1. Why do some patients not receive generic drugs when they are available?
Most patients on patented medicines can be given the generic version when available. An important exception is when patients are on medicines with a narrow therapeutic or safety index that requires close monitoring and dose titration, (e.g. anti-rejection medicines used after transplant and anticoagulants) are usually kept on the same brand.
When patented and generic medicines are interchangeable, there could be a few reasons this does not happen:-
a) Providers of the medication (Doctors, Pharmacists) or even consumers themselves may not be aware that generic versions of the drugs are already approved in Singapore. Many often rely on the drug company’s sales or marketing staff to provide information on new drugs, both innovator & generics;
b) Even when they are aware, there might be mistaken belief about the quality of generic drugs in comparison with the innovator.
c) Lack of official channels to announce the patent status of major drugs. This is one potential gap which the media, for the public or professional alike, could help disseminate such information;
d) Lack of commercial incentive to switch to cheaper generic drugs. Innovator or patented drugs often cost more & are thus sold at higher prices. Higher priced items will attract higher profits for the medication provider in absolute terms than a cheaper priced product.
e) Level of service and support - like many other businesses, suppliers of generic drugs have lesser resources compared to large multinational pharmaceutical companies that are the originators of the patented drugs. Therefore, patented drugs may offer the medication provider better support and services when he/she continues to use patented drugs; something which the generic drug suppliers may not afford.
f) Lack of empowerment by the consumers/patients themselves. The decision of what type of medication is often the prescriber’s professional judgment; but the choice of what version (generic or innovator/patented) recommended by prescriber is seldom discussed. The end effect has always been that the consumer/patient receives what their medication provider offers to them, be it straight from the prescriber or by filling the prescription at a Pharmacy. This is one area of patient empowerment which consumers are often either not aware of or not given an option.
2. Are generic drugs as efficacious and safe as brand name/innovator drugs?
Generic medicines are chemically equivalent to patented medicines and are manufactured to the same safety and quality standards. For new generic medicines, the Health Sciences Authority requires the manufacturer to ensure that generics to be marketed are not just chemically equivalent, but also biologically equivalent (or bioequivalent) in the drug’s effect within the human body, usually to an acceptable limit (within +/- 20% for most medicines). With such a stringent regulation in Singapore, there are no strong reasons to believe that innovators are more efficacious or safer compared to generic medicines.
3. What does equivalent efficacy and safety mean? Do the generic drugs have to show 100 per cent of the efficacy and safety of the innovator product? Or is anything above 90 per cent considered equivalent?
As mentioned above, generics to be marketed has to demonstrate that they are not just chemically equivalent, but also biologically equivalent (or bioequivalent) in the medicine’s effect within the human body, usually to an acceptable limit (within +/- 20% for most medicines). As long as this stringent criteria is fulfilled, it is believed that the generic medicine will result in the same effect (efficacy)/side effects (safety) as the patented medicine.
The other aspect of safety relates to the manufacturing processes whereby stringent quality standards are imposed to ensure purity and exclusion of external contaminants like harmful heavy metals, microbial contaminations etc. The above standards/requirements apply to both innovator and generic medicines.
4. Can you give some advice to patients on how to save on their drug costs?
- Know your medicines, get it right. Learn what the medicines are used for and understand how to use them properly. Most chronic diseases require chronic medical treatment and adhering to medication treatment schedules will ensure good control and prevent treatment failures or complications which will incur additional costs.
- Ask your medication provider if a cheaper and equally efficacious alternative is available. This may help you save costs especially if you are taking the medications on a long term basis.
- Let your doctor or pharmacist know if you have the same medicines left from previous visits so that you don’t purchase additional supply. Stockpiling or purchasing more than what you need especially medicines for chronic ailments e.g. medications for chronic pain, diabetes, hypertension, etc is not only wasteful, but can be dangerous as you may unknowingly overdose yourself with the same medications purchased from different hospitals/clinics/pharmacies.
- Compare prices from different providers when prescribed medications. MOH guidelines require every patient to get an itemized medication bill, which must show each and every medication dispensed and the amount charged when they visit a doctor. A patient who finds a cheaper alternative can and must be allowed to get a prescription to buy the medication from any pharmacy. For a start, the Pharmaceutical Society of Singapore has come up with a price list for 300 commonly used medications from community pharmacies. You may use this as a reference when paying for your medications.
- When in doubt, always consult your doctor or pharmacist. Visit your pharmacist for a medication check-up. Take this chance to sort out your medications and get any queries answered by your pharmacist.