FDA proposes new class of medicines

This is an old article, but I thought it was interesting to see that the FDA is considering a "behind the counter" status, much as we have in Canada.

From the Dallas Morning News:
Physicians might be losing their lock on Americans' medicine cabinets.

For years, consumers either showed up at the drugstore with a doctor's prescription or settled for less powerful medications sold over the counter.

Now the U.S. Food and Drug Administration is considering creating a class of medicines dubbed "behind the counter." It would let consumers buy routine medicines that could include birth control pills, cholesterol drugs and migraine medicine without a prescription – as long as they discuss it with a pharmacist first.

Pharmacists and drug companies like the idea; doctors think it's dangerous. If approved, the new drug classification could go into effect as early as next year.

"We believe having certain drugs behind the counter but available only after a consultation with a pharmacist could significantly increase patient access," said Ilisa Bernstein, the FDA's director of pharmacy affairs. ...more

Misadventures in medicating

From the Victoria (BC) Times Colonist:
Many of the patients filling Canada's crowded hospitals are there because of side effects and other problems with their medication -- and most of those drug "misadventures" could be prevented, a new study suggests.

Almost one in four admissions to the internal-medicine ward of British Columbia's largest hospital was the result of adverse drug reactions, doctors prescribing the wrong medicine or similar glitches, the study found.

The lead researcher says he expects similar results from a follow-up look at emergency cases that has just been completed. ...more

A few older posts below

The next four posts below are from a couple of weeks ago that are interesting reads and are not really that time sensitive.

Be aware of cough syrup abuse, parents told

From the Whitehorse (YT) Star:
Porter Creek Secondary School’s drug awareness co-ordinator is warning parents to watch for any over-the-counter medications their kids are bringing home.

Doug Green began his three-year contract for the Canines for Safer Schools program in September.

During an interview Tuesday, he said it’s become clear there are students who are using high doses of what’s known as DXM, or dextromthorphan (the active ingredient in many cough syrups and cold medications), to get high.

“It was one of the first things that hit my radar when I came up here and it wasn’t exclusive to this school,” he said.

Already, he’s spoken to two students about using DXM, but Green stressed it’s not exclusive to Porter Creek Secondary School or even Whitehorse.

It’s an issue in many regions as Internet forums and web pages have sprung up on the subject.

Many of the pro-use sites include suggestions on how much to use to get high given a person’s weight, but don’t point to the negative effects which come with the drug use. ...more

Study questions long-term use of Alzheimer’s drugs

From the National Post:
As the main class of drugs licensed to treat Alzheimer's disease in Canada, they have limited impact on the devastating illness at the best of times. Now a troubling new study suggests that cholinesterase inhibitors may often be prescribed long after they can do any good, potentially exposing patients to unpleasant side effects for no real reason and burdening taxpayer-funded drug plans.

As well, more than a third of patients in the Ontario-based study were at the same time taking other drugs that would counteract the Alzheimer's pills' positive effects.

"We're using them much longer than they've ever been studied for and we're using them longer than they are in other locations," said Dr. Nathan Hermann, the study's lead author and head of the psychiatry division at Toronto's Sunnybrook Health Sciences Centre. ...more

Extend dental coverage, doctors urge

From the National Post:
Something must be done to extend health insurance for dental care and prescription drugs to the millions of Canadians who lack such coverage now - even if taxpayers end up footing the bill, the president of Canada's largest doctors group said yesterday.

Brian Day is best known for wanting to give the private sector a bigger role in health care, but after a speech in Toronto, the new head of the Canadian Medical Association advocated essentially expanding the public system. He lamented the fact that some Canadians have health insurance through their workplace that pays for dental care, medication and other health needs not covered by government plans - while many have no such coverage.

"There is something wrong with 30% not getting their drugs paid for, getting a bill when an ambulance takes them to a hospital, not having their crutches paid for," Dr. Day told reporters. "I think they should get it, somehow. And if they can't afford to pay the premiums, the government should pay the premiums for them." ...more

Drug body's advice against provinces paying for MS drugs seen as unfair

From the Canadian Press:
An expert panel's advice that provinces and territories not cover the cost of two Multiple Sclerosis drugs creates a system of two-tiered care, MS advocates say.

They view the recommendation as leaving people with the disease, who don't have private drug insurance, unable to afford medication that could slow progression of the condition and ease the pain they suffer.

Late last month, the Common Drug Review advised that governments not put the MS pain medication Sativex on the list of medicines that provincial and territorial drug plans cover for eligible people. That follows a "do not list" recommendation issued in the spring for Tysabri, a drug that slows progression of the disease.

Those decisions put these drugs out of reach for many people with MS, an expert and a spokesperson for the MS Society argue. ...more

Pharmacy rebates should make generics cheaper for patients: Competition Bureau

From the Canadian Press:
Many generic drug companies compete for space on pharmacists' shelves by offering rebates to the retailers - but those benefits are not finding their way into consumers' wallets in the form of lower prices, a study by the Competition Bureau has found.

The study by the independent agency found that rebates average about 40 per cent of the price the pharmacy is charged on paper for various generic drugs.

"Rebates provide incentives for pharmacies to select a particular manufacturer's product," bureau commissioner Sheridan Scott said Monday in releasing the study results.

Scott said that public sources of information and interviews conducted as part of the study show prices actually paid by pharmacies in most provinces were "on average at least 40 per cent below what the pharmacy was invoiced." ...more

Pope urges pharmacists to reject abortion pill

I thought this was relevant as I'm sure a notable percentage of Canadian pharmacists are Catholic.

From Reuters:
Pharmacists must be allowed to refuse to supply drugs that cause abortion or euthanasia, Pope Benedict said on Monday, calling on health professionals to be "conscientious objectors" against such practices.

The Pope told a convention of Roman Catholic pharmacists that part of their job was to help protect human life from conception until natural death -- the Church teaching that rules out any deliberate termination of pregnancy or euthanasia.

"It is not possible to anaesthetise the conscience, for example, when it comes to molecules whose aim is to stop an embryo implanting or to cut short someone's life," the Pope said. ...more

Chronically ill lobby for national drug plan

From the Edmonton Journal:
Early retirement doesn't look so rosy to George Rozon, when it means the end of his employee drug insurance plan that pays thousands of dollars on his medication bills.

Rozon's plan has been paying the $7,500 annual cost for his diabetes and heart medication, as well as covering drug costs for his wife.

Moving to Nova Scotia to be closer to family is also a concern. Alberta covers his $2,000 monthly bill for anti-rejection drugs needed after a kidney transplant in 2001. He doesn't know if he will qualify for such coverage in the Maritimes. ...more

Pharmacists caught in the squeeze

From the London (Ont.) Free Press:
When the pharmacist leaves his store for a break, he makes sure to take off the white jacket that identifies his profession.

"I don't want people to know I am a pharmacist," he says. "I have kids coming up to me and bugging me. 'Can you get me some Oxy?' "

It can be just as tense inside the pharmacy.

Occasionally, obvious members of outlaw motorcycle clubs have come in with legitimate doctor's prescriptions for large amounts of OxyContin, he says.

Rather than question them or the doctor, he has filled them out. ...more

New Zealand example touted at hearing on universal drug plan

From the Saskatoon Star Phoenix:
The campaign for a national drug plan arrived in Saskatoon smack in the middle of a provincial election where drug coverage is an issue.

"It is a coincidence that we are here during an election campaign," said Michael McBane of the Canadian Health Coalition in Saskatoon on Thursday.

The Saskatoon stop is the first of 13 in a cross-Canada tour designed to gather personal stories from people about their struggles to pay for prescription drugs. Planning for the hearings began last January, said McBane.

And while those making presentations on Thursday were reminded to not use the hearing for partisan purposes, NDP Premier Lorne Calvert was one of about a dozen presenters. ...more

Study to probe whether acne drug can slow MS

From CTV News:
Researchers in Calgary are preparing to begin a new study to see whether a commonly available acne medication could help delay the crippling effects of multiple sclerosis.

The medication, called minocycline, has been available for over 30 years. If it's proven effective in delaying the progress of MS, it could offer an inexpensive option for the treatment of early stages of the disease.

A small study on 10 patients a few years ago yielded promising results. Now, clinical researchers in 14 Canadian centres will be taking an in-depth look at the drug in a $4-million, two-year study funded by the MS Society of Canada.

Minocycline is a prescription antibiotic used to control acne by killing the germs that prompt outbreaks. But the drug also offers anti-inflammatory properties, which researchers believe are responsible for its ability to slow the progress of MS. ...more

FDA says safety board recommends halt to Canadian-led drug trial

From the Globe and Mail:
The U.S. Food and Drug Administration has revealed that the safety board overseeing a large Canadian-led trial has recommended the trial be stopped because of concerns the drug being tested increases the risk of death.

The FDA statement says that the Data Safety Monitoring Board has recommended no new patients be enrolled in the trial.

The study, which goes by the acronym BART, is led by Ottawa researcher Dr. Paul Hebert.

It was designed to test the drug aprotinin — marketed as Trasylol by Bayer Inc. — against other drugs used to reduce blood loss during heart bypass surgery. ...more

Part D killing small pharmacies

It's not a Canadian story, but I thought it would be a good idea to mention some of the difficulties that independent pharmacies are feeling in the States. Would a Canadian national pharmacare program have similar issues? I think it's possible.

From Newsday (NY):
While I was on the phone with Frank Deluco, a Staten Island pharmacist, he had a typical emergency.

The customer was in pain and needed his prescription quickly but couldn't figure out his benefits under Part D. Deluco filled the prescription and helped relieve the elderly customer's pain and confusion.

But Deluco, 56, whose Delco Pharmacy has been in business 40 years, may be a dying breed; thousands of neighborhood drugstores like his represent an endangered species. Deluco explained one reason why: A 90-day supply of the drug for his customer costs him $216 and change, but he'll be reimbursed only about $214 by the insurer and the Pharmaceutical Benefit Manager (PBM) he deals with.

"We're supposed to make at least $10 or $15 as a dispensing fee," he said. "But we get $1.50 or $2, so we lose money most of the time and we have no power to get a better price from the PBMs. And they're often late in paying us for the prescriptions we fill." ...more

For real relief, treat cold symptoms one by one

This article presents a key piece of information that I have given parents for years -- treat children with single entity over the counter products. Avoid the multiple ingredient products and focus on the most problematic symptom.

From the Globe and Mail:
Last Friday, an advisory panel to the U.S. Food and Drug Administration called for all over-the-counter pediatric cough and cold medicines to be banned.

The advice from the independent experts was unequivocal: These drugs should never be given to children under the age of 6 because they are potentially dangerous.

The panel members were also clear about this key point: The drugs don't work in children. They don't make a cough go away and they don't alleviate any other cold symptoms. Never have and never will.

Most manufacturers have voluntarily withdrawn some products from the market, namely those aimed at children under the age of 2. ...more

Doctors could use more info on drug costs: study

I have to concur with this article. Generally, physicians are somewhat unaware of the price of medications. I just had an example of this in my practice where a physician was incorrect in their price estimate of a drug by thousands of dollars per month of treatment. Perhaps a pharmacist working collaboratively with a physician could help these types of situations. Ultimately, costs could be contained and patient outcomes could be improved.

From CTV News:
Soaring drug bills in Canada could be cut if doctors simply paid attention to the cost of the medications they prescribe, says a new federal report.

The study, commissioned by Industry Canada, found that Canadian physicians are generally oblivious to drug prices and often prescribe an expensive pharmaceutical when a cheap one would do.

"In Canada, there is no formal mechanism that credibly brings cost into the physician's decision-making process'' when issuing prescriptions, says the report by IMS Health Consulting Inc. ...more

Expert warns against cheap vitamins

From the Victoria (BC) Times Colonist:
Canadians are taking a chance on their health by trading their strong dollars for cheaper dietary supplements across the U.S. border, says B.C. vitamin expert Lyle MacWilliam.

Canada has some of the toughest regulations in the world, he says, while the U.S. lets the industry regulate itself -- "a regulatory loophole that you could drive a Mac truck through."

Health Canada demands that supplements meet pharmaceutical-style standards, while the U.S. Food and Drug Administration lets manufacturers classify supplements as food -- a much less rigorous standard.

"There is a real cause for concern when it comes to U.S. products -- there's a lot of room for error," says MacWilliam, a biochemist and former MLA and MP who was among the experts who developed new regulations that went into force in 2004 at a cost to the federal government of $40 million. ...more

Stroke therapy fights cell death

From the Globe and Mail:
In recent years, huge advances have been made in the treatment of the most common type of stroke in which a clot blocks the flow of blood to part of the brain.

If a patient gets to a hospital within three hours of the onset of symptoms, doctors can administer a clot-busting drug that quickly restores blood flow and reduces the chances of long-term disability.

But there is a catch: A lot of patients don't make it to an emergency room in time to receive this brain-preserving therapy.

A new study suggests there may be another option for the latecomers. People treated with the antibiotic minocycline within six to 24 hours of the stroke suffered far fewer long-term disabilities than patients who didn't get the medication. ...more

Man pleads guilty to beating, locking pharmacist in trunk

From the Montreal Gazette:
Roger Grenier, who has a long history of violent robberies, doesn't remember much about his latest heist, in which he beat and robbed Outremont pharmacist Marie-Josée Caron, then stuffed her into the trunk of her car.

But yesterday, the 54-year-old Grenier, fresh from a psychiatric evaluation at the Philippe Pinel Institute, pleaded guilty to forcible confinement, armed robbery, aggravated assault and possession of a prohibited weapon. ...more