The current debate over the provision of Consumer Medicine Information leaflets (CMIs) misses the fundamental point of patient health literacy, says Anthony Tassone
It is perhaps a measure of the “silly season” where news outlets scramble for something to report that this current debate has been given the legs it has – as it seems to be based on anecdotal reports of a few consumers apparently speaking to the Consumers Health Forum (CHF). Interestingly the CHF has produced no empirical evidence to date to back claims that pharmacists and doctors are somehow falling down on the job in providing medicine information to patients.
It seems that a couple of anecdotes should, in the eyes of the CHF, be seen as the ‘norm’ of what happens in pharmacy.
Quite clearly, the focus of this debate should be on increasing the health literacy of patients, not mandating the distribution of a document that may not necessarily be fit for purpose in all instances and is in need of being reviewed and updated to be more useable from a patient perspective.
That CMIs need to be rethought is clear given the dramatic changes in how patients access health and medicine information since CMIs for prescription medicines were first made available by manufacturers in 1993. A program in the 2000-2005 Third Community Pharmacy Agreement resulted in wider opportunities for the availability of CMIs.
In kicking off this debate, the Chief Executive of the CHF, Leanne Wells, was reported as saying CMIs should “ideally” be placed inside prescription medicine packets (the impracticality of which I address below) and directing patients to a website was “not of any use to those consumers, particularly older patients who may not use the internet”.
Interestingly, Australia’s older population has a greater uptake of the internet than their overseas counterparts. According to the Digital Lives of Older Australians report by the Australian Communications and Media Authority, 79 per cent of older Australians have accessed the internet at some point in their lives, with 71 per cent going online in the three months to June 2015.
Comparable international 2015 data indicates that 58 per cent of adults aged 65 and over in the United States reported using the internet. In the United Kingdom, 56 per cent of those aged 65 and over reported having access to the internet at home or elsewhere. This places Australia ahead of the UK and US in terms of internet use among older users.
Nevertheless, Ms Wells is reported as saying: “It should be standard practice for pharmacies to give printed CMIs when dispensing prescription medicines.”
Is this a broad view of consumers to receive a printed leaflet every time they receive a prescription?
This view may have had some vague relevance years ago, but the reality is that times have changed, and changed dramatically.
Increasingly, consumers turn to the internet for health information. True, this can raise some issues if the content is not credible, but we have to recognise it is becoming a standard approach by the public.
While many sites may provide dubious advice, there also are many reliable and credible sources of content and information available online, including one for CMIs (www.medicines.org.au). There also is a raft of government sites and those from not-for-profit special interest groups providing health information that pharmacies may refer patients to.
Often in my pharmacy even when I offer a patient a CMI they reply: ‘It’s OK I will just look online if I have any questions’. I have tried to ensure they at least receive a CMI which is a formal document from the manufacturer rather than relying solely on potentially non-curated content online. But that is today’s reality – many patients prefer the online information to a printed paper which they may consider to be environmentally wasteful and possibly less convenient.
And we also have to factor into the debate that pharmacists counsel patients on medicines, particularly when it is the first time it has been dispensed to the patient. Pharmacists exercise their professional judgment and clinical discretion in determining the best way to inform patients of what they need to know, always in the patients’ best interest.
This counselling includes discussion of side effects, compliance, interactions and so on but this fact seems to have been lost in the current debate.
What this current debate is centring on is whether it should be standard practice for pharmacists to give printed CMIs in all patient interactions when dispensing prescription medicines, regardless of the additional counselling provided by the pharmacist or the availability of other sources of information.
This narrow focus simply serves to confuse the issue as to whether every single medicine that is dispensed requires a CMI. This needs to be seen in the context of the PSA’s professional guidelines which give guidance on scenarios that are more likely to warrant the need for extra counselling, but not excluding any occasion when a consumer requests further information. CMIs must be seen as complementing the advice given by the pharmacist, not a stand-alone source.
The PSA guidelines state that “CMI leaflets have a role in assisting pharmacists facilitate QUM including:
- if the patient is commencing a new medicine
- if brand substitution has occurred
- if the dosage form has been changed
- after each supply of medicine providing regular reinforcement of information may be required (e.g. the medication is cytotoxic, teratogenic, or there are major contraindications to the use of a medicine)
- at the request of the patient
- when the patient has special needs
- at regular intervals for medicines used for long-term therapy (e.g. every 6 months, or on dispensing the last repeat of a prescription with five repeats)
- when the pharmacist has received advice that a sponsor has made significant changes to the CMI.
The true situation regarding patient and pharmacist interaction was clearly articulated in the Pharmacy Guild’s submission to the Pharmacy Remuneration and Regulation Review (The King Review).
In the submission the Guild stated that pharmacists have a professional responsibility to counsel patients about the use of their medicines.
“.. this is reflected in the PSA’s Professional Practice Standards and the Pharmacy Board’s guidelines for pharmacists which recognises that counselling is mostly verbal and may make use of other resources such as CMIs.
The Guild also address whether pharmaceutical companies should include CMIs as package inserts.
“The Guild believes community pharmacy is an appropriate and reliable location for CMI to be provided to improve a person’s understanding of a medicine and enhance the quality use of medicines, improve adherence and reduce medicine misadventure.”
Community pharmacists dispense medicines and provide relevant counselling to accompany the supply of medicines. Pharmacists are not required by law to provide a CMI but to use their professional judgement on the need for and provision of the counselling, counselling which may include the provision of a CMI when appropriate. Any suggestion that pharmacists are withholding information or negligent purely because they are not giving CMIs out with very patient interaction is not only wrong – it is offensive to all members of the community pharmacy team.
Pharmacists have long been and continue to be a trusted health professional in the community and the public having a high level of satisfaction with their experiences in community pharmacy. Every health profession, pharmacy included, can improve on the quality of care delivered to patients.
Sadly, the latest resurfacing of this issue has not acknowledged that every day community pharmacies impart medicines information to members of the public in different ways; face to face, over the phone and increasingly via digital means. But the pharmacist is the preferred source of information and the Consumer Needs report, prepared as part of the Fifth Community Pharmacy Agreement, noted: “93% of participants reported that they generally follow the pharmacist’s advice about prescription medicines and the preferred method of receiving information on prescription medicines was talking with the pharmacist (53%).”
It’s not uncommon for a member of the public who may not even be a patron or patient of a community pharmacy to contact them unsolicited for advice and receive it at no charge! What other profession would provide such timely and wide access to a highly trained university educated professional with no out-of-pocket expense for the consumer?
Let’s prioritise the debate to one that looks to make medicines information more relevant and useable by patients and consumers rather than demanding a document with known limitations accompany every interaction with prescription medicines in a pharmacy.
Anthony Tassone is the President of the Pharmacy Guild of Australia (Victoria)