Stiff Penalties Tied to Purple Pain, TB-500 By Blood-Horse Staff Updated: Tuesday, July 2, 2013 11:50 AM Posted: Tuesday, July 2, 2013 11:24 AM

The Racing Medication and Testing Consortium has noted that two substances available only through compounding pharmacies are unclassified medications that will be regarded as high-level violations if used in racing.

The RMTC Tactical Research Committee has reviewed data from laboratory analysis of the two substances of concern in racing that have been marketed as powerfully effective drugs: "Purple Pain" and "TB-500."

Both of these substances are non-FDA-approved and only available through compounding pharmacies. Accordingly, under the RCI guideline regarding unclassified medications and foreign substances, the RMTC recommends that any administration of these substances be treated as a prohibited act and that a finding for either substance or their metabolites be treated as a finding for a prohibited substance.

As such, these substances should be treated as an Association of Racing Commissioners Class 1 substance (highest level violation) with Class A penalty guidelines (most severe) attached.

The results of these studies and additional information on those drugs was provided in recent bulletins issued by the RMTC to horse racing drug-testing laboratories, the Organization of Racing Investigators (ORI), and the Association of Racing Commissioners International (RCI).

Purple Pain is marketed as a pain reliever. TB-500 is claimed by some marketing materials to build muscle, speed muscle recovery, stop bleeding, increase red blood cells, and decrease inflammation.

"This effort is part of the RMTC's renewed focus on identifying and detecting illicit substances and eliminating them from racing," stated RMTC scientific advisory committee co-chair Dr. Rick Arthur. "This type of work is intended to ensure the integrity of racing as well as the safety of the equine and human athletes."

The University of California-Davis Kenneth L. Maddy Laboratory, an RMTC accredited laboratory, performed analysis on samples of both of these compounds. Those results were shared with the RMTC.

"We are grateful to the UC-Davis Kenneth L. Maddy Laboratory and the California Horse Racing Board for sharing this information with the RMTC," said RMTC chairman Dr. Robert Lewis. "The pooling of efforts allows the RMTC and all racing stakeholders to make limited funding dollars stretch further."

Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/79187/stiff-penalties-tied-to-purple-pain-tb-500#ixzz2XunD4pzV

GOP senator urges vote on drug compounding bill By Elise Viebeck - 07/02/13 01:04 PM ET

The Senate Health (HELP) Committee's top Republican urged leadership to schedule a vote on his bill empowering federal regulators to oversee certain compounding pharmacies. 

In a statement Tuesday, Sen. Lamar Alexander (R-Tenn.) said the legislation would prevent future tragedies caused by drug compounders, such as an outbreak of fungal meningitis that has killed more than 60 people since last fall. 

"Americans continue to lose loved ones from the meningitis outbreak, and the Commissioner of the Food and Drug Administration has warned us that this will happen again if Congress fails to act," Alexander said. 

Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/308925-gop-senator-urges-vote-on-drug-compounding-bill#ixzz2Xulx6TNc 
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Alexander: Senate Must Vote On Compounding Legislation “As Soon As Possible” Tuesday, July 02, 2013

The lead Republican on the U.S. Senate health committee today called for the full Senate to vote “as soon as possible” on legislation unanimously approved by the health committee in May to clarify oversight of drug compounders, as Centers for Disease Control and Prevention reports the number of deaths caused by a multistate outbreak of fungal meningitis has risen to 61.

Contaminated drugs traced last year to a Massachusetts compounding pharmacy led to the outbreak that has led to 749 illnesses and 61 deaths, the CDC reported Monday. 

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Maryland Law Changes Regarding Compounding Pharmacies

Compounding pharmacies will now be subject to state review. These pharmacies change medicine to fit the needs of a particular patient. An example of this is a dose not usually made for infants. Or avoiding a particular part of the medicine if someone is allergic, for example, flu immunizations are grown in eggs and therefore people who are allergic cannot receive them but a compounding pharmacy could create it differently, without the egg.

These pharmacies have not been regulated in the same way as traditional pharmacies are but that is changing after a meningitis outbreak was traced back to a contaminated steroid created in a compounding pharmacy.

Read more: http://communities.washingtontimes.com/neighborhood/out-and-about-dc/2013/jul/1/new-laws-start-today-maryland-and-virginia-will-af/#ixzz2Xu0qpPSD
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Pharmacy Practice News - Hi-Tech Tools Boost Savings, Safety

Pharmacy Practice News - Hi-Tech Tools Boost Savings, Safety

Medication shortages noted as a 'public health crisis' More than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain, and more are in short supplyShady vendors buy injectable drugs, often from "compounding" pharmacies, then resell the drugs at big markups. July 1, 2013

The Philadelphia Inquirer

PHILADELPHIA, Pa. — Rationing medical care is denounced as immoral in the United States, yet it goes on daily in hospitals, clinics, nursing homes, ambulances, and pharmacies.

Since 2006, this country has had worsening shortages of sterile generic injectables — drugs given by shots or intravenously. Currently, more than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain, and more are in short supply.

The reasons for this predicament are complex, and the fixes, elusive. The scope, however, is clear from surveys of medical and trade groups. The latest, a University of Pennsylvania poll of oncologists released this month, found 83 percent had dealt with shortages by delayingcancer treatments, omitting doses, using second-choice drugs, or sending patients elsewhere.

"Oncologists are facing wrenching decisions about how to allocate lifesaving drugs," said cancer specialist Keerthi Gogineni, who led the Penn survey.

Why aren't patients and families up in arms?

They may not realize their care was compromised or complicated by a shortage unless their caregivers are unusually candid.

"Patients in an intensive care unit often don't know they've been impacted," said pharmacist Erin Fox, who tracks shortages as manager of the University of Utah's drug-information service. "And the hospitals don't want folks to talk about it. They don't want to admit, 'We had a patient who died because we didn't have this drug.' "

The secret human toll is rising. In the last three years, dozens of deaths due to contaminated drugs have been linked to producers and vendors who have capitalized on shortages. The Institute for Safe Medication Practices (ISMP) in Horsham received hundreds of reports of medication errors, near-disasters, and 15 deaths related to shortages when it surveyed 1,800 health-care practitioners in 2010.

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A Few Things the Senate Needs to Consider With Regard to Pharmaceutical Compounding Quality and Accountability Act- Before It Comes Before the Senate for A Vote

July 2, 2013

by Sue Tuck Richmond

There are a few a things the United States Senate needs to consider as it debates the Pharmaceutical Compounding Quality and Accountability Act.  First, pharmacy is pharmacy in the states.  Veterinary pharmacy is not separate for the most part.  While a few states such as Virginia and Texas have specific veterinary regulations addressing compounding that apply to veterinarians, these regulations do not apply to pharmacies or pharmacists.  The state board of pharmacy rules and regulations apply to compounding.  I have posed the questioned of whether pharmacy should be pharmacy and whether veterinary pharmacy should be separated out, but right now it is is not in the states.  In light of this treatment in the states, it makes little sense for federal legislation to apply only to human compounding.  Nor is it clear that the current draft as        written would only apply to human compounding.  

Second, I have also discussed this issue:  the do not compound list.  The legislation should require that a committee or a commission.  The committee or commission should be made up of not only FDA officials but also knowledgeable compounding pharmacists, pharmaceutical representatives, doctors, veterinarians, marketing representatives, and consumers who meet, discuss and recommend a do not compound list to Congress who must approve it much like it does the United States Sentencing Guidelines factors.  This will prevent the FDA from having complete authority over what cannot be compounded.

TN State Pharmacy Board Strengthens Oversight of Drug Compounding

By: CINDY SANDERS

Posted: Monday, July 1, 2013 11:01 am

In the wake of another suspect drug case with reports of adverse patient events, the Tennessee Board of Pharmacy has announced actions to better assure the safe, sterile compounding of drugs by state-licensed entities.The latest incident found officials with the Tennessee Department of Health (TDH) and other state and federal agencies working through the Memorial Day weekend to investigate problems with methylprednisolone acetate (MPA) products produced by Main Street Family Pharmacy, LLC, in Newbern, Tenn.
Reports of adverse events first surfaced in Illinois and North Carolina from patients who received injections of preservative-free MPA (80 mg/mL) after Dec. 6, 2012. By May 24, seven reports of illness had been logged with no report of meningitis or other life-threatening infection. The suspect MPA was shipped to physicians and clinics in 14 states. In Tennessee, seven facilities received the questionable drug — Quality Care, Jackson; PinnaclePain Management Clinic, Union City; Getwell Family Clinic, Jackson; Walker Pain Management Center, Jackson; First Choice Clinic, Dyersburg; Christian Care Clinic, Newbern: and Axis Medical Clinic, White House.
The Tennessee Board of Pharmacy first licensed Main Street Family Pharmacy in 1985, with a license as a manufacturer/wholesaler/distributor being added in 2010. State officials reported the staff of Main Street Family Pharmacy had fully cooperated with the investigation and launched a voluntary recall of all its sterile products even though no known adverse effects have occurred from any other product. The pharmacy is currently on probation as a result of this investigation.
The new measures adopted by the Tennessee Board of Pharmacy collectively address the need for safe, effective medicines while preserving access for patients. “The board is working cooperatively to identify solutions to improve safeguards for public health while not placing unnecessary barriers on sterile compounding pharmacies that would hamper production of much-needed drugs already in short supply,” said Charles E. “Buddy” Stephens, DPh, president of the Board of Pharmacy. “We believe our actions enhance existing safeguards and offer new steps to ensure safe and effective medications are there when needed.”
The board has taken action to:

• Expedite suspension of sterile compounding by a pharmacy or manufacturer when a serious problem is discovered. With cause, a sterile compounder’s license can be suspended jointly by an officer of the Board of Pharmacy, its authorized executive director, and the commissioner of the Tennessee Department of Health without having to wait for a full Board of Pharmacy meeting.
• Enhance oversight and regulation of drug manufacturing operations in the state. The license for manufacturers will be a separate category. Prior to this move, manufacturers were included in a combined classification with wholesalers and distributors.
• Work more closely with the U.S. Food and Drug Administration. The new requirements call for drug manufacturers in Tennessee to show proof their operations are registered with the FDA.
• Add a sterile compounding registration to the regular pharmacy license, to the manufacturer license, and to the wholesaler/distributor license.

These initial actions are not expected to be the last. A workgroup from the Board of Pharmacy is collaborating with staff at the TDH to identify additional measures and improvements to address the manufacturing and distribution process. Items under consideration include more proactive inspection with additional emphasis on critical reviews of maintenance and quality control records, interim self-assessment and applicable reporting by the licensed entities, and adoption of applicable U.S. Pharmacopeia Standards. Additionally, three more licensed pharmacists are being recruited by the Board of Pharmacy to serve as inspectors and another administrative staff person will be added to facilitate the new self-assessment and reporting responsibilities.
“It’s a great challenge to strike a thoughtful, protective balance between addressing the daily drug shortages faced by patients and healthcare providers across Tennessee with the absolute need to assure safety and effectiveness in the compounded product,” said TDH Commissioner John Dreyzehner, MD, MPH. “While we wish the current situation associated with a Tennessee pharmacy had not happened and that patients had not been affected, the actions taken by the board, along with legislation passed recently, are moving us forward in assuring the safety and availability of important medications.”
 quoted from here

Veterinarian Survey This information is taken from a May 2013 survey of the customers of one of the largest veterinary compounding pharmacies in the U.S.

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Moving Closer to Achieving Our Vision July 1, 2013

IN THE LAST 20 YEARS, the ASHP House of Delegates has debated and passed important proposals like support for the entry-level Pharm.D., universal health insurance, mandatory reporting of medication errors and “just culture,” collaborative practice, and the implementation of health information technology. In recent years, the ASHP House of Delegates has approved policies that set future goals for residency training for all practitioners in direct patient care roles; defined the role of pharmacist prescribing in interprofessional patient care; called on federal officials to take action on compounding, drug shortages, REMS, and meaningful use standards; and pushed for standardized education, certification, registration, and licensure requirements for pharmacy technicians. These policies touch every facet of pharmacy practice and have a profound impact on medication use in this country. ASHP’s professional policies offer a vision for the future of the profession in which pharmacists are essential members of every health care team and where medication use is optimal, safe and effective for all people, all of the time. Last month, the ASHP House of Delegates approved more than 20 new professional policies during its session at the 2013 Summer Meeting in Minneapolis. Along with passing measures that support training in team-based patient care for student pharmacists and residents and the reclassification of hydrocodone combination products under the Controlled Substances Act, delegates also took strong positions on compounding safely and achieving provider status for pharmacists. These actions are emblematic of the leadership that ASHP has taken on key medication-use issues throughout its history. ASHP’s professional policies provide a solid foundation for the Society to pursue transformative solutions to the issues that affect our ability to care for our patients. In particular, the newly approved policies on compounding by health care professionals and pharmacist recognition as health care providers highlight this principle. Compounding ASHP is actively engaged in federal efforts to close gaps in the regulatory oversight of pharmaceutical compounding activities. We’ve worked closely with members of Congress and congressional staff on legislation that we expect the Senate to vote on this month; namely, the Pharmaceutical Quality, Security, and Accountability Act. While this legislation addresses federal authority, our new policy focuses on the laws and regulations that govern traditional compounding that occurs in hospitals, clinics, and other areas within health systems. It advocates for the adoption of applicable standards of the United States Pharmacopeia by state legislatures and boards of pharmacy. The laws and regulations governing compounding vary from state to state. It is essential for the safety of all patients that all pharmacies that compound medications, regardless of the setting, adhere to the very highest standards. A uniform standard will help to ensure that the medications our patients receive are safe and that they are not harmed by agents that are intended to help them. Pharmacist Recognition as a Health Care Provider - 

See more at: http://www.ashpintersections.org/2013/07/moving-closer-to-achieving-our-vision/#sthash.hlcampvp.dpuf