The U.S. Pharmacopeia (USP) and Medication Errors
(12/4/03)- The release of the results from the fourth annual database from the U.S. Pharmacopeia Center for the Advancement of Patient Safety, a non-profit group of pharmacists and other medical professionals that develops standards for prescription-drug use and medication errors shows that prescription drug errors continue to be a growing problem.
For 2002, the year of the latest study, the database saw what it called a "large upsurge" in reported errors. Reported errors increased by 82% even though the database grew by only 31%. This increase may have been caused by a change in culture at many of the reporting institutes that are now encouraged to report any medication errors. There were 192,477 reports of medication errors in 2002. According to the study, older patients, meaning those over 65 were twice as likely to be harmed by a medication error. Of the cases reported about 1.7%-required intervention to save patients lives or resulted in permanent harm.
Data from the third annual study, which covered the year 2001 done by the U.S. Pharmacopeia's Center for the Advancement of Patient Safety about 2.4% of the 105,603 medication errors in 2001 documented by American hospitals resulted in patient injury or fatality. The study further determined that incorrect administration of drugs is a significant cause of errors in hospitals, especially in the case of children and emergency-room situations.
Data for the study were voluntarily provided by 368 health-care facilities across the country and compiled by Medmarx, a database administered by U.S. Pharmacopeia. The study attributed most of the errors to the increased workload for doctors and nurses. Inexperienced or inadequate staff accounted for about 43% of the factors contributing to errors, an increase from 33% in 2000 and 27% in 1999. "We've heard a lot about the nursing shortage, but what we're seeing is there are errors from shortage of respiratory therapists or pharmacists," said Dianne Cousins, vice president of the Center for the Advancement of Patient Safety.
Have you ever looked at the bottle or explanation of contents containing vitamins, herbal supplements, medications etc. and seen the words "Made to U.S. Pharmacopeia (USP) quality, purity and potency standards"? What is the U. S Pharmacopeia?
The U.S. Pharmacopeia was established in 1920. It has been trying to set standards in a multivariate drug industry fraught with potential danger to the users of medications. Today, it is charted as nonprofit, nongovernmental organization to set standards for identity, strength, purity, nomenclature, labeling, and packaging drug products and related articles. USP is cited in federal and state statutes, and its standards are enforceable by the U.S. Food and Drug Administration.
The USP defines its "standard of quality" as follows: "The U.S. Pharmacopeia (USP), a non-government organization, promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. These standards are developed by a unique process of public involvement and are recognized worldwide. USP has six additional public health programs focusing on promoting optimal health care, including the Dietary Supplement Verification Program, Pharmacopeial Education, Health Care Information, Patient Safety, Veterinary Care, and the Public Policy Center. USP is a not-for-profit organization that achieves its goals through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations." (From USP website.)
In 1991, the USP became involved in medication error reporting, using the USP Medication Error Reporting (MER) Program. This is a voluntary, practitioner-based reporting program that allows health care professionals to confidentially (and if desired, anonymously) report medication errors.
The USP enters reported information into a nationally recognized repository and subsequently tracks, monitors and analyzes medication errors from a system perspective. The reports are reviewed by USP’s health care staff for immediate healthcare/safety concerns and coded based on details of the event. By analyzing medication errors, USP may either create or review standards or implement recommendations to help prevent further errors. Since its inception, more than 5,000 reports of actual and potential medication errors have been recorded. The MER Program uses information submitted to its drug standards setting activities to educate practitioners about the reported problems and possible error prevention strategies. It informs, but does not punish possible violators.
In 1995, the USP led in the formation of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), comprising USP, health organizations and federal government agencies. In 2000, the Safe Medication Use Expert Committee was added to USP’s Council of Experts.
The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) has adopted a set of recommendations aimed at establishing and reinforcing safe dispensing techniques. Some of the steps recommended by this council to date include: spelling back the name of the drug when a phone-in prescription is received; providing the indication for use when appropriate; questioning new prescriptions if the drug does not seem to be appropriate for the patient's condition when the patient profile is current; and flagging similar sounding product names in computer entry and pharmacy computer systems.
In August 1998, USP developed MedMARXsm, an Internet-accessible database designed as an internal performance tool for hospitals to reduce medication errors. This database differs from the MER program, but is also intended as complimentary to the MER program. It is an interactive medication tool that enables hospitals to anonymously report and track medication errors in a standardized form. The more than 250 hospitals that subscribe to this tool have used it to identify processes that can result in improved medication use systems and higher quality patient care.
The data collected by both programs include the severity of outcome to the patient, where in the medication-use process the error originated, the type of error, cause of error, generic name of medications involved in the error, changes in patient level of care required subsequent to error and actions taken or recommended to avoid a similar error in the future.
In November 2001, the USP announced its intent to monitor the dietary supplement industry, which was having bad press due to the investigative reports that showed varying purity of active ingredients in products of the same type. (See our articles on herbal medications.)
"With the approval of its Board of Trustees, the United States Pharmacopeial Convention (USP) announces the availability of its Dietary Supplement Verification Program. Based on USP’s assessment of the manufacturer’s capability to produce a dietary supplement and testing to USP standards, USP will issue a certification mark that can be used by the manufacturer on the dietary supplement container label. The presence of this mark on a dietary supplement product container is an indication to the practitioner, consumer, retailer, and other interested parties that the product contains the dietary supplement ingredient in the designated amount, meets acceptable limits of undesirable elements, and is manufactured appropriately. " (USP press release.)
USP is named in the Dietary Supplement Health and Education Act amendments (DSHEA) to the Federal Food, Drug and Cosmetic Act as the nation’s official compendium for dietary supplement standards. They plan to be involved in the programs listed below:
The Dietary Supplement Verification Program does not address health or other claims provided for under DSHEA. The USP Council of Experts’ (CoE) Dietary Supplement Information Expert Committee will initially review all products submitted for verification where safety concerns have been raised.
In an answer to the question of how USP’s programs lead to reduction in medication errors, the USP website news release, Dec. 2000, contains the following statement: "USP supports a non-punitive interdisciplinary systems approach to medication error reduction. USP medication errors reporting programs provide critical information to health care practitioners and institutions by allowing them to learn from the experiences of others. By applying lessons learned, institutions can take actions to prevent future errors. The information collected by USP can be used to:
The difficulty one encounters with all these systems to try to reduce medication error relates to the concept of "non-punitive approach". Does a slap on the wrist create an economic incentive to change? Monitoring of medications is essential because of the need to investigate causes of medical errors, the long-term effects of medications and the economic incentive to downplay errors by the drug manufacturers.
Medical literature would indicate that medical error is a continuing theme that has yet to be solved. The Institute of Medicine report entitled "To Err is Human: Building a Safer Health System" indicated that medication errors are estimated to account for 7000 deaths annually, with indications that medical errors kill between 44,000 and 98, 000 people in hospitals each year. The numbers of deaths attributable to medication errors is, in absolute terms, no different from the 7,391 individuals in 1993, whose death certificates indicated they died of medication error. In relative terms, it is a much lower percentage due to the increased numbers of patient-physician contacts and potential for error. However, it is no excuse for this absolute number being so high. (See: Institute of Medicine. To Err is Human: Building a Safer Health System. Washington DC. National Academy Press, 1999.)
More teeth need to be put into the consequences of medication errors. The Food and Drug Administration will have to play a greater proactive role than it has been playing. It will mean enhancing its investigative and monitoring arm. In many industries the idea of self-monitoring has become questionable and even unreliable. The crisscrossing of individuals between industrial and academic settings makes it tempting to "miss" potential problems. The drug industry support is necessary for this endeavor, no matter how much paper work they would have to submit or the cost of this step, nor the spectra of more government intervention. Concomitant with this is the need to develop a punitive system that is more than a slap on the wrist to global pharmaceutical companies.
No one questions the need to save lives. How we go about doing this task appears to be the issue. A non-governmental organization needs an overwhelming force to help maintain its effectiveness. Monitoring organizations such as USP are a step in the right direction. Someone must take a forceful role in regulating the pharmaceutical industry and in protecting the integrity of the drug market.
A NY Times editorial on January 14, 2002 stated "Harvey Pitt was recently quoted in Barron’s as saying that ‘there is nothing rotten with the accounting profession.’ What makes the assessment alarming, instead of just laughable, was that Mr. Pitt is (now is the former chairman) the chairman of the Securities and Exchange Commission. Mr. Pitt was a prominent litigator who represented Arthur Anderson and other major accounting firms before being appointed to the S.E.C. by President Bush. The pharmaceutical industry arrangements with academic centers hold a similar potential danger."
The creditability of the drug industry needs to be shored up to counteract the wariness of the public as to the safeguards they have come to rely on. With rising drug prices and limited ability to afford their medications, many consumers are turning to unproven herbal supplements that may have untoward effects on their health.
Monitoring does work in many cases as seen in the August 8, 2001 withdrawal of Baycol by Bayer. This drug had caused a potentially fatal muscle-wasting side effect in some patients. Another example is the monitoring of eight medication errors submitted to the USP Medication Errors Reporting Program involving the products Depakote® and Depakote® ER. Both products contain the active ingredient divalproex sodium and are available in 500-mg strengths. The products, however, differ in their approved indications, and in their mechanisms of release. Following input of this data, the USP posted alerts to hospitals and physicians indicating that two formulations of this product exist and precautions should be undertaken as to which is prescribed. This reporting system relies on facilities physicians, and pharmacists reporting the errors, which many may be reluctant to do. Many times it takes independent chart reviewers to pick up such errors.
Another type of error that can lead to serious consequences involves similar drug names. The USP had received a number of reports focusing on the products, Lamictal® (lamotrigine), an antiepileptic drug, and Lamisil® (terbinafine hydrochloride), an antifungal drug. Of eleven reports received, three reported that these sound-alike and look-alike brand names had the potential to cause an error, while the remaining eight described errors that actually transpired. Complicating this issue is the confusion between the generic brand name products. Patients have received lamivudine (Glaxo Wellcome’s antivral, Epivir 150 mg) instead of lamotrigine 150 mg. Again, USP sends out alerts to this effect. The question remains as to how carefully these alerts are read. There is a need to develop zero tolerance for medication errors.
Individuals can also play a role in preventing medication errors by following the 10 step advisory (listed below) issued by the USP:
"How can consumers protect themselves? When consumers use a medicine or help others use their medicines, they become part of the "drug therapy chain". USP has established the following ten tips on medication safety to help consumers take an active role in the drug therapy chain:
A growing problem that we will have more to say in later articles is the Internet pharmacy, both domestic and foreign-based sites and issues of effective public-and private sector consumer protections.
For additional information on this topic please see:
"Medication Errors: a Growing Problem"
"Seals of Approval"-Part II
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"How to Select a Nursing Home"Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated December 4, 2003
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