When dispensing a prescription, by law pharmacists are required to ask patients if they would like the originator/brand-name medicine to be substituted by a generic medicine should one be available. This holds cost implications for both patients, and the pharmacy.
Generic substitution helps patients save on their medical expenses. which in turn may encourage patients to visit the pharmacy more frequently. This is a good ‘add-on’ service the pharmacist can render.
As a pharmacist you should also be able to answer any questions the patient has regarding implications of generic substitution.
It is important to explain to patients what the generic looks like and which originator it is replacing.
Also take note that the prescriber may indicate on the prescription whether the medicine can be substituted or not.
The role of the pharmacist when originators are substituted by generics
A pharmacist should be knowledgeable about substitution to generics and plays a key role in educating patients. Below are some common questions with the answers to guide you in explaining the implications of generic substitution to your patients: 1
What are generics?2
The key difference between an originator product and a generic is essentially its name. An originator medicine is a medicine that was first authorised worldwide for marketing purposes as a patented product based on its documentation of its efficacy, safety, and quality, according to requirements at the time of authorisation. The originator product always has a brand name; this name may, however, vary between countries. Generics, intended to be interchangeable with the originator, are manufactured without a licence from the originator manufacturer and marketed after the expiry of patent or other exclusivity rights of the originator. Generic medicines are marketed either under a non-proprietary name (INN), or occasionally under another approved name, however, they are also quite frequently marketed under brand names, also known as “branded generics”.
What is the difference between originator medicines and generics?3
A generic medicine is:
- Bioequivalent to the originator
- Has the same API(s), strength and dosage
- Taken in the same manner e.g., orally
- Approved by SAHPRA.
Are generics as effective as originators?
Yes, a generic medicine is bioequivalent to the originator and approved by SAHPRA just like the originator.
Why do generics cost less?
Developing a medicine is very costly. As generic manufacturing companies do not require research and development, it costs less to bring the medicine to market.
What are the major similarities/differences allowed between an originator and a generic?
- The generic can have a different shape, colour, coating, or flavouring.
In an era of evolving healthcare systems and increasing emphasis on cost-effective treatments, being able to answer patients’ questions about switching from originators to generics is crucial for optimising patient care and maximising healthcare resources.
- Anglo Medical Scheme. Generic Medicine. Available at: https://www.angloms.co.za/portal/ams/generic-medicines - accessed: 26 May 2023
- Dunne, S., Shannon, B., Dunne, C., Cullen, W., 2013. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology 14, 1.. https://doi.org/10.1186/2050-6511-14-1
- Available at: https://haiweb.org/wp-content/uploads/2015/07/Glossary-EN-Measuring-Medicine-Prices-Methodology.pdf - accessed: 16 June 2023