The Newfoundland government can’t say yet whether the province’s prescription drug program will cover a new drug, OxyNEO, expected to be marketed by Purdue Pharma early next year as a replacement for OxyContin.
OxyContin, Purdue Pharma’s trademark, time-release oxycodone drug, is now available only through special authorization to people eligible for coverage un-
der the Newfoundland and Labrador Prescription Drug Program (NLPDP).
But there are at least 15 other generic oxycodone drugs on the NLPDP’s interchangeable drug formulary.
A spokeswoman for the Department of Health said Tuesday “all new medications considered for coverage under the NLPDP must be reviewed by the Atlantic Expert Advisory Committee, the national Common Drug Review or the pan-Canadian Oncology Drug Review.”
These committees are comprised of physicians, pharmacists and others with expertise in drug therapy.
Once the review has been completed, she said, the recommendations will be considered by the provincial government and a determination will be made regarding coverage.
The College of Physicians and Surgeons of Newfoundland and Labrador has notified doctors in the province that OxyContin will soon be discontinued by the manufacturer and replaced with OxyNEO.
Purdue Pharma communications manager Lucy Lai confirmed that Health Canada has approved OxyNEO, a new long-acting oxycodone product, to replace OxyContin.
She said it will be the only controlled-release oxycodone with unique properties of “hydrogelling and hardened tablets” in Canada.
“Purdue has begun discussions with provincial drug plans and other stakeholders,” Lai said, “and is working towards the introduction of OxyNEO in early 2012.”
The recommended dose for OxyContin is one tablet every 12 hours and one of the main concerns with the drug has been that abusers crush and modify the pills for faster absorption or to snort or inject the drug. It’s believed that this will be more difficult with OxyNEO.
Sandra Carey, president of the Pharmacists’ Association of Newfoundland and Labrador, said she’s aware of this claim by the company, but wouldn’t comment on that aspect of the new drug.
Having done a fair amount of speaking on drug abuse issues and misuse, Carey said, “I can tell you that the people who are using prescription drugs for those purposes have very inventive ways of being able to make these drugs work.”
It’s a big business, she said, but with respect to Purdue’s decision, “any process that stops the flow of drugs to the street is a good process.”
The removal of OxyContin from the market, however, doesn’t mean that the main ingredient in it, oxycodone, will no longer be available.
There are numerous generic oxycodone drugs available. The long list of generics in the province’s prescription drug program formulary include some with oxycodone alone and some in combination with acetylsalicylic acid or acetaminophen.
Carey said most of these drugs have been around for six or seven years and the only differences between them and OxyContin is they’re immediate-release drugs, rather than time-release drugs, and the dosages are lower, from about five to 20 mgs.
OxyContin pills contain a maximum of 80 mgs of oxycodone. A 160-mg pill was produced about 10 years ago in the U.S., but was withdrawn from the market by the manufacturer because of concerns about drug abuse.
Carey said there are legitimate chronic pain patients who take oxycodone drugs responsibly and are being cared for very well.
She said she believes these people will continue to have their pain needs met.
“That’s not the concern. The issue is the drugs that are being filtered to the street.”
Patients who are on OxyContin now have to obtain a special authorization to have it covered under the province’s drug program, Carey said.
“So, they have been through a process which shows that this is the drug that works best for them and I’m sure that after some review, the department would look at (OxyNEO) in the same way.”
Carey said prescription drugs “have a huge capacity to do good when used appropriately and an even bigger capacity to do harm if not applied properly.”
It doesn’t matter if it’s OxyContin, morphine, codeine, any of the narcotics, she said — if taken for purposes they weren’t intended, they can cause harm and cause addiction.
Carey said all of these drugs, when they filter to the street, can increase the incidence of holdups at pharmacies, break-ins and thefts, and put pharmacists at risk.
The pharmacists’ association is working with the Department of Health, the provincial government and the police to make sure the needs of the public are met and the safety of pharmacists is ensured, Carey said.
When asked to comment on the generic immediate-release oxycodone pills available and the likelihood that they could be used inappropriately, Carey said, “they’re crushed, they’re snorted, they’re free-based, absolutely.”
But if drug users consume large amounts of oxycodone and acetylsalicylic acid, she said, they can damage their kidneys, while overuse of oxycodone/acetaminophen combination pills can cause potential liver issues.
OxyNEO became available in the U.S. in April 2010.
In recent years, Purdue’s OxyContin pills have been the subject of legal actions in the United States with the manufacturer accusing several other companies of infringing on its patents by producing generic versions. However, most of those legal actions, according to Purdue news releases, were resolved before they reached the courts.
Purdue’s patents for OxyContin are said to begin to expire in 2013. It’s not known if other manufacturer’s, at that time, will produce a similar generic drug.