Diprivan and the Death of Michael Jackson

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Milk of amnesia, propofol, diprivan, whatever you want to label it, diprivan has always been a medication that I put in the category of a medication that definitely needs hospital or long-term care support when administrating. Now because of the latest error a physician made in the case of Michael Jackson, the drug is propelled into the spotlight. Just recently:

Propofol: Limited Recall Due to Elevated Endotoxin Levels − July 2009

Teva Pharmaceuticals USA has announced a voluntary recall of certain lots of propofol injectable emulsion 10 mg/mL 100 mL vials. The lots identified are being recalled due to elevated endotoxin levels in some of the vials. Teva has received reports of 41 propofol treated patients experiencing postoperative fever, chills, and other flu-like symptoms; most cases reported appeared to be self-limiting. Possible adverse effects associated with elevated endotoxin exposure include fever, chills, and rigors. High endotoxin level exposure may be associated with more serious adverse effects including disseminated intravascular coagulopathy, acute respiratory distress syndrome, and death.

But, that only included certain lots. Sounds scary, huh?

High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Um, no brainer. It's a medication that is an intravenous infusion and has several pharmacological purposes includng induction of anesthesia in patients ≥3 years of age; maintenance of anesthesia in patients >2 months of age; in adults, for monitored anesthesia care sedation during procedures; sedation in intubated, mechanically-ventilated ICU patients.

And straight from the books:

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: May rarely cause hypersensitivity, anaphylaxis, anaphylactoid reactions, angioedema, bronchospasm, and erythema; medications for the treatment of hypersensitivity reactions should be available for immediate use.

• Hypertriglyceridemia: Because propofol is formulated within a 10% fat emulsion, hypertriglyceridemia is an expected side effect. Patients who develop hypertriglyceridemia (eg, >500 mg/dL) are at risk of developing pancreatitis. Serum triglyceride levels should be obtained prior to initiation of therapy and every 3-7 days thereafter. Monitoring of serum triglycerides should especially be considered with therapy >48 hours with doses exceeding 50 mcg/kg/minute (Devlin, 2005). An alternative sedative agent should be employed if significant hypertriglyceridemia occurs. Use with caution in patients with preexisting hyperlipidemia as evidenced by increased serum triglyceride levels or serum turbidity.

• Hypotension: The major cardiovascular effect of propofol is hypotension especially if patient is hypovolemic or if bolus dosing is used. Hypotension may be substantial with a reduction in mean arterial pressure occasionally exceeding 30%. Use with caution in patients who are hemodynamically unstable, hypovolemic, or have abnormally low vascular tone (eg, sepsis).

• Injection-site reaction: Transient local pain may occur during I.V. injection; lidocaine 1% solution may be administered prior to administration or may be added to propofol immediately prior to administration to reduce pain associated with injection (see Administration).

• Myoclonus: Perioperative myoclonus (eg, convulsions and opisthotonos) has occurred with administration.

• Propofol-related infusion syndrome (PRIS): PRIS is a serious side effect with a high mortality rate characterized by dysrhythmia (eg, bradycardia or tachycardia), heart failure, hyperkalemia, lipemia, metabolic acidosis, and/or rhabdomyolysis or myoglobinuria with subsequent renal failure. Risk factors include poor oxygen delivery, sepsis, serious cerebral injury, and the administration of high doses of propofol (usually doses >83 mcg/kg/minute or >5 mg/kg/hour for >48 hours), but has also been reported following large dose, short-term infusions during surgical anesthesia. The onset of the syndrome is rapid, occurring within 4 days of initiation. The mechanism of the syndrome has yet to be determined. Alternate sedative therapy should be considered for patients with escalating doses of vasopressors or inotropes, when cardiac failure occurs during high-dose propofol infusion, when metabolic acidosis is observed, or in whom lengthy and/or high-dose sedation is needed (Jacobi, 2002; Corbett, 2008).

Sound familiar???

Pharmacy News for the Moment January 2009

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BISMARCK – One of the most anticipated issues of the session finally comes up for its hearing this week. It’s the pharmacy ownership bill, which proposes to repeal a 1960s law that requires pharmacies in North Dakota to be majority-owned by pharmacists. Other bills getting hearings this week call for a new issuance of license plates, higher traffic fines, a ban on bottle rockets, no sales tax on clothing and a mandated annual football game between the University of North Dakota and North Dakota State University. The pharmacy law repeal is House Bill 1440, and such a huge crowd is expected for the hearing that it has been moved to the Heritage Center auditorium. It is 9 a.m. Tuesday.

Both supporters and opponents of the repeal have been running television ads for months asking the public to contact legislators.

Supporters of the repeal include chain stores Wal-Mart and Walgreens, which helped form North Dakotans for Affordable Health Care, www.ndrx.org.

Opponents, who want to keep the law, countered with North Dakotans for Prescription Facts, www.knowtherxtruthnd.com.

Last week, a group of opponents of the repeal – the North Dakota Farmers Union, North Dakota Retail Association and North Dakota Grocers Association – said that if HB 1440 is enacted, it could mean the loss of 600 rural North Dakota jobs and 70 small town pharmacies.

They quoted from the New Rules Project of the Institute for Local Self-Reliance in Minneapolis, which published “The Benefits of North Dakota’s Pharmacy Ownership Law,” www.newrules.org.

there are no words...

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The Food and Drug Administration has issued an alert about two pharmacies in Baltimore suspected of distributing expired or counterfeit drugs. The agency said patients who have received the following drugs should contact their physician for new prescriptions:

  • Lisinopril (20 milligrams)
  • Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
  • Gabapentin (100 mg, 300 mg and 400 mg)
  • Metoprolol (50 mg)
  • Nifedipine (30 mg)
  • Diclofenac Sodium (30 mg)
  • Glucophage (500 mg Extended Release)
  • Glucovance (125 mg and 500 mg)
  • Glipizide/Metformin (2.50 mg/250 mg)
  • Furosemide (20 mg)
  • Tamoxifen Citrate (10 mg)
  • Metformin HCl ER (500 mg)
  • Calcitrol (0.25 micrograms)

The two pharmacies in question are at 8035A Liberty Road and 5900 Reisterstown Road and are managed by Pamela Arrey, R.Ph. According to Joseph Kum, an attorney for Arrey, his client denies the charges and maintains that the drugs under investigation were obtained from charitable organizations and were never meant for interstate commerce. Rather, some drugs were in drums being prepared for inspection and some drugs were in totes getting ready for destruction. They were not on the pharmacies' shelves for sale, he said. FDA said pharmacies outside of these two locations show no evidence of being involved.

Drug Topics contacted Medicine Shoppe's parent, Cardinal Health, for a response and got the following reply: "Medicine Shoppe International, Inc. (MSI), the franchisor of Medicine Shoppe pharmacies, has learned that two of our system's Baltimore-area pharmacies, located at 8035A Liberty Road and 5900 Reisterstown Road, were recently found by the Food and Drug Administration (FDA) to have sold expired medications. Medicine Shoppe pharmacies are franchised businesses and the individual pharmacist or franchisee who owns the store is responsible for all business decisions and practices. MSI is taking this matter very seriously. The health and welfare of our customers is our system's main priority, and we do not condone these types of infractions by our licensed pharmacies. Medicine Shoppe pharmacists have received national recognition as dedicated professionals who provide excellent customer service."

Please stop flushing!

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I have always thought as I hear of someone "flushing their old prescriptions down the toilet" that something would come of it.  Not only that, but the thought of tiny amounts of antibiotics in our water supply really creeps me out as to what else is in there that is not removed through normal processes? And it's not only the flushing of meds... it's also the excretion of medications, sometimes unchanged or even unchanged in active metabolite form, in urine and feces. 

YUMMY!

Paternity Testing Available More Discreetly

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Friday , February 29, 2008

By Marrecca Fiore

Who needs Maury Povich when paternity tests are now available at Rite Aid, Meijer and other pharmacies for just $29.99?

The Identigene DNA Paternity Test Collection Kit was first rolled out in Washington State, Oregon and California in November last year, according to Rite Aid spokeswoman Ashley Flower. The company continues to evaluate whether it should expand the kits to other states, she said.

According to the Identigene's Web site, the tests compare genetic information obtained from cheek swabs collected from both the child and the father. The swabs are then sent to the company's laboratory along with a $119 lab fee. The results are mailed within five business days.

While the tests are believed to be accurate (the company's Web site says they're 99 percent accurate), there are some reasons why women and couples may want to consult a professional laboratory for paternity tests, said Brad Imler, president of the American Pregnancy Association.

"There's no risk of harm from a medical standpoint," he said. "Although they're not admissible in court. And, from an emotional standpoint, it's a good idea to see a professional. It doesn't have to be a doctor, but someone who is prepared to discuss the result with you if it comes back in a way you were not expecting."

Imler said some people, especially married couples, may find the results of paternity tests traumatic.

"Whatever the circumstances are that bring someone to the point of needing a paternity test, that's irrelevant," he said. "The professionals associated with the laboratories are trained to present the results in a way that doesn't cause panic or in a way that reduces panic."

Both Rite Aid and Identigene representatives say the tests have brought no more controversy than at-home home pregnancy, blood pressure, cholesterol and drug tests did when they were first introduced.

"There was a lot of concern when the home pregnancy test first came out," said Douglas Fogg, chief operating officer for Identigene. "Would people use it correctly? Would people be able to handle the results?

"We have been providing home DNA testing since 1993 and on the rare occasion we'll have a client that has a hard time dealing with the results," he continued. "Most of our clientele are aware of what the results will be. They don't want to involve lawyers or physicians. They just want confirmation in a quick, easy and confidential way."

Fogg said the company’s Web site provides consumers with counseling information

"Some people are devastated by the result of a paternity test," he said. "A paternity test can have a life-changing result. For those that need professional help in dealing with their situation, our Web site offers references to family counseling services that can provide people with the help they need."

Fogg said 60 percent of Identigene's clients are females. Some users are looking to confirm their own paternity. Almost 30 percent of purchasers buy the test for someone other than themselves, according to the company's own surveys.

The tests are sold in 1,000 pharmacies nationwide, Fogg said. He said all pharmacies have reported sales and the company is pleased with the interest. The tests are also marketed online and through resellers.

Baseball and steroids

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I don't know if Roger Clemens is guilty or not of using steroids.  If you look at old clips of him pitching the years that the Mitchell reports claims, maybe he looks puffier?  I don't know.  Part of me feels bad for the guy because wonder if he is INNOCENT?  Either way, it seems to me that steroids are NOT going to just go away.  HGH and steroids can make an athlete stronger and younger which equals more money. I just got a kick out of the interview with Clemens because he was talking about how he was taking Vioxx like "eating Skittles."  Are you serious?  Are you kidding me?  He then went on to discuss how if he did go before a senate hearing committee, that he would have to bring up the Vioxx question...  why was this drug on the market if it had the potential to harm?

Does he and the rest of the pill popping Americans not KNOW that every drug has some potential (some more than others) to harm?  You can KILL yourself with an overdose on acetaminophen just as one example.

It's just that I'm surprised he was eating Vioxx like candy with very specific dosing limits spelled out, etc...

They all want to be smart and in the know when on their meds but then later when the med is taken off the market, they want to play the dumb card.  For Roger, the dumb card would be not to find out the max daily dose of Vioxx prior to taking it?  Perhaps?  I mean eating Vioxx like candy means more than 1-2 day obviously!

The Wonder Drug

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Study hails heart wonder drug They have been hailed as a wonder drug - the pill of life - a magic bullet in the fight against heart disease, one of the world's biggest killers.

Now new research supports claims by international drug manufacturers that statins, already the world's biggest-selling medication, dramatically reduce the risk of heart attack and death in high-risk middle-aged men. Statins may also provide health benefits up to 10 years after a patient stops using the drug, the research has found.

Statins are a cholesterol-lowering medication taken in pill form that prevents plaque buildup in arteries.

About 10,500 Kiwis die from cardiovascular disease each year.

It is one of the country's biggest killers, accounting for 40 per cent of all deaths.

Nearly 300,000 New Zealanders already consume one million prescriptions annually of the fully subsidised drug, marketed here as Lipex and Lipitor, at a cost to taxpayers of about $50 million.

But a leading Wellington cardiologist is urging calm following the latest findings, warning that statin use is no magic panacea against heart attacks for those most at risk - diabetes sufferers, smokers, Maori men, and people with high blood pressure or high cholesterol levels. Medical experts have just published the results of a 15-year trial in Scotland involving 6500 men aged between 45 and 64 who had not had heart attacks but showed elevated cholesterol levels.

Half were given the drug Pravastatin for five years and the rest given a placebo. Another study then tracked the men's progress for 10 years after the initial trial.

The results show a 25 per cent lower risk of heart attack or death from heart disease among those in the statin group - even though many stopped taking the drug a decade earlier.

Some health experts now suggest the drug - which has little or no side effects - should be prescribed preventively to those who are not high-risk.

Stewart Mann, Wellington School of Medicine Associate Professor of cardiovascular medicine, warned that statins are not a miracle panacea: "There are benefits and I strongly support their use, but particularly in those who are at enough level of risk that it will substantially reduce their risk. It does not guarantee freedom from heart attack."

Pharmac medical director Peter Moodie said people at high risk of heart disease could not substitute healthy living for a magic drug.

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The magic pill that most lazy people are looking for... statins. (after this is the disclaimer warning that the side effects of statins include and are not limited to: Percentages as reported with immediate release tablets; similar adverse reactions seen with extended release tablets.

>10%: Neuromuscular & skeletal: CPK increased (>2x normal) (11%)

1% to 10%:

Central nervous system: Headache (2% to 3%), dizziness (0.5% to 1%)

Dermatologic: Rash (0.8% to 1%)

Gastrointestinal: Abdominal pain (2% to 3%), constipation (2% to 4%), diarrhea (2% to 3%), dyspepsia (1% to 2%), flatulence (4% to 5%), nausea (2% to 3%)

Neuromuscular & skeletal: Myalgia (2% to 3%), weakness (1% to 2%), muscle cramps (0.6% to 1%)

Ocular: Blurred vision (0.8% to 1%)

10x normal), depression, dryness of skin/mucous membranes, dyspnea, eosinophilia, erectile dysfunction, erythema multiforme, ESR increased, facial paresis, fatty liver, fever, flushing, fulminant hepatic necrosis, GGT increased, gynecomastia, hemolytic anemia, hepatitis, hepatoma, hyperbilirubinemia, hypersensitivity reaction, impaired extraocular muscle movement, impotence, leukopenia, libido decreased, malaise, memory loss, myopathy, nail changes, nodules, ophthalmoplegia, pancreatitis, paresthesia, peripheral nerve palsy, peripheral neuropathy, photosensitivity, polymyalgia rheumatica, positive ANA, pruritus, psychic disturbance, purpura, rash, renal failure (secondary to rhabdomyolysis), rhabdomyolysis, skin discoloration, Stevens-Johnson syndrome, systemic lupus erythematosus-like syndrome, thrombocytopenia, thyroid dysfunction, toxic epidermal necrolysis, transaminases increased, tremor, urticaria, vasculitis, vertigo, and vomiting.

Wonder....FUL!