OBRA-90: Pharmacy Compliance with Counseling and Profiling in Ohio Residents

Raymond R. Carlson, R.Ph.

RC Compounding Services, LLC
RC Outsourcing, LLC

Toni L. Bisconti, Ph.D., Michael T. Vale, MA, & Jennifer Sublett

University of Akron

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 OBRA-90: Pharmacy Compliance with Counseling and Profiling in Ohio Residents

As part of the current study, we surveyed approximately 600 Ohio adult residents who have had at least
one interaction with a pharmacy over the past year. Specifically, we examined whether the general
adult public is interested and/or offered medication counseling by their pharmacists. Additionally, we
sought to gauge compliance with respect to pharmacists’ ability to obtain patient-specific information
prior to filling a prescription. We explored general attitudes about pharmacies/pharmacists and other
issues and/or interactions that occur at the pharmacy.

Information collected during the Fall of 2018 is housed anonymously on the survey system Qualtrics
through the University of Akron. Before any surveys were distributed, UA’s Institutional Review Board
reviewed and approved the study. After that process, we used a word-to-mouth and crowd surfing
method in order to collect data via listserves and social media. All of the researchers involved in the
project are from the NE Ohio area, so the counties in which the information was collected was clustered
in that area (although 39 of the 88 Ohio counties had at least one participant).

According to Federal (OBRA-90) and/or Ohio Board of Pharmacy Rules (OAC 4729), a pharmacy must
offer the service of medication counseling on all matters that fall under the pharmacist’s professional
judgement with each individual to whom a prescription is being dispensed. That medication information
should include but is not limited to the following:
 The name and description of the medication
 The dosage form, dosage, route of administration, and duration of the drug therapy
 Any special directions and precautions for preparation, administration and use of the drug
 Common severe or adverse side effects and/or drug interactions
 Techniques for self-monitoring drug therapy
 Proper storage
 Refill information
 Action to be taken if I miss a dose

According to Federal Law (OBRA-90) and/or Ohio Board of Pharmacy Rules (OAC 4729), the dispensing
pharmacist shall be responsible for ensuring that a reasonable effort has been made to obtain,
document, and maintain at least the following records:
 Full name of the patient for whom the drug is intended
 Residential address and telephone number of the patient
 Patient’s date of birth
 Patient’s gender
 Known drug related allergies
 Previous drug reactions
 History of our active chronic conditions or disease states
 Other drugs and nutritional supplements including OTC drugs used on a routine basis
 Use of medical devices

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The primary goal of the project in which Mr. Carlson spearheaded was to examine whether pharmacists
are complying with this law. Because of his own vested interest in the information, Mr. Carlson used a
University of Akron research team to create and distribute the survey. Broadly speaking, according to
approximately 600 consumers in Ohio, pharmacists are NOT complying with the offer to counsel law and
are falling short of what would be considered a “reasonable attempt” to obtain patient-specific
information for profiling purposes. Please see the data below for specific questions and answers.

If you have specific questions about the methodology or data collection, please contact the Transitions,
Resilience and Identity -Lab (uatrilab@gmail.com or Dr. Toni L. Bisconti (tb33@uakron.edu). If you have
any questions about the content or the substance of the information, contact Mr. Ray Carlson
(rccompounding@sbcglobal.net).

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 DESCRIPTIVE DATA REPORT1

N = 627 Ohio residents (Answers to questions ranged from 541-627 due to missing data)

Age
N = 623
Range: 18-84; M = 45.37

Gender
N = 626
Female = 495; 79%; Male 126; 20%; Transgender = 5; .08%

County
N = 626
Allen .8% Franklin 2.7% Mahoning 22.6% Seneca .3%
Ashtabula 1.4% Geauga 1.0% Medina .6% Stark 1.0%
Butler .2% Greene .2% Meigs .2% Summit 33.9%
Carroll .3% Hamilton .5% Montgomery .6% Trumbull 1.0%
Columbiana .8% Huron .2% Ottawa .3% Van Wert .2%
Crawford .2% Lake 21.7% Pickaway .2% Vinton .2%
Cuyahoga 4.1% Licking .3% Portage 1.6% Warren .5%
Delaware .5% Logan .2% Richland .2% Wayne .2%
Erie .2% Lorain .6% Ross .2% Wyandot .2%
Fairfield 2.7% Lucas .2% Scioto .2%
***78.2% of the sample came from 3 counties; all of which are in NE Ohio

Do you pay out of pocket for your prescriptions or do you use a prescription insurance card?
N = 627
12.4% paid out of pocket
87 .6% paid through insurance card

On average, how many times a month do you regularly have a prescription dispensed in your name?
N = 627
18.2% fill 0 prescriptions
66.5% fill 1-3 prescriptions
2.2% fill 7-10 prescriptions
1.6% fill 10+ prescriptions

Where do you fill your prescriptions?

N = 627
7.2 % Independently owned
26.6% Big Box
53.3% Stand alone retail
9.1% Mail Order
4.3% Hospital Pharmacy

1
Due to rounding errors, not all percentages add to 100. If you’d like the specific sample for any question or the
actual sample size, please contact Dr. Bisconti.

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SECTION 1: COUNSELING

It is clear when interacting with the pharmacy staff which person(s) is the actual pharmacist.
59.6% Yes
40.4% No

Your regular pharmacist knows your name.

23.3% Yes
76.7% No

At the time a script is dispensed to you, how much time do you typically spend talking with your
pharmacist (NOT solely the staff) in regards to it?
70% None (70%)
19.5% Less than a minute
9.6% 2-5 minutes
1% 5-10 minutes
0% Over 10 minutes

How often does the pharmacist discuss the following topics with you when you pick up your scripts?
a. Name and description of the medication
50.8% Never
23.4% Rarely
15.3% Sometimes
5% Often
5.5% Always

b. The dosage form, dosage amount, route of administration and duration of the drug therapy
53.3% Never
23.2% Rarely
13.8% Sometimes
4.4% Often
3.4% Always

c. Any special directions and precautions for preparation administration and use of the drug
46.7% Never
23.2% Rarely
19.5% Sometimes
5.5% Often
5% Always

d. Common severe or adverse side effects and/or drug interactions

61.3% Never
19% Rarely
12.6% Sometimes
4.5% Often
2.5% Always

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e. Techniques for self-monitoring drug therapy
77.6% Never
13.8% Rarely
5.5% Sometimes
2.5% Often
1.5% Always

f. Proper storage
73.1% Never
13.4% Rarely
9.6% Sometimes
2.4% Often
1.5% Always

g. Refill information
63.4% Never
19.3% Rarely
11.6% Sometimes
3.7% Often
2% Always

h. Action to be taken if I miss a dose

76.8% Never
14.6% Rarely
6.4% Sometimes
1.3% Often
.8% Always

How frequently has your pharmacist made an error (not related to price or insurance) when
dispensing your script?
78.2% Never
16.95 Rarely
4.7% Sometimes
.2% Often
0% Always

Do you believe this error would have been caught with more direct conversation with your pharmacist
at the time you ordered or received your script?2
63.1% Yes
36.9% No

2
This is based on the 23.8% who reported this question was applicable.

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SECTION 2: THE OFFER TO PROVIDE MEDICATION COUNSELING SERVICES
When I have a question about my medication at the pharmacy, I feel like the pharmacist is too busy to
bother.3
32% Never
21.3% Rarely
26.1% Sometimes
12.5% Often
8.1% Always

When I have a question about the medication I have received from a mail order pharmacy, I feel as
though there are too many barriers to call and talk with a pharmacist.4
19.2% Never
14.1% Rarely
23.9% Sometimes
16.9% Often
25.8% Always

Are you required to sign anything when you pick up your scripts?
84.3% Yes
15.7% No

Has it been made clear to you what it is you are signing when you pick up your script?5
58.8% Yes
41.2% No

SECTION 3: THE LAW

According to Federal and State law, a pharmacy must offer the service of medication counseling on all
matters that fall under the pharmacist’s professional judgement with each individual to whom a
prescription is being dispensed. That medication information should include but is not limited to the
following:
 The name and description of the medication
 The dosage form, dosage, route of administration, and duration of the drug therapy
 Any special directions and precautions for preparation, administration and use of the drug
 Common severe or adverse side effects and/or drug interactions
 Techniques for self-monitoring drug therapy
 Proper storage
 Refill information
 Action to be taken if I miss a dose

Prior to reading the above definition, did you know that there is an “offer to counsel” law?
38.4% Yes
61.6% No

3
This is based on the 94.4% who reported this question was applicable.
4
This is based on the 36.3% who reported this question was applicable.
5
This is based on the 86.1% who reported this question was applicable.

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According to Federal and State law, a qualified pharmacy staff member must offer to provide
medication counseling to the customer whenever any prescription is dispensed.

How well do you think the above offer to provide medication counseling is being made to you?
19.5% Not at all
24.5% Not very
28.4% Somewhat
18.4% Very
9.3% Extremely

Are you aware that you were declining the service of medication counseling when you signed at the
time you received your medication?6
38.8% Yes
61.2% No

How necessary do you think this law is?

(Missing data 86/627, 13.7%)
.7% Not at all (.7%)
4.1% Not very (4.1%)
26.6% Somewhat (26.6%)
42.7% Very (42.7%)
25.9% Extremely (25.9%)

How often do you think your pharmacist(s) complies with this law?
5.2% Never
25.9% Rarely
28.6% Sometimes
18.1% Often
22.2% Always

Given that a medication counseling session could take 5-10 minutes per drug, how often do you think
that your pharmacist(s) could reasonably comply with this law?
5.2% Never
5.7% Rarely
9.6% Sometimes
13% Often
66.5% Always

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This is based on the 89.9% who reported this question was applicable to them.

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According to Ohio drug dispensing law, the dispensing pharmacist is responsible for making sure that
a reasonable attempt has been made to obtain the following information prior to processing your
prescription. Please rate how often this information is asked of you:

1. Your full name

5.2% Never
5.7% Rarely
9.6% Sometimes
13% Often
66.5% Always

2. Your address and telephone number

24.8% Never
21.1% Rarely
15.5% Sometimes
11.3% Often
27.3% Always

3. Your date of birth

4.4% Never
4.1% Rarely
6.4% Sometimes
9.6% Often
75.4% Always

4. Your gender
76.6% Never (76.6%)
9.1% Rarely (9.1%)
3.6% Sometimes (3.6%)
2% Often (2.0%)
8.7% Always (8.7%)

5. Drug related allergies you have

40.4% Never
20.3% Rarely
15.7% Sometimes
7.8% Often
15.8% Always

6. Previous reactions to drugs you have had

78.2% Never
16.9% Rarely
4.7% Sometimes
.2% Often
0% Always

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7. History of or active chronic conditions or disease states
67.4% Never
14.5% Rarely
9.1% Sometimes
3.9% Often
5% Always

8. Other prescription drugs you are taking

55.9% Never (55.9%)
16.1% Rarely (16.1%)
16.1% Sometimes (16.1%)
4.5% Often (4.5%)
7.5% Always (7.5%)

9. Nutritional supplements you are taking

77% Never
11.9% Rarely
5.7% Sometimes
1.6% Often
3.7% Always

10. Nonprescription drugs you are taking

76.6% Never
12.3% Rarely
5.2% Sometimes
2.7% Often
3.2% Always
Mean (1.43)

11. Any medical devices you use (c-pap, catheter, insulin pump, nebulizer, etc.)
80.7% Never
10.7% Rarely
3.2% Sometimes
1.4% Often
3.9% Always

Given that a Federal law enacted in 1990 established rules of information gathering and counseling and
was meant to “thwart the abuse and misuse of prescription drugs”, how important a role do you feel
that pharmacists should play in the control of drug distribution?
3.7% Not at all
5.5% Not very
23% Somewhat
32.6% Very
35.1% Extremely

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