Each week we will aim to bring out a concise email that provides 4-5 key pieces of information addressing a specific issue in clinical therapeutics.
This week: Generic medicines (part 1)
Pharmacists, doctors and nurses are often asked about the relative safety and efficacy of generic medication products. There is often considerable misinformation about this issue, which can be a source of apprehension for patients, families and even aged care facility staff.
- All medicinal drug products contain a therapeutic compound, sometimes referred to as a “chemical entity” or “molecule.” This is the drug that produces the intended therapeutic effects (and potentially, also the side effects). The compound was developed, tested and patented by a pharmaceutical company, and during the patent period this company will usually hold sole rights to market, distribute and ultimately provide the drug for sale. During this period, there is no effective competition in the sale of the drug, and the brand of the medication produced by the company is often sold at a premium price. This product is sometimes referred to as the “originator brand.”
- After the patent expires, other pharmaceutical companies may produce their own versions of this drug, often marketed at very much lower prices than the originator brand. Although tbe product may look different and be packaged differently to the originator, in Australia strict standards are applied to ensure “bio-equivalence” – that is to say, that the generic products must contain the stated amount of the therapeutic drug, formulated in such a way to ensure that treatment outcomes would not be different to those expected when the originator brand is used.
- The differences in appearance, packaging and pricing of generic products can be a source of confusion for consumers and health care professionals. Careful explanation is sometimes needed to allay possible concerns about the safety and efficacy of these products.
Please consider these issues when preparing or interpreting RMMR reports or education sessions. Contributions of content or suggested topics are welcome and should be sent directly to email@example.com.