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John Perrin, a member of the Royal Pharmaceutical
Society resident in Florida
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Obtaining drugs by e-mail is practised mostly for the wrong reasons
in the US. Searching the web shows that there are hundreds of US-based
on-line
pharmacies that are usually independently owned. They are commonly used
to obtain drugs without seeing a doctor. The patients decide which drug
they want, filling in a diagnosis form, and the pharmacy provides a doctor,
who signs a prescription. The drug is then mailed to the patient.
The patient is aided in making his diagnosis by the advertising of drugs
by the pharmaceutical industry and the willingness of the physician,
local to the pharmacy, to sign these prescriptions. Although the physician
will be licensed, he is clearly not the “cream of the crop”.
He may have malpractice problems or be compelled by greed. Some of these
pharmacies are “off shore” in the Caribbean, the Far East
and even Europe. NBC TV recently did a piece on such an arrangement in
Holland. The physician, when challenged, showed no remorse or regret.
Some patients use this type of pharmacy to avoid embarrassment, for example,
when they want Viagra. I know some British people obtain their Viagra
in this manner from US pharmacies. The Viagra they receive may not be
in a tablet, but in a capsule and the capsule may have been filled from
bulk sidenafil. For a low-dose, larger tablets are broken up, sifted
and divided.
This type of compounding is practised by 30 to 50 per cent of independent
pharmacists in the US. There is no effective policing of pharmacy in
the US because of the political protection that has been built up over
the years by these small businessmen and their chief supply company based
in a southern state. Other favourite products of the compounders are
inhalation fluids, hormone replacement therapy products, pain products
(intravenous and sustained release), flavouring for paediatric medicines
and drugs unapproved in the US.
Such products will clearly not be made in the UK because of the model
policing of pharmacy by the authorities. And to their credit the Australian
authorities have moved to stamp out this compounding practice, centred
around the same supply company, before it reaches the cult status it
enjoys in the US. The flavouring of paediatric medicines is also practised
by some chains and compounding in general is practised by franchisees
of a small chain. Some publicly traded companies, involved in specialised
services such as home inhalation therapy and IV infusion, are also involved
in compounding but demand prescriptions from the patient’s physician,
usually by e-mail.
In a recent lawsuit filed in a federal court (Med 4 Home v DLJ Pharmaceuticals
[Radix] and Monte McDowell US District Court for Western District of
Missouri, August 2004), one large compounding company is suing another
following illnesses due to contamination of inhalation fluids. About
19,000, mostly online customers had to be contacted. One of these compounders
supplied the other with two million vials a month.
Prescriptions are usually shipped by normal mail from online pharmacies.
This makes theft a possibility but such a problem has not been brought
to my attention. However products can be exposed to extremes of temperature
during shipping. (Some major pharmacy chains offer an ethical e-mail
service as a convenience to their patients, with the prescription usually
being picked up at the pharmacy.)
The online pharmacy programme
accepted by the UK government is closer in design to US mail order pharmacy
than US online pharmacy. In the US the chronically sick patient sends
his doctor’s prescription to the mail-order pharmacy and receives
a three-month supply by ordinary mail. Such pharmacies are huge and are
capable of handling enormous quantities of drugs. They are probably owned
by the patient’s insurer or are under contract to that insurer,
ie, the patient has no choice of pharmacy.
This is ethical pharmacy and the drugs are genuine but even under this
system, my concern is of shipped products being exposed to extremes of
temperature. In the US mail is placed in the owner’s mail box which
may be close by but, in remote areas, may be several miles away from
the residence and not collected on a daily basis. The UK mail system
makes this less of a problem in temperate Britain — or does it?
An article in the Journal of the Royal Society of Medicine (2004;
97:328–9)
drew attention to the effect of heat, after last summer’s heat
wave, to drugs carried in doctors’ bags and stored in their car
boots. This caused me to wonder if pharmacists in the UK warn mothers
to take their newly reconstituted paediatric suspensions straight home
and not to dally over lunch or shopping. I suspect not. A few hours in
a hot car can significantly lower the concentration of clavulanic acid
in Augmentin suspensions, for example. Obviously such products are not
for the chronically sick and not appropriate for online pharmacies. The
Royal Pharma-ceutical Society will need to draw up a list of drugs that
are unsuitable for online prescriptions.
Bulk buying by US pharmacies and the provision of three-month quantities
to the patient results in significant savings to the insurers and the
insured. Furthermore, distance is not an issue in mail order pharmacy
in the US. Even if the patient lives next door to the pharmacy his medicine
must still come in his mail. As I understand it, the UK online service
is intended for the chronically ill who cannot easily reach a pharmacy,
and shipping is by registered mail. Might it be an option to have a three-month
supply delivered by a health worker who could evaluate the patient and
possibly perform appropriate tests? Ultimately this might be less expensive,
and require less policing than will be needed for online pharmacy.
A further problem is now arising from the US. Prompted by the bizarre
pricing of drugs some US individuals, organisations and communities have
started to purchase drugs from Canada, often online.The manufacturers
are retaliating by stopping the supply to the Canadian pharmacies that
offer such services.The manufacturers and the Food and Drug Administration
say that counterfeit drugs are involved — and this in spite of
the fact that the FDA is reluctant to stop the supply of millions of
doses of counterfeit compounded drugs taken by Americans on a daily basis
for fear of political reprisal. Even an ultra right wing politician has
said: “Nonsense. Show me the dead Canadians!”
Recently the State of Illinois has said it is considering obtaining drugs
from Ireland and the UK for its employees, no doubt online, and the FDA
has already implied that such drugs could be counterfeit. The UK Govern-ment
and the Royal Pharmaceutical Society need to have a plan to handle these
proposals. Of course, were the US government to negotiate with the manufacturers
over the price of drugs, these problems would be redundant — but
that would be socialised medicine! |
The
Pharmaceutical Journal