Three Pharmacies Snared By Unannounced State Inspections

December 7, 2012
 State House New Service

The Patrick administration on Thursday replaced three members on the state Board of Pharmacy, including one member who worked at Ameridose in Westborough, and announced three new cease-and-desist orders issued to Massachusetts pharmacies for the improper preparation and storage of drugs.
Inspectors began unannounced spot checks of compounding pharmacies last month as part of the emergency response to tainted steroids traced back to a Framingham pharmacy responsible for a deadly nationwide outbreak of fungal meningitis.
The Board of Pharmacy issued a cease-and-desist notice to OncoMed Pharmaceuticals in Waltham the day before Thanksgiving due to problems found related to the storage of chemotherapy drugs, and is currently working with the lab on a corrective plan, according to the Department of Public Health.
Pallimed Solutions Pharmacy in Boston was also ordered to stop production of sildenafil citrate, a drug used in Viagra and other brand-name treatments for erectile dysfunction, after inspectors found they had been preparing and distributing the medication using improper components.
A third pharmacy – The Whittier Pharmacist in Bradford - was ordered to cease operations until changes were made to bring its sterile compounding operations into compliance with federal standards.
So far, the board has conducted spot checks on more than a dozen pharmacies, finding other "minor deficiencies" that have been corrected or are currently being addressed, according to the Department of Public Health.
Dr. Lauren Smith, the state's interim public health commissioner, also announced an expected shake up of the 11-member board, replacing two members whose terms had expired and filling a third vacancy.
Patrick Gannon, vice president and chief quality officer for Southcoast Health System, will replace Sophia Pasedis. Pasedis had been asked by Patrick to resign because she worked at Westborough-based Ameridose LLC, which is under investigation for its ties to the New England Compounding Center blamed for the meningitis outbreak.
Edmund Taglieri, executive director of the Beaumont Rehabilitation and Skilled Nursing Center, will replace George Cayer, and Jane Franke, senior director of performance improvement innovations at Blue Cross Blue Shield of Massachusetts, has been named to the open seat.
Gannon, Taglieri and Franke will bring a diversity of experience to the board that critics, including Gov. Patrick, expressed concerns about being too insular and heavily represented by pharmacists.
"These respected health care professionals will use their experience to bring change to the Board of Pharmacy to enhance our oversight of this industry. We expect additional changes to the Board after the Commission of Pharmacy Compounding issues its recommendations to Governor Patrick at the end of the month," Smith said in a statement.
The board earlier this week held a public hearing to solicit feedback on the emergency regulations passed in November, and plans a vote within the next month to finalize those changes.
Industry leaders testified that the state should require out-of-state pharmacies doing business in Massachusetts to go through a registration process, and said regulators should allow pharmacies found in violation of state rules to have a hearing a quickly as possible.
The emergency regulations also required for the first time that sterile compounding pharmacies report the volume and distribution figures of their drug operations to the state, helping the board determine whether the pharmacy should be regulated as a manufacturer, which would require an FDA license.
New England Compounding Center was found to be in violation of the state's distribution regulations, shipping large quantities of compounded steroids to other states without specific patient prescriptions.
Unsanitary conditions were also discovered at the lab, contributing to the tainted drugs infecting 541 patients to date and leading to 36 deaths in 19 states. The Board of Pharmacy permanently revoked NECC's license to operate in Massachusetts, and criminal investigations are ongoing.
Source found here

University of New England students developing custom drugs for pets

By Jackie Farwell, BDN Staff

Posted Dec. 03, 2012, at 4:24 p.m.
Last modified Dec. 04, 2012, at 9:03 a.m.

PORTLAND, Maine — Pharmacy students at the University of New England are learning how to formulate custom medications not only for their future customers, but also for those customers’ pets.

Doctoral students are studying how to safely compound veterinary drug prescriptions, mixing up batches of the same medications humans take but in doses and applications better suited to cats, dogs, exotic creatures and other companion animals, according to UNE assistant professor Cory Theberge.

Take Valium, for example. Humans swallow the drug in pill form, most commonly to combat anxiety. Veterinarians sometimes request that pharmacists mold the drug into a suppository that can be administered to a dog as it’s experiencing a seizure, when a pill or shot isn’t practical, he said.

“Many drugs do not come formulated for a certain species or a specific animal use, so veterinarians commonly order compounded drug prescriptions for their patients,” he said.

Dosing human drugs for animals is much more complicated than just figuring out a pound-to-pound conversion, Theberge said.

“[The drugs] have the same function as in the human body, but they need a much different dose, and that’s due to the fact that the animal’s biology is different,” he said. “It’s not metabolizing the drug in the same way, it’s not absorbing the drug through its intestinal tract in the same way. Its blood chemistry is different.”

Creams and lotions that deliver medications through the skin are commonly requested by vets because they’re easier to administer to pets, Theberge said. Cats with hyperthyroidism are often treated with a medicated cream that’s rubbed into their ears, where the blood vessels are close to the skin’s surface, he said.

Then there’s flavor — much like humans, critters have their preferences. Horses prefer hay and oat-flavored oral medications, while tropical birds, naturally, are more inclined to take drugs when they taste like fruit, Theberge said.

Cats, which make up most of the market for compounded veterinary drugs, are especially finicky, he said. Felines often get medications flavored with a blend of sardines, tuna and salmon, and are more likely to tolerate square-shaped tablets than round ones in their delicate mouths, he said.

Cost-conscious pet owners are increasingly looking to buy compounded drugs for their pets at the same retail and community pharmacies where they pick up their own prescriptions, Theberge said.

“If you can get it down the street at Pharmacy X, Y or Z for $20 less, most people will,” he said.

Compounding of drugs for livestock is treated separately and is more highly regulated, Theberge said.

Pharmacists who can speak knowledgeably with veterinarians and possess the skills to mix drugs for animals will have a professional edge, he said.

Katelyn Richard, a student pharmacist at UNE, said she valued the elective class as the market becomes more competitive.

“Pets are now considered another member of the family,” she said. “Taking this class has given me an advantage over other pharmacy students to provide another level of care to customers’ furry friends.”

The inaugural class of UNE’s College of Pharmacy will graduate in May 2013. Doctoral students, who learn the basics of drug compounding as part of their regular curriculum, can take the veterinary compounding elective in their third year.

A lab for the elective was co-organized by Steve Hauke, a veterinary pharmacist and owner of PetScripts in Yarmouth, which formulates custom drugs for animals. Big pharmacy chains are beginning to carry and advertise pet medications — more often preformulated drugs such as Frontline and Heartgard — but their pharmacists typically don’t have much time to compound drugs, he said.

Medications specifically formulated for pets could evolve into significant niche for corporate pharmacies, Hauke said.

“I see this as a small component of a larger retail market,” he said.

Source found here

Congress investigating compounding trade group--IACP - Business Wire - The Olympian - Olympia, Washington news, weather and sports

Congress investigating compounding trade group - Business Wire - The Olympian - Olympia, Washington news, weather and sports

State might further scrutinize compounding pharmacies after meningitis outbreak

Orlando Business Journal by Abraham Aboraya, Reporter

Date Friday, December 7, 2012, 1:18pm EST
Abraham Aboraya

Reporter- Orlando Business Journal

 

If you’re a compounding pharmacy in Central Florida, be warned: The state may take a harder look at regulating the industry after a fungal meningitis outbreak killed three people in Florida.

The problem is this: In Florida, there is no separate permit for a pharmacy or a compounding pharmacy. So the state has no way to track or regulate the industry and, potentially, make sure outbreaks don’t happen.

A pharmacy sells bulk drugs (think Walgreens). A compounding pharmacy is designed to mix a special compound not commercially available.

Central Florida has a huge cluster of specialty pharmacy companies. According to the Metro Orlando Economic Development Commission, 70 percent of the country’s specialty pharmaceuticals are distributed through Central Florida.

According to Health News Florida, the Pharmacy Board sent out a survey in October to all of the state’s pharmacies, asking who compounds their own drugs. They got a paltry return rate of 20 percent.

So the board passed an emergency rule threatening to punish pharmacies that don’t return the survey, which is due Dec. 10.

According to the same article, Assistant Attorney General David Flynn told the Board of Pharmacy at an all-day hearing in Orlando that the state has no power to regulate companies selling drugs in Florida that aren’t located here.

“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box.”

Outbreak Shows Gaps in Regulation in Florida

By Carol Gentry

Originally published on Thu December 6, 2012 11:07 am

When the nationwide fungal meningitis outbreak exploded into headlines two months ago, Florida health officials responded quickly, tracking the contaminated drug lots and finding potential victims. On Wednesday, they announced the 25th case, including three who died.
While the response was swift, Florida health officials concede the state failed to foresee the danger and take steps to reduce the risk. New England Compounding Center, identified as the source of the tainted drugs, had a Florida non-resident license that allowed it to send drugs into the state.
Florida relied on Massachusetts to oversee NECC's operations and make sure its drugs were safe. After the extent of its problems were exposed, NECC was shut down.
Florida law gives health officials in this state no power to regulate companies that sell drugs inside Florida but aren’t located here, Assistant Attorney General David Flynn told the Board of Pharmacy at a recent all-day hearing in Orlando.
“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box."
No permit is required
It was mere chance that the meningitis outbreak began in a different state, Board of Pharmacy members discovered. It could just as easily have started in Florida, because the state has no information on how many of the 7,897 licensed pharmacies are compounders. No permit is required.
State officials sent out a survey to all pharmacies in October, trying to learn which ones were making their own drugs, especially drugs that require a super-sterile manufacturing environment. But only 10 percent of the pharmacies filled out the survey.
So the Pharmacy Board passed an emergency rule that requires pharmacies to answer the survey or face punishment. The answers must be in by Monday.
Of all states, Florida should have foreseen trouble with compounding, after the 2009 deaths of 21 polo ponies that were scheduled to compete in a championship in Wellington. The drugs -- supposed to be vitamins -- had been made by a veterinary compounding pharmacy in Ocala.
'I couldn't answer the question'
After the NECC outbreak became big news at the beginning of October, calls started coming in to the Health Department from reporters, asking how many compounding pharmacies Florida has. Cassandra Pasley, chief of the bureau that regulates health care practitioners, saw there was a gap in the state's information.
"I couldn't answer the question as to how many compounding pharmacies we have in Florida because we really don’t have a permit called 'compounding pharmacies,'" she said.
Family doctor Kenneth Woliner says he tried to sound a warning about compounding pharmacies in early 2011 after receiving a marketing flier from Rejuvi Pharmaceuticals Inc. in Boca Raton. The flier touted the profits that doctors could make by buying drugs in bulk from Rejuvi at wholesale prices and then selling them to patients at a mark-up.
To Woliner, that didn't seem right. Compounding pharmacies are allowed to tailor-make a drug for an individual patient who can't use the official mass-produced version -- if they have a doctor's prescription. They're not supposed to mass-produce other companies' patented drugs and sell them in bulk.
Specializing in hormone replacement
Rejuvi's specialty, the flier said, was hormone replacement therapy. It advertised human growth hormone and HCG, a pregnancy hormone, for anti-aging and body-building, purposes for which the drugs are not FDA-approved. While it is legal for doctors to prescribe the drugs for non-approved purposes, drug makers are not supposed to tout them for those uses.
Woliner said he thought what Rejuvi was suggesting might be illegal for the pharmacy, the doctors, or both. He felt it was certainly unethical. He filed a complaint in April 2011.
“I’ve been frustrated because I’ve seen enough of my patients who have come in from other physicians that have been exploited financially and also hurt physically because they are prescribed drugs inappropriately in excessive quantities," he said. "It's mainly because the doctor went for the mark-ups, not because the patients needed therapy.”
A month after submitting his complaint to the Health Department, Woliner got a reply. DOH said there wasn’t enough evidence to warrant action.
Complaints disappear without a trace
Woliner says this type of abuse happens all the time—and he has filed numerous complaints -- but he says the Health Department seldom does anything with them.
"It’s almost like they do not want to do the work to investigate and prosecute these cases or protect the health of the public because it’s work for them to do,” he said.
A Health Department inspector finally visited Rejuvi in early October, 18 months after Woliner filed his complaint. The inspector found a long list of problems, as Health News Florida reported. They included mouse droppings, dead insects, dirty water standing in the sink, and a covering of dust all through the compounding area.
In addition, information on patients and prescriptions was missing from the pharmacy, and drug labels were missing crucial information on the dose, lot number, and prescribing physician, the report said. Without that information it would be impossible to track down and recall the drugs if a lot were contaminated, the report said.
'Never been as horrified'
The pharmacy had been cited for problems before, the report said, but this time was worse. The inspector “has never been as horrified by the conditions of a pharmacy department as he was by the conditions of Rejuvi,” the report said.
Surgeon General John Armstrong issued an emergency suspension order on Rejuvi, shutting it down along with another compounding pharmacy.
The owner of Rejuvi declined to speak with Health News Florida; his attorney, Julie Gallagher, said of the Woliner complaint that went nowhere: “I have no comment on hearsay and speculation. If a case was closed for lack of legal sufficiency, that should tell you something. “
The Health Department can’t explain why Dr. Woliner’s complaint was so quickly shelved; in fact, officials can’t even confirm they ever got the complaint. Unless formal charges are brought, under the law the complaint remains confidential.
Gallagher says Rejuvi will appeal the suspension unless it reaches an amicable settlement.
Friday: Making compounding safer.

Source found here

Scandal leads to new members for embattled state Pharmacy Board

Scandal leads to new members for embattled state Pharmacy Board

Bugs, Birds & Ignored Complaints At A Compounder

22 hours ago by editor 0

By Ed Silverman

In the latest bit of evidence to raise disturbing questions about some compounding pharmacy operations and regulatory oversight, the FDA recently sent 14 investigators and three microbiologists to inspect Ameridose, which is owned by the same folks who own the New England Compounding Center, and found another remarkable series of troubling findings.

Such as? There were cracked and corroded walls where products are prepared; rodents were in the building; insects were found in sterile areas where products are packaged and stored; a bird – yes, a bird – was flying around in the same area; final drug products were not tested for potency; and 53 instances of microbiological contamination and three sterility failures were not investigated, according to the FDA.

In addition, patient complaints were not classified as adverse events or followed up and patient outcomes and interventions were not adequately investigated. These incidents involved compounded versions of such popular treatments as heparin, fenatyl and oxytocin. In some cases, complaints related to potency or ‘under-filled’ products – which refers to less drug than should have been provided – were defined as ‘non-complaints.’

It gets worse. For example, the quality control unit “failed to adequately investigate and implement permanent corrective action after 45 environmental microbiological excursions (mold and bacteria) were isolated from critical areas such as personnrl fingers inside class 100 hoods and controlled manufacturing areas during the manufacturing of sterile injectables” this year, the FDA found.

These infractions, among many others, were contained in a so-called 483 inspection report posted on the FDA web site last night as the agency grapples with the fallout from a fungal meningitis outbreak traced back to the NECC (here is the 483 report). So far, 438 cases, including 32 deaths, have been reported in nearly two dozen states (see the breakdown here).

The 483 report was released ahead of a pair of Congressional hearings that will take place this week to examine the controversy over regulatory oversight of compounders – the House Energy & Commerce Committee holds a hearing tomorrow (look here) and the Senate Health, Education, Labor & Pensions Committee holds its hearing on Thursday (see this).

Both will feature FDA commish Margaret Hamburg, who will be on the hot seat as she attempts to explain her interpretation of agency oversight and enforcement powers. The FDA has been criticized for not moving faster to regulate the NECC, especially since the agency issued a 2006 warning letter and the compounder had moved beyond traditional compounding – preparing specific medicines for individual patients – into a larger-scale manufacturing operation.

Court rulings have confused the matter, although in response to a 2002 US Supreme Court ruling, the FDA decided to defer most oversight to state board pharmacies and health officials. However, the FDA has also indicated as recently as earlier this year that it would pursue enforcement actions, such as safety concerns or the equivalent of mass production.

In recent weeks, the FDA responded to the meningitis outbreak by scrambling to investigate NECC and Ameridose, both of which are owned by Greg Conigliaro and Barry Cadden, who is also scheduled to testify at both hearings. The NECC report similarly yielded a long list of infractions, including ‘greenish-black foreign matter’ on sterilization equipment and air conditioning systems that were turned off at night (back story with report).

Both compounders have issued recalls and suspended operations as various investigations continue. Last week, for instance, Massachusetts state health officials fired state pharmacy board Jim Coffey and placed board attorney Susan Manning on leave for allegedly ignoring a complaint last July that bulk shipments of drugs were distributed to hospitals in Colorado. Coffey was to have testified at the House hearing tomorrow.

However, Massachusetts officials are also being scrutinized because Sophia Pasedis, who sits on the 11-member Massachusetts Board of Registration in Pharmacy, is also vp of regulatory affairs and compliance at Ameridose. The conflict has raised criticism and concern that state authorities may have been lenient, even though complaints had been registered against the NECC in recent years (back story).

Prior to the meningitis outbreak, the board had investigated at least twelve separate complaints concerning NECC or Cadden, issued at least four advisory letters and/or informal reprimands, and entered into a consent agreement with the company in 2006, according to a memo released by the House Energy & Commerce Committee in advance of its hearing.

One complaint cited Cadden for providing a health care practitioner with blank prescription pads referring to NECC, which violated board regulations. In June 2001, the board investigated a report submitted by the Idaho Board of Pharmacy that NECC was soliciting business for drugs that should have been discontinued by the manufacturer.

There were also indications that Cadden and Conigliaro were chafing at the regulatory attention. In one incident in September 2004, FDA and state officials conducted a joint investigation into products using Trypan blue dye. An investigator asked Cadden whether the dye was used and he denied this. But he was asked to open a drawer marked ‘Trypan Blue’ and it contained.. drum roll… 189 vials.

Cadden agreed to quarantine the products, but on their next visit, he told investigators that his attorney informed that he was not required to do so and responded “there is no regulation which states that Compounding Pharmacies cannot compound FDA non-approved drugs.” Cadden added that he intended to continue dispensing a medication containing the dye and he became “indignant [and] he said that he does not really have the time to sit with us [and] answer all those questions,” an FDA investigator wrote in a report. Cadden then told Conigliaro, who is his brother-in-law, “don’t answer any more questions!”

More than a year earlier, in February, 2003, FDA inspectors met with NECC and concluded in a report by writing that the agency emphasized “the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.” The agency inspector, in fact, suggested that NECC be prohibited from manufacturing. However, the FDA acknowledged that “so long as a pharmacy’s operations fall within the scope of the practice of pharmacy (as outlined in FDA’s Compliance Policy Guide 460.200), FDA will generally continue to defer to state authorities for regulatory oversight” (Here is the Committee memo).

Meningitis victims can likely inspect pharmacy linked to outbreak

Meningitis victims can likely inspect pharmacy linked to outbreak

Utah moving to fortify regulation of compounding pharmacies

By Kirsten Stewart

| The Salt Lake Tribune

First Published 4 hours ago • Updated 20 minutes ago

The Massachusetts-based pharmacy blamed for a meningitis outbreak that has killed dozens andsickened hundreds can no longer ship drugs to Utah.

New England Compounding Center (NECC) voluntarily surrendered its mail-order privileges in October, not in response to any action taken by state licensers, said David Young, chairman of the Utah Board of Pharmacy. "We’re not the only state. After losing their license in some states, I think they voluntarily surrendered them in multiple other states."

The move is mostly a formality, considering the compounding pharmacy closed in October and none of its tainted injections made it to Utah. But the scandal has highlighted regulatory weaknesses that states, including Utah, are moving to fortify. As a starting point, state inspectors are going to pharmacies statewide to determine which are compounding drugs.

It’s not that the rules or standards for compounders are too loose, Young said. The problem, he said, is that some compounders are acting more like drug manufacturers without the same oversight.

Compounders are regulated by states, whereas drugmakers are overseen by the U.S. Food & Drug Administration. But the lines between the two are blurry, Young said.

In setting compounding rules, state regulators typically defer to standards set the by the National Association of Boards of Pharmacy, Young said.

Utah law defines compounding as making a "limited quantity" drug, product or device as prescribed by a doctor, or for research, chemical analysis or teaching. Compounding does not include preparing a drug "in a dosage or form that is commonly available from a manufacturer" or preparing a drug that has been pulled from the market for safety reasons, the law states.

"What NECC was doing is making 17,000 doses of stuff and shipping it all over the place," Young said. "That’s manufacturing, not compounding."

But Young isn’t aware of any state that clearly defines when a compounder has crossed the line and should be subject to FDA oversight.

Drugmaking "is a different beast" that states aren’t equipped to handle, Young said. "If [like NECC] you’re making a steroid solution for injection into the spine, you need to be testing [drug] lots on a continuous basis and following quality control measures. The FDA has solid, tight rules on that stuff."

Congress is weighing various proposals for defining how and when the FDA should intervene. One fix could be to create a special class of compounders, Young said.

Another would be state-based rules to set compounders apart from other pharmacies.

Mark Steinegal, director of the state Division of Occupational and Professional Licensing (DOPL) estimates there are about 30 compounders in Utah.

"We do not have a complete list," because, he said, "they do not have a unique license ... [and] are lumped with other pharmacies in our databases."

To get an accurate count, DOPL is dispatching inspectors to pharmacies statewide. Results from their survey will be sent to the National Association of Boards of Pharmacy, which is reviewing its standards.

Depending on what action Congress takes, Young said Utah may also revise its compounding rules.

Utah’s compounding pharmacies

Regulators are surveying pharmacies statewide for a tally of how many compound their own drugs. To date, they know of 30:

Larry’s Smithfield Pharmacy

Edgemont Pharmacy

Roe Rx Inc.

Peterson Foodtown Inc.

South Valley

Mt. Olympus Compounding

Rock Canyon Pharmacy

Jolley’s Corner Pharmacy

Jolley’s Corner Pharmacy 3

Jolley’s Sandy Pharmacy

TMJ Inc. (Jolley’s Corner)

The Medicine Center

Skyline Pharmacy #2

Gibson’s Pharmacy

Hurricane Family Pharmacy

Dry Creek Pharmacy

The Medicine Shoppe

Taylor Drug

Mountainwest Apothecary

North View Pharmacy

Salmons Pharmacy

Stapley Pharmacy

EJV F LLC (Bulloch Drug)

Superior Care Pharmacy Inc.

Rocky Mountain Infusion Clinic

Intermountain Homecare Pharmacy @ Dixie

Infusion Innovations

CNS Pharmacy

Superior Care Pharmacy Inc.

Mountain Care Pharmacy

Coram Healthcare Corporation of Utah

Source found here

The Op-Ed: A Slew Of Off-Label Promotion Is Unlikely

By Ed Silverman // December 6th, 2012 // 12:09 pm

Earlier this week, a federal appeals court panel overturned the conviction of a former sales rep for allegedly encouraging doctors to prescribe a drug on an off-label basis, ruling that his conviction violated his First Amendment rights. The ruling may not be the final word on the issue, but a vigorous debate – including considerable speculation – has since ensued. So what happens next? Will this reach the US Supreme Court? Is all off-label promotion now protected free speech? And will consumers see a barrage of off-label advertising. Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, looks at his crystal ball and finds…

The split-decision by a three judge panel of the US Second Circuit Court of Appeals in United States v. Caronia (see back story and ruling here) has pharmaceutical and First Amendment lawyers all abuzz. In fact, there has already been at least one law firm webinar on the subject a mere few days after the decision was rendered.

Just to recap, over a vigorous dissent, a two-judge majority held that, in order to avoid a First Amendment violation, the Federal Food, Drug, and Cosmetic Act should be construed as not prohibiting mere off-label promotion of an FDA-approved drug that is neither false or misleading.

In concluding that the defendant’s conviction should therefore be overturned, the majority relied to a considerable extent on the U.S. Supreme Court’s decision in Sorrell v. IMS Health (back story with ruling).

In that case, the court concluded that “(s)peech in aid of pharmaceutical marketing… is a form of expression protected by the… First Amendment” and, on First Amendment grounds, overturned a Vermont statute that prohibited the use of physician-identifiable prescribing data in detailing to doctors.

The dissent in the Caronia case by Judge Debra Ann Livingston focused to a considerable extent on the implications of the majority decision on a bedrock principle of food and drug law – “intended use” – and on the historical understanding that each intended use of a new drug must be separately approved by the FDA.

Otherwise, there would be little incentive for companies to seek approval of new drug application, supported by “substantial evidence” as that term is defined in the Food, Drug & Cosmetic Act, for an indication as yet unapproved by the agency.

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