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.

for the information click here

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

Virginia’s Griffith works on draft proposal for compounding legislation July 01, 2013 Association comments on compounding discussion draft

In June 21 comments on Rep. Morgan Griffith’s (R-VA) compounding discussion draft, APhA recommended modifications in the draft pertaining to radiopharmaceuticals, an advisory committee on compounding, more clarity on state oversight, and more resources forinspections.

Griffith has taken the lead on drafting compounding legislation for the House Energy & Commerce Subcommittee on Health. He requested an updated comment letter from the Association. APhA is working with Griffith’s office as the legislative process moves forward.

“There needs to be clear delineation with respect to state and FDA authorities and requirements regarding compounding and inspection authorities,” APhA wrote in the letter on the topic of state oversight. “While we agree FDA should have inspection authority if a pharmacycrosses the line into manufacturing, this line should be drawn in advance to avoid surprises.”

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