Download new york city pharmacists and prospective drug

Drug Information Journal, Vol. 30, pp. 601-608, 1996
Printed in the USA. All rights reserved.
0092-8615/%
Copyright 0 1996 Drug Information Association Inc.
NEW YORK CITY PHARMACISTS AND
PROSPECTIVE DRUG UTILIZATION
REVIEW UNDER OBRA '90
MARTHAM. RUMORE,PHARMD,JD, RAC, FAPHA
Associate Professor, Pharmacy Administration,
Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Brooklyn, New York
STANLEY
FEIFER,RPH, MS
Associate Professor, Pharmacy Practice and Director, Community Externship Program,
Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Brooklyn, New York
JOSEPHS. RUMORE,RPH, MS
Assistant Director of Pharmacy, Wyckoff Heights Medical Center, Brooklyn, New York
New York regulations to implement the Omnibus Budget Reconciliation Act of 1990
(OBRA '90) have been in effect more than one year yet little is known aboutpharmacists' experience with, or effectiveness oJ the prospective drug utilization review
(DUR) mandate. A n anonymous questionnaire distributed to 287 New York City
pharmacists and interns achieved a 67% (194) response rate. Time, personnel, and
expense constraints were the most frequently mentioned implementation problems.
A number of pharmacists and interns misinterpreted various prospective DUR requirements of the New York regulation. Some erroneously believe the requirement
to review the drug therapy only applies to new prescriptions but not renewals. Others
do not believe the pharmacist must ascertain a complete listing of all medications.
Half of the respondents indicated their pharmacy has had to hire more personnel
or purchase computer software to comply. Interns appeared more optimistic than
pharmacists about the future success of OBRA '90. Approximately two thirds of respondents believe the regulations will increase pharmacists' liability.
Key Words: OBRA; Pharmacists; New York City; Drug utilization review; Liability
INTRODUCTION
UNDER OBRA '90
are
required to perform prospective drug use
review for all Medicaid patients (1). New
York regulations became effective on December 4, 1992 and apply to all patients
Presented at the American Pharmaceutical Association 141~tAnnual Meeting, March 19-23.1994. Seattle, Washington.
Reprint address: Martha M. Rumore, PharmD,
JD, RAC, FAPhA, Associate Professor, Pharmacy
Administration, Arnold & Marie Schwartz College
of Pharmacy and Health Sciences, Brooklyn, NY.
(2). Under the New York regulation a review of drug therapy is required before
each prescription is filled or delivered to
the patient. This review shall include
screening for potential drug therapy problems due to therapeutic duplication, drugdrug interactions, including serious interactions with over-the-counter drugs,
incorrect drug dosage or duration of treatment, drug-allergy interactions, and clinical abuse or misuse (2). In addition, a patient medication profile and an offer to
patients regarding their medicstion Are required. The pharmacist's desknee may obtain the information for the
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601
Martha M . Rumore. Stanley Fever, and Joseph S . Rumore
602
profile and make the offer to counsel but
the actual counseling and prospective DUR
must be conducted by the pharmacist: For
the counseling and DUR provisions, in
New York patient refusals must be documented and kept in a retrievable form for
five years (2,3).
Several studies have shown that pharmacists are not aware of the requirements
that affect them under OBRA '90 and little
is known about the attitudes of pharmacists with regard to implementation of the
act ( 4 3 ) . This study attempted to identify
the ramifications of the prospective DUR
requirements and their impact on pharmacy practice in New York City.
METHODOLOGY
The instrument for this study was a 15item questionnaire (Appendix 1) that was
pretested for clarity on 20 pharmacists and
graduate students. Based on the pretest
several questions were reworded. Multiple
choice responses were included in the following major categories: demographic data,
law interpretation, and perceptions regarding liability. The target population was
New York City-based interns and pharmacists. The sample selected was a convenience rather than a random sample. A letter of transmittal guaranteeing anonymity
and a copy of the survey were mailed in
Fall 1993 to 100 community or hospital
pharmacists. In addition, 200 questionnaires were distributed in fifth year undergraduate and graduate classes. Students
were instructed to distribute the survey to
a pharmacist for completion or, if a pharmacist was not readily available to them,
they were to complete the survey themselves. Only practicing interns or pharmacists were eligible to participate.
The results were tabulated and statistically analyzed (6). Chi Square analyses
were conducted to determine if the responses differed between pharmacists and
interns or because of practice setting. The
level of significance was set at p < 0.05.
A limitation of the study is that respon-
dents, who volunteered to participate,
may differ from nonrespondents. The
findings, therefore, may not be generalizable to all New York City pharmacists or
interns. The authors did not explore information regarding the size of the pharmacy, volume of prescriptions, or number
of employees.
RESULTS
Forty-eight of the mailed and 146 of the
classroom distributed surveys were returned to provide 48% and 73% response
rates, respectively. Since a number of
graduate students were pharmacists and
some surveys were given to pharmacists by
the students, the number of pharmacist respondents was 95. Demographic details
concerning the New York City sample are
provided in Table 1. The majority of respondents (69%) indicated 'independent'
TABLE 1
Demographic Information
Practice Site
Pharmacists
(n = 95)'
Interns
(n = 99).
72
11
62
22
14
16
7
Independent
Chain
Hospital/clinic/
HMO
Not specified
* 10 respondents indicated multiple practice
sites.
Pharmacists' Years in Practice
~~
Years
n
0-3
4-7
8-1 1
12-15
16-19
20-23
24-27
28-31
32-35
36-39
> 40
15
19
14
12
9
7
6
6
3
3
1
Mean = 13.9 + I - 5.9
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Pharmacists and Prospective DUR Under OBRA ’90
as a practice site. There was an approximately equal number of pharmacists and
interns (49% vs. 51%). Questions 1-6, 8,
10, and 14 specifically addressed the
OBRA ’90counseling requirement and are
discussed elsewhere (7).
Question 7 sought to identify problemddeficiencies in implementation of
the law. Time, personnel, and expense
constraints were the most frequently mentioned. Table 2 shows a complete listing of
the responses to this question.
In question 9 respondents were requested to identify the following statement as true or false, because the law does
not only apply to renewal prescriptions:
“The pharmacist shall review the drug
therapy before each prescription is filled
or refilled.” The vast majority (96%) (92/
96) of pharmacists and interns (89%) (87/
98) correctly identified the statement as
true. Although more pharmacists correctly identified the statement as true,
603
based on Chi Square analysis there was no
significant difference in responses between pharmacists and interns (X’ =
3.38; df = 1; p = 0.05).
Question 11 requested respondents to
indicate whether or not they feel pharmacists are skillful enough in history taking
to be able to interview patients. An overwhelming majority of pharmacists (86%)
(81/94) and interns (82%) (82/100) indicated that pharmacists possess the needed
skills. Based on Chi Square analysis, there
was no significant difference in responses
between pharmacists and interns ( X 2 =
0.6276; df = 1; p = 0.05).
Question 12 asked if the respondent felt
that the time, reimbursement, and professional education issues are so great to
overcome that OBRA ’90 will never be a
reality. The respondents were almost
evenly split; 60 agreed that the barriers are
too great to overcome and 70 disagreed.
There was a significant difference, how-
TABLE 2
ProblemslDeficIencles Observed in Implementation
of the Law
Reason
n
Time constraints
Lack of pharmacist reimbursement
Expense constraints
Patient indifference
Information provided may decrease patient compliance
Lack of privacy or space for counseling
Lack of pharmacist knowledge
No standardization
Patient not willing to supply information
Conflicts with what physician has told patient
Language barriers
Patients refuse to wait
Patient confusion over what term ‘counseling’ means
Redundant
Increases patient wait time
Inadequate patient profiles
Increases paperwork
Belligerenthude patients
Raises too many nonpeninent questions
Not supported by upper management
Law not being taken seriously
Increased pharmacist liability
Other
5
76
18
18
13
13
13
11
10
10
9
9
8
8
6
6
5
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5
5
4
4
4
3
20
Martha M. Rumore, Stanley Fever, and Joseph S. Rumore
604
ever, in the opinions of interns and pharmacists. A majority of the interns were
optimistic whereas a majority of the bharmacists took the pessimistic view. This difference was statistically significant (x’ =
9.49; df = 1; p < 0.01). Chi Square
analysis by practice site revealed no significant effect in response (X2 = 1.28; df =
1; p = 0.05). The second part of this
question asked if the pharmacy has had to
hire more personnel or purchase computer
software to comply. Sixty-eight respondents indicated that they did and 64 respondents did not, indicating that half of
respondents have hired more personnel or
upgraded computers to comply and half
have not. Because of the ambiguity of the
question the authors could not split out
what was done, either more personnel
and/or a computer upgrade.
Question 13 tested the respondent’s
knowledge of the prospective DUR requirement via the following statement: “In
order to fulfill the prospective DUR obligations of the law, the pharmacist (or intern) must interview every patient each
time a prescription is dispensed, to ascertain a complete listing of all medications,
both prescription and OTC.” Only 68%
(63/93) of pharmacists and 71% (71/100)
of interns correctly identified the statement as true. Chi Square analysis did not
reveal any significant differences in the responses of interns and pharmacists to this
question ( X 2 = 0.24; df = 1; p = 0.05).
Question 15 asked whether or not the
respondent feared that the new law would
prompt increased lawsuits. Almost 66%
(128/194) of respondents believe that
OBRA ’90 will lead to increased lawsuits
of pharmacists whereas 32% (63/194)
do not.
DISCUSSION
The results of this survey reveal both positive and negative responses to the prospective DUR requirement by New York City
pharmacists. It revealed differences in responses between interns and pharmacists
as well as obstacles and misinterpretations
regarding the obligations under the law.
Interns’ attitudes were much more optimistic with regard to the ability of pharmacists to interview patients and intervene
with physicians.
Apparently, many pharmacists erroneously believe that only new prescriptions
require medication review. As revealed in
question 13, only 68% of pharmacists correctly identified the statement as a prospective DUR requirement. Therefore, almost a third of the pharmacists surveyed
erroneously believe that they do not need
to interview every patient each time a
prescription is dispensed to ascertain a
complete listing of all medications, both
prescription and OTC. For renewals,
questioning about any over the counter
(OTC) or prescription additions to the
profile would appear extremely pertinent.
Some respondents, however, probably interpreted question 13 differently than intended. While all pharmacists should
know that they must keep a record of all
medications taken by their patients, some
respondents may have answered ‘false’ to
this question because they do not have to
‘interview’ each patient to obtain this information. Therefore, the number of
pharmacists who actually understand the
requirements was probably understated.
Many obstacles to implementation of
the law were identified. A study to ascertain pharmacists’ ability to comply with
the OBRA ’90 DUR provisions revealed
that 82% of the 12,456 pharmacists have
a computer system for DUR. The results
also showed, however, that the majority
of pharmacists ( > 5 5 % ) could not screen
for drug-disease contraindications, drugOTC interactions, incorrect drug dosage,
duration of treatment, clinical abuse/misuse, or underutilization. Therefore, a majority of the respondents could not screen
for six out of nine drug therapy items
listed in the prospective DUR requirement
(8). Online claims processors in New York
City (eg, PAID, PCS) have the capability
to perform DUR in seconds and let the
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Pharmacists and Prospective DUR Under OBRA '90
pharmacist know if there is a potential
drug interaction, duplicate therapy, or refill discrepancy (9):
Due to inherent limitations in the software that most pharmacies currently use,
all the information required for the patient profile will not fit on the pharmacists'
comments section of the computer profile.
Many of the current pharmacy computer
systems allow the recording of only limited information about the patient, suchas
a profile of prescriptions dispensed by the
pharmacy for the patient. T o carry out
prospective DUR, however, the pharmacy
will need to maintain and process a detailed patient profile.
The Health Care Financing Administration (HCFA) predicts that to meet the
statutory requirements for prospective
DUR, software could cost anywhere from
$1 ,OOO to $2,000 to upgrade, but it doubts
that pharmacists will have to completely
revamp their hardware to meet the DUR
requirement of the act (10). In this study,
only half of the respondents have upgraded their software. By implication,
therefore, the other half of the respondents either already had such software in
place, are using a manual system, or are
not complying with the prospective DUR
provisions of the act.
Lack of reimbursement for cognitive
services and time limitations were strongly
identified as barriers to implementation.
In addition to the one to two dollar HCFA
counseling estimate per patient, other
costs include establishing a patient profile,
calling physicians, and upgrading computers. In one study, hourly prescription volume was negatively correlated to the rate
of pharmacist intervention, suggesting
that pharmacists' willingness or ability
to intervene in problematic prescriptions
decreases as the prescription volume increases ( 5 ) . It seems logical that highvolume pharmacies are especially burdened by the OBRA '90 obligations. There
were no differences by practice site, however, when respondents were asked if the
time, reimbursement, and professional ed-
605
ucation issues were too great to overcome
t o make OBRA '90 a reality. Chain pharmacists were not more likely to respond
affirmatively to this question.
Some pharmacists appear hopeful that
the HCFA demonstration projects may
help provide a rationale for pharmacist reimbursement. On June 24, 1994 Senator
David Pryor (D-Ark.) and Senator Jim
Sasser (D-Tenn.) introduced The Pharmaceutical Marketplace Reform Act of 1994
(S.2239) which would require pharmacists
to provide DUR under the current Medicare program, as well as under state Medicaid plans. The secretary of Health and
Human Services (HHS) would be required
to establish a method to pay pharmacists
for these services. The bill uses language
adopted from OBRA '90 and requires a
DUR allowance to reimburse pharmacists
( 1 1). This bill, however, was not enacted
into law.
Almost two thirds of the respondents
indicated the risk for increased liability because of the OBRA '90 requirements. The
prospective screening requirement of the
act appears to create a duty to warn (12).
Although OBRA '90 does not specify what
the pharmacist should d o once a problem
is identified, the legally expected action is
for the pharmacist to try to resolve it if
possible (13). The act, therefore, imposes
the duty to warn; as there would be no
need to require screening for drug therapy
problems if the pharmacist does not warn
the prescriber or patient (13). Failure to
monitor and correct drug underutilization
is an emerging source of pharmacist malpractice liability (14). Other potential
OBRA '90 liability issues include: confidentiality, duty to counsel, and recordkeeping and maintenance. A pharmacy litigation group has recently been created at
the Association of Trial Lawyers of
America to assess the changing standards
of patient care that have come about because of OBRA '90.
Approximately one third of the respondents (and the authors) believe that the act
will not lead to increased lawsuits. Al-
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Martha M. Rumore, Stanley Feger, and Joseph S. Rumore
606
though none of the respondents mentioned it, the regulations may actually decrease liability as failure to counsel had led
to liability. Many of the misfilling or
wrong directions cases could have been
avoided if the pharmacist had counseled
the patient.
CONCLUSION
Some pharmacists and interns in New
York City perceive the requirements of
OBRA '90 as directives that erode independent professional judgement, mandate
uncompensatable services, and lead to increased liability. Others believe that OBRA
is going to move pharmacy from a product-oriented practice to a cognitive-oriented practice. It has the potential to restore pharmacists' historical role of
providing care directly to the patient.
REFERENCES
1. The Omnibus Budget Reconciliation Act of
1990. Pub L. No. 101-508, 104 Stat 1388.
2. Education Law Clarified. N.Y.S. Council of
Hospital Pharmacists Newsletter 1992; 11(4):1.
3. New York State enacts rules to implement
OBRA. N . Y.S. Council of Hospital Pharmacists
Newsletter. 1993; 12(1):1,5.
4. Reutzel TJ, Wilson LA, Mickel M. Inner-city
pharmacies: can they meet the OBRA '90 mandates? A m Pharm. 1993;33:44-51.
5 . Anon. Pharmacists report problems caused by
OBRA '90. Pharmacy Today. Nov 22, 1991:3-4.
6. Dixon WJ, Massey FJ. Introduction to StatisticalAnalysis. Third ed. New York: McGraw Hill;
1969.
7. Rumore MM, Feifer S, Rumore JS. New York
City pharmacists and OBRA '90- One year later.
A m Pharm. 1995;35:29-34,66.
8. Nardi KM, Dix Smith M. National Pharmacy
Forum on Medicaid Drug Amendments: Pharmacist's survey report. Med Inter. (Aug) 1992:
38-49.
9. Salma R. Confronting the information gap:
Pharmacist's emerging hot issues. Pharm Times.
1993;59:37-42.
10. Martin S . What you need to know about OBRA
'90. A m Pharm. 1993;33:26-28.
11. Pryor introduces bill to pay pharmacists for
counseling. Pharm Today. July 4, 1994,33:1,7.
12. Holleran MJ. The Pharmaceutical Access and
Prudent Purchasing Act of 1990: Federal law
shifts the duty to warn from the physician to the
pharmacist. Res Ipsa Loquitur. 1993;20:4.
13. Brushwood DB. Pharmaco-legal considerations
in the clinical use of decongestants. Pharmacother. 1993;13:1355-1428.
14. Vivian JC. The new liability. Drug Topics. Nov
22, 1993:48.
APPENDIX I
ARNOLD & MARIE SCHWARTZ
COLLEGE OF PHARMACY
OBRA '90 Survey
The Omnibus Budget Reconciliation Act of 1990
(OBRA '90) was signed into law and became effective
January 1, 1993. In recognition of the OBRA requirements, N.Y.S. amended section 63.6 of Title 8
NYCRR to clarify standards of practice in pharmacy, require pharmacists to maintain patient medication profiles and offer to counsel patients regarding their medication therapy. These requirements
became effective December 4, 1992.
Please take a few minutes to complete this research survey based on your experience with the new
law. Responses are anonymous and will be used
strictly for academic research being conducted
jointly by the Departments of Pharmacy Administration and Pharmacy Practice.
Thank you in advance for your commitment to
excellence in pharmacy.
Martha M. Rumore, Pharm.D., J.D., MBA
Associate Professor, Pharmacy Administration
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Pharmacists and Prospective DUR Under OBRA ’90
607
Demographic Info:
Pharmacist (# years in practice)
Intern
~
~
Practice Site
-Independent
-Chain
-HospitaVClinic
1. Has the counseling requirement of the law been implemented correctly? Explain.
2. Who makes the offer to counsel more than 50% of the time?
__ Pharmacist
-Technician
__ Intern
-Clerk
3. Approximately what percentage of patients choose not to supply information necessary for maintenance
of a medication profile or to accept counseling:
-All accept counseling
-25-50’70
-<lo%
50-75%
~
~
10-25%
~
>75%
4. Please list the reason(s) given, if any, for not accepting counseling.
5 . How do you document such refusals in the records of the pharmacy?
6. How long does the typical counseling session take and is there a separate counseling area?
7. What are some of the problems/deficiencies you have observed in implementation of the law?
8. Is there a “wait” for patients to receive counseling once they accept the offer to counsel?
9. Is the following statement true or false: “The pharmacist shall review the drug therapy before each prescription is filled or refilled.”
-True
-False. The law only applies to new prescriptions.
10. Do you support the inclusion of pharmacy interns in thedefinition of “pharmacist” under the state regulation for the purpose of patient counseling, insofar as the intern’s actions are under the direct supervision
of a pharmacist?
__ Yes.
-No.
1 1 . Do you feel pharmacists are skillful in history taking to be able to interview and effectively counsel pa-
tients?
__ Yes.
~
No.
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Martha M . Rumore, Stanley Fever, and Joseph S. Rumore
608
12. Do you think the time, reimbursement and professional education issues are so great to overcome that
OBRAPO will never be a reality? Has your pharmacy had to hire more help or buy computer software to
i
comply? Explain.
13. Is the following statement true or false: "In order to fulfill the prospective DUR obligations of the new
law, the pharmacist (or intern) must interview every patient each time a prescription is dispensed, to ascertain a complete listing of all medications, both Rx and OTC."
-True
-False
14. Which of the following are discussed each time a prescription is dispensed:
Always
Often
Rarely
Never
Medication name & description
~
~
~~
~
Dosage form, route, duration of therapy
Proper storage
Special directions & precautions for preparation,
administration & use
~
Common severe side effects or interactions including their
avoidance & action if they occur
Techniques for self-monitoring
~~~
Refill information
Actions to be taken in the event of a missed dose
15. Do you fear that the new law will prompt increased lawsuits against pharmacists?
-Yes.
-No.
Thank you on behalf of the Department of Pharmacy Administration.
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