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Pharmedia Commentary - Schedule 3, CMI's and Counselling

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	Neil Johnston articles by this author...
Introducing current ideas, perspectives and issues, to the profession of pharmacy

Australian pharmacy has been innovative in many of its activities when compared to pharmacy development in other countries.
Schedule 3 is one such innovation where drugs are able to be sold without prescription but require counselling support from a pharmacist, perhaps backed up again with written information such as a Consumer Medication Information (CMI) leaflet or other acceptable format. The US is moving towards a Schedule 3 equivalent and so it seems is the UK according to the letter below by Jeffrey Aronson, published in the BMJ in May 2009.
Concerns have been raised for some time about S2 and S3 implementation in Australia and pharmacies have come under criticism for the management of this schedule.
Not all patients require ongoing counselling with repetitive sales of a single product and there is patient resistance to accepting CMI's with every sale. They see it as wasteful in terms of paper usage and duplication of existing knowledge and information.
There is also not a full support from pharmacists for CMI's because of the way they are structured.
There is a perception that CMI's are more for manufacturer protection rather than for patient education.
Pharmacists had little input into CMI original design when they were first conceived, and see little reason to support them.
The bureaucratic "stuff up" in this area has given critics of pharmacy a wider range of options to highlight and portray pharmacists as being unprofessional and not doing their job.
Jeffrey Aronson sees pharmacists as providing a monitoring and referral function utilising linked electronic records that extend to facilitating research into patient outcomes.

This all sounds great, but in the Australian climate, how is this all going to be paid for?
On paper it looks good and could be a great impetus for clinical pharmacists, but who is going to supervise the relentless flow of prescriptions (electronic or paper-based) to generate sufficient time to accommodate this service and how will the cost be maintained at an economic level.
Given the competition waged by warehouse style pharmacies, there will never be sufficient product margin to fund all this activity.
So where to from here?
Two related papers have been recently published.
One is about Schedule 3 (here) and the other is about couselling (here).
Please read these papers in conjunction with the BMJ letter to inform yourself about the material being published that government will refer to when making decisions involving schedule 3 drugs and their availability.
Then read Mark Coleman's commentary to see if you agree and please register your own comments through the link at the base of this page.

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Ref: BMJ 2009;338:b1899

Increasing access to medicines

Time for category of pharmacist consultation and supply

Finch and Garner are rightly concerned that bacterial resistance will increase when drugs such as azithromycin become available over the counter.¹ And there is a more general problem about switching a prescription only medicine (PoM) to pharmacy status (P).

Drugs that have switched from PoM to P have traditionally been used in treating minor ailments or injuries, health promotion, or palliative care. However, in recent years, in political response to a perceived public demand for readier access to medicines, increasing numbers of medicines have been switched. At the same time, medicines have become readily available to the public by direct purchase over the internet, giving them the chance to bypass the prescription only barrier, without guarantee of quality, safety, and efficacy. Categories of drug that pose particular problems when switching is demanded include lifestyle drugs such as sildenafil, which is currently being considered for P status, and long term treatments such as simvastatin, which has been given P status in too low a dosage formulation to be fully effective.

There is now a case for creating an intermediate category, pharmacist consultation and supply (PCS).² Briefly, a PCS medicine would be available for purchase from pharmacists, who would monitor its use and either repeat the order if they considered it appropriate or refer the patient back to the doctor. Pharmacists who supplied PCS drugs could be required to inform the patient’s doctor, via linked electronic records if available, thus controlling the extent of supply and facilitating research into outcomes. A PCS scheme would be comparable to the pharmacist only scheme in Australia and the restricted medicines scheme in New Zealand.^{3 4} It would provide safeguards and improve the availability of some medicines under more careful control than is currently available for over the counter medicines.

Jeffrey K Aronson reader in clinical pharmacology, Department of Primary Health Care, University of Oxford, Oxford OX3 7LF jeffrey.aronson@clinpharm.ox.ac.uk

Competing interests: None declared.

1. Finch R, Garner S. Increasing access to medicines. BMJ 2009;338:b1397. (7 April.)
2. Aronson JK. From prescription-only to over-the-counter medicines (‘PoM to P’): time for an intermediate category. Br Med Bull (in press).
3. Emmerton L. The “third class” of medications: sales and purchasing behavior are associated with pharmacist only and pharmacy medicine classifications in Australia. J Am Pharm Assoc 2009;49:31-7.
4. Norris PT. Purchasing restricted medicines in New Zealand pharmacies: results from a “mystery shopper” study. Pharm World Sci 2002;24:149-53.

Mark Coleman Comments

There is no doubt about it, Jeffrey Aronson is on the right track.
But before the pharmacists of Australia can commit to this process there has to be a tidy up performed in-house.
First point, the split between pharmacy owners and employed pharmacists needs to be recognised.
While pharmacy owners follow straight retail processes involving minimal pharmacist participation, there will be insufficient margins to cover pharmacist wages, let alone the development of new services.
Second point, there needs to be a direct reimbursement by government to the pharmacist (not the pharmacy, as it is currently structured) for the delivery of counselling and CMI, and it should embrace S3 and counselling activities outside of the PBS as well as mandated PBS clinical type services.
This will provide stimulation to refine and provide good quality services through clinical pharmacists.
Third point, while the type of information delivered to patients needs to have consistency in the form of a CMI, the actual coalface material delivered by the pharmacist to the patient needs to evolve out of each clinical pharmacist's professional experience.
Quite often this will take the form of a checklist of basic details that need to be collected, plus reinforcement information relating to drug administration and safety aspects that is to be relayed back to the patient.
Fourth point, the data collection should be with a system that can be networked or uploaded into the standard dispense system. There should be a dedicated computer in a privacy area specifically for counselling and the sale of S3 items.
Input to this system should be as fast as possible - swipe of medicare card, swipe of driver's licence, scanning system for other documents that can be converted to text and images in the same database.
Fifth point, pharmacists that embrace this activity will possibly evolve to servicing pharmacies as a contractor. In that format they will invest a proportion of their own capital into developing and extending the S3/counselling services.
This could include direct investment into computers and system software, also education to create accredited clinical pharmacists to prescribe schedule four drugs for patients (provided they do not have a financial interest in a pharmacy).
Sixth point, boundaries need to be established around the ownership of any information derived from this type of activity.
Because clinical pharmacists will be acting in a consultative form, technically they can claim title to the information.
Information of this type will form the base for research that may be able to be on-sold to generate other income streams.
Seventh point, government is keen to downschedule drugs safely as a means of delivering medications more economically. Independent clinical pharmacist contractors can facilitate this process, provided there is an equitable share in the savings generated between both parties.
Jeffrey Aronson points to the transfer of azithromycin and Viagra to schedule 3, and the potential for bacterial resistance to develop with incorrect use of azithromycin.
This would be effectively dealt with using clinical pharmacists embedded in pharmacy environments to deliver integrated health services.
Eighth point, clinical pharmacists will have to formally organise themselves into a political lobby group in order to provide the umbrella structure to back up the services provided and to manage government grants.

The current system of community pharmacy is depressing to say the least, and pharmacy owners appear to be developing the model of a discount retailer.
To me that implies developing a model that can be sold quickly to a major retailer when the time comes, rather than investing for the next generation of pharmacists.

The other consideration is that Australian pharmacy has not demonstrated that it should be the sole custodian for drugs, and downscheduling to a level that allows major retailers (non pharmacy) to participate. They may even consider hiring their own pharmacists to provide the necessary advice, thus putting pressure on pharmacy human resources and allowing traditional income to escape as drug inventories build up elsewhere.

Pharmacy needs to develop a whole of profession plan and begin to get its act together immediately.
The consequences of not so doing are evidenced by the continuing and accelerating erosion of the primary health agenda.

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