15/12/2008 by admin.

The December 2008 issue of Drug and Therapeutics Bulletin (DTB) has two articles. The first is a review of the two HPV vaccines, ▼Gardasil and ▼Cervarix. The second article reviews ▼zolendronic acid, a bisphosponate licensed for treatment of patients with osteoporosis that requires only a once-yearly intravenous administration. The issue also contains a reminder that a full list of those people that we would like to thank for their contribution to our articles this year can be found on our website www.dtb.bmj.com.

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30/11/2008 by admin.

UK doctors will be drawn into new efforts to boost cost effective prescribing in the next few months as part of a deal agreed this month between the government and industry. The newly revised pharmaceutical price regulation scheme (PPRS), designed to cut the overall NHS drug bill by about 5% in its five year life, will result in two initiatives to change current prescribing practice.

The first initiative, to be phased in by 2010, introduces generic substitution, which is designed to save costs directly by ensuring that pharmacists switch from any branded drugs named on prescriptions to cheaper generic alternatives unless a doctor ticks a box to insist on the branded drug.

The second initiative, to be tested in pilot programmes from next year, will experiment with paying doctors to encourage them to prescribe newer, more effective drugs even when they are more expensive, in line with the latest guidance from the National Institute for Health and Clinical Excellence (NICE).

Industry estimates that about 17% of prescriptions cite a specific drug by brand, with the result that 17% of dispensed drugs are also branded. But with generic substitution, whereby the pharmacist can substitute the generic equivalent, the proportion should fall, in turn stimulating competition in pricing.

In negotiations with the government, industry preferred substitution to the originally proposed idea of imposing a flat 1.1% price cut on branded drugs for which the patent had expired as well as a cap on the price of these drugs at 50% more than their generic equivalents.

More importantly, industry has reached agreement for measures designed to stimulate and reward innovative drug development through “prescribing incentive schemes”; payment by results; and publication of the uptake of “clinically and cost effective medicines,” locally, nationally, and internationally.

The measures are designed to respond to industry’s frustration that the NHS lags behind many of its counterparts in other countries in using newer drugs, such as recently approved treatments for cancer.

The government will provide a better process in which companies that face having NICE recommend against the NHS paying for their drugs can reopen discussions about pricing with the Department of Health. It will also allow drug companies to raise the price of existing drugs if subsequent clinical data show additional cost and clinical effectiveness.

These measures, combined with fresh industry pledges to make drugs not yet approved by NICE more widely available, could help to defuse the current tensions surrounding expensive new cancer drugs.

Harpal Kumar, head of Cancer Research UK, welcomed the initiatives as a way to boost patients’ access. But the NHS Confederation warned that primary care trusts could need assurances of additional funds and improved access to the latest assessments to implement NICE guidelines more fully.

The new PPRS is staggered, with an initial 3.9% cut to the price of patented drugs due to start in February 2009.

The delay reflected lengthy discussion on the fine print and concerns that its introduction at the start of the year could stimulate more export of drugs by UK wholesalers to more profitable markets elsewhere in Europe, creating shortages in pharmacies in the holiday period.

BMJ 2008;337:a2699

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07/11/2008 by admin.

The November 2008 issue of Drug and Therapeutics Bulletin (DTB) has two articles. The first is a review of ▼Alateris, the first licensed glucosamine (as hydrochloride) available for osteoarthritis. The second article reviews ▼ivabradine, the first of a new class of drugs for stable angina. The issue also contains short corrections for two previous DTB articles: What role for ▼tigecycline in infections? (August 2008) and ▼Retapamulin for impetigo and other  infections (October 2008).

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07/10/2008 by admin.

 Plans to make two antibiotics for treating urinary tract infections available to buy over the counter in the United Kingdom rather than being prescription only are governed by commercial rather than public health concerns, say doctors and pharmacists.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is currently considering reclassifying trimethoprim and nitrofurantoin for the treatment of uncomplicated urinary tract infections, such as cystitis.

The move follows the agency’s approval earlier this month of a similar switch for the antibiotic azithromycin, for the treatment of chlamydia infection.

But members of the British Society of Antimicrobial Chemotherapy oppose the move, the GPs’ magazine Pulse reports (www.pulsetoday.co.uk, 28 Aug, “Fury over decision to make first mainstream antibiotic OTC”). In a letter to health ministers they express concerns that “approvals of this type are determined commercially and not on the basis of medical need.”

doi:10.1136/bmj.a1538

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07/10/2008 by admin.

An unprecedented attack on drug companies’ prices by the head of England’s drug approvals body shows that it is jockeying for a key role in the forthcoming overhaul of drug pricing, observers say.

Michael Rawlins, who chairs the National Institute for Health and Clinical Excellence (NICE), has criticised the industry for profiteering. In an interview in The Observer (www.guardian.co.uk, 17 Aug, “Health chief attacks drug giants over huge profits”) he said that drug companies aimed for “double-digit growth year on year … not least because their senior management’s earnings are related to the share price.”

“All these perverse incentives drive the price up,” he said.

His comments came after NICE was criticised fiercely for failing to approve a batch of new kidney cancer drugs (BMJ 2008;337:a1262, 14 Aug, doi: 10.1136/bmj.a1262).

Joe Collier, an emeritus professor of medicines policy at St George’s, University of London, said that Professor Rawlins was “jockeying for a central role in price negotiation” in the forthcoming overhaul—due to be announced in the next few months—of the pharmaceutical price regulation scheme.

Richard Barker, director general of the Association of the British Pharmaceutical Industry, said, “NICE was not created to set medicine prices—nor indeed to drive them down, as NICE’s chairman now seems to see as his mission.”

BMJ 2008;337:a1422

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07/10/2008 by admin.

 In the United States, commercial support for continuing medical education has grown steadily over the past decade. In 2006 it provided more than half, about $1.5bn (£0.75bn, 0.95bn) or 60%, of the income for educational programmes doctors must take to maintain their medical licences. Evidence shows that commercial support distorts what doctors learn.

In 2007  the Josiah Macy, Jr conference on Continuing Education in the Health Professions: Improving Healthcare Through Lifelong Learning (www.josiahmacyfoundation.org) recommended ethat organisations providing accredited continuing education should not receive commercial support from drug or medical device companies.

BMJ 2008;337:a1023 (http://www.bmj.com/cgi/content/full/337/aug14_1/a1023?eaf)

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07/10/2008 by admin.

 Doctors in the United States should brace themselves for a substantial decrease in conference dinners but a big increase in the quality of drug industry sponsored education. Responding to criticisms of the way that continuing medical education is funded by the drug industry and run by profit making, third party companies, Pfizer last month decided to cut education funding in 2008 from $80m to $60m (£43m to £32m; 55m to £41m). Its decision indicates a sea change in sponsorship of continuing education in the US that could have implications for the United Kingdom.

“Our analysis demonstrated that higher quality grants would increase the percent of funding that directly benefited learning while reducing expenditures on non-educational expenses like meals,” the company stated. By September it says some 90% of its funding will go into educational programmes run by academic institutions, hospitals, or medical societies.

In January, a report by the influential Manhattan based philanthropic institution, the Josiah Macy Foundation, went even further, concluding that drug manufacturers should not support continuing medical education.1 It says industry sponsorship affects the independence of doctors, invites bias, endangers professional commitment to evidence based learning, and promotes and validates an “entitlement” mindset among doctors that education should be paid for by others. It also says the conference lecture circuit isn’t improving patient care, it’s simply about “promotion and physician welfare.”

BMJ 2008;337:a1399 (http://www.bmj.com/cgi/content/full/337/aug26_1/a1399?eaf)

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07/10/2008 by admin.

Continuing medical education has become so heavily dependent on support from drug and medical device companies that the ethical underpinnings and the reputation of the medical profession may be compromised. Continuing medical education is compulsory in Italy, and the Ministry of Health has recommended that local health authorities spend 1% of their total budget on educational activities. Nevertheless, most authorities spend much less than the recommended amount and up to 60% of the money comes from drug companies.

Here, Alfredo Pisacane gives an interesting  proposals for limiting the commercial support to continuing medical education including concentrating on small groups, agreeing objectives for educational activities, evaluating providers, health institutions committing resources, making use of new technology, creating a central fund, asking doctors to pay.

BMJ 2008;337:a973 (http://www.bmj.com/cgi/content/full/337/aug14_1/a973)

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02/10/2008 by Merav.

The October 2008 issue of Drug and Therapeutics Bulletin (DTB) has three articles. The first is a review of ▼aliskiren, the first of a new class of antihypertensive drugs. The second article reviews ▼retapamulin, a new topical antibiotic licensed for impetigo and other skin infections. The third article reviews ▼erdosteine, a mucolytic, and whether it has a place in COPD exacerbations. Go to http://dtb.bmj.com/ to have a read.

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22/09/2008 by Merav.

Bristol will be holding the pharmaware AGM in February 2009. The team would like to get some input from you, current members as to what content you would like to include in this AGM, especially if there is anything that you would like clarified or would help a new branch to grow. They would also like to know if anyone has any suggestions for the debate to be held at this AGM. Contact them at Bristol@pharmaware.co.u

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