Volume 192 - Issue 7
Generic medicines literacy — minimising the potential for patient confusion
Author: Andrew J McLachlan
Med J Aust 2010; 192 (7): 368-369. || doi: 10.5694/j.1326-5377.2010.tb03555.x
Published online: 5 April 2010
Published online: 5 April 2010
For generic substitution to be safe, consumers and clinicians need to fully understand what is the same or different about various brands of the same medicine
A main aim of the National Medicines Policy is to provide Australians with access to safe, high-quality medicines at prices consumers and government can afford.1 As such, generic medicines have an important place in health care. Consumers see generic medicines as an opportunity to access cheaper medicines, while governments see the opportunity to achieve the same health outcomes for patients at a lower cost. Clinicians, on the other hand, have mixed views regarding the role of generic medicines. Many pharmacists see generic medicines as an opportunity to reduce patient costs while maintaining effectiveness, whereas some prescribers express concern that generic medicines are not appropriate or equivalent alternatives in some therapeutic areas (eg, anticonvulsants) and that brand substitution is a challenge to their clinical decision making, with a significant risk of patient confusion.
Brand substitution is investigated by Ortiz and colleagues in this issue of the Journal (Ortiz et al).2 This is an important study in many ways, and it provides quantitative information on the extent of brand substitution and switching, a question which is often shrouded in anecdote. As it turns out, these data suggest that the extent of switching between brands of three major classes of medicines on the Pharmaceutical Benefits Scheme is probably less than many clinicians suspect. The study found that about 20% of patients switched brands of selected medicines two or more times during the course of a year. Not surprisingly, medicines that had more brands on the market were generally more likely to be switched. An interesting observation was that brand switching was less likely to be undertaken by older people than younger people. This may be related to a range of factors, including greater caution on the part of the prescriber and pharmacist when dealing with medications for older people.
The results of this study, derived from community-dispensing information, need to be considered in the broader context of the health system. Generic (or brand) substitution occurs regularly when patients are admitted to or discharged from a public hospital. Hospitals typically stock only a limited number of brands of a medicine, and these are often generic products. Ortiz et al conclude that generic substitution is occurring and is likely to increase in the future.2 Indeed, their data may underestimate the current brand-switching situation, as the study was conducted before August 2008, when incentives for pharmacists to supply a generic medicine (where one exists) were introduced.
The impact of medicine brand switching on health outcomes in the Australian community is unknown. However, a meta-analysis of cardiovascular studies found that different brands of (bioequivalent) medicines were clinically equivalent.3 Ortiz et al speculate on the “potential for patient confusion”.2 Patient confusion about medicines and the risk of double dosing of medicines that contain the same active ingredient are a real concern. There are a number of strategies that can be used in combination to reduce the risk of confusion about medicines, especially in the context of generic substitution. These include:
Knowing the drug name. Prescribers and pharmacists should explain the name of each medicine, with the aim of helping consumers know the active ingredient in the medicine they are taking rather than the product’s brand name.
Medicines information. Information such as consumer medicine information should be provided (and explained).
Knowing what the medicine is for. Consumers should be encouraged to know what each medicine is for.
Up-to-date medicines list. Consumers should be supported in keeping a list of their current medicines that includes the name of the active ingredient (sometimes called the generic name), the brand name and the dosage regimen.
Clear medicine labels. Labelling of prescription (branded and generic) medicines should be improved so that the active ingredient in the product is displayed with equal or greater prominence to the brand name on the packaging, as recommended by the Therapeutic Goods Administration in the Best practice guideline on prescription medicine labelling.4
Each of these strategies relates to health literacy5 and points to the need for greater “medicines literacy” for consumers and carers. There have been recent attempts to improve “generic medicines literacy” among clinicians in Australia, many of whom still challenge the foundation principle of bioequivalence6 and the quality of generic medicines.7-9
Generic medicines provide an opportunity for consumers and government to offset the rising cost of health care. However, the quality use of generic medicines10 requires careful attention by prescribers and pharmacists to the strategies outlined here to minimise the potential for confusion on the part of the patient. If there is a risk of dose duplication, generic substitution may need to be avoided (independent of the drug involved) unless the patient or carer fully understands both the similarities and the differences between various brands of the same medicine.
Competing interests
I am a pharmacy academic who has acted as a paid consultant and education provider to manufacturers of innovator and generic medicines. I am currently a member of the Pharmaceutical Subcommittee of the Australian Drug Evaluation Committee and the Chair of the National Medicines Policy Committee.
References
- Australian Government Department of Health and Ageing. National Medicines Policy 2000. Canberra: Commonwealth of Australia, 1999. http://www.health.gov.au/internet/main/publishing.nsf/Content/nmp-objectives-policy.htm (accessed Dec 2009).
- Ortiz M, Simons LA, Calcino G. Generic substitution of commonly used medications: Australia-wide experience, 2007–2008. Med J Aust 2010; 192: 370-373. 0_i1091888
- Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008; 300: 2514-2526. 0_i1091890
- Therapeutic Goods Administration. Best practice guideline on prescription medicine labelling. Canberra: TGA, 2005. http://www.tga.gov.au/pmeds/pmbestpractice.htm (accessed Dec 2009).
- Nutbeam D. Building health literacy in Australia [editorial]. Med J Aust 2009; 191: 525-526. 0_i1091894
- Pearce GA, McLachlan AJ, Ramzan I. Bioequivalence: how, why and what does it really mean? J Pharm Pract Res 2004; 34: 195-200. 0_i1091896
- Hassali MAA, Stewart K, Kong DCM. A national survey on knowledge and perceptions of senior medical students in Australia about generic medicines [letter]. Med J Aust 2008; 188: 123-124. 0_i1091898
- Crawford P, Feely M, Guberman A, Kramer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure 2006; 15: 165-176. 0_HJIFGJDA
- Birkett DJ. Generics – equal or not? Aust Prescr 2003; 26: 85-87. 0_i1091901
- Hassali A, Stewart K, Kong D. Quality use of generic medicines [editorial]. Aust Prescr 2004; 27: 80-81. 0_i1091904