Perspectives
General medicine Pharmacology
Volume 195 - Issue 11

What’s in a name? Brand name confusion and generic medicines

Authors:  Shane L Carney, Madlen Gazarian, Justin T Denholm, David M Reith, Robert K Penhall, Christine R Jenkins, Kay A Wilhelm, Paul A Komesaroff, Mary M Osborn and Richard O Day

Med J Aust 2011; 195 (11): 650-651. || doi: 10.5694/mja10.10968
Published online: 12 December 2011
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We need an urgent review of medicines labelling in Australia and New Zealand

Almost 25% of patients admitted to hospital a decade ago received inappropriately prescribed medicines.1 As 40% of patients aged over 70 years receive more than five medicines, they are increasingly vulnerable to medication errors.1 Increasing brand substitution due to the proliferation of generic medicines adds to the potential for consumer and practitioner confusion and the likelihood of medication misadventure.2

Clinical scenario: Ms M J, aged 79 years, when questioned about her current prescribed medicines by her physician during an initial consultation, produced a list that included an angiotensin-converting enzyme (ACE) inhibitor, a selective serotonin reuptake inhibitor, a benzodiazepine, an anticonvulsant, and both Oroxine 100 μg and Eutroxsig 100 μg daily; the latter two preparations are both thyroxine sodium. Brand substitu-tion by her pharmacist was confirmed as the cause.

There is anecdotal evidence that the progressive increase in innovator (new medicines) and especially generic brand names is associated with inappropriate prescribing and medicine use.3,4 Furthermore, the widespread practice of brand substitution by pharmacists, in which one brand (innovator or generic) is substituted for another, increases confusion, particularly among consumers but also among doctors, nurses and pharmacists. In some cases, such as the above, it can lead to duplicate prescriptions of a medicine.5 Juliet’s reflection in Romeo and Juliet, “What’s in a name? That which we call a rose by any other name would smell as sweet”, may be true for flowers, but clearly not pharmaceuticals.

Brand name proliferation

Although the increasing number of pharmaceuticals has obvious health benefits, the potential for confusion resulting from the thousands of associated brand names requires action. Some prescribers and consumers find brand names more convenient than generic names, but the frequent absence of any relationship between a brand name and the active ingredient or the condition being treated is problematic.

Antihypertensive agents illustrate the breadth of brand proliferation. Eight different ACE inhibitors are used in Australia, excluding combinations, whereas 81 brands have Therapeutic Goods Administration (TGA) approval (Box). Enalapril maleate, which has been available for decades, is available in 12 brands, and only six of these use the active ingredient as part of their brand name. While prescribers and dispensers will recognise the active ingredient in these names, many consumers might consider Enalapril-DP and Enalapril Winthrop to be different, and would not necessarily know that Auspril and Alphapril are the same.

The proliferation of brands today contrasts sharply with the situation 20 years ago, when only three ACE inhibitor preparations, Capoten, Amprace and Renitec — representing two individual medicines — were available. Even a relatively new generic medicine such as amlodipine is now available in 10 brands, excluding combinations, and many prescribers would be challenged to define the active ingredient of Ozlodip (amlodipine) from its name. Newer brand names of other antihypertensive agents such as Deralin (propranolol), Fibsol (lisinopril), Tryzan (ramipril) and Nyefax (nifedipine) clearly do not contribute to the quality use of medicines.

Although there may be marketing sense behind the choice of a catchy name for a new product, generic brands are rarely marketed to prescribers, and pharmacists’ decisions are more likely to be based on cost, not persuasive advertising. Consequently, as a first step, companies that use the active ingredient name within their brand name should be supported. Some companies market the same active ingredient under different brand names but use identical tablet colours and shapes, which may limit brand confusion. However, it is worth noting that Oroxine and Eutroxsig are concomitantly used in the clinical scenario above, and are manufactured by the same company.

Consequences of labelling confusion

Consumer confusion and adherence problems are related not only to names but also shape, colour, taste, packaging, printing and excipients. The Second national report on patient safety noted that “look-alike or sound-alike” medicine names cause errors and system failures in hospitals and the community.7 The United States Institute for Safe Medication Practices reported that about 25% of serious complications relating to use of medicines resulted from name confusion, with another 25% due to labelling and packaging confusion.8

Another recent US study demonstrated poor emergency department patient knowledge concerning paracetamol in over-the-counter and prescription analgesics: for example, 49% of patients did not know that Tylenol, a commonly used US analgesic, contained paracetamol.9 Lack of knowledge about the paracetamol content of commonly used over-the-counter preparations (including combination products) given to children by parents and carers has resulted in many cases of paracetamol overdose and toxicity in young children.10

Generic brand substitution

Already a common occurrence in hospitals, generic brand substitution is increasingly practised by community pharmacies. A recent study, which evaluated three major classes of Pharmaceutical Benefits Scheme medicines, found that about 20% of patients switched brands two or more times over 12 months, with the likelihood of substitution directly related to the number of available brands.2

Dealing with brand proliferation and confusion

In 2006, the Australian Pharmaceutical Advisory Council submitted a safe and effective brand substitution policy to government, promoting the use of active ingredient names.11 Unfortunately, this recommendation was not implemented, nor was a subsequent compromise agreement established by the Joint Expert Committee on Labelling Requirements for Medicines. The Pharmacy Guild of Australia has stated that “Medicine naming and packaging is a quality use of medicine issue and requires a systems/continuous quality improvement approach”.12 A recent editorial in the Journal recommended strategies to reduce medication confusion, including clear medicine labels with the active ingredient being displayed with equal or greater prominence to the brand names,13 and this was supported by the Advisory Committee on Prescription Medicines.14 Current TGA labelling guidelines recommend that

Both the product name and the active ingredient names and strength should be prominently and equally displayed . . . To distinguish between the product name and the active ingredient name, the first letter of the product name should be in upper case and of the active ingredient name in lower case with a different colour for each. Fonts may be used to differentiate, but all fonts should be clearly legible.15

Guidelines are voluntary and our conclusion is that industry compliance is low.

Solutions to the problem

We call on the responsible authorities, as a matter of urgency, to amend Australian and New Zealand drug labelling laws to ensure the active ingredient or generic name is displayed more prominently and in a larger font than the brand name on all pharmaceutical labels, whether prescribed or over-the-counter. This should apply to both innovator and generic products.

In addition, to further distinguish between brand and generic names, we propose that the font and colours used for generic names should be unique and comparable for all medicines so as to aid consumer recognition. Brand confusion is a patient safety and a quality use of medicines concern,16 which will only worsen with time if no action is taken.

National awareness and incentive campaigns funded by government and industry to ensure that all prescribers and consumers have access to electronic medicines information, including electronic health records, will be a complementary strategy to achieve quality use of medicines for all.

Angiotensin-converting enzyme inhibitors available in Australia, 20106

Name

No. of brands

Captopril

6

Enalapril

12

Fosinopril

6

Lisinopril

17

Perindopril

10 (erbumine 9; arginine 1)

Quinapril

9

Ramipril

13

Trandolapril

8 (8 active ingredients — 81 brands)

Authors

  • Shane L Carney MB BS, PhD, FRACP1
  • Madlen Gazarian MB BS(Hons), MSc(ClinEpi), FRACP2
  • Justin T Denholm BMed, MBioethics, FRACP3
  • David M Reith FRACP, PhD4
  • Robert K Penhall MB BS, FRACP, FRCP5
  • Christine R Jenkins MB BS, MD, FRACP6
  • Kay A Wilhelm MD, BS, FRANZCP7
  • Paul A Komesaroff MB BS PhD8
  • Mary M Osborn MPH2
  • Richard O Day MD, FRACP2
  • 1. John Hunter Hospital, Newcastle, NSW.
  • 2. University of New South Wales, Sydney, NSW.
  • 3. Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, VIC.
  • 4. Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
  • 5. Department of Geriatric and Rehabilitation Medicine, Royal Adelaide Hospital, Adelaide, SA.
  • 6. Concord Hospital, Sydney, NSW.
  • 7. St Vincent’s Hospital, Sydney, NSW.
  • 8. Alfred Hospital, Melbourne, VIC.

Correspondence: osborn88@optusnet.com.au

Competing interests

Shane Carney is a member of the Generic Medicines Industry Association of Australia Code of Conduct Committee. Robert Penhall received a grant from Novartis for the International CARE study (a 24-week multi-centre open-label evaluation of compliance and tolerability of once-daily 10 cm2 Exelon patch formulation in patients with probable Alzheimer disease) in 2008 and received travel assistance from Servier for the Australian and New Zealand Bone and Mineral Society Meeting, Sydney, 2009. Christine Jenkins has received payments from the pharmaceutical industry for membership of advisory boards and speaker's fees in the past 3 years, but not from any entities mentioned in this articles. Richard Day is a board member of the Drug Information Association; has been on advisory boards for Reckitt Benckiser; GlaxoSmithKline, Abbott Australasia, and the data and safety monitoring board for CBio and Progen; and is an independent member of the Medicines Australia Code of Conduct Committee nominated by the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.

References

Provenance: Not commissioned; externally peer reviewed.

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