Would you prefer the cheaper alternative of that drug?
In an increasingly commercial society, brand names influence the products people buy. It's not uncommon to pay ten times the price for the logo on a t-shirt or choose a more expensive brand of food because it carries a health endorsement.
One of the brand purchasing decisions Australian consumers are increasingly faced with is whether to buy a branded or generic version of a prescription medicine.1 Since the approval of generic medicines for sale in 1994,2 It has become common practice for pharmacists to offer a generic substitute when filling a prescription; in fact, research shows that 88% of people filling a prescription in the last two years have been recommended a generic medicine by their pharmacist instead of the original medicine their doctor has prescribed.1 Yet Australian consumers continue to fork out an extra $51 million per year to stick to the big name brands.3
For many people the differences between generic and brand name medicines and the reasons one might choose one over the other are unclear.4 It is important to understand what generic medicines are, how they differ to the original brand and the risks and benefits of taking them, so you are informed the next time your pharmacist asks, "Would you like to purchase the generic version?"
What's in a name? The difference between the original and generic medicines
Branded (or original) medicines are those developed by pharmaceutical companies, which do research about pharmacologically active ingredients, develop medicines containing these ingredients, and conduct large studies to determine whether the medicines are safe and effective in treating a particular disease or condition. When a company creates a new effective medicine, they typically patent it.5
The patent gives the company which created the medicine exclusive rights to sell it for a period of time, usually several years. However, when the patent expires, other companies can make 'copy medicines' which contain the same active ingredient (e.g. paracetamol) in the same concentration, but which are sold using a different or no brand name.5
Generic versions are legal medicines which have been manufactured in safe conditions and tested for equivalence to the brand that they copy.5 They should not be confused with counterfeit medicines. These are untested illegal medicines which may contain different amounts of, or completely different, active ingredients.6
The red pill or the blue pill? I can see they're not the same!
The active ingredient in any medicine is the chemical that affects the body, for example to provide pain relief or fight infection. While generic medicines contain equivalent amounts of active ingredients, they do not necessarily look or taste the same because they contain different inactive ingredients.5
Inactive ingredients (also known as excipients) are those components of the medicine which do not affect the body. For example, dyes used to colour the medicine, flavours used to change its taste and binders and fillers used to shape tablets and give medicines volume. Although they do not affect how the medicine works in the body, they may affect the way the medicine (the active ingredient) looks or tastes, for example its colour or shape.10 This can be confusing for some people, such as those who have been taking the medicine for a long time.4
Particularly for elderly people and those with visual or cognitive impairment, sticking to the same brand of medication may help avoid confusion. It can also help you avoid medicine mistakes, for example taking the original drug and the substitute at the same time, thinking they are different medications rather than substitutes of the same thing.7
So-called 'double-dosing' is a real problem experienced by some individuals, according to Dr Suong Ngo, senior lecturer in Pharmacology at the University of Adelaide.
"Some patients can become confused when switching to a generic version of the drug they're used to taking and may end up taking both the generic and branded medication at the same time. This is called double-dosing," she said.
Some inactive ingredients (e.g. dyes, gluten and starch) may have marked and dangerous effects in an allergic individual. For a person with allergies, the branded medicine might be more suitable because it doesn't contain allergens, or vice versa. Be sure to check the inactive ingredients list for allergens.5
The same or 20% different?
Generic medicines need to be tested to ascertain their equivalence before being approved for sale as substitutes.8 Generic medicines are legally allowed to have a 20% margin of error below or 25% difference above the original drug.9 This accounts for differences such as the rate at which the medicine is absorbed in the gastrointestinal system or the concentration in which it is distributed to various body organs. These differences arise because the inactive ingredients in the medicine influence its affect on the body.11
Professor Jon Emery, Chair of General Practice at the University of Western Australia, says that reducing this equivalence range could have benefits for patients and physicians.
"Reducing the equivalence range would force manufacturers to produce generic pharmaceuticals to tighter standards in regard to efficacy and safety profiles. This in turn gives faith to the practitioners, pharmacists and patients that the generic medication is likely to be truly equivalent to the branded product," Prof Emery said.
For treating certain critical conditions it is thought that the 80–125% equivalence range is too large. This is particularly so when very small adjustments in the dose can cause marked changes to the medicine's effects, as with those used to treat epilepsy.9 If your doctor feels it is necessary, they can include instructions on the prescription that substitutes should not be used and the pharmacist must not offer you a substitute.2
"Individuals who are reliant on medications for which the generic alternatives may have questionable equivalence (but currently acceptable according to regulatory guidelines), may need to be careful when switching medications. For some conditions it may be important for the patient to continue to use the same brand of medication to avoid these equivalency issues," said Prof Emery.
Dr Ngo also has concerns about generic medications being used to treat critical conditions.
"Not all drugs have a wide therapeutic window and using generic versions of medications with a narrow therapeutic index can have serious complications for the patient. For instance, in conditions such as epilepsy and arrhythmia, changing to a generic medication which is technically 'equivalent' may cause complications due to the variation in therapeutic activity that is allowed," she said.
For most conditions, your doctor may not put this instruction on the prescription because your medicine is suitable for substitution. However, you can always talk to your doctor if you have any concerns about substituting the medication you take.
How does the cost of generic medicines compare to their branded equivalents?
Cost is a major factor influencing the choice of drug. When thinking about the cost of generic and branded medicines, it's important to be aware that generic medicines are not (despite popular opinion) always cheaper. Laws in Australia prevent generic versions from being sold for more than the original medicine, but they can be sold for the same price. When there is a price difference, it's usually less than $5.7
"Generics can be cheaper but the situation is more complex than simply saying generic medications are cheaper than their branded counterparts. In Australia at the consumer level you can often find a slightly cheaper generic alternative, but this isn't always due to them being a generic per se. Pharmaceutical products not listed on the PBS can have greater price fluctuations between pharmacies, so simply shopping around can find a cheaper alternative of the same product. This can be equally true of generic and branded medications," said Prof Emery.
Even a few dollars difference may make the generic an appealing option if you need to take the medicine for a long time or are experiencing financial difficulties. However, over two-thirds (68%) of generic medicines are the same price as the original.12 Despite this, over half of people (55%) don't ask their pharmacist if the generic is any cheaper before purchasing it.1 If cost is the same, most Australians (62%) would prefer the original medicine their doctor prescribed over the generic their pharmacist is offering.
Why do Australians prefer the original brands?
A considerable number of Australians (44%) say they prefer the medicine brands that their doctor has prescribed because they trust their doctor will prescribe the correct medicine.1 Others (30%) have trust in the brand name and are sceptical regarding the effectiveness of generics,1 despite legislation requiring all generic medicines to be demonstrated equivalent prior to sale.8
Prof Emery has studied patient response to changing brands of medication and said, "Even for drugs which are considered bioequivalent, some patients will claim to experience different side-effect profiles when switching generic products. In our study, some patients believed that superficial changes in the medication, such as taste and appearance, made them less acceptable."
Dr Ngo can see several benefits to sticking to the medication you're currently taking.
"Those patients with critical diseases such as epilepsy and arrhythmia should be careful of changing medications. The elderly or people taking multiple medications also need to be aware that changing to a generic medication which looks different to the medication they had been taking previously may lead to accidental double-dosing. For patients with long-term conditions such as hypertension where the doctor has issued a script with multiple repeats, having the prescription filled at different pharmacies may lead to the individual being given different generics," she said.
"It is also important to consider that while a generic and a branded product might be therapeutically equivalent, individuals may still have unexpected reactions to a different formulation of the medication.
"In a three-month period I have seen five patients taking ACE-inhibitors for cardiovascular conditions experience allergic reactions immediately upon changing medications. These unexpected reactions may have been due to the different excipients present in different versions of the same medication."
Which pill to take?
Legislation is designed to protect your health and your hip pocket. Your doctor can provide you with additional advice on the difference between the generic and branded medicine for your situation. The 'right' medicine depends on you, the condition you're treating, your allergies, budget, habits, memory and preference. Make sure you've considered all these before you're next posed with the question, "Would you like to purchase the generic version?"
- Briggs D. Generic Medicines Study for Viva Communications. Galaxy Research. 2010.
- Donovan J. Is there a role for generic medicines in the pharmaceutical benefits scheme? Health Issues. 2003;75:9-11. [Full text]
- Probyn AJ. Some drugs are more similar than others: Pseudo-generics and commercial practice. Aus Health Rev. 2004;28(2):207-17. [Full text]
- Bulsara C, MacKenzie A, Sanfillipo F, et al. 'Not the full Monty': A qualitative study of seniors' perceptions of generic medicines in Western Australia. Aust J Prim Health. 2010;16(3):240-5. [Abstract]
- Same medicine, different brands [online]. Strawberry Hills, NSW: National Prescribing Service; 15 October 2008 [cited 3 April 2009]. Available from: URL link
- Counterfeit medicines [online]. Geneva: World Health Organization; January 2010 [cited 20 October 2010]. Available from: URL link
- NPS News 55: Generic medicines: Dealing with multiple brands [online]. Strawberry Hills, NSW: National Prescribing Service; 1 December 2007 [cited 3 April 2009]. Available from: URL link
- Choi L, Caffo B, Rohde C. A survey of the likelihood approach to bioequivalence trials. Stat Med. 2008;27(24):4874-94. [Abstract | Full text]
- Vajda FJE. Generic substitution in epilepsy: A controversial issue. The Epilepsy Report [online]. Baulkham Hills, NSW: Epilepsy Australia; October 2006 [cited 3 April 2009]. Available from: URL link
- Other ingredients in your medicine [online]. Strawberry Hills, NSW: National Prescribing Service; 2011 [cited 11 April 2011]. Available from: URL link
- Gidal BE, Tomson Y. Debate: Substitution of generic drugs in epilepsy: Is there cause for concern? Epilepsia. 2008;49(Suppl 9):56-62. [Abstract | Full text]
- Medicines Australia Facts Book. Deakin, ACT: Medicines Australia; 2009 [cited 11 April 2011]. Available from: URL link
For more information about generic and branded medicines, including their similarities and differences, see Generic Medicines and Branded Medicines.
For more information about drugs, including an introduction to pharmacology, generic versus branded drugs, and the meaning of drug schedules and pregnancy categories, see Drugs.
Article Date: 2/5/2011
- Generic medicines: Questions to ask your pharmacist (Part 1)
- Generic medicines: Questions to ask your pharmacist (Part 2)
- Generic medicines: Questions to ask your pharmacist (Part 3)
- Generic medicines: Three questions to ask your pharmacist
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