Rx: Take with Food, Water & Caution How Prescription Drug Dispensing Errors Threaten the Health of New Yorkers

1. 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

2. 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

3. 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 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 Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

4. 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 Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

5. SECTION 1: Drug Dispensing Errors- A National Problem Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

6. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

7. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

8. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

9. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

10. Over 30,000 Dispensing Errors Have Been Voluntarily Reported In The Last 3 Years From Outpatient Pharmacies in Hospitals To U.S. Pharmacopeia Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

11. About 1 in 184 Dispensing Errors Reported by Outpatient Pharmacies in Hospitals Caused Harm to Patients 1 in 184 errors are harmful Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

12. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

13. SECTION 2: Drug-Filling Errors in New York State Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

14. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

15. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

16. Klein’s Survey Results Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

17. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

18. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

19. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

20. Over 1,200 Complaints Were Made to the NYS Office of Professions Regarding the Drug Dispensing Process from 2005-2007 Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

21. Dispensing Mislabeled or Misbranded Drugs is the Most Common Dispensing Error Resulting in Disciplinary Action by the Office of Professions Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

22. Office of Professions’ Data Further Reveals Systemic Problems That Increase the Likelihood of Dispensing Errors. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

23. Disciplinary Action Taken Against Chain Pharmacies (2005-2007) by the NYS Office of the Professions Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

24. SECTION 3: Causes of Prescription Drug-Dispensing Errors Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

25. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

26. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

27. SECTION 4: Solutions Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

28. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

29. 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 Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

30. 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). Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

31. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

32. 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. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors

33. Solutions- Klein’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 1-800-442-8106, fax (212) 951-6449, or email: conduct@mail.nysed.gov. Senator Jeffrey D. Klein - Rx Drug Dispensement Errors