Primary care physician attitudes and perceptions of the impact of FDA-proposed REMS policy on prescription of extended-release and long-acting opioids

Figures & data

Table 1 Demographics of sample

	PCPs (n = 201)
Degree, MD/DO	100.0%
Specialty
Family medicine	49.3%
Internal medicine	50.7%
Gender, male	68.2%
Years since medical school graduation, mean (SD)	23 (10)
Attended medical school in US	74.6%
Patients seen per week, mean (SD)	112 (63)
Patients with chronic noncancer pain seen per week, mean (SD)	27 (25)
Patients with prescription for long-acting/extended release opioid seen per week, mean (SD)	16 (27)
Practice size
Solo	28.4%
Small group (1–5)	39.8%
Large group (>5)	31.8%
Physicians in practice, mean (SD)	10 (22)
Practice location
Urban	35.8%
Suburban	46.8%
Rural	17.4%
Has nurse practitioner or physician assistant in practice	50.2%
Currently prescribe opioids for
Acute pain	99.0%
Chronic cancer-related pain	90.0%
Chronic noncancer pain	96.5%
Participation in educational programs on safe and effective opioid use in past 2 years
REMS certification/training program required for prescribers	6.0%
Voluntary REMS certification/training program	4.0%
Continuing medical education program	64.2%
Other	4.0%
None	31.8%

Abbreviations: PCPs, primary care physician; SD, standard deviation; REMS, Risk Evaluation and Mitigation Strategies.

Figure 1 Familiarity and attitudes towards requirements proposed by the US Food and Drug Administration for ER/LA opioids. (A) Nearly a third of the primary care physicians in the sample (n = 201) reported that they were not familiar with REMS requirements proposed by the US Food and Drug for ER/LA opioids, rating familiarity as 1 or 2 on a 10-point scale. (B) Physicians vary widely on the effects of prescribing requirements on patient care (n = 201).

Notes: There is no consensus amongst surveyed physicians on whether prescribing requirements will reduce abuse and misuse of ER/LA opioids, improve patient education, lead to under-treatment, or cause a shift to shorter-acting therapies.
Abbreviations: FDA, Food and Drug Administration; ER/LA opioids, extended-release/long-acting opioids; REMS, Risk Evaluation and Mitigation Strategies.

Table 2 Impact of potential components of opioid prescribing requirements on patient care (n = 201)

	Greatest positive impact on patient care	Greatest negative impact on patient care	No impact on patient care*
Medication guide	17.4%	16.9%	59.7%
Elements to assure safe use	38.8%	21.9%	13.4%
Implementation system	19.9%	49.8%	14.9%
Communication plan	23.9%	11.4%	23.9%

Note:

* Respondents were allowed to select more than one option.

Figure 2 Physician and patient barriers to opioid prescription. (A) Respondents were asked to rate how significant certain potential requirements would be when prescribing currently available and emerging ER/LA opioids (n = 201). Locally available training and less time spent on mandatory education are factors seen as less burdensome to prescribing either set of opioids. Physicians also seem more likely to find training on currently available medications less burdensome than emerging therapies. (B) A third of surveyed primary care physicians (n = 201) would consider requiring patients receiving opioids to complete patient education to be a significant barrier to prescribing these therapies.

Note: The burden to prescription increases if regulations require national patient registries.
Abbreviation: ER/LA opioids, extended-release/long-acting opioids; CME, continuing medical education.