OUTCOME Report

SACE no. 248298G

Introduction
The research question that has been researched is, What advice should be given to
customers to help them choose between generic and brand name prescription drugs.
Discussion is based on key findings that were found to be both common and
significant throughout the research process, such as generic drugs effectiveness in
comparison to brand name drugs, how generic drugs are financially beneficial to both
the economy and the consumer and also how suitable they are for each patient.
Advice is then provided under each key finding to help make the decision between the
generic and brand name prescription drugs simpler for consumers.
Key Finding #1
For a generic drug to be TGA (Therapeutic Drugs Administration) approved it has to
be deemed bioequivalent, therefore this shows that generic products are as effective
because the 90% confidence interval has to fall between 80-125 % interval.
Generic prescription drugs are deemed as effective as brand named prescription
drugs as they are approved by the TGA as bioequivalent (the property where in two
drugs with identical active ingredients or two different dosage forms of the same drug
possess similar bioavailability and produce the same effect at the site of physiological
activity1). The TGA ensures each generic drug meets certain standards of safety and
performance equivalence, each generic drug undergoes stringent procedures before it
is approved, these procedures include four clinical trails2. Additionally, for the drug to
be regarded as bioequivalent, the bioavailability of the generic drug, which refers to
the rate and extent of absorption, needs the 90% confidence interval to fall between
80-120% of the regulatory limits. These limits are referred to as the area under the
curve (AUC), the C-max and T-Max, the area under the curve (refer the figure 13)
represents the total area under the plasma drug concentration-time curve, the C-max
represents the maximum plasma drug concentration and the T-max represents the
time required to achieve a maximal concentration4. According to Pharmacist Duc
Nguyen, the 90% confidence interval is a good indication of bioequivalence as it
makes the drugs value during testing stay close enough to the curve, hence make
the limits smaller and have a higher confidence of being true to the original5. As
illustrated in figure 1, product A (brand name drug) has a larger AUC (124.9 mg.h/L)
which therefore means it has a higher rate of absorption, and thus is slightly better.
However, product b (generic drug) had a smaller AUC (112.4 mg.h/L) but still has a
90% confidence interval (0.9) that falls between 0.8-1.25. Consequently, product B
1 Bioequivalence - Definition and More from theFreeMerriamWebsterDictionary.2014.BioequivalenceDefinitionandMorerom
theFree Merriam-Webster Dictionary. [ONLINE] Available at: http://www.merriam-webster.com/dictionary/bioequivalence.
[Accessed 07 May 2014].

2 TGA approval for sale | NPS MedicineWise. 2014. TGA approval for sale | NPS MedicineWise. [ONLINE] Available at:
http://www.nps.org.au/topics/how-to-be-medicinewise/regulation-clinical-trials/tga-approval. [Accessed 07 May 2014]

3 Generics - equal or not? - Australian Prescriber. 2014. Generics - equal or not? - Australian Prescriber. [ONLINE] Available at:
http://www.australianprescriber.com/magazine/26/4/85/7. [Accessed 09 March 2014].

4 Australian Prescriber. [ONLINE] Available at: http://www.australianprescriber.com/magazine/26/4/85/7. [Accessed 09 March

2014].

5 Duc Nguyen (Nguyen, D. (2014). Generic Drugs)

can still be approved, this indicates that although they are not the same, they are still
very similar and are therefore bioequivalent.
From the analysis of Data collected through a public survey6, it was found that 85% of
respondents believe that generic prescription drugs are as effective as brand name
drugs. The 15% of those who consider generic drugs to be less effective than brand
name drugs, noted that through past experience
they found that the generic equivalent did not
work as well for them as the brand name drug,
Tried a Panadol once, didn't work and also the pill
and it was no good6. Only a small portion of the
participants and the public in general believe that
generics are not as effective and therefore an
inferior product. However, there is no scientific
research to prove why this should be the case7 (if
the generics 90% confidence interval falls
between 80-125%of the limits, the consumer
should not be able to tell the difference between
the generic and brand name drug). Consequently,
extraneous variables may have effected the
efficiency of the generic drug at the time.
Advice: Generic drugs are approved using the 80125% interval and are therefore ascertained to be
as effective as the brand name equivalent.
Generic drugs and brand name drugs have
extremely similar absorption rates for the active
ingredient and consequently there should be no
noticeable difference. Nevertheless, there may be
a slight difference which should be taken into
consideration. Generally, the generic equivalent is
proved to be as safe and effective as the brand
name drug. Therefore, other factors should be taken into consideration such as the
cost difference and how suitable they are for you (this refers to if the generic
equivalent is suitable for the medical issue or if you have had any previous
complications with generic prescription drugs)8.
Key Finding #2
Generic drugs are financially beneficial for both the individual and the economy.
Generic drugs are financially beneficial for consumers and the Australian economy,
yet, as stated by Generic Medicines Industry Association Chief Executive Ms. Lynch, our
role in returning hundreds of millions of dollars to the economy is barely recognized 9.
6 Rice, K, 2014, Stage 2 Research Project Survey, survey, 1 May
7 Minorities More Likely to View Generic Drugs as Inferior | Center for Advancing Health. 2014. Minorities More Likely to View
Generic Drugs as Inferior | Center for Advancing Health. [ONLINE] Available at: http://www.cfah.org/hbns/2012/minorities-morelikely-to-view-generic-drugs-as-inferior. [Accessed 21 May 2014].

8 Australian Prescriber. [ONLINE] Available at: http://www.australianprescriber.com/magazine/26/4/85/7. [Accessed 09 March

2014].

9 Generic drugs key to unlocking savings for Australian economy, says MJA. 2014. Generic drugs key to unlocking savings for
Australian economy, says MJA. [ONLINE] Available at: http://www.thepharmaletter.com/article/generic-drugs-key-to-unlockingsavings-for-australian-economy-says-mja. [Accessed 21 May 2014].

Generic drugs are cheaper mainly because the original brand company would have
been selling the active ingredient for many years and therefore there is a considerable
amount of information already known in regards to the safety and performance of the
active ingredient10. Consequently, once the patent expires (a patent protects the
original pharmaceutical company for a period of time so that no other company can
sell that same medical drug11) on the original brand name drug, generic companies
can manufacture the medicine at a lower cost and spend less on promoting the drug
(as the advertising would have been done from the original drug company12). Duc
Nguyen stated, increased sales of generic drugs, increases the savings to the PBS 13,
therefore, if there was a new weighted price average disclosure on generic drugs, it
would result in the PBS reducing the payment gap on generics and original brand
name drugs and allow that money to be used elsewhere in the health system .

According to The Pharma Letter, A follow-on generic medicine is only used in

Australia across 36% of all prescriptions as compared to the USA at 78%14. In Mark
Crottys opinion (medical journalist), if Australia adopted pharmaceutical schemes that
have already been put into place in various countries, to promote and increase the
sale of generic drugs by only 4%, Australia could save $205 million dollars 15. This
highlights the importance that generic drugs have on the Australian economy. Not
only do they benefit the economy, but they also benefit consumers. For general
patients, if the prescription is under the PBS threshold of $36.90, they may be able to
receive vast savings. For example, Lipitor 40mg (original brand name drug) is $28.00
where as its generic equivalent is $15.9916 (this could save a consumer $144.12 per
year). From a public survey conducted16, it was found that 81% said that they would
purchase the generic equivalent over the brand name drug due to its lower co st, this
highlights how financial benefits can ultimately influence ones decision when
choosing between generic and brand name prescription drugs. However, generics
may not benefit all consumers financially, if patients have a concession, repatriation
or disability and wanting a prescription where the originator has no surcharge, then
there is no price difference for them as they already receive the prescription at a
lower cost17.
10 . 2014. . [ONLINE] Available at: http://www.guild.org.au/docs/default-source/public-documents/issues-and-resources/FactSheets/generic-medicines---facts-and-fallacies-.pdf?sfvrsn=0. [Accessed 03 March 2014].

11 Patents | IP Australia. 2014. Patents | IP Australia. [ONLINE] Available at: http://www.ipaustralia.gov.au/get-the-rightip/patents/. [Accessed 11 May 2014].

12 .2014..[ONLINE]Availableat:http://www.guild.org.au/docs/defaultsource/publicdocuments/issuesandresources/FactSheets/genericmedicinesfacts
andfallacies.pdf?sfvrsn=0.[Accessed03March2014].

13 Duc Nguyen (Nguyen, D. (2014). Generic Drugs)

14 Generic drugs key to unlocking savings for Australian economy, says MJA. 2014. Generic drugs key to unlocking savings for
Australian economy, says MJA. [ONLINE] Available at: http://www.thepharmaletter.com/article/generic-drugs-key-to-unlockingsavings-for-australian-economy-says-mja. [Accessed 27 April 2014].

15 Replacing branded medicine with generics can save economy millions. 2014. Replacing branded medicine with generics can
save economy millions. [ONLINE] Available at: http://www.smh.com.au/comment/replacing-branded-medicine-with-generics-cansave-economy-millions-20130729-2quvn.html. [Accessed 09 March 2014].

16 Rice, K, 2014, Stage 2 Research Project Survey, survey, 1 May

17 Duc Nguyen (Nguyen, D. (2014). Generic Drugs)

Advice: It is important to take financial benefits into consideration when choosing

between the generic and brand name prescription drugs. Generic prescription drugs
are a safe and effective alternative to the brand name equivalent, therefore in order
to save money the generic equivalent may be better for you. However, if you have a
concession, repatriation or disability discount, it may be better to focus on how
suitable the generic equivalent is for you, ie. Does it ever show signs of irritation when
you consume the drug? However, if you have never had the generic equivalent it is
important to take into consideration that they are not completely the same but use
the same active ingredients. It is also important to take into consideration that generic
drugs benefit the economy and could potentially benefit the economy even more in
the future, conversely one could base their choice on that factor alone18.
Key Finding #3
Generic drugs may not be suitable for everyone, especially if they have idiosyncratic
sensitivity to certain colours or fillers, or it may take the body a small period of time
to adjust to the generic equivalent, as it may be that high a concentration of the drug
is sitting in their stomach and therefore making them feel nauseous
Generally generic prescription drugs do not cause adverse affects for consumers,
however in some cases generic drugs are not suitable for everyone. Although the
active ingredient is the same in both brand name drugs and the generic drugs, certain
colours and fillers (inactive ingredients) which make up the drug, are different19.
Some patients may have Idiosyncratic Sensitivity to certain colours and fillers used in
the generic drugs and therefore have an allergic reaction such as a headache or
upset stomach, which usually terminates after a short period of time20. The
ingredients used to increase the size of pills to usable dimensions (you would barely
be able to see a pill that actually weighed 25mg) vary from manufacturer to
manufacturer21. Due to manufacturers using different inactive ingredients, the only
way to ensure consistency is to take notice of the brand, as pharmacies may change
which generic brand they purchase. This is why one generic equivalent may be fine,
but another generic equivalent may not be suitable for the consumer. Conversely, this
problem is not restricted to generic equivalents, this problem can also occur when
changing between brand name drugs as well22.
According to Medical Doctor Craig Weber21, idiosyncratic sensitivity may not be the
only cause of stomach pain (from the consumption of the generic equivalent), it could
be due to the dissolving rates of the inactive ingredients. For the drug to be approved
the bioavailability of the generic drug must be the same as its brand name equivalent,
however some pills allow the inactive ingredients to dissolve quicker in the stomach
whilst the active ingredient dissolves at the same rate21. This may cause a higher
18 Generic drugs key to unlocking savings for Australian economy, says MJA. 2014. Generic drugs key to unlocking savings for
Australian economy, says MJA. [ONLINE] Available at: http://www.thepharmaletter.com/article/generic-drugs-key-to-unlockingsavings-for-australian-economy-says-mja. [Accessed 21 May 2014].

19 Generic drugs explained - body+soul. 2014. Generic drugs explained - body+soul. [ONLINE] Available at:
http://www.bodyandsoul.com.au/health/health+news/generic+drugs+explained,9305. [Accessed 21 May 2014].

20 Switching to Generic Drugs - Side Effects of Generic Drugs. 2014. Switching to Generic Drugs - Side Effects of Generic

Drugs.
[ONLINE] Available at: http://highbloodpressure.about.com/od/genericdrugs/f/generic-switch.htm. [Accessed 11 March 2014].

21 Switching to Generic Drugs - Side Effects of Generic Drugs. 2014. Switching to Generic Drugs - Side Effects of Generic Drugs.
[ONLINE] Available at: http://highbloodpressure.about.com/od/genericdrugs/f/generic-switch.htm. [Accessed 11 March 2014].

22 Generics - equal or not? - Australian Prescriber. 2014. Generics - equal or not? - Australian Prescriber. [ONLINE] Available at:
http://www.australianprescriber.com/magazine/26/4/85/7. [Accessed 09 March 2014].

concentration of the active ingredient to sit on the lining of the stomach and cause
irritation or nausea, often the consumer may just need to wait for a short period of
time for the body to adjust to the new formulation23.
Advice: Generic drugs are as safe and effective as brand name drugs, however are not
suitable for everyone, this can only be found out from past experience. It is very rare
to have idiosyncratic sensitivity to certain colours and fillers however it can happen,
this needs to be taken into consideration. Nevertheless, just because one generic
equivalent has not worked for you in the past does not mean that another wont work
(this is because each manufacturer uses different inactive ingredients). Additionally, if
a generic equivalent has given you stomach irritation or nausea, you may need to
wait for a short period of time for your body to adapt to the new formulation. These
are important points to take into consideration when choosing between the generic or
brand name prescription drug in relation to its suitability to you24.
Conclusion:
Overall, there are many considerations that need to be made when choosing between
brand name and generic prescription drugs. The consumer needs to decide whether
cost plays a hefty role in their decision making, if so the generic alternative may be
the better option. Additional to cost, the consumer needs to be comfortable that
generic drugs are as effective and as safe as brand name drug. Lastly, the consumer
needs to take into consideration that each generic drug has certain colours and fillers
which may cause idiosyncratic sensitivity. This then means they may need to try a
different generic alternative or change back to the brand name drug. Also, the
consumer may just need to wait a short period of time for the body to adapt to a
different formulation. Overall generics are a good alternative and advice has been
provided to help the consumer make the decision making process between the two
prescription medications easier.
Word count: 1999

Reference List
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Duc Nguyen (Nguyen, D. (2014). Generic Drugs)
Rice, K, 2014, Stage 2 Research Project Survey, survey, 1 May
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