Rx: Take with Food, Water

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Rx Take with Food, Water Caution How
Prescription Drug DispensingErrors Threaten the
Health of New Yorkers

• Senator Jeffrey D. Klein
• Deputy Minority Leader
• 34th Senate District
• JULY 2008

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• Senator Jeffrey D. Klein
• Deputy Minority Leader, New York State Senate
• Prepared By
• Alex Camarda
• Virginia Curtis
• Office of Senator Jeffrey D. Klein

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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 doctors referral
  and their patient receiving the recommended drug.
• Numerous studies have now documented the growing
  and significant number of prescription drug
  miss-fills 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 Errors-
• A 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
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About 1 in 184 Dispensing Errors Reported by
Outpatient Pharmacies in Hospitals Caused Harm to
Patients
1 in 184 errors are harmful
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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 dont 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 Kleins 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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Kleins Survey Results
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Kleins 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 widely-known,
  transparent and public efforts to comprehensively
  track retail prescription drug-filling mistakes
  in New York.

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Kleins 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.
• Kleins 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
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Dispensing Mislabeled or Misbranded Drugs is the
Most Common Dispensing Error Resulting in
Disciplinary Action by the Office of Professions
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Office of Professions Data Further Reveals
Systemic Problems That Increase the Likelihood of
Dispensing Errors.
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Disciplinary Action Taken Against Chain
Pharmacies (2005-2007) by the NYS Office of the
Professions
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• SECTION 3
• Causes of Prescription Drug-Dispensing 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
  21 from 11 in recent years.
• 4. Doctors 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
  dispenseprescription 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 Fuschillos 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 Drugs 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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Solutions- Kleins 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 1-800-442-8106, fax [phone],
  or email conduct_at_mail.nysed.gov.