Pharmacy Regulation Answers 2007


1. Are all generic medicines ‘equal’ in terms of effectiveness? Explain your answer.
Two products are bioequivalent when they give rise to the 'same' concentration-time profile in plasma (therefore, same efficacy). However, no two formulations are identical, therefore they are different. We are able to tolerate a difference of 80-125% of AUC compared to the innovator drug. This can lead to problems if generic A has a 10% higher AUC than the innovator compared to generic B with an AUC 10% lower. Generic A and generic B would not be bioequivalent and may cause problems if switching from one generic to another (although 20% difference should be ok)

2. With reference to the figure below, discuss the specific considerations you would take into account when asked to substitute Generic Medicine B for Generic Medicine A in a patient who has been using Generic Medicine A for several months.
external image genericdn7.png

consider:
- allergy to different excipients in each generic
- confusion over multiple boxes
- differences in packaging that may make taking the medicine easier or more difficult for the patient; ie blister/bottle, plain blister/dated blister, colour-shape-size of the dose form

As described above, generic A may have a 10% higher AUC than the innovator compared to generic B with an AUC 10% lower. Generic A and generic B would not be bioequivalent and may cause problems if switching from one generic to another (although 20% difference should be ok).
3. The National Drugs and Poisons Schedule Committee reviews the Drugs and Poisons Schedule on a regular basis. A decision to reschedule a medicine is made after consideration of a number of factors. Some of these relate to the use of the drug for an individual’s health; others relate to wider societal issues. List factors related to an individual’s health that may result in rescheduling of a medicine from a Prescription Only to a Pharmacist Only medicine:

individual's health
- need for access to the medicine (more easily accessed, so health condition could be better managed)
- risks, benefits and potential hazards associated with use (potential for less monitoring if visiting the doctor less often)
- if requires counselling and the pharmacist does not provide info, this can lead to inappropriate use
- medication would have previously required a specific diagnosis or management (if this does not occur, can lead to inappropriate use)
- medication would have interactions that are not just with common medications or food
- if it is a new therapeutic substance, potential for new adverse effects to be revealed once used on a larger scale

wider societal issues
- potential for misuse (diversion - using drug to create an illicit drug, as with pseudoephedrine)
- if pharmacists are shown to not provide adequate info once the medication is downscheduled, this can give the profession a bad name

4. Pantoprazole (an irreversible inhibitor of the gastric ‘proton pump’) tablets are marketed and used widely in Australia for the treatment of, amongst other things, peptic-ulcer disease and gastro-oesophageal reflux disease. This preparation is currently scheduled as a Prescription Only medicine. Suppose that the National Drugs and Poisons Schedule Committee (NDPSC) had received an application to reschedule pantoprazole tablets to Pharmacist Only. Provide one consideration that the NDPSC would take into account from an individual consumer perspective and one consideration from a general population perspective regarding this hypothetical application for rescheduling; include a brief explanation for each of your points.

individual consumer perspective
- risk of masking a serious disease or compromising medical management of a disease: a patient may be suffering from a sinister condition that happens to manifest as reflux, which is masked using the PPI
- less cost/time needed to obtain medication to the patient: no need to book a doctor's appointment, diagnosis and then visit the pharmacist to dispense the medication

general population perspective
- may eventually lead to pantoprazole being used in the supermarkets: pharmacists no longer play a role in the patient's condition
- cheaper for society as patient pays for medicine instead of contributing to bulk-billed Dr's appointment and subsidised medicine.

5. An unknown customer presents to your pharmacy late on a Sunday evening with a prescription for a DDA. The signature/identity of the prescriber is also unknown to you. You try to verify the prescription with the doctor by phone, but find that they do not work Sundays. What would you do?

As it is a Sunday, the DDU (drugs of dependence unit) is unavailable and cannot be contacted. You could tell the patient 'there is legislation - I do not know the doctor and therefore I cannot supply'. Ask for photo ID. If they can provide this, can supply 2 days worth of the DDA. If they can't provide photo ID, offer to supply OTC pain meds or send them to the hospital for emergency medication.

6. A prescriber without a Section 33 authority must not treat an individual (less than 70 years of age) for more than:
a) 2 months
b) 3 months
c) 2 weeks
d) 2 days

If prescriber authorised: "Section 33 authority"
recorded with the DDU
- dependent persons
- non-dependent persons receiving >2 months
- only one authorised prescriber per patient

exceptions to Section 33 authority

>70 year old
- except dextromoramide, hydromorphone or pethidine (due to SE profile, abuse potential)
life expectancy <12 months (Minister informed, each prescription endorsed "NPCP" - notified palliative care patient)
- except drugs mentioned above
inpatient of a hospital with existing Section 33 authority (must notify authorised prescriber)
- another prescriber authorised and only while in hospital
- may be being treated for drug dependence (dose restrictions)
inpatient of government hospital without authority (duration not >14 days)
prescriber works in same practice or is locum for authorised prescriber (and treatment with approval of that prescriber)


Therefore, a prescriber without a section 33 authority can treat an individual who is an inpatient of a government hospital, but for no longer than c) 2 weeks