Patient Knowledge of Safe Use of ER/LA Opioid Analgesics Following Implementation of the Class-Wide REMS: A Survey Study

Figures & data

Table 1 Knowledge Assessment Questions by REMS Risk Message

Risk Message (RM)/Knowledge Question	Correct Answer
RM-1. The patient understands the serious risks associated with the use of their ER/LA opioid analgesic
a. Taking or using too much ER/LA opioid, also called overdose, may cause life-threatening breathing problems, respiratory depression, or abnormally slow breathing that can lead to death.	True
b. ER/LA opioid analgesics can make you dizzy, lightheaded or sleepy.	True
c. Constipation is a possible side effect when using [OPIOID]	True
d. [OPIOID] can cause serious side effects that can lead to death, even when used as recommended	True
e. Addiction is a risk associated with use of [OPIOID]	True
f. Death is a risk associated with use of [OPIOID]	True
g. Unintentional overdose is a risk associated with use of [OPIOID]	True
RM-2. The patient knows what to do if they take too much drug
h. You should get emergency medical help if you take or use too much or overdose on [OPIOID], even if you feel fine.	True
i. You should get emergency medical help if you experience side effects such as trouble breathing, shortness of breath, fast heartbeat, chest pain or swelling of your face, tongue or throat, after taking or using [OPIOID].	True
RM-3. The patient understands the need to store the drug in a safe place
j. You should store [OPIOID] in a medicine cabinet with other medications in the household.	False
k. After you stop taking or using [OPIOID], it is okay to throw any unused medicine in the trash.	False
l. If a child takes or uses your [OPIOID], they could die.	True
RM-4. The patient knows they should not share the drug with anyone
m. It is okay for you to give [OPIOID] to other people who have the same condition as you have.	False
n. Selling or giving away your [OPIOID] is against the law.	True
RM-5. The patient understands how to use the drug safely
o. It’s okay to stop taking or using [OPIOID] without talking to your healthcare provider.	False
p. If the dose you are taking or using does not control the pain, it is okay to take or use more medicine without talking to your healthcare provider.	False
q. It’s okay to drink alcohol while taking or using [OPIOID].	False
r. It’s not necessary to read the attached Medication Guide every time you fill your [OPIOID] prescription.	True
s. You do not have to tell your healthcare provider about all the other medications you use.	False
t. You do not have to tell your healthcare provider if you have a history of abuse of street or prescription drugs, alcohol addiction, or mental health problems.	False
u.You do not have to tell your healthcare provider about over-the-counter medicines, vitamins, and dietary supplements.	False
v. It’s okay to drink caffeine while using [OPIOID].	True
w. If you miss a dose of the ER/LA opioid analgesic, you should take the missed dose as soon as possible.	True
x. (ORAL Only) If you have trouble swallowing your medication, you should split or crush the pill.	False
y. (ORAL Only) If you miss a dose of [OPIOID], you can take more when it is time for your next dose.	False
z. (PATCH Only) You need to tell your healthcare provider if you have a fever.	True
aa. (PATCH Only) If you still have pain, you should try using a hot tub or sauna while using [OPIOID].	False
bb. (PATCH Only) It is okay to cut your patch in half if you want to use less medicine.	False

Note: When answering the survey, respondents saw the name of the product that they used in the place of “[OPIOID].”

Figure 1 Survey sample disposition.

Table 2 Demographic and Clinical Characteristics of Survey Respondents

	Commercial		Medicare Advantage		Medicaid
	N	(%)	N	(%)	N	(%)
Total number of respondents	382	(100)	43	(100)	40	(100)
Age in years, mean (SD)	53.1	(10.17)	72.5	(7.09)	47.5	(12.83)
Gender, n (%)
Female	243	(64)	30	(70)	23	(58)
Male	138	(36)	13	(30)	17	(43)
Refused	1	(0)	0	(0)	0	(0)
U.S. Census region of residence, n (%)
Northeast	68	(18)	4	(9)	0	(0)
South	115	(30)	11	(26)	0	(0)
Midwest	121	(32)	28	(65)	0	(0)
West	78	(20)	0	(0)	0	(0)
Unknown	0	(0)	0	(0)	40	(100)
Race/Ethnicity, n (%)
White, Caucasian	332	(87)	37	(86)	37	(93)
Other	50	(13)	6	(14)	3	(7)
Marital status, n (%)
Married/Living with partner	235	(62)	15	(35)	17	(43)
Single, separated, divorced, widowed	147	(38)	28	(65)	23	(58)
Income level, U.S. dollars
Less than $25,000	94	(25)	22	(51)	17	(43)
$25,000 or more	258	(68)	16	(37)	23	(58)
Don’t know	30	(8)	5	(12)	0	(0)
Education level
High school or less	101	(26)	19	(44)	8	(20)
Some college	145	(38)	16	(37)	13	(33)
College graduate/Graduate school	132	(35)	8	(19)	19	(48)
Other	4	(1)	0	(0)	0	(0)
Specific ER/LA opioid analgesic(s) used, n (%)
Oral drugs that are not methadone only	259	(68)	21	(49)	25	(63)
Patch and no methadone	77	(20)	15	(35)	4	(10)
Methadone	44	(12)	7	(16)	11	(28)
Patch and methadone	2	(1)	0	(0)	0	(0)
New user, n (%)
First use	77	(20)	8	(19)	11	(28)
Used before	301	(79)	35	(81)	29	(73)
Not sure	4	(1)	0	(0)	0	(0)
Time since last prescription, n (%)
Less than one month ago	210	(55)	23	(53)	21	(53)
One month to less than six months ago	96	(25)	15	(35)	12	(30)
Six months to less than 12 months ago	60	(16)	2	(5)	6	(15)
12 months or more ago	13	(3)	2	(5)	1	(3)
Not sure	3	(1)	1	(2)	0	(0)
Time since most recent visit to the healthcare provider who prescribed ER/LA opioid analgesic, n (%)
Less than one month ago	190	(50)	18	(42)	14	(35)
One month to less than six months ago	144	(38)	18	(42)	23	(58)
Six months to less than 12 months ago	33	(9)	2	(5)	3	(8)
12 months or more ago	13	(3)	5	(12)	0	(0)
Not sure	2	(1)	0	(0)	0	(0)
Time since healthcare provider first prescribed ER/LA opioid analgesic, n (%)
Less than one month ago	18	(5)	3	(7)	4	(10)
One months to less than six months ago	45	(12)	6	(14)	15	(38)
Six months to less than 12 months ago	85	(22)	4	(9)	4	(10)
12 months or more ago	222	(58)	28	(65)	17	(43)
Not sure	12	(3)	2	(5)	0	(0)
Type of healthcare provider that first prescribed the survey index ER/LA opioid analgesic drug, n (%)
Pain specialist	187	(49)	17	(40)	13	(33)
Primary care physician, general practitioner, internal medicine specialist, or family practice  physician	86	(23)	18	(42)	19	(48)
Other type of healthcare provider	107	(28)	6	(14)	8	(20)
Not sure	2	(1)	2	(5)	0	(0)

Note: Percentages may not sum to 100% due to rounding.

Abbreviations: ER/LA, extended-release/long-acting; GED, General Education Degree; N, number; SD, standard deviation; US, United States.

Table 3 Patient Recall of Medication Guide, Patient Counseling Document, and Specific Counseling Topics

Total Number of Respondents	Commercial		Medicare Advantage		Medicaid
	N	(%)	N	(%)	N	(%)
	382	(100)	43	(100)	40	(100)
Received and/or read MG (Yes); N (%)	375	(98)	43	(100)	38	(95)
Received MG from pharmacist with last ER/LA opioid analgesic prescription fill (Yes); N (%)	356	(93)	39	(91)	32	(80)
Received MG from pharmacist in the last 12 months (Yes); N (%)	360	(94)	40	(93)	32	(80)
Received MG from any source besides pharmacist in the last 12 months (Yes); N (%)	38	(10)	4	(9)	11	(28)
Read MG; N (%)
Read all, with each pharmacy fill	86	(23)	11	(26)	5	(13)
Read all, at least once	214	(56)	20	(47)	19	(48)
Read some, at least once	73	(19)	11	(26)	16	(40)
Never read MG	9	(2)	1	(2)	0	(0)
Usefulness of the information in the MG; N (%)
Very useful	246	(64)	32	(74)	14	(35)
Somewhat useful	115	(30)	6	(14)	19	(48)
Not very useful/Not useful at all	13	(3)	5	(12)	7	(18)
Refused	3	(1)	0	(0)	0	(0)
Understood all/most information in the MG; N (%)	358	(94)	36	(83)	31	(78)
Received and/or healthcare provider referenced PCD (Yes); N (%)	180	(47)	28	(65)	21	(53)
Received PCD from healthcare provider when first prescribed current ER/LA opioid analgesic (Yes); N (%)	143	(79)	20	(71)	17	(81)
Healthcare provider referred to or discussed PCD when prescribing the current ER/LA opioid analgesic in the last 12 months (Yes); N (%)	103	(57)	14	(50)	16	(76)
Healthcare provider completed a Patient Prescriber Agreement (PPA) or patient contract when the current ER/LA opioid analgesic was prescribed in the last 12 months (Yes); N (%)	116	(64)	18	(64)	18	(86)
Frequency healthcare provider did following activities in the past 12 months when visited (Always or Regularly); N (%)
a. Used the PCD on ER/LA opioids for discussions.	140	(37)	21	(49)	18	(45)
b. Cautioned about important risks associated with ER/LA opioid analgesics, including overdose or taking or using too much.	259	(68)	33	(77)	26	(65)
c. Discussed how to safely discontinue ER/LA opioid analgesics if they are no longer needed.	192	(50)	21	(49)	27	(68)
d. Counseled on the most common side effects from using ER/LA opioid analgesics.	260	(68)	28	(65)	27	(68)
e. Instructed about the importance and how to safely dispose of any unused ER/LA opioid analgesics.	175	(46)	24	(56)	24	(60)
f. Instructed about keeping ER/LA opioid analgesics safe and away from children.	250	(65)	32	(74)	25	(63)
g. Instructed not to share ER/LA opioid analgesics with anyone else.	242	(63)	29	(67)	26	(65)
h. Asked about medical history when prescribing ER/LA opioid analgesics.	300	(79)	28	(65)	35	(88)
i. Talked about how much medication to take or use when ER/LA opioid analgesics were prescribed.	327	(86)	35	(81)	35	(88)
j. Talked about what to do with extra medication when ER/LA opioid analgesics were prescribed.	180	(47)	22	(51)	23	(58)

Note: Percentages may not sum to 100% due to rounding.

Abbreviations: MG, medication guide; ER/LA, extended-release/long-acting; KAS, knowledge assessment score; PCD, patient counseling document; SD, standard deviation; N, number.

Table 4 Knowledge Assessment Scores and Statements (KAS)

Total Number of Respondents	Commercial		Medicare Advantage		Medicaid
	N	(%)	N	(%)	N	(%)
	382	(100)	43	(100)	40	(100)
Knowledge Assessment Score (KAS), mean (SD)	87.4	(9.73)	81.1	(13.01)	77.9	(15.53)
Knowledge Assessment Score (KAS), median		88.2		84.6		80.0
Knowledge Assessment Scores (KAS), n (%)
≥ 80% correct	325	(85)	26	(60)	21	(53)
<80% correct	57	(15)	17	(40)	19	(48)
RM-1. The patient understands the serious risks associated with the use of their ER/LA opioid analgesic
a. Taking or using too much ER/LA opioids, also called overdose, may cause life-threatening breathing problems, respiratory depression, or abnormally slow breathing that can lead to death (Correct), n (%)	368	(96)	40	(93)	37	(93)
b. ER/LA opioid analgesics can make you dizzy, lightheaded, or sleepy (Correct), n (%)	340	(89)	35	(81)	34	(85)
c. Constipation is a possible side effect of opioids (Correct), n (%)	361	(95)	35	(81)	34	(85)
d. Opioid can cause serious side effects that can lead to death, even when used as recommended (Correct), n (%)	277	(73)	24	(56)	25	(63)
e. Addiction is a risk associated with use of opioid (Correct), n (%)	357	(93)	36	(84)	37	(93)
f. Death is a risk associated with use of opioid (Correct), n (%)	306	(80)	28	(65)	27	(68)
g. Unintentional overdose is a risk associated with use of opioid (Correct), n (%)	314	(82)	32	(74)	33	(83)
RM-2. The patient knows what to do if they take too much drug
h. Seek emergency medical help for ER/LA opioid analgesic overdose, even if the respondent feels fine (Correct), n (%)	356	(93)	36	(84)	35	(88)
i. Seek emergency medical help for side effects such as trouble breathing, shortness of breath, fast heartbeat, chest pain, or swelling of their face, tongue, or throat after taking or using ER/LA opioid analgesics (Correct), n (%)	379	(99)	41	(95)	38	(95)
RM-3. The patient understands the need to store the drug in a safe place
j. Do not store ER/LA opioid analgesics in a medicine cabinet with other medications in the household (Correct), n (%)	295	(77)	34	(79)	23	(58)
k. Do not throw any unused ER/LA opioid analgesic in the trash (Correct), n (%)	352	(92)	41	(95)	29	(73)
l. A child could die if they take or use the respondent’s ER/LA opioid analgesics (Correct), n (%)	353	(92)	39	(91)	33	(83)
RM-4. The patient knows they should not share the drug with anyone
m. Do not give ER/LA opioid analgesics to other people who have the same condition as you (Correct), n (%)	378	(99)	42	(98)	31	(78)
n. Selling or giving away ER/LA opioid analgesics is against the law (Correct), n (%)	379	(99)	40	(93)	36	(90)
RM-5. The patient understands how to use the drug safely	377	(99)	40	(93)	33	(83)
o. It’s okay to stop taking or using opioid analgesics without talking to your healthcare provider (Correct), n (%)	377	(99)	40	(93)	33	(83)
p. Talk to a healthcare provider about taking or using more ER/LA opioid analgesics if the current dose does not control the pain (Correct), n (%)	343	(90)	41	(95)	29	(73)
q. It is not okay to drink alcohol while taking or using ER/LA opioid analgesics (Correct), n (%)	369	(97)	38	(88)	37	(93)
r. Read the attached MG every time an ER/LA opioid prescription is filled (Correct), n (%)	299	(78)	23	(53)	30	(75)
s. Inform healthcare provider about all the other medications being used (Correct), n (%)	367	(96)	39	(91)	33	(83)
t. Inform healthcare provider about any history of abuse of street or prescription drugs, alcohol addiction, or mental health problems (Correct), n (%)	350	(92)	36	(84)	33	(83)
u. Inform healthcare provider about over-the-counter medicines, vitamins, and dietary supplements (Correct), n (%)	342	(90)	38	(88)	35	(88)
v. It is okay to drink caffeine while using ER/LA opioid analgesics (Correct), n (%)	206	(54)	22	(51)	19	(48)
w. If you miss a dose of the ER/LA opioid analgesic, you should take the missed dose as soon as possible (Correct), n (%)	213	(56)	22	(51)	20	(50)
x. ER/LA opioid analgesic pills should not be split or crushed if the respondent is having trouble swallowing their medication (Correct), n (%)^a	219	(85)	14	(67)	13	(52)
y. Do not take more when it is time for the next dose if a dose of ER/LA opioid analgesics was missed (Correct), n (%)^a	244	(94)	20	(95)	24	(96)
z. Inform healthcare provider of any fever (Correct), n (%)^b	63	(82)	12	(80)	3	(75)
aa. Do not use a hot tub or sauna while using ER/LA opioid analgesics if pain persists (Correct), n (%)^b	61	(79)	12	(80)	1	(25)
bb. Do not cut ER/LA opioid analgesic patches in half to use less medicine (Correct), n (%)^b	62	(81)	14	(93)	2	(50)

Notes: ^aSurvey questions only asked of non-methadone oral drugs only respondents (N = 259, 21, and 25; for Commercial, Medicare, and Medicaid, respectively). ^bSurvey questions only asked of patch and non-methadone respondents (N=77, 15, and 4; for Commercial, Medicare, and Medicaid, respectively). Percentages may not sum to 100% due to rounding.

Abbreviations: KAS, knowledge assessment score; SD, standard deviation; ER/LA, extended-release/long-acting; MG, medication guide; PCD, patient counseling document; RM, risk message; N, number.