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.

Continue reading here

Mass. acts against 3 pharmacies after inspections

Mass. acts against 3 pharmacies after inspections

A Compounding Fracture at the FDA

The agency has been slow to exercise control over pharmacies that mass produce drugs.

By SCOTT GOTTLIEB AND SHELDON BRADSHAW

The recent deadly outbreak of meningitis caused by spinal injections of a contaminated steroid has cast a spotlight on the practice of pharmacy compounding—when pharmacists mix or adapt medicines to make a specific prescribed treatment. The House and Senate are holding oversight hearings this week on the tragedy that has sickened at least 438 people and is believed to have killed more than 30.

Congress wants to know why the Food and Drug Administration didn’t do more to prevent the production and sale of tainted steroids by the New England Compounding Center. The FDA will likely say that it doesn’t have enough authority to regulate the pharmacies that compound drugs.

But the FDA does have enough authority. And it did in 2006, when the agency sent a warning letter to the New England Compounding Center, in effect telling the NECC to stop manufacturing certain drugs or face legal action. In 2006, the warning came because the compounding pharmacy was, among other things, violating regulatory rules by producing drugs that were already commercially available from FDA-approved manufacturers. Six years later, NECC was not only still operating but also, it has become clear, selling tainted drugs. Where was the FDA? What was the problem?

The trouble didn’t come from traditional compounding, which is a legitimate part of the practice of pharmacy. Compounding pharmacies mix or alter drug ingredients to adapt a medicine based on a doctor’s prescription—for example by changing a pill into a formula, tailoring chemotherapy, or adding cherry flavoring to a child’s medicine. The practice lets physicians customize drugs to individual patients. Traditional pharmacy compounding typically is performed on a small scale and is always performed in response to a valid prescription.

The FDA normally doesn’t get involved with such practices because it isn’t tasked with regulating the legitimate practice of pharmacy. Like the practice of medicine, pharmacy is largely left to professional and state oversight. But once pharmacies begin manufacturing and shipping medicines on a mass scale, they become “drug manufacturers” and fall squarely under the FDA’s extensive authority.

There are unambiguous rules governing when a compounding pharmacy crosses the line and becomes subject to FDA supervision. The practice of compounding, for example, does not allow the manufacture of copies (or near copies) of FDA-approved drugs that are commercially available. By all accounts, the New England Compounding Center was hardly a pharmacy as generally understood; it was manufacturing unapproved duplicates of FDA-approved drugs and distributing them for a large-scale market without first receiving valid prescriptions for the individual drugs.

This all put the NECC firmly in violation of FDA rules—if the agency had chosen to enforce existing provisions. But in recent years the FDA has seldom drawn clear lines between practices that are legal and beyond its purview and ones over which it clearly has authority. The regulatory hesitation has meant that some of the shadiest compounding outfits haven’t been reined in. And it magnified risks by emboldening more pharmacies to go well beyond traditional compounding and engage in large-scale drug making—because it seemed a fairly safe bet that the FDA wouldn’t come knocking.

Meanwhile, the agency has been focused on enforcement activity that could instigate legal showdowns and set judicial precedents that would expand FDA power over the full scope of the practice of pharmacy. Part of this strategy is philosophical: Many at the agency have long believed that all of the professional practice of pharmacy belongs under the FDA’s oversight. Then there is regulatory languor: The FDA reasons that if it can assert jurisdiction over the entire profession, then it can more easily pick and choose where to focus its energies, instead of having to establish in advance which firms are crossing the line.

Take, for example, the FDA’s recent (and unsuccessful) enforcement action against the compounding firm Franck’s Pharmacy, a maker of customized veterinary drugs. Rather than allege that Franck’s had crossed the line from traditional pharmacy compounding to drug manufacturing, the FDA took the expansive position that it had the authority to regulate the practice of pharmacy in general and traditional pharmacy compounding in particular. The federal judge overseeing the Franck’s case easily rejected FDA’s power grab (although the judge didn’t dispute, and specifically noted, that the FDA has the authority to regulate drug manufacturing carried out under the guise of traditional compounding).

Ironically, the FDA is now using legal defeats like the one in the Franck’s case as the excuse for why it couldn’t be tougher on the steroid-maker NECC. This week, the FDA will ask Congress for new authorities to expand its oversight over the practice of pharmacy.

Instead, Congress should instruct the agency to issue regulations that assert the authorities that the FDA already has—drawing a bright line between the traditional practice of pharmacy (regulated by states) and the place where a compounder has crossed the line into drug manufacturing, making itself subject to federal regulation.

The FDA has failed for decades to clearly establish enforcement policies related to pharmacy compounders because the agency doesn’t want to concede that it was never supposed to have jurisdiction over the legitimate, local practices of pharmacy and medicine. In the process, the agency has undermined its own mission.

Dr. Gottlieb, a resident fellow at the American Enterprise Institute, was deputy commissioner of the FDA from 2005-07. Mr. Bradshaw was the FDA’s chief counsel from 2005-07. He was retained by Franck’s Pharmacy as an expert witness in the FDA case against the company.

A version of this article appeared November 14, 2012, on page A15 in the U.S. edition of The Wall Street Journal, with the headline: A Compounding Fracture at the FDA.

Source found here

American College of Veterinary Pharmacists Basic Veterinary Compounding Course 1/7-8/2013

1/7/2013 8:00 AM - 1/8/2013 5:00 PM Basic Veterinary Compounding Course

ACA National Training Laboratory (map)

Basic Veterinary Compounding Course Basic Veterinary Compounding is a 15 hour course The overall goal of this practice based course is to introduce the pharmacist and pharmacy technician to veterinary pharmacy compounding.This program provides the fundamental techniques for compounding medications for animals, as well as establishing and marketing a veterinary pharmacy practice. For Additional Information and to REGISTER ONLINE - Click Here $1095 (Non Member price) * $995 (Membe...

 Basic Veterinary Compounding Course Outline.pdf

Prosecutors want to be in on pharmacy inspection - Boston News, Weather, Sports | FOX 25 | MyFoxBoston

Prosecutors want to be in on pharmacy inspection - Boston News, Weather, Sports | FOX 25 | MyFoxBoston

STATE OF WISCONSIN Board of Pharmacy

will discuss Federal Letters Requesting State Information as it Relates to Compounding Pharmacies at the next board meeting on December 12, 2012.  See here

GAP Sues FDA for Wrongful Withholding of Animal Drug Data

The Food and Drug Administration's decision to withhold agency data regarding the sale of antibiotics for use in food animals is unlawful, the Government Accountability Project (GAP) said in a lawsuit filed today.  Read article here

Recalled Meds Found in N. Prov. Spa | WPRI.com

Recalled Meds Found in N. Prov. Spa | WPRI.com

druganddevicelaw: Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds

Monday, December 03, 2012

Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds

The long wait is over. Here is the Second Circuit's decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012). By a 2-1 vote, Mr. Caronia's conviction for off-label promotion is reversed on First Amendment grounds. The ruling is unmistakable. There was no question that off-label promotion had occurred. Slip op. at 14-16. The sole basis for vacating the conviction was the government's failure to prove that any of the alleged promotion was false.
off
Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only "plays an evidentiary role" in a criminal prosecution for misbranding. Slip op. at 27 (emphasis original). Thus:

The government contends that Caronia was not prosecuted for his speech, but that Caronia's promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”
Id.

The majority in Caronia didn't buy the change of tactics. "[T]hat is not what happened in this case." Id. at 28.
Continue reading here

Official: Meningitis outbreak could have been prevented

December 5, 2012

Official: Meningitis outbreak could have been prevented

By Matt Murphy 
State House News Service

---- — BOSTON — As the state’s pharmacy board considers final regulations to improve oversight of retail and compounding pharmacies, some in the industry believe it was the lack of enforcement of existing rules that led to a deadly fungal meningitis outbreak.

“In retrospect, we feel this situation could have been prevented if either the FDA or the Board of Pharmacy enforced the regulations already on the books,” Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, told the News Service yesterday after testifying before the board.

Brown and David Miller, of the International Academy of Compounding Pharmacists, offered feedback yesterday to the Board of Registration in Pharmacy on emergency regulations put in place Nov. 1 following the linkage of the meningitis outbreak to tainted steroids produced by the New England Compounding Center in Framingham.

Only three people testified on the regulations that apply to an industry that has come under scrutiny in Massachusetts and at the federal level in the wake of the outbreak.

Brown called it “ironic” that a Massachusetts pharmacy would be responsible given the relatively strict regulations already in place, and he called NECC an “outlier” that flaunted the state’s regulations and yet their violations went undetected.

Board president James DeVita and counsel Heather Engman alone were on hand to collect public comment on the regulations adopted at the direction of Gov. Deval Patrick in early November. The state at that time also permanently revoked NECC’s pharmacy license and Patrick established a special commission to report back before the end of the year on legislative steps the state could take to improve its oversight and pharmacy licensing laws and regulations.

The board also began periodic, unannounced inspections of compounding labs in the state.

While the regulations governing Massachusetts-based pharmacies are already strong, according to Brown and Miller, both said they had concerns that there was no registration process for out-of-state pharmacies doing business in Massachusetts. Georgia and Pennsylvania are the only other two states that don’t require out-of-state registration.

“It is a concern to us whenever we see a board that doesn’t have the same type of protections for citizens of pharmacies and compounding pharmacies outside its borders,” Miller said.

Brown said he has been in contact with legislators who have agreed to file legislation regarding the registration of out-of-state pharmacies in Massachusetts, though he declined to name lawmakers with whom he has been working.

Miller also raised concerns about the amount of time allowed before a pharmacy shut down by the board can have a hearing. The emergency regulations specify that a pharmacy is entitled to a hearing within 21 days of receiving a cease-and-desist order, but Miller said that could be very detrimental to both the business and patients looking to get their prescriptions filled. He recommended holding a hearing within five days.

“We’re placing our patients at risk with not being able to obtain their medications,” Miller said.

The emergency regulations adopted by the board require compounding pharmacies to report to the state the volume and distribution of drugs to determine whether they are acting more like a manufacturing facility that would be subject to Food and Drug Administration oversight.

The regulations also require pharmacies to report to the state when they are the subject of an investigation by another state or federal authority, and create stiffer penalties if pharmacies fail to comply with rules and regulations.

Brown suggested clarifying the definition of compounding, and limiting the requirement that pharmacies report “adverse events” to the state to those associated with compounding or when compounding products cause serious harm attributed to the accuracy, potency or sterility of the product.

Paul Garbarini, a pharmacist and attorney who represents pharmacies sanctioned by the board, also took issue with the requirement that pharmacists report pending criminal charges to the board.

“I think it flies in the face of common sense and fair play,” he said, suggesting convictions would be more relevant.

Source found here

 

F.D.A. Finds Safety Problems at Company Supplying Drugs

21 hours ago by editor 0

By DENISE GRADY and SABRINA TAVERNISE

A federal inspection has turned up a long list of unsanitary conditions and unsafe practices at Ameridose, a drug supplier with some of the same owners as the pharmacy whose tainted steroid caused a nationwide outbreak of fungal meningitis that has killed 32 people and sickened more than 400 others.

A 20-page report issued on Monday by the Food and Drug Administrationdescribed drug solutions contaminated with germs, rusted and unsanitary equipment, and insects and a bird flying around in areas where sterile products were packaged and stored.

Inspectors also said the company failed to “adequately investigate” complaints of serious reactions in patients that might have indicated problems with drug potency — reactions including fetal distress, a hyperstimulated uterus and maternal hemorrhaging from a drug used in labor, and oversedation and breathing trouble from fentanyl, a powerful narcotic. There were also complaints of low potency in a sedativeused to relieve anxiety in children undergoing surgery.

“F.D.A. inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients,” Sarah Clark-Lynn, a spokeswoman for the agency, said in an e-mail.

So far, Ms. Clark-Lynn said, no infections have been linked to Ameridose, but all its products have been recalled, and its operations have been suspended since early October at the request of state regulators, who say they need more time to investigate.

Ameridose said in a statement that it had had no instances of product contamination in its six-year history, during which it had shipped “70 million units of product.” However, problems with potency did result in at least one recall. The company said it was “committed to addressing all observations in order to enhance our existing systems.”

Eric S. Kastango, the president of Clinical IQ, a consulting firm that advises compounding pharmacies, said the F.D.A. findings at Ameridose were “just stupefying.”

“It’s an operation that is totally out of control,” he said. “Especially when you look at the patient complaints, that is scary as all get-out.”

Ameridose has been a major supplier of sterile injectable medications to hospitals and sells more than 2,200 blended drug products, including tranquilizers, anesthetics andantibiotics, according to its Web site.

The inspection report dealt another blow to the family behind Ameridose and its sister company, the New England Compounding Center, which made the fungal-tainted steroid medication that caused the meningitis outbreak. The report comes just two days before the House Committee on Energy and Commerce is scheduled to hold a hearing on the outbreak. Barry Cadden, the chief pharmacist at the New England center, was subpoenaed by the committee after he declined its initial request to testify. Federal officials have said Ameridose was investigated because of concerns that it had some of the same business practices as New England Compounding.

Ameridose, founded in 2006, is a private company and is not required to report its financial status publicly. Weeks of no activity seem to have taken their toll on the company, which has laid off or furloughed most of its 650 employees, as well as 140 employees of its sales affiliate, Medical Sales Management.

 Ameridose was founded by the same people who owned the New England Compounding Center — Mr. Cadden, who has since lost his license; Gregory Conigliaro, a businessman; and Mr. Conigliaro’s sister-in-law, Carla Conigliaro. It is based in Westborough, Mass.

Robert C. Coleman, a retired F.D.A. investigator, said in an e-mail that while the inspection report was not the worst he had seen, “I would not want to use any of the company’s products.”

Mr. Kastango said part of the problem was that Ameridose, while run by pharmacists, had become a major drug manufacturer, without the proper procedures for safe mass production.

“It’s just unfathomable that they were able to operate for as long as they did,” he said, adding that he doubted Ameridose would ever be able to open for business again.

Andrew Pollack contributed reporting.

Bill Would End Current State-by-State, Patchwork System--DeLauro, Lowey Introduce Legislation Strengthening Oversight Of Compounding Pharmacies

December 05, 2012

WASHINGTON, DC—Representatives Rosa DeLauro (D-CT) and Nita Lowey (D-NY) introduced legislation today to improve the failed regulatory framework currently governing compounding pharmacies and clarify the Food and Drug Administration (FDA)’s ability to oversee such pharmacies. A compounding pharmacy in Massachusetts was responsible for the meningitis outbreak that sickened over 500 people and caused at least 36 deaths.

“I wish this legislation were not necessary, but  tragic events have proven that it is,” DeLauro said. “The actions of the New England Compounding Center have made clear that strong Federal authority is necessary to ensure patients know they are receiving safe compounded drugs. It has also become clear that federal and state regulators must better communicate to identify trouble facilities and leverage their resources to protect patients. 

“Yesterday’s announcement that multiple NECC products were contaminated simply underscore that this was not an isolated incident. We must end the current regulatory morass so that no more lives are placed at risk.”

Lowey said: “As recent events have made clear, it is critical to ensure compounding pharmacies are operating safely and the products consumers receive will improve - not jeopardize - their health. Federal oversight is critical to identify and correct potential problems and keep consumers safe.”

The Supporting Access to Formulated and Effective (S.A.F.E.) Compounded Drugs Act would:
Require compounding pharmacies to register their facility with the FDA
Ensure patients know they are receiving a compounded drug
Require compounded drugs to be labeled appropriately
Establish a FDA database of information on compounding pharmacies to inform oversight by the FDA and appropriate state regulators
Ask the FDA to set minimum production standards
Direct the FDA to offer training opportunities for state regulators
Seek additional information on third party accreditation and the various models used by state regulators
Improve communication between federal and state regulators to facilitate more comprehensive inspections
DeLauro, a senior member of the committee responsible for funding the FDA, announced she would introduce the legislation on October 9, the same day she wrote to Health and Human Services Secretary Sebelius on the issue. On October 19 she and Representative Sanford Bishop wrote to Sebelius and Veterans Affairs Secretary Shinseki to ensure the safety of pharmaceuticals given to participants in Medicare, Medicaid, and the Veterans Health Administration.

Source found here

Rosa DeLauro introduces S.A.F.E. legislation- The New Haven Register - Serving New Haven, Connecticut

Rosa DeLauro introduces S.A.F.E. legislation- The New Haven Register - Serving New Haven, Connecticut

Bill would make drug compounders register with FDA:Supporting Access to Formulated and Effective Compounded Drugs Act, or SAFE Compounded Drugs Act

By Paul Barr

Posted: December 5, 2012 - 5:15 pm ET

A bill that would require compounding pharmacies to register with the Food and Drug Administration was introduced in the House, according to a news release from the two sponsors of the bill, Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.).

The bill, called the Supporting Access to Formulated and Effective Compounded Drugs Act, or SAFE Compounded Drugs Act, would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders, according to the news release. In addition, it would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators. 

A compounding pharmacy in Massachusetts is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths.

Read more: Bill would make mixing pharmacies register with FDA | Modern Healthcare http://www.modernhealthcare.com/article/20121205/NEWS/312059954#ixzz2EFMwRWEs 
?trk=tynt 

FDA Fights Web Pharmacies Selling Unapproved Drugs

posted: Oct 05, 2012 3:55 PM CDTUpdated: Oct 05, 2012 3:55 PM CDT

WASHINGTON (AP) -- The Food and Drug Administration is stepping up its fight against counterfeit and other potentially harmful medicine sold over the Internet.

The agency is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.

The FDA has sent warning letters to three companies behind most of the websites. It's also seized some illegal medicines, filed civil and criminal charges against companies and people, and contacted Internet registrars and service providers, asking them to suspend the 4,100 websites.

Those efforts are part of a global crackdown on online sellers of counterfeit and illegal medical products. Interpol, the international police agency, says about $10.5 million worth of medicines were seized worldwide last week and more than 18,000 illegal pharmacy websites were shuttered.

Source found here

 

Rhode Island spa kept recalled drugs, state officials say

Rhode Island spa kept recalled drugs, state officials say

Pols back new rules in wake of NECC flap

Pols back new rules in wake of NECC flap

It’s Time for FDA, States to Step Forward for Public Health

DECEMBER 5, 2012 BY PATRICK STONE LEAVE A COMMENT

Patrick Stone, President, TradeStone QA

It’s clear that the FDA should have more compounding pharmacy oversight but how long will it take them to make other important decisions on public health?

The recent news is troubling.

Example: According to state and federal records, it took FDA approximately 684 days to issue a warning letter that may have saved lives and time. Usually it should only take 90 days for compliance branch a local district directors to decide on a firm’s regulatory outcome. The FDA mandates strict 483 fifteen day response letter times and should also be held to a 60 or 90 day turnaround.

As a former FDA inspector, I’ve been there. Some of the cases I was involved with took 24 months to get a final warning letter decision. This is unacceptable because there is a 6 month follow up that should be conducted.

But if regulators give the regulated industry time to make more  lethal products who is to blame? Usually FDA gets local state authorities involved for immediate detention and embargo of harmful products. Each state has unique authority over products made within it’s borders if they are held for interstate trade. The New England region was also involved with the FDA inspections. The state could have stopped many products from interstate trade before the situation escalated.

The FDA’s initial inspection on this product began in September 2004 and ended on January 19, 2005. In the Dallas district an Investigator would be reprimanded for taking five months on an inspection. It does not take that long to conduct a compound pharmacy inspection or to collect product samples. It usually takes two or maybe three weeks for this type of inspection. Each district has time limits that can be spent on any one assignment. There seems to be a pattern of errors here that could have prevented lives from being lost with much time wasted.

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Reform is Coming::The Blog Has Accomplished One of It's Purpose

When I began this blog in March 2012, I was stunned at the lack of education and knowledge about compounding in the veterinary and medical world.  I have learned so much since beginning this blog. I hope you have to.  In the beginning of this blog, I could foresee a tragic event such as the NECC meningitis outbreak happening.  I hoped it wouldn't.  I hoped the worst of tragedies had already been seen in cases such as Franck's, and Apothecure and similar cases, but I knew the odds were great that something bad would happen based on the way things were done or not done in the compounding world and when it did happen it would be big.  The one good thing that can possibly come out of that big bad thing is reform of the compounding world--better knowledge, better education, better procedures, better practices, better communication, better enforcement, better everything.  It is not enough for organizations to point their finger at the federal government.  All share in the blame. All must take responsibility and all must work together to improve the situation to make sure nothing like the NECC meningitis outbreak happens again.  Whether the federal government passes some sort of legislation and takes over most of the jurisdiction of compounding or the states keep the jurisdiction and strengthen the teeth of the rules and regulations they have, reform is needed and I have no doubt reform is headed our way.  There is much left for many to do.  There is much knowledge to be gained.  There is much education that still  must be accomplish.      

FDA Significant Compliance Actions: 2012 Warning Letters

• 2012
  • Warning Letters
    • Advanced Specialty Pharmacy (dba Meds IV)
    • Infupharma
    • Franck’s Lab (dba Franck’s Compounding Lab)
      
      
      Source found here

Michigan News Briefs: Hune renews call to suspend pharmacy's license

1:36 AM, Dec. 4, 2012'

State Sen. Joe Hune, R-Hamburg Township, on Monday renewed his call for suspending the Michigan license of a Massachusetts compounding pharmacy linked to a national fungal meningitis outbreak.

Hune, for a second time, called on the Michigan Department of Community Health to suspend New England Compounding Center's Michigan license following news of 10 more Michigan cases of meningitis-related infections linked to contaminated steroids produced at the facility.

"I once again demand
the license be revoked. I would like to see the de-partment investigate this wrongdoing so we can prosecute to the fullest extent of the law," Hune said in a statement.

The department on Monday announced that there are 201 cases and 13 deaths in Michigan tied to the infections, The Associated Press reported.

Additional cases of infection were announced Monday afternoon, bringing the state total up from 188 infections in a count last week.

Four of the deaths were of Livingston County residents, the state reported. Three of the Michigan deaths are being counted
as Indiana cases because that is where treatment occurred in those cases.

Hune in recent weeks first called for suspending the Massachusetts company's Michigan license. An October order of summary suspension filed by Gov. Rick Snyder and Attorney General Bill Schuette awaits the signature of the state Bureau of Health Professions director.

If signed, the order will suspend the New England Compounding Center's Michigan license and force the company to cease its operations in Michigan, Hune said.

Continue reading here

Pharmacist’s Corresponding Responsibility

The responsibility for the proper prescribing and
dispensing of medications lies primarily with the
prescribing practitioner. However, a corresponding
responsibility rests with the pharmacist who fills
a prescription order. The DEA recommends that a
pharmacist scrutinize each prescription. Some things to
look for are quantities, directions, or dosages that differ
from usual medical usage or practice. Check to see if the
prescription has been presented in a reasonable length
of time since the prescriber wrote it. If the patient is
returning too frequently or refilling the same prescription
on a weekly or even a daily basis, it may be fraudulent.
To prevent diversion, know the patient and his or her
medication history. Get to know your prescribers and
their signatures and DEA registration numbers. If you
see anything that is suspicious, call the prescriber using
the telephone book or your record of his or her telephone
number and not the number on the prescription for
verification or clarification. If you believe that you have
received a forged, altered, or counterfeit prescription, do
not dispense it. Call your local police department.

Source found here

Office Use in Kansas

Office Use Prescriptions
The Board has been asked on occasion whether
an “office use” prescription is valid. The answer is
no. Medications prescribed must be dispensed to a
patient. When medication is sent from a pharmacy to a
practitioner for administration, the transfer is considered
a distribution.
The transfer of a prescription medication is permitted
from one pharmacy to another pharmacy or practitioner.
The transfer must be documented with an invoice record.
The invoice record must have the name, strength, form of
the medication, the name and address of both the seller
and the purchaser, and the date of the sale. This record
should be maintained for five years with your pharmacy
records.
If the transfer is a controlled substance, the invoice
must also include the DEA number of both the seller
and the purchaser. If the medication is a Schedule II
medication, the purchaser must provide a DEA Form 222
to the seller before the transfer is completed.
A retail pharmacy may transfer prescription drugs to
another retail pharmacy to alleviate a temporary shortage,
except that the gross dollar value of these transfers
shall not exceed 5% of the total prescription-only drug
sales revenue of either the transferor or the transferee
pharmacy during any period of 12 consecutive months.
If a pharmacy is selling more than 5% they should be
registered as a wholesale distributor
Source found here

Officials: Nat'l drug shortage having distinct effect in Az

Posted Dec 3, 2012, 8:38 pm

Lorri AllenCronkite News Service

PHOENIX – A national drug shortage is endangering patients’ health and forcing doctors, pharmacists and first responders to scramble to find supplies, according to experts who shared their stories with Cronkite News Service.

“It’s a terrible problem,” said Tom Van Hassel, vice president of theArizona State Board of Pharmacy and director of pharmacy at Yuma Regional Medical Center. “On any given day, there are 15-20 drugs we’re scrambling to find.”

Pharmacists, especially in rural Arizona, are paying more and spending more time to get drug supplies, Van Hassel said.

“These are drugs used every day in our hospital. I don’t think any hospital in the state has escaped this shortage,” he said. “When we’re out, we’re truly out. The nearest hospital is 150 miles away.”

Continue reading here

Legislators to look at drug shortages Doctors, medical administrators testify at hearing

Andrea K. Walker, The Baltimore Sun

6:57 p.m. EST, December 4, 2012

The staff at Anne Arundel Medical Center considered canceling some surgeries on a recent weekend because the hospital was running low on a common drug used to help bring people out from under anesthesia.

It is the kind of problem hospitals and doctors around the country continue to face as drug shortages that began a few years ago threaten the way everyday medicine is practiced.

The problem has persisted even after calls from Congress and President Barack Obama to find a solution and a federal investigation that found widespread abuses in the drug manufacturing and distribution system. Maryland lawmakers are jumping into the fray with plans to introduce legislation to tackle the issue at the state level.

On Tuesday, the Joint Committee on Health Care Delivery and Finance held a hearing to gather insights on what role the state could play.

Dr. Barry Meisenberg, chair of quality improvement and health systems research at Anne Arundel Medical Center, said the shortages force doctors to make tough decisions on how to treat patients. The hospital decided not to cancel surgeries that weekend, but Meisenberg said the issue was real.

"I used this as an example of how serious this has become," Meisenberg said.