Generic Medications by Sue Henderson

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Generic Medicationsby Sue Henderson
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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).

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Brand V Generic development
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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, 2007a)

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Medication labels
Original brand name
Generic brand name
28 Prozac Capsules 20 mg 10.26(Fluoxetine) Take
ONE capsule with a glass of water in the
morning. Mr. John Doe Dr Good 20/02/08 Full cost
29.50 KEEP OUT OF REACH OF CHILDREN QUM
Pharmacy, 2 down street, Melbourne Tel 03 9515
63333
28 Terry White Chemists (Fluoxetine) GenRx
capsules 20mg 5.00Take ONE capsule with a
glass of water in the morning. Mr. John Doe Dr
Good 20/02/08 Full cost 23.79 KEEP OUT OF REACH
OF CHILDREN QUM Pharmacy, 2 down street,
Melbourne Tel [phone]
Chemical name Fluoxetine is the same active
ingredient in both
(NPS, 2007a)
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Activity

• Ask consumers and or carers to bring in
  medications and teach them how to read a
  medication label

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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).

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Generic brands in Australia

• Often named according to pharmacy chain selling
  them
• Chem mart
• GenRx
• Terry White etc (Birkett, 2003).

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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, 2007b)

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Activity

• Which of the following medications is Fluoxetine?

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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
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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

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PBS Safety Net
PBS safety net threshold PBS safety net contribution
General Patients 1141.80 5.00
Concession care holders 290.00 Free
If consumers choose a more expensive brand of
medicine, or their doctor prescribes one, the
extra amount they pay wont count towards the PBS
Safety Net (DHS, 2008).
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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
  (McLachlan, Ramzan, Milne, 2007, NPS, 2007b)

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Activity

• Ask consumers and or carers to bring in
  medications and teach them how to keep their own
  medication record (see NPS handout)

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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, McGuffin,
  Craig, 2005, NPS, 2007).

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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) (McLachlan, Ramzan, Milne,
  2007)
• When the consumer has a negative attitude to
  substitution (NPS, 2007b).

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Resources on Generics

• National Prescribing Service (NPS)
• www.nps.org.au
• Medication List can be downloaded from
• www.nps.org.au/resources/content/medicines_list.pd
  f
• Choice Magazine (on line)
• www.choice.com.au go to Alphabetical list then
  drugs then generic.

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References

• Aitchison, K. J., Basu, A., McGuffin, 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/service
  s/msn/pbs.shtml
• McLachlan, A. J., Ramzan, I., Milne, R. W.
  (2007). Frequently asked questions about generic
  medicines Australian Prescriber, 30(2), 41-43.
• National Prescribing Service. (2007a). Generic
  medicines explained. MedicinesTalk, 21.
• National Prescribing Service. (2007b, December).
  Generic medicines Dealing with multiple brands.
  NPS News National Prescribing Service Newsletter,
  55, 1-4.