Transcript Drug Dispensing Errors

Rx: Take with Food, Water & Caution
How Prescription Drug Dispensing
Errors Threaten the Health
of New Yorkers
Senator Jeffrey D. Klein
Deputy Minority Leader
34th Senate District
JULY 2008
Senator Jeffrey D. Klein
Deputy Minority Leader, New York State Senate
Prepared By:
Alex Camarda
Virginia Curtis
Office of Senator Jeffrey D. Klein
Senator Jeffrey D. Klein - Rx Drug
Dispensement Errors
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Introduction
Dear Reader,
As the baby boom generation progresses into its golden years, more and more New Yorkers are relying
on prescription drugs to ensure that they can continue to live healthy and productive lives. The
promise these invaluable drugs provide is jeopardized when breakdowns occur during the process
between a doctor’s referral and their patient receiving the recommended drug.
Numerous studies have now documented the growing and significant number of prescription drug missfills or dispensing errors, from customers receiving the wrong drug or dosage to improper directions for
ingestion. Estimates are that millions nationwide and over a hundred thousand in New York State have
their health seriously impacted by prescription drug-filling errors. It is long past time that we develop a
robust system to track these errors and take aggressive steps to prevent them altogether.
To that end, this report makes projections measuring the extent of such mistakes in New York State,
evaluates the causes, and proposes legislation and tips to consumers to minimize errors. With the
proper reforms, we can create a seamless system with essential safeguards effectively connecting
doctors, patients and pharmacists. New Yorkers, particularly the elderly and infirm, deserve nothing
less.
Regards,
State Senator Jeff Klein
34th State Senate District
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Table of Contents
Section 1: Drug Dispensing Errors- A National Problem
Section 2: Prescription Drug-Filling Errors in New York State
Section 3: Causes of Dispensing Errors
Section 4: Solutions- Legislative and Tips for Consumers
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SECTION 1:
Drug Dispensing ErrorsA National Problem
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Prescription-Filling Has
Increased Nationwide
• The number of prescription drugs
filled through retail establishments
has skyrocketed in recent years, from
under 2 billion in 1992 to 3.3 billion
in 2007.
• The typical pharmacy fills over 200
scripts a day with large chain
pharmacies processing hundreds
more.
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Dispensing Errors Have Grown with
the Rise in Prescription Drug Use
•
•
As prescription drug use has increased,
mistakes have also risen during the
prescription drug-filling process. Errors
occur during the interval between a doctor
prescribing a medication and a patient
receiving it from their pharmacist.
While it is not known how many
prescription drug dispensing errors actually
occur nationwide every year, some
estimates are that over 3 million serious,
health-threatening errors occur nationally.
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Error Rates Range with Most Sources
Projecting Millions Per Year
Nationwide.
•
•
•
A 2003 Auburn University direct-observation one-day
study scrutinizing 50 pharmacies in 6 cities found that
pharmacies filling 250 prescriptions make 4 errors
daily, with 1 in 1,000 health-threatening.
A 2007 Ohio State University study estimated there
were 5.7 errors per 10,000 prescriptions, or 2.2
million dispensing errors a year.
A 20/20 investigation of chain stores in 4 states in
2007 revealed a whopping 22 percent error rate in
filling prescriptions.
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Some Nationwide Data on Prescription
Drug Dispensing Errors is Available
Through U.S. Pharmacopeia
•
•
The non-profit organization, United States
Pharmacopeia (USP), collects data on dispensing
errors in reports voluntarily provided by outpatient
pharmacies at hospitals through its MEDMARX
medication errors reporting program.
USP is the official public standards-setting authority
for all prescription and over-the-counter medicines,
dietary supplements, and other healthcare products
manufactured and sold in the United States. USP sets
standards for the quality of these products and works
with healthcare providers to help them reach the
standards.
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Over 30,000 Dispensing Errors Have Been
Voluntarily Reported In The Last 3 Years From
Outpatient Pharmacies in Hospitals To U.S.
Pharmacopeia
5 Most Frequent Types of
Prescription Drug Dispensing Errors
(As Voluntarily Reported to U.S. Pharmacopeia by Outpatient Pharmacies at
Hospitals from 2004-2006)
Error Type
Improper Dose/Quantity
Unauthorized/Wrong Drug
Wrong Patient
Drug Prepared Incorrectly
Wrong Dosage Form
Total Number % of Total Errors
10,642
35%
7,304
24%
3,976
13%
2,707
9%
2,513
8%
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About 1 in 184 Dispensing Errors Reported
by Outpatient Pharmacies in Hospitals
Caused Harm to Patients
Nationwide Prescription Drug Dispensing Errors
By Level of Severity
(As Voluntarily Reported to U.S. Pharmacopeia by Outpatient Pharmacies
at Hospitals from 2004-2006)
Key
Error Severity Code
A
B
C
D
E
F
G
H
I
Total Errors
Total Harmful Errors
Number
0
15811
13494
536
130
30
2
0
1
30004
163
Percentage of Overall Errors
0%
53%
45%
1.79%
0.43%
0.1%
0.007%
0%
0.003%
1 in 184
errors
are
harmful
0.54%
A= Circumstances or events that have the capacity to cause errors (potential error)
B= An error occurred but the error did not reach the patient
C= An error occurred that reached the patient but did not cause patient harm
D= An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required
intervention to prevent harm
E= An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention
F= An error that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization
G= An error occurred that may have contributed to or resulted in permanent patient harm
H= An error occurred that required intervention necessary to sustain life
I= An error occurred that may have contributed to or resulted in a patient's death
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Actual Error Rates are Not
Known
• Actual nationwide error-rates are not
known, because data is collected by
variety of groups and agencies often
through voluntary reporting.
• Chain store pharmacies also collect
data on error-rates but don’t make it
available for public scrutiny.
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SECTION 2:
Drug-Filling Errors
in New York State
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Projected Drug Dispensing
Errors in New York
•
In New York, over 210 million prescriptions were filled by
4,700 retail pharmacists in 2006, an average of over 10
prescriptions per New Yorker.
•
There are a projected 210,000 health-threatening
prescription dispensing mistakes in New York every
year*
*=this number is calculated by applying the Auburn study error rate of
1 health-threatening error per 1,000 prescriptions filled to the number
of prescriptions processed in New York in 2006.
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Polling New York Seniors on
Drug Dispensing Errors
• Senator Klein’s office conducted a
health survey of nearly 400 seniors in
2007 at senior centers in the Bronx
and Westchester.
• The survey covered a wide-range of
health issues, including asking seniors
whether they had ever received the
wrong medication from their
pharmacist.
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Klein’s Survey Results
Have you ever received the wrong medication from your pharmacy?
Chain Mail/Internet Other Indy Pharmacy Total Responses
Received Wrong Medication from Pharmacy
14
6
3
2
23
Never Received Wrong Medication from Pharmacy
166
118
64
110
348
Have you ever received the wrong medication from your pharmacy?
Chain Mail/Internet Other Indy Pharmacy Total Responses
Received Wrong Medication from Pharmacy
7.78%
4.84%
4.48%
1.79%
6.20%
Never Received Wrong Medication from Pharmacy
92.22%
95.16%
95.52%
98.21%
93.80%
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Klein’s Survey Conclusions
• Over 6 percent of seniors polled
reported having received the wrong
medication from their primary retail
pharmacist.
• Seniors whose primary pharmacy was
a chain store received the wrong
medication at more than 4 times the
rate of those getting prescriptions
filled at independent pharmacies.
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Actual Dispensing Error Rates in New
York are Not Known.
• Surveys and projections from
academic studies give us approximate
estimates of the magnitude of drug
dispensing errors in New York.
• Unfortunately, there are no widelyknown, transparent and public efforts
to comprehensively track retail
prescription drug-filling mistakes in
New York.
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Klein’s Office Evaluated Prescription Drug
Dispensing Errors Data Reported to The
New York State Office of Professions
•
•
A small fraction of overall retail prescription drug
dispensing errors in New York surface through The Office
of Professions in the New York State Education
Department (NYSED), which investigates allegations of
misconduct of many professions, including pharmacists.
Klein’s office analyzed complaints to the New York State
Office of Professions between 2005 and 2007 regarding
dispensing errors and the dispensing process, as well as
disciplinary actions taken by the Office.
•
•
1,275 complaints related to the prescription drug
dispensing process were made between 2005 and 2007.
106 formal Regents disciplinary actions (the highest level
of disciplinary action) related to prescription drug process
were taken from 2005 to 2007.
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Over 1,200 Complaints Were Made to the NYS
Office of Professions Regarding the Drug Dispensing
Process from 2005-2007
Complaints Filed with the Office of Professions Related to the Drug Dispensing Process
Type of Complaint
2005
2006
2007
Total
Negligence / Incompetence
126
148
161
435
Wrong Medication Dispensed
119
114
117
350
Practicing Fraudulently
62
87
61
210
Wrong Quantity of Medication Dispensed
35
24
20
79
No Pharmacist on Duty
4
12
43
59
Failure to Provide Proper Supervision
7
23
16
46
Failure to Notify Pharmacy Board of Change of Supervisor
1
24
18
43
Rx Labeling Mistake
11
10
15
36
Aiding or Abetting an Unlicensed Person to Dispense Drugs
3
6
8
17
1275
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Dispensing Mislabeled or Misbranded Drugs is the
Most Common Dispensing Error Resulting in
Disciplinary Action by the Office of Professions
Disciplinary Actions Taken Related to Dispensing Drugs
Distribution-Related Disciplinary Actions
Type of Disciplinary Action
2005-2007
Giving mislabeled/misbranded drugs to consumers, or keeping them in stock
11
Providing prescription drugs to consumers without a prescription or with an
invalid prescription
9
Failure to “counsel” consumers and/or keep a counseling log, as required by
Law
8
Distributing the wrong drugs to consumers
6
Maintaining outdated drugs in a pharmacy
6
Providing drugs of the wrong strength to consumers
5
Distributing the wrong number of doses of a drug to consumers
5
General dispensement error not specified
3
Failure to package drugs in child resistant containers or to maintain records
that the patient had requested otherwise
1
TOTAL
54
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Office of Professions’ Data Further Reveals
Systemic Problems That Increase the Likelihood of
Dispensing Errors.
Disciplinary Actions Taken Related to Drug Dispensing
Oversight and Administration-Related Disciplinary Actions
Type of Disciplinary Action
2005-2007
Failure to maintain adequate and/or accurate records such as
prescriptions filled and refilled, and a daily record identifying practitioners
making the order
23
Failing to employ a supervising pharmacist to oversee the operation of
the pharmacy, as required by law
15
Running a pharmacy without a pharmacist on duty
5
Failure to notify the State Board of Pharmacy of a change in the identity
of the supervising pharmacist
4
Pharmacist failing to provide documentation of education credentials to
be registered and practicing.
3
Delegating professional responsibilities to technicians and other support
staff that must legally be done by pharmacists
2
TOTAL
52
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Disciplinary Action Taken Against Chain
Pharmacies (2005-2007) by the
NYS Office of the Professions
Rite Aid of New York,
Inc.
● Registrant admitted to
the charge of willfully
failing to have a
supervising pharmacist
oversee the operation of
its pharmacy
● Registrant admitted to
the charge of failing to
notify the State Board of
Pharmacy of a change in
the identity of the
supervising pharmacist
● Respondent admitted
to charges of committing
a dispensing error, failing
to maintain a counseling
log, and failing to offer
counseling.
Genovese Drug Stores,
Inc.
d/b/a Eckerd
● Registrant admitted to
charges of willfully failing
to notify the Pharmacy
Board of a change in
supervising pharmacist
and to have a licensed
pharmacist having
personal supervision of
the pharmacy
● Registrant admitted to
the charge of having
failed to have a licensed
pharmacist having
personal supervision of
the pharmacy
● Respondent does not
contest the charge of
failing to have a
supervising pharmacist
employed and on duty
between May 15th and
July 17th, 2005
● Registrant admitted to
the charge of having the
pharmacy open without
a licensed pharmacist on
duty
CVS
● Registrant admitted to
charges of failing to
maintain a daily record,
signed by the dispensing
pharmacists, of all
prescriptions filled and
refilled, and of holding
for sale misbranded
drugs
Duane Reade
● Licensee admitted to
the charge of operating
the pharmacy without a
supervising pharmacist
for two months
Senator Jeffrey D. Klein - Rx Drug
Dispensement Errors
Walgreen Eastern
Company, Inc.
● Registrant did not
contest charges of
maintaining misbranded
drugs in active stock and
maintaining the
pharmacy in unsanitary
condition
Eckerd Corporation
● Respondent admitted
to the charge of failing to
employ a supervising
pharmacist of the retail
pharmacy operated by
respondent during the
period from January 6,
2004 to February 10,
2004.
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SECTION 3:
Causes of Prescription DrugDispensing Errors
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Causes of
Dispensing Errors

There are many reasons for the surge in prescription drug
dispensing errors:
1. Chain Stores Pressure Pharmacy Staff to Process Transactions
Quickly
Walgreens expects pharmacists and/or technicians processing a prescription
drug transaction in 2 minutes, making meaningful consultation difficult.
Unsurprisingly, a 2004 survey by the Midwest Pharmacy Workforce Research
Consortium revealed that the majority of pharmacists at chain stores were
stressed due to inadequate staff.
2. Counseling Violations
Legally-mandated discussions between pharmacists and consumers about
their prescription drug regimen are frequently not done or circumvented.
Pharmacists may ask consumers to sign a sheet effectively waiving
counseling, except for new or changed therapies. Mail-order pharmacies put
the impetus on the consumer to call rather than taking responsibility for
initiating the conversation with consumers.
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Causes of
Dispensing Errors (continued)
3. Increased Use of Technicians
Technicians not held to the same standards as pharmacists are increasingly
taking over their tasks. There is no age requirement or minimum education
level for technicians, despite their ability to “count, pour, lick and stick.” In
New York State, the ratio of technicians to pharmacists in a retail store was
increased to 2:1 from 1:1 in recent years.
4. Doctor’s Illegible Handwriting
Doctors’ infamously unreadable scripts also contributes to errors made in
filling prescription drugs.
5. Untranslated Scripts for Limited English Proficiency (LEP)
Consumers
A 2007 New York City Academy of Medicine study revealed that of 200 chain
and independent pharmacies surveyed in New York City, only 34% reported
translating scripts daily even though 88% reported serving LEP customers
every day. This low translation exists despite the capacity of 80% of New
York City pharmacists to translate scripts.
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SECTION 4:
Solutions
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Empower the New York State
Office of the Professions

1) Strengthen the Office of the Professions

Senator Klein will introduce legislation that will:
•
Require all major retail drug errors (those causing physical harm)
to be reported to the Office of Professional Responsibility.
•
Empower the Board to monitor prescription volume and staffing
ratios at pharmacies, as is done by the North Carolina Board of
Pharmacy, to ensure quality is not compromised for speed.
•
According to North Carolina Administrative Code (NCAC) 46
.1811, “Pharmacists shall not dispense…prescription drugs at
such a rate per hour or per day as to pose a danger to the
public health or safety.”
•
2 technicians per pharmacist is the accepted ratio by the North
Carolina Board. Pharmacies must obtain waivers from the
Board to operate with higher ratios of technicians to
pharmacists.
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Make the Public Aware of the
Process for Filing Complaints
 2) Promote the process for registering
complaints with the Office of
Professions in NYSED
•
•
Klein will introduce a bill requiring all
pharmacies to prominently display information
on how consumers can file a complaint about
pharmacy-related practices with the Office of
Professions in NYSED.
Specifically, the toll-free number to register
complaints will be listed on prescription drug
bottles and posted in pharmacies
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E-Prescribing Will Reduce
Dispensing Errors

3) Incentivize Electronic Prescribing (E-Prescribing)
•
E-prescribing refers to the creation, transmission, recording, or storage of
prescriptions electronically (including but not limited to the use of faxes).Doctors
can send prescriptions to pharmacies electronically through computers, handheld
PDAs or faxes rather than using the traditional pen and pad.
•
Slowness in implementation is largely due to costs in setting up a secure
and convenient electronic transmission system. It requires a high-speed Internet
connection, a special networking service, and the doctors’ prescription software.
•
Despite a 2003 law authorizing e-prescribing in New York State, less than 2
percent of prescriptions were “written” electronically in 2007.
•
Just 7 percent of office-based physicians were e-prescribers
•
56 percent of community pharmacies received e-prescriptions
•
Senator Klein proposes legislation providing tax credits to doctors and
pharmacists in smaller, independent offices to adopt transmission technology
with costs offset by projected savings from e-prescriptions (The Congressional
Budget Office estimates $1.5 billion in savings over 5 years for a bipartisan
federal proposal(the Medicare Electronic Medication and Safety Protection Act)
mandating e-prescribing for Medicare patients).
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Raise Qualifications for
Technicians
 4) Improve standards for technicians
• Senator Klein supports Senator Fuschillo’s bill,
S5034, requiring certification for pharmacy
technicians. The bill requires that all pharmacy
technicians be high school graduates, 18 years
of age or older, pass an examination, and be
registered by NYSED. This bill will improve the
quality of technicians working in pharmacies and
thereby, reduce prescription-related errors.
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Legible Scripts with the Drug’s
Purpose will Reduce Errors
 5) Requiring legible scripts that include
the purpose of the medication
• Senator Klein will introduce legislation
building on that of S2667 that will not
only require doctors to convey scripts in
a legible manner but also require the
purpose of medication (with permission
from the patient) so confusion between
similar-sounding drug names is avoided.
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SolutionsKlein’s Tips for Consumers




1) If your doctor provides you with a handwritten script,
make sure the drug name and purpose of the drug (where
appropriate) is clearly written down. Share this information
with your pharmacist.
2) Inform your doctor and pharmacist of other medications
you are taking to prevent harmful mixtures of drugs.
3) Be sure to “counsel” with your pharmacist rather than a
technician, discussing the procedure for taking your
prescribed medication. Ask about relevant topics like side
effects and dosage.
4) Register complaints regarding poor pharmacy-related
service by contacting the Office of Professional Discipline at
one of its offices throughout New York State. For the fastest
response, complete a complaint form and contact the office
closest to you. You may also telephone toll-free at 1-800442-8106, fax (212) 951-6449, or email:
[email protected].
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