Examples of the Impact of the ISMP Medication Error Reporting Program (MERP)

I. Early warning system

Nationwide hazard alerts
(description of the safety issue along with error-reduction recommendations)

In direct response to analysis of specific types of errors and hazards submitted to the MERP, ISMP electronically distributed timely, nationwide, hazard alerts to healthcare providers on the following topics:

Fatal events involving concentrated electrolytes (1996)
Mix-ups between various protease inhibitors, some new to the market (1996)
Change in packaging of Clintec Nutrition 10% amino acid solution, which has led to mix-ups with look-alike containers of 10% dextrose solution (1996)
Errors from confusing dose labeling on Camptosar (irinotecan hydrochloride injection, CPT-11) (The alert leads to labeling changes) (1996)
Ambiguous presentation of a cisplatin regimen published in the Journal of Clinical Oncology (The alert leads to correction published in subsequent journal) (1997)
Fatal overdoses of cisplatin due to labeling and packaging similarity with carboplatin (The alert leads to labeling and packaging changes) (1997)
Fatal events involving magnesium sulfate overdoses (1997)
Fatal errors stemming from confusion between lipid-based products (amphotericin B, doxorubicin, daunorubicin) and their conventional counterparts (1998)
Repeated warnings about errors from confusing dose labeling on Cerebyx (fosphenytoin) (The alert leads to labeling changes) (1998)
Methotrexate overdoses due to inadvertent administration daily instead of weekly (2002)
The need for immediate, nationwide replacement of Brethine (terbutaline) ampuls with available vials to avoid potentially fatal mix-ups with look-alike ampuls of Methergine (methylergonovine) (2004)

Press releases to the lay and healthcare media
(description of the safety issue, error-reduction strategies, and link for additional information)

In direct response to analysis of specific types of errors and hazards submitted to the MERP, ISMP electronically distributed timely, nationwide press releases to the lay and healthcare media on the following topics:

The risk of accidental acetaminophen overdoses in children if parents or healthcare providers fail to recognize that there are different dosage strengths available on the market (2003)
Remind parents during the flu season about the risk of acetaminophen overdoses and that aspirin is not a suitable alternative for children who have fever, headaches, or other signs of a virus infection (2003)
The dangerous practice of “PCA by proxy” and other risks associated with pain control when using patient controlled analgesia (2003)
Fatal errors that have occurred because medications or solutions were unlabeled in the sterile field (2004)
A call for definitive action by the FDA and manufacturers on longstanding labeling and packaging problems that have led to serious errors (e.g., vaccines with look-alike packaging, medications packaged in look-alike low density polyethylene containers, concentrated liquid morphine without a prominent warning) (2004)
Life-threatening tubing misconnections in hospitals, including the risk of fatal connections between IV ports and blood pressure device hoses, air supply hoses, oxygen tubing, and other forms of medical tubing (2004)
The risk of methemoglobinemia associated with benzocaine spray products and the difficulty with detection of the potentially fatal reaction because arterial blood gas or pulse oximetry readings can be near normal (2004)
Improper and sometimes fatal intrathecal injection of ionic contrast media prior to diagnostic radiological tests (2004)
Fatal overdoses that have occurred when using transdermal fentanyl patches (2005)
Warning that the same brand name may be used for different drugs in different countries, causing harm in some cases (2005)

II. Learning

Dissemination of error-prone trends and error-reduction strategies

In direct response to analysis of errors and hazards submitted to MERP, ISMP took the following actions to facilitate widespread dissemination of the error-prone trends uncovered and suggested error-reduction strategies:

Published the fist list of dangerous drug abbreviations, as identified from voluntary practitioner reports of errors1 (1987)
Published the first mention in the medical literature of the dangers of free-flow infusion pumps2 (1992)
Published the first scholarly article on application of failure mode and effects analysis in healthcare settings3 (1994)
Surveyed U.S. hospitals about serious medication errors and drugs most prone to these errors; combined with data from the MERP, these findings become the source of the nation’s first high-alert drug list (1995)
Created a website for clinicians and consumers to access free medication safety information electronically, as learned from reports to the MERP (1995)
Launched the ISMP Medication Safety Alert!® newsletter; the biweekly publication shares blinded stories about errors reported to the MERP and recommendations for multidisciplinary prevention of medication errors in acute care settings (1996)
Held its first seminar for the pharmaceutical industry, Strategies for Error-Proofing Drug Labeling, Packaging & Nomenclature, in Princeton, NJ, based in large part on associated errors reported to the MERP; ISMP holds annual educational programs thereafter (1998)
Published in a peer-reviewed journal the first list of high-alert medications that are more likely to be involved in serious medication errors4 (1998)
Disseminated the first ISMP Medication Safety Self Assessment® for Hospitals, conducted in partnership with AHA and the Healthcare Research and Education Trust (HRET); the safety practices highlighted in the self-assessment are derived from analysis of hospital error reports submitted to MERP (2000); findings were later published5 (2003)
Launched the first certificate program in medication safety, offered as part of Temple University’s Doctor of Pharmacy program; blinded error reports from the MERP are used to teach students about medication safety (2000)
Issued a white paper on electronic prescribing calling for the elimination of handwritten prescriptions, which were clearly associated with harmful errors reported to the MERP6 (2000)
Conducted a Medication Safety Self Assessment® for Community/Ambulatory Pharmacy, cosponsored by the APhA Foundation and National Association of Chain Drug Stores; the safety practices highlighted in the self-assessment are derived from analysis of community practice error reports submitted to MERP (2001)
Launched the ISMP Medication Safety Alert! ® Community/Ambulatory Care Edition; the monthly publication shares blinded stories about errors reported to the MERP and recommendations for multidisciplinary prevention of medication errors in community settings (2002)
Launched the ISMP Medication Safety Alert! ® Consumer Edition and the ISMP Nurse Advise-ERR ®newsletters; the monthly nursing and bimonthly consumer publications share blinded stories about errors reported to the MERP and recommendations for prevention of medication errors in acute care and self-care (home) settings (2003)
Published a review of all medication errors associated with patient-controlled analgesia in ISMP Medication Safety Alert!, along with recommendations for its safe use; the findings are later used to brief FDA staff who evaluate medical devices, and to hold a 1-day educational meeting devoted to safety issues associated with patient-controlled analgesia (2003)
Conducted the second ISMP Medication Safety Self Assessment® for Hospitals; the safety practices highlighted in the self-assessment are derived from analysis of hospital error reports submitted to MERP (findings [to be published] show that hospitals have made improvement in virtually every category since the 2000 assessment) (2004)
Issued the ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Hospitals; many of the safety practices highlighted in the self-assessment are derived from analysis of errors submitted to MERP (2004)

III. Change

Drug and device packaging, labeling, and nomenclature changes

In direct response to errors or hazards submitted to the MERP that involved unclear or look-alike packaging and labeling, or look- and/or sound-alike drug names:

ISMP convenes a national meeting that influences the U.S. Pharmacopeia (USP) and US Food and Drug Administration (FDA) to establish a federal requirement that potassium chloride concentrate for injection have black caps, closures, and warning statements to prevent confusion with other parenteral drugs (1987)
ISMP promotes changing vincristine labeling to reduce the likelihood of inadvertent intrathecal injection; this advocacy leads to an updated USP standard requiring special warning labels (1991)
ISMP convenes a national meeting to discuss elimination of cardiac lidocaine in 1 and 2 g concentrate prefilled syringes, due to reports of error-related deaths from mix-ups with 100 mg prefilled syringes; their manufacturers subsequently pull products off the market (1992)
ISMP successfully promotes inclusion of a maximum dose statement on cisplatin vial caps and seals to increase recognition of dose limits for this cancer agent (1997)
ISMP published nationwide warnings and filed a petition with the United States Adopted Names Council that led to renaming of amrinone as inamrinone, to prevent sound-alike confusion with amiodarone (2000)
Abbott redesigned the label on Carpuject boxes of metoclopramide injection 10 mg/2 mL to reduce similarity with another Carpuject product, metoprolol 5 mg/5 mL (2000)
Abbott discontinue packaging nonnutritional medications, and dopamine and potassium chloride injections, in the Universal Additive Syringes (UAS) to prevent the risk of fatal direct IV injections of the concentrated products (2000)
Genentech revised the label on Herceptin (trastuzumab) vials and its accompanying diluent to prevent further errors when reconstituting the product (2002)
Bedford Laboratories changed the color of the flip-off cap on ephedrine vials to prevent further errors related to similar appearance with its ketorolac injection vials (2003)
Bedford Laboratories redesigned its acetazolamide injection 500 mg labels based on reports that they looked dangerously close to the company’s acyclovir 500 mg vials, using color differences and tall man letters (2003)
Lilly revised its labels on Zyprexa (olanzapine) containers using tall man letters to help prevent further mix-ups with Zyrtec (cetirizine) containers (2003)
Abbott Laboratories revised the background colors on the label for its labetalol injection vials and cartons to help prevent further mix-ups with Dopram vials from ESI Lederle (2003)
Abbott Laboratories Hospital Products Division revised the labels of its premixed product, lidocaine, to give it a unique appearance and to print important information on both sides of the overwrap (2003)
BD Medical Systems re-engineers its hypodermic syringes to remove tip caps to eliminate the risk of accidental choking if, although contraindicated by BD, used for oral medications (2003)
ISMP petitioned USP for elimination of ratio expressions for epinephrine; ISMP also calls for labeling changes to reduce the chance of name mix-ups between epinephrine and ephedrine (2004)
KV Pharmaceuticals, and its subsidiary, Ther-Rx, revised the unit dose labels for Niferex and Chromagen (multivitamins with iron) products to specify the total iron content on each individual blister for all strengths of these products (2004)
Janssen revised the labels on its unit dose packages of Risperdal (risperidone) M-Tab to make the product name and strength more prominent, and removed the numbered directions for opening the package, which had been confused as the dose (2005)
Mayne Pharma added the warning statement “Not for intrathecal or epidural use” to the front of applicable vial and carton labels, and moved the statement “No bacteriostat added” to the side and back of the carton to reduce initial misunderstanding that the product contains no preservatives (2005)
Mayne Pharma revised its label on hydromorphone vials so it is clear that only 1 mL (2 mg) is available in the 2 mL vials (2005)
Johnson & Johnson’s McNeil Consumer & Specialty Pharmaceuticals recalled several Tylenol (acetaminophen) products after due to confusing labels that made it unclear if one or two tablets were needed for an 80 mg dose (2005)
Janssen changed the brand name of its Alzheimer’s drug Reminyl (galantamine hydrobromide) to Razadyne to prevent further mix-ups with the antidiabetic agent Amaryl (glimepiride) (2005)

Organization system changes

In direct response to ISMP publication of errors or hazards submitted to the MERP, individual organizations reported the following examples of system changes that had been made (based on surveys):

Established protocols for electrolyte replacement, Cerebyx, TPA, heparin, methadone, and conscious sedation (2000)
Separated products with look-alike names or packaging, and/or purchased them from different manufacturers (2000, 2004, 2005)
Programmed computer alerts and applied auxillary labels for neuromuscular blocking agents, concentrated oral morphine products, lipid-based products, and drugs with look-alike names (2000)
Monitored compliance with prohibited abbreviations (2000, 2004)
Programmed computer alerts for cross allergies (e.g., Atrovent and peanut allergies) (2000, 2004)
Removed concentrated electrolytes, ketamine, concentrated esmolol, and Cerebyx from patient care units (2000, 2004)
Removed nifedipine capsules from crash carts and prohibited its sublingual use (2000)
Improved control of drug samples (2000)
Removed from service infusion pumps without free-flow protection (2000)
Limited morphine PCA to a single concentration (2000)
Instituted full unit-dose dispensing of all neonatal intensive care unit drugs (2000)
Abandoned tabulating error rates based upon voluntary practitioner reporting (2000)
Removed TB syringes with orange color-coded 25 gauge needles from patient care units (2003)
Sequestered neuromuscular blocking agents that are stored on units (2003)
Changed the concentrations of drugs stored in pediatric code carts to match those listed on the Broselow tape (2003)
Included newsletter information in new staff orientation and other education programs (2003, 2005)
Used the information to support implementation of computerized prescriber order entry (CPOE) systems (2003)
Placed markers at the bedside for IV line labeling (2005)
Stocked oral syringes in all patient care areas for use with liquid medications (2005)
Removed outdated drug reference books (2005)
Created new processes for reporting near misses and hazardous situations (2005)
Made format changes to computer-generated medication administration records to reduce the risk of errors (2005)

Individual practice changes

In direct response to ISMP publication of errors or hazards submitted to the MERP, individual practitioners reported the following examples of practice changes that had been made (based on surveys):

Established nurse/pharmacist double checks for medication cart exchanges (2000)
Dispense insulin or oral hypoglycemic drugs only after confirmation of a diagnosis of diabetes, intolerance of glucose load with TPN, or some other therapeutic reason for the medication (2002)
Increased reporting of drugs with similar names and labels (2003)
Decreased personal use of dangerous abbreviations (2003, 2005)
Eliminated the numbering of orders and the use of checkmarks during transcription to avoid misinterpretation of orders and medication administration entries (2003)
Always ask prescribers to read their orders to staff before leaving the unit (2003)
Improved systematic and consistent read back of telephone orders (2005)
Overcame embarrassment when asking for a double check (2005)

IV. Standards

National safety guidelines, standards, and goals

In direct response to analysis of reports submitted to the MERP and trended findings:

USP responds to repeated reports of accidental intrathecal injection of vincristine submitted to the MERP and requires manufacturer labeling to state: FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. Individually prepared doses must also be placed by the dispenser in an overwrap labeled with a similar warning7 (1991)
USP responds to errors stemming from confusion caused by the apothecary system of measurement by eliminating a conversion table in its national formulary publication, ceasing to officially recognize the apothecary system, and requiring drug strengths to be expressed only in metric units on the container label8 (1994)
Fatal chemotherapy errors reported to the MERP became the impetus for a national forum organized by ISMP on preventing chemotherapy errors; recommendations were later published in the American Journal of Hospital Pharmacy9 (1995, 1996)
ISMP and USP worked with the National Coordinating Council on Medication Error Reporting and Prevention to recommend greater clarity in prescription writing to prevent the types of errors reported to MERP (e.g., eliminating trailing zeros for whole number doses) (1996)
ISMP began a formal campaign that spurred the Veterans Administration to require removal, and Joint Commission (JC) to urge nationwide removal, of potassium chloride concentrate for injection from all patient care areas (1997)
ISMP prepared test cases of medication safety alerts for computerized physician order entry, based upon the types of prescribing errors reported to the MERP, used by First Consulting Group and the Leapfrog Group, which brings together more than 100 organizations that provide healthcare benefits to seek improvement in medical quality, safety, and outcomes (1999)
Upon ISMP’s request, FDA asks pharmaceutical companies to use tall man lettering for labeling of products with look-alike drug names, particularly for twenty generic drug name pairs prone to confusion (2001)
JC adopts recommendations from ISMP’s list of error-prone medication abbreviations, symbols, and dose designations for use in its National Patient Safety Goals (2002)
ISMP and the Pediatric Pharmacy Advocacy Group issue pediatric pharmacy medication safety guidelines designed to reduce the incidence of medication errors among children (2002)
Guidelines for safe electronic communication of medication orders are drafted and posted on ISMP’s website and American Society for Health-System Pharmacists (ASHP) listserve for comments (2003)
JC adopts recommendations from ISMP’s list of look- and sound-alike drug names gathered from the MERP along with related error reduction strategies for use in its National Patient Safety Goals (2004)
JC adopts ISMP’s recommendations to prohibit use of infusion pumps without protection for accidental free-flow for use in its National Patient Safety Goals (2003); the goal is later retired with full compliance nationwide among accredited organizations (2006)
JC responds to repeated descriptions of errors related to unlabeled products on the sterile field and issues a National Patient Safety Goal to help improve labeling practices (2006)

V. Public policy advocacy

Advocacy activities

In direct response to trended findings from errors and hazards submitted to the MERP, ISMP led the following public policy advocacy activities:

ISMP staff member appeared on the first segment of the first Dateline show on ABC, which discussed fatal medication errors reported to the MERP involving lidocaine concentrate syringes, unlabeled medications, and a vincristine overdose that killed a small child; this brought national attention to medication errors and their prevention (1992)
Held the first Global Conference on Medication Error Reporting Programs with U.S. and international experts and approximately 100 pharmacists from around the world (1994)
ISMP partnered with the American Hospital Association (AHA) in a national initiative to help hospitals examine and further improve medication safety; ISMP staff met with President Clinton and participated in White House press briefing to announce the national initiative, which was based in part upon findings from the MERP (1999)
Participated in national policy discussions exploring types of error reporting programs; Institute experts met with Senate and House staff, testified in Senate committee hearings, and presented a Senate staff briefing with AHA and the American Pharmaceutical Association (APhA); this, along with ongoing USP and ISMP advocacy, contribute to the subsequent passage of legislation in 2005 offering evidentiary protection of patient safety data and error reports submitted to agencies such as ISMP and USP (1999)
Published a discussion paper on adverse event and error reporting in healthcare; paper is highly acclaimed, and serves as a conceptual model for error reporting position statements by leading healthcare organizations10 (2000)
ISMP staff member testified at an FDA public meeting on bar code labeling regulations; findings from the MERP are used to support the need for bar codes on unit dose packages of medications; ISMP also issued a white paper on bar coding11 (2002)

References

Cohen MR. Play it safe: don’t use these abbreviations. [Journal Article] Nursing, 1987 July 1987; 17(7):46-7.
Cohen MR, Davis NM. Free flow associated with electronic infusion devices: an underestimated danger. Hospital Pharm. 1992; (27):384-90.
Cohen MR, Senders JD, Davis NM. Failure mode and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hospital Pharmacy. 1992; 29(4): 319-324, 326-328, 330.
Cohen MR, Proulx SM, Crawford SY. Survey of hospital systems and common serious medication errors. J Healthc Risk Manag.1998 Winter; 18 (1) 16-27.
Smetzer JL, Vaida AJ, Cohen MR, Tranum D et al. Findings from the ISMP Medication Safety Self Assessment® for Hospitals. Joint Com Journ on Qual and Safety 2003; 29(11):586-597.
Institute for Safe Medication Practices. A call to action: eliminate handwritten prescriptions within 3 years! Electronic prescribing can reduce medication errors; Huntingdon Valley, PA: ISMP; 2000. Available at: www.ismp.org/MSAarticles/Whitepaper.html. Accessed October 24, 2005.
United States Pharmacopeia–National Formulary (USP–NF), fourth Supplement to the USP22 — NF17, May 15, 1991.
United States Pharmacopeia–National Formulary (USP–NF), USP23 — NF18; 1994.
Cohen MR, Anderson RW, Attilio RM, Green L, Muller RJ, Preumer JM. Preventing medication errors in cancer chemotherapy. Am J Health-System Pharm. 1996; 53 (7):737-46.
Institute for Safe Medication Practices (ISMP). Discussion paper on adverse event and error reporting in healthcare. Huntingdon Valley, PA: ISMP; Jan 24, 2000. Available at: www.ismp.org/Tools/whitepapers/concept.asp. Accessed October 24, 2005.
Institute for Safe Medication Practices (ISMP). A call to action: safeguard drug administration within 2 years! Bar coding of unit doses can reduce medication errors; Huntingdon Valley, PA: ISMP; November 2002. Available at: www.ismp.org/MSAarticles/WhitepaperBarCodding.htm.