME MEASURES: Frequency of use, availability of, and pharmacists' satisfaction with resources on alternative medicines, defined in the survey as any product including herbal remedies, vitamins, minerals, and natural products that may be purchased at a health food store, pharmacy, supermarket, alternative medicine store/magazine for the purpose of self-treatment. RESULTS: A total of 64 pharmacists characterized their frequency of use of resources on alternative medicines while formulating responses to questions as: never (n = 5; 7.8%), seldom (n = 31; 48.4%), often (n = 24; 37.5%), or always (n = 4; 6.3%). A total of 30 different resources were available to 40 respondents. The most commonly available resources were the PDR for Herbal Medicines (42.5%), The Review of Natural Products (20.0%), and the Web site of the National Center for Complementary and Alternative Medicine (12.5%). Of 54 respondents, 4 (7.1%) reported being completely dissatisfied with the available resources; 17 (31.5%) were somewhat dissatisfied; 25 (46.3%) were somewhat satisfied; and 8 (14.8%) were completely satisfied with the resources available to them. Topics the pharmacists most commonly wanted to see improved included safety (72.7%), interactions (70.9%), and uses (69.1%). CONCLUSION: Community pharmacists do not use information resources on alternative medicine products frequently, and many are not satisfied with the resources available to them.

Weight variability of pharmacist-dispensed split tablets.

OBJECTIVE: To determine the level of weight uniformity of fragments from tablets split into halves and dispensed by pharmacists. DESIGN: Pre-post comparison. SETTING: Laboratory analysis of split tablets returned unused from four long-term care facilities. INTERVENTIONS: Twenty-two dispensed prescriptions containing 560 split tablet halves were collected, and fragment weights (FWs) were determined. Theoretical weights (TWs) of split tablets of the same medications were determined mathematically. MAIN OUTCOME MEASURES: Comparison of the mean FW with the mean TW of each dispensed prescription and determination of whether fragments met United States Pharmacopeia 24 (USP) criteria for weight variation of whole tablets. RESULTS: A significant difference (P < .05) between mean TW and mean FW was found in 2 (9.1%) of the 22 dispensed prescriptions. Overall, 30 (5.4%) of 560 fragments, contained in 10 (45.5%) of the 22 dispensed prescriptions, had weights that deviated by more than 15% from the mean FW. Of the 560 fragments, 32 (5.7%), contained in 10 (45.5%) of 22 dispensed prescriptions, had weights that deviated by more than 15% from mean TW. A total of 15 (68.2%) of the 22 dispensed prescriptions had standard deviations (SDs) that were more than 6% of the mean FW. None of the TWs displayed an SD greater than the USP limit of 6%. Only 7 (31.8%) of the 22 dispensed prescriptions met USP standards, with FWs not exceeding 15% of mean FW and SDs of no greater than 6%. CONCLUSION: Tablet splitting resulted in an unacceptably high incidence of weight variation. Standards should be developed to ensure uniformity of split tablets.