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FDA and the pharmaceutical industry must be more responsive for a safer healthcare system



From the November 4, 2004 issue


The landmark Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System, was released in November 1999. During the next several weeks, many healthcare providers, researchers, consumer advocacy groups, and patient safety agencies will be reporting on progress over the past 5 years in making healthcare safer for patients.

One significant resource to help evaluate progress in medication safety will be the comparative results from the 2000 and 2004 ISMP Medication Safety Self Assessment for hospitals. ISMP is pleased to report that our initial review of the findings shows that, collectively as a nation, hospitals have made considerable headway in adopting safe practices known to reduce medication errors.

One of the most noteworthy improvements (31% increase since 2000) involves taking steps to reduce the risk of errors with drug products that have similar or confusing manufacturer labeling or packaging, or drug names that look or sound alike. The Joint Commission's new 2005 National Patient Safety Goal (NPSG) related to look- and sound-alike drug names should spur even further improvements in this area.

We are encouraged by the progress. But while we stand behind the Joint Commission's NPSG and genuinely applaud hospitals for stepping up to the plate on this issue, we can't help but feel frustrated when we and others in the patient safety world encounter reluctance by many in creating and sustaining a less hazardous healthcare environment. To cite just one example, the pharmaceutical industry as a whole has not responded with equal accountability for problematic drug names, packages, and labels.

While there are certainly a growing number of exceptions, too many pharmaceutical companies continue to downplay the important role they play in improving medication safety through expert pre-market testing of brand and generic names, packaging, and labeling, as well as effective post-marketing actions when potentially harmful problems are identified. Unfortunately, when notified of serious errors, many pharmaceutical companies sit tight or feel that sending a letter to increase awareness of the problem suffices. If changes in the product name, label, or package do occur, the time lag may be long, and the older product often remains in inventory until exhausted, instead of being recalled. Sadly, it's also not uncommon for a pharmaceutical company, after notification of an error, to simply respond to the reporter and/or ISMP and USP with a letter stating, "Reading the label is Nursing 101" (quoted from a letter we received this week) or similar comments implying that the problem lies entirely with the healthcare provider who did not read the label correctly.

This inertia to change is not peculiar to medication use processes; it's also seen in the related worlds of medical device design and other areas of healthcare delivery. After all, for the most part, training and rote procedures to address adverse events, rather than system redesign, is what has been emphasized in management, legal, medical, nursing, and pharmacy education. In the meantime, we continue to receive reports of the same types of errors over and over again. To cite just a few:

---Since 1999, we've been receiving reports (a few each week, even now) about respiratory medications, flush solutions, eye medications, and even injectables packaged in look-alike low-density polyethylene (LDPE) containers with poorly visible embossed labels. Although an FDA advisory committee met to discuss the problem in 2004, no specific changes in labeling or packaging resulted. In fact, it will likely take years before any changes reach inventories.

---We received yet another report of a fatal error this week in a nursing home because containers of concentrated forms of liquid morphine (ROXANOL) are still packaged without a prominent warning that it is highly concentrated. It's clear that a "Dear Healthcare Professional" letter from Elan sent in June 2003, to warn about the potential for this error, is simply not enough.

---First reported in 1999, ampuls of BENTYL (dicyclomine) 10 mg/mL still are not labeled in a way that clearly alerts healthcare providers that there are 2 mL (20 mg) of medication in each ampul. While the manufacturer agreed early in 2001 to include the total volume on the ampul label, preexisting inventory still remains in stock, so we continue to receive reports of double dosing errors in 2004.

---We've been writing about look-alike packaging of BRETHINE (terbutaline) and METHERGINE (methylergonovine) injection for years, from our first report about an injury to a new mother and her infant 4 years ago, to a hazard alert in the last newsletter. The drugs have opposite pharmacological effects but identical packaging, with labels that are difficult to read.

---Our recently published study about medication errors with oral methotrexate over a 4-year period (Am J Health-Syst Pharm. 2004; 61:1380-4) revealed over 100 cases, resulting in 25 deaths and 48 other serious outcomes. Most involved patients who accidentally took their dose daily instead of weekly as indicated. These errors could be avoided with specific labeling and packaging changes.

---Dangerous, sometimes fatal, overdoses continue to occur due to confusion between lipid-based products and their corresponding conventional forms (e.g., amphotericin, doxorubicin). Similar nomenclature is the most common cause of mix-ups between these products, yet nothing has changed in the years since our first national alert in August 1998.

---Acetylcysteine containers are still available with labels that list percent concentration, not mg/mL, risking errors because the product is most frequently dosed in mg amounts.

---Various vaccines continue to be confused with each other due to look-alike packaging from the same manufacturer, affecting countless patients, including more than 100 people who were accidentally given tuberculin skin tests with tetanus toxoid containing products. See below for a report of two new cases of confusion between one manufacturer's tuberculin skin test and influenza vaccine.

---While ISMP presented the need for standard definitions for drug name suffixes (e.g., sustained release, extended release) to FDA in 1989, no action has been taken. The result? Ongoing confusion, including with drugs such as BUDEPRION SR (labeled extended release), a branded generic bupropion confused with WELLBUTRIN SR (sustained release). WELLBUTRIN XL is the extended release. Appropriately, a recent article we wrote about this problem was entitled, XL, SR, ER, CD, LA... confused? So are we!

And the list goes on. Just check out our ongoing Worth Repeating columns, a sad commentary in itself about the poor response from some pharmaceutical manufacturers as well as regulatory and standard-setting organizations.

What is FDA doing to prevent and remedy look- and sound-alike problems with medications? Labeling, packaging, and nomenclature issues admittedly play a role in about half of all medication errors reported to MedWatch, according to Janet Woodcock, head of the FDA Center for Drug Evaluation and Research. In response, 5 years ago, the IOM committee asked the FDA to: (1) develop and enforce standards for the design of drug packaging and labeling to maximize safety; (2) require pharmaceutical testing of proposed drug names; and (3) establish an appropriate response to problems identified through post-marketing surveillance, especially those that are perceived to require immediate response to protect the safety of patients.

To date, there are no new labeling or packaging guidance documents; pharmaceutical companies are not required to test proposed drug names and packaging; a standard process for this testing has not been established; and at times, FDA response to problems uncovered through reporting programs is slow or non-existent. Perhaps the FDA division that looks at medication errors, the Division of Medication Errors and Technical Support (DMETS), needs additional support and stronger influence on other divisions within the FDA to which they report their findings. In some cases, FDA may not have the authority to require action on the part of the pharmaceutical industry. FDA's authority must be examined so that necessary legislative changes occur, enabling FDA to intervene on behalf of patient safety when needed.

Fixing blame with the pharmaceutical industry, FDA, standard setting organizations, or healthcare providers will not solve the problem; successful change requires a team effort. We should join in a concerted effort to 'flip people's brains around 180 degrees' to get all key stakeholders to work together toward the lasting changes needed to reduce errors related to drug names, packages, and labeling.

Open communication among all key stakeholders, especially FDA, pharmaceutical companies, standard setting organizations like USP, and patient safety advocacy organizations like ISMP, is a must. Secrecy and other barriers that inhibit open communication, especially on the part of FDA, need to be examined and removed. Yes, healthcare providers must continue to take steps to reduce the risk of errors related to medications with ambiguous or similar packages, and look- or sound-alike names. But many of these strategies, even some suggested in the 2004 ISMP Medication Safety Self Assessment, are really just a stop-gap measure until FDA and the pharmaceutical industry take a more prominent and accountable role in preventing labeling, packaging, and nomenclature problems, and are more willing to act quickly when a new problem surfaces through post-marketing surveillance.

We shouldn't have to wait until a sufficient number of people die before action is taken. If we can't solve these long-standing problems, why should practitioners continue to report problems to ISMP, USP, FDA, and the companies? How can we ask our patients to trust the healthcare system? We simply must do better.


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