Showing posts with label Canada. Show all posts
Showing posts with label Canada. Show all posts

Monday, May 6, 2013

Chemo IV drugs weren’t properly labelled, firm says London, Ont. firm acted as broker between chemo drug provider and five hospitals CBC News Posted: May 6, 2013 3:31 PM ET Last Updated: May 6, 2013 10:50 PM


Executives from Medbuy, the company that arranged hospitals' contracts for intravenous chemotherapy drugs, told an Ontario legislature committee that the labels on the IV bags didn't accurately describe the contents.
The executives testified Monday at Ontario's standing committee on social policy, which is looking into diluted chemotherapy treatments given to about 1,200 cancer patients in Ontario and New Brunswick.
Medbuy, a London, Ont.-based group purchasing organization, works with hospitals to reduce the cost of their health-care supplies, such as medication and surgical masks.
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Friday, April 5, 2013

Chemo scandal: Pharmacists’ regulator refuses to disclose inspection reports for implicated drug supplier Despite more nearly 1,200 Canadians receiving diluted chemotherapy medication, the public has received little information about what transpired.


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The public agency responsible for licensing pharmacies in Ontario refuses to provide inspection reports for Marchese Hospital Solutions, the company that hospitals say supplied weaker-than-prescribed chemotherapy drugs for nearly 1,200 Canadian patients.
There is almost no information about what Marchese and companies like it do to keep patients safe. One researcher who investigates mistakes in health care has just launched a review of the issue.
“The study we’re doing addresses the question of how much error is occurring in the mixing process because we don’t know that with any degree of reliability,” said Tony Easty, a researcher with Toronto’s University Health Network whose review was prompted by his investigation of a fatal chemotherapy overdose in an Edmonton patient in 2006.
“We don’t know which processes are truly the optimal processes to follow,” said Easty. “We’re trying to bring evidence to that so you’re not just hoping double-checking is effective.”
His study, which focuses on hospitals that perform in-house mixing, could affect quality control in all facilities that compound chemotherapy drugs.
Ontario’s cancer care system was thrust into the spotlight this week when revelations of weakened chemotherapy doses surfaced. Outside of the fact that almost 1,000 patients in Ontario and 186 in New Brunswick were affected, the public has received very little information about what exactly happened.
Windsor Regional Hospital, where 290 people were affected, held its first town hall Friday for patients and their families. The sessions were described as emotional in a memo from hospital president David Musyj to its board of directors.
Three more patients who received the watered-down doses have since died, bringing the total to 20, according to the memo.
Investigations are underway by Cancer Care Ontario and the Ontario College of Pharmacists, in partnership with Health Canada. Premier Kathleen Wynne has also called for a yet-unnamed third-party to conduct a review.
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Sunday, November 18, 2012

Canada's Policy on Compounding Drugs

can be viewed here.  Is it better than what we have in the United States?  Is there anything we can use as a model in the United States?

Monday, October 8, 2012

Canada's Policy on Compounded Drugs

To read Canada's Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051), click here

Tuesday, September 18, 2012

Vets face difficult drug shortages in Canada


Shared from Trends Magazine found here:

Vets face difficult drug shortages in Canada 

The situation is worsening for Canadian veterinarians in desperate need of key drugs to treat their patients.
Veterinarians continue to remain in short supply of important drugs including morphine, fentanyl and Phenobarbital after production issues with generic drug manufacturer Sandoz, a subsidiary of Novartis.
A fire at a Sandoz production plant halted production of its 235 products, according to the Montreal Gazette. The fire, which broke out March 4, stopped production for about a week before limited production resumed March 12.
Making matters worse, in 2011 Sandoz began a major production upgrade at its Boucherville plant following warnings from the U.S. Food and Drug Administration (FDA) that it had discovered serious deficiencies in its production methods. The FDA warned the company that it would block its exports to the U.S. unless the deficiencies were corrected.
The upgrade caused a slowdown in production, which affected distribution of drugs to both human and animal doctors.
Suzanne Misisaszek, DVM, of Whitemud Creek Veterinary Clinic in Edmonton, Alberta, said she has had trouble finding the drugs she needs for her practice.
According to Misiaszek, the list of drugs in short supply includes glycopyrrolate, diazepam, midazolam, phenobarbital, meperidine, morphine, fentanyl and hydromorphone.
Misiaszek says that Sandoz has told her that no human drugs will be delivered to veterinary wholesalers before the end of 2012, as the priority is to supply human hospitals first.
For Misiaszek, the Canadian VMA and the American Veterinary Medical Association (AVMA) have been giving her practice the most guidance in how to approach the situation.
"This shortfall came without warning and our provincial and national VMAs have really stepped up to help with recommendations," Misiaszek said.
Misiaszek says her clinic has had to turn to alternatives for anesthesia in order to keep a reserve of anesthetics that are presently in short supply. Sometimes, compounded drugs are the only alternative, forcing veterinarians to spend more and pass on cost increases to clients.
"We are using alternative products for anesthesia in regular patients to ensure we have some of the shorted drugs for special cases," Misiaszek said. "An example of a shortfall concern is epileptic patients that use rectal valium as part of their rescue protocol. This is now unavailable without being compounded. This greatly increases the expense and decreases the shelf life of the product."
Sandoz announced that in mid-February, it introduced an allocation system based on 2011 demand which ensures that each customer receives a fair share of available medicines. Further improvements in output are expected which should increase allocation levels for all products in production to at least 100 percent of forecasted market needs by November 2012, the company announced. However, Sandoz has said it will maintain its allocation system through the first quarter of 2013, in order to avoid unnecessary stockpiling and potential backorders.
Sandoz said it had optimized production output at the plant while correcting its production practices, allowing the company to meet the vast majority of Canadian market needs for its entire injectable portfolio. In May, Sandoz Canada reported that it is now supplying more than 80 percent of market needs for its entire injectable portfolio, and more than 90 percent for the products currently in production.
"Sandoz Canada continues to make strong progress in its efforts to maintain a reliable supply of essential medicines following the temporary slow-down in production announced at its Boucherville plant earlier this year," Sandoz announced May 16, 2012.
Still, the situation is forcing veterinarians into a corner, Misiaszek says.
"We are now using more expensive drugs that we have less experience with," Misiaszek said.
Misiaszek said she is starting to use more alfaxalone, and relying more heavily on dexdomitor and using a butorphanol/buprenorphine combo instead of hydromorphone. Being in short supply of hydromorphone has led her clinic to revamp its anesthetic protocols entirely.
Misiaszek says she has also had a hard time treating seizuring patients without injectable phenobarb or valium. In such instances, she often ends up having to compound.
She recommends that veterinarians keep the shortfall drugs in stock for emergencies, using alternatives whenever possible.
"Try to be as familiar as possible with all products available to veterinarians - you never know when you will have to rely on them," Misiaszek said. "We tend to get stuck in our comfort zone."
However, cost to clients can often rise as a result of using alternative drugs.
Misiaszek also recommends webinars led by a boarded anesthesiologist that address alternative drug options.
Using an adverse event book for any new protocol instituted can also track how patients are doing on certain medication combinations, allowing practitioners to make adjustments in a timely manner, Misiaszek said.
Misiaszek says she has had to take staff time to revamp protocols, restructure ordering and pricing, and train staff on the new procedures.
Unfortunately, Misiaszek says she doesn’t see the shortage problem going away any time soon.
"This is a long term problem for us that will probably get worse as our ‘stock’ supply diminishes," she said. "I think that we will be able to cope with alternatives and compounded medications to ensure we have the proper drugs to treat our patients."
Looking long-term, however, Misiaszek says she hopes the drugs will be back in stock and that Health Canada will not source all of the drugs to only one supplier in the future.

Wednesday, September 12, 2012

Nevada State board reprimands doctor Who Used Compound Purchased on Internet from Canadian Pharmacy Not Licensed in State


Tuesday, Sept. 11, 2012 | 9 p.m.
In another settlement, the board said Dr. Samuel Beck advertised Botox injections, mostly sought by women at his Allure Med Spa in Reno. In reality he was injecting a compound called "Dysport" purchased on the Internet and a Canadian pharmacy not licensed in Nevada.
The board dismissed the counts in the complaint that accused Beck of false advertising by having a large sign on the front window of his business saying Botox injections were available and brochures in his office touting Botox.
But he was penalized for using a drug from unlicensed sources in Canada. In addition to the public reprimand, he was ordered to attend 12 hours of classes on medical ethics and reimburse the board $1,337 for the cost of its investigation.

Entire article is found here.

Friday, June 29, 2012

Canadian Operator of Internet Drug Outlet Indicted for Distribution of Fake Drugs to US Consumers



Andrew J. Strempler, a Canadian citizen, was arrested by United States officials in Florida and faces charges relating to his operation of a Web site selling drug products to US residents including distribution of counterfeit and non-Food and Drug Administration (FDA)-approved drugs. “According to the indictment, from around January 2005 through June 9, 2006, Strempler and his co-conspirators unlawfully enriched themselves by selling prescription drugs to individuals in the United States, falsely representing that RxNorth was selling safe prescription drugs in compliance with regulations in Canada, the United Kingdom and/or the United States. The indictment further alleges that Strempler obtained the prescription drugs from various other source countries without properly ensuring the safety or authenticity of the drugs. In fact, the indictment alleges that some of the drugs sold by Strempler included counterfeit drugs,” indicates a press release from the US Attorney’s Office, Southern District of Florida. Strempler faces one count of conspiracy to commit mail fraud and wire fraud, in violation of Title 18, US Code, Section 1349, and two counts of mail fraud, in violation of Title 18, US Code, Section 1341. The government is also seeking forfeiture of $95 million.

Wifredo A. Ferrer, US attorney for the Southern District of Florida stated, “FDA regulations are designed to promote and ensure the safety and integrity of prescription drugs sold and used in the United States. The US Attorney’s Office is committed to assisting the FDA enforce these regulations to protect American consumers from unsafe, adulterated and counterfeit drugs.” David W. Bourne, special agent in charge, FDA, Office of Criminal Investigation (OCI), Miami Field Office, stressed that the FDA OCI is committed to “aggressively pursuing individuals” who seek to sell counterfeit, adulterated, and misbranded drug products to US consumers via the Internet. Strempler appeared in federal court on June 14, 2012, before US Magistrate Judge John O’Sullivan. If convicted, Strempler faces a possible maximum statutory sentence of up to 20 years in prison on each count.

Additional details about the charges against Strempler are available in the US Attorney’s Office
press release. The indictment (PDF) is available for download from the Department of Justice Web site. The press release notes that an indictment is only an accusation and a defendant is presumed innocent until proven guilty.