State Initiatives to Avoid Prescription Drug Errors
Several laws enacted and bills considered anticipate problems and use state powers to provide some solutions, 2003-2008
Updated: January 2009
A report from the Institute of Medicine (IOM), Preventing Medication Errors, released July 20, 2006, finds that "medication errors are surprisingly common and costly to the nation." They conclude that at least 1.5 million preventable "adverse drug events" (ADEs) occur in the United States each year. It outlines a comprehensive approach to decreasing the prevalence of these errors. This approach will require changes from doctors, nurses, pharmacists, and others in the health care industry, from the Food and Drug Administration (FDA) and other government agencies, from hospitals and other health-care organizations, and from patients. See IOM Report details below.
Federal Responses: U.S. Health and Human Services Secretary Michael Leavitt has called for mandated electronic prescribing for Medicare patients. At the 2008 HIMSS Conference in Orlando on Feb. 26, he also indicated mandates on use of electronic health records under Medicare are a distinct possibility. Electronic prescribing can enable physicians to access formulary data at the point of care and prescribe appropriate but less expensive drugs. “The time has come to make the change to e-prescribing,” Leavitt said in his keynote address. “We can no longer afford to pay reimbursements for people to prescribe in the most expensive way.” And he added this caveat for provider organizations that have been slow to adopt EHRs: “The day is not long off until we do the same for electronic health records.” [article 2/28/08]
State Responses: In response to the IOM report over almost two years, NCSL reports that, beginning five years ago, at least 15 states have passed laws aimed at reducing prescription drug errors, including Arizona, Colorado, Delaware, Florida, Idaho, Illinois, Louisiana, Maryland, Massachusetts, Michigan, Montana, South Dakota, Tennessee, Texas and Washington. They address improved legibility, clearer or "common sense" labeling of bottles, regulating telepharmacy and electronic records. In addition, a number of states are supporting expanded use of electronic medical records, which would impact Rx as well as other areas of medical practice. "Legislators in states from Florida to Montana already took action to reduce medication errors, based on state and local data. Some of those laws, requiring legible prescriptions, electronic files and clearer labels, may be starting points for issues raised in the new report."
E-PRESCRIBING INITIATIVES
E-prescriptions slowly catch on:
> Pharmacy Health Information Exchange™ operated by SureScripts®
> National Progress Report on E-Prescribing published by PHIE
> E-Prescribing State Map
> Doctors Start To E-Prescribe Ahead of New Medicare Rule - SureScripts-RxHub estimates that the number of U.S. doctors who have adopted electronic prescribing technology has more than doubled this year. Some industry observers attribute the shift to a new Medicare rule scheduled to take effect in January 2009 that will offer a 2% payment bonus to physicians who use e-prescribing. AP/Boston Globe. 12/16/08.
Health Experts Launch New Web Site to Educate Consumers on Medication Safety - The Center for Improving Medication Management (The Center) today launched http://www.learnaboutrxsafety.org/, a new Web site where consumers can learn how to use medications safely. Developed in conjunction with the National Council on Patient Information and Education (NCPIE), the Web site is primarily intended as a resource for families and all individuals seeking information on medication safety. 12/15/08.
> Physicians, Pharmacies Use E-Prescriptions To Boost Patient Safety - By the end of 2008, experts estimate that 85,000 physicians nationwide will be using electronic prescriptions. More than 70% of pharmacies in the country are equipped to accept e-prescriptions, according to SureScripts. IHealthBeat, 5/28/08.
> Texas article 4/29/08
The recent laws listed below are examples of state action; they are not an exhaustive survey of activities in all fifty states and territories. A separate table includes examples of bills filed and/or debated in seven other states.
RECENT STATE LAWS [Table 1]
State / Citation
|
Summary of law/ legislative history |
AZ
HB 2255
Rep. Stump |
Establishes a "continuous quality assurance program" to review pharmacy procedures for addressing pharmacy medication errors. Defines records as peer review documents not subject to use in arbitration or civil court proceedings.
(Filed 1/18/07; passed House 46y-9n, 2/19/07; passed Senate 16y-10n, 4/18/07; signed into law by governor as Chapter 121, 4/24/07) |
AZ
HB 2136
Rep. Stump
Chapter 269 |
Authorizes a controlled prescription drug monitoring program, including a computerized central tracking database.
(Substitute adopted, 3/16/07; passed House 6/20/07; passed Senate 5/10/07; signed into law by governor as Chapter 269, 7/2/07)
|
AR
SB 189
Sen. Malone |
Prohibits the sale of online pharmaceuticals in Arkansas if the patient hasn't consulted a prescribing practitioner.
Filed 1/25/07; passed Senate; passed House; signed to law by governor as Act 128, 2/21/07) |
CA
SB 472
Sen. Corbett |
Adopts a standard format for the labeling of prescription drug containers dispensed in the state, that would include regulations for the font size of printed words on the label and the placement of information of the prescription and would provide that translated prescription drug labels should be made available to the patient if the patient's primary language is not English.
(Filed; passed Senate 5/29/07; passed Assembly 74y-4n, 9/5/07; signed into law by governor, 10/11/07, Chapter 470.) |
CO
HB03-1063
Rep. Johnson |
Allows the patient to request the prescription label to list the purpose or symptoms for which the prescription is written. In the case of anabolic steroids, it is mandatory. Also requires the prescriber to notify the patient of this option but not grounds for discipline if they do not.
(Filed 1/8/03; passed House 1/20/03; passed Senate 3/10/03; signed into law by governor 3/25/03) |
DE
HB 33
Rep. Miro |
Allows a pharmacist to put the symptom or purpose for the drug being prescribed on the drug container label, but only if a practitioner indicates that the patient or their authorized representative requests information on the label.(Filed 1/25/05; passed House 6/21/05; passed Senate in final form 6/30/05; signed into law by governor 7/7/05) |
|
DE
SB 48
Sen. Sorenson
|
Would require prescriptions to be written legibly so that pharmacists filling them can do so accurately and thereby avoid potential harm to the consumer.
(Filed 3/22/05, passed Senate 6/15/05; passed House 6/28/05; signed into law by governor 7/12/05) |
FL
SB 2084
Sen. Wasserman |
Requires that written drug prescriptions "must be legibly printed or typed" to assure they can be understood by pharmacists. Effective date July 1, 2003.
(Filed 3/4/03; passed Senate 4/30/03; passed House 5/1/03; signed into law by governor 5/23/03 as Chapter 2003-41) |
ID
37-2725 |
Requires prescriptions to be legible by a pharmacist and provides for disciplinary measures by the Board of Pharmacy if it is not. |
|
IL
SB 2253
(2004)
Sen. Demuzio
|
Amends the Pharmacy Practice Act, by adding the activities of "preparation, computer entry and verification of medication orders, medical devices and prescriptions" as steps regulated under pharmaceutical dispensing.
(Passed Senate 3/25/04; passed House 5/26/04; signed into law by governor as Public Act 93-1075, 1/18/05) |
IL
SB 595 (2007)
Sen. Koehler |
Creates a program in the Dept. of Aging to help those over age 60 with managing their medications.
(Filed 2/8/07; passed both chambers 5/31/07; signed into law by governor as Public Act 95-0535, 8/28/ |
LA
HB 523
Rep. Thompson |
Prohibits pharmacists from issuing a prescription based solely upon the results of an electronic questionnaire.
(Filed 4/19/07; passed House 5/16/07; passed Senate 6/24/07; signed into law by governor as Act 318 7/9/07) |
MD
HB 433
Del. Boutin |
Requires prescribers to print or type written prescriptions in a legible manner.
(Filed 1/29/04; passed House 3/12/04, passed Senate 4/4/04; signed into law by governor as Chapter 503, 5/26/04) |
MA
S 3, H 4141
item 4000-0500
(2007) |
FY08 budget authorizes a CMS Medicaid Transformation Grant to fund a MassHealth e-Prescribing pilot project to introduce electronic prescription writing (e-prescribing) to Medicaid providers for developing, piloting, evaluating and rolling out a real-time decision support solution that can be integrated into providers’ workflow that will be accomplished by integrating prior authorization, preferred drug lookup, and other components of Affiliated Computer Services’ application used by MassHealth providers with the Rx Gateway for prescription routing and related services already under development by MA-SHARE (Massachusetts Simplifying Healthcare Among Regional Entities)
(Filed 2/07; passed Senate and to Joint Conference Comm. 5/25/07; signed into law by governor as Chapter 61 of 2007, 7/12/07)
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MI
HB 4434
Rep. Salva, Rep. Hummel
|
Allows a licensed pharmacy to perform "centralized prescription processing services," or to outsource those services to another licensed pharmacy, if certain conditions are satisfied. Would require that pharmacies share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to prepare a prescription drug order. Would require that each prescription drug dispensed under such a system would have to bear a label containing an identifiable code providing a complete audit trail of the preparation and dispensing of the drug and patient care activities.
(Filed 3/15/05; HB 4434 passed House 104y-0n, 4/21/05; passed Senate 37y-0n, 5/12/05; signed into law by governor as Public Act 72, 7/19/05)
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MT
HB 254
Rep. Harris
|
Establishes a civil penalty for not writing legible prescriptions.
(Filed 1/27/05; passed House 1/27/05; passed Senate 4/12/05; signed into law by governor 4/28/05)
|
NV
AB 235 |
Would allow the symtpom or purpose of a prescription to be on the label if the patient desires.
(Filed and sent to committee 3/1/07; passed Assembly 4/17/07, passed Senate 5/23/07, signed by governor 5/25/07 as Chapter 203) |
NH
H 1396
Rep. Rosenwald |
Requires that a prescription be ordered only as part of "a practitioner-patient relationship" by rewriting the definitions of prescription to include the "medical connection between a licensed practitioner and a patient that includes an in-person exam, a history, a diagnosis, a treatment plan" and documentation of all drugs and dosages. Prohibits a prescription to be ordered by submission of an electronic or on-line medical history form that fails to establish a valid practitioner-patient relationship.
(Filed 1/2/08 passed House; passed Senate; signed into law by governor as Chapter 217 of 2008, 6/16/08) | ) |
SD
HB 1031
Health & Human Services |
Provides for the regulation of telepharmacy; including licensing, staffing, annual fee up to $250 and use of remote pharmacy auotmated dispensing machinces.
(Filed 1/9/07, passed House 65y-4n, passed Senate 31y-4n, 2/20/07; signed into law by governor 3/1/07) |
TN
HB 3298
SB 3127
Public Chapter No. 936 |
Requires pharmacists to indicate on the label of a prescription drug for an elder person the condition for which the drug is prescribed if the elder person or the person's physician requests it.
(Filed 1/16/08; HB 3297 passed House and Senate; signed into law by governor as Chapter 936, 5/21/08) | |
TN
SB 2162
Sen. Dixon |
Creates the "Medication Error Reduction Act" for a uniform standard format, requiring written prescription orders to be legible and comprehensible to a pharmacist; would limit the liability of pharmacists for delay incurred when clarifying a prescription that the pharmacist cannot understand.
(Filed 1/04; SB 2162 passed Senate 3/24/04; passed House 4/29/04; signed into law by governor as Chapter 678, 5/18/04) |
TN
SB 470
Sen. Turner |
Makes clarifying changes to the requirement that prescriptions written by various health care practitioners drug must be legibly handwritten or typed or computer generated so that it is comprehensible by the pharmacist.
(Filed 2/3/05; SB 470 passed Senate 3/2/05; passed House 3/14/05; signed into law by governor as Chapter 12, 4/4/05)
|
TX
HB 948
Rep. Davis |
Establishes requirements for prescription drug retail labels, including cautionary statements, be printed in visible type at least 8-point size, to avoid potential patient error. Effective September 1, 2007.
(Filed 1/30/07; passed House; passed Senate; signed into law by governor 6/16/07) |
WA
HB 2798
Rep. Ballard |
Establishes prescription legibility requirements so they are readable by a pharmacist which reduces medication errors.
(Filed 2/1/00; passed House 2/9/00 ; passed Senate 3/1/00; signed into law by governor as Chapter 8, 3/17/00) |
BILLS NOT ENACTED - EXAMPLES, 2003-2007 [Table 2]
| State / Citation |
Summary of bill/ legislative history |
|
NJ
A 2718
Assm. Chiappone
|
Would require that pharmacists provide additional prescription drug information, notifying consumers, when a generic drug product is dispensed, about the characteristics of that drug product, other than its active ingredient, which differ from the brand-name drug product for which it is being substituted and may be important in the therapy of a particular patient.
(Filed 5/6/04; carried over to 2005 session & held in committee 10/05)
|
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MA
S 1276
Sen. Moore
|
Would convene a task force to study methods for reducing medication and prescription errors, including recommendations on prescription legibility, drug labeling and packaging, medication error reporting plans, automated drug ordering systems, and patient education.
(Filed 1/26/05; hearing 9/21/05; favorable committee report 3/28/06) |
MA
S 419, S 432
Sen. Moore |
Would relate to the safe administration of medications and legible prescriptions reducing medication and Rx errors. S. 432 Would require pharmacies to inform the Department of Public Health of medication dispensing errors.
(Filed 1/9/07; ought to pass 10/25/07 and sent to Health Care Financing 10/25/07) |
MO
SB 835
Sen. Engler |
Would require licensed practitioners to issue all written prescriptions. The prescriptions shall be legibly printed or typed, dated with the month written in textual letters and signed by the prescribing practitioner on the day issued. The prescriptions shall also contain the name of the prescribing practitioner, the name, strength and quantity of the prescribed drug, and directions for using the drug.
(Filed and referred to committee 1/10/06; did not pass by end of 2006 regular session)
|
NY
S 6498
Assm. McDonough |
Would require prescriptions to be typewritten, electronically printed or handwritten in ink or indelible pencil in a legible manner; requires that handwritten prescriptions shall only be written in print letters; prohibits the use of script letters in handwritten prescriptions.
(Filed and sent to committee 3/16/04; did not pass by end of session 12/04; refiled for 2005-06 as A 4090, A 4437 & S 2231 ) |
|
OK
SB 614
Sen. Reynolds
|
Would clarify language and require placement of the symptom for which a drug is prescribed on the prescription label under specified conditions.
(Filed 3/10/05; passed Senate; passed House, did not pass conference committee 5/27/05*)
|
WA
HB 1780
Rep. Schual-Berke |
Would require improved legibility of prescriptions.
(Filed 2/4/05; held in committee; did not pass by end of regular session 4/24/05*) |
WI
AB 689
Rep. Wieckert |
Would require that prescription drug labels specify the symptom or purpose for which the drug is being prescribed if the patient wants the symptom or purpose to appear on the label. The practitioner who prescribes the drug must ask the patient if the patient wants the symptom or purpose to appear on the label. If the patient wants that information on the label, the practitioner must add that information to the prescription order and the pharmacist must include that information on the prescription drug label.
(Filed and sent to committee 12/5/03; did not pass by end of session) |
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Pharmacy Health Information Exchange
Updated 12/2008
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The IOM Medication Error Report
The following are some resources related to the latest IOM Report, including key quotes from IOM and direct links.
Almost everyone in the modern world takes medication at one time or another. According to one estimate, in any given week four out of every five U.S. adults will use prescription medicines, over-the-counter drugs, or dietary supplements of some sort, and nearly one-third of adults will take five or more different medications.
THE UNACCEPTABLE COSTS OF MEDICATION ERRORS
In hospitals, errors are common during every step of the medication process—procuring the drug, prescribing it, dispensing it, administering it, and monitoring its impact—but they occur most frequently during the prescribing and administering stages. When all types of errors are taken into account, a hospital patient can expect on average to be subjected to more than one medication error each day. However, substantial variations in error rates are found across facilities. An ADE arising from an error is considered preventable. It is difficult to get accurate measurements of how often preventable ADEs occur. One study estimated 380,000 preventable ADEs in hospitals each year, another estimated 450,000, and the committee believes that both are likely to be underestimates.
The numbers are equally disturbing in other settings. One study calculates, for example, that 800,000 preventable ADEs occur each year in long-term care facilities. Another finds that among outpatient Medicare patients there occur 530,000 preventable ADEs each year. And the evidence suggests that both of these numbers are likely to be underestimates as well. Furthermore, none of these studies includes errors of omission—failures to prescribe medication in cases where it should be. Taking all of these numbers into account, the committee concludes that there are at least 1.5 million preventable ADEs that occur in the United States each year. The true number may be much higher.
Currently, fewer than 20 percent of prescriptions are electronic. Three percent of hospitals have electronic health records, the New York Times reported.
- Medication Safety Public Report Release - IOM 7/20/06
- Report Brief. Preventing Medication Errors - IOM, 7/20/06 [406K, 4 pages]
- Fact Sheet. What You Can Do to Avoid Medication Errors - IOM, 7/20/2006
- IOM Full Report - only available for sale as download or print copy, $47.50 and up.
- Report: Drug errors injure more than 1.5M AP/Yahoo News 7/20/06
- Mark McClellan, M.D., PH.D., CMS speaks to IOM Report - CMS release, 7/20/06
- NPR Discusses IOM Report on Medication Errors, E-prescribing - NPR's "Talk of the Nation/Science Friday" on 7/28/06 discussed a recent Institute of Medicine report finding that all prescriptions should be written electronically by 2010 in an effort to reduce prescription drug errors. Audio.
ADVERSE RX, per JAMA
Adverse reactions to some of the most commonly prescribed medications result in more than 700,000 emergency department (ED) visits annually, according to a study published in the Journal of the American Medical Association. Researchers examined data from the first two years -- 2004 to 2005 -- of a national surveillance project on outpatient medication safety developed by the Centers for Disease Control (CDC), Food and Drug Administration and the Consumer Product Safety Commission. They found:
- Reactions to medications accounted for at least 701,547 ED visits
- The most common adverse reactions among ED patients involved accidental overdoses and allergic reactions
- About 17 percent of ED patients who experienced adverse reactions to medications required hospitalization.
The authors also found:
- The medications most commonly involved in adverse reactions among ED patients where insulins used to treat diabetes, pain medications that contain opiates and blood thinners.
- The medications most commonly involved in allergic reactions among ED patients were antibiotics that contain amoxicillin and antihistamines and other over-the-counter cold treatments.
- Patients ages 65 and older who experienced adverse reactions to medications were twice as likely to visit EDs and seven times as likely to require hospitalization as younger patients.
"These are estimates just of the patients who make it" to the ED, CDC epidemiologist Daniel Budnitz said, adding, "We don't even attempt to estimate the number of patients who never make it to treatment."
Source: Daniel S. Budnitz et al., "National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events," Journal of the American Medical Association, Vol. 296, No. 15, October 18, 2006. For JAMA Abstract: http://jama.ama-assn.org/cgi/content/abstract/296/15/1858?maxtoshow=
(text courtesy of NCPA Daily Policy Journal (c) 10/19/2006)
Related Articles and Reports
Bar Code Technology Could Help Curb Drug Errors at Hospitals Serious injuries reported to FDA because of hospital drug errors have doubled in the last decade. A bar code technology system that verifies the medication and dosage prior to being administered to patients could help curb the increasing number of medication errors, but fewer than 20% of U.S. hospitals have adopted the expensive systems.
> "Hospital drug errors far from uncommon" Los Angeles Times, 11/22/07.
Prescription Drug Safety: Emergency Controls, Scams and Long-distance Sales - NCSL report covering anti-terrorism and natural disaster situations from a health and safety perspective. Updated 11/07.
"Wide Gap Between Vision For E-Prescribing And Reality In Physician Practices;" Physicians Report Major Barriers To Using Advanced E-Prescribing Features; "Physicians’ Experiences Using Commercial E-Prescribing Systems" - full text, PDF. Health Affairs new 4/3/07.
Georgetown Suspends E-prescribing Pilot After Security Breach - Georgetown University Hospital in Washington, D.C., last week suspended an electronic prescription pilot program after learning of a data security breach affecting between 5,600 and 23,000 patients. Wired News 7/26/06.
Expert Sources: Committee on Identifying and Preventing Medication Errors, Institute of Medicine.
Research for Adverse Drug-Events And Reports (RADAR) - "Serious adverse drug reactions (sADRs) account for over 100,000 deaths annually. Investigation into barriers in identification and dissemination of sADR information for drugs is likely to have a direct benefit on patient safety, save lives, and identify areas for future policy changes. These considerations are especially important for cancer drugs, where the emphasis has been on accelerated FDA approval and shorter review times, raising concern that attention to sADRs may not be sufficient." Study by Charles Bennett, MD, MPH, Northwestern University, 2005.
Legislation excerpted from NCSL State Prescription Drug reports of 2003, 2004, 2005, 2006 and 2007, available online. Compiled by the NCSL Health Program - Denver.
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This report is posted online at: www.ncsl.org/programs/health/RxErrors.htm
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