Life Science Compliance Update

September 29, 2015

Improving Diagnosis in Health Care


When providing health care to patients, it is crucial to get the proper diagnosis as soon as possible to help the patient make the best decisions for their health and long-term goals. Recognizing that diagnostic errors have been around for decades, affecting the accuracy of patient diagnoses, the National Academies of Sciences, Engineering, and Medicine convened a committee of experts to research and better understand how diagnostic errors occur and to propose recommendations on how to improve patient diagnosis.

The committee defined diagnostic error as “the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.” The committee determined that while diagnostic errors stem from a variety of causes, the definition of diagnostic error should be defined from the patient’s perspective because they hold the ultimate risk of harm from diagnostic errors.

The committee understood that since diagnostic errors stem from multiple causes, a singular, narrow focus on reducing diagnostic errors would not achieve the extensive change the committee believes to be necessary. Instead, the committee developed a conceptual model to better articulate the diagnostic process and to identify eight goals to reduce diagnostic error and improve diagnosis.

Those eight goals centered around the importance of the continuous improvement of teamwork, education and training, technology, and research. For example, one particular goal was to enhance healthcare education and training in the diagnostic process. "Getting the right diagnosis depends on all health care professionals involved in the diagnostic process receiving appropriate education and training," the article stated. "Improved emphasis on diagnostic competencies and feedback on diagnostic performance are needed." Education to improve diagnoses is especially important as health care delivery has gotten increasingly complex, the authors note.

The committee concluded with a reminder that nearly everyone has a responsibility in working to reduce diagnostic error: “just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers.”

In addition to the recommendations made to physicians, the National Academies of Sciences, Engineering, and Medicine also put out a pamphlet geared toward patients. The pamphlet’s purpose is to help patients better understand how diagnostic errors occur and what they, as the ultimate risk-bearers of diagnostic error, can do to avoid them. The pamphlet emphasizes how important effective communication and collaboration with medical providers is. It provides a checklist for patients to ensure that they are doing their part in communicating with their medical professionals, including items like: be clear, complete and accurate when describing their illness; keep track of helpful treatments; and keep good medical records.

Overall, there are many factors that contribute to diagnostic error, and many possible solutions that have the potential to reduce the number of misdiagnosed patients. Effective education, collaboration, and continuous improvement are key components of the solution. 

September 04, 2015

Education Positively Impacts Safe Opioid Prescribing Among Clinicians

CMS Open Payment Info 2

A recent study in the journal Pain Medicine, looking at the impact of continuing medical education (CME) on opioid prescribing found that educating clinicians on how to safely prescribe opioids can help decrease misuse among chronic pain sufferers. 

While untreated or under-treated chronic pain causes reduced function and quality of life, including increased risks of suicide, more aggressive chronic pain management with opioid analgesics has been associated with an increase in prescription opioid misuse including addiction and overdose deaths. Due to the high prevalence of prescription opioid misuse, the U.S. Food and Drug Administration (FDA) mandated a Risk Evaluation and Mitigation Strategy (REMS) requiring manufacturers of extended release/long acting (ER/LA) opioids to fund continuing education based on an FDA Blueprint. The ER/LA Opioid Analgesics REMS was designed to ensure that the benefits of ER/LA opioid analgesics outweigh the risks in patients whose clinicians have determined ER/LA opioid analgesics to be an appropriate treatment option. 

"SCOPE" of Pain Program

Boston University School of Medicine, the first CME provider to receive ER/LA opioid REMS funding, launched its Safe and Competent Opioid Prescribing Education (SCOPE of Pain) program in 2013. It is offered as a three-hour live or online activity. The live programs included 20 half-day standalone meetings across the US in 16 states. The live and online curricula are identical and presented using a clinical case involving three separate visits: initial visit - assessing chronic pain and opioid misuse risk; one week later - initiating (continuing) opioid therapy safely and months later - assessing and managing aberrant medication taking behaviors. This allows participants to apply the ER/LA opioid REMS content to a common clinical scenario.

SCOPE of Pain is an online educational program designed to help HCPs "safely and competently use opioids, if appropriate, to manage [ ] patients with chronic pain." Through the case of Mary Williams, a 42 year old with painful diabetic neuropathy and chronic low back pain, HCPs learn how to:

  1. Decide on appropriateness of opioid analgesics
  2. Assess for opioid misuse risk;
  3. Counsel patients about opioid safety, risks and benefits;
  4. Competently monitor patients prescribed opioids for benefit and harm;
  5. Make decisions on continuing or discontinuing opioid analgesics; and
  6. Safely discontinue opioids when there is too little benefit or too much risk and harm

Scope Training Program Results

A total of 10,566 participants have completed SCOPE of Pain since its inception through June 2014, writes the Boston University Medical Center. Twenty-seven percent (2,850/10,566) were considered the primary target group (defined as being physicians, advanced practice nurses or physician assistants licensed to prescribe opioid analgesics and a member of 13 specialties that routinely manage patients with chronic pain).

Immediately post-program, 87 percent of participants stated they were planning to make at least one change to align their practice with guideline-based care. The most frequently stated changes were 1) to improve opioid prescribing documentation (56 percent); 2) to implement or improve opioid prescribing patient education or communication (53 percent); and 3) to institute or improve Patient-Prescriber Agreements (47 percent).

Two months after the training, approximately two-thirds of participants reported increased confidence in guideline-based opioid prescribing practices and 86 percent improved how they prescribe opioids and monitor patients for benefits and harm.

"Our program improved knowledge, attitudes, confidence and clinical practice in safe opioid prescribing," explained corresponding author Daniel Alford, MD, associate professor of medicine and assistant dean at Boston University School of Medicine and course director of the SCOPE of Pain program.

The report notes that while SCOPE of Pain improved clinician-level safe opioid prescribing outcomes, its impact on mitigating opioid misuse risk and harm while maintaining access to opioids for those who are or would benefit remains an unanswered question according to the researchers. "While education cannot be the only strategy to combat this national crisis, it can help improve clinician behaviors and be a major part of the solution," added Alford who is also the medical director of the Office-Based Opioid Treatment (OBOT) at Boston Medical Center.



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