Europe
and UK
Pressures on de-scheduling ( or 'switching' in the USA) medical
prescription to non-prescription drugs continue to build in Europe
and USA the world's two pharmaceutical powerhouses.
The European Medicines Evaluation Agency said 2002 applications
for new drugs fell to 31 in 2002 from 58 in 2001 and 54 in 2000
while the USA's Food and Drug Administration reported just 16 in
2002, 24 in 2001 down from "
1996's record 53
"
(A1).
The FDA's approval time for new drug applications lengthened to
a median 15.3 months in 2002, from 14 months in 2001 and 12 months
in 2000.
The FDA lag for 'priority' breakthrough drugs jumped to 19.1 months
from under six months since 1997. The slowdowns in the numbers of
new drug registrations and approval times for new drugs cuts patent
times on the main profit-making drugs and more competition from
'me-toos' in the same therapeutic group.
Consequently switching from prescription to non-prescription status
accelerated in 1995 with H2-receptor antagonists pushed by the mighty
US pharmaceutical industry .
It has failed in 2001 with omeprazole and the lipid-lowering statins.
The UK's Office
of Fair Trading (OFT) recommended in January 2003 to the Department
of Health for the deregulation of dispensing pharmacies in supermarkets
and department stores which comprise 4.1% of all UK pharmacies
(B).
Publicly listed Boots and Alliance Unichem equities dropped in
response.
This event follows the May 2001 action to erase resale price maintenance
from over-the-counter drugs . OTC prices fell widely in the big
store pharmacies.
Their share of medicine sales will rise sharply if the OFT's January
2003 advice is taken.
Table
1. Pharmacy media reports in Europe and North America : Dec. -
January 2003
Pharmacy
topic |
Reference
|
A
.1. Requests for drug approvals fall sharply2. Approval
times for new drugs increase slightly.
|
A.1.
Dyer J. Financial Times (UK) 30 December 2003 : 13.2. Adams
C. The Wall Street Journal 16 January 2003 : D4 .
|
B.Big
stores welcome pharmacy overhaul : OFT announces prescription
for change at the chemists. |
B.Murray-West
R. Daily Telegraph (UK) 18 January 2003: 33. |
C.1.
For ill immigrants doctors' orders get lost in translation.2.
America's ethnic shift : Latinos pass blacks |
C.1.
Newman B.. The Wall Street Journal January 9 , 2003 : 1, A82.
Hendricks T. San Francisco Chronicle 22 January 2003 : A3. |
D.1.
States organising a nonprofit group to cut drug costs.2. The
overtreated American. |
D.1.
Freudenheim M. The New York Times 14 January 2003 : 1, A202.
Brownlee S. Atlantic Monthly Jan-Feb 2003 : 89-91 |
E.1.
Prescription-drug abuse soars; youth at forefront.2. Use of
'go pills' a matter of 'life and death', air force avows.
|
E.1.
Kumar A. Los Angeles Times 17 January 2003 : A30 -312. Hart
L. Los Angeles Times 17 January 2003 : A27 |
F.1.
Manitoba Net pharmacies may sue if Glaxo halts sales.2. Glaxo
backtracks on ultimatum to Canadian drug firms. |
F.1.
Zehr L. The Globe and Mail (Toronto) 14 January 2003 : B22.
Agovino T. San Francisco Chronicle 22 January 2003 : B2 |
G.New
tools can help patients reduce cost of medications. |
G.Greene
K. The Wall Street Journal 21 January , 2003 : D2. |
H.1.
Women deserve facts on abortion.2. Bitter abortion rhetoric
only marginalizes the extremists. |
H.1.
Gallagher KM. San Francisco Chronicle 22 January 2003 : A21.2.
Editorial. USA Today 22 January 2003, :A10 |
I.1.
Bigger portions, bigger people.2. Health chief faults insurers'
approach. |
I.1.
Stein R. San Francisco Chronicle 22 January 2003 : A4.2. Pear
R. San Francisco Chronicle 22 January 2003 : A4 |
USA
and Canada
Latinos or Hispanic-Americans equalled African Americans with
13% of the US population each in the April 2000 census.
Latinos are growing faster than any other minority and constitute
most of the 15% or 40 million in the US who have poor-English
comprehension (C2).
They pose big translation costs to US medical and other health
workers (C1).
Australia's community pharmacies reported free counselling to
an average 2.54 poor-English patients daily (95% CI, 2.22 to 2.86)
for their prescription medicines equating to over four million
instances annually and another reason for more remuneration!
Dozens of
States in the USA have sharply escalating multi-billion dollar
deficits.
Health care spending through State-administered health insurance
comprise a major part of the deficits and medicines are the fastest
growing component.
In 2001 New York spent $USD 2.4 billion or 7.5% of all Medicaid
on medicines - 75% more than 1998 . New York, the District of
Columbia and eight other states have combined to replace existing
private State-based 'pharmacy benefit managers' and ' drug company-
incentive driven' formularies by a shared drug benefit manager
and a list of 'drug benefits' based on expert advice on appropriate
and cost-effective drugs, a process similar to that underlying
Australia's Pharmaceutical Benefits Scheme (D1). The USA's highest-in-the-world
health spending ( by percentage of GDP ) is spread unevenly between
regions and allocated inappropriately by age and morbidity.
For example the last six months of life in the USA consumes over
20% of lifetime Medicare expenses (US health-insurance program
for the aged and disabled), and the 1-2% of people with terminal
illnesses account for 30% of health costs.
In New Jersey, Franklin Health engages nurses at $7,000 a terminal
patient saving $16,000 per case (D2).
While the
US congress has dallied with Medicare prescription-drug benefits
for needy patients, State governments and drug companies have
introduced interim relief measures through 240 programs for nearly
800 drugs .
They have also constructed free Internet sources (eg www.medicarerights.org
) to inform users on ways to obtain lower medication costs by
guiding them to government and non-government (drug company) programs,
Internet-based discount pharmacies, generic drugs and other sources
( G).
The Internet is now a large established form of providing prescription
access and medication information .
GlaxoSmithKline
Inc threatened Canadian pharmaceutical wholesalers and Internet
pharmacies in January 2003 to cut supplies of drugs being sold
for about half the US dispensed price (resulting from exchange
rate differences and Canada's capping of drug prices) to an estimated
one million Americans who access pharmacy websites or cross the
border for prescription medicines (F1).
This international dispensing , supported by some US health insurance
plans, grew so much in 2002 that other pharmaceutical companies
sent letters of concern to Canadian clients (F2).
In Curtin University's 2002 national survey, 2.4% of Australia's
community pharmacies reported offering medications online.
Of the estimated
11 million people in 2001 in the USA who reported misusing prescription
drugs for recreational or non-medical reasons almost half were
younger than 25 and nearly three million were aged 12 to 17 years
( E1).
The opioid analgesics hydrocodone and oxycodone and the combination
codeine paracetamol products ranked highest for misuse.
The 'Medical Journal of Australia' in 2000, 2001 and 2002 published
the Curtin University team's drug usage analyses showing high
levels of misuse of licit opioids and psychostimulants over the
past decade in some Australian jurisdictions.
In 1973 the
US Supreme Court ruled abortion was a constitutional right.
By 2002 rates of abortion in 15-44 year old US females had fallen
to its lowest level (H1,H2).
The 72-hours-after emergency hormonal contraceptives are now prescribed
by pharmacists in three States, Canada, UK and New Zealand.
The processes for accrediting pharmacists, consumer satisfaction,
outcomes and other experiences are being evaluated for their application
in Australia.
Nearly 1 in
4 of adult Americans and 1 in 5 adult Australians are obese (body
mass index over 30kg/m2).
National food consumption surveys (1977-78 and 1987-88) and the
US Continuing Surveys of Food Intakes by Individuals (1991 to
1996) consistently showed the consumption of much larger portion
sizes of snack foods including potato chips, desserts, soft drinks,
hamburgers and Mexican foods.
The "driving force" underlying the obesity epidemic
seems to be the "trend toward bigger helpings" ( I1).
In Curtin University's 2002 national survey, 8.7 % of Australia's
community pharmacies reported trained or accredited staff in weight
reduction and another 2.1% planned to offer a weight reduction
service in the following 12 months .
Conclusions
The growing deregulation of medicines from medical prescription
to non-prescription in the USA and towards non-pharmacy control
of distributing medicines in the UK require vigilance by pharmacy
bodies in Australia.
The custodianship and other 'duty of care' elements in Australia's
pharmacies need to be quantified to corroborate the activities
employed and facilities available to ensure the public health
and safety of non-prescription and prescription medicines .
Experiences in the USA suggest the Pharmaceutical Benefits Scheme
in Australia is a good system for access to medically prescribed
drugs and that pharmacy's custodianship of restricted drugs needs
to be evaluated by comparing licit restricted drug usage between
regions and subpopulations in this country.
The use of the Internet for prescription dispensing in Canada
and access to prescription benefits in the USA should be monitored
for their adaptation in Australia.
The free provision of counselling for prescription medicines to
patients with poor English language comprehension needs to be
compared with the USA for possible additional remuneration.
The extension of primary care services into prescribing emergency
hormonal contraception by accredited pharmacists is being worked
on by national bodies in Australia.
The epidemic of obesity worldwide and in Australia and its consequences
on many forms of morbidity together with the modest level of staff
in pharmacies trained in weight reduction indicate a heavier emphasis
in undergraduate teaching , graduate training and the wider involvement
in non-drug approaches in Australia's pharmacies.
The importance of Curtin University's 2002 national survey of
Australia's community pharmacies in quantifying health-related
activities and facilities has widespread applicability for assessing
pharmacies in the provision of preventive and health care methods
presently and in the future.
Con
Berbatis
Lecturer
School of Pharmacy
Curtin University of Technology of Western Australia
Chief Investigator
National Community Pharmacy Database Project
24 February 2003.
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