Generic Depakote gets FDA approval
July 31, 2008
A generic version of Depakote delayed-release tablets (divalproex sodium), used to treat seizures, bipolar disorder, and migraine headaches, was approved this week by the Food and Drug Administration. “Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high-quality, safe, and effective drug as the name product,” said Gary J. Buehler, director of the FDA’s Office of Generic Drugs. “This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder, and migraines.” The generic version will carry the same warnings as Depakote (Abbott Laboratories), cautioning against the risk of liver damage and pancreatitis. Separately, Noven Pharmaceuticals reported that its Stavzor (valproic acid delayed-release capsules) has received FDA approval. Like divalproex sodium, Stavzor is also indicated for treating bipolar disorder, seizures, and migraines. However Stavzor is not interchangeable with Depakote.
Via Drug Topics
HPV vaccine is linked to more adverse incidents
July 29, 2008
Judicial Watch, a public interest group that investigates and prosecutes government corruption, reported that it has obtained new Food & Drug Administration records about Merck’s vaccination for human papillomavirus (HPV) Gardasil. The records show that there have been 10 new deaths since September 2007 and 140 serious adverse events since January 2008. These new data come on top of thousands of adverse event reports that Judicial Watch had obtained previously from the agency. In light of these negative incidents, Judicial Watch urges FDA to refrain from mandating this vaccine for children and reevaluate its safety for minors.
By Judy Chi, DrugTopics.
Technician Discovery Brings down Pharmacist
July 25, 2008
David T. Flaherty IV, a former Rite Aid pharmacist, told police he created a complex system of fake profiles for fictitious customers that allowed him to steal about 7,800 Oxycodone and amphetamine pills from the pharmacy in Connecticut.
Flaherty told police a three-year addiction to painkillers fueled the theft and, at the height of addiction, was taking 25 Oxycodone pills each day.
According to Flaherty’s arrest warrant released on Tuesday in Waterbury Superior Court, his elaborate system of defrauding Rite Aid unraveled after he left a single Oxycodone pill in a counting tray and it was discovered by a pharmacy technician.
Flaherty surrendered to police earlier this month after a warrant was issued for his arrest. He’s charged with third-degree larceny and 79 felony counts of fraudulently obtaining a prescription through the use of a false name.
Flaherty, who said he worked for Rite Aid for about 10 years, told police he fabricated the names of 20 customers and used them to fill illegal prescriptions for himself.
He told police the names he created for the fake profiles were similar to names of actual customers. He used legitimate prescriptions on file to obtain Oxycodone and amphetamine. At the same time, he would fill an antibiotic script using his own name, or that of his dog, but would put Oxycodone pills in the bottle and check out. Flaherty would then ring up a soda for $2 and place $182 in the register so the money in the till would balance the purchases made throughout the day, according to the warrant.
Police said Flaherty did this for more than a year. His system was uncovered in May when the stray pill was found. That’s when store officials became suspicious and started investigating. They found Flaherty was the last person to fill an order for Oxycodone which should have been in the store, but wasn’t found, according to his arrest warrant.
Flaherty’s addiction to pain killers started when a customer found her son with some pills and brought them to Flaherty for him to identify. Instead of throwing them away, he took them for himself.
According to Flaherty’s statements, he has practiced pharmacology in New York state and Vermont. Records filed with the state’s Department of Consumer Protection show he surrendered his pharmacist’s license in May.
Flaherty’s attorney, Audrey J. Porzio, appeared in court to have the case postponed to Aug. 6. Porzio declined to comment on any specifics until she could review court documents. She did say her client worked long shifts, often 12-14 hours each day.
“It’s an extremely stressful, demanding job as a pharmacist,” she said.
BY JON SHUGARTS REPUBLICAN-AMERICAN
Aetna formulary now on-line
July 23, 2008
Aetna has set up a Web site expressly for pharmacists, providing participating pharmacy providers with access to drug pricing information, formularies, a guide to Aetna’s policies and services, and other resources. Pharmacists must register to get in. The assigned username will always be the pharmacist’s NCPDP number.
The Website address is www.aetnapharmacists.com.
Teva to buy Barr
July 23, 2008
Teva, the world’s largest generic drugmaker, has agreed to buy Barr Pharmaceuticals, the No. 4 generic player, for $7.6 billion. Teva will also assume $1.5 billion in outstanding Barr debt. The two companies said the deal should close during the fourth quarter. The combined company will have a portfolio of over 500 products, more than 200 ANDAs pending with the FDA, and about 3,700 product registrations pending worldwide. Bill Marth, president and CEO of Teva North America, said the new company will control about 24% of the U.S. generic drug market, well below the threshold that should trigger any antitrust concerns. The acquisition deal is subject to antitrust approvals in the United States and Europe as well as by Barr shareholders.
Article: Fred Gebhart
Via Drug Topics
E-Rx on controlled drugs possible.
July 21, 2008
Last month I posted a news update about the possibillity to the FDA allowing e-prescriptions for controlled substances. Today, DrugTopics has posted an update to the new rule, moving closer to approval.
The proposed rule, released in June from the Drug Enforcement Administration, will enable physicians to prescribe controlled medications electronically. The rule also features security controls for physicians and pharmacists, which increase possible liabilities.
Physicians will be required, according to the rule, to register in person with law enforcement agencies and allow for routine audits by third-parties of prescription records. The weekly mandate would require pharmacists to prove that physicians prescribing the drugs are licensed and in good standing. It would be the responsibility of pharmacists to maintain an electronic record of prescriptions and inform DEA of any security breach within 24 hours.
*Administratos note: Seems to me that this could place some undue burden on both pharmacist and doctors to relieve minor inconveniences for the few laws already in place. Opinions?
Free Law C.E.: Medical Marijuana
July 19, 2008
The following link will take you to a free law C.E. about the use of Medical Marijuana. The goal it to review the proposed medical uses of marijuana and the effects directed towards its legalization or decriminalization.
It is hosted by TheCESolution.com and requires free registration to take the exam.
Click here to read the monograph. The TAKE EXAM link is at the end of the course.
Court of Appeals Overturns Temporary Restraining Order on Ten Percent Medi-Cal Cuts
July 19, 2008
The California Pharmacists Association was shocked to learn late Wednesday night that the Ninth Circuit Court of Appeals reversed the injunction blocking the ten percent Medi-Cal cuts to pharmacy. This news came in just minutes after CPhA issued a news release decrying the Department of Health Care Services delay in removing the cuts per the TRO through their fiscal intermediary.
In DHCS’ appeal they asserted that the losses suffered by pharmacies are outweighed by the cost the State would suffer to implement the injunction. The court accepted this argument and rapidly reversed the injunction they issued on July 11. In further action today, the court has agreed to reconsider the injunction and will allow both parties to submit additional legal arguments on the issue by close of business on Monday, July 21, 2008.
“It is our fervent hope that the court thoroughly reads the information submitted by the plaintiff’s attorney, Lynn S. Carman, in this case,” said Lynn Rolston, chief executive officer of the California Pharmacists Association. “We are baffled by the state’s assertion and know that countless pharmacies, both chain and independent, are bearing significant losses, with many reporting that they are losing hundreds upon hundreds of dollars per day. Many pharmacists have continued to serve Medi-Cal patients even though they are bearing these losses personally. We have received countless calls from pharmacists today who say the state has put them in an untenable position, forcing them, in some cases, to turn away patients, which could have disastrous consequences.”
“This puts me in the position of a terrible moral dilemma,” said Jerry Shapiro, owner of Uptown Drugs and a plaintiff in this case. “I will now have to turn away these patients, which for many of them could be the equivalent to signing their death warrant.”
“I provide medications for a large number of mental health patients who will decompensate very quickly when I am forced to turn them away,” said Bruno Tching, owner of Inland Pharmacy. “I just don’t know where they can go for help other than the emergency room, which will further compound the problem.”
“It seems like the courts, the state and the legislature will only act if there are dead bodies in the street,” said Dave Wilcox, owner of ten pharmacies in the greater Fresno area.
“The pharmacists in the state remain hopeful that a solution can be found before serious problems occur. It is becoming more doubtful by the day that this crisis can be averted,” continued Rolston.
Via MarketWatch/CPHA
Teen in coma after wrong dose of medication
July 15, 2008
A teenager is in a coma because he was given the wrong dose of a pain medication. Eighteen-year-old Jessie Scott was given what was supposed to be a safe teaspoon of the drug. Actually it was a potentially lethal dose.
Jessie Scott is now at the HealthSouth Rehabilitation Center as his family and therapists do everything they can to stimulate his senses. He’s been in a coma since April 30.
The high school graduate with a 4.0 grade point average is a far cry from where he was 75 days ago. At University Hospital, Wayne and Laurie Scott were told to gather their family.
Via KSL.com
“If you’ve got family, now’s the time to call them up and let them pay their respects,” Wayne Scott said. “So we made a bunch of calls, and the family responded.”
Jessie’s organs were failing. He was on a ventilator. One lung had collapsed. Physically and mentally, he was shutting down. All this happened within hours after he was given one teaspoon of prescribed oxycodone hydrochloride to help him sleep a bit and relieve pain from a strep throat. What happened?
The prescription was filled at the pharmacy. The label clearly indicates one teaspoon every four hours, and that’s exactly what Laurie did: She gave Jessie one teaspoon in a cup.
But instead of five milligrams, attorney David Olsen says, “The dosage she gave was 20 times what was ordered. [It was] 100 milligrams instead of five. That’s because it was undiluted.”
What Laurie had in her hands was a liquid concentrate that, according to Olsen, was suppose to have been diluted at the Wal-Mart pharmacy where the prescription was filled. The Scotts still can’t believe it happened. Wayne Scott said, “This is obviously a horrible mistake.”
Laurie Scott said, “This shouldn’t have happened. It was needless. It was senseless and it’s changed lives forever, not just Jessie, but there are other people who love him and his future.”
Laurie trusted what she gave her son, what had been filled, was correct.
“I always ask questions. I’ve always medicated him his whole life. I’m the caregiver and it makes it extremely difficult,” she said.
After 16 days in ICU, Jessie moved to intermediate care for another four days, then to HealthSouth for intensive therapy.
Wal-Mart Corporation issued the following statement to KSL News: “This is a very sad situation. Our thoughts are with this young man and his family.”
There are signs Jessie is responding. For example, the eyes! His family sees response in them.
How much damage is done? How much repair will the brain pull off? Doctors don’t know. But this 18-year-old is strong, and so is his family.
Wayne Scott said, “His brain is still very plastic, still very elastic, and we’re hoping and praying that it can find ways around those areas to connect back up. That’s our hope.”
There was a dramatic turn of events this weekend. For the first time, Jessie spoke, though the words are limited and intermittent. We will continue following his story in the weeks and months to come.
Pharmacy mistake blamed for heparin overdoses at Texas hospital
July 12, 2008
One baby has died and another is in critical condition after at least 17 in the neonatal intensive care unit at a hospital in Corpus Christi, Texas, were given overdoses of the blood thinner heparin.
Bruce Holstien, president and CEO of Christus Spohn Health System, said the problem was discovered Sunday, two days after the infants were given a more concentrated form of heparin than was prescribed.
A preliminary investigation by the hospital indicated the error occurred during the mixing process within the hospital pharmacy. Hospital officials said corrective measures have been taken.
Richard Davis, the hospital’s chief medical officer, released a statement that said the baby who died “was seriously ill, and we do not know at this time what role, if any, the higher than expected concentration of heparin played in this baby’s death. Our deepest sympathy goes out to this family.”
Davis said 12 of the 16 babies are in stable condition, three have been discharged, and one is in critical condition.
This heparin overdose incidence is eerily similar to one last November when actor Dennis Quaid’s newborn twins accidentally received 1,000 times the prescribed amount of heparin at a Los Angeles hospital. They survived, but consumer advocates are urging hospitals to embrace technology to reduce such errors.
“People need to ask whether their local hospital has a computerized medication system in place before they seek care. If they don’t, they should ask why not?” Leah Binder, CEO of the Leapfrog Group, a Washington, D.C.-based employer coalition, said. “Studies suggest that (computerized physician order entry systems) reduce medication errors by 50% to 100%.”
(Via Drug Topics)
