Counselling patients through a brand change

Why the change?

The rationale for change is outlined in the patient information leaflet produced by PHARMAC. Giving this pamphlet to the patient and working through the key points with them should provide the patient with sufficient understanding of the reasons for the change.

Is it the same medicine, and will it do the same job?

A confident response can be supported with the professional knowledge and data the pharmacist has on bioequivalence (see related article) and other information in this journal.

From the patient information leaflet...
'The medicine itself is not changing, only the brand. Medsafe, the agency that approves medication for use in New Zealand, approved Loxamine after carefully considering clinical study data. To gain this approval, the new supplier had to show that Loxamine delivers the same amount of the same medicine at the same rate as Aropax. This means you should have the same clinical effect from taking Loxamine as you would from Aropax. If you notice any change you should discuss this with your doctor.'

Will there be any side effects?

Understanding the potential for "new' side effects is key to an effective response to this question, and will require a considered approach from the pharmacist. Some side effects are related to the dose of medicine and are increased if the amount of medicine received is increased - others can occur when the dose of medicine received is suddenly reduced.

At the extremes of compliance with international standards of bioequivalence testing it is possible that content could vary (0.8-1.25) compared with the reference product. At these extremes the appearance of discontinuation effects are unlikely but there is a possibility of some dose related side effects. However, information received from Pacific Pharmaceuticals shows that the results of the studies on Loxamine are well within the bioequivalence acceptance limits and that any variations in the dose received compared with Aropax are very unlikely to be clinically significant. (For more information on bioequivalence refer here).

Consider the following...

The government agency Medsafe requires that Loxamine is tested to ensure that it is equivalent to Aropax and will give the same therapeutic effect without increasing the chance of side effects.

However, equivalent does not mean identical and there will always be slight variations in the amount of medicine in tablets due to manufacturing processes. This means that there are even slight variations in the amount of medicine between individual tablets and different batches of the same brand. The testing that Medsafe requires on Loxamine means that any variation in the amount of medicine between Loxamine and Aropax is very unlikely to be any different from variations between different batches of Aropax.

It is very unlikely patients will experience any change in side effects with Loxamine but if they are concerned they should be encouraged to discuss this with their pharmacist and doctor.

Other side effects may be due to fillers and colouring used to make the tablet rather than the active medicine. A comparison of the excipients contained in Aropax and Loxamine can be found here.

Independent testing indicates that Aropax and Loxamine are very similar in taste.

There is no evidence that Loxamine is more likely to cause indigestion or is difficult to swallow. Some patients (even adults) crush tablets to make them easier to swallow. In this case, point out that any difference in taste or texture is likely to be due to different fillers which hold the tablet together and not a difference in the active medicine.

Is it made by a reputable company?

People may be interested in where Loxamine is made and the extent to which it has been used in other countries. Loxamine tablets are manufactured in Australia. It is widely used in about 20 European countries including the UK and sales for 2005 and 2006 exceeded 150 million tablets.

Do I have a choice?

From the patient information leaflet...
‘Loxamine will become available (fully subsidised) from 1 April 2007. The subsidy for Aropax will decrease from 1 June 2007, and be removed altogether from 1 September 2007. Your pharmacist will explain your options during this transition.’

There will be an expectation from the patient that the pharmacist will be fully informed of the options available to them, so pharmacists will need to be prepared for this. Explaining the change has been initiated by PHARMAC, and clearly outlining the cost implications should they choose to remain on Aropax will help the decision making process for the patient.
Patients can contact PHARMAC on 0800 66 00 50

When communicating with patients it is helpful to see things through the patient's eyes. This includes understanding cultural influences on their health and taking the time to understand what is important to your patient.

In this article we suggest an approach to cross cultural communication. While this may feel uncomfortable at first, this 'Pause, Ask and Act' approach can lead to an improvement in health care providers interactions with their patients and their families.

'Pause'

Be aware of how your own cultural outlook might impact on the interaction with the patient

The cultural backgrounds of health care providers and patients strongly influence their values and beliefs. These can become so entrenched that they feel intrinsically 'right'. Differences in viewpoint across the clinician-patient relationship can lead to misunderstanding, discomfort, non-cooperation and a lack of trust.

Core issues which have potential for cross-cultural misunderstandings include those relating to:

• authority
• spirituality
• physical contact
• communication styles
• gender, sexuality, and family

'Ask'

Don't be afraid to ask - you're not expected to be an expert on everything

Seeing the health issue through the patient's eyes is the key to patient-centred medicine. It is especially important in cross-cultural consultations as there are increased opportunities for misconceptions and misunderstandings. The best way to gain an understanding of the way each individual patient sees the situation is to ask open questions. It is very unlikely that a patient would be offended if you were to ask them to give you more information on specific cultural conventions.

Issues to be explored include:

• patient's beliefs about their illness and expectations for the future
• spiritual, social, emotional and physical effects of their illness
• patient's usual social and health supports

'Act'

Create the opportunity for patients to actively participate in the management of their own health

Enabling people to participate in the management of their own or their family's health issues does not necessarily mean passing over decision making. It is more likely to include encouraging and supporting people to:

• Ask questions
• Formulate the problem
• Set goals
• Choose between management options
• Exercise control over various interventions

The degree to which people want to participate in the management of their health issues varies from person to person. People may prefer a family member to take on this active role. In some cultures this is a close male family member, in others an elder female. For example, in Māori culture with its tradition of collective responsibility and decision making the whole whānau may be involved. This concept is often referred to as a 'Whānau-centered approach'.

Pharmacists can actively encourage patients and their families to be involved in all aspects of health care and decision-making. The patient may nominate a person to speak on their behalf.

Questions that enable involvement are:

• Is there anything you want to ask?
• This is my understanding so far - is there anything you would like to add?
• What would you like to see happen from here?
• These are the options as I see them. What do you think?
• How would you like us to go about that?