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Physician attitudes regarding the risks, safe use, and regulations of long-acting or extended-release opioids for patients with chronic pain
CEOutcomes LLC, Nov 2011, Pages: 41
BACKGROUND AND PROJECT OVERVIEW
Hundreds of millions of Americans suffer from chronic pain, significantly reducing their quality of life. With this, opioid therapy is becoming more common, leading to increases in concern on issues of abuse and misuse. Additionally, the FDA recently released a statement notifying sponsors and manufacturers of long-acting and extended-release (LA/ER) opioids of the need to develop Risk Evaluation and Mitigation Strategies (REMS) programs in order to ensure the benefits of this therapy choice outweigh any potential risks. There is little research on the current processes physicians use when deciding when and how to counsel patients on the risks and safe use of opioid therapy, nor are there detailed studies on physician opinions of opioid-prescribing and education regulations. This paper presents initial data on the factors involved in the decision-making process of initiating a conversation about the risks and safe use of LA/ER opioids. Additionally, information is gathered on the attitudes surrounding new opioids regulations, including familiarity with the FDA-proposed REMS requirements.
STUDY OBJECTIVES
Based on the identified gaps in the current medical literature, the following objectives for this study were identified:
- Establish a baseline on the current physician attitudes toward initiating discussions with their patients about the risks and safe use of LA/ER opioids
- Understand the current physician attitudes toward additional regulations on prescribing LA/ER opioids
- Identify the factors involved in physicians’ decision to initiate a discussion with their patients about the risks and safe use of LA/ER opioids
- Determine the barriers to patient care that may be raised by increased educational and regulatory requirements for prescription of LA/ER opioids
KEY RESULTS
- Half of surveyed PCPs do not always discuss the risks and safe use of LA/ER opioids with their patients when providing a new prescription, although they mostly have positive attitudes regarding doing so.
- A main factor when deciding to initiate a discussion is whether the patient and physician have a trusting and lengthy relationship, a decision model which could lead to many patients not getting the counseling that they need.
- Most PCPs are not familiar with the FDA-proposed REMS requirements for LA/ER opioids; REMS familiarity is correlated with participation in an educational activity in the past 2 years.
- There is no PCP consensus on whether prescribing requirements will reduce abuse and misuse of LA/ER opioids, improve patient education, lead to under-treatment, or cause a shift to shorter-acting therapies.
- Increasing requirements for time and distance for opioid education increases the physician burden for prescription of LA/ER opioids, whether current or emerging.
- Almost half of physicians view a national patient registry as a significant barrier to prescribing LA/ER opioids.
- The main predictor of initiation of discussions regarding risks and safe use of LA/ER opioids is whether their colleagues, office, and staff expect them to have discussions and if they find such actions important.
CONCLUSIONS
These data highlight many gaps in the care of patients with chronic pain that can be utilized by educational, informational, or policy interventions. Additionally, the physician attitudes toward increased regulatory oversight of opioid therapy prescriptions should be taken into consideration by groups developing these interventions to ensure that they do not cause undue burden on the already overtaxed PCP. Key insights, including recommended actions to increase patient discussions about risks and safe use of opioids, can be inferred from this data and used to improve patient outcomes.
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