Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, July 30, 2013
Contaminated steroids cause two more deaths in Livingston County
LIVINGSTON COUNTY (WKZO) -- State health officials say the tainted steroids that were shipped to four Michigan Clinics last year from a compounding lab in Massachusetts, continue to kill and maim.
Two more people have died from the tainted shots. A 75-year-old man and a 64-year-old woman from Livingston County, bringing the total who have died in Michigan to 22.
Three of them come from Southwest Michigan and received their shots at a northern Indiana clinic.
264 michiganders suffered symptoms from the tainted shots and many of them continue to require regular treatments.
Angela Minicuci with the Michigan Department of Public Health says Michigan has been hit harder than any other state. Its inspired doctors to find treatments to prevent the injections from blossoming into full blown cases of fungal meningitis.
quoted from here
American Society of Health-System Pharmacists (ASHP) July 30, 2013 Letter to the Senate
July 30, 2013
The Honorable Tom Harkin, Chairman
The Honorable Lamar Alexander, Ranking Member
The Honorable Pat Roberts
The Honorable Al Franken
The Honorable Barbara Mikulski
Senate Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20515
Dear Chairman Harkin, Ranking Member Alexander, and Senators Roberts, Franken and Mikulski:
On behalf of the American Society of Health-System Pharmacists (ASHP), I am writing to express our
strong support for S. 959, the “Pharmaceutical Compounding Quality and Accountability Act” of 2013.
This bipartisan legislation will address the regulatory gaps that exist with respect to sterile compounding
and help prevent a tragedy such as the meningitis outbreak of 2012 from occurring in the future. In
addition, it will assure health-system pharmacists, physicians and other purchasers of compounded
products that compounding manufacturers have been inspected by the Food and Drug Administration
(FDA) and adhere to Current Good Manufacturing Practices.
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy
technicians, and pharmacy students who provide patient care services in hospitals, health systems, and
ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication
use and enhance patient safety.
S. 959 would create a new category of registration through the FDA for large scale commercial
compounders now referred to as compounding manufacturers. We believe this will close the regulatory
gap and jurisdictional uncertainty between FDA and state boards of pharmacy while maintaining state
oversight of the practice of pharmacy, which includes traditional pharmacy compounding.
Furthermore, we are pleased to see that hospitals and health systems—as purchasers of products from
compounding manufacturers—are treated as traditional compounders. Hospitals and health systems
are fully accountable for the comprehensive care of their patients and no medication, compounded or
otherwise prepared, is administered to the patient unless there is a patient-specific medication order.
Compounded medications prepared by hospital pharmacy departments and all other medications used
in health systems are prescribed or ordered based on established relationships with the medical staff.Senate Committee on Health, Education, Labor and Pensions
July 30, 2013
Page 2
We firmly believe this bipartisan legislation recognizes shifts in the current environment and provides
FDA oversight of a new type of large scale compounder that prepares sterile compounded products as a
service to hospitals and other providers who administer them to patients, rather than a traditional
pharmacy compounder who prepares sterile compounded products pursuant to a prescription, or in
limited quantities for anticipatory use. In addition, we are grateful the Committee recognized the
valuable role that traditional compounding pharmacies play in patient care, and that the bill keeps
traditional compounding pharmacies (including hospitals and health systems) under state board of
pharmacy purview.
Finally, ASHP strongly supports the exception for compounding commercially available products that are
on the FDA’s drug shortage list. Shortages of critical medications continue to present challenges as
caregivers scramble to obtain medications in short supply. We believe the allowance to compound
products in short supply will help address this challenge.
Again, ASHP thanks you for your leadership in addressing the regulatory gaps in non-patient specific
sterile compounding and ensuring that entities preparing sterile products and introducing them into
interstate commerce are properly inspected by and accountable to the FDA. We hope the full Senate
will consider this legislation soon and look forward to working with you and the full Congress to pass this
critical legislation. If you have any questions or need additional information, please contact Joseph Hill
on my staff at 301-664-8710 or jhill@ashp.org.
Sincerely,
Paul W. Abramowitz
Quoted from here
The Honorable Tom Harkin, Chairman
The Honorable Lamar Alexander, Ranking Member
The Honorable Pat Roberts
The Honorable Al Franken
The Honorable Barbara Mikulski
Senate Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20515
Dear Chairman Harkin, Ranking Member Alexander, and Senators Roberts, Franken and Mikulski:
On behalf of the American Society of Health-System Pharmacists (ASHP), I am writing to express our
strong support for S. 959, the “Pharmaceutical Compounding Quality and Accountability Act” of 2013.
This bipartisan legislation will address the regulatory gaps that exist with respect to sterile compounding
and help prevent a tragedy such as the meningitis outbreak of 2012 from occurring in the future. In
addition, it will assure health-system pharmacists, physicians and other purchasers of compounded
products that compounding manufacturers have been inspected by the Food and Drug Administration
(FDA) and adhere to Current Good Manufacturing Practices.
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy
technicians, and pharmacy students who provide patient care services in hospitals, health systems, and
ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication
use and enhance patient safety.
S. 959 would create a new category of registration through the FDA for large scale commercial
compounders now referred to as compounding manufacturers. We believe this will close the regulatory
gap and jurisdictional uncertainty between FDA and state boards of pharmacy while maintaining state
oversight of the practice of pharmacy, which includes traditional pharmacy compounding.
Furthermore, we are pleased to see that hospitals and health systems—as purchasers of products from
compounding manufacturers—are treated as traditional compounders. Hospitals and health systems
are fully accountable for the comprehensive care of their patients and no medication, compounded or
otherwise prepared, is administered to the patient unless there is a patient-specific medication order.
Compounded medications prepared by hospital pharmacy departments and all other medications used
in health systems are prescribed or ordered based on established relationships with the medical staff.Senate Committee on Health, Education, Labor and Pensions
July 30, 2013
Page 2
We firmly believe this bipartisan legislation recognizes shifts in the current environment and provides
FDA oversight of a new type of large scale compounder that prepares sterile compounded products as a
service to hospitals and other providers who administer them to patients, rather than a traditional
pharmacy compounder who prepares sterile compounded products pursuant to a prescription, or in
limited quantities for anticipatory use. In addition, we are grateful the Committee recognized the
valuable role that traditional compounding pharmacies play in patient care, and that the bill keeps
traditional compounding pharmacies (including hospitals and health systems) under state board of
pharmacy purview.
Finally, ASHP strongly supports the exception for compounding commercially available products that are
on the FDA’s drug shortage list. Shortages of critical medications continue to present challenges as
caregivers scramble to obtain medications in short supply. We believe the allowance to compound
products in short supply will help address this challenge.
Again, ASHP thanks you for your leadership in addressing the regulatory gaps in non-patient specific
sterile compounding and ensuring that entities preparing sterile products and introducing them into
interstate commerce are properly inspected by and accountable to the FDA. We hope the full Senate
will consider this legislation soon and look forward to working with you and the full Congress to pass this
critical legislation. If you have any questions or need additional information, please contact Joseph Hill
on my staff at 301-664-8710 or jhill@ashp.org.
Sincerely,
Paul W. Abramowitz
Quoted from here
Compounding Legislation: Your Voice Urgently Needed Now! - July 30, 2013
It’s hard to believe that after the many deaths and illnesses associated with the alleged practices at the New England Compounding Center last Fall, the bipartisan Senate bill (S.959) that is designed to prevent a tragic repeat could be facing tremendous opposition.
ASHP strongly supports this legislation. Yet, it appears that opposition to the Senate bill is forming, because certain interests want to protect the status quo, which we believe could be at the expense of protecting patients from another compounding tragedy.
These special interests are also threatening to severely limit how pharmacists in hospitals and health systems serve and protect patients. ASHP supports the provision in the bill that exempts health systems from being designated as compounding manufacturers. Without this important exemption, many hospitals and health systems would have to register with the Food and Drug Administration (FDA) as compounding manufacturers, since anticipatory compounding is required for us to meet the needs of our sickest and most vulnerable patients. Also, without the exemption, many hospitals would not be able to prepare compounded preparations and send them to their wholly owned outpatient clinics, surgery centers, smaller inpatient facilities, and medical office practices. This is a critical distinction, based on the fact that hospitals and health systems are fully accountable for the comprehensive care of the patient – as compared to a compounding manufacturer that sells its products across state lines without a prescription or knowledge of the patient to a third party for administration.
This distinction between health systems and compounding manufacturers is based on very important differences:
- Hospitals and health systems have well-established quality improvement, infection control, and risk management committees, as well as adverse event monitoring and reporting systems.
- Health systems must comply with the Centers for
Medicare & Medicaid Services (CMS) Hospital Conditions of Participation and are accredited by quality improvement organizations such as The Joint Commission and DNV Healthcare, both of whom have deemed status with CMS.
- Hospitals and health systems have Pharmacy and Therapeutics Committees that control approved drug formularies.
We must protect the important work that pharmacists do in hospitals and health systems to take care of their patients. In addition, hospital pharmacists and other providers must be assured that when they need to purchase compounded products from outside suppliers that they can expect to receive products that are safe and effective for their patients. Therefore, we must enact into law urgently needed regulatory control over compounding manufacturers to prevent another tragedy.
You can make a difference. Your voice really matters to your elected Senators and Representatives in Congress!
ASHP has made it as easy as just a few clicks on your computer for your voice to be heard.
Tell your Senators that you want them to vote “YES” in support of S. 959. This legislation creates a new category, “compounding manufacturer,” which will be regulated by the FDA. Hospitals and health systems are considered traditional compounders in the legislation and will remain under the purview of state boards of pharmacy and other accrediting bodies.
Tell your Representative that the House should take a similar approach to the legislation and give the FDA the tools it needs to prevent another tragedy.
Your support today can go a long way in getting this important legislation passed!
- See more at: http://www.ashpintersections.org/2013/07/compounding-legislation-your-voice-urgently-needed-now/#sthash.JPRzl7wj.dpufIACP Update on S. 959
IACP’s team of seven full-time Washington, D.C. lobbyists continue to find no evidence in their meetings with key Hill offices this morning that there will be a Senate vote this week on S. 959. All intelligence is indicating that a vote will come after the August recess. In the meantime, IACP’s Vice President of Government Affairs Sarah Dodge reports that IACP continues to work with several Senate offices who have reached out to IACP on amendment language to the bill, which also indicates that a vote is more likely after the recess. Please emailiacpinfo@iacprx.org if you have any questions on this information.
IACP Perspective: Why the Current Draft of S. 959 is Still Unworkable
- The compounding community has been collaborating with lawmakers and their staff on the development of legislation that will ensure we never have another NECC.
- The bill that has emerged from the Senate HELP Committee, Senate 959, will not protect patient safety and therefore IACP and the compounding community is not supporting it at this time.
- The bill exempts hospitals, health systems, and pharmacy benefit managers from the very protections it is putting in place, and we believe that these large exemptions will create safety gaps. We believe that every patient should be assured of the same level of safety, whether they get their compounded medications from a pharmacy, a hospital, or a mail order pharmacy.
- The bill also could interfere with patient access to compounded medications. For instance, it prohibits the re-packaging of certain medications even when those re-packaged medications are far less costly. It creates restrictions on anticipatory compounding and office use, two methods for patients receiving medications when they need them.
Posted 7.30.13
From the FDA Blog--Dietary Supplements Containing Unsafe Food Additive Destroyed
In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA).
In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week.
The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths.
continue to read here
Question of the Day July 30, 2013 Will the US Senate Be Successful in Using "unanimous Consent" to Pass Senate Bill 959, The Pharmaceutical Compounding Quality and Accountability Act.?
Unanimous Consent is a procedure prevents any debate, prohibits amendments, and no Senator is forced to go on the record and affirmatively support the bill. The Senate Website does not currently have the bill listed for consideration next Monday but rumors are that is when it may be considered. At least one U.S. Senator, Tom Colburn from Oklahoma, has indicated he will not agree to unanimous consent of the bill. Stay tuned to the blog for more information.
National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy
Pharmacists Group Lobbies Against Senate Compounding Bill
Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy and is relying on a parliamentary continue to read here
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