Franck's Pharmacy head opens new health care facility

By Carlos E. Medina
Correspondent

Published: Sunday, September 2, 2012 at 6:30 a.m.

Last Modified: Friday, August 31, 2012 at 5:42 p.m.

Say hello to the new boss of a new health care facility on Southeast 17th Street — and it's the same boss of the recently shuttered Franck's Pharmacy at the same location.

To read more, click here.

New details in DA's admonishment in Signature Pharmacy case

Soares' characterization in pharmacy case earned criticism, papers show

By James M. Odato

Published 10:02 p.m., Wednesday, August 29, 2012

ALBANY — With two weeks to go before Primary Day, a sworn deposition from Albany County District Attorney David Soares offers new details about his secret admonishments by a judicial panel that criticized him for publicly characterizing defendants in a steroid case as drug dealers and for discussing the investigation of a local police chief.

In a 145-page transcript of sworn testimony from Soares, the two-term Democrat seeking re-election this year sparred with an attorney for owners of Signature Compounding Pharmacy, who though facing indictment are suing Soares for defamation.

Soares was twice admonished by a state judicial panel for inappropriate comments by the district attorney that were later published in the newspaper, according to a legal records filed in federal court in Florida on Tuesday. The deposition and other documents were shared with reporters covering Soares' primary campaign against Lee Kindlon. The two will square off in a Sept. 13 primary.

The promptly produced transcript from last week's testimony shows Soares was admonished for characterizing those involved with Signature Pharmacy as akin to Tony Montana, the fictional cocaine kingpin in the movie "Scarface." Soares made the comments in an interview about the illegal pharmaceutical industry and Signature's lawyers contend the comments harmed their reputations. The plaintiffs accused Soares of defamation and the deposition was taken as part of that legal case. The case is slated to go to trial in February. Five operators of the pharmacy face felony charges after allegedly being implicated in a steroids distribution network.

During questioning, Soares also revealed a separate admonishment was for comments he made about Guilderland Chief James R. Murley to a Times Union editorial board. In October 2008, Soares was quoted as saying Murley, who was accused of defrauding the government by going to a casino while on public time, was in discussions about a plea bargain. In October 2009, Murley pleaded guilty to misdemeanor, admitting that on more than 50 occasions he claimed to have been working when he was actually gambling at an Oneida County casino.

The admonishment letters have never been revealed to the public. Soares told the attorney who questioned him that he shredded the admonishments and could not provide them.

Soares' testimony took place on Aug. 24.

Read more: http://www.timesunion.com/local/article/New-details-in-DA-s-admonishment-3825865.php#ixzz25A31tH2P

Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall - Risk of Fluid Entry into Device Keypads

[Posted 08/29/2012]

AUDIENCE: Risk Manager, Pharmacy

ISSUE: FDA notified healthcare professional of a Class I recall of Baxter Healthcare Automix Automated Nutrition Compounder Systems, due to incorrect key press responses, caused by fluid entry into device keypads, and intermittent electrical failures. Fluids, such as water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator's key press. The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN) Solution. Causes for the intermittent electrical failures have not been determined.

The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect solutions, and/or solution incompatibilities). For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in dosing in highly vulnerable patients could lead to serious injury and/or death.

BACKGROUND: Baxter Healthcare Corp. Automix Compounder Systems are automated nutrition compounders that use weight-based (gravimetric) measuring, often controlled by software, to provide compounding of total parenteral nutrition (TPN) solutions to a patient.

RECOMMENDATION: Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call             1-800-332-1088       to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/29/2012 - Recall Notice - FDA]

FDA Now Has A Presentation Library On-Line

The Center for Drug Evaluation and Research now has a presentation library on-line that can be viewed here.

One Company Working to Bring Back Animal Parasiticides and Therapeutic Brands

Novartis pleads with veterinarians: ‘Save us a spot’

August 29, 2012
By: Jennifer Fiala
For The VIN News Service 

Novartis wants veterinarians to know that the company is “working diligently” to return its parasiticides and therapeutic brands to market after nearly 10 months of manufacturing setbacks and is imploring practitioners to resume using the company’s products once they come back.   

In a letter dated Tuesday to veterinarians, Novartis Animal Health sales executive Andy Ferrigno did not provide firm distribution dates for Interceptor Flavor Tabs and Sentinel Flavor Tabs. Both of the popular anti-parasitics have been backordered since Novartis’s manufacturing plant in Lincoln, Neb., closed last December. The shutdown followed a series of U.S. Food and Drug Administration (FDA) reports that revealed manufacturing mishaps and sloppy quality control procedures. 

Other veterinary-specific drugs including the anti-anxiety medication Clomicalm (clomipramine hydrochloride); Program tablets and suspension; Milbemite; and the arthritis pain medication Deramaxx (deracoxib) also are casualties of manufacturing woes at the Lincoln facility.   

The absence of Interceptor and Sentinel, however, is attracting the most attention from veterinarians; the drugs are used monthly for parasite control. With production of Novartis pet parasiticides on hiatus, drug companies carrying competing products might offer discounts and delayed payment options to veterinarians. In a densely populated and competitive market, one objective might be to provide veterinarians with enough stock to ensure they won’t return to Novartis brands once distribution recommences.  

“Your clinic will be approached in the coming months by our competitors, offering you load-in deals and terms that may draw your interest,” wrote Ferrigno, vice president of sales. “While we understand your need to do what is right for your business, patients and clients, we hope you will seriously consider saving us a spot on your shelves. We politely ask that you give your Novartis sales representatives a chance to earn back your business …”   

Despite the plea, Dr. John Daugherty thinks Novartis’s market share in animal health might be damaged permanently. Like his colleagues, he has 20 or more flea and tick products and roughly 10 heartworm preventatives from which to choose. Once an exclusive user of Interceptor and Sentinel, the practice owner in Poland, Ohio, said he’s not returning to Novartis-brand parasiticides anytime soon.   

“I had 1,500 patients on Interceptor,” Daugherty said. “We can’t go a whole year without heartworm preventative. At this point, we have almost all of our clients switched over to something else. I’m not going to tell them next year that they now need to switch back.”    

Other veterinarians are angered that Novartis continues to offer vague re-release dates. At least one practitioner took to the message boards of the Veterinary Information Network (VIN), an online community for the profession and parent of the VIN News Service, to vent his frustration about the lack of concrete information in Ferrigno’s letter.  

“This really isn’t an update (but) more than a PR (public relations) letter,” wrote Dr. Rich Selkowitz, a practitioner in Rockaway, N.Y. “I am sick of giving clients a date on the return of your products based upon information given by drug reps, and then having to inform them that, nope, we don’t have it yet.”   

Another source of contention: The online pharmacy Drs. Foster & Smith and some other retail outlets are stocked with Interceptor and Sentinel despite the halt in production and Novartis’s policy to only sell its products to licensed veterinarians.   

“To find out that I have clients getting it from Foster and Smith after telling them that there was no way that Foster and Smith had any only makes me look like a lying you-know-what to my clients,” Selkowitz wrote in the discussion. “If you want me to ‘save a spot’ on my shelf, give me real dates as to when I can expect product shipment.”   

A representative of Wisconsin-based Drs. Foster & Smith confirmed that the company is carrying Interceptor and Sentinel in select weight classes for dogs. Both of the drugs require a veterinary prescription.   

Spokesman Gordon Magee declined to confirm whether Novartis sells directly to Drs. Foster & Smith or if the online pharmacy is supplied with backordered Novartis products via gray market channels — a means of distribution that allows retail and online pharmacies to circumvent manufacturers’ policies to sell their products exclusively through veterinary practices. The system is legal, at least for non-prescription medications, but considered unethical by much of the veterinary profession.   

“We do keep detailed records for where we source our products, but we don’t reveal sources,” Magee said by email. In a phone interview, he explained that Drs. Foster & Smith keeps its sources confidential to stay abreast of competition from other online pharmaceutical outfits catering to animals.  

Contacted by the VIN News Service, PetMed Express cited a “nationwide shortage” when asked if the online pharmacy had Interceptor or Sentinel in stock. A Costco pharmacy in Middleton, Wis., carried a supply of Sentinel, but not in every weight class.   

In his letter, Novartis’s Ferrigno insinuated that the company is investigating how its products are cropping up online despite the fact that veterinarians can’t get their hands on them.   

“Over the past several weeks, we have received numerous comments from our veterinary customers that some of our out-of-stock brands have been found in certain retail chains and stores,” he wrote. “This has prompted some concern and frustration that we may be selling our limited supply of product into that segment rather than to the veterinary channel. I can personally assure you that this is not the case.”   

He reaffirmed Novartis’s policy to distribute products only to veterinarians and alluded to the possibility that practitioners who purchased Novartis products may have resold them to brokersthat supply online and retail sectors.   

“Any product that found its way into those retail channels was most likely diverted without our knowledge … either from residual customer inventory that predated our product shortages or, quite disappointingly, product shipped from our limited inventory this year,” Ferrigno wrote. “We will continue to investigate the situation and put measures in place that will help ensure the integrity and proper administration of our products.”   

Dr. Maren Bell Jones of Columbia, Mo., doubts the company’s sincerity.   

“I would like to be 100 percent moved on from Novartis products,” she said. “Don’t promise that you’ll be back up and running, fail to do that and then get product out to these other (retail and online) places. I’d like them to be straightforward instead of being so vague. The whole thing irritates me.”  

Novartis spokesman Joe Burkett said by email that he couldn’t “speak to” the frustration expressed by some veterinarians. When asked to pinpoint a re-release date for products manufactured in Lincoln, he pointed to a fact sheet posted on the company’s website, reporting that some Novartis Animal Health are in “various stages of pre-production and production.” 

“Production, packaging and shipping of the 5-mg strength of Clomicalm (clomipramine hydrochloride) is now ongoing at the Lincoln plant, and shipments of that stock keeping unit (SKU) began in mid-June,” the website says. “We also have initiated validation batch production of Sentinel (milbemycin oxime/lufenuron) Flavor Tabs at the plant, a critical phase of process testing that is required before full scale production can begin. As we validate, technical issues do arise.   

“Due to the evolving situation at the plant, we cannot give exact dates when product will be shipping."   

Article is found here.

 

 

Animal Endocrine Clinic: Methimazole-Handling Precautions for Cat Owners

Animal Endocrine Clinic: Methimazole-Handling Precautions for Cat Owners

Hospital pharmacists must get creative amid drug shortages

By TIMOTHY MAGAW 4:30 am, September 3, 2012 The medicine cabinets at Northeast Ohio's hospitals are sparse these days, and while it's no fault of their own, a nationwide drug shortage has forced pharmacists to come up with creative ways to make supplies of medications last. Although the federal government has offered a few tools to ease the burden, local hospital pharmacists say the shortages show few signs of easing. More than 200 drugs are in short supply or unavailable entirely; the bulk of these are generic injectable drugs. Alternatives, if they exist, often are sold at high markups. One hard-to-come-by pain medication typically costs the Cleveland Clinic 10 cents a dose. But, given the difficulty in securing the drug, the health system instead purchases an alternative that costs upwards of $10 a dose, according to Scott Knoer, the system's chief pharmacy officer. “Every hospital is working on this, and most of the public never even knows how much work goes into handling the problem,” said Mr. Knoer, who has a full-time staff mem-ber devoted to managing the issue. The reasons for the drug shortages are wide-ranging. Several drug manufacturers have closed or consolidated operations in the face of shrinking profit margins, a trend health care observers say has suffocated the supply chain. In addition, the U.S. Food and Drug Administration contends more than half of the shortages are a result of quality issues that forced regulators to shutter, either permanently or temporarily, drug manufacturing plants. That was the case at Ben Venue Laboratories Inc., which last year halted production operations at its headquarters in Bedford after multiple inspections turned up dozens of quality control issues. Ben Venue's shutdown led to a critical shortage of injectable methotrexate, a drug used to treat leukemia in children and rheumatoid arthritis in adults. “It's going to take a long time to figure this out,” said Dr. Michael Anderson, chief medical officer at University Hospitals Case Medical Center, in talking about how to address the shortage. “It'll take a long time to find the right balance between the needs of companies and the needs of patients.” A lobbying effort It wasn't until this summer — thanks to a lobbying effort in Congress led by the Cleveland Clinic — that larger health systems by law could repackage certain drugs into smaller doses and share them among hospitals within their system. Previously, the Clinic only could repackage drugs and share them on its main campus; it was barred, for example, from sharing them with Hillcrest Hospital, just 10 miles east in Mayfield Heights. Still, the Clinic's Mr. Knoer estimates the repackaging legislation will help extend the life of only about 10% of the drugs on short supply. The new provision doesn't apply to controlled substances. It's also unclear how the provision might affect hospitals loosely affiliated with one another, instead of those that are wholly owned. On the plus side, the FDA now requires drug manufacturers to provide six months' advance notice of decisions to discontinue certain drugs, so that hospitals and the market can react accordingly. Such disclosures in the past were voluntary. “This has been a problem that's been brewing for a while,” UH's Dr. Anderson said. “It's reassuring to me as a leader to see the FDA and Congress taking it seriously.” Locally, the Center for Health Affairs, an advocacy group for Northeast Ohio hospitals, has decided to step up its lobbying efforts at the state level after surveying its member hospitals to gauge the breadth of the problem. “The hospitals basically validated that they felt the shortage was somewhat severe,” said Lisa Anderson, a registered nurse and the Center for Health Affairs' vice president of member services. “Years ago, it was sporadic. Now it's more of a chronic problem.” The group is looking to ease restrictions on drug compounding — the method by which drugs are concocted from raw materials at hospitals' in-house pharmacies. At present, the Ohio State Board of Pharmacy permits hospitals to compound drugs on a patient-by-patient basis, rather than stockpile compounded drugs in anticipation of need. State regulations also limit the transfer of compounded drugs between a health system's member hospitals. The Center for Health Affairs also plans to lobby state lawmakers in support of legislation that would forbid pharmacies from selling drugs in short supply to wholesalers, who in turn resell them to hospitals at high markup. The new normal? Hospital officials say it's still too early to tell whether measures to curb the problem will have a lasting impact. Wiggle room, maybe, but a cure-all appears nowhere in sight. “It's bad,” said Stacey Zorska, director of pharmacy at Southwest General Health Center in Middleburg Heights. “It's a daily struggle, and we really can't anticipate what the next crisis is going to be. I think our team has gotten very good at what to do no matter what the shortage is, but it's a struggle.” Kevin Zupancic, director of pharmacy at Parma Community General Hospital, said he's reminded of the shortage daily. He has had to buy a second dry-erase board to keep track in his pharmacy of the mounting list of drugs on short supply. Local hospital officials acknowledge the drug shortages often force them to tweak patients' treatment plans. They said patients haven't been hurt, but the prospect of opting for backup drugs so regularly is a concern. Article found at Crain's Cleveland Business at this page.

Good Manufacturing Practice: A Global Standard for Pharmaceutical Quality

This PowerPoint can be viewed here.

PowerPoint on Contemportary Pharmaceutical Compounding from Dr. Loyd Allen

Here is a PowerPoint Presentation entitled Contemporary Pharmaceutical Compounding from a well-respected expert in the field Dr. Loyd Allen.  To view the PowerPoint can be viewed here.

Powerpoint Presentation on Animal Drug Compounding

Neal Batalier, DVM for the FDA Center for Veterinary Medicine, presented this Powerpoint at the AAVPT 14th.  While it  is dated 2005, it still contains valuable information.  Note, however, that some portions such as those regarding current investigations, etc. are outdated.  To view the Powerpoint, click here.