Ankle brachial indices and anaerobes: is peripheral arterial disease associated with anaerobic bacteria in diabetic foot ulcers?

Background: Lower extremity amputations from diabetic foot ulcers (DFUs) are rebounding, and new biomarkers that predict wound healing are urgently needed. Anaerobic bacteria have been associated with persistent ulcers and may be a promising biomarker beyond currently recommended vascular assessments. It is unknown whether anaerobic markers are simply a downstream outcome of peripheral arterial disease (PAD) and ischemia, however. Here, we evaluate associations between two measures of anaerobic bacteria-abundance and metabolic activity-and PAD. Methods: We built a prospective cohort of 37 patients with baseline ankle brachial index (ABI) results. Anaerobic bacteria were measured in two ways: DNA-based total anaerobic abundance using 16S rRNA gene amplicon sequencing and resulting summed relative abundance, and RNA-based metabolic activity based on bacterial read annotation of metatranscriptomic sequencing. PAD was defined three ways: PAD diagnosis, ABI results, and a dichotomous definition of mild ischemia (versus normal) based on ABI values. Statistical associations between anaerobes and PAD were evaluated using univariate odds ratios (ORs) or Spearman's correlations. Results: Total anaerobe abundance was not significantly associated with PAD diagnosis, ABI results, or mild ischemia (ORPAD = 0.47, 95% CI = 0.023-7.23, p = 0.60; Spearman's correlation coefficientABI = 0.24, p = 0.17; ORmild ischemia = 0.25, 95% CI = 0.005-5.86, p = 0.42). Anaerobic metabolic activity was not significantly associated with PAD diagnosis, ABI results, or mild ischemia (ORPAD = 1.99, 95% CI = 0.17-21.44, p = 0.57; Spearman's correlation coefficientABI = 0.12, p = 0.52; ORmild ischemia = 0.90, 95% CI = 0.03-15.16, p = 0.94). Conclusion: Neither anaerobic abundance nor metabolic activity was strongly associated with our three definitions of PAD. Therefore, anaerobic bacteria may offer additional prognostic value when assessing wound healing potential and should be investigated as potential molecular biomarkers for DFU outcomes.

Association of Prescription Drug Monitoring Program Use With Opioid Prescribing and Health Outcomes: A Comparison of Program Users and Nonusers.

Prescription drug monitoring programs (PDMPs) are a response to the prescription opioid epidemic, but their effects on prescribing and health outcomes remain unclear, with conflicting reports. We sought to determine if prescriber use of Oregon's PDMP led to fewer high-risk opioid prescriptions or overdose events. We conducted a retrospective cohort study from October 2011 through October 2014, using statewide PDMP data, hospitalization registry, and vital records. Early PDMP registrants (n = 927) were matched with clinicians who never registered during the study period, using baseline prescribing metrics in a propensity score. Generalized estimating equations were used to examine prescribing trends after PDMP registration, using 2-month intervals. We found a statewide decline in measures of per capita opioid prescribing. However, compared with nonregistrants, PDMP registrants did not subsequently have significantly fewer patients receiving high-dose prescriptions, overlapping opioid and benzodiazepine prescriptions, inappropriate prescriptions, prescriptions from multiple prescribers, or overdose events. At baseline, frequent PDMP users wrote fewer high-risk opioid prescriptions than infrequent users; this persisted during follow-up with few significant group differences in trend. Thus, although opioid prescribing declined statewide after implementing the PDMP, registrants did not show greater declines than nonregistrants. PERSPECTIVE: Factors other than PDMP use may have had greater influence on prescribing trends. Refinements in the PDMP program and related policies may be necessary to increase PDMP effects.

Clinicians' Use of Prescription Drug Monitoring Programs in Clinical Practice and Decision-Making.

Objectives: Little is known about clinicians' use of prescription drug monitoring program (PDMP) profiles in decision-making. The objective of this qualitative study was to understand how clinicians use, interpret, and integrate PDMP profiles with other information in making clinical decisions. Design: Qualitative interviews of clinician PDMP users. Setting: Oregon registrants in the state's PDMP. Subjects: Thirty-three clinicians practicing in primary care, emergency medicine, pain management, psychiatry, dentistry, and surgery. Methods: We conducted semistructured telephone interviews with PDMP users. A multidisciplinary team used a grounded theory approach to identify patterns of PDMP use and how PDMP profiles influence clinical decisions. Results: PDMP use varied from consistent monitoring to checking the PDMP only on suspicion of misuse, with inconsistent use reported particularly among short-term prescribers. Primary care clinicians reported less routine use with existing pain patients than with new patients. In response to worrisome PDMP profiles with new patients, participants reported declining to prescribe, except in the case of acute, verifiable conditions. Long-term prescribers reported sometimes continuing prescriptions for existing patients depending on perceived patient intent, honesty, and opioid misuse risk. Some long-term prescribers reported discharging patients from their practices due to worrisome PDMP profiles; others expressed strong ethical grounds for retaining patients but discontinuing controlled substances. Conclusion: Greater consistency is needed in use of PDMP in monitoring existing patients and in conformity to guidelines against discharging patients from practice. Research is needed to determine optimal approaches to interpreting PDMP profiles in relation to clinical judgment, patient screeners, and other information.

Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naïve Patients: A Statewide Retrospective Cohort Study.

BACKGROUND: Long-term efficacy of opioids for non-cancer pain is unproven, but risks argue for cautious prescribing. Few data suggest how long or how much opioid can be prescribed for opioid-naïve patients without inadvertently promoting long-term use. OBJECTIVE: To examine the association between initial opioid prescribing patterns and likelihood of long-term use among opioid-naïve patients. DESIGN: Retrospective cohort study; data from Oregon resident prescriptions linked to death certificates and hospital discharges. PARTICIPANTS: Patients filling opioid prescriptions between October 1, 2012, and September 30, 2013, with no opioid fills for the previous 365 days. Subgroup analyses examined patients under age 45 who did not die in the follow-up year, excluding most cancer or palliative care patients. MAIN MEASURES: Exposure: Numbers of prescription fills and cumulative morphine milligram equivalents (MMEs) dispensed during 30 days following opioid initiation ("initiation month"). OUTCOME: Proportion of patients with six or more opioid fills during the subsequent year ("long-term users"). KEY RESULTS: There were 536,767 opioid-naïve patients who filled an opioid prescription. Of these, 26,785 (5.0 %) became long-term users. Numbers of fills and cumulative MMEs during the initiation month were associated with long-term use. Among patients under age 45 using short-acting opioids who did not die in the follow-up year, the adjusted odds ratio (OR) for long-term use among those receiving two fills versus one was 2.25 (95 % CI: 2.17, 2.33). Compared to those who received < 120 total MMEs, those who received between 400 and 799 had an OR of 2.96 (95 % CI: 2.81, 3.11). Patients initiating with long-acting opioids had a higher risk of long-term use than those initiating with short-acting drugs. CONCLUSIONS: Early opioid prescribing patterns are associated with long-term use. While patient characteristics are important, clinicians have greater control over initial prescribing. Our findings may help minimize the risk of inadvertently initiating long-term opioid use.

Clinical Styles and Practice Policies: Influence on Communication with Patients Regarding Worrisome Prescription Drug Monitoring Program Data.

OBJECTIVES: Clinician communication with patients regarding worrisome findings in Prescription Drug Monitoring Programs (PDMPs) may influence patient responses and subsequent care. The authors studied the range of approaches clinicians report when communicating with patients in this situation and how practice policies and procedures may influence this communication. DESIGN: Qualitative interviews of clinician PDMP users. SETTING: Oregon registrants in the state's PDMP. SUBJECTS: Thirty-three clinicians practicing in pain management, emergency medicine, primary care, psychiatry, dentistry, and surgery. METHODS: The authors conducted semi-structured interviews via telephone with clinicians who routinely used the PDMP. A multidisciplinary team used a grounded theory approach to identify ways clinicians reported using information from the PDMP when communicating with patients, and policies that influenced that communication. RESULTS: Clinicians reported using a range of approaches for communicating about PDMP results, from openly sharing, to questioning patients without disclosing access to the PDMP, to avoiding the conversation. Clinicians also reported practice policies and procedures that influenced communication with their patients about prescribing and ongoing care, including policies that normalized use of the PDMP with all patients and those that facilitated difficult conversations by providing a rationale not to prescribe in certain circumstances. CONCLUSION: Clinicians' self-reported approaches to sharing PDMP findings and communicating prescribing decisions with patients vary and may be facilitated by appropriate practice policies. Such communication may have implications for patient engagement and alliance building. More research is needed to identify best practices and potential guidelines for effectively communicating about PDMP findings, as this may enhance health outcomes.

Leading a Horse to Water: Facilitating Registration and Use of a Prescription Drug Monitoring Program.

OBJECTIVES: Prescription Drug Monitoring Programs (PDMPs) can help inform patient management, coordinate care, and identify drug safety risks, abuse, or diversion. However, many clinicians are not registered to use these systems, and use may be suboptimal. We sought to describe outreach efforts in 1 state (Oregon); quantify uptake of system use; identify barriers; and identify potential system improvements. METHODS: Program reports of outreach efforts and operational metrics provided rates of registration and use. A statewide survey identified perceived barriers and potential improvements from users and nonusers of the system. RESULTS: Even with extensive registration efforts, <25% of clinicians and pharmacists acquired PDMP accounts over 2 years of operation. Rapid increases in registration and use in 2013 corresponded to new requirements among large pharmacy chains that pharmacists register for and use the PDMP. Among surveyed PDMP nonusers, nearly half were unaware that they could register. Among users and nonusers, over two thirds indicated that time constraints were a major barrier and over half thought that inability to delegate access was a major barrier. Desired improvements included linking state systems, faster entry of pharmacy data, and use of unique patient identifiers. Users also wanted better insurance coverage for mental health and addiction referrals. DISCUSSION: Increasing registration and use of PDMPs remains important. Clinician feedback indicates that program enhancements and health care system changes would facilitate using and responding to PDMP information. It appears premature to judge the efficacy of PDMPs until best practices for their use are identified and impacts are assessed.

How clinicians use prescription drug monitoring programs: a qualitative inquiry.

OBJECTIVES: Prescription drug monitoring programs (PDMPs) are now active in most states to assist clinicians in identifying potential controlled drug misuse, diversion, or excessive prescribing. Little is still known about the ways in which they are incorporated into workflow and clinical decision making, what barriers continue to exist, and how clinicians are sharing PDMP results with their patients. DESIGN: Qualitative data were collected through online focus groups and telephone interviews. SETTING: Clinicians from pain management, emergency and family medicine, psychiatry/behavioral health, rehabilitation medicine, internal medicine and dentistry participated. PATIENTS: Thirty-five clinicians from nine states participated. METHODS: We conducted two online focus groups and seven telephone interviews. A multidisciplinary team then used a grounded theory approach coupled with an immersion-crystallization strategy for identifying key themes in the resulting transcripts. RESULTS: Some participants, mainly from pain clinics, reported checking the PDMP with every patient, every time. Others checked only for new patients, for new opioid prescriptions, or for patients for whom they suspected abuse. Participants described varied approaches to sharing PDMP information with patients, including openly discussing potential addiction or safety concerns, avoiding discussion altogether, and approaching discussion confrontationally. Participants described patient anger or denial as a common response and noted the role of patient satisfaction surveys as an influence on prescribing. CONCLUSION: Routines for accessing PDMP data and how clinicians respond to it vary widely. As PDMP use becomes more widespread, it will be important to understand what approaches are most effective for identifying and addressing unsafe medication use.

Who uses a prescription drug monitoring program and how? Insights from a statewide survey of Oregon clinicians.

UNLABELLED: Prescription drug monitoring programs (PDMPs) are relatively new but potentially useful tools to enhance prudent prescribing of controlled substances. However, little is known about the types of clinicians who make the most use of PDMPs, how these programs are incorporated into clinicians' work flow, or how clinicians and patients respond to the information. We therefore surveyed a random sample of Oregon providers, with 1,065 respondents. Clinicians in emergency medicine, primary care, and pain and addiction specialties were the largest number of registrants, but many frequent prescribers of controlled substances were not registered to use the PDMP. Among users, 95% reported accessing the PDMP when they suspected a patient of abuse or diversion, but fewer than half would check it for every new patient or every time they prescribe a controlled drug. Nearly all PDMP users reported that they discuss worrisome PDMP data with patients; 54% reported making mental health or substance abuse referrals, and 36% reported sometimes discharging patients from the practice. Clinicians reported frequent patient denial or anger and only occasional requests for help with drug dependence. More research is needed to optimize how clinicians use PDMPs across settings and how clinicians and patients respond to the data. PERSPECTIVE: This study examined differences between PDMP users and nonusers and how clinicians in various specialties use PDMPs in practice. A better understanding of effective PDMP use will facilitate access to treatment for patients with pain while curbing the prescription drug epidemic and may ultimately reduce abuse, misuse, and overdose death.

Measures such as interstate cooperation would improve the efficacy of programs to track controlled drug prescriptions.

In response to increasing abuse of prescription drugs, forty-four states have implemented--and five more states will soon adopt--monitoring programs to track prescriptions of controlled medications. Although these programs were originally designed to help law enforcement officials and regulatory agencies spot possible illegal activity, health care providers have begun to use data from them to help improve patient safety and quality of care. For this article we reviewed government documents, expert white papers, articles from the peer-reviewed medical literature, and reports of the experiences of local health officials. We found some evidence that prescription drug monitoring programs are a benefit to both law enforcement and health care delivery. However, the programs have strengths and weaknesses, and their overall impact on drug abuse and illegal activity remains unclear. We believe that improving the efficacy of prescription drug monitoring programs will require such changes as more standardization and interstate cooperation, better training of providers, more secure funding, and further evaluation.