LEDA at Harvard Law School LEDA at Harvard Law School
A DRUG BY ANY OTHER NAME:
THE POWER OF NAMING AND THE MEDICAL AND REGULATORY
IMPACT OF “MISNAMING” PRESCRIPTION DRUGS
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“The protection of trademarks is the law’s recognition of the psychological function of symbols. If it is true that we live by symbols, it is no less true that we purchase goods by them”[1]
- Felix Frankfurter, Supreme Court Justice
A COMPELLING NAME is the essence of identity. It can embody personality, value, and power. It may be strategic in sight and in sound.[2] And it can be a company’s best asset, positioning it above its peers. A luxury car evokes the speed of a Jaguar™; an anti-perspirant gives confidence to be Sure™; and a paper overdue is guaranteed FedEx™!
A memorable name is undoubtedly one of the most important factors in how quickly a company or product gains recognition, as well as the eventual degree of success it enjoys, provided all other elements are in place. But in today’s global marketplace, commercial naming has become increasingly difficult as there are already more than 650,000 active federally registered trademarks and countless thousands more that are registered in states or are being used without registration.[3]
The naming of prescription drugs is an even more complex and challenging process, involving pharmaceutical companies, marketing specialists, the Patent and Trademark Office (PTO) and the Food & Drug Administration. (FDA). And, while the derivation of drug nomenclature may be similar to that of other consumer products in that both are driven by marketing considerations, the stakes for drug names are profoundly higher. [4] Not only do they affect market appeal, but they can also bear significant medical consequences—drug names that sound or look alike, such as Tobrex and Tobradex are often confused, sometimes with fatal results.[5]
As prescription drugs take on increasing importance in modern medicine, consumer demand has exacted pressure on pharmaceutical companies to bring forth their discoveries faster than ever. It is also no small challenge for a company with a new drug to invent a name that is befitting of its product while avoiding trademark infringement or confusion. With more than 20,000 prescription drugs on the U.S. market, and the number of FDA drug approvals rising 54 percent in the 1990’s from the previous decade, pharmaceutical companies are forced into even more exhaustive searches for naming their products.[6] Furthermore, trade names are particularly important for pharmaceuticals given that manufacturers are only protected under their patent for 17 years and thereafter must rely on the strength of their branding and consumer loyalty to capitalize on their initial investment.[7] Advertising, and ultimately, the success of a new pharmaceutical product will revolve around the trademark selected for it.
Drug trademarks affect a variety of competing interests. Pharmaceutical companies can expend over $250,000 to devise a unique and memorable name to appeal to the public.[8] Letter for letter, companies invest more promotional dollars in the trademark than any other element in the product profile.[9] The pressure to invent fanciful trademarks has resulted in drug names as similar as Celebrex and Cerebyx, creating confusion for the doctors and pharmacists who need to differentiate between them. However, pharmaceutical companies have not been subject to liability for claims arising out of medication errors from proprietary name confusion. On the contrary, as owners of legally-approved trademarks, these companies are shielded from lawsuits challenging the quality of their marks. Martha Rumore points out that “to date there is no reported judicial decision in which a court has ruled that a drug is misbranded or misleading because its trademark is likely to be confused with a mark for another drug.”[10]
That the current system regulating pharmaceutical trade names fails to fully protect the public from medication errors due to name confusion underscores the dissonance between the FDA’s approach to trademarks and its concern for ensuring product safety and effectiveness. The agency’s NDA approval process focuses primarily on testing the chemical effects of an experimental drug and gives considerably less scrutiny over the most fundamental element of a drug—its name. I will argue, however, that with prescription drugs, the name itself requires sober inquiry and examination, not simply for its implied claims, but for its potential to be confused with already existing drugs, which undoubtedly affects its safety and effectiveness.
In understanding the importance of drug naming, it is helpful first to examine how a new drug is named, both from a marketing as well as a regulatory perspective. This inquiry illuminates the tensions that surround the approval of drug trademarks, particularly since it is fragmented process involving pharmaceutical companies, marketers, the FDA, and the PTO. Given the current method of developing drug trademarks, and the FDA’s limited authority in its regulation, the likelihood of introducing similar drug names into commerce becomes inevitable. The second section of this paper will discuss the medical impact of naming or misnaming prescription drugs—specifically how confusing nomenclature can be further exacerbated by missteps in the healthcare system which result in serious medication errors. This will lead us to policy considerations ranging from suggested best practices (such as switching to electronic prescriptions) to alleviate drug name errors in the short-term, to enhanced post-marketing surveillance and reporting methods that may identify and reduce errors in the long-term. Alternative regulatory proposals to reform and restructure the process of approving drug trademarks will also be explored and critiqued. A greater systemic approach will hopefully prevent confusing drug names from reaching the market in the future.
Ultimately, this paper hopes to show how increased examination of drug names will result in well-founded confidence in the safety and effectiveness of drugs by healthcare practitioners and the public so that new medications can reap the marketing advantages of its trademark without being undermined by its own name.
“Your name is your most important weapon in the battle for the mind”
- Al Ries and Jack Trout[11]
SINCE NAMES TRANSMIT such powerful imaging and positioning messages, it is crucial for pharmaceutical companies to develop and trademark the optimal name. Prescription drugs increasingly have strange or unusual names, such as Cipro, Ventolin, or Paxil. Many companies are following this strategy, using exotic, made up names to convey a feeling about the product.[12] Part of the reason for this is that most common words are already trademarked, so companies have to invent words to get a new mark.[13]
This section will discuss how drugs get their names and the competing interests involved—from their etymological origins, which are driven by marketing tactics, to the trademark approval process, which is primarily concerned with protecting the owner’s rights to fair trade.
Like other consumer products, prescription drugs are given their names not by the scientists and developers who discovered their formulations, but by the marketing or advertising departments of pharmaceutical companies.[14] Moreover, in recent years, the complexity of drug naming has spawned a growing industry of consultants, and manufacturers are increasingly outsourcing this task to creative and branding agencies.[15] Naming experts suggest that this trend has contributed to a shift away from technical-sounding names reflecting a drug’s chemical structure to “fanciful,” made-up names, which are snappier and easier to trademark.[16] “It’s a shift from speaking the doctor’s language to the patient’s language,” notes Amy Mills, director of naming at Addison Whitney Inc, an identity consulting firm.[17] Thus, whereas generic names are evaluated by their usefulness to health care providers, brand names, in trying to “speak the patient’s language”, are chosen by what, and how, it communicates to the consumer: does the name exude confidence? Is it memorable, effective, and relevant? And will it warrant distinction and sustainable differentiation in a competitive environment? Furthermore, companies must consider the international market and whether the selected name can integrate into other countries.
According to Rivkin & Associates, a branding agency, the following is a general criteria for selecting an ideal product name:[18]
But how can so much be packed into a name? The multi-phase process of developing, eliminating, and settling on a name requires creative talent and much trial and error.[19] While creating a generic name is a science, creating a brand name is more of an art, employing a variety of techniques.[20]
Some drug names are derived from their function: Lomotil slows intestinal motility; Skelaxin is a skeletal muscle relaxant; Prevacid prevents stomach acid; and Lorelco lowers elevated cholesterol. Others may be related to the disease the drug will be treating. For example, the combination of the Latin root “cor,” relating to the heart, with a suffix that implies “protector” produces Corgard, a drug used in hypertension or angina.[22] This medication has an added advantage of being only two syllables, making it easy to pronounce and remember by physicians, pharmacists, and patients alike.
A positive-sounding or memorable name, such as Prozac, can help boost sales, particularly in an era where consumers are bombarded with drug advertisements goading them to demand prescriptions for specific brands from their doctor. The most successful names imply effectiveness, safety, and reliability, and give the impression that the product is the best drug for a particular condition (e.g., Zyban, to “ban” depression”, or Xenecal, to “x-out” the calories).[23]
Drug names that have psychological appeal are often euphonies that are soothing or suggest a desired state. Names derived using this method include Viagra, (suggesting vigor and virility), Placidyl (a sedative), Equanil, (from the word “equanimity”), and Claritin (to “clear up” allergy symptoms).
Another trend that has been observed is a move to real, or close to real names such as Alleve, Accolate and Augmentin.[24] Other examples include the flu vaccine, Prohibit, and Effexor, an anti-depressant that “practically says effective in the name”[25] Likewise, Merck & Co. has an asthma drug, Singulair, which was chosen because it is a once-a-day drug.[26]
Lastly, drugs have also been named for their investigators, for historical or sentimental reasons, and for place names. Gustase, a gastrointestinal enzyme used for indigestion is comprised of the suffix “-ase,” which describes an enzyme and the first name of the research director of Geriatric Pharmaceutical Corp., Gustave Bardfeld. The generic name for Squibb’s Mycostatin is nystatin, because the two women investigators who discovered it—Dr. Rachel Brown and Dr. Elizabeth Hazen—were from Staten Island in New York. [27] And Miltown, a tranquilier, was named for a quiet country town.
While drug names have to convey the right overtones of power and effectiveness, they also cannot promise more than they deliver. The FDA rejects any name suggesting a use for which a drug is not approved or a claim that was not proven. For example, Pharmacia & Upjohn wanted to market its hair-restoration drug under the name Regain, but had to settle for Rogaine.[28]
Ultimately, finding a catchy name is just one hurdle. With most drugs sold worldwide, manufacturers must ensure the name is not already trademarked. This is the toughest task, given that there are approximately 2,000 active drug brand names and nearly 18,000 active generic names in the U.S. alone.[29] As such, pharmaceutical companies must follow a complex process to register their trade names.
Unlike generic names, which are created by the manufacturer in conjunction with the U.S. Adopted Names (USAN) Council and targeted to health care professionals, choice of brand names, as we have seen, are motivated by marketing considerations.[30] While manufacturers will likely screen a proposed name for potential conflict with existing trademarks, the depth of the search depends on the importance of the product, the geographical area to be marketed, and the financial resources of the company.[31] This highlights the absence of a standardized model of evaluation at the pharmaceutical manufacturer level. The next section will discuss the roles of the PTO and the FDA in reviewing proposed drug trademarks, and their respective goals. The different incentives that currently govern the process show how the approval of drug trademarks is also flawed at both the PTO and the FDA levels. [32]
The PTO’s trademark approval process is characterized by a limited inquiry into a business’ proposed mark. Barring names that are generic, highly descriptive, or confusingly similar to others, a trademark generally will be registered within one year of application.[33]
The primary purpose of the Federal Trademark Act of 1946 (“Lanham Act”) is to grant rights and protection to the owner of a federally registered mark. Fifty years after its enactment, the Act is still considered
the embodiment of the purpose to secure to every businessman the advantage which public preference for his goods gives him and to protect him in the exclusive right to the names and marks which perpetuate the good will which merit earns.[34]
This underscores that federal trademark protection, which stems from the power of Congress to legislate under the Commerce Clause, serves particular economic ends.[35] Businesses specifically seek federal protection because trademark registration guarantees owners certain nationwide rights.[36] The rights that flow from federal registration enable a manufacturers to identify their goods in commerce and to protect themselves from attempts by competitors to trade on the their goodwill.
The source-denoting function protected by federal trademark regulation should be considered in conjunction with the Act’s proscription against confusing marks. The PTO has exclusive jurisdiction at the administrative level over the likelihood of confusion regarding trademarks for pharmaceuticals. Under the Lanham Act, a proposed mark will be denied registration if it
consists of or comprises a mark which so resembles a mark registered in the Patent and Trademark Office or a mark or trade name previously used in the U.S. by another and not abandoned, as to be likely, when used on or in connection with the goods of the applicant, to cause confusion or to cause mistake, or to deceive.[37]
Moreover, because serious and potentially fatal consequences may result from drug trademark confusion, a “doctrine of greater care” has been applied to pharmaceutical trademarks. However, while the doctrine acknowledges the seriousness of drug confusion and requires “a lesser quantum of proof” to establish confusion, it can only be invoked during the course of litigation, before which the public may be harmed irreparably. Furthermore, because the Act vests rights in the holder of a trademark, reliance on the doctrine of greater care requires owners to be vigilant in enforcing the Act’s protections. If a trademark owner determines it is not worthwhile to bring an infringement or unfair competition suit on the grounds that another company’s mark is arguably confusing, the public may continue to be harmed without remedy. Lastly, while the Act provides a trademark holder with a cause of action against anyone who uses a “reproduction, counterfeit, copy or colorable imitation of a registered mark” in a way that “is likely to cause confusion or... mistake, or to deceive”, a court ordinarily will not consider consumer confusion when a product is legitimately trademarked.[38] In these respects, the language of the Act must be read in light of its fundamental focus on manufacturers and trade. Consumer protection as to the source of goods is related directly to protection against a manufacturer passing off its goods in attempt to benefit from the trademark of another manufacturer. Thus, “confusion” in PTO terms is a limited concept that does not encompass broad considerations of consumer well-being.
Statutory underpinning for the FDA to review trademarks for likelihood of confusion arises from Sections 505(d) and 502(a) of the Food Drug & Cosmetic Act pertaining to false and misleading advertising.[39] However, FDA’s role in the regulation of trademarks does not include any right to deny trademark registration.[40]
Up until the end of 1999[41], proposed trademarks were reviewed by the FDA’s Labeling and Nomenclature Committee (LNC).[42] The Committee was informed by the Code of Federal Regulations which provides that labeling may be misleading by virtue of its “designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient.”[43] The CFR also instructs those evaluating drug trademarks that labeling may be misleading by reason of:
the employment of a fanciful proprietary name for a drug or ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition when, in fact, the drug or ingredient is a common substance, the limitation of which are readily recognized when the drug or ingredient is listed by its established name.[44]
The LNC’s role, however, was strictly consultative. The seven permanent and two ad hoc members met “once a month for a couple of hours” to discuss proposed names.[45] Furthermore, its review of drug names was done on a voluntary basis—rather than reviewing all drug trademarks, the Committee evaluated only those names forwarded to it by different reviewing divisions, which typically were ones “where a potential concern [had] already been identified.”[46] Hence, prior to the year 2000, FDA’s regulation of drug trademarks was slim, involving only discretionary review and the issuance of non-binding recommendations. Only if trademarks were deemed unacceptable would a pharmaceutical company be required not us use its registered mark because to do so would subject it to charges of false advertising.[47]
It should be noted, however, that the FDA created a new program in October 1999 for the review of proprietary drug names that includes testing in clinical settings rather than relying solely on a panel of experts.[48] The Office of Postmarketing Drug Risk Assessment (OPDRA) took over the review of proposed trade names from the LNC and now evaluates names by simulating real practice settings with the help of approximately 100 volunteer medical professionals within the FDA.[49] Under this new system, OPDRA investigates every proposed trade name before approval of an New Drug Application (NDA).[50] Nevertheless, it is still the case that the agency simply provides a name recommendation to the manufacturer that may or may not be accepted.[51]
Despite the review of proprietary names by both the PTO and the FDA, there is a growing problem of look-alike or sound-alike pharmaceutical trademarks. Diane Cousins, Vice President of the U.S. Pharmacopeia’s Practitioner and Product Experience Division, notes that “drug names that look dangerously alike, or sound frighteningly similar, have been reported between brand names, between generic names, and between one brand name and one generic name.”[52]
The causes of PTO examiners’ failure to detect trademark flaws are numerous. First, there is the basic constraint of limited funds.[53] In analyzing the PTO’s commitment of its resources to various functions, it has been noted that less than 10 percent is typically devoted to the trademark process.[54] Rather, the PTO has consistently allocated most of its resources to patent review. More significantly, the current process illustrates the PTO’s relative lack of expertise in reviewing drug names. The PTO examiner seldom has information about product details that can be critical in the dispensing cycle and may also lack information and knowledge about existing chemical and drug nomenclature. Further, the examiner may overlook generic names that are not on the register or other trade names that are not registered federally but enjoy state common law status.[55] Lastly, as discussed earlier, the PTO, in granting federal trademark protection, is primarily concerned with economic ends. Reflecting the agency’s mandate, the PTO’s focus on misleading and confusing marks is different from the concerns of confusion central to the FDA’s mission. Concerns arising from consumer well-being and the safety and effectiveness implied by trademarks pertain more to the provenance of the FDA.
The FDA, however, under the previous LNC review, only examined those names forwarded by different reviewing divisions. But, as noted, prior to 2000, the divisions were not required to submit proposed proprietary names to the LNC before approving an NDA.[56] Under such a system, it was inevitable that potentially confusing trade names were approved. Even with the functions of the LNC having been assumed by the OPDRA, there still remains issues of resource constraint, countervailing incentives, and lack of authority. That the OPDRA has only eight people researching at least 25 names a month, continues to make the trademark process susceptible to error and oversight.[57] Furthermore, we can also speculate whether the 1992 Prescription Drug User Fee Act (PDUFA), intended to speed access to new drugs, might contribute to the approval of drugs with confusingly similar names. That reviewing units are under pressure to evaluate NDAs in less than a year might have the unintended effect of accelerating approval despite trademark issues. Lastly, the FDA may still lack teeth if its recommendations are non-binding.
Finally, the system of government regulation of pharmaceutical trade names seems to sanction rather than guard against a name selection process at the manufacturer level that is also flawed. As mentioned, pharmaceutical companies do not employ standardized models of evaluation—it is often the marketing department or an outside agency that selects a trademark for a new product using general branding strategies.[58] Sometimes a short-list of potential marks are provided to a panel of physicians and selection is simply based on popularity. [59] As pharmaceutical companies increasingly target patients directly, spending an estimated $3.5 billion in 2000, the importance of creating an attractive trademark leaps in commensurate proportion. It is no surprise, then, that manufacturers have created names that arguably fall under the headings of misleadingly descriptive and confusing. [60] That the PTO and FDA have different standards and definitions for “confusing” and “fanciful” only adds to the ambiguity of what is an acceptable name.[61]
While business incentives may encourage manufacturers to differentiate their marks from other names to avoid charges of infringement, the courts have thus far shielded them from suits by patients challenging the quality of their marks.[62] Since there have been no rulings that a drug is misbranded because its trademark is likely to be confused, and since pharmaceutical companies have not been held liable for mismedication arising out of such confusion, it is likely that they will continue to invent descriptive, fanciful names to appeal to the public.
With an increasing number of new drugs coming to the market, creativity has also lead to confusion. This has resulted in a problem where a high percentage of medication errors are due to drug names that look or sound alike. Confusing trademarks are further corrupted by poor handwriting, storage habits, and other practices in the healthcare system.
The next section looks at the medical impact of naming and shows why the FDA’s responsibility is not completed when the safety and efficacy of a drug product are determined. We will see why naming is not just a marketing word game, but has significant medical consequences.
Look-alike and sound-alike products have continuously been one of the top causes of errors reported over the nine years we’ve been running MERP.
- Diane Cousins, USP[63]
Source: Jill Ghormely in JAMA, Vol. 282, No. 15; October 20, 1999.
Scope of the Problem
EXPERTS HAVE ALWAYS RECOGNIZED that medical errors exist and compromise health care quality but the response to the November 30, 1999 release of the Institute of Medicine’s (IOM) report, To Err is Human: Building a Safer Health System, brought medical errors to the forefront of public attention.[64] The report’s estimate that 44,000 to 98,000 Americans die each year not from the medical condition they checked in with, but from preventable medical errors, captured the public’s concern and resulted in a sense of urgency about increased attention to safety in the health care system.[65]
Even the seemingly simple process of giving a patient medicine—the right drug, in the right dose, to the right patient, at the right time—is teeming with opportunities for error. The IOM report revealed that more than 7,000 people succumb to medication errors each year in hospitals alone, exceeding workplace injuries.[66] Outpatient deaths caused by medication errors rose 848% during the 10-year period between 1983 and 1993 and a 237% increase was noted in medication-related inpatient deaths.[67] But because most adverse drug reactions (ADRs) are not fatal, the overall personal and economic cost to society is actually much larger than the mortality figures alone would suggest. [68] The FDA reports that medication errors injure approximately 1.3 million people annually.[69] Up to ten percent of hospital admissions are drug-related and 50 percent of those are preventable.[70]
But even the authors acknowledge that the IOM Report does not tell the full story. People in hospitals are just a small proportion of those at risk. Doctors’ offices, clinics, and outpatient surgical centers treat thousands of patients each day, retail pharmacies fill countless prescriptions, and nursing homes and other institutional settings serve vulnerable patient populations.[71]
Name confusion is among the most common causes of drug-related errors, according to Peter Honig, M.D., an FDA expert on drug risk-assessment. [72] Brands can look like other brands when written or be mistaken for another drug when ordered verbally. Generic names can resemble other generics, or as in the case of ethambutol and Ethomozine, a generic name can have too much in common with a brand name. The Medical Errors Reporting Program (MERP),[73] estimates that one in every four medication errors involves a name that looks or sounds like another drug.[74] (But even this figure may offer an underestimation of the real extent of the problem, since the reporting system is voluntary and many incidents of drug confusion are not reported.) In fact, mixing up similar drug names that sound-alike (phonologically similar) or look-alike (orthographically similar) happens so often that it has coined its own term: cognitive toxicity.[75]
The rapidly expanding U.S. Pharmacopoeia (USP) increases the risk of prescriber or pharmacist confusion over similar names. [76] Nicoderm looks like Nitroderm; Xanax sounds like Zantac. The USP estimates that there are over 1,100 pairs[77] of similar prescription drug names, each with the potential for significant harm when incorrectly administered. [78] For example, a prescription ulcer medication originally known as Losec was commonly mistaken for Lasix, a diuretic, and resulted in at least one death. Losec’s brand name was later changed to Prilosec, but now Prilosec and Prozac, the antidepressant, are among the most commonly confused drug pairs.[79] Luckily, the results are not deadly when these two drugs accidentally get switched. Yet even minor episodes of confusion provide a disturbing reminder that competent practitioners are vulnerable and that some mistakes can be deadly.[80]
Potential problems due to the administration of an incorrect drug include exacerbation of an underlying condition. If Lamictal, an antiepileptic drug is inadvertently substituted for Lamisil, an antifungal drug, an epileptic patient would be untreated and could experience continuous seizures. The reverse situation could lead to serious side effects, where patients erroneously receiving Lamictal might experience blood pressure changes or irritable rashes while their infection goes unchecked.[81]
The likelihood of confusion is magnified when products have similar dosage and intake schedule. In such a case, a pharmacist or technician might find positive confirmation bias when reading the prescription instructions, which could lead to uncritically accepting the drug choice.[82] For example, prescriptions for Avandia have been misread as Coumadin because both drugs come in a 4-mg strength and can be given once daily, so “Avandia, 4 mg p.o. daily,” can become “Coumadin, 4 mg p.o. daily.”
Finally, the combination of trade and generic drug names adds to the confusion, especially when doctors are accustomed to using brand names and not familiar with their generics counterparts.[83] One death was reported by the USP when a 70 year old hypotensive woman was brought into the hospital emergency room for shortness of breath and abdominal pain. When her heart rate continued to decline, the emergency physician, after consulting with the patient’s cardiologist, ordered amrinone. The nurse phoned the order to the pharmacists who asked specifically if it were for amrinone or amiodarone. The pharmacist then spoke with the physician, referred to amiodarone by its trade name, Cordarone, and asked if that was the requested drug. The physician, confused, confirmed that it was, and amiodarone, instead of amrinone was prepared and delivered. The infusion was administered and the patient died about 2 hours after admission.[84] In this case, both drugs were used in the ICU for patients with cardiac disease, but they have the exact opposite pharmacological effect—amrinone is used for patients with congestive heart failure whereas amiodarone is an antiarrhythmic agent.[85]
Cases of mistaken drug identity have plagued pharmacists for at least 35 years, as indicated by decades-old references in the medical and pharmacy literature.[86] Hundreds of look-alike and sound-alike combinations have turned up at one time or another. Yet experts generally agree that the “vast majority of errors do not cause serious harm to patients.”[87] If a minority of prescriptions is filled in error, only a small percentage of these cases are likely to spur dangerous events. However, the problem arises when over three billion prescription drugs are dispensed in outpatient pharmacies each year. [88] Given the amount of prescriptions, even a very small percentage translates into a significantly high number of medication errors.
While the events leading to medication errors often begin with the drug name, it is important to recognize that other factors compound the risk. Errors do not occur because of one aspect of a drug name but from a series or combination of missteps that often results from interaction within an elaborate health care system.
A Broken Process: Contributory Causes of Look-Alike / Sound-Alike Medication Error
The anatomy of a medication error is complex and not confined to a singular cause. It can occur anywhere during the delivery of a drug to the patient, including during the prescribing, ordering, repackaging, dispensing, or administering of the drug.[89] And since the distribution of a drug involves a series of actors—specialists, physicians, nurses and pharmacists—any health professional along the continuum may contribute to real or potential errors. Like children playing telephone, an order for a drug in a confusing name pair can pass through different individuals who can make multiple errors, such that the resulting order is nothing like the one intended.
Several types of name confusion errors exist, including those related to visual perception, auditory perception, cognitive failure, and perhaps most fundamentally, systemic or environmental factors.
There are visual perception errors involving typewritten names, handwritten names, and names presented on a computer monitor, and all of these are caused by slightly different kinds of similarity.[90] By far, however, the most common cause for confusion among look-alike drugs is difficulty in interpreting handwritten orders.[91] Doctors are notorious for their poor penmanship, such that even drugs that do not appear very similar when typed out, such as Flexeril and Plendil, may be similar enough to cause confusion when written illegibly. Errors can also arise when medical abbreviations are used. For example, patients have been reported to receive Proleukin (interleukin-2) for metastatic renal cell carcinoma instead of Neumega (interleukin-11), a drug that promotes platelet production, because the abbreviation IL-11 was mistaken for IL-II.[92] Finally, look-alike errors often occur when labeling or packaging is perilously similar.[93] A pharmacist filling an order may simply grab the wrong box or bottle off the shelf, especially if similarly packaged drugs are arranged in alphabetical order.[94]
Name brands can also be mistaken when there is a misunderstanding of verbal orders—a doctor might ask a nurse to order Liquibid, but the nurse, hearing Lithobid, will request the wrong prescription.[95] Diane Cousins gives another example of the effect accent and inflection can have on similar-sounding drugs: when a woman called the MERP to report an error between Seldane and Feldene, her Southern tones confused Cousins’ northeastern ear so that she was unable to tell which drug the woman mentioned first and which one she said second.[96]
Yet in comparing the frequency of look-alike vs. sound-alike errors, community pharmacists tend to find more errors in written orders (49%) than in verbal ones (12%), perhaps reflecting the benefits of person-to-person consultation with a doctor or nurse and the opportunity for pharmacists to serve as a check by verbally confirming a prescription.[97]
Visual and auditory errors can also be a function of cognitive failure on the part of the individual receiving an order. One problem that Bruce Lamberts[98] has studied is the recognition memory that pharmacists and technicians use when filling or checking prescriptions. This entails looking at the drug name in an order, putting the order down, and then recalling the drug name when looking for the product on the shelf or checking an already filled prescription. Lamberts explains that in this process, the drug name is stored in the brain as a short-term sound memory, or “phonological loop”—a memory area that is limited in capacity and subject to quick decay. [99] More important, phonologic loops can easily be degraded by similar sounds such that even drug names that do not look alike, such as Xanax and Zantac are easily confused in memory as the brain converts visual patterns of letters into sound patterns for memory storage.[100]
Another type of cognitive error is confirmation bias—a tendency to look for evidence that supports an early hypothesis and ignores data that contradicts it.[101] This occurs when one party thinks they have heard or seen something that they expected to hear or see. For example, an error was reported where an order for Prilosec (an ulcer medication) was substituted with Prozac (an anti-depressant) because a patient was in a psychiatric ward and it was simply assumed that the doctor was prescribing the anti-depressant.[102] Confirmation biases also occur when heath professionals have not been educated about a new drug. When ritonavir (the generic name for Norvir) first entered the market, it had been approved within 78 days, so even though a physician might write a legible order, someone who had never heard of ritonavir would think the prescription was for Retrovir.[103]
C. Structural and Environmental Factors
Finally, the underlying causes for many of the errors that have been mentioned thus far can simply be attributed to poor practice habits or distracting environments. Haste and inattention are perhaps the most common factors that lead to simple errors in spelling, abbreviation, and even dosage (e.g. when decimal points are misplaced). It is also apparent that physicians, nurses, or pharmacists who engage in multiple tasks while writing, taking, or filling orders, increase their likelihood of confusing similar drug names.[104] Furthermore, inadequate training, lack of product knowledge, and outdated information systems can be the cause of, or contribute to, medication errors.[105] That transmission of a physician’s order often goes through more than one step or person before it reaches the pharmacist’s counter or the patient only compounds the risk of drug confusion.
In addition to human failings, the environment of a hospital or pharmacy is equally important. A doctor with the handwriting of a grammar school teacher or a nurse as articulate as a speech coach will still commit errors in a frazzled or unorganized setting. Likewise, pharmacists facing excessive dispensing loads or lacking technical support cannot take the extra steps to ensure quality patient care[106] and fulfill their role as effective monitors. In short, factors that decrease the time available for patient care increase the chance of errors reaching patients. Yet, at the same time, it can be argued that these are systemic failures that are realistically unavoidable in the competitive industry of managed care, where healthcare professionals are pressured to work long hours or under constant stress because limited resources do not permit hiring additional staff.
Hence we see that while the events leading to look-alike or sound-alike errors often begin with a drug name, the complexity of the healthcare environment contributes to the likelihood that a confusing name pair will be translated into a medication error. Moreover, these complexities may help explain why pharmaceutical companies have thus far been shielded against liability for confusingly similar trademarks. Manufacturers may claim that medication errors involving look-alike or sound -alike drugs are attributable to other factors in the health care system and argue that the real culprit is poor handwriting or inexperienced practitioners and not the drug name itself.
In contemplating remedial measures, it would seem that the most straight-forward solution to medication errors caused by confusing name pairs is simply to change the names of look-alike or sound-alike drugs. However, once a trademark is approved and the drug is marketed, changing its name is a very difficult process. Millions of dollars, above and beyond the investment in research and development, may have been spent establishing a trade name.[107] Thus, while consumer advocates might admonish manufacturers to remedy potentially fatal confusion, companies that have invested considerable sums in developing, testing, and ultimately marketing a particular trade name will undoubtedly be reluctant to divest themselves of their officially-registered marks.[108] In addition to the cost considerations, pharmaceutical companies may be unwilling to change their product names, lest it be perceived as an admission of fault. Hence, in the recent history of the pharmaceutical industry, there have been very few examples of name changes.
Celebrex was originally called Celebra, but Searle, its manufacturer, modified the name of its arthritis drug before it was marketed to prevent confusion with Celexa, the antidepressant.[109] Despite the name change, there have been over 100 reports of drug name errors and potential errors involving Celebrex, Celexa, and Cerebyx, an epilepsy medication, illustrating a case where fixing one problem led to another.[110] In the wake of these reports, Searle launched an information campaign for medical professionals, but at the same time maintained that the confusion is more a minor nuisance than a life-or-death concern. [111] Meanwhile, after tens of millions of dollars in marketing expenditures have made Celebrex one of the nation’s best known drugs, the FDA may require another name change if the problem does not improve.[112]
Searle and its parent, Pharmacia Corp., have a lot to lose in changing Celebrex’s name. According to Competitive Media Reporting in New York, the company spent $25.6 million on print and television advertising in the first quarter of 2000 alone.[113] Since a name change could significantly threaten sales for Celebrex, (which has generated nearly 30 million prescriptions since January of 1999) the company is aggressively trying to avoid this action. As of now, the FDA is taking a wait and see attitude.[114]
But if changing an existing trademarked name is difficult and undesired, the situation is perhaps even more complex when patents on prescription drugs have expired and generic versions are available. Because changes in generic names entail an arguably more complicated process, they are as unusual as changing trade names. For example, a modification would affect all the companies that manufacture the generic compound, not to mention the various software programs that refer to it.[115]
Given that name changes are rare, even when drugs names have empirically been shown to be confusing, it seems that the problem of look-alike and sound-alike drugs will continue, if not worsen, as an increasing number of new drug are introduced into an already crowded market of trade names. If it is unavoidable fact that there are confusingly similar drug names on the market, it will be helpful to look at alternate methods by which medication errors of this type might be avoided or at least reduced.
“Mistakes are a fact of life. It’s the response to the error that counts.”
- Nikki Giovanni
American poet, 1943-
ADOPTING NEW POLICIES TO REDUCE MEDICATION ERRORS
IF WE CONCEIVE OF MEDICATION ERRORS as a kind of illness in the health care system itself, we might begin by fixing the symptoms of the problem and then look to ways to eliminate other strains of the “virus.” In effect, designing safety into the system is a two-part proposition. First, given that there are already hundreds of confusing name pairs in the marketplace, how do we address an existing and unavoidable problem to minimize the chances of look-alike and sound-alike errors? And second, how do we prevent new trade names with the potential to confuse from entering the market in the future?
As we have seen, name confusion errors often result in patient injury because of the complex interactions during the process of prescribing, ordering and dispensing medications. As illustrated in the following figure, participants in the system include: a) manufacturers who develop drug products and submit applications for their approval to the FDA, b) the FDA, which has an extensive premarket review and uses a series of postmarketing surveillance programs to gather data on and assess risks; c) the healthcare delivery system, including its many elements, and finally d) patients, who rely on the ability of this system to provide them with needed interventions while protecting them from injury.[116]
With confusing proprietary names that have already been approved, a risk-management strategy can only focus on the post-marketing phase, particularly where FDA’s responsibility ends and health professionals’ judgment takes over. As Peter Honig, an FDA expert on drug risk-assessment notes, “FDA must do everything within its authority to maximize the likelihood that approved products will be used correctly in the real world...but [it] doesn’t regulate the practice of medicine, such as sloppy handwriting when prescribing a drug.”[117]
Recognizing that FDA’s mission to ensure the safety of drug products cannot be accomplished without effective partnerships with healthcare practitioners and the public, this section will explore and critique changes in practice that may improve the process of distributing prescription drugs and alleviate the immediate concerns involving look-alike and sound-alike names.
Having identified some of the cognitive processes involved in name-related medication errors, we should start by addressing and fixing these contributory causes. While there are numerous “best practice” approaches that can be adopted to reduce the incidence of drug name confusion (such as using both generic and brand names in prescriptions), I will focus on a few initiatives that potentially can have the greatest impact in reducing medication errors: 1) using electronic prescribing and tracking systems; 2) leveraging the role of pharmacists; 3) enhancing post-market surveillance through reporting and information sharing, and 4) educating consumers and health care practitioners about medication errors and best practices. These initiatives involve each of the key participants within the post-market system of managing medication risks. (see above diagram—the numbered initiatives correspond to the responsible actors)
A. Handwriting Workshops
Cases of medication errors caused by poor physician handwriting are well-documented and legion. In response to heightened attention on patient safety issues, a number of hospitals across the country have initiated programs to bring doctors back to the classroom for courses in basic penmanship.[118] While a noble effort, such action may achieve only marginal improvement at first and even less sustained improvement over time. A recent study demonstrated that problems with legibility are inherent in average human writing and that physician penmanship is no worse than that of non-physicians.[119] Therefore, despite isolated pockets of penmanship courses, it is likely that handwritten orders will continue to pose a risk for misinterpretation.[120] Even orders written with good penmanship can be misinterpreted for stylistic reasons, especially when a drug name closely resembles another.
Much more evidence is needed to be sure that penmanship classes have sustained effect on medical safety, given the variability of real life situations and the effects of busy schedules, fatigue, disruption, and preoccupation. Moreover, a course in penmanship should not give the public or health systems a false sense of security and forestall strategic plans to implement computerized methods for prescribing that specifically address illegible handwriting and have been proven to reduce errors.[121]
While electronic prescribing technology is available and can reduce medication errors by more than 50%, less than 5% of the nearly three billion annual prescriptions are paperless.[122] The Institute for Safe Medication Practices (ISMP) attributes the slow adoption of electronic prescription (hereinafter, “e-Rx”) technology to several problems. Until recently, clinicians were hesitant about computer use in general and there was a lack of hardware and software that would make it convenient for prescribers to select medications electronically.[123] Providers also feared the cost of such technology, creating a chicken-or-the-egg proposition—physicians wanted pharmacies to be able to receive e-Rxs before they would sign on, and pharmacists wanted physicians to begin transmitting e-Rxs before they would invest.[124]
The ISMP believes that the advent of wireless handheld devices could overcome these problems and has launched a campaign that calls for the elimination of handwritten prescriptions by 2003.[125] Many states, including Washington, support this goal and may adopt new legislation to end error-prone written prescriptions.[126] With a handheld device, the physician chooses the drug and strength and the prescription can either be communicated by radio frequency to the office printer, or, with new software, can be connected through the Internet to the pharmacy computer system.[127] Furthermore, integrated programs may enhance the prescribing process beyond addressing penmanship alone. Hand-held devices can give on-screen prompts for drug-specific dosing information with reminders to ensure that look-alike and sound-alike drugs are not confused.[128] They can also alert practitioners to potential drug or allergy interactions via up-to-date databases of medications that are connected with patient records, thereby avoiding ADRs that would otherwise go unrecognized.[129]
However, while e-Rxs offer many opportunities and benefits, they also raise a variety of legal issues and cost considerations. First, while some states have addressed electronic prescriptions through new legislation and board of pharmacy rules, in states without such laws, this new form of transmission remains subject to, but may not comply with, existing law. For example, the Wisconsin board of pharmacy recently fined a pharmacy operation for continuing to test an e-Rx system after a state administrative law judge had ruled that such prescriptions were not legal because they did not contain a prescriber’s signature.[130] Thus, pharamacists must understand state and federal law requirements for traditional prescriptions and ensure that unless a new law specifically exempts it, the e-Rx system being used conforms to those requirements.[131]
A second obstacle is funding the transition to electronic prescribing. The capital cost of acquiring and implementing new technology for smaller hospitals and clinics could be prohibitively expensive, particularly during an era of declining financial margins. As such, federal and state assistance may be necessary if this technology is to become commonly adopted in all hospitals and pharmacies. In addition, the e-prescribing units themselves must be offered with a low cost of entry and have open interfaces with other devices, so that doctors can use one service and still guarantee patient choice in retail pharmacies.[132] Creative strategies will need to be developed to help providers and healthcare institutions address these issues of cost. One model might involve a relatively low monthly subscription fee for access to a broad range of e-Rx capabilities. This fee may be offset by other savings realized through the use of technology, such as reducing the number of call-backs from pharmacists and streamlining the dispensing process. Another approach might be to have the use of e-Rx tools underwritten by a third-party stakeholder, such as a pharmaceutical manufacturer. These strategies are worth exploring if they can lead to more prescribers embracing a technology that could prevent or reduce the human and financial costs associated with medication errors.
If initial pilot programs prove this technology successful, Congress should consider legislation that will formally end handwritten prescriptions by a target date.
Similar to the concept of electronic prescribing is the idea of using bar coding systems in hospitals to prevent and track errors due to drug name confusion. The Department of Veterans Affairs (VA) is held up by the IOM as a success story in confronting and reducing medical errors using this technology.[133] Generally, under the bar-coding system, ID strips are worn by nurses and patients and are attached to medications. Before giving a patient a drug, a nurse scans all three ID strips into a computer, which verifies that the drug is being given correctly and will not cause drug interactions. If the program identifies a potential problem, it flashes a warning. Otherwise, it simply keeps a record of the activity. In a test of the bar-coding technology at two VA hospitals in Kansas, the medication error rate dropped 70 percent over a five-year period.[134]
Of course, the value of electronic devices depends on the care with which practitioners enter information. Despite technological advances, preventing mistakes will always depend on the vigilance of heath professionals. Otherwise, human carelessness can render useless the very systems designed to avert mistakes. Furthermore, automation does not guarantee precision as systems too, can fail. Raymond L. Woosley, MD, professor and chairman of pharmacology at Georgetown University Medical Center cautions: “It’s true that if you have a prescription drug with an electronic bar code on it—the right code—it can help prevent errors. But if the wrong code is on there, you may have even more errors.[135] Still, while technology does not offer a perfect solution, the ISMP does believe that electronic prescribing and bar-coding systems, if appropriately and aggressively used, holds promise for researching, identifying, reporting and ultimately reducing, medication errors.
Technology is but one part of a larger solution that includes other simple and low-tech strategies. Another means of improving the drug-delivery system is to strengthen and enlarge the role of pharmacists who effectively are the “last line of defense” between drug manufacturers, physicians, and patients. Pharmacists are not only in a unique position to guard against errors but they can also insert several low-tech safety measures into the dispensing process.
A. Safeguarding the Guardian
The pharmacist’s role as health-care guardian is a well-established tradition, but it is also one that is perceived to have diminishing value. Some groups, such as physician dispensers and the repackaging industry, question whether patients still need the “checks and balances” inherent in the separation of powers between physician and pharmacists. However, studies have made a strong case that the guardianship function remains one of the chief values pharmacists add to the delivery of safe and effective health-care services. The prevailing impression among researchers who study medication errors is that most errors are caught at the dispensing stage and that pharmacists have been the key element in the prevention of harm due to medications.[136] At the community pharmacy level, 21% of practitioners reportedly detect 10 or more errors a week and nearly half come across at least one mistake during the same interval. Among hospital pharmacists, 32% report between five and 10 errors and 6% find “21 or more” medication mistakes every week.[137]
Yet in order for pharmacists to adequately function as guardians, it is important that a system be put in place to safeguard their role. First, state boards of pharmacy should define the number of prescriptions per hour that pharmacists can safety manage. Although no state thus far has set a specific number of prescriptions a pharmacists may manage in a given amount of time, the Iowa State Board of Pharmacy, in 1993, did establish a restriction of no more than 14.2 prescriptions per pharmacist per hour.[138] Secondly, pharmacy boards should evaluate the role of pharmacy technicians and define a minimum level of necessary training. And finally, states should consider developing regulations to limit the number of hours a pharmacist will be allowed to work daily and weekly. These measures will hopefully serve to reduce dispensing errors while allowing pharmacists to engage in practices that help detect medication errors.
B. Drug Utilization Review and Patient Counseling
Perhaps the most important and simplest safety checks in the dispensing process are drug utilization review (DUR) and patient counseling. Prospective DUR is an important safety net because it allows the opportunity to detect potential drug therapy problems or questionable orders.[139] An essential component of prospective DUR is examining a patient’s profile before dispensing a newly prescribed medication. In knowing or inquiring about a patient’s health condition or problem, a pharmacist can gauge whether it is reasonable that a patient would be taking a particular drug. If an inconsistency is detected, a call to the prescriber can confirm the prescription.
Similarly, pharmacists who counsel patients are most likely to catch prescription mistakes. This is hardly a new idea, but it is one that will undoubtedly prevent many errors. When counseling, pharmacists should ask patients why their physician prescribed a particular medication, and verify that the dispensed drug is correct. Pharmacists can also prevent errors by showing patients what their medication looks like. In so doing, patients become more aware of what they should expect to see with their refills.
Both the practice of patient counseling and prospective DURs can significantly decrease the chances of error due to look-alike and sound-alike drugs. These precautionary measures again highlight the importance of pharmacy management and of staffing pharmacies with enough personnel to allow the time necessary to execute essential components of quality patient care.
C. Reducing Dispensing Errors by Separating and Differentiating Prescription Drugs
Pharmacists can also reduce the chances of dispensing errors by modifying their own systems. As discussed earlier, an increased risk for look-alike drug errors may be present itself in the arrangement of stock on shelves. Pharmacists can alleviate this risk by separating drugs with confusing names or moving particularly troublesome drugs to a separate area. Another option is to mark labels so that the differences between names are highlighted. Alphabetizing, though convenient, promotes look-alike and sound-alike errors when drugs share a number of common letters in their names. If these products come in the same strength, as do metoclopramide, 10 mg, and metoprolol, 10 mg, the likelihood of a mistake grows larger. [140] Storing drugs by manufacturer can also be problematic, as the labeling may be similar in appearance.
Another option for pharmacists is placing warnings in the computer so that they will be reminded to take another look when the drug of choice looks or sounds like another product. By using a note filed to insert a warning, the computer can automatically caution a pharmacist to double-check when dispensing certain error-prone drugs.[141]
Finally, the alphabetized listing of product names in computerized systems can provoke mix-ups when pressed for time and selections are made swiftly. Some health care practitioners have pointed out that it might be helpful if drug names were not alphabetized. A different arrangement might force practitioners to read the list more closely and choose the drug they want instead of quickly moving down the list and highlighting something that may not look very different from the drugs above and below it.
D. The Pharmacist as Monitor and Evaluator
Lastly, pharmacists can serve an important reporting function by notifying the FDA’s MedWatch program or the MERP of all errors and potential errors. This data will allow the agencies to understand and predict which names are most likely to be confused and to prevent future errors by giving notice to health care practitioners.[142]
Another question that will be explored in greater depth in Section 5 is whether focus groups of pharmacists should review products for name confusion before they are submitted to the FDA for approval. Or, put differently, should FDA require companies to submit trademark review studies that involve pharmacists as part of their NDA submissions?
In any event, given their access to patient information and their direct interaction with doctors and patients, pharmacists are in a unique position to identify drug-related problems and act as a double shield against error. As such, any measure to facilitate their effectiveness or expand their role will go a long way towards reducing name-related medication errors.
Enhancing Post-marketing Surveillance and Risk Assessment[143]
Perhaps most critical component in reducing name-related confusion systemically is encouraging practitioners and consumers to report errors when they do occur, since understanding the scope of the problem is integral to addressing and solving it. (Borrowing the corporate adage: “You can’t improve what you can’t measure.”) The process of recording medication errors often results in the identification of the same error repeated. For this reason, even trivial errors and “close calls” should be recorded. Recording errors emphasizes the problem to all caregivers and can increase their vigilance in guarding against the sources of error, thereby producing changes as simple as rearranging pharmacy stock on the shelves to restructuring the medication prescribing practices throughout an institution. As Bruce Lambert has expressed, “The more people who participate in reporting, the more accurate our picture of problems will be...we’ll get more data that will help us understand—and predict—which names are most likely to be confused. The goal is to prevent any more confusing names from entering the market.”[144]
The IOM recommends that a nationwide error reporting system be established and that these systems have both mandatory and voluntary components. The mandatory reporting systems would provide for the collection of standardized information by state governments about adverse events that result in death or serious harm.[145] Furthermore, the IOM recommends that the program be linked to systems of accountability and made available to the public.[146] While the scope of events targeted by mandatory reporting makes good sense, the public disclosure component should be implemented with greater care. By limiting required reporting to the most serious of errors, this approach will effectively target egregious problems and minimize the cost of operating such a system. Moreover, relying on states to develop their own programs will allow the system to see how each state implements mandatory reporting and to evaluate which program works best. However, in consolidating the information gathered and making it public, the system should ensure that there would be no identification of patients or the individual health care professionals that may have committed the error(s). Such a measure would underscore the importance of public disclosure, but would not promote its use as a tool for punitive actions by State and local authorities.[147] Rather, the mandatory reporting system would appropriately be used as a mechanism to provide the public with information about the safety of its health systems and to highlight errors that can and should be prevented.
The IOM also advocates the establishment of a voluntary reporting system which would focus on errors that result in little or no harm to patients. Information from voluntary or anonymous reporting systems is usually gathered by an independent entity and is used to identify patterns of errors. To fully capture the benefits of voluntary reporting, however, existing Federal voluntary reporting systems (such as FDA’s MedWatch[148] or the MERP[149]) should be integrated with data collection efforts by States and private organizations. Furthermore, these programs should be confidential to encourage reporting and to protect the privacy of patients, institutions, and providers who report errors or potential errors.
In short, by instituting both mandatory and voluntary reporting systems, the FDA and other organizations, such as the National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP)[150] will be better able to engage in post-marketing surveillance. The information collected will ultimately allow FDA to identify precursors to errors and to initiate various risk management and communication actions, such as giving notice or warnings to doctors, pharmacists, manufacturers, and consumers. On rare occasions, it could even support FDA’s reevaluation of a marketing decision (e.g. requiring Celebrex to change its name). Given its enormous potential in preventing patient harm, reporting expected or potential medication errors should be viewed as a shared health responsibility among healthcare practitioners, patients, consumers, manufacturers, and healthcare providers.
However, in practice, legitimate liability concerns discourage the reporting of errors. Thus, for reporting to be effective and a true estimation of the state of the health care system, protections from liability must be extended.
Despite its demonstrated benefits, most experts agree that mandating medical error reporting, in itself, will not surmount the hesitancy of doctors. More than 20 states currently have mandatory reporting systems, yet state officials reveal that underreporting persists.[151] As Nancy Dickey, the former president of the AMA asserts, “the proposal for mandatory reporting will not improve patient safety and may, in fact, have the perverse result of driving errors underground.”[152] Even voluntary reporting programs, such as FDA’s MedWatch, faces the problem of “tremendous underreporting.”[153]
Because any medical error is a potential malpractice suit, the fear of liability suppresses discussions about medical errors and creates a “culture of secrecy” that keeps the medical community from learning about its mistakes and how to correct them. Thus, protections must be put in place before any reporting process can take hold. The IOM urges Congress to pass legislation extending peer review protections to data related to patient safety and quality improvement that are collected by health care organizations for the purposes of improving safety and quality.[154]
Legislative initiatives such as tort reform might also be considered to provide incentives to mitigate mistakes instead of litigating cases. Ultimately, by reframing medication errors as patient safety issues (rather than quality issues), the system will likely see more success in both mandatory and voluntary reporting.[155]
Educating Practitioners and Consumers
A. Expanding the Role of Health Plans
Similar to error reporting and prevention organizations, the role (or value) of health plans is information-based. Health care plans perform an important function by credentialing and re-credentialing their participating providers. Given their information resources, health plans can also provide hospital-specific reports that track sentinel events or quality issues and standard profiling for participating physicians.[156] But these are just a few standard examples of the data-driven contributions health plans are poised to make.
The role of health plans should be expanded to provide information back to physicians and other providers in the form of generally accepted national guidelines in the delivery of care. Furthermore, health plans should supply information regarding the provider’s specific practice pattern that address variation in care around these standards. The IOM also recommends that health care organization be required to implement meaningful patient safety programs with defined executive responsibility.[157] Hence, health plans can supplement FDA’s post-market surveillancing by influencing the practice of medicine—they can identify a series of clinical best practices and disseminate them to all providers, facilitate the implementation of proven medication safety programs, and monitor the results. In this capacity, health plans can provide a value-added service by using their data resources and network management efforts to improve patient safety and the quality of care.
B. Encouraging Public Awareness of Medication Errors
Lastly, patients themselves can and should influence the quality of care they receive. Peter Honig, M.D., an FDA expert of drug risk assessment, calls consumer education the “secret weapon” in the war against medical errors. He notes that “It’s unfortunate that people research buying a car better than they research health-care decisions. They’re willing to tolerate more uncertainty with their health case than their mode of transportation.”[158]
Since there is nothing to stop pharmaceutical companies from marketing already approved drugs that look or sound alike, it is often up to consumers to protect themselves. Janet Woodcock, director of CDER encourages consumers to help prevent errors by being vigilant about their health care—understanding their treatment, keeping organized records of what doctors they see and what medications they take, and asking questions when things don’t seem right. With everyone from pharmaceutical manufacturers to consumers playing a role in improving the safety of the health system, Woodcock believes that “already safe” medical systems in the U.S. will become even safer.”[159]
“Error is the discipline through which we advance.”
– William Ellery Channing
19th century essayist
JUST AS TAKING MEDICATION often alleviates the symptoms of an illness, but does not cure the disease, a strategy focusing only on post-marketing risk management may address an existing problem, but it does not fix the system in the long-term. Minimizing medication errors associated with confusing proprietary drug names entails a two-front approach. A sustainable solution requires both reducing prescribing and dispensing errors during the post-market period and introducing mechanisms during the pre-market phase so that confusing trade names are caught before they can cause harm. Thus, it is necessary to return again to the source of the problem and consider ways in which the review process for NDAs and drug trademarks may be improved to prevent new look- alike and sound-alike drug names from being introduced into the marketplace.
Most of the medication errors associated with drug name confusion can be eliminated in the future by screening potential trademarks for similarities with existing drug names. While this ostensibly is done to some extent in the current system, the fact that products sounding as homophonic as Celebrex, Celexa, and Cerebyx have thus far been allowed on the market reveals that the administrative procedure for acquiring rights in a trademark is, at some level, flawed. Perhaps, as Boring and Doninger have written, the failure to detect confusingly similar trademarks reflects a “need to balance the regulation of pharmaceutical trademarks between the Food and Drug Administration and the Patent and Trademark Office.[160]
As examined earlier however, the express mandate of the PTO does not encompass the same goals as those of the FDA—the former seeks to grant rights to the owner of a trademark to secure his economic interests while the latter is concerned with identifying risks related to public health. In this context, “confusion,” with respect to trademarks, holds different meanings in PTO and in FDA terms.[161] How, then, can we reform the current system regulating pharmaceutical trade names to recognize the weighty goals of protecting manufacturers and trade as well as the public? And how can we balance these interests against the goals of ensuring confidence in safe and effective medication without sacrificing innovation and time?
Alternate Proposals for the Trademark Approval Process
Danielle Gentin’s article comparing the functions of the PTO and the FDA contemplates several ways in which the approval process for drug trademarks may be revamped.[162] One option is to vest complete authority in the PTO and remove any FDA review mechanisms that now function under the guise of labeling and misbranding. But as Gentin points out, such a system would have the advantage of efficiency, but would require the PTO to familiarize itself with the thousands of unregistered but potentially confusing drug names. This would impose an inordinate burden on the agency and would amount to an inefficient effort to educate a populace of attorney examiners ill-equipped to assume the daunting task of serving as FDA officers as well. Moreover, were the PTO to act as sole reviewer of drug trademarks, it arguably would have to wait for FDA drug approval to ensure that the proposed name is not deceptive, which may increase the difficulty for drug manufacturers to apply for registration within the intent-to-use provision’s two year limit.[163] Finally, the prospect of vesting all authority in the PTO ignores the fact that the express mandate of the PTO does not encompass the same goals of consumer well-being as those of the FDA.
Gentin maintains that a converse proposal to endow FDA with complete authority over the drug trademark approval process is similarly ill-conceived. To do so would overlook the fundamental purpose of the Lanham Act and stifle incentives for competitive marketing, denying pharmaceutical manufacturers the benefits that all other trademark owners can derive from the Act’s protections. Furthermore, vesting sole authority over drug trademarks in the FDA would impose additional resource constraints on an agency whose central mission is not the regulation of trademarks.[164]
A third alternative calling for government to create names for all drugs is admittedly extreme, but could ensure that very different names be assigned to all drugs and could also free manufacturers from the time consuming and costly process of selecting a name. However, this approach is also flawed in that is simply shifts the burden on resources to the government without offering an inherent guarantee that government names would be better suited to avoid confusing nomenclature. Moreover, such an approach ignores the role of trademarking in a market-based economy. inspire
Thus, Gentin concludes that the best proposal for drug trademark reform is combined PTO and FDA involvement with an eye to the incentives driving pharmaceutical manufacturers and to the degree of knowledge and sophistication of the average physician and patient. The PTO, Gentin maintains, should remain the central force in screening proposed marks against already registered names. In this capacity, the agency can “continue to recognize the potential conflicts between a would-be drug called Clernoz and a previously registered vitamin supplement called Clernos, that did not go through FDA’s approval process.”[165] The FDA however, should recommend to the PTO whether a proposed mark is confusing or claims more than it can accomplish. Under these circumstances, the PTO might move to reject drug trademark registration on the grounds that a mark is deceptive which would ensure that the mark does not enter the consumer arena.
Gentin’s final point is that the key to reforming the regulation of drug trademarks involves empowering the LNC. She argues that unlike federal trademark approval, which specifically fulfills the mandates of the Lanham Act by assuring the rights of trademark owners and protecting against consumer confusion as to a product’s source, the FDA’s approach to drug trademarks does not reflect the agency’s vital concerns in ensuring a product’s safety and effectiveness. The central critique of the system, then, is that FDA does not do enough.
Thus, empowering the LNC and strengthening the Committee’s influence on drug manufacturers, would be an effective first step, especially if it were required to review all marks systematically as part of the NDA approval process. Additionally, Gentin notes that the LNC could undertake more innovative approaches to counter confusion by using random samplings of doctors, pharmacists, and consumers to identify problematic trademarks. It was precisely these recommendations that were adopted when the OPDRA took over the functions of the LNC in late 1999 and initiated a new program for the review and risk-analysis of proprietary names for drug products.
While each new proprietary name is now evaluated for possible sound- or look-alike confusion under the authority of the OPDRA, considerable obstacles still exist in the name review process. First, the agency’s recommendations continue to be non-binding.[166] As long as this is the case, the OPDRA is effectively without teeth because drug manufacturers are unlikely to abandon marks merely because an advisory group notes potential concerns. It is still too early to tell whether the pharmaceutical executives will react to OPDRA’s review with due caution. If the industry continues to believe and find market-based evidence that fanciful or descriptive names such as Celebrex will result in substantial profits, it is entirely possible that new trade names like Celebrite will still be proposed. Firms, rather than deferring to the OPDRA’s recommendations, may instead dispatch a team of attorneys to the FDA to challenge its determinations. This limitation suggests that in order for OPDRA to truly fulfill FDA’s mandate in ensuring the safety and effectiveness of a drug, it must have binding review and the authority to refuse approval of an NDA on the grounds of a confusing trademark.
Secondly, the OPDRA is still limited by the familiar constraint of budgetary resources. With only eight people researching approximately 300 names a year, the extent to which the group will be successful in ferreting out confusion in drug trademarks is debatable.[167] Moreover, as of yet, the office has not employed computer software that can improve FDA’s ability to detect orthographic or phonological similarities in proprietary names more accurately and efficiently.[168] This technology, which has already been used by MED-ERRS and the USAN Council, is much needed given the volume of names being proposed as well as those currently in circulation.[169] Such a program would also enable the FDA to review trademarks in precisely those areas where the PTO lacks the expertise and the agency mandate to do so (e.g drug names that are not registered federally but enjoy common law status). Lastly, using a computer program may give the FDA more ammunition when debating names with manufacturers who can make or lose millions on such marketing decisions. By basing review on an arguably more “scientific” and objective approach, the agency may be less open to criticism or challenge from drug manufacturers.
Whether the FDA will need to raise user fees (as the PTO had to do by 69%)[170] in order to increase scrutiny of proprietary names, and whether this will be met with resistance, remains to be seen. One option that the FDA might consider in order to ease its resource demands is to put the onus on manufacturers to submit pre-screening results as part of their NDA.
As discussed in Section II, manufacturers currently do not employ standardized models of evaluating trademarks; rather, their choice of trade names is often selected with minimal screening against existing products.[171] As such, the rigors of scrutinizing proposed trademarks, employing clinical testing, and searching various directories, registers and handbooks for potential confusion is shifted onto the PTO and the FDA, both of which are constrained by limited time and resources.
It is, however, in the manufacturer’s best interest not to have a confusing trade name on the market: a later name change is not only more costly from a branding and advertising perspective, but it also exacts a reputational cost from having a drug associated with injury or death. Therefore, since it is the manufacturer who derives real and tangential benefits from having a unique trademark, the burden should be placed on them to demonstrate up-front that their proposed drug name is not confusingly similar to any existing drug names.
The FDA should present the pharmaceutical industry with a method of testing proprietary names for possible confusion and develop clear standards for determining acceptable names in the same way it has established criteria for presenting evidence of a product’s safety and effectiveness. And, just as manufacturers must submit data with their NDAs to show that a product meets the statutory standard for market approval, it should also provide data to the OPDRA indicating that a chosen name has been tested through a pre-screening process.
Pre-screening may require manufacturers to use healthcare practitioners to simulate clinical settings where potential errors can be identified and remedied. While an increasing number of companies are asking pharmacists to be part of the evaluation process in assessing the likelihood that proposed trademarks will be confused with already marketed drugs, the FDA might consider formalizing this process in a regulation or guideline. The agency should mandate that manufacturers employ a systematic process that predicts how and where things are likely to go wrong, so corrections can be made before a drug is launched. Such a system, which has been referred to as failure-mode or error prevention analysis, should be required as part of the routine NDA assessment.[172]
Failure-mode or error-prevention analysis has already been used by some members of the pharmaceutical industry, albeit on a voluntary basis. The ISMP’s MED-ERRS division works with drug companies that ask the group to test a single proposed product name or multiple choices under consideration for a particular product.[173] The names are written out to provide six to eight variations in handwriting. MED-ERRS then sends a survey to pharmacists, nurses, and physicians which asks the practitioners to look at each version and assess their potential to be confused with other products, list what those other products are, and how serious the consequences of a mix-up might be. Participants are also asked whether the name looks like any medical term or abbreviation. A second aspect of the test examines how practitioners pronounce the proposed drug name. After worldwide testing, sampling various accents, practitioners are asked whether the name sounds like any other drug name or medical term and whether there is potential for confusion and subsequent harm. A final recommendation is made to the client once all the data is collected and analyzed.
In addition to using practitioners to review trademarks, special look-alike/sound-alike software, dubbed LASA, has also been developed for possible use in the pharmaceutical industry, the PTO and the FDA.[174] The software screens proposed trademarks for orthographic and phonologic similarities against databases of existing names and computes a numerical similarity score between drug names. The names are then sorted in decreasing order of similarity, with the most analogous hits at the top of the list.[175] Those that break through some agreed-upon threshold of similarity can be rejected. Error prevention analysis using the LASA technology might involve an initial computer search to screen out highly problematic names and a secondary screening by practitioners. The remaining proposed names would be put though more careful scrutiny by a panel of practicing health professionals who have a greater awareness of the context in which these drugs will be used.
While the software has been used by both MED-ERRS and the USAN Council, it has so far been rejected by the pharmaceutical industry as unnecessary. [176] Despite the benefits of this program, unofficially, pharmaceutical companies are concerned that screening product names for similarity might open the industry to negligence claims. They claim that if reducing similarity between drug names is found to prevent dispensing errors caused by product-name mix-ups, plaintiffs may argue that it should have been done years ago.[177]
Notwithstanding this possibility, it is a less than convincing reason for manufacturers to reject a technology that can prevent potential medication errors related to drug name confusion. The argument is analogous to the rationale for the categorical exclusion rule in evidence in which remedial measures taken by defendants cannot be used as proof of negligence.[178] But just as the policy reasons behind the evidence exclusion rule are weak, the argument that screening drug names will actually lead to liability is misleading. Rather, it is in knowing that there is a remedy for confusingly similar trademarks—namely drug screening technology—and in not taking such precautions, that manufacturers will be held liable. Moreover, refusing to screen names despite this prior knowledge could elevate their offense from negligence to gross negligence, thereby making manufacturers accountable for punitive, and not just monetary, damages.
* * *
Liability issues aside, the FDA must first and foremost heed its mandate and consider the public health consequences of any proposed or actual proprietary name as part of its overall risk-to-benefit decision on a product. In so doing, FDA should recast drug name evaluation in the pre-approval stages to include a combination of computer screening and practitioner review, since it is the application of drug names in real situations that will illuminate how certain names might be susceptible to visual, auditory, and cognitive errors. To balance its own resource constraints, however, the FDA should place the responsibility on manufacturers to include these trademark review studies as part of their NDA submissions. This would not only alleviate some of the time and financial burdens on the FDA, but more importantly, may ensure that manufacturers take greater care in their internal name selection process. Requiring error-prevention analysis and setting clear standards might discourage manufacturers from submitting descriptive or confusing names that have little chance of being approved. It also lessens the chances that an NDA approval will be stalled because inappropriate names need to be re-worked and re-submitted by the manufacturer, thereby subverting the countervailing incentive on the part of pharmaceutical companies and the FDA to see that newly-approved drugs become available as soon as possible.[179]
While admittedly an “elaborate process”, the ultimate goal, as Jerry Phillips, associate director for medication error prevention at the FDA, has emphasized, “is to drive down the number of post-marketing reports of medication errors due to trade-name confusion.”[180] Mandatory pre-screening by pharmaceutical companies may be the least restrictive means of protecting manufacturers’ interest in trade as well as the public’s right to safe and effective products while recognizing the limits of time and resources.
“The spotlight on the health system’s problems might be just what the system needs to transform itself.”
SO, WHAT’S IN A NAME? Plenty. From the marketers and advertisers who struggle to invent the perfect brand names to the physicians and pharmacists who must differentiate between them, and from the PTO and FDA who review trademarks to the manufacturers and consumers they are respectively meant to protect—it is clear that drug names affect a variety of competing interests.
Names and naming, as we have seen, are fundamental to any product development. But there is perhaps even more at stake in the naming of prescription drugs. While pharmaceutical companies “battle for the mind” (and wallet) with fanciful combinations like Zocor, Zantac, and Zyban, it is the health care practitioners who are ultimately liable for errors arising from their confusion. And, while the regulatory agencies serve as gatekeepers, they are pressured to ensure that safe and effective products reach the public without undue delay. Naming, then, becomes more than a marketing word game; it is a delicate balance of interests.
This paper has attempted to highlight some of the salient tensions in drug naming and to underscore the significant public health consequences of misnaming prescription drugs. The findings of the IOM report forcefully brought the extent of preventable medical errors to the forefront of public discourse, and estimates by the MERP that 25-30% of medication errors are caused by look-alike and sound-alike drugs only corroborates the seriousness of this issue. These alarming statistics will hopefully elevate the topic of proprietary drug naming and galvanize the industry to change the culture and the systems that lead to mistakes.
To begin with, both pharmaceutical companies and the healthcare community should reframe the process of naming drugs from a marketing consideration, which is necessarily subjective, to a patient safety consideration, which can be measured in more objective terms.
Moreover, preventing future errors is best achieved by designing a safer overall system. This approach, which looks at the products, tasks, and processes involved in medication errors, recognizes that “the real-world practice of medicine occurs within an intricate system and that it is this complexity, coupled with the limitations of humans, that makes avoiding mistakes a consuming task.”[181]
Thus, a broad strategy to reduce proprietary drug name confusion must start with the naming process and end with the patients themselves. While FDA’s pre-market review processes play an important role in the overall system, they are by no means the only factors in pharmaceutical risk management. Rethinking the regulation of drug trademarks must also account for the point where FDA’s responsibility ends and health professionals take over. After all, for look-alike and sound-alike products already on the market, ensuring patient safety is principally the responsibility of the physicians, nurses, and pharmacists who make risk-benefit decisions on an individual basis. It is therefore essential to understand the root causes of errors, identify best practices to avoid them, and accelerate their widespread adoption. A targeted approach also involves installing mechanisms to improve the practice of medicine, such as employing new technology, leveraging pharmacists, and establishing nationwide reporting to identify and learn from errors. An accurate picture of the problem allows FDA to monitor and assess what is happening in the industry and use this information to initiate various post-marketing actions when necessary.
The challenge, then, is to tackle each of the stress points in the clinical setting while implementing changes in the way new drug trademarks are approved. Regulators, government agencies, healthcare providers and professional oversight organizations will be under a spotlight, perhaps made brighter by the IOM report, to contribute to the framework of providing safe medical care through regulation, incentives, knowledge, and effective leadership. Yet it is important to accept that there will always be mistakes, though they will be different as the systems change. Thus, improving the safety of drug trademarks in the long-run will require a concerted and continued effort by all participants, including manufacturers, the FDA, patients, and consumers. After all, as the IOM report notes, “ it may be part of human nature to err, but it is also part of human nature to create solutions, find better alternatives, and meet the challenges ahead.”[182]
APPENDIX A
HOW A DRUG GETS ITS NAME
A drug that will, under certain circumstances, reverse (anti) delirium.
An attenuated measles vaccine
An injectable drug for multiple schlerosis; the letter”a” gets it listed at the top of drug fromularies. The “nex” suffix suggests next, or advanced.
Tablets whose name has their roots in three components of the product: belladonna, ergotamine, and phenobarbital.
An antibiotic that suggests action and elimination.
Conray
A contrast X-ray agent
An antidepressant that suggests “effective” in its name; the “or” suffix connotes power and potency.
Inocor
A variation of the prefix from inotropy, which refers to the contractile force of the heart.
Named in memory of the pharmaceutical company president’s late wife, Kay and young daughter, Robin.
Honoring Dr. Kendall, the discoverer of hydrocortisone, the drug is an improved analog hydrocortisone.
Describes a compound that lowers elevated cholesterol
A dental care product made of sodium fluoride. Previously proposed names, all beginning with the letter “F,” were rejected because of trademark conflicts.
An antacid composed of three antacids was named using the Latin word “magnus” meaning great, and “tri” meaning three.
An antacid made of calcium and magnesium carbonates, which chemically can also come from marble.
A modern diruretic.
Named for its therapeutic effect—an oral diuretic.
Derived from Greek “pan” meaning “all” and the Wisconsin Alumni Research Foundation (WARF), where warfarin, the generic was made.
Vaccine used against red measles was derived from “rubeus”—red in Latin.
A weight loss product based on the word anorexiant, which means appetite suppressant.
Medication which is a specific histamine antagonist for ulcers whose generic is cimetidine.
Derived from Latin “tussis” for cough, is designed to end coughing.
Sources
APPENDIX B
PRESCRIPTION ERRORS DUE TO SIMILAR DRUG NAMES
The United States Pharmacopeia has compiled more than 1,000 drug name pairs that look or sound alike. The following are a sampling of the most commonly confused drug names
III. Accupril |
IV. Accutane |
Cardene SR |
Cardizem SR |
Celebrex |
Celexa and Cerebyx |
Chlorpropamide |
Chlorpromazine |
Clonidine |
Klonipin |
Clinoril |
Clozaril |
Clomipramine |
Clomiphene |
Cytoxan |
Cytotec |
Dolobid |
Slo-bid |
Estraderm |
Testoderm |
Ethambutol |
Ethmozine |
Feldene |
Seldane |
Fentanyl |
Sufentanil |
Flutamide |
Flumadine |
Glipizide |
Glyburide |
Hydrocodone* |
Hydrocortisone |
Lamisil |
Lamictal |
Lanoxin |
Levoxine |
Lodine |
Iodine / Codeine |
Lovastatin |
Lotensin |
Monopril |
Minoxidil |
Norvasc* |
Navane |
Penicillamine |
Penicillin |
Prilosec* AND Proscar |
Prozac* |
Premarin* |
Primaxin |
Propranolol |
Propulsid |
Provera |
Provir |
Retrovir |
Ritonavir |
Reserpine |
Risperidone |
Sulfasalazine |
Sulfisoxazole |
Synthroid* |
Symmetrel |
Toradol |
Inderal |
Vincristin |
Vinblastine |
Source: USP MERP; “Prescription Errors Due To Similar Drug Names” at www.voiceoftheinjured.com;
and Cynthia Starr, When Drug Names Spell Trouble. DRUG TOPICS, No. 10, Vol. 144; p 49. May 15, 2000.
* Among the ten most prescribed drugs in the US in 1999. Source: RxList; About.com
The USP Practitioners’ Reporting Network (PRN) offers an online list of confusing and similar drug names. The compilation can be found at www.usp.org/reporting/review/rev066.htm
APPENDIX C
ADDITIONAL RESOURCES
A number of Internet sites provide additional information on the subject of medication errors caused by look-alike/sound alike drugs.
|
Agency for Healthcare Research & Quality
|
|
|
American Pharmaceutical Society
|
|
|
American Society of Health-Systems Pharmacists
|
|
|
Institute of Medicine report
|
|
|
Institute for Safe Medication Practices
|
|
|
MedErrors
|
|
|
National Corrdinating Council for Medication Error Reporting
and Prevention
|
|
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National Patient Safety Foundation
|
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United States Pharmacopeia
|
[1] Citing the power of names, Rivkin & Associates, a corporate branding agency, advises that reason alone does not make a great name. Oftentimes, intuition and emotive factors play a greater role in determining the effectiveness of a name. See www.namingnewsletter.com/tips.and.tactics.for.smart.naming.html.
[2] Consider, for example the psychological importance of sight and sound in naming illnesses and how they are treated. In its campaign to eliminate leprosy, the NIH has advocated changing the name of the illness to Hansen’s Disease. It noted that unlike any other disease, its name alone evokes repulsion rather than sympathy, which in turn hinders treatment. Since patients fear ostracism, many hide their condition and are unwilling to openly take medication for leprosy. The NIH asserts that by changing the name of the disease, it will change the way people look at, and react to, the condition. See “How Not to Abolish Leprosy,” The Economist. November 30, 2000.
[3] The Federal Trademark Act of 1946 (Lanham Act) defines “trademark” as “any word, name, symbol, or device or any combination thereof” adopted by a person engaged in commerce “to identify and distinguish his or her goods, including a unique product, from those manufactured or sold by others and to indicate the source of the goods.” 15 U.S.C. §1127. See The Trademark Register for a listing of U.S. trademarks registered and renewed since 1881 and The Directory of U.S. Trademarks for U.S. registrations and information regarding pending applications.
[4] While every drug receives three names—a chemical name, a non-proprietary (generic) name, and a brand, or trademark name—each involving distinctly separate processes, this paper will focus primarily on trade names for prescription drugs with some reference to generics as a comparator. Although the three names exist partially to avoid confusion, we will see in later sections how they sometimes inevitably engender it. See Linda Gunderson, The Complex Process of Naming Drugs, ANNALS OF INTERNAL MEDICINE. October 15, 1998.
[5] Cynthia H. Starr, When Drug Names Spell Trouble, DRUG TOPICS, No. 10, Vol. 144; p. 49. May 15, 2000. The monetary and reputational costs of changing drug names after such an incident is both costly and damaging to marketability. A product name associated with adverse effect, even if it had nothing to do with the safety and effectiveness of the drug itself, is harmful to its perception and can affect demand.
[6] “Too Similar Drug Names Causing Pharmaceutical Mishaps, Legal Headaches.” Chicago Tribune. August 1, 2000.
[7] The Patent Restoration Act states that the patent can be renewed up to 5 years from the time of patent issue to the date of FDA approval in addition to the 17-year protection period. During that time, only the manufacturer, or those companies licensed by the original manufacturer, are allowed to market the drug. After the patent expires, however, any company can manufacture and sell the drug, but under the generic or a different trade name. Trade name drugs are more expensive than generic ones because the manufacturer must protect its initial investment which went into the discovery of the new drug. Generic firms do not invest in development so they can sell the drug cheaply. For example, the tranquilizer Miltown when sold under the trade name costs approximately $6.50/100 tablets while the generic form (meprobamate) costs approximately $1.50/100.
[8] Linda A. Johnson, “Naming a New Drug is a Tricky Business” Associated Press. May 25, 1998.
[9] Martha M. Rumore, The Role of Pharmacists in the Pharmaceutical Trademark Evaluation Process, 6 J. PHARMACY & L 83, 96 (1997).
[10] Id., at 85. For example, in wrongful death suits resulting from medication errors, the physician or pharmacist may be charged with mistaking medication such as Lamictal and Lamisil, but the drug company is not liable.
[11]Authors of “Positioning—The Battle for Your Mind.” Publication of the NameTrade division of Cintara, a full service branding agency. Cintara is an identity design firm which specializes in logo development and complete corporate identity services, including name and graphic design. See www.cintara.com
[12] For example, in the effort to invent unique names, companies try to use seldom used letters such as “z” or “x” which have become the most popular letters in drug naming: e.g. Prozac, Zocor, Zofran, Vioxx, Zoloft, Zovirax, Zyloprim, Zantac, Zyban etc. Ironically, the influx of drug names with the letter “z” has contributed to name confusion, rather than serving to distinguish the drug.
[13] Similarly, most Internet domain names have been taken, so by giving a drug an unusual name, the word may be available as a domain name and be unique in online search engines. Consumers searching for information will find pages that deal only with that specific product, allowing them easier access to information. See Marshall Brain, How Stuff Works, “Question of the Day” at www.howstuffworks.com/question140.htm
[14] As Pamela May, the attorney for SmithKline Beecham explains, “a trademark is chosen by the company that wants to market the product, and it’s very much like how you name a car or any other product—it’s a marketing decision.” See Gunderson, supra note 4.
[15] Branding agencies are comprised of experts in a number of languages, linguistics, market research, psychology, public relations, trademark research, and testing who use an amalgam of resources, including online and print specialized, industry-specific and multilingual dictionaries, encyclopedia, thesauri, and proprietary naming software. See, e.g., NameTrade website at www.nametrade,com.
[16] Examples of brand names derived from a drug’s chemical name include Tylenol (acetylaminophenol) and Triaminic (contains 3 amines: 2 antihistamines and one sympathomimetic).
[17] Johnson, supra note 8. For example, names like Diflucan, which sounds like its generic name fluconazole, are becoming passe while made up names such as Zoloft are popular.
[18] See www.namingnewsletter.com for tactics and strategies for developing company, product, and service names.
[19] For example, the company NameTrade initially generates over one thousand names which will typically yield only several hundred feasible candidates. These candidates are subjected to screening through marketing, semantics, phonetics, sound symbolism, and legal filters. However catchy, powerful, or exciting a name may seem at first, it may be unavailable if it is already registered or too similar to a name already registered as to cause confusion in the marketplace. If a name has hidden or inconsistent linguistic or marketing messages or has negative connotations in the primary languages of a targeted international marketplace, it would not longer be considered a viable candidate. See www.nametrade.com.
[20] Generic names are the official names of drugs which are listed in the U.S. Pharmacopeia (USP) and the National Formulary. Federal law mandates the use of generic names in advertising and on labels and brochures. The generic name is essential to pharmacists and other health care professionals primarily because of the stem. Given the systematic approach to developing a generic name, pharmacists can often tell the chemical composition of a generic and what its indications and adverse reactions are.
[21] See Appendix A for a more comprehensive listing of drug name etymology.
[22] Steven I. Baskin and Barbara E. Stephens. What’s in a Drug Name? DRUG TOPICS. Vol. 127, p. 80. February 7, 1983.
[23] Linda A. Johnson, “’Fanciful New Drug Names Suggest Power, Effectiveness,” Associated Press. May 25, 1998. [hereinafter, Johnson, “Fanciful Names”]
[24] Jonathan Bell, naming director at Interbrand in New York, a naming consultancy that works with many top pharmaceutical companies. See www.nando.net/newsroom/ntn/biz/052598/biz6_29287_body.html.
[25] Melissa Kalish, Managing partner at Interbrand. Id.
[26]Danielle Halstrom, Merck spokeswoman. Id.
[27] Baskin and Stephens, supra note 22.
[28] Linda A. Johnson, “What’s in a Drug Name?” J.REC., May 27, 1998.
[29] Id.
[30] The USAN Council is made up of three sponsoring organizations: the American Medical Association (AMA), the American Pharmaceutical Association (APA), the U.S. Pharmacopeia (USP), with a liaison from the FDA. The Council establishes principles for naming drugs generically (based on stems related to a drug class) and is responsible for their assignment. The generic name describes the active ingredients of the drug.
[31] The search may include any of the following: the Federal Trademark Register and the Directory of U.S. Trademarks, State Trademark Registers, Common Law sources, Foreign Trademark Registers, trade directories and journals, World Heath Organization Stems, USAN Stems, medical abbreviations, and Internet domain names. See generally, Glenn A. Gundersen, Methods of Searching Trademark Availability Aren’t Simple Anymore, NAT’L L.J., May 16,1994.
[32] See generally, Danielle A. Gentin, You Say Zantac, I Say Xanax: A Critique of Drug Trademark Approval and Proposals for Reform, 55 FOOD DRUG L.J. 255.
[33] Ian Kaufman, Comparison of U.S. and Foreign Trademark Law, 229 PRACTISING L. INST. 323 (1986). There are several procedures whereby marks can be registered. The two most frequently used authorize the PTO to register trademarks to the owner of a mark used in commerce or intended for use in commerce. 15 U.S.C.§§1051(a) and (b).
[34] Joseph D. Garon, The Lanham Act: A Living Thing, 7 Grodham Intell. Prop. Media Ent. L.J. 55 (Autumn 1996).
[35] U.S. Constitution, Article I, §8.
[36] These rights include: 1) use of federal registration symbol ®; 2) registration acting as prima facie evidence of the validity of a registered trademark, of the ownership of said trademark, and of the registrant’s exclusive right to use the trademark; 3) the ability over time to have the registered trademark become incontestable (subject to certain statutory defenses) to strengthen further owner’s rights; 4) registration serving as constructive notice of an ownership claim to eliminate any good faith adoption and use of defenses being made after registration; 5) federal jurisdiction in infringement actions without showing a specific amount in controversy; 6) recovery in federal courts of profits, damages, costs, treble damages and attorney’s fees; and 7) registration being used as a bar to the importation into the U.S. of goods bearing an infringing mark.
[37] 15 U.S.C. §1052(d).
[38] Rumore, supra note 9 at 85.
[39] Pub.L.No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)). §502(a) provides: a “drug shall be deemed to be misbranded...[when] its labeling is false or misleading in any particular.”. FDCA §505(d) provides that an application shall be refused if “based on a fair evaluation of all material facts, such labeling is false or misleading in any particular.”
[40] Gentin, supra note 32 at 258. The question is whether FDA properly undertake to review trademarks for likelihood of confusion, when Congress has specifically granted that authority to another Federal agency. Rumore notes that a Memorandum of Understanding (MOU) between the PTO and the FDA refers only to patent restoration provisions of Waxman-Hatch and is silent with regard to trademarks. 52 Fed. Reg. 17,830 (May 12, 1987). Rumore, supra note 9, n.15.
[41] In October 1999, the FDA’s Office of Postmarketing Drug Risk Assessment (OPDRA) took over the review of proposed trade names for drug products. The new program began in December 1999 with the creation of a medication error staff. The functions of OPDRA in the review of proprietary names will be discussed in greater detail later in this paper. See Final Summary of Food and Drug Administration (FDA) Action Items- Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Food and Drug Administration, February 22, 2001.
[42] The Committee, created by the Center for Drug Evaluation and Research, was initially an internal consulting group on trademark matters for the FDA reviewing divisions. The LNC’s role was expanded in 1993 to include official and methodological review of trademarks, including the mark’s appearance on labels, dosage, regimen, and other indications. See Rumore, supra note 9 at 88 and Gentin, supra note 32 at 259.
[43] 21 C.F.R. pt. 210.10(c)(5).
[44] 21 C.F.R. pt. 210.10(c)(3).
[45] Jerry Phillips, RPh and Associate Director of the Medication Error Program, FDA in “Too Similar Drug Names Causing Pharmaceutical Mishaps, Legal Headaches.” Chicago Tribune. Aug. 1, 2000. [hereinafter, “Pharmaceutical Mishaps, Legal Headaches”]
[46] Rumore, supra note 9, n.22.
[47] 15 U.S.C. §1125(a).
[48] Starr at supra note 5.
[49] Final Summary of Food and Drug Administration (FDA) Action Items—Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and their Impact. FDA. February 22, 2001. [hereinafter, FDA Action Items.]
[50] Id. OPDRA provided reviews for approximately 300 proprietary names in 2000 alone. This can be compared to the number of trademarks the LNC examined on a voluntary basis, which totaled approximately 600 between 1990 and 1996. See Rumore, supra note 9 at 88 for statistical data.
[51] Starr, supra note 5.
[52] Michael F. Conlan, Medstakes: Experts Offer Suggestions for Eliminating Rx Errors. DRUG TOPICS. No. 3, Vol. 142, p. 87. February 2, 1998.
[53] Rumore, supra note 9 at 89. For example, in 1990, the PTO had to boost user fees by 69% to make up for budget cuts.
[54] Id. Citing the U.S. General Accounting Office, Intellectual Property. Patent Examination and Copyright Office Issues. Testimony from Hearing Before the Committee on the Judiciary, U.S. Senate, September 18, 1996.
[55] Id. at 89.
[56] Conlan, supra note 52.
[57] Mike Mitka, What’s in a (Drug) Name? JAMA. Vol. 282, No. 15, October 20, 1999.
[58] While the USAN Council has exact guidelines for assigning generic names, the guidelines for assigning brand names outline what a company should not do. For instance, the FDA and the USAN discourage the use of stem since putting a stem in a brand name may increase its similarity to the generic name. Although a brand name is not required to indicate the drug’s use, it cannot imply a wrong indication. The FDA also forbids use of words that make promises, such as “cure” or “safe.” The use of “cap” or “tab” for a capsule or tablet is also discouraged because other formulations may become available. As long as drug companies adhere to these guidelines, they are essentially free to choose any name for their products. See Gundersen, supra note [ ].
[59] Pharmaceutical companies have also, on occasion, organized contests among their employees to choose a name for a drug, selecting winners because they are “catchy,” easy to pronounce and remember by physicians and the public, and not too technical sounding. See Baskin and Stephens, supra note [ ].
[60] Dan Boring, FDA’s head of drug naming evaluation notes that companies are getting better at “learning what FDA wants” and at submitting names that “encode promise” without crossing the line. This worries organizations such as the Public Citizen’s Health Research Group, especially with dramatic increase of direct-to-consumer advertising. Co-founder Dr. Sidney Wolfe maintains, “what companies have tried to do is come up with a smooth-sounding name, overstate the benefits, and understate the risks...FDA made a serious mistake in allowing TV ads.”
[61] The PTO generally will not approve a trademark that is “merely descriptive” and grants greatest protection to names that are “fanciful.” The FDA, on the other hand, will consider a label “misleading” if it employs a “fanciful proprietary name” that implies “unique effectiveness or composition” See 21 C.F.R. pt 210.10(c)(3). This seeming contradiction has led to arguably “descriptive” and “fanciful” names such as Elavil, a mood elevator and Prohibit, a flu vaccine.
[62] Rumore, supra note 9.
[63] Diane Cousins, R.Ph is the Vice President of the USP’s Practitioner and Product Experience Division.
[64] To Err is Human: Building a Safer Health System. Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, eds., Committee on Quality of Health Care in America. Institute of Medicine. (2000) [hereinafter IOM Report] Using the report’s definitional standards, an error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. An “adverse event” refers to an injury or undesired outcome caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a “preventable adverse event” and an “adverse drug reaction” (ADR) connotes some potential relationship between the undesired outcome and a medication.
[65] Id. The statistics in the IOM report, which were based on two large studies, suggest that medical errors are the eighth leading cause of death among Americans, with error-caused deaths each year in hospitals alone exceeding those from mother vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516), three causes that receive far more public attention.
[66] Id. The National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional, patient or consumer.” Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, ordering, communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use. See CDER, “Medication Errors,” at www.fda.gov/cder/drug/MedErrors/defualt.htm.
[67] Starr, supra note 5.
[68] Statement by Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA before the Committee on Heath, Education, Labor and Pensions. United States Senate. February 1, 2000. [hereinafter Testimony by Janet Woodcock]
[69] Based on a study conducted by Lucian Leape, M.D. See FDA Medical Bulletin; “Medication Errors” at www.fda.gov/cder/handbook/mederror.htm.
[70] Testimony by Janet Woodcock, supra note 68. Woodcock cites a study which estimates that the health care cost from ADRs incurred in the outpatient setting exceeds $75 billion annually.
[71] Tamar Nordenberg, Make No Mistake: Medical Errors Can Be Deadly Serious, FDA CONSUMER MAGAZINE. September-October 2000.
[72] Id. Similar labeling and packaging was the No. 1 cause of wrong drug errors. Brand names that look alike came in second, and in eighth place were sound-alike names. See Conlan, supra note 52.
[73] The MERP is a cooperative effort of the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP).
[74] According to Susan M. Proulx, Pharm.D., president of Medication Error Recognition and Revision Strategies (MED-ERRS), a for profit subsidiary of the non-profit ISMP. The MERP has catalogued thousands of errors due to similar drug names. See also Bruce Stuart and Becky Briesacher, “Medication Decisions—Right and Wrong,” Background report for the Department of Health and Human Services conference on Pharmaceutical Costs and Pricing Practices. August 9, 2000. http://aspe.hhs.gov/health/reports/Drug-papers/Stuart-Final.htm
[75] Fred Gebhart. Deadly Drug-Name Confusion Avoidable, Researchers Say. in DRUG TOPICS, No.1, Vol 143, January 4, 1999. Bruce Lambert, the acting head of the department of pharmacy administration at the University of Illinois at Chicago (UIC) College of Pharmacy borrowed techniques used to create word processing spell checkers to develop lists of increasingly similar drug names, taken from the U.S. Pharmacopoeia. The drug names were then matched for prescribing frequency across the levels of similarity and tested on practicing UIC pharmacists. The results were disheartening, though not surprising. Lambert’s pharmacist colleagues confused up to 27% of look-alike drug names and 22% of sound-alike names. This was a scientific elaboration of the obvious—that it is easier to confuse more similar words.
[76] Carol Hart. Drug Approvals: Safety At Any Speed? MODERN DRUG DISCOVERY; September-October 1999, p. 25-26.
[77] See Appendix B for a sample list of commonly confused drugs names.
[78] “Medication Errors: Similar Drug Names,” www.pharmacology.about.com/health/pharamcology/library/weekly. Sept. 12. 2000. [hereinafter, “Medication Errors”]
[79] Sarah Smith, “Dangerous Drug Mishaps,” Ladies Home Journal. May 1999.
[80] Some of the high-profile medication errors have resulted in patient deaths, creating a heightened awareness of the medication-error problem within both in the medical community and the patient population. In a famous Texas case, a patient died when his pharmacist mistakenly substituted Plendil, a blood-pressure drug for the hear medication, Isodril. Both the physician and the pharmacist were held liable. See Starr, supra note 5.
[81] See “Medication Errors”, supra note 78.
[82] Sound-alike Horror Stories; Prescription Errors, DRUG TOPICS, No. 19, Vol. 141; p.44. October 6, 1997. [hereinafter, Sound-alike Horror Stories]
[83] Bill Robinson, Pharmacists Stand Watch Against Prescribing Errors, DRUG TOPICS, Vol. 131, p. 40. June 15, 1987.
[84] Mitka, supra note 57. The USP and the USAN have proposed changing amrinone to inamrinone—using the “in” prefix of the innovator’s brand name Inocor, and changing amiodarone to camiodarone—using the “c” prefix appearing in the innovator’s brand name Cordarone. The USP said it hoped the name changes will help heath care providers distinguish the two drugs by alphabetic separation and by creating different verbalization. Amrinone was officially changed to inamrinone, as of July 1, 2000. See “Amrinone changes to inamrinone,” Drug Topics, No. 5, Vol. 144, p.9, March 6, 2000.
[85]See Gundersen, supra note 4.
[86] Starr, supra note 5. Lambert notes that many citation stem from the work of Michael R. Cohen, M.S., R.Ph, president of ISMP, and his colleagues.
[87] Id.
[88] Id.
[89] Minimizing Medical Product Errors: A Systems Approach. (Workshop sponsored by the FDA). January 9, 1998.
[90] Starr, supra note 5.
[91] Carol Ukens, “Are You Ready? Electronic Prescribing Exploding onto Pharmacy Scene.” Drug Topics, No. 14, Vol. 144, p.34. July 17, 2000. Poor penmanship is one of the two leading causes of fatal medication mistakes, according to data analyzed by the Swedish technology firm PharmaPoint.
[92] Id.
[93] A classic example is cisplatin and carboplatin. Fatalities occurred before Bristol-Myers Squibb changed the packaging on cisplatin. Confusion between Glaxo Wellcome’s Alkeran (melphalan), Leukeran (chlorambucil), and Myleran (busulfan) has been traced to packaging. The labels were recently altered in an effort to improve the situation.
[94] See, e.g. Comment by Dr. Marvin Lipton in “Drug Names,” Consumer Reports. January 27, 2000 at www.channel4000.com/partners/tv/consumer/partners-tv-consumer-20000127-221432.htm. One of Dr. Marvin Lipman’s patients almost died when he accidentally received the wrong medication. The pharmacist confused the drugs Tolinase and Telectin. The two packages “were standing side-by-side on the pharmacy shelf, and the pharmacist gave the patient the wrong medication.... so an arthritic patient was receiving an anti-diabetic drug and within three days was in the emergency room in a coma.”
[95] Sound-alike Horror Stories, supra note 82.
[96] Starr, supra note 5.
[97] Robinson, supra note 83.
[98] See supra note 75 for background on Bruce Lamberts.
[99] Gebhart, supra note 75.
[100] Id. Lamberts explains that phonologic loop memories rely heavily on tongue motor control signals. The sounds of the initial and terminal syllables, the stressed syllable and the number of syllables in a word are major memory triggers, so words like Xanax and Zantac or Zyvox and Vioxx are easily confused.
[101] Imelda C. Coleman, “Medication Errors: Picking up the Pieces,” Drug Topics, No. 6, Vol 143, p.83
[102] Susan Proulx in Starr, supra note 5.
[103] Id.
[104] For example, pharmacists who fill a prescription while taking another order or fail to write down a verbal order.
[105] FDA Bulletin: “Medication Errors,” at www.fda.cder/handbook/mederror.htm.
[106] For example, confirming a prescription with the ordering physician, examining a patient’s profile, or giving counseling to a patient at the time of pick-up.
[107] Starr, supra note 5.
[108] See, e.g. Carol Ukens, Pharmacists Urged to Beware Levoxine-Lanoxin Name Game. DRUG TOPICS, Vol. 138, No. 9, p.19. May 9, 1994. While an “unusually high” number of pharmacists reported errors cause by misreading prescriptions for Levoxine as Lanoxin, Mike Cohen, president of the ISMP, reported that he had tried unsuccessfully on several occasions to persuade Daniels, the manufacturer, to change the name. David Duquette, the director of marketing and sales at Daniels maintained that the company had no plans to change the name because a switch “would be really detrimental to Levoxine and its growth.”
[109] Mitka, supra note 57. See also, Hart, supra note 76.
[110] Medication Errors: Similar Drug Names. www.pharmacology.about.com/health/pharamcology/library/weekly. Sept. 12. 2000. See also, Erika Lowndes, “Celebrex, Celexa, Cerebyx: Which Drug for Which Diagnosis?” http://nursing.about....nursing/library/2000/aa000131a.htm.
[111] See “Pharmaceutical Mishaps, Legal Headaches”, supra note 45. The campaign involved advertising in medical journals and sending out 50,000 letters to physicians and pharmacists reminding them to take extra care when dispensing these products.
[112] Associated Press, “Drug Names a Prescription for Confusion.” The Holland Sentinel. September 7, 1999. Celebrex was one of the fastest-selling new drugs ever, with $1 billion in sales in 1999 and projected to have upwards of $4 billion in sales by 2002.
[113] “Pharmaceutical Mishaps, Legal Headaches,” supra note 45.
[114] Id. According to Jerry Phillips, R.Ph. associate director for medication error prevention at the FDA, the results of a survey designed to determine the effect of Searle’s information campaign are currently under analysis at the FDA.
[115] Starr, supra note 5. Nonetheless, as discussed earlier, the drug amrinone was changed to inamrinone as of July 1, 2000, based on decisions made by the USP Nomenclature Committee and the United States Adopted Names Council. Medication errors, some fatal, occurred when amrinone was confused with amiodarone.
[116] This schematic is adapted from the Report to the FDA Commissioner from the Task Force on Risk Management. Managing the Risks from Medical Product Use: Creating a Risk Management Framework, May 1999. [hereinafter, FDA Risk Management Framework]
[117] Nordenberg, supra note 71.
[118] See, e.g. “Medical error prevention Gains Attention.” Family Practice Management. July/August 2000. The Washington Post reported that Cedars-Sinai Medical Center in Los Angeles recently arranged a penmanship workshop for medical staff to reduce prescription-related errors. Two handwriting specialists led the course, which focused on “box and stick” style letters. The chief of staff encouraged the participation of several dozen doctors identified by nurses as having particularly poor penmanship
[119] D. Berwick and D. Winickoff, “The Truth About Doctor’s Handwriting: A Prospective Study.” BMJ 1996; Vol. 313: 1657-8.
[120] ISMP, “In the Long Run, Penmanship Classes for Doctors Won’t Do Much for Patient Safety.” January 10,2001.
[121] D.W. Bates, L. Leape, D.J. Cullen, “Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Error” JAMA 1998; Vol. 280, p. 1311-1316.
[122] Carol Ukens, “Are You Ready? Electronic Prescribing Exploding onto Pharmacy Scene” Drug Topics, No. 14, Vol. 144, p.34. July 17, 2000. An October 1998 article in the Journal of American Medical Association (JAMA) reported a 55% drop in the rate of potentially harmful medication errors at a Massachusetts medical center after an electronic order-entry system was installed. In a study of intensive care patients, a computerized system helped physicians reduce allergic drug reactions and excessive drug dosages by 75%. See also Imelda Coleman, supra note 101 (citing statistics from the Bates, Tierney and Evans studies on error reductions using computerized systems.)
[123] “Safe Rx Group Calls for Elimination of Written Prescriptions.” June 13, 2000. www.pharmandther.com/public/industry_news/index.asp?ixPage=80.
[124] Ukens, Electronic Prescribing, supra note 122.
[125] ISMP website: http://www.ismp.org. The Organization has written a detailed white paper that outlines the use of electronic prescribing with handheld devices
[126] Carol Ukens, Washington Board Joins in Offering Med Error Remedies, DRUG TOPICS. January 1, 2001. No. 1, Vol. 145; p.25. Washington state has also adopted a symbolic regulation requiring that all prescriptions be legible (the legislation was adopted in 2000 but lacks any penalties for noncompliance by prescribers).
[127] Cohen (ISMP President) in Starr, supra note 5.
[128] Gebhart, supra note 75. Pharmacy computer systems can easily be programmed to warn of potential name confusions with existing products, according to Lambert. Pharmacists are already accustomed to checking for drug interactions and other alerts. Adding a screen for potential confusion between similar drug names is a minor program update for software vendors that could prevent dozens of deaths each year.
[129] Ukens, Electronic Prescribing, supra note 122.
[130] Walter L Fitzgerald, Electronic Rxs—The New Wave; Pharmacists Who Accept Electronic Prescription Face Ambiguous State, Federal Rules,” DRUG TOPICS, Vol. 140, No. 14, p.68. July 22, 1996.
[131] Id. In many cases, state pharmacy practice acts may be ambiguous. Eg. If an act defines a prescription as “any written or verbal order by an authorized practitioner for a medication or device” it is not clear whether an e-Rx is “written” or a “verbal” order. In such a case, it is necessary to seek opinion from the state board of pharmacy.
[132] The most common e-Rx system uses the Script standard, though there are several companies that market different versions of hand-held devices. The APA and NACDS is currently examining the issue of where e-Rx will be filled. The concern is that patients will want the flexibility to fill prescriptions at local pharmacies, mail-service operation, or on-line drugstores, but e-Rx manufacturers will want to direct prescriptions to their own on-line pharmacy.
[133] The VA has the largest health-care system in the country, by one estimate serving more than 3 million veterans a year at its 172 hospitals and its 1,000 plus outpatient clinics, nursing homes, counseling centers, and other health programs. The VA counted almost 3,000 errors—some 700 deaths among them—within its health network between June 1997 and December 1998. See IOM Report, supra note 64.
[134] Nordenberg, supra note 71. In the Final Summary of FDA Action Items report (February 22, 2001), the FDA announced it will release recommendations from the National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) conference which addressed standardizing bar coding on medication packaging to reduce medication errors and improve patient care.
[135] Id.
[136] Robinson, supra note 83.
[137] Id. Based on a survey sample of 287 community and 145 hospital practitioners conducted by Drug Topics. See also Coleman, supra note 101 citing a study conducted in two pediatric hospitals where pharmacists intercepted and prevented, respectively, an average of three and five medication errors per 1,000 orders. Briceland et al. conducted a 20-month study at New York’s Albany Medical Center Hospital showing that pharmacists prevented 1,048 errors in prescriptions for antibiotics. This represented 7.5% of al prescriptions written, where 14% of the errors were potentially harmful and 16% could have led to the patient’s death.
[138] Coleman, supra note 101.
[139] Sound-alike Horror Stories, supra note 82.
[140] Starr, supra note 5.
[141] Id.
[142] For example, Advise-ERR is an error prevention feature provided by CDER’s OPDRA and linked on the ISMP Medication Safety Alert. These advisory bulletins give warnings about reported errors involving confusing drug names and offers safe practice recommendations to avoid future errors.
[143] See Jerry Phillips, FDA Efforts at Minimizing the Risks of Preventable Adverse Drug Events. Medscape Pharmacists. (2000). To assist with the post-marketing risk assessment and management, the FDA maintains a system of programs (e.g. MedWatch) to collect and identify adverse events, including medication errors, that were not identified during development and pre-marketing review. The FDA monitors these suspected adverse events and medication errors and uses the information to initiate various risk management and communication actions..
[144] Starr, supra note 5.
[145] IOM Report, supra note 64. The report states that adverse event reporting should initially be required of hospitals and eventually be required of other care delivery systems.
[146] Id.
[147] See the Report of the Quality Interagency Coordination Task Force (QuIC) to the President. “Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact,” February 2000. [hereinafter, QuIC Report].
[148] Actual and potential medication errors can and should be reported by the practitioner or the patient to MedWatch, the FDA’s Medical Products Reporting and Safety Information Program. This program is one way for the FDA to become aware of safety issues related to marketed drug products, to identify areas in need of intervention, and to enable prompt action. See Phillips, supra note 143.
[149] The MERP is a reporting nationwide program that makes it possible for health care professionals who encounter actual or potential medication errors to report confidentially to the USP. USP reviews each report for health hazards and forwards all information to the FDA and the product manufacturer. USP acts as a liaison with the FDA and the manufacturer is individuals wish to submit a report anonymously. The MERP is presented in cooperation with the ISMP. See www.usp.org/reporting/mer.htm.
[150] Formed in 1995, the NCC MERP is a collaborative effort to 1) increase awareness of medication errors and methods of prevention; 2) stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and prevent medication errors; 3) stimulate the development of a medication error reporting and evaluation system; 4) examine and evaluate the causes of medication errors; and 5) develop strategies relative to system modifications. See FDA Risk Management Framework, supra note 116.
[151] Nordenberg, supra note 71.
[152] Jeff Levine, “Clinton Announces Plan to Reduce Medical Errors,” WebMD. February 22, 2000. http://content.health.msn.com/content/article/1728.55165
[153] Id.
[154] QuIC Report, supra note 147.
[155] An example where this has been shown is the New England teaching hospital that decided to accurately identify the scope of adverse events. By promising not to fire people who filed reports and offering protection from liability, incidence reporting increased by 700% almost immediately. See Gay-Lynn Carpenter, “IOM Report Puts Patient Safety on the Public’s Radar Screen” Virginia Association of Health Plans. (2000). http://www.vahp.org/newleter/winter00/iom.html. See also, “Medical error prevention Gains Attention.” Family Practice Management. July/August 2000. (discussing the Department of Veterans Affairs’ (VA) plan to hire NASA to establish a system that will allow workers at the 172 VA medical centers to report medical mistakes without fear of penalty; NASA will use the Aviation Safety Reporting System as a starting point for developing the new system.)
[156] Carpenter, supra note 155.
[157] IOM Report, supra note 64.
[158] Nordenberg, supra note 71.
[159] Id.
[160] Daniel Boring and Chris Doninger, The Need for Balancing the Regulation of Pharmaceutical Trademarks Between the Food and Drug Administration and the Patent and Trademark Office, 52 FOOD & DRUG L.J. 109 (1997)
[161] See supra note 61.
[162] See Gentin, supra note 32.
[163] Id.
[164] Id.
[165] Id.
[166] Starr, supra note [ ].
[167] Jerry Phillips, Update on the New FDA Office of Postmarketing Drug Risk Assessment (OPDRA) 1999 DIA Annual Meeting. [hereinafter, Update on OPDRA]
[168] Mitka, supra note 57. See also Jerry Phillips, FDA Efforts at Minimizing the Risk, supra note 143.
[169] Starr, supra note 5.
[170] Rumore, supra note 9.
[171] Anthony Vecchione, “What’s in a Drug Name? Food and Drug Administration Proposes Plan to Eliminate Packaging Confusion.” Drug Topics, No. 20, Vol. 140, p.37. October 21, 1996. The plan is based on a similar system used by the Nuclear Regulatory Commission (NRC) for predicting nuclear power plant failure. The FDA hopes to use similar methods for predicting drug product error.
[172]See Vecchione, supra note 171 and Conlan, supra note 52.
[173] See Starr, supra note 5 for a detailed description of the MED-ERRS screening process. Rumore, (supra note [ ]) also notes that the ISMP has been working for years to increase awareness of factors that contribute to errors. Working with trademark development and testing firms, they have developed an Error Index whereby practicing pharmacists, pharmacy technicians, and nurses screen proposed trademarks in simulated medication orders that are handwritten by practicing physicians. These types of analysis are being used more and more by trademark attorneys and have already prevented some potentially confusing trademarks from being marketed.
[174] Id. LASA was designed by Bruce Lambert of the University of Chicago, who used similar technology to test the frequency with which orthographically and phonologically similar drug names were confused.
[175] Starr, supra note 5.
[176] Gebhart, supra note 75. Since June 1, 1999 the USAN Council has contracted with the University of Illinois to use the LASA computer program to help flag problems with proposed generic names. The Council does not use the program for existing non-proprietary names.
[177] See Lambert’s remarks in Gebhart, supra note 5.
[178] See ERIC D. GREEN, CHARLES R. NESSON, AND PETER L. MURRAY, PROBLEMS, CASES, AND MATERIALS ON EVIDENCE. (Aspen Law and Business, 2000)
[179] This is a source of tension since reviewing units under pressure to evaluate drugs most likely are loathe to stall approval because of trademark issues. Approvals delayed because of naming concerns, may detract from the intent of the PDUFA and the performance goals that are set to decrease the review time of NDAs. This could be used to question the effectiveness of user fees when the Act is up for renewal.
[180] Starr, supra note 5.
[181] Janet Woodcock in Nordenberg, supra note 71.
[182] IOM Report, supra note 64.