This kit was developed in light of the proliferation of generic medicine brands, which means more consumer choice and the potential for increased confusion and medicine misadventure. Faced with more options, many consumers will seek the assistance of pharmacists and pharmacy assistants.

We developed this kit in collaboration with the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia.

This kit, comprising an article and the PowerPoint presentation below, aims to:

• upgrade pharmacy staff’s knowledge and skills about generic medicines so they can manage general questions about generic medicines, and
• prompt pharmacists to review their own knowledge, policy and practice standards regarding generic medicines.

This information was previously published by the Pharmaceutical Society of Australia, as part of its Pharmacy Self Care program, in December 2007. The information was included in a special edition of inPHARMation and an accompanying pharmacy training storyboard, Communicating with consumers.

• Safe and appropriate use of generic medicines (article below) 
• Safe and appropriate use of generic medicines (Powerpoint presentation: 434KB).

Pharmacists conducting a staff training session using the generic medicines training material are eligible for continuing professional development (CPD) points/credits. This activity is recognised by the:

• Pharmaceutical Society of Australia Continuing Professional Development & Practice Improvement (PSA CPD&PI) program for 4 credit points per training session
• Australian Association of Consultant Pharmacists (AACP) for 4 credit points per training session
• Pharmacy Board of South Australia as suitable for inclusion in the ENRICH program.

Conducting a staff training session using this material assists the pharmacist to meet various competency standards as set out in the Pharmaceutical Society of Australia Competency Standards for Pharmacists in Australia 2003. To view specific competency standards addressed by this program click here.

See drugs and therapeutic topics for more information and resource on generic medicines.

Article: Safe and appropriate use of generic medicines

• Introduction
• A potted patent history
• QUM: the abridged version
• Bioequivalence in brief
• When is brand switching inappropriate?
• Brand premiums make a difference
• Do excipients matter?
• Minimising confusion in using generic medicines
• The pharmacy's brand switching policy
• References

Introduction

Pharmacists, as the custodians of medicines, have a professional obligation to ensure that consumers are able to make informed and safe decisions about the use of generic medicines.

As part of this obligation, pharmacists are responsible for ensuring that all staff handling prescriptions or assisting with medicine dispensing are familiar with the pharmacy policy regarding the offering and dispensing of generic medicines. Training provides staff with the knowledge and skill required to handle questions from consumers relating to generic medicines.

The PowerPoint presentation accompanying this article will assist pharmacists to inform staff of the major considerations relating to the choice and use of generic brand medications.

Ensuring that pharmacy staff are competent to manage general questions about generic medicines will be an ongoing requirement, as over the next two years, more medicine patents will expire, and more generic medicine brands will enter the Australian market.

However, before pharmacists upgrade their staff's knowledge and skills in regard to generic medicines, they should review their own policy and practice standards in regard to:

• the dispensing of generic medicines
• their own understanding of bioequivalence
• when brand switching may be inappropriate
• consumers perceived barriers to such switching.

^ top

A potted patent history

In Australia, prescription medicine patents usually last 20 years. This is considered adequate time for developing and testing new medicines (which must occur before medicines are approved for marketing) and exclusively marketing new medicines to recover development costs and achieve a return on investment.

Once a patent on a therapeutic substance has expired, any medicine manufacturing company, including the company that originally developed the substance, is entitled to manufacture medicines containing the same therapeutic substance. As other manufacturers have not incurred expenses in developing the medicine or consolidating a market for the medicine, they may be able to market the medicine at a lower price than the original manufacturer.

The Australian Therapeutic Goods Administration (TGA) is responsible for approving all medicines before they are allowed to be marketed in Australia. All medicines, regardless of whether they are the original or a generic brand, must meet the same high manufacturing standards. Where and when applicable, manufacturers also have to provide the TGA with sufficient evidence to prove the claimed bioequivalence.

^ top

QUM: the abridged version

The use of generic medicines should be underpinned by the Quality Use of Medicines (QUM): one of the central objectives of Australia's National Medicines Policy.¹

Consumers are at the centre of QUM, which involves the judicious selection of medicine management options, choosing suitable medicines if necessary, and the safe and effective use of these medicines. Therefore, the use of generic medicines must benefit consumers without putting them at risk of medicine misadventure, and consumers must be consulted before switching medicine brands.

---

Consumers need to know

• All prescription medicines available in Australia, including generic medicines, must meet the same high standards set by the Therapeutic Goods Association (TGA).

• Only brands of medicines which have been proven to be bioequivalent (i.e. tested to produce similar therapeutic effect in the body) are interchangeable.

• Generic medicines contain the same active ingredient as the original brand of medicine, but may appear different (e.g. different colours, shape or size).

• The decision to use or not to use generic medicines is the consumer's choice.

• The use of generic medicines may save the consumer money.

• Familiarity with the active ingredient of a medicine may help to avoid potential confusion when brands are changed.

---

The use of generic medicines is also influenced by other National Medicines Policy¹objectives, including timely access to medicines at a cost that individuals and the community can afford. The use of generic medicines may offer cost savings to consumers as individuals, as well as taxpayers.

Also, the introduction of generic medicine brands can benefit the community as a whole through price competition among manufacturers. This competition is important as it positively impacts on the sustainability of the Pharmaceutical Benefits Scheme (PBS).

^ top

Bioequivalence in brief

Revising your knowledge of bioequivalence will assist your discussions with consumers about generic medicines, and help consumers make informed decisions about medicines.

Two preparations are bioequivalent if they have been administered on separate occasions to the same group of people, and the rate and extent of absorption of both therapeutic substances are so similar that the clinical effects of the two preparations can be expected to be the same.² The statistical analysis used to measure bioequivalence ensures that any difference in bioavailability between any two products is less than 10%.²

The Schedule of Pharmaceutical Benefits indicates which medicine brands are bioequivalent, using either an 'a' or 'b' superscript. Brands of any therapeutic substance marked 'a' can be substituted one for the other and similarly brands marked 'b' can also be substituted. However those marked 'a' cannot be substituted with those marked 'b'.³

Note that not all medicines containing the same amount of the same active ingredient have been proven to be bioequivalent or accepted as bioequivalent by the Department of Health and Ageing. For example, both Maxolon and Pramin tablets contain 10 mg of metoclopramide hydrochloride, but as they have no 'a' or 'b' subscript they are not interchangeable.

Non-PBS generic brands are also available. In considering whether to offer generic brand substitutes for such products, pharmacists will need to ascertain if the generic brand is bioequivalent to the brand originally prescribed, for example by citing appropriate references which should be provided by the product's sponsor. A copy of this information should then be maintained in the dispensary files.

---

Bioequivalence and choice

• Only medicines that are proven to be bioequivalent can be interchanged. Note that, not all medicines containing the same amount of the same active ingredient are bioequivalent.
• Remember that brand switching is the consumer's choice. Be mindful and respectful of the reasons why a consumer may not wish to change brands.
• Even when bioequivalent brands are available and the consumer consents, brand switching may not be appropriate if:
  • the prescriber has indicated it is not permitted,
  • the medicine has a narrow therapeutic window,
  • the consumer has an intolerance or allergy to one of the excipients,
  • the consumer may become confused as a result of the change.

---

^ top

When is brand switching inappropriate?

Switching to a generic medicine brand should not occur if two brands of the same medicine are not bioequivalent. For example, the two brands of warfarin available in Australia (Coumadin and Marevan) are not bioequivalent and should not be used interchangeably.²

Also, brand switching should not occur without the consumer's or carer's consent. The consumer has the right to choose, and there are varying reasons why a consumer may not wish to accept a generic medicine brand.

---

Why consumers choose to keep using their original medicine brand

• Their prescriber has not recommended that they switch brands.
• They feel that a generic brand may be less effective.
• They feel considerable effort has been put into achieving benefits from their current medicine brand.
• They perceive that the less expensive generic medicine is inferior.
• They have previously experienced an unsuccessful switch to a generic brand.⁶

---

Even when bioequivalent brands are available and the consumer consents to the switching, there are some situations where brand switching may not be appropriate:

The prescriber has indicated that brand switching is not permitted
Prescribers may disallow brand switching by ticking the relevant box on the PBS prescription form. If the 'brand substitution not permitted' box is ticked but the consumer wants to switch to a generic brand, the pharmacist should discuss this with the consumer. Switching brands should not occur unless the consumer or the pharmacist on the consumer's behalf has obtained the prescriber's approval.

Medicines with a narrow therapeutic window
Special consideration is required for a small number of medicines with a narrow therapeutic window (e.g. sodium valproate, cyclosporine).²

Where possible, the decision to use a generic medicine should ideally be made at the start of treatment.⁴ Switching brands is best avoided when consumers are stabilised on medicines with a narrow therapeutic window.⁴

Consumers with documented allergies to excipients

Care should be exercised when switching brands for consumers who have documented allergies or intolerance to excipients (e.g. dyes, gluten, lactose). (See below for more information).

May disadvantage the consumer
Consumers that show signs of cognitive impairment or confusion or are unable to understand and manage change may be at an increased risk of medication misadventure from brand switching. Other consumers may, due to vision impairment, rely on the consistent shape and colour of a particular medicine brand and/or packaging to assist them in recognising their medicines. Careful consideration needs to be given as to whether brand switching is appropriate for these consumers. Consultation with the prescriber or family members may be appropriate in some circumstances.

The consumer's health should always be the pharmacist's prime consideration, and brand switching should not place the consumer at risk.⁵

^ top

Brand premiums make a difference

While many generic medicine brands may cost less than the original brand, some generic and original brands attract a brand premium under the PBS.

Where there is more than one bioequivalent brand of a particular medicine listed on the PBS, the Australian Government subsidises this medicine to the level of the lowest priced brand.³

Other manufacturers are allowed to set a price above the price charged by the manufacturer/s of the lowest priced brand/s. The price difference between the lowest priced brand and higher priced brands is passed on to the consumer as the brand premium.

There is potential for cost savings if consumers choose brands which don't attract a brand premium. This saving may be considerable for consumers who are prescribed multiple medicines.

Note that brand premiums do not count towards the consumer's prescription safety net.

^ top

Do excipients matter?

As excipients may differ between bioequivalent products, they should be discussed with some consumers who are contemplating a switch to generic medicines.

Adverse reactions to excipients are very rare and, in general, the differences in excipients between bioequivalent preparations should not result in consumers experiencing different effects. The exception is in very rare situations where the consumer has an allergy or intolerance to the excipient.

Wheat starches containing gluten and the milk sugar lactose are sometimes used as excipients. Consumers with coeliac disease or lactose intolerance may enquire as to whether the preparation contains gluten or lactose, respectively. Pharmacists should discuss with the consumer the severity of a particular intolerance and advise the consumer on the most appropriate course of action.²

While only dyes with low risk are used, a very small proportion of the population may also be allergic to the dyes used to colour the preparations.

For a list of the excipients and colours in each medicine, check Consumer Medicine Information (CMI) leaflets.

^ top

Minimising confusion in using generic medicines

Pharmacists are ideally placed to prevent consumer confusion around using or choosing generic medicines.

Pharmacy staff must obtain consumer consent before switching the prescribed medicine brand to another brand. This should occur regardless of whether the prescribed medicine is new for the consumer. Besides meeting a professional obligation, obtaining consent also ensures that the consumer is aware that there will be a change.⁵ When supplying dispensed medicines, explain which medicine this brand replaces, and discuss any differences (e.g. colour, size, shape) in the packaging or the actual medication.

Encourage the patient to become familiar with both the name of the active ingredient and the brand name of any medication they take. Consider circling or highlighting the name of the active ingredient on the label or package.

Provide the patient with a Medicines List, available free of charge from the National Prescribing Service which includes the name of the active ingredient. This is a simple and effective tool to assist patients and reduce the risk of confusion over medicines, provided its currency is maintained.

---

Switching to a different brand

• Follow the pharmacy's brand switching policy.
• The consumer's consent must be obtained before switching between brands.
• Note the change of brand on the container of the new brand dispensed (e.g. by placing Label 15, "This medicine replaces ... Do not use both").
• Point out the active ingredient to the consumer and consider highlighting the name of the active ingredient on the label or packaging.
• Explain the change carefully to the consumer and make sure they understand which brand the medicine replaces.
• Note the indication for use and consider writing it on the label or packaging if that is helpful for the consumer.
• Offer a Medicines List (available free of charge from the National Prescribing Service Limited). When kept up-to-date, this is a simple and effective tool to assist consumers and reduce the risk of confusion over medicines.
• Note the consumer's preferred brand in their medicines history and try to maintain this brand consistently over time.
• If appropriate, consider using a medicine administration aid (Websterpak or similar).
• Encourage consumers to use the same pharmacy — being familiar with the consumer's needs and preferences, and having a good record of the consumer's medication history may help to prevent medication misadventures.

---

The pharmacist should exercise discretion when determining which of these strategies may be implemented by pharmacy staff and which should be reserved for the pharmacist. For example, while it may be practical for pharmacy assistants to place Label 15 on a dispensed medicine, it may be prudent for a pharmacist to explain the change to the consumer.

Medicines administered during a hospital stay and/or provided on discharge from public hospitals may be another potential source of confusion. In Australia, most public hospitals only stock one brand of any particular medicine, and this may not be the brand that the consumer is familiar with. If the consumer receives a package that is unfamiliar and without adequate explanation, when she/he is discharged from hospital, she/he may believe this is a new additional medicine. As a result, the consumer may take this as well as other brands they have received previously. Such confusion can result in overdosing and re-admission to hospital.

^ top

The pharmacy's brand switching policy

The "Guidelines for Pharmacists on PBS Brand Substitution" published by the Pharmaceutical Society of Australia provide general advice to support and assist pharmacists in exercising their professional judgement when offering brand switching.⁵

All community pharmacies that are accredited under the Pharmacy Guild of Australia's Quality Care Pharmacy Program must maintain and adhere to a brand switching policy. All staff that handle prescriptions should be familiar with the policy.

---

Pharmacy policy

• Ensure that the pharmacy has a policy on the use of generic medicines, which is consistent with the recommended guidelines.
• Have clear guidelines for pharmacy staff to enable them to interact appropriately and effectively with consumers.
• Consider how the pharmacy will decide which brands of generic medicines to stock.
• The following points may help:
  • Is the packaging easily differentiated from other products in the dispensary?
  • Is the name of the active ingredient prominently displayed?
  • Will consumers with dexterity problems struggle to access the actual medicine?
  • Is there reasonable confidence that there will be consistency of supply over an acceptable period of time?

---

This brand switching policy should consider:⁷

• when brand switching will be offered,
• obtaining consumer consent,
• recording consumer brand switching preferences,
• brand consistency,
• addressing consumer brand switching requests that go against the stated intention of the prescriber.

 

Suggested template for a pharmacy's brand switching policy

Offering brand switching

It is ... pharmacy's policy that:

Generic brands will be offered to all consumers presenting PBS prescriptions for which there are bioequivalent preparations available, unless the prescriber has ticked the "brand substitution not permitted" box, or the pharmacist has recorded in the consumer's profile switching should not take place.

Brand switching will not occur without the consent of the consumer.

When the consumer consents to brand switching this is noted on the prescription and recorded in the consumer's medication profile.

All care is exercised to continue to supply the same brand while the consumer continues to frequent the pharmacy and to be prescribed that medication. If there is a need to switch brands, all care is taken to ensure the consumer agrees to the further brand switching.

Stocking consistent brands

It is ... pharmacy's policy to:

Only stock two generic brands of each PBS therapeutic item and maintain stock of these brands for at least one year, unless stock becomes unavailable.

Interaction with prescriber

It is ... pharmacy's policy that:

When a consumer requests generic medicine brand switching against the stated intention of the prescriber, this matter should be referred to the pharmacist on duty.

The pharmacist should explain to the consumer that the prescriber has requested that no switching occur. The pharmacist should ask the consumer if she/he wants the pharmacist to contact the prescriber on her/his behalf or she/he wants to discuss this matter directly with the prescriber.

If the consumer is in urgent need of the preparation ordered, the pharmacist should explain that without the prescriber's consent to the contrary the pharmacist is required to provide the brand of medication prescribed.

Pharmacies will also need to establish stock policies, so consistent brands are available

It is important that pharmacy team members have clear guidelines as to their roles regarding brand switching and generic medicines. See the flow chart in the associated PowerPoint slides for guidance on this issue.

Whether or not brand switching occurs, pharmacist should counsel consumers on the first occasion they receive a medicine.

Ultimately, it is the pharmacist's responsibility to discuss the safety and suitability of alternate brands, to provide advice and, where necessary, to discuss any issues relating to the use of generic medicines with the prescriber.⁵

^ top

References

1. Australian Government Department of Health and Ageing. The National Strategy for Quality Use of Medicines Executive Summary. Canberra; 2002.
2. McLachlan AJ, Ramzan I and Milne RW. Frequently asked questions about generic medicines. Australian Prescriber 2007; 30:41-43.
3. Department of Health & Ageing. Schedule of Pharmaceutical Benefits. Available from: http://www.pbs.gov.au/.
4. National Prescribing Service Limited. Generic Medicines: Same difference? NPS News 2006;44.
5. Pharmaceutical Society of Australia. Guidelines for Pharmacists on PBS Brand Substitution. Canberra: Pharmaceutical Society of Australia; 2004.
6. Stancombe Research and Planning. Project generic: Syndicated Consumer Research on Attitudes to Generics — Qualitative Phase Report. Sydney: Stancombe Research and Planning; 2004 (unpublished).
7. Pharmacy Guild of Australia. Quality Care Pharmacy Program: 2000 Brand Substitution Policy P2B. Pharmacy Guild of Australia; 2000.

 

To present this information to your staff or other interested parties, download the accompanying PowerPoint presentation.

Pharmaceutical Society of Australia Competency Standards for Pharmacists in Australia 2003

The competency standards addressed by the generic medicines training program are:

Competency Unit 1.2: Practise to accepted standards

Competency Unit 1.3: Pursue life-long professional learning & contribute to the development of others

Competency Unit 2.1: Apply communication skills

Competency Unit 6.2: Address primary health care needs of patients

Competency Unit 7.3: Disseminate information

Competency Unit 8.1: Plan and manage work time

Competency Unit 8.3: Supervise staff

Competency Unit 8.4: Work in partnership with others

Competency Unit 8.5: Plan and manage pharmacy resources

Competency Unit 8.6: Plan and manage pharmacy services and the work environment.

<return to top of page> 

Footer