..Information to Pharmacists
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    MARCH, 2003

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    CON BERBATIS

    From a Researcher Perspective

    Pharmacy worldwide Dec-January 2003 .
    Part 1 : Public Media Reports

    This is the first of two reports by Con Berbatis after a round-world trip from 12 December to 29 January 2003.
    Part 1 summarises UK and North American public media reports on pharmacy issues (A to J in Table 1).
    Part 2 will have observations and interviews with practicing pharmacists and leading pharmacy figures in Europe, North America and Hong Kong.

    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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