Generic Medications by Sue Henderson Definition Generic medications
Generic Medications by Sue Henderson
Definition Generic medications are: • A copy of the original (bioequivalent) and interchangeable with the innovator drug • Manufactured without a license from the innovator company. • Marketed after expiry of patent or other exclusive rights (Birkett, 2003, p. 85). Generic Medications by Sue Henderson
Brand V Generic development TGA approval TGA Approval TGA review (2 ½ yrs) TGA Review (1 ½ to 2 ½ yrs) Extensive Human clinical studies (3 yrs) Clinical studies effectiveness (2 yrs) Clinical studies safety (1 yr) Laboratory and animal studies (3 ½ yrs) Generic Medications by Sue Henderson Bioequivalence study Safety and Efficacy Established by Clinical Trials of Innovator
Medication names • • Every medication has 2 names 1 Chemical (active ingredient) 2 Brand name (original or generic) A medication is often known by the brand name it was given by the innovator, for example Prozac (Brand) • The chemical and brand name both appear on the medication label (NPS, 2007 a) Generic Medications by Sue Henderson
Original brand name Medication labels 28 Prozac Capsules 20 mg $10. 26 (Fluoxetine) Take ONE capsule with a glass of water in the morning. Generic brand name 28 Terry White Chemists (Fluoxetine) Gen. Rx capsules 20 mg $5. 00 Take ONE capsule with a glass of water in the morning. Mr. John Doe Dr Good 20/02/08 Full cost $23. 79 Full cost $29. 50 KEEP OUT OF REACH OF CHILDREN QUM Pharmacy, 2 down street, Melbourne Tel 03 9515 63333 Chemical name Fluoxetine is the Generic Medications by Sue same active Henderson ingredient in both (NPS, 2007 a)
Activity • Ask consumers and or carers to bring in medications and teach them how to read a medication label Generic Medications by Sue Henderson
Prescribing/dispensing generics • The pharmacist can dispense any brand of the drug when the prescriber writes the generic name on a prescription. • Generic substitution can occur when a TGA evaluated interchangeable drug (marked with the letter a or b on the schedule of Pharmaceutical Benefits) is available, unless the prescriber has stipulated otherwise (Birkett, 2003). Generic Medications by Sue Henderson
Generic “brands” in Australia • Often named according to pharmacy chain selling them: • Chem mart • Gen. Rx • Terry White etc (Birkett, 2003). Generic Medications by Sue Henderson
Bioequivalence • Same amount of active ingredient • Manufactured under same stringent conditions • Many generics have different inactive ingredients (*coating, binders, fillers) and may look different to the original (NPS, 2007 b) Generic Medications by Sue Henderson
Activity Which of the following medications is Fluoxetine? Generic Medications by Sue Henderson
Brand names: Fluoxetine Auscap (Sigma) 20 mg capsule Fluhexal (Hexal) 20 mg capsule Lovan (Alphapharm) 20 mg capsule & tablet Prozac (Eli Lilly) 20 mg capsule & tablet Zactin (Alphapharm) 20 mg capsule Generic Medications by Sue Henderson
Medication cost • Cost influences adherence • The average amount that a brand name differs from a generic drugs is $3. 00 • Generics are cheaper to the PBS • Pharmacist get $1. 50* for each generic medication they substitute & dispense • Selecting the more expensive medication does not count toward the PBS safety net Generic Medications by Sue Henderson
PBS Safety Net General Patients Concession care holders PBS safety net threshold PBS safety net contribution $1141. 80 $5. 00* $290. 00 Free* *If consumers choose a more expensive brand of medicine, or their doctor prescribes one, the extra amount they pay won’t count towards the PBS Safety Net (DHS, 2008). Generic Medications by Sue Henderson
Education minimises confusion • Teach consumers how to read medication labels to identify the active ingredient. • Encourage consumers to use a medication record in which they write the active ingredient (see NPS Medication List Handout) • Consistency - use the same generic brand • Pharmacist should use label 15, which states “This medicine replaces … Do not use both” (Mc. Lachlan, Ramzan, & Milne, 2007, NPS, 2007 b) Generic Medications by Sue Henderson
Activity • Ask consumers and or carers to bring in medications and teach them how to keep their own medication record (see NPS handout) Generic Medications by Sue Henderson
Response to medications • Not everyone responds in the same way to the same medication. Response may be affected by: • Age/Gender • Organ function (e. g. liver, kidneys) • Other health problems including allergies • Drug interactions • Length of treatment, route of administration, dose • Psychological factors (placebo response) • Genetic factors • Lifestyle • Other unknown factors (Aitchison, Basu, Mc. Guffin, & Craig, 2005, NPS, 2007). Generic Medications by Sue Henderson
When is substitution not appropriate? • Clinically significant intolerances to inactive ingredients • Consumers who are more likely to become confused (Cognitive or vision impaired, communication difficulties) • Medications with a narrow therapeutic index (Warfarin, Digoxin) (Mc. Lachlan, Ramzan, & Milne, 2007) • When the consumer has a negative attitude to substitution (NPS, 2007 b). Generic Medications by Sue Henderson
Resources on Generics • • National Prescribing Service (NPS) www. nps. org. au Medication List can be downloaded from: www. nps. org. au/resources/content/medici nes_list. pdf • Choice Magazine (on line) • www. choice. com. au go to Alphabetical list then drugs then generic. Generic Medications by Sue Henderson
References Aitchison, K. J. , Basu, A. , Mc. Guffin, P. , & Craig, I. (2005). Psychiatry and the 'new genetics': Hunting for genes for behaviour and drug response. British Journal of Psychiatry, 186, 91 -92. Birkett, D. J. (2003). Generics: Equal or not? Australian Prescriber, 26(4), 85 -87. Department of Human Services. (2008). PBS Safety Net. Retrieved 10 January, 2008, from http: //www. medicareaustralia. gov. au/public/services/msn/pbs. shtml Mc. Lachlan, A. J. , Ramzan, I. , & Milne, R. W. (2007). Frequently asked questions about generic medicines Australian Prescriber, 30(2), 4143. National Prescribing Service. (2007 a). Generic medicines explained. Medicines. Talk, 21. National Prescribing Service. (2007 b, December). Generic medicines: Dealing with multiple brands. NPS News National Prescribing Service Newsletter, 55, 1 -4. Generic Medications by Sue Henderson
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