Ruth Shrensky and Cheryl Edridge, 2009
Note: This paper was originally researched and written by Cheryl Edridge of CRIA in 2003. It was updated by Ruth Shrensky in 2009.
Here are some startling figures: a review of hospital admissions (Roughead 1999) estimated that at least 80,000 medication-related hospitalisations occurred in Australia every year, of which between 32% and 69% were considered avoidable; some years later, the Australian Council for Safety and Quality in Health Care suggested that 2–3% of all hospital admissions related to the over-use, under-use or inappropriate use of medications (ACSQHC 2002), increasing to 20% with age (AIHW 2007); and recent studies found that one in ten general practice patients had experienced an adverse drug event or reaction (ADE/ADR) in the six months prior to publication (McInnes, Saltman & Kidd 2006; SAND 2008).
Not all of these preventable ADEs and ADRs arise from ignorance on the part of the medicine user. They can result from deliberate misuse, inadequate hospital procedures, erroneous prescribing, or other events. But too many arise from consumers not knowing the correct actions to perform with their medications. In other words, as found by Bhasale, Miller, Reid & Britt (1998), one of the commonest contributory factors (23%) was poor communication between patients and healthcare professionals. This point is emphasised by Roughead:
What the data on ADRs in hospitals indicate is our failure to focus on management strategies for ADRs as a specific topic within the national initiatives…To improve ADR management, we must improve our information sources…Providing lists of ADRs does little to change behaviour…While Consumer Medicine Information is now available for over 2000 products, it is not provided routinely and continues to be regarded negatively among some health professionals, despite consumer calls for information on side effects. (Roughead 2005, italics added).
A year later, Roughead & Lexchin (2006) pleaded for action. ‘Consumer Medicine Information needs to be routinely used in medical encounters, so that patients can recognise ADEs and know what to report to their GP’.
The crying shame of all this is that Consumer Medicine Information (CMI) has been available, indeed mandatory, for many years. Since the introduction of mandatory CMI in 1994, the pharmaceutical industry, consumer groups, and other interested stakeholders have been concerned that CMI is neither routinely used nor achieving its objective of providing consumers with better information about the medicines they are taking. Two reasons usually given are, firstly, that consumers and health professionals may not be aware of CMIs, and secondly, that pharmacists do not automatically hand out relevant CMIs when they dispense prescription medicines.
The first has been dealt with many times over the years, with various publicity and education campaigns to raise awareness and knowledge. The second is more problematic: in fact, pharmacists have been demonstrating strong organisational resistance to CMIs from the beginning, despite many opportunities given to them to overcome their objections.
This paper discusses the pharmacists’ resistance to the automatic routine delivery of CMI.
(One major point of contention has been the length of individual CMIs. Most CMIs comprise two pages—three to four sides—but some groups, and pharmacists in particular, have been demanding one-page CMIs from the outset. A companion paper to this one, Shorter CMIs: The sad failure of a design project by Edridge & Shrensky, is being prepared on the topic.)
The purpose of CMI is to provide accurate, up-to-date information to consumers about prescription medicines and pharmacy-only medicines. CMI is provided in the wider context of health information as a communication and counselling link between healthcare providers and medicine consumers; and just as healthcare providers have an obligation to promote the quality use of medicines, so medicine consumers have a right to accurate, up-to-date information, in order to make informed decisions (NHMRC 1993; Graham & Kwok 1995; PHARM 2000; Tasker 2005–6; Wheatland 2006–7; APC 2008; among many others).
Individual CMI leaflets (CMIs) in Australia are developed by pharmaceutical companies to provide information for medicine users, and should provide all the information users might need about a specific medicine product. CMI is specially designed according to performance requirements: this means that, through a comprehensive tested format of headings and sections, CMI allows users to find essential or important information about their medicines easily and quickly, and to use that information appropriately to perform tasks that were agreed to by all stakeholders; specific CMI are also tested to make sure that consumers can indeed perform those tasks (see Sless & Shrensky 2006, 2007, especially Chapters 11, 12, and 13).
The content of a CMI leaflet is taken from the Product Information (PI) of the medicine written by the medicine’s sponsor or manufacturer; nothing may appear in the CMI that is not in the PI, so consumers can be confident that they are being given reliable information. Also, nothing may appear in the CMI that can be seen as an advertisement or endorsement of the brand. Guidelines and standards for writing CMI are provided by professional health and pharmaceutical organisations such as the Commonwealth Department of Human Services and Health (1995), the Royal College of Nursing Australia (RCNA 1999), the Pharmaceutical Health and Rational Use of Medicines (PHARM 2000, 2002), and the Pharmaceutical Society of Australia (PSA 2006b), among others, and by CRIA (the Communication Research Institute of Australia) [now CRI, the Communication Research Institute], a specialist organisation in the field of communication and information design which has developed the CMI designs since 1994 (Sless & Wiseman 1994, 1997; Sless & Shrensky 2006, 2007). Professional consultancy is provided by APAC (the Australian Pharmaceutical Advisory Council) and CRI.
CMIs can be provided in various ways: as inserts in medicine packages, as leaflets and standup cards for community pharmacy counters, as published compendia, and as computer printouts from websites. (A ‘community pharmacy’ is a pharmacy serving the public—a high street chemist as opposed to a hospital or specialised pharmacy. All references to pharmacies in this paper refer to community pharmacies.)
The preferred method of delivery is computer printouts by pharmacies at the point of dispensing, as this ensures that the information is current and standard; a comprehensive survey of community pharmacies in 2003-4 found that electronic CMI was included within dispensing computer systems at 98.4% of Australian pharmacies (PGA 2004, section 4, p. 123).
The pharmaceutical industry meets the costs of writing and publishing CMI, while intellectual property rights are held by the individual pharmaceutical company responsible for producing any particular CMI. A media release in 1998 (Commonwealth Department of Health and Ageing 1998) stated that a distinctive logo was being developed to help people identify CMI—when they saw the logo on a CMI leaflet, they would know the leaflet contained unbiased, quality information about that particular medicine. A CMI logo did appear briefly in demonstration designs in 1999 and 2002, but has never been in general use.
Beginnings of CMI in Australia
In 1991, the release of the Baume Report on drug evaluation triggered major reforms in the way that drugs were prescribed, dispensed and used. New standards of quality and safety were set, and consumer groups began lobbying in earnest for better information about medicines. The Commonwealth Government established two groups, PHARM (Pharmaceutical Health and Rational Use of Medicines) and APAC (Australian Pharmaceutical Advisory Council), to advise on all matters relating to pharmaceutical education and policy.
In 1992, PHARM framed the Quality Use of Medicines (QUM) policy, whose success depended on the partnership between the government, the pharmaceutical industry, healthcare professionals, and the community. This partnership facilitated production of CMI for all prescription and pharmacy-only drugs, as recommended by the Baume Report. Since 1994, pharmaceutical companies have been legally required to provide consumer information on prescription products: the companies prepare CMI for the medicines they develop, and their content must be factual and must not contain any promotion for the brand.
In the initial stages of CMI design, PHARM sponsored consultative meetings with key stakeholders and organisations involved with medicines to develop CMI guidelines and set up a process for its consistent development. CRIA received government funding to develop usability guidelines for preparing CMI, Writing about Medicines for People, first published 1994, 2nd edition 1997, 3rd edition 2006 (electronic) and 2007 (print); CRIA also undertook to redesign the format of CMI when necessary, to ensure its continued effectiveness as an information tool.
APAC established a CMI Standing Committee to oversee CMI development; an Electronic Distribution Working Group (EDWG) was established to manage the preferred electronic delivery of CMI process; and a CMI Content Quality Assurance Reference Group (QARG), comprising representatives from consumers, doctors, nurses, pharmacists, the pharmaceutical industry, CMI writers, EDWG, and CRIA (CRI), was set up to monitor the quality of information provided to users.
Barriers to CMI delivery
It is now fifteen years since CMI became mandatory, yet it is still necessary to address the problem of how to promote wider knowledge, delivery and use of CMI. From the beginning, surveys have demonstrated that some consumers and healthcare professionals are not aware of CMI or, if aware, do not use them appropriately; and consumer groups and others have long been concerned that many pharmacies do not routinely deliver CMIs to prescription medicine users.
Since pharmacists do not automatically offer a CMI when dispensing prescription medicines, consumers have been encouraged to ask for one, starting with PHARM’s National Medicines Week campaigns (1996-1998) which included messages to raise awareness of CMI and to urge consumers to ask their pharmacists for a CMI leaflet when they had prescription medicines dispensed (PHARM & APAC 2001). PHARM & APAC noted that while awareness of CMI increased from 19% to 26% over the period of the campaigns, uptake of CMI was slow, ‘primarily because of barriers to its delivery’ (2001, p 31).
From the pharmacists’ point of view, the barriers to routine delivery are many and seemingly insurmountable. Aslani (2006) cites surveys which have identified several reasons why health professionals have generally failed to routinely deliver CMIs to consumers: CMIs are too long (that is, they use more than one A4 double-sided sheet); some pharmacists are unaware of CMI; some pharmacists lack the relevant counselling skills; CMIs are believed to have a negative impact on consumers’ medicine-taking behaviour; pharmacists are unhappy about the extra, unpaid time spent explaining CMIs to medicine users; and many explained that they do not have adequate technology, especially the right kind of printer, to satisfy the government’s requirement for the electronic distribution of CMI.
Much has been done, and is still being done, to remove these barriers.
Barrier 1: CMI length
To address the perennial complaint that CMIs are too long, CRIA designed double-sided one-sheet CMIs over the following years, sadly to no effect. See Shorter CMIs: The sad failure of a design project (Shrensky & Edridge in preparation) for a full description of the projects, including test results.
Barrier 2: CMI skills
To address pharmacists’ lack of awareness or negative approach, educational workshops have been delivered. To address pharmacists’ lack of counselling skills, professional bodies have published guidelines on CMI use: CMI and the pharmacist (PSA 2000) and Using CMI: A guide for health professionals (PHARM 2000). The guidelines include specific circumstances when pharmacists are expected to hand out a CMI and use it as a counselling aid:
- when a medicine is first provided to the patient
- when there has been a significant change to the CMI
- if the dosage form has been changed (e.g. from injection to tablet)
- with each supply of medicine for which there are valid reasons for regular reinforcement of information (e.g. the medication could cause birth defects, there are other reasons where caution is required, or the patient has special needs)
- at the request of the patient
- at regular intervals, for medicines used for long-term therapy (e.g. every six months)
- when the pharmacist has received advice that a sponsor has made significant changes to the CMI.
The guidelines made little difference. The barriers to delivery persisted. In January 2002, PHARM’s Consumer Sub-Committee published its first newsletter, MedicinesTalk, in which one of the writers urged, ‘Don’t forget, if you want a CMI leaflet, ask for it—after all, it is your right to have one!’ (Wood 2002). And as recently as 2006, a PSA media release, while berating pharmacists for not routinely delivering CMIs in accordance with its 2000 guidelines, was still putting the onus on consumers: ‘Ask for a CMI with your next prescription’ (PSA 2006a). Pharmacists responded by noting that earlier versions of the CMI guidelines stated that any kind of appropriate information, not necessarily CMI, could be offered with prescription medicines; and that pharmacists could exercise their professional judgement in deciding when to provide a CMI.
Barrier 3: financial and technological
To address the financial and technological barriers and to promote the QUM policy, the PGA developed its Medicines Information for Consumers (MIC) program, principally to encourage pharmacists to deliver CMIs and use them for counselling. As part of the program, pharmacists were provided with financial incentives via a Commonwealth Government research and development grants program (part of the Third Community Pharmacy Agreement between the Minister for Health and Aged Care and the Pharmacy Guild of Australia 2000). Pharmacists participating in the MIC program
‘[were] required to provide Consumer Medicine Information (CMI) to consumers in accordance with PSA professional standards and guidelines’ (PGA 2002).
Every pharmacist in Australia who wanted to be part of the MIC program was given AU$3000 as a readiness payment to purchase a duplex laser printer dedicated to the provision of CMI. As well, the fee given for every PBS medicine dispensed included counselling on its proper use.
A major survey and review of the MIC program found that the incentives were not working as well as hoped (TNS 2004). Among the reasons for this were:
- many pharmacists had ‘minimal understanding’ of the PSA guidelines (pp 14–15), contributing to their failure to change their practices
- pharmacists did not properly understand what the MIC program entailed (p 16), including not understanding that it required a change of practice: ‘There was a strong perception among pharmacists that they were being “paid to do what they already had been doing” ‘ (p 14)
- there was not enough consumer awareness or expectation of CMI to create enough demand to ‘facilitate behavioural change on the supply side’ (p 14), thus putting the onus back onto the consumer
- many pharmacists mistakenly believed that consumers would suffer ‘anxiety and fear’ when receiving a CMI (p 14), and so withheld it
- the MIC procedure for claiming the counselling fee was unnecessarily complicated and time consuming, as it had to be claimed separately from the PBS dispensing fee (although the incentive amount was incorporated into the dispensing fee).
The last point above has been easy to deal with: one of the provisions of the Fourth Community Pharmacy Agreement (2005–2010) is that pharmacists do not now have to make separate claims for CMI incentive payments.
Time to get serious
But the other points have not been so easily solved. A submission to the Therapeutic Goods Administraton (TGA) by the Consumers’ Health Forum of Australia (CHF 2005) noted:
‘We continue to hear from consumers that they are still unaware that specific written information exists for them about prescription medicines they are using. Further, research with health care providers themselves shows that professional standards for CMI delivery are not always sufficient to ensure consumers receive a CMI even when it is indicated.’
As the title of Roughead’s (2005) article declares: it is time to get serious. Research shows that hospitalisations due to ADRs have risen to more than 140,000 yearly, of which 50-75% are preventable (PSA 2007b). It is not enough to wait until consumers ask for a CMI; health professionals, and especially pharmacists, must automatically provide CMIs with the prescriptions, and show consumers how to use the CMIs to take appropriate actions with their medicines.
And indeed, organisations concerned about CMI delivery are getting serious.
For one thing, the PSA has recently made two significant changes to its guidelines (PSA 2007a):
- CMI is now the appropriate primary form of medicines information, so pharmacists should not provide any other kind of written information
- PSA does not support the withholding of CMI from consumers, even if requested to do so by a prescriber; pharmacists are strongly advised to use the CMI for counselling.
For another thing, the Australian government, which is rightly concerned that the incentives it pays to pharmacists is used properly, has added its voice: as reported in an APP (Australian Pharmacy Professional) Conference 2008 news item headed ‘Lift your game on CMI: government’ (Roberts 2008), Senator McLucas told pharmacists to improve their delivery of CMI, reminding them that CMI delivery was ‘not optional, but a professional obligation’. (‘This has been a problem right from day one’, said the PSA president in response.)
And for yet another thing, ‘The Australian Pharmacy Council [APC] issues CMI warning’, cried the Pharmacy Daily (2008), citing the APC’s concern that consumers are still not receiving CMI automatically with their medicine prescriptions; and you could almost feel the exasperation when the Pharmacy News (2008), reporting the same warning, told its readers that pharmacists had ‘again been told’ to improve CMI delivery, ‘this time by the APC’.
No-one can say that the pharmacists have not been told. The inappropriate use of medicines is too high, and adverse drug events are on the increase; importantly, consumers have a right to receive accurate, up-to-date information about their medicines, of the kind that can only be provided on a performance-based, evidence-tested CMI. Pharmacists have a professional obligation to routinely deliver CMIs with prescription and pharmacy-only medicines, and to use them to counsel consumers on the appropriate use of their medicines. There really is no option here.
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