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Manipulation of Pharmacists is now Excessive

Peter Sayers
Pharmacy Practice Management Perspective

Issue 71: May 2008
Page: 1 of 1 Author's Profile | Send to a Friend | Printer Version

Every day it seems that some group of individuals seem to wish for pharmacy control or manipulation to suit their view of the world.
This group contains diverse organisations such as Choice, global manufacturers, major retailers media groups and various government agencies.
Recently, we have seen the upscheduling of infant medicines containing antihistamines and pseudoephedrine, moves to upschedule Nurofen Plus to schedule 8 and now an attempt by the TGA to add a layer of regulation to compounding pharmacies.
This activity must be stopped in its tracks.
Reeling from one blow after another, community pharmacists can be forgiven if they feel they are a target.


Australia was the first western economy to introduce a pharmacist-only group of medications that could be sold without a doctor’s prescription, but requiring  patient counselling as an alternative. The flack pharmacists took initially, in the formation of a schedule 3, was that they would monopolise this group of medications and profiteer from them.
Well that never happened. Quite the reverse in fact because Australia ended up with a supervised group of affordable medicines for those genuine patients in need (as distinct from those involved in diverting drugs for other purposes).

The system has worked well, particularly for children under the age of 2, as there has been no evidence of Australian misadventure in the sale of cough and cold remedies.
The position overseas, particularly in the US, is a totally different picture.
Medications are sold openly in supermarkets and do not require professional supervision, and as a direct result, there has been recorded misadventure, including death.
It is particularly demeaning that the Australian drug scheduling authority (NPDSC) has ignored local evidence and simply fallen in behind the US experience.
Don’t these people have a mind of their own?
One must also query the collective quality of their decision-making as well as the total costs, ranging from “bums on seats” at meetings and having a talkfest about nothing, plus being highly paid from taxpayer monies to achieve decisions that have further negative consequences.

Parents must now visit a doctor at a much higher cost, or if deterred from this course, allows their child to have their condition worsen, requiring hospitalisation at a much greater cost again.
And, of course, there is the loss of revenue by pharmacy in such a market shift.
We are seeing similar undertones in the review of regulations controlling compounding pharmacies.
In February of this year I wrote of an organised campaign by US drug companies to lobby the FDA to prevent pharmacists from compounding a range of drugs that has more to do with the impact on the bottom line of a manufacturer than with supposed problems generated through compounding pharmacies.
Accompanying the story was a warning to watch for similar moves here in Australia.

The February story and link follows:

“Compounding Pharmacists vs Global Manufacturers - a War That Must be Won

http://archive.i2p.com.au/?page=site/article&id=913

There is a war about to erupt in the US in which compounding pharmacists, a significant group of anti-ageing physicians and health professionals, are squarely in the front line.
It seems very much about corporate greed and the US system of drug regulation that appears to have become corrupted.
The Food and Drug Administration (FDA) is almost totally funded by the proceeds of the registration of a manufacturer’s products.
The potential to be “soft” on manufacturers rises exponentially with any possible loss of revenue that may occur if a manufacturer cannot patent and register a product e.g. as in the case of bio-identical hormones.
The war has the potential to erupt around the world, including Australia, as s global drug manufacturers seek every means of controlling the sale of medications to exclude any form of competition.
Compounding pharmacies and community pharmacies have become unwitting pawns in this race to world domination.
Australian pharmacists need to study and support their US “cousins” in the battle that will impact here in Australia, to an extent that will only be limited by how well local pharmacists organise to face this threat. Global drug manufacturers seek every means of controlling the sale of medications to exclude any form of competition.
Compounding pharmacies and community pharmacies have become unwitting pawns in this race to world domination.
Australian pharmacists need to study and support their US “cousins” in the battle that will impact here in Australia, to an extent that will only be limited by how well local pharmacists organise to face this threat.”

The devil in the Australian detail is that the TGA is seeking to limit compounding only to drugs that are listed on the Australian register.
Just because drugs do not appear on the register does not mean they lack efficacy – only the lack of funds to generate clinical trials to generate a listing.
This occurs commonly where a drug may not be able to be patented because it occurs in nature

Much like the US efforts; the moves here in Australia appear to be targeting bioidentical hormones.

These are the hormones you and I spend today and the rest of our lives with and are essential for good health. Evidence is accumulating that disruption of these hormones can lead to the development of major lifestyle diseases.
It only takes commonsense, not clinical trials, to understand that if bioidentical hormones are prescribed by a clinician and monitored for the normal physiological range, there will be no clinical problem.
End of story.
The only rationale for interfering with the freedom to prescribe, and to have such drugs dispensed, is political garbage and corporate greed.
It is only the synthesised hormones that have serious side effects and have dubious efficacy.

What concerns me is the lack of fighting spirit by pharmacists generally and their representative bodies.
Although compounding in community pharmacy has diminished in recent years, it does not mean that it should be thrown away.
It is core business!
And it may be a useful tool to get around some of those other restraints e.g. the scheduling of infant cough mixtures.
Surely pharmacists can formulate a safe alternative pediatric cough mixture without unreasonable restraint?

What is being proposed in the regulation of compounding pharmacies is a restraint on professional practice.

Are you all dead out there?


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