Wednesday, April 23, 2014

Today's Shortages


ASHP/FDA





Caffeine and Sodium Benzoate Inj.




Ciprofloxacin Inj.





Cisatracurium Inj.





Dacarbazine Inj.





DTAP





Fluromethalone Opthalmic Ointment




Flourouracil Inj.





Hydromorphone Hydrochloride Inj

US drug shortage could change death penalty

The United States is having difficulty getting the drugs it needs to kill condemned prisoners humanely, putting the death penalty under pressure.
Companies don’t want to be connected to it, and abolitionists are against the older ways of killing.
Oklahoma has suspended the executions of Clayton Lockett and Charles Warner — a man who raped and murdered a woman and a man who raped and murdered a baby — after the state was unable to answer their questions whether an untested combination of drugs sold as lethal would work as predicted.
The constitution says those to die have a right to know how it will be, but more authorities are being secretive about supplies, as traditional sources dry up, complicating things.
One crucial case was that of Dennis McGuire, who took more than 20 minutes to die last January. It is reported that he suffered. It was a first-time use of the drugs.
In 1989, McGuire raped and murdered 22-year-old Joy Stewart, who was seven months pregnant.
Death row inmates in the US have a constitutional protection from cruel and unusual treatment, and critics’ calls are increasing for a moratorium on capital punishment.
Since 2011, European firms have refused to sell barbiturates to American prisons for executions. The last American company that made the anaesthetic that was commonly used in the past ended production in that same year. States turned to a product used on animals. But then the last European exporter of that, a Danish company, stopped. In this cycle of what experts have called experimentation, several states, such as Texas, Missouri and Oklahoma, have turned to pharmacies which customise small batches of drugs — a grey area of business.
The Supreme Court reinstated capital punishment in 1976. Since then, more than 1,300 people have been executed. More than 3,000 are waiting for it. The death penalty is still on the law books for use in 32 states, and by the army and federal government.
Also still allowable by law in at least some of these are the methods of lethal injection, the electric chair, the gas chamber, hanging and the firing squad.
Tennessee is close to approving bringing back the chair, though the Death Penalty Information Centre said this would probably be challenged on the grounds that electrocution is, by today’s standards, unconstitutionally cruel compared with lethal injection.

Chemo drug shortage halts treatment

Johannesburg -
A shortage of key chemotherapy drugs at Charlotte Maxeke Johannesburg Academic Hospital has halted treatment for certain cancer patients, a Gauteng official said on Wednesday.
“The company that supplies the drug ran out of stock to supply the hospital,” health spokesman Simon Zwane said.
“They have, however, indicated that they have received some consignment and it is still undergoing quality testing before being released to the hospital. The drug is expected this week.”
He said the shortage was not because the supplier had not been paid, but was related to a stock shortage from the supplier's side.
Zwane said the department had worked hard to improve availability of essential drugs and had implemented interventions aimed at “improving efficiencies” at the medical supplies depot.
He said these interventions included monitoring supplier performance, and continuous review of re-order levels.
“As a result of these interventions, (there has been) a notable change in the availability of medicines from the 76 percent reported in April last year to more than 82 percent in January this year,” Zwane said.
The Democratic Alliance said patients who needed to be treated with Gemzar had been told the drug was not available.
“Gemzar is a chemotherapy drug used to treat non-small cell lung cancer, pancreatic cancer, metastatic breast cancer, and ovarian cancer,” the party's Gauteng health spokesman Jack Bloom said in a statement.
“This chemo drug shortage is totally unacceptable as it is endangering the lives of vulnerable patients.”
He said in one case a breast cancer patient's chemotherapy was halted in the middle of a multi-week treatment, which was extremely dangerous.
Bloom said swift action was needed to procure drugs and answers were needed about medicine shortages in provincial hospitals. - Sapa

Hospira announces voluntary nationwide recall of one lot of 1% Lidocaine HCI injection

Hospira Inc. has initiated a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP to the user level due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial, the company announced April 18. Hospira said they have identified the particulate as iron oxide.
Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. If the particulate, or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur, according to news release from Hosipra. This lot was distributed nationwide to distributors, wholesalers, hospitals and clinics from September 2013 through October 2013. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The lot number affected by the recall is:
Hospira recall lot number
Hospira said they have initiated an investigation to determine the root cause and corrective and preventive actions. Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification.
For medical inquiries, please contact Hospira Medical Communications at 800.615.0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Hospira said.

WSJ - Pharmagen Completes Bridge Financing to Support Consolidation and Capital Restructure Plan

SILVER SPRING, Md., April 22, 2014 /PRNewswire/ -- Pharmagen, Inc. (OTCQB: PHRX) (the "Company" or "Pharmagen") today announced that it has completed its bridge financing lead by Pharmagen's Chairman, Richard A. Wolpow and Bagel Boy Equity Group II, LLC. Completion of this round helps get Pharmagen one step closer to following through on a plan of consolidation and restructuring which was initiated in October 2013.
"I am excited to get this part of the plan behind us", says Richard A. Wolpow, Chairman of Pharmagen, Inc. "Much has transpired since October and there is still much to do, however, I expect only positive things moving forward. I have been very impressed with the Pharmagen team, their willingness to embrace new ideas, people, and direction for the Company." Wolpow stated.
"We're very thankful for Richard's involvement in Pharmagen. He believes in Pharmagen's long term vision. We believe Richard's wealth of experience in our market coupled with his longstanding relationships in the capital markets will prove to be the game changer for us and the entire compounding industry," said Mackie A. Barch, CEO of Pharmagen.
About Pharmagen
Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. offers innovative solutions to the nations sterile pharmaceutical crisis. With a multi-solution approach, Pharmagen is helping to meet the demand of the health provider market through independent wholesale, compounding, and IT solutions. Nationally focused, Pharmagen is a distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins. Pharmagen currently functions as a just-in-time source of supply for hospitals for those products that are hard-to-find.
Contact: 888-264-4597 or info@pharmagenrx.com
Follow Us on Twitter: @pharmagenrx or
The Drug Shortage Report http://drugshortagereport.blogspot.com/
About Bagel Boy Equity Group II, LLC
Bagel Boy Equity Group II, LLC, was founded by its Managing Partner, Richard A. Wolpow. Mr Wolpow has been advising and operating small to mid-size private and public companies for over 20 years. He is or has been founder and chief operator of a number of companies primarily in the Healthcare industry. Currently, Mr. Wolpow is on the Board of Directors of three companies, is an operating partner of a healthcare specific private equity firm and is the trustee for a private charitable trust.
Contact: 888-264-4597 or info@pharmagenrx.com
Safe Harbor Statement
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pharmagen actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Pharmagen's filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Pharmagen herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pharmagen disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.

Tuesday, April 22, 2014

Weekly FDA Enforcement Report For Drugs And Biologics 4/16/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 16, 2014. The agency publicizes recalls in its weekly report. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification, the danger level. 
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
  • Biologics: No Class I biologics recalled this week.
  • Drugs: Slim Beauty USA of Kearney, NE recalled three products: Dr. Ming's Chinese Capsule, Magic Slim capsules, and Dream Body Slimming Capsule due to undeclared sibutramine and phenolphthalein. American Lifestyle from Pittsford, NY recalled Vicerex A Powerful And Fast Acting Male Sexual Enhancer and Black Ant due to undeclared tadalafil and sildenafil. RX Formulations Services recalled Calcium Gluconate 10% for Injection due to microbial contamination.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
  • Biologics: No Class II biologics recalled this week.
  • Drugs: RX Formulations Services recalled Magnesium Sulfate, Potassium Phosphates, Oxytocin, Sodium Bicarbonate, Bupivacaine, and Vitamin B-12 injections due to poor aseptic practices. Agila Specialties Private Ltd. recalled Etomidate injection due to the presence of particulates. Terra-Medica Inc. recalled Pleo Not, Pleo Nota-Quent, Pleo Quent, Pleo Fort, Pleo Ex, and Pleo Stolo (ointment, suppositories, capsules, tablets, drops, and portable sips) due to penicillin cross contamination.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
  • Biologics: No Class III biologics recalled this week.
  • Drugs: Novartis recalled Ritalin HCl (methylphenidate HCl) USP, 10 and 20 mg due to Medication Guide errors. Hospira recalled Demerol injection due to a missing label. Boehringer Ingelheim Roxane Inc. recalledSpiriva HandiHaler due to interaction of the drug product powder with the lubricant on the interior of the capsule shell.

Hospira recalls 7 lots of propofol and one of lidocaine

Sterile injectable drug maker Hospira ($HSP) last year ramped up production of the sedative and analgesic propofol, a drug CEO F. Michael Ball said he knew the market was anxious to see a bigger supply of. But the drugmaker is now recalling 7 lots of the drug because glass and metal particles have been found in some vial samples.

In a release, the drugmaker said that it was recalling propofol injectable emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level. It reported that the glass vial contained visible embedded metal particles. It said that upon further analysis, it also discovered free-floating metal particles in vials. The company has taken steps in its manufacturing process so the problem won't recur and said it has not had any reports of adverse effects.

In a separate notice, Hospira recalled a single lot of preservative-free 1% lidocaine HCI injection, USP, 10mg/mL, 30-mL single dose after a customer complained of orange and black particles both in the solution and embedded in the glass vial. Hospira said that turned out to be iron oxide.

Propofol landed on the FDA drug shortage list several years ago when both Hospira and Teva Pharmaceutical Industries ($TEVA) quit producing the anesthetic because of manufacturing problems. Ball made a point to analysts during an earnings call in November 2012 to say that its plant in Clayton, NC, was again producing the drug and that it expected to ramp up production through 2013. During that time, however, it had to recall three lots of the drug because particulate matter was found in retained samples. Teva returned to the market with its propofol product in March 2013. It is not currently on the FDA shortage list. 

Manufacturing http://www.fiercepharmamanufacturing.com/story/hospira-recalls-7-lots-propofol-and-one-lidocaine/2014-04-21#ixzz2zdC6RGKY