Anesthesia Drug Shortage

Propofol Shortage: The Economic Problem of a Generic Injectable

May 10, 2012 lawmed No comments

Propofol drug shortages: The economic problem of a generic injectable

Propofol might best be known as the anesthetic Michael Jackson used inappropriately as a sleeping aid. Administered properly, the drug widely is used in hospitals to sedate patients. It also happens to be part of an industrywide drug shortage affecting hospitals throughout the country.

Injectable drugs maker Hospira (NYSE:HSP) is among the dwindling number of propofol manufacturers. The company recently restarted propofol production after a stoppage at its manufacturing plant in Clayton, North Carolina. The stoppage was voluntary and temporary, CEO Michael Ball said during during the company’s conference call to discuss first quarter financial results. Without going into detail, Ball said that Hospira has “completed corrective action” at the plant and propofol production has restarted. But restarting production isn’t a solution to the industrywide propofol shortage. And it’s not Hospira’s fault. Blame economics.

Three … (Continued…)

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Drug Shortages Epidemic In Anesthesiology

May 03, 2012 lawmed 1 Comment

There is no end in sight to the now business as usual reality of drug shortages in medicine. Anesthesiology is hit particularly hard in the number of medications which are not being manufactured to meet demand. Here is a list of medications common to anesthesia practice which the FDA lists as being in short supply, and the reasons given. It contains the three most frequently administered medications in the practice of anesthesia: propofol, fentanyl and midazolam. Law Med points out that it is no coincidence that only drugs which are off patent and now generics seem to have shortages.

Alfentanil Injection Material shortage and increased demand.

Atracurium besylate Manufacturing delays.

Atropine Sulfate Injection Manufacturing delay and increased demand.

Bupivacaine Hydrochloride Injection Manufacturing delay.

Calcium Chloride Injection Manufacturing delay.

Chloroprocaine (Nesacaine) Injection Increased demand and manufacturing delay.

Etomidate Injection increased demand and manufacturing delay.

Fentanyl Citrate Injection Manufacturing delay causing increased … (Continued…)

Where Has All the Propofol Gone?

January 16, 2012 lawmed No comments

By Kurt Stone OpEdNews.com

Propofol — one of the drugs that led to Michael Jackson’s untimely death — is a short-acting, intravenously administered hypnotic agent. Known in some circles as “Milk of Amnesia,” its uses include the induction and maintenance of general anesthesia, sedation for mechanically-ventilated patients, and procedural sedation. Propofol — and its generic equivalents — has been widely and successfully administered in hospital operating rooms around the world for nearly 30 years. And, as of June 4, 2010, Teva Pharmaceuticals, the Israeli-based firm that was the major supplier of Propofol, no longer manufactures it. Today, it is almost impossible to find.

Where has all the Propofol gone?

And while we’re at it, where has all the Doxil, Adderall, Mitomycin, Morphine Sulphate, Avalide, Ondansetron, Succinylcholine, Dextrose, B-12 and more than 200 others medicines gone? Shockingly, between 2006 and 2010, drug shortages increased by more than 200% according to a … (Continued…)

Company Increases Availabillity Of Propofol

October 18, 2011 lawmed No comments

APP Pharmaceuticals increases Propofol production.

From Pharmaceutical Business Review

APP Pharmaceuticals, a subsidiary of Fresenius Kabi Pharmaceuticals, has increased the availability of its drugs including APP Diprivan (propofol 1%) and APP Propofol 1% (generic Diprivan).

The company is said to have increased the production to supply the US market and meet the clinical needs of health care professionals. Propofol, marketed under the brand name, Diprivan, is a fast-onset sedative-hypnotic agent used for the induction and maintenance of anesthesia or sedation.

APP Pharmaceuticals president and CEO John Ducker said in order to maintain a consistent supply of this drug, the company has responded promptly in the face of drug shortages to meet market demand.… (Continued…)

Juries Slap Propofol Companies With Over $280M Damages In Hep C Cases

October 15, 2011 lawmed 1 Comment

Two separate juries have levied a combined total of over $250 Million in punitive damages for 5 plaintiffs in two separate trials. The plaintiffs were suing after they contracted Hepatitis C from what their lawyers argued was contaminated propofol. The defendants were Teva Pharmaceutical Industries Ltd. and Baxter International Inc., manufacturers and distributors of the drug.

Plaintiffs argued that the pharmaceutical companies were negligent when they packaged the propofol in large vials thereby encouraging multiple use of what is supposed to be a single use vial. Propofol is particularly prone to contamination and its formula promotes growth of viruses and bacteria.

Michael Washington and his wife, Josephine, alleged that Mr. Washington was diagnosed with Hepatitis C in 2007 after he received Propofol from a reused vial at a Las Vegas Endoscopy clinic run by Dr. Dipak Desai. They were awarded $90 Million in punitive damages Friday. The same jury awarded … (Continued…)

Discontinuation of Pentothal Leads to Historic Videotaped Execution

July 25, 2011 lawmed No comments

For the first time in history, a lethal injection execution has been videotaped. And it is all because the anesthetic sodium thiopental (Pentothal) is no longer manufactured. The Georgia Supreme Court and U.S. Supreme Court has let stand a Fulton County, Ga., judge’s order to videotape then execution of Andrew Grant DeYoung, 37, which took place Thursday at 8 pm.

The camera recorded his last words — “I’m sorry for everyone I’ve hurt” — and his eyes blinking as the drugs took effect. It registered his last breaths and the time of his death: 8:04 p.m.

The decision to videotape is the result over defense attorneys arguing that a drug replacing thiopental, pentobarbital (Nembutal), is untested and risks causing unnecessary suffering during the execution. Previously sodium thiopental was used as the first drug in a series of three to kill the accused, but the manufacturer stopped making it, causing a … (Continued…)

Teva Wins HUGE In Propofol Case Credit U.S. Supreme Court

June 24, 2011 lawmed No comments

It has been over a year since we told you about a jury verdict in Nevada against Teva Pharmaceuticals a while ago that cost them $500 Million Dollars. The case involved a Nevada resident who contracted Hepatitis C allegedly from contaminated propofol, the anesthetic used to sedate him for a colonoscopy at the clinic of infamous Dr. Desai where 40,000 former patients were potentially exposed to the virus. In a novel approach, the plaintiff sued the drug manufacturer claiming that improper packaging of the drug encouraged re-use of the single use vial, which led to the contamination. The jury agreed and punished the drug makers with a huge judgment.

Easy come, easy go, Teva is off the hook.

On Thursday, the U.S. Supreme Court ruled that Teva Pharmaceutical Industries and other generic drug makers “cannot be sued under state law over allegations that they failed to provide adequate label … (Continued…)

Anesthesia Drug Propofol Shortage Update

June 10, 2011 lawmed No comments

Shortages of the anesthesia drug propofol are lessening, with APP Pharmaceuticals notifying health care providers that their supplies are now available from all of their distributors. Hospira reports that higher than anticipated demand continues to cause shortages. The exit of Teva Pharmaceuticals from the propofol manufacturing business as well as product recalls and manufacturing problems has led to a significant supply disruption. See the FDA Drug Shortage webpage for the latest info on all drug shortages HERE.

From APP:

APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section

APP has available ALL generic Propofol 1% sizes (20mL, 50mL and 100mL) and generic Novaplus propofol (20 mL, 50mL and 100 mL) vials available through wholesalers and distributors. Effective May 19, 2011 orders should be placed directly with wholesalers and distribution centers. See http://www.apppharma.com/our-products/product-updates.html for more information.

APP Diprivan … (Continued…)

Hospira Resumes Propofol Manufacturing

April 29, 2011 lawmed No comments

From the FDA Drug Shortage website, updated 4/22/11:

Hospira states their 2009 recall has been resolved and they are following FDA recommendations for good manufacturing practices. The company has their 20 mL and 50 mL presentations on intermittent back order due to increased demand and the 100 mL vials are on back order due to the prioritization of the 20mL and 50mL. We expect to be shipping the 100 mL vials to customers in May . All product is being shipped to sole contracted customers at this time.… (Continued…)

Inmates Sue FDA Over Death Penalty Drug Shortage

February 11, 2011 lawmed No comments

Death Penalty Drug: Death Row Inmates Sue FDA

A FindLaw Blog post

While there are many arguments in the death penalty debate, our duty as a nation is to make sure that the process remains humane. The Food and Drug Administration, however, may have just called even that into question.

Thiopental, a so-called death penalty drug, has seen better days. The anesthesia, designed to prevent inmates from feeling any pain, has been difficult for states to acquire, delaying executions across the country. And now that Hospira, Inc., the drug’s maker, has announced that it will be discontinuing production, states will be scrambling even harder.

This is why states using thiopental petitioned the FDA to allow them to import the thiopental from overseas. And it agreed. And then the FDA got sued.

The FDA is required by law to ensure that only safe drugs enter into the United States. … (Continued…)

Anesthesia Drug Shortages Serious Threat to Patients

February 03, 2011 lawmed No comments

We have covered the shortages of propofol, sodium thiopental (pentothal), vecuronium and other popular drugs in anesthesia at length. Manufacturing difficulties from contamination, large jury verdicts and the practice of capital punishment in the US have created a perfect storm resulting in a previously unimaginable scenario for anesthesia practitioners. The most widely used induction agent for anesthesia, propofol, is in great shortage and the first and best choice alternative, Pentothal, is no longer being made.

More than a mere inconvenience, this turn of events will impact patient care and sometimes negatively. None of this comes about because the drugs are unsafe or do not work. Much the opposite. They are the BEST medications for their intended purpose….safely anesthetizing patients for surgery in every operating room in the world.

In the case of sodium thiopental the FDA has REMOVED it from their ‘Drug Shortage‘ list and placed … (Continued…)

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