The inactive ingredients, such as fillers, coatings, flavourings and preservatives, of generic medicines may differ from the originator.
When a pharmaceutical company manufactures its own generic, it is often referred to as a clone. A clone is an exact duplicate (with the same active, as well as inactive, ingredients) of the originator medicine and is often manufactured in the same production line as the originator. The clone is registered with a different name. Most times, a clone is available before the patent on the originator has expired.
Generic medications (and clones) must comply with the same strict controls of quality, efficacy and safety as the original medicines and must be approved by the South African Health Products Regulatory Authority. The generic manufacturer has to prove bioequivalence with the originator medicine. This means the amount of medicine found in the blood of the patient after taking the generic should be the same as after taking the originator.
Most generics offer substantial cost savings and therefore medical aid schemes may have rules in place where the maximum price of the generic product is being reimbursed. If you decide to take the originator instead, you may be liable for the difference in cost through a co-payment.
When filling a prescription, a pharmacist is required by law to inform the patient that a generic alternative is available and substitute the originator with a less expensive generic, unless the doctor indicates no substitution is allowed or the patient declines the substitute.
Generic medication is as safe and effective as the originator and by choosing a generic alternative together with your pharmacist you can help to reduce healthcare costs without compromising quality of medical care.
* Thealdi Mitchell is a qualified registered pharmacist (B.Pharm) and managing editor of MIMS, a leading South African medical reference publisher owned by Arena Holdings (Pty) Ltd. She has experience in retail and hospital pharmacy, manufacturing and the medical aid industry. She believes in a holistic approach to health and taking small, daily steps to make better choices in self-care.
Do you have a question for our pharmacist? Email your question to: pharmacist@timeslive.co.za
Unfortunately, not every question can be published and our pharmacist cannot enter into private correspondence with readers. If your question is not published, keep an eye out for information that generally relates to the topic in future columns.
ASK THE PHARMACIST | How safe is it to use generic medicine?
Introducing a new weekly column on TimesLIVE, our resident pharmacist answers your questions ranging from troubling medication side effects to beneficial nutritional supplements
Image: Masi Losi
I am often asked about generic medicine. What is it exactly and, more importantly, is it safe to use?
In a nutshell, when a new medicine is researched, developed and registered it is patented for a specific number of years. This is called the originator or branded medicine. As soon as the patent expires, another pharmaceutical company may manufacture the same medicine and register it as a generic. Generics are not available for all medications.
Basically a generic medication is manufactured to be the same as the originator medication already available on the market, but it is generally more economical.
The generic medicine is the same as the original medicine when it comes to the following: the active ingredients, the dosage form (such as tablet, capsule or syrup), the route of administration (via mouth or injection), the intended use and the quality and performance characteristics.
The inactive ingredients, such as fillers, coatings, flavourings and preservatives, of generic medicines may differ from the originator.
When a pharmaceutical company manufactures its own generic, it is often referred to as a clone. A clone is an exact duplicate (with the same active, as well as inactive, ingredients) of the originator medicine and is often manufactured in the same production line as the originator. The clone is registered with a different name. Most times, a clone is available before the patent on the originator has expired.
Generic medications (and clones) must comply with the same strict controls of quality, efficacy and safety as the original medicines and must be approved by the South African Health Products Regulatory Authority. The generic manufacturer has to prove bioequivalence with the originator medicine. This means the amount of medicine found in the blood of the patient after taking the generic should be the same as after taking the originator.
Most generics offer substantial cost savings and therefore medical aid schemes may have rules in place where the maximum price of the generic product is being reimbursed. If you decide to take the originator instead, you may be liable for the difference in cost through a co-payment.
When filling a prescription, a pharmacist is required by law to inform the patient that a generic alternative is available and substitute the originator with a less expensive generic, unless the doctor indicates no substitution is allowed or the patient declines the substitute.
Generic medication is as safe and effective as the originator and by choosing a generic alternative together with your pharmacist you can help to reduce healthcare costs without compromising quality of medical care.
* Thealdi Mitchell is a qualified registered pharmacist (B.Pharm) and managing editor of MIMS, a leading South African medical reference publisher owned by Arena Holdings (Pty) Ltd. She has experience in retail and hospital pharmacy, manufacturing and the medical aid industry. She believes in a holistic approach to health and taking small, daily steps to make better choices in self-care.
Do you have a question for our pharmacist? Email your question to: pharmacist@timeslive.co.za
Unfortunately, not every question can be published and our pharmacist cannot enter into private correspondence with readers. If your question is not published, keep an eye out for information that generally relates to the topic in future columns.
Image: Supplied
Disclaimer: Although every effort has been made in compiling and checking the information in this column to ensure it is accurate, the author, publisher or their agents shall not be responsible or liable for the continued accuracy of the information, or for any errors, omissions and inaccuracies, whether arising from negligence or otherwise or for any consequences arising therefrom. The information contained in this column is not a substitute for a medical doctor’s diagnosis and treatment. Always consult a qualified healthcare practitioner with any questions you may have regarding a medical condition or treatment. Never ignore professional medical advice or delay in seeking it because of something you read in this column or on this website.
READ MORE:
More than 50,000 people collect chronic medication at post offices
Plenty of Americans still drinking 'deadly bleach cure' for sale on Amazon
WHO investigating links between 'contaminated' cough syrups and 300 child deaths
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.
Most read
Latest Videos