Monday, December 31, 2012

Porposed Rules in Jan. 2013 Delaware--Include Compounding for Office Use

To read the entire proposed regulations much of which deal with compounding click here

Finding Compounding and Stability

December 2012
Finding Compounding and Stability
Information in the IDIS 4.0 Drug Database

Pharmacists are sometimes called upon to compound a drug product for a patient. The key to
finding information related to extemporaneous preparation of drug products in the IDIS 4.0 Drug
Database is Descriptor PREPARATION 35. “Extemporaneous Compounding” and “Extemporaneous
Preparation” are cross-referenced to descriptor PREPARATION 35.  The IDIS 4.0 definition for
descriptor 35 is “Preparation of a drug immediately prior to administration to the patient, (e.g., pH
adjustment, dilution, extemporaneous techniques, directions for in vivo or in vitro labeling of
radiopharmaceuticals”).  Combining a drug or drug names with descriptor PREPARATION 35 and an administration descriptor (e.g. ADMIN RECTAL 101 or TOPICAL 65) is a good search strategy for finding articles related to compounding and preparing drug products for a specific unique route of

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Aranesp Misbranding - Amgen Agrees $762 Million Payment

After being found guilty of promoting off-label use of Aranesp (darbepoetin alfa), an anemia drug, Amgen Inc. agreed to pay $150 million in criminal fines and penalties. Prosecutors added that the company will also pay $612 in civil settlements.

The settlement would include a payment to a former Aranesp product manager, Kassie Westmoreland, to resolve a whistleblower lawsuit. Westmorland worked at Amgen from 2002 to 2005. The suit alleged that the company gave "liquid kickbacks" to doctors, as well as other incentives. She accused the company of overfilling Aranesp vials so that doctors could have extra medication free of charge, the company would then encourage the doctors to overcharge private insurers and Medicare for this extra amount, resulting in more profits for the company.

The court has not yet revealed how much the whistleblower settlement is. Law firm, Sanford Heisler, which represents the former Amgen employee, wrote in a communiqué that it could amount to $612 million. The law firm then withdrew its statement after the judge said clearly that the settlement would not be approved until Wednesday.

Westmoreland is also suing the company for retaliation and wrongful termination. She will most likely receive a part of the Amgen settlement under federal law for whistleblowers.

Amgen knew it would find it hard to compete against Johnson & Johnson's Procrit (Epoetin alfa), a well established medication which is used once every two weeks. The company used a statement in the product labeling to its advantage that stated that Aranesp had a longer serum half-life than Procrit, which may suggest a less-frequent dosing schedule for the patient.

Pursuing profits at the risk of patient safety

Amgen pharmaceutical sales representatives promoted Aranesp for the once monthly dose (off label), according to a complaint filed by the US Attorney's Office in the Eastern District of New York. The complaint was filed last Tuesday.

The company had tried to get Aranesp's dosage's listing in the Pharmacopeia's Drug Information, which would then allow Medicare and Medicaid to reimburse its usage off-label.

The criminal complaint stated "As part of its strategy to increase sales of Aranesp, Amgen instructed its sales representatives to distribute laminated reprints of the Aranesp compendia listing for the (once monthly) QM dose to healthcare professionals with the intent that the healthcare professionals would use Aranesp for QM dosing."

Prosecutors explained that Aranesp is administered intravenously or by injection. Patients often find it painful, so changing from twice a month to once a month would make it more desirable.

Prosecutors said that Amgen had been "pursuing profits at the risk of patient safety".

A doctor can legally prescribe a medication for off-label uses. However, pharmaceutical and biotech companies are not allowed to promote off label usage to doctors.

According to Amgen in October 2011, $780 million had been put aside to settle the allegations. At least 15 states have filed lawsuits against the company, alleging that it tried to encourage doctors to overcharge Medicaid and Medicare for Aranesp prescriptions.

According to Amgen, the company will enter into a corporate integrity agreement with the US government so that it can carry on selling medications through public health care programs.

Should Amgen board members and executives commit similar offenses in the future, the agreement makes these people personally liable. Marshall Miller, a US Attorney's Office for the Eastern District prosecutor said "We're placing those individuals on the hook for any future violations."

According to the Justice Department charges, Amgen promoted Aranesp at higher doses and at intervals the FDA had not approved. Aranesp had been approved for use in kidney disease and cancer. It was initially approved in September 2001 for the treatment of anemia caused by chronic kidney (renal) failure and chemotherapy.

Marshall L. Miller, from the US Attorney's Office in Brooklyn said after the proceeding "Today's guilty plea represents a sweeping victory for the American public."

Aranesp sales reached $2.3 billion in 2011, down from $4.1 billion in 2006. Sales declined steadily amid increased scrutiny regarding its costs to Medicare and safety warnings.
Source found here

The Year in Synthetic Drugs Posted on December 31, 2012 by tothemaximus

Dirk Hanson has a lot of things to say about synthetic drugs in 2012.  This is his year in review:

To read his review click here

Case Count: 656* States: 19* Deaths: 39* as of December 28, 2013

Last updated: December 31, 2012 2:10 p.m. AP IMPACT: Big Pharma cashes in on HGH abuse

A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.
The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.
But since then, Big Pharma has been satisfying the steady desires of U.S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.
From 2005 to 2011, inflation-adjusted sales of HGH were up 69 percent, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12 percent in that same period.
Source found here

NABP to Inspect Compounding Pharmacies

Kate Traynor
LAS VEGAS, NV 28 December 2012—The National Association of Boards of Pharmacy (NABP) in December launched a nationwide program to identify and inspect compounding pharmacies.
NABP Executive Director Carmen Catizone, speaking December 5 at ASHP's Midyear Clinical Meeting in Las Vegas, said critical information about the pharmacies, including disciplinary actions taken against them, will be collected in a database.
The database will allow state boards of pharmacy to better regulate nonresident pharmacies that want to do business in the state, he said.
"Before a state decides to renew a license for a nonresident pharmacy, or issue a license for a nonresident pharmacy, they will have access to this database so they can really see what's going on," Catizone said.
Ultimately, he said, NABP will have a list "of every pharmacy in the United States, whether it's involved in compounding, sterile compounding," or so-called nontraditional compounding.
The undertaking is part of NABP's response to the outbreak of fungal meningitis and other infections in patients treated with methylprednisolone acetate made by the New England Compounding Center (NECC) of Framingham, Massachusetts. As of December 17, more than 600 people had been sickened during the outbreak and 39 had died.
"Every single one of us was responsible for this tragedy," Catizone said. "The regulatory system broke down, the pharmacy compounding system broke down, the collaboration between the FDA and the states broke down, the purchasing of the products broke down."
Catizone said NABP will first inspect "nonresident" pharmacies identified by the Iowa Board of Pharmacy that sell products to entities in the state. NABP will serve as the designated agent of the Iowa pharmacy board and will work in cooperation with pharmacy boards in states that are home to the compounding pharmacies.
Catizone said the Iowa Board of Pharmacy has provided NABP with an initial list of 582 nonresident pharmacies.
The first wave of inspections will run through February and involve pharmacies whose compounding activities seem to be of a scope or scale that go beyond traditional practice, Catizone said.
A second round of inspections, scheduled for March through June, will focus on other nonresident pharmacies, including those that engage in sterile and nonsterile compounding.
Catizone called drug shortages the driving force behind increased reliance on compounding and compounding pharmacies. He said conflicts exist between hospitals that need critical drugs for patient care and regulatory bodies that oversee the practice of compounding.
According to FDA, hospitals aren't the only entities that purchased compounded drugs from NECC. The agency's list of customers included hospitals, ambulatory surgery centers, eye clinics, pain clinics, and plastic surgery centers.
State regulators aren't able to reliably ensure that compounding pharmacies are operating in compliance with the law, Catizone said.
"The primary problem is resources. The states don't have the resources, in many cases, to inspect pharmacies on a regular basis," he said. "That's unacceptable."
He urged pharmacists to demand that the licensing fees that they pay to their state be used to support pharmacy boards so that they can adequately oversee compounding pharmacies.
The Massachusetts Board of Registration in Pharmacy in November approved rules that allow the state to track the volume and distribution of products made by compounding pharmacies. The rule is intended to help the state determine whether a compounding pharmacy is acting as a manufacturer and should thus be subject to federal oversight.
During congressional hearings last November, NECC was said to have behaved as a manufacturer.
According to FDA, 14,000 patients throughout the country may have been treated with NECC-compounded methylprednisolone acetate that was prepared and then recalled last year. At least two recalled lots have tested positive for fungal contamination, and FDA has confirmed the presence of microorganisms in other compounded products made by the company.
Over the years, NECC has been investigated for allegedly preparing compounded drugs in the absence of a patient-specific prescription. The Colorado State Board of Pharmacy in 2011 issued a cease-and-desist order to NECC for engaging in this practice and determined last year that the company was violating the order.
Catizone emphasized that, for liability purposes, hospitals need to know the location of any compounding pharmacy they purchase from and whether the pharmacy follows its own state pharmacy regulations.
"If any of your institutions purchased medications from NECC, and they were not on a per-prescription basis, or if they were for office use or clinic use, you broke the law. Because that's against the law in Massachusetts," Catizone said.
Federal regulation of pharmacy compounding has been hindered by conflicting court opinions over a law enacted in 1997. FDA officials say this lack of legal clarity prevents the agency from exercising its authority against pharmacies like NECC or even defining precisely when a compounder is, in reality, a drug manufacturer.
Catizone said that situation will soon change, and he said pharmacists need to work with other stakeholders and be a responsible part of the process.
"We can't sit back, we can't argue . . . for 20 more years about the definition of compounders," Catizone said. "We have to act."
Source found here


NABP to Inspect Compounding Pharmacies

Full story: ASHP

The database will allow state boards of pharmacy to better regulate nonresident pharmacies that want to do business in the state, he said.

Activist says Mass. Department of Public Health stalling release of Lyme disease report

December 31, 2012
 - A Lyme disease activist and sufferer claims two high-ranking state Department of Public Health officials are stalling the release of a report that could shed more light on the disease.
Patricia A. McCleary of Sturbridge said state epidemiologist Dr. Al DeMaria and state veterinarian Dr. Catherine Brown are not endorsing the findings of the Massachusetts Lyme Disease Commission’s report, which was originally slated to be released in October.

Mrs. McCleary, Dr. DeMaria and Dr. Brown all served on the 21-member commission that researched the report.

Mrs. McCleary said Dr. DeMaria and Dr. Brown told members of the commission they didn’t realize they were representing their department and, as a result, did not have the authority to sign off on the final report.

“They have delayed us now for a couple of months, and now they’re saying, no, we will not sign off on it, knowing that it is going to hold up future legislation that could come from this report that could help people,” Mrs. McCleary said. “This is holding up a huge process for people who really need it and it’s not OK that our DPH is getting away with this.”

State Rep. David P. Linsky, D-Natick, commission chairman, said neither Dr. DeMaria nor Dr. Brown has supported the findings of the report.

“I am disappointed that the DPH appointees chose not to sign the final version of the report,” Mr. Linsky said. “I have asked the DPH commissioner for a specific list of reasons why they cannot and I am waiting for that response.”

On April 28, 2011, the House of Representatives approved creation of a Lyme Disease Commission to investigate the need for new screening programs and other steps to combat the illness, which is spread by bacteria from bites by infected ticks.

The amendment authorizing the commission charged it with studying the value of public health screening in high-risk areas, more prevention steps in schools and more medical research on the progression and treatment of Lyme disease.

“If you look at the language of the statute that set up the commission, there were various people that were appointed by various agencies and they were there to represent the interests of their agencies or organizations,” Mr. Linsky said. “From day one, the people of the commission should have had the authority to speak on behalf of their agencies or organizations.”

Although no one has officially signed the Lyme Disease Commission’s final report, Mr. Linsky said there is a consensus of the commission to the report’s current text, with the exception of the DPH appointees.

When it is signed and finalized, Mr. Linsky said the report will be published and posted and he and his fellow legislators serving on the commission will file any necessary legislation based on the findings and recommendations agreed on in the report. However, issues dealing with the budget will have to be taken up during the budget process.

Mrs. McCleary said she is not surprised by the state Department of Public Health’s stance on the matter, calling them “gatekeepers” for the Center for Disease Control and Prevention and the Infectious Disease Society of America.“We can go forward without them but it sure would have been nice when we’re talking about such a crisis and epidemic here that the Massachusetts Department of Public Health is concerned about it and want to improve on what’s happening. And once again, they’re showing us they’re not.”

But Sam R. Telford III — a commission member and professor in the department of biomedical sciences and infectious diseases at Cummings School of Veterinary Medicine at Tufts University in North Grafton — said he thinks the delay in Department of Public Health members’ signatures has to do with all the difficulties the department has had in the last two months.

In mid-September, state Public Health Commissioner John Auerbach and Lab Bureau Chief Dr. Linda Han both resigned and Julie Nassif, the director of the state’s analytic chemistry division, was fired in the wake of the scandal at the state drug lab. State chemist Annie Dookhan allegedly tampered with drug evidence for tens of thousands of criminal cases.

A national fungal meningitis outbreak was linked to New England Compounding Center in Framingham, a speciality pharmacy that was regulated by the agency’s Board of Registration in Pharmacy.

Laura Smith is serving as the department of public health’s interim commissioner.

“My guess is that it’s an administrative glitch because of the flux in leadership at the Department of Public Health,” Mr. Telford said. “The DPH has done a marvelous job considering the limited resources that they have in terms of defining the problem here.”

Anne Roach, media relations manager at the Department of Public Health, said her department commends the commission “for its efforts to produce a meaningful report that examines the seriousness of Lyme disease in Massachusetts.”

“The department’s first priority is to protect the public health and it will continue to identify ways to reduce the transmission of Lyme disease and all tick-borne illnesses,” Ms. Roach said. “As part of its efforts to increase awareness about the growing extent and seriousness of Lyme disease in Massachusetts, DPH is working collaboratively with the commission. DPH focuses its efforts on the promotion of proven prevention methods through educational materials available online as well as outreach to local boards of health and community groups.”

Mrs. McCleary said the report has “some pretty shocking” stories from chronic Lyme disease sufferers, as well as “good and really important” recommendations, including the need for better testing methods, better education of physicians about Lyme disease’s symptoms and treatment, and more up-to-date information readily available to the public, especially on the department’s website.

“The standard treatment that is available right now is not working for people, quite frankly, and there are other options out there,” Mrs. McCleary said. “In Massachusetts, people have to go out of state and they have to self-pay for their treatment and that’s not OK.”

Mrs. McCleary said her husband and their two adult sons have been treated for Lyme disease.On top of that, Lyme disease has cost the McCleary family a small fortune.

“By the time we saved my life, there was no college fund or anything when it came time for my kids to go to school. We are hanging by a thread. Our house is on the market. But you do what you have to do,” she said. “Anybody who got this disease is in debt, unless they are a millionaire.”

Source found here

Mass. lawmakers face budget, drug lab questions |

Mass. lawmakers face budget, drug lab questions |

County stung by meningitis deaths in 2012

December 31, 2012
Lilian Cary knew she wasn't feeling well, but what the late Howell resident didn't know — what no one knew — was that she would be among the first victims of a fungal meningitis outbreak whose impact will continue into the new year and beyond.
While remembered for her kindness and friendliness, the 67-year-old Cary's death Sept. 30 from fungal meningitis put a local focus on the national outbreak.
Livingston County remained at the forefront, even as the outbreak grew nationwide.
Meningitis is an inflammation of the membranes surrounding the brain and spinal cord.
By year's end, 13 Michigan residents had died, including four from Livingston County, and more than 200 others required medical treatment for meningitis or related symptoms.
Nationally, the outbreak claimed 39 lives, with at least 620 cases reported in 19 states from Florida to Idaho. Michigan, with at least 223 cases, was the state most heavily affected.
Many of those who fell ill had previously received steroid shots to relieve back pain at Michigan Pain Specialists, a Genoa Township-based medical facility. The steroid solutions, however, had been contaminated during mixing at the New England Compounding Center, a now-closed facility in Framingham, Mass.
Substances found in the contaminated steroid solutions were likened to black mold.
Due to the rising number of local cases, Saint Joseph Mercy Hospital in Washtenaw County gained emergency state permission to expand operating room capacity and add equipment to handle the outbreak.
The hospital system had earlier consolidated its meningitis treatment facilities at the Ypsilanti-area site, but officials admitted the outbreak was unlike any other.
"We don't have a lot to draw on — and by that, I mean the medical community at large," Dr. Lakshmi Halasyamani, Saint Joseph's chief medical officer, said in mid-October as the outbreak took hold.
The outbreak came in two waves. While the number of patients who developed meningitis began to taper off by late October, a second wave of patients developed epidural abscesses — painful infections near the injection site which themselves could have spread meningitis if left untreated.
Among Michigan residents, there were 64 cases of meningitis, including 38 with additional epidural abscesses; 142 reports of abscesses alone; 20 joint infections; and one meningitis-related stroke, in addition to the fatalities.
At the same time, Congress, began debating tougher restrictions on compounding facilities, like NECC, which produce large amounts of drugs for national distribution.
Compounding facilities, including neighborhood pharmacies, have generally been exempt from U.S. Food and Drug Administration regulation because their newly created compounds are made from already-approved drugs.
U.S. Rep. Mike Rogers, R-Brighton, was central to the initial congressional investigation as a member of the House Energy and Commerce Committee, which held a mid-November hearing on the outbreak.
At the same time, the Rogers' stepmother was being treated for a meningitis-related abscess at Saint Joseph Mercy Hospital.
Congressional hearings didn't forestall individuals from filing lawsuits against the compounding center.
In subsequent news, the compounding center linked to the outbreak filed for Chapter 11 bankruptcy protection, while its owners promised to create a fund to compensate victims.
It remains to be seen whether that action will forestall additional lawsuits, which could take years to resolve.
Families of those whose loved ones were still in treatment, or slowly recovering at home said they were worried the outbreak would soon fade from memory even as their struggles continued.
It also remains to be seen whether Congress will expand federal oversight into compounding pharmacies.
Contact Daily Press & Argus reporter Wayne Peal at 517-548-7081 or at
Source found here