One of many disturbing realities

by Manuela Moraru

A 50 year old woman, who received a prescription of Volmax, a bronchodilator, was hospitalized after taking Flomax, a drug used for prostate hyperplasia. The case report was handed out to the Food and Drug Administration (FDA) where several other similar cases of errors due to name confusion are reported annually .(1) Since November 2003 to July 2005 in the UK alone, 236 incidents caused by wrong patient identification were reported by the United Kingdom National Patient Safety Agency. (2) Although the health care has tremendously improved during the last centuries, patient safety is surely not a problem of the past times. While health care develops, different problems related to the care delivery keep causing unintended patient harm; and an important part of these faults are caused by human errors.

Aiming to “acknowledge this disturbing truth” the World Health Organisation (WHO) launched in October 2004 the World Alliance for Patient Safety. In May 2007, the Alliance and the WHO Collaborating Centre for Patient Safety Solutions have presented the "Nine patient safety solutions" package, a guide for the redesign of the patient care process towards the efficient prevention of the health care related harm affecting millions of patients worldwide. “Implementing these solutions is a way to improve patient safety" said WHO Director-General Dr. Margaret Chan.

The package available onlineat www.jcipatientsafety.org identifies as the first cause of danger in health care delivery the look-alike, soundalike medication names. (3) And this is in accordance with the current available evidence. The US Pharmacopeia / Institute for Safe Medication Practices (USP/ISMP) reveals that at least one quarter of the reports of medication errors involve look-alike sound-alike drug names. (4) Each year in the US alone, about 10 000 patient injuries are caused by confusion of drug names. (5) Thus, the enormous development of drug industry and their products can be both useful and harmful at the same time. While new and efficient drugs help treating a multitude of difficult-to-control pathologies, with hundreds of thousands of pharmacological products available on the market, finding names that will not relate in any way with the already approved ones, and thus will avoid confusions is virtually impossible. 

The broad problem…

Although efforts are being made to ensure that new drugs receive names that are significantly different than the already commercialized ones, problems related to drug name confusion are far from being controlled. Even if the issue gained importance in the latter years, similar problems were reported back in 1969 (6) and most probably they occurred even before that date.

The drug naming process can be far more complex than one can imagine. Some details about the drug naming procedures can help a deeper understanding of how this can result in medication errors. Each drug has three types of names: chemical, generic (nonproprietary) and brand (proprietary, trademark) names. While generic names are elaborated as a result of global cooperation, brand names are developed by the product sponsor thus they are difficult to control.

The WHO International Nonproprietary Names (INN) Committee is actively involved in the generic naming process, ensuring the provision of names accepted worldwide and that are not in conflict with any other existing drug names, either brand or generic. (7) But different national agencies work on the same issue, such as the United States Adopted Names (USAN) Council in the US or the British Pharmacopeia Commission in the UK, and several generic names are still different from one country to another. (8) The generic names usually use a specific suffix for each group of medicines, a procedure which proved to help identify the drug class. Although these similarities help remembering, they also contribute to name confusion.

Even more work and research is involved in brand names development process. Several issues should be taken into consideration in this process, from semantic to orthographical; syllabic sequences to create a rhythmic consonance are as important as any relation to what the drug does, the producing company, the drug dosage or its’ generic name. Various different brand names exist for each drug, depending on the producing company or the country where they are commercialized. In order to control this process, brand names shall be approved by designated commissions such as the FDA in the US or the European Agency for the Evaluation of Medicinal Products (EMEA) in the European Union. (3, 8) Yet, with tens of thousands of brand names on the market, similarities are difficult to avoid and thus confusions continue to occur.

Additional causes for drug name confusion are illegible handwriting, the use of verbal (telephone) orders or incorrect selection of a similar name from a comresembling dosages or indications. Furthermore, language barriers can also contribute to the perpetuation of these problems, especially for the foreign physicians. Finally, abbreviations, acronyms or different signs used in medication prescriptions represent more potential causes for errors. Errors can appear at different levels, from prescribing to dispensing, thus actions for minimizing these risks should cover all these levels. Proposed solutions… The WHO proposes a set of solutions to the described problems, which involve actions taken by health authorities to pharmaceutical companies and all settings where medications are ordered, dispensed or administered, including self-medication or care-giver involvement. They promote existing interventions and coordinate international interventions to ensure that the proposed solutions reach their targets. (3)

The drug naming

As the majority of the problems arise from drug naming, this process should be properly controlled. For example in the US, the FDA annually revise about 400 new drug names before these are launched on the market, and only about two thirds are approved. They focus on handwriting and voice analysis, labelling and packing and the name evaluation in general. (1, 8) The existing or new organisations in charge of drugs brand name evaluation should follow similar processes of control and revision of the naming process, for both new and existing names. (3) Creating a universal drug naming convention should represent a long-term aim.

Furthermore, efforts should be made so that the organisations responsible for the procurement of drugs should consider the dangers of look-alike sound-alike drugs in the process of new product purchase, and that they are aware of the fact that one brand name may correspond to different drugs depending on the providing country. (3)

Prescribing and dispensing

Suggested measures to avoid prescription errors include the introduction of specific, clinical protocols aiming to minimize the use of verbal orders, to stress the need to check the reason for the medication, or to include both generic and brand name on prescriptions. Moreover, strategies that avoid confusions due to illegible orders refer to the printing of the drug names and dosages or the use of “tall man” letters. Finally, the computerized prescriber order entry (CPOE) can prove to be a useful tool if correctly used, yet the current WHO guidelines include it among the suggested strategies for the future.

According to the WHO and the Collaborating Centre, the problems related to the storing and dispensing of the medicines can be avoided by using separate (nonalphabetical) locations, especially for look-alike, sound-alike drugs, colours or boldface differences, or automated dispensing tools. (3)

Patient involvement

As far as the involvement of patients and/or their caregivers is concerned, proposed solutions relate to providing complete, written medication information, pharmacist reviewing of the medication with the patient, as well as to the development of specific schemes for sight or hearing impaired, for the foreign patients or the ones with limited knowledge of health related issues. (3)

Finally, efforts should be made as to ensure that “all steps in the medication management process are carried out by qualified and competent individuals” (3). In order to reach this goal, specific education on potential look-alike sound-alike medications for professionals can prove to be a useful tool.

Potential obstacles and possible risks…

The broad inconstancy in pharmaceutical regulations at country level can be a major barrier in implementing the proposed solutions. As an international organisation, the WHO should play a key role in advocating for the homogenization of these national rules. Important as it may be, this is only one of a sum of several possible problems which can be encountered.

Financial, human and logistics resources are crucial issues in the public health systems. In our particular case, funds and trained staff will be needed for technical support in prescribing technology applications, as well as for education campaigns directed to both health care personnel and patients. Finally, problems can also arise from the systematic use of brand names alone, and the unwillingness of both professionals and health authorities to promote the use of the generic names.

Although important steps have been taken towards reducing health care-related dangers, human errors are inevitable and the direct benefit from the proposed solutions remains to be determined. "Countries around the world now face both the opportunity and the challenge to translate these solutions into tangible actions that actually save lives" argues Dr. Dennis S. O'Leary, president of the Joint Commission.