Patient Counseling—A Pharmacist's Responsibility to Ensure

Patient Counseling—A Pharmacist’s Responsibility to Ensure Compliance

Content Summary

This booklet educates pharmacy personnel about the requirements surrounding patient counseling

standards. Pharmacists will understand the Federal requirement under the Omnibus Budget

Reconciliation Act of 1990 (OBRA ’90) to offer patient counseling to Medicaid patients.

Pharmacists will understand that laws established by each State may differ and will recognize

the importance of compliance with State regulations. This booklet provides guidance on when

counseling may not be required as well as alternative methods to offer counseling when a patient

is not present in the pharmacy or when language barriers exist. Finally, this booklet discusses

the provision of written materials to supplement patient counseling and the importance of

documentation to demonstrate compliance with the requirement.

Patient Counseling—A Pharmacist’s Responsibility to Ensure Compliance 3

A patient’s complete understanding of how to use a prescription medication is critical to successful adherence

to medication therapy. An effective counseling session between patient and pharmacist ensures that the patient

receives essential educational information related to the medication and provides an opportunity for the patient to

ask questions. Not only is patient counseling the right thing to do, it is mandated by law in most States. It is vital

to document this care provision to validate compliance.

The Omnibus Budget Reconciliation Act

Section 4401 of the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) was enacted by Federal lawmakers to

ensure scally responsible spending of Federal funding while concurrently ensuring safe and effective therapeutic

outcomes for Medicaid patients. OBRA ’90 includes three key drug utilization review (DUR) components

that impact the practice of pharmacy: prospective drug utilization review, record-keeping requirements, and

a requirement to offer counsel.[1] OBRA ’90 further outlines specic information that the pharmacist, while

exercising professional judgment, should discuss with the patient when the offer to counsel is accepted, such as:

•

Name of the drug (brand name, generic, or other descriptive information);

•

Intended use and expected action;

•

Route, dosage form, dosage, and administration schedule;

•

Common severe side effects or adverse effects or interactions and therapeutic contraindications that may

be encountered, including how to avoid them and the action required if they occur;

•

Techniques for self-monitoring of drug therapy;

•

Proper storage;

•

Potential drug-drug[2] interactions or drug-disease contraindications;

•

Prescription rell information; and

•

Action to be taken in the event of a missed dose.[3]

As a condition of participation and to receive continued Federal funding for State Medicaid programs, OBRA ’90

and regulations adopted by CMS[4] require States to establish standards regarding implementation of patient

counseling requirements. Although the original Federal requirements of OBRA ’90 were intended to apply

only to Medicaid beneciaries, States established unique patient counseling regulations for both Medicaid and

non-Medicaid beneciaries. As a result, all patients are entitled to the benets associated with patient counseling

standards of care.

Counseling When the Patient Is Not Present

When prescriptions are delivered or mailed to patients, pharmacies are not exempt from the patient counseling

provision of care. Pharmacies must establish a process to offer patient counseling services when a patient is not

present. One method to ensure compliance is to provide printed drug information that includes pharmacy business

hours as well as a toll-free telephone number for patients to speak with a pharmacist. Mail order pharmacies

commonly use this method. Some States establish regulations specically for mail order pharmacies, according

to the National Health Law Program (NHeLP). It is common to require the pharmacy to provide information that

includes a toll-free phone number on the prescription bottle or label as well as the pharmacy’s business hours.

In addition, States may have specic regulations that require a mail order pharmacy to be open a certain number

of hours (and sometimes a certain number of days) per week in order to be compliant.[5]

Limited English Procient Patient

Depending on local and regional demographics, pharmacies may interact with different degrees of non-

English speaking patients. The largest numbers of limited English procient (LEP) patients speaking Spanish,

Chinese, Korean, Vietnamese, or Tagalog who spoke English “less than very well” lived in the States of New

York, California, Texas, and Florida, according to the 2011 language mapper from the U.S. Census Bureau.[6]

New York has passed a law that requires language services to LEP patients. Any pharmacy that is part of a group

of eight or more pharmacies located within New York State and owned by the same corporate entity is required

to provide, at no charge, LEP individuals with oral language translation services for medication labels, associated

warning labels, and other written materials.[7] It is important to become familiar with the regulations in your

State and establish a means to safely provide medications and counseling to LEP patients in your pharmacy to

ensure compliance.

Patient Counseling—A Pharmacist’s Responsibility to Ensure Compliance 5

Provision of Written Information

Providing written information to a patient as a supplement to oral counseling ensures patient access to important

medication information after he or she leaves the pharmacy. States may have laws that require the provision

of written information to a patient under specic circumstances. Four States—New York,[8] California,[9]

Texas,[10] and North Carolina[11]—have requirements for the provision of written materials in certain

circumstances. More information on the implementation of these requirements, including translation of certain

materials into other languages, is summarized in a 2010 study by the National Health Law Program.[12]

California has a number of written materials regulations. One of these regulations requires provision of an

emergency contraception fact sheet when dispensing emergency contraception to any patient.[13] To accommodate

the large number of LEP individuals in the State, PDF versions are available to pharmacies in 10 different

languages through the California Board of Pharmacy website for patient distribution.[14] California also requires

the provision of culturally sensitive patient information, which is printed in certain languages in order to participate

in the State’s HIV treatment program (Cal. Health & Safety Code §125092).[15]

Oral Counseling Exclusions

Circumstances may exist when patient counseling is not required by a State or not desired by the patient.

According to NHeLP, many States exempt pharmacists from patient counseling requirements when drugs are

dispensed to patients as part of institutional care.[16] For example, patient counseling requirements may not

apply when the medication is administered to the patient by a health care professional during an inpatient hospital

admission, in a long-term care facility, or in another institutional setting. In addition, not every patient may want

to be counseled on his or her medication therapy. OBRA ’90 mandates that an “offer to counsel” must be made;

however, pharmacists are not required to provide counseling to a patient (or patient’s caregiver) who refuses

the offer.[17] Pharmacists, pharmacy interns, and pharmacy technicians should consult their State statutes to

determine when oral counseling exclusions are applicable.

Comparison of State Requirements

According to the 2010 NHeLP Analysis of State Pharmacy Laws, 47 States, plus the District of Columbia, have

enacted laws that require patient counseling or an offer to counsel.[18] All States except for Hawaii, Louisiana, and

Vermont include provisions related to the requirement for patient counseling in their statutes.[19] Requirements

for compliance in each State vary widely. Pharmacists, pharmacy interns, and pharmacy technicians should

consult their State Medicaid agency and Board of Pharmacy to ensure that pharmacy personnel understand and

are in compliance with State regulations. Table 1 compares common State requirements.

Table 1. State Compliance Requirements and Patient Counseling Documentation Requirements by State

State

Require oral

counseling

in certain

situations or

an “offer to

counsel”

Documen-

tation of

“offer to

counsel”

required by

State

Documen-

tation of

patient’s

refusal for

counseling

Counsel new

prescriptions

and rells

Process for

counseling

when patient

is not in the

pharmacy

Discuss with

patient prior

to generic

substitution

Require

distribution

of written

materials

Alabama Y Y N N N N Y

Alaska Y N N N Y Y N

Arizona Y Y Y N Y Y Y

Arkansas Y N N N Y Y N

California Y Y N N Y Y Y

Colorado Y Y Y N N Y Y

Connecticut Y Y Y Y N Y N

Delaware Y Y Y N Y Y Y

District of

Columbia

Y Y Y N Y N Y

Florida Y Y N Y Y Y Y

Georgia Y N N Y Y N N

Hawaii N Y N N N Y Y

Idaho Y Y

N Y N N N

Illinois Y Y Y Y N N N

Indiana Y Y N Y Y N Y

Iowa Y Y Y N N N N

Kansas Y Y N N N Y N

Kentucky Y Y Y N N N Y

Louisiana N N N N N N N

Maine Y Y Y N Y Y Y

Maryland Y N N N N Y Y

Massachusetts Y Y Y N Y N N

Michigan Y Y N N Y Y N

Minnesota Y Y N N Y Y Y

Mississippi Y Y N Y Y Y N

Missouri Y N N Y Y N Y

Montana Y Y Y N N N N

Nebraska Y Y Y Y N Y N

Nevada Y Y N N Y Y Y

New Hampshire

Y Y N N Y Y Y

New Jersey Y Y Y N Y N N

New Mexico Y Y N N Y N Y

New York Y Y Y N Y Y Y

North Carolina Y Y N N Y N N

Patient Counseling—A Pharmacist’s Responsibility to Ensure Compliance 7

Table 1. State Compliance Requirements and Patient Counseling Documentation Requirements by State (cont.)

State

Require oral

counseling

in certain

situations or

an “offer to

counsel”

Documen-

tation of

“offer to

counsel”

required by

State

Documen-

tation of

patient’s

refusal for

counseling

Counsel new

prescriptions

and rells

Process for

counseling

when patient

is not in the

pharmacy

Discuss with

patient prior

to generic

substitution

Require

distribution

of written

materials

North Dakota Y N N Y Y Y Y

Ohio Y Y Y Y Y N N

Oklahoma Y Y N N Y N N

Oregon Y N Y N Y Y N

Pennsylvania Y Y Y N Y Y Y

Rhode Island Y Y Y N N Y N

South Carolina Y Y N N N Y N

South Dakota Y N Y N Y N Y

Tennessee Y Y N N Y N N

Texas Y Y Y N Y Y Y

Utah Y Y Y N Y Y N

Vermont N Y Y Y N N N

Virginia Y Y Y

N Y Y Y

ashington Y N N Y Y N Y

West Virginia Y Y Y N N Y N

Wisconsin Y N N Y Y N N

Wyoming Y Y Y N

N N N

Total number

of States with

requirement

48 40 25 14 33 28 24

Documentation Requirements

Documenting that patient counseling was offered and indicating whether it was accepted or declined is critical

to ensuring compliance with State statutes. There is currently no Federal requirement for documentation, and

compliance requirements vary by State. The patient (or patient caregiver) may simply mark a “yes” or “no”

checkbox when the prescription is picked up to satisfy the documentation requirement in most instances.

Key Points

Pharmacists, pharmacy interns, and pharmacy technicians should consider the following aspects of patient

counseling to ensure compliance:

•

Understand the patient counseling components of OBRA ’90;

•

Be familiar with State patient counseling regulations;

•

Establish a process to ensure compliance when the patient is not present in the pharmacy;

•

Understand when oral counseling is not required;

•

Provide written materials to supplement oral counseling;

•

Establish processes to accommodate LEP individuals; and

•

Comply with State documentation requirements for acceptance or refusal of the counseling offer.

Conclusion

The provision of quality patient counseling requires much more than having effective communication skills.

It entails understanding the patient counseling requirements as outlined in OBRA ’90 as well as complying with

State-specic regulations. In addition, there need to be processes in place for provision of counseling when

the patient is not present or when the patient is non-English speaking, as well as for the provision of written

materials to supplement oral counseling. Finally, establishing a process to document the acceptance or refusal of

the counseling offer is critical. If there is no documentation that patient counseling was offered, there is no proof

to demonstrate compliance.

References

1 Omnibus Budget Reconciliation Act of 1990. Pub. L. 101-508, § 4401, 104 Stat. 143. Retrieved September 29, 2014, from

http://uscode.house.gov/statutes/pl/101/508.pdf

2 Payment for Covered Outpatient Drugs, 42 U.S.C. § 1396r-8(g)(1)(A). Retrieved September 29, 2014, from http://www.gpo.gov/

fdsys/pkg/USCODE-2008-title42/html/USCODE-2008-title42-chap7-subchapXIX-sec1396r-8.htm

3 Payment for Covered Outpatient Drugs, 42 U.S.C. § 1396r-8(g). Retrieved July 18, 2014, from http://www.gpo.gov/fdsys/pkg/US

CODE-2008-title42/html/USCODE-2008-title42-chap7-subchapXIX-sec1396r-8.htm

4 Prospective Drug Review, 42 C.F.R. § 456.705. Retrieved September 29, 2014, from http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=

&SID=40186ffdc8d94276897981632b944bc0&n=pt42.4.456&r=PART&ty=HTML#se42.4.456_1705

5 National Health Law Program. (2010, February). Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of

Language Services (p. 12). Retrieved July 18, 2014, from http://www.aacp.org/resources/education/documents/pharmacylawbooklet%20

nal.pdf

6 United States Census Bureau. U.S. Department of Commerce. 2011 Language Mapper. Retrieved July 18, 2014, from http://www.census.

gov/hhes/socdemo/language/data/language_map.html

Patient Counseling—A Pharmacist’s Responsibility to Ensure Compliance 9

7 N.Y. Comp. Codes R. & Regs. tit. 8, § 63.11 (2014). Retrieved October 1, 2014, from https://govt.westlaw.com/nycrr/Document/Ib6

ca32d5cea011e282c80000845b8d3e?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&cont

extData=(sc.Default)

8 N.Y. Comp. Codes R. & Regs. tit. 8, § 63.11 (2014). Retrieved October 1, 2014, from https://govt.westlaw.com/nycrr/Document/Ib6

ca32d5cea011e282c80000845b8d3e?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&cont

extData=(sc.Default)

9 Cal. Code Regs. tit. 16, § 1707.5(b). Retrieved October 1, 2014, from https://govt.westlaw.com/calregs/Document/IFE27E510F90E1

1DFB96893E0B9DE518D?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=

(sc.Default)

10 22 Tex. Admin. Code § 291.33(c)(1)(B)(v). Retrieved October 1, 2014, from http://info.sos.state.tx.us/pls/pub/readtac$ext.

TacPage?sl=T&app=9&p_dir=F&p_rloc=169050&p_tloc=14851&p_ploc=1&pg=2&p_tac=&ti=22&pt=15&ch=291&rl=33

11 21 N.C. Admin. Code 46.2507(d) (2014). Retrieved October 1, 2014, from http://reports.oah.state.nc.us/ncac/title%2021%20-%20

occupational%20licensing%20boards%20and%20commissions/chapter%2046%20-%20pharmacy/21%20ncac%2046%20.2507.pdf

12 National Health Law Program. (2010, February). Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the

Provision of Language Services (p. 14). Retrieved August 19, 2014, from http://www.aacp.org/resources/education/documents/

pharmacylawbooklet%20nal.pdf

13 Cal. Code Regs. tit. 16, § 1746. Retrieved October 1, 2014, from https://govt.westlaw.com/calregs/Document/IE328F2D0941211E2

9091E6B951DDF6CE?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.

Default)

14 State of California. Department of Consumer Affairs. Board of Pharmacy. Consumers. Emergency Contraception. Retrieved

July 18, 2014, from http://pharmacy.ca.gov/consumers/emergency_cont

15 Cal. Health & Safety Code § 125092. Retrieved October 1, 2014, from http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&

group=125001-126000&le=125050-125119.5

16 National Health Law Program. (2010, February). Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of

Language Services (p. 11). Retrieved July 18, 2014, from http://www.aacp.org/resources/education/documents/pharmacylawbooklet%20

nal.pdf

17 Payment for Covered Outpatient Drugs, 42 U.S.C. § 1396r-8(g). Retrieved July 18, 2014, from http://www.gpo.gov/fdsys/pkg/

USCODE-2008-title42/html/USCODE-2008-title42-chap7-subchapXIX-sec1396r-8.htm

18 National Health Law Program. (2010, February). Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of

Language Services (p. 9). Retrieved July 18, 2014, from http://www.aacp.org/resources/education/documents/pharmacylawbooklet%20

nal.pdf

19 National Health Law Program. (2010, February). Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of

Language Services (p. 9). Retrieved July 18, 2014, from http://www.aacp.org/resources/education/documents/pharmacylawbooklet%20

nal.pdf

Disclaimer

This booklet was current at the time it was published or uploaded onto the web. Medicaid and Medicare policies

change frequently so links to the source documents have been provided within the document for your reference.

This booklet was prepared as a service to the public and is not intended to grant rights or impose obligations.

This booklet may contain references or links to statutes, regulations, or other policy materials. The information

provided is only intended to be a general summary. Use of this material is voluntary. Inclusion of a link does not

constitute CMS endorsement of the material. We encourage readers to review the specic statutes, regulations,

and other interpretive materials for a full and accurate statement of their contents.

November 2014