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
Thursday, November 8, 2012
Statement From IACP EVP/CEO David Miller, R.Ph. Regarding Congressman Markey's Bill
WASHINGTON, Nov. 8, 2012 /PRNewswire-USNewswire/ -- The International Academy of Compounding Pharmacists
(IACP) has reviewed the legislation filed by Congressman Edward Markey in
response to the meningitis outbreak that emanated from contaminated steroid
injections prepared by New England Compounding Center, and we applaud the
Congressman's efforts to ensure safety and advance quality in the compounding
profession. The nation's compounders provide a vital service to patients in
need and the Congressman's legislation recognizes and protects this service.
As with any piece of complex legislation, there are provisions that
we support and those that we do not. Most notably, we support the preservation
of state regulatory authority for traditional compounding pharmacy activities.
All boards of pharmacy must be adequately funded by state legislatures in a
manner sufficient to hire trained/educated pharmacists to conduct regular
inspections of all pharmacies. Too many boards have been "de-funded" by the
diversion of revenue from the Boards into the states' general funds, leaving
administrative gaps.
Drug manufacturers are not compounders, and
for that reason the IACP also supports ensuring that the FDA takes action
against any business engaged in illegal drug manufacturing while still
preserving the individual state's authority and right to govern the practice of
compounding pharmacy.
The IACP also supports the following provisions:
- Allowing collaboration between the FDA and pharmacies to compound preparations to fulfill drug shortages or to protect public health.
- Providing for a process by which pharmacies may compound preparations to provide physicians, hospitals and clinical practice sites with medications necessary for administration to patients as part of their medical treatment.
- Ensuring that the FDA has clear authority to inspect any compounding pharmacy to assure that the storage and handling of medications are conducted in such a manner as to protect the health and safety of the public, although we would note that such authority already exists.
- The continuation of the FDA "Do Not Compound" list of drugs that have been determined by the FDA to be clinically unsafe. IACP believes this list must be created in collaboration with experts from the pharmacy and medical practice communities as the current FDA list was created without any review or input from practitioners.
While we support the concept of actively reporting adverse reactions
to compounded preparations to the FDA's MedWatch program, the existing system is
designed in such a manner as to actually impede pharmacists' participation.
This will require more collaboration between the FDA and compounding pharmacists
before it can be implemented.
Regarding a requirement that all compounded preparations be labeled
as such, IACP has professional standards that specifically recommend such
disclosure and encourages open communication with patients and prescribers about
compounded medicines. Those labeling standards have been shared with Congress.
IACP would only support mandating labeling to report serious adverse drug
reactions for compounded preparations if identical wording is also required for
all manufactured finished drug products as well as all medications compounded or
dispensed by physicians, veterinarians or other health professionals.
We will continue to maintain an active role throughout the
legislative process so that we can safeguard high quality and vitally important
compounding services.
Contact:David Ball, Ball Consulting Group, LLC
On behalf of IACP
O: 617-243-9950
E: david@ballcg.com
On behalf of IACP
O: 617-243-9950
E: david@ballcg.com
SOURCE International Academy of Compounding Pharmacists
(IACP)
RELATED LINKS
Meningitis outbreak: 150 patients received older medications--Shelf Life Too Long
Written By comlim on Kamis, 08 November 2012 | 22:34
By Tom Wilemon and Walter F. Roche Jr. | The Tennessean
Nearly 150 patients who were exposed to potentially contaminated steroid
injections in Tennessee got medicine that was more than 7 weeks old, even though
industry guidelines say its shelf life should have been no longer than 24
hours.
Almost one in five of those patients developed fungal infection -- a rate dramatically higher than for those who were treated with fresher medicine, according to the Tennessee Department of Health.
The methylprenisolone acetate produced by Massachusetts-based New England Compounding Center is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31, including 13 in Tennessee.
Under best-practice guidelines from the U.S. Pharmacopeia Convention, the drug would be considered a "high-risk" product -- made from nonsterile ingredients and lacking antimicrobial preservatives. In the absence of a sterility test, storage time should not exceed one day at room temperature or three days at a cold temperature, the guidelines say.
In Tennessee, NECC's vials were stored at room temperature, as specified in the package instructions, state health officials said in a paper published Tuesday in the New England Journal of Medicine.
The compounding laboratory claimed to have performed sterility tests on its products, but the Massachusetts Board of Pharmacy has said that testing was inadequate and shipments were made before the safety of medicines had been verified.
Continue reading here
Almost one in five of those patients developed fungal infection -- a rate dramatically higher than for those who were treated with fresher medicine, according to the Tennessee Department of Health.
The methylprenisolone acetate produced by Massachusetts-based New England Compounding Center is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31, including 13 in Tennessee.
Under best-practice guidelines from the U.S. Pharmacopeia Convention, the drug would be considered a "high-risk" product -- made from nonsterile ingredients and lacking antimicrobial preservatives. In the absence of a sterility test, storage time should not exceed one day at room temperature or three days at a cold temperature, the guidelines say.
In Tennessee, NECC's vials were stored at room temperature, as specified in the package instructions, state health officials said in a paper published Tuesday in the New England Journal of Medicine.
The compounding laboratory claimed to have performed sterility tests on its products, but the Massachusetts Board of Pharmacy has said that testing was inadequate and shipments were made before the safety of medicines had been verified.
Continue reading here
How many other Complaints Against Bad Compounding Pharmacies Have Been Filed Where State Boards Have Failed to Take Action or the Proper Action?
In light of the recent discovery that the Colorado State Board of Pharmacy had filed with the Massachusetts' Board of Pharmacy a 34-page complaint alleging NECC had
distributed manufactured drugs to their state without patient-specific
prescriptions, which was a violation of NECC’s Colorado and Massachusetts’ licenses. This complaint was sent to the Director of the Massachusetts' Board of Pharmacy, James Coffey and the board's attorney Susan Manning, who would have been responsible
for ordering an investigation. Neither did so according to news reports. Coffey has been fired, and Manning has been placed on administrative leave.
These event in Massachusetts make me wonder how many other state boards of pharmacy have:
1) taken no action or not strong enough action on complaints against compounding pharmacies and pharmacist who pose a health and safety risk;
2) received a complaint from another state and done nothing with it;
3) referred the complaint to the FDA or another state with nothing having been done;
4) inspected the pharmacy once and written it up, but not reinspected it to determine if it took corrective measures; (i.e., written up a compounding pharmacy or pharmacist for a violation, but the pharmacy or pharmacy and pharmacist are still doing the same thing).
Are state boards being proactive and examining the complaints that they have received within the last couple of years regarding compounding pharmacies and pharmacists? In light of potential liability issues and health risk, not to mention the possibility of being fired, if I were on a state board of pharmacy or an inspector for a state board of pharmacy, I would be reviewing the complaints and inspections of compounding pharmacies and pharmacists for at least the last two years and making sure I had all my i's dotted and my t's crossed.
If the proper course of action had not been taken on a complaint or inspection, then I would get busy trying to figure out how to fix it before it becomes another NECC nightmare. If no action has been taken on a complaint, take the appropriate action. If the proper or not strong enough action was taken, reinspect or figure out a way to fix the health and safety risk. If a complaint has been received from another state, take the appropriate action on that complaint. If a complaint has been referred to the FDA or another state, followup with the FDA or that state to make sure they received the complaint, inquire if they need any additional information from your state, and find out what has or will happen to the pharmacy or pharmacist. Reinspect any pharmacies that have been written up for violations and determine if corrective measures are in place; if not take immediate action to fine or close down the pharmacy. By being proactive and taking the proper actions, state boards of pharmacy members and employees can not only limit potential exposure to liability (even though most states have statutory limits on this already in place), but they can also less the risk to the health and safety of the public.
These event in Massachusetts make me wonder how many other state boards of pharmacy have:
1) taken no action or not strong enough action on complaints against compounding pharmacies and pharmacist who pose a health and safety risk;
2) received a complaint from another state and done nothing with it;
3) referred the complaint to the FDA or another state with nothing having been done;
4) inspected the pharmacy once and written it up, but not reinspected it to determine if it took corrective measures; (i.e., written up a compounding pharmacy or pharmacist for a violation, but the pharmacy or pharmacy and pharmacist are still doing the same thing).
Are state boards being proactive and examining the complaints that they have received within the last couple of years regarding compounding pharmacies and pharmacists? In light of potential liability issues and health risk, not to mention the possibility of being fired, if I were on a state board of pharmacy or an inspector for a state board of pharmacy, I would be reviewing the complaints and inspections of compounding pharmacies and pharmacists for at least the last two years and making sure I had all my i's dotted and my t's crossed.
If the proper course of action had not been taken on a complaint or inspection, then I would get busy trying to figure out how to fix it before it becomes another NECC nightmare. If no action has been taken on a complaint, take the appropriate action. If the proper or not strong enough action was taken, reinspect or figure out a way to fix the health and safety risk. If a complaint has been received from another state, take the appropriate action on that complaint. If a complaint has been referred to the FDA or another state, followup with the FDA or that state to make sure they received the complaint, inquire if they need any additional information from your state, and find out what has or will happen to the pharmacy or pharmacist. Reinspect any pharmacies that have been written up for violations and determine if corrective measures are in place; if not take immediate action to fine or close down the pharmacy. By being proactive and taking the proper actions, state boards of pharmacy members and employees can not only limit potential exposure to liability (even though most states have statutory limits on this already in place), but they can also less the risk to the health and safety of the public.
STATEMENT OF INTERIM COMMISSIONER DR. LAUREN SMITH ON NECC INVESTIGATION
FOR IMMEDIATE RELEASE:
November 7, 2012
FURTHER INFORMATION:
Anne Roach (617) 624-5006
STATEMENT OF INTERIM COMMISSIONER DR. LAUREN SMITH ON NECC
INVESTIGATION
BOSTON -- Wednesday, November 07, 2012 – The following is a statement from
Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren
Smith:
Today I am announcing a development in our ongoing investigation into NECC and
administrative changes at the Massachusetts Board of Pharmacy. These personnel actions
stem from troubling information that has come to light during our ongoing review of the
Board’s oversight of NECC.
We have discovered a Colorado Board of Pharmacy complaint against NECC, which was
forwarded to James D. Coffey, Director of the Massachusetts Board of Pharma cy, on July
26, 2012.
The information shared by Colorado showed that NECC had distributed manufactured
drugs to many hospitals in that state between 2010 and 2012 without patient -specific
prescriptions, in violation of NECC’s Colorado and Massachusetts l icenses. The
Colorado Board of Pharmacy contacted the FDA who confirmed that NECC was not a
licensed manufacturer.
As seen in the attached documents, this information was provided in detail by Colorado
to Mr. Coffey in July, which he then forwarded to Boa rd attorney Susan Manning and
Board inspectors. The director of the Board is responsible for ordering investigations. Mr.
Coffey failed to order an investigation or take any other action on the Colorado
complaint.
It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado
complaint given NECC’s past, and their responsibility to investigate complaints.
Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint
to leadership at DPH.
As a result of these findings, we have terminated James Coffey and placed Susan
Manning, a member of a bargaining unit, on administrative leave pending the final
conclusions of our investigation. We have identified highly qualified individuals to fill
these positions and the important work of the agency will continue with even greater
resolve at this critical juncture.
There is no evidence at this time that staff informed Board members about the Colorado
issues.
Read full release here
Texas Board of Pharmacy Discussed Compounding at November 2012 Meeting
| Agency Name: | Texas State Board of Pharmacy |
| Date of Meeting: | 11/06/2012 |
| Time of Meeting: | 9:00:00 AM (Local Time) |
| Committee: | |
| Status: | Active |
| Street Location: | 333 Guadalupe Street, Suite 2-225 |
| City Location: | Austin |
| Meeting State: | TX |
| TRD ID: | 2012007448 |
| Submit Date: | 10/25/2012 |
| Emergency Meeting?: | No |
| Additional Information From: | Becky Damon, Executive Assistant 512-305-8026 Becky.Damon@tsbp.state.tx.us |
| Agenda: |
A. Announcements
* Meeting Procedures
* Board Members
* Staff
* Continuing Education
B. Discussion and Approval of Minutes
* TSBP Board Business Meeting Held August 7, 2012
* Temporary Suspension Hearings
C. Discussion of and Possible Action Regarding Rules
C.1 Final Adoption of Rules
C.1.1 Amendments to §291.17 Concerning Inventory Requirements
C.1.2 Amendment to §291.74 Concerning Automated Devices and Systems
C.1.3 Amendments to §291.93 Concerning Labeling Prescriptions for Partner Therapy in Class D Pharmacies
C.1.4 Amendments to §291.104 Concerning Submission of Controlled Substance Prescription Information to the Texas Department of Public Safety by Class E Pharmacies
C.2 Proposal of Rules
C.2.1 Amendments to §291.31 Concerning Definitions
C.2.2 Amendments to §291.32 Concerning Personnel
C.2.3 Amendments to §295.8 Concerning Continuing Education Requirements
C.3 Rule Reviews in Accordance with Government Code, Section §2001.039
C.3.1 For Proposal
C.3.1.1 Chapter 297 Concerning Pharmacy Technicians (§§297.1-297.9)
C.3.1.2 Chapter 291 Concerning Pharmacies (Services Provided by Pharmacies(§§291.120-291.121, 291.123, 291.125, 291.127, 291.129, 291.131, 291.133)
D. Discussion of and Possible Action Concerning the Following Reports and Discussions
D.1 Financial Update
D.1.1 Review of FY2012 Expenditures
D.1.2 Review of Board Member Travel Budget
D.1.3 Update on Legislative Appropriations Request for FY2014-2015
D.2 Update Concerning Program to Aid Impaired Pharmacists and Pharmacy Students
D.2.1 Update on Number of Participating Individuals
D.2.2 Professional Recovery Network (PRN)
D.2.2.1 Presentation and Discussion Concerning PRN Expenditures and Activities by PRN Director Courtney Bolin
D.2.2.2 Review and Approval of Professional Recovery Network Program Audit
D.3 Discussion Concerning Problems With Sterile Compounding at an Out-of-State Compounding Pharmacy
D.4 Discussion Concerning Biosimilar Drug Products
D.5 Discussion Concerning Community Pharmacy Accreditation
D.6 Discussion Concerning Health Information Exchanges and/or Private Entities Maintaining Patient Records
D.7 Report on Appeals of Disciplinary Actions
D.8 Report on Dissemination of Information to Board Members Prior to Informal Conferences
D.9 Report on Shared Regulatory Data Base Project
D.10 Discussion Concerning Board Member E-Mail Addresses
D.11 Discussion of Possible Statutory Changes for Consideration During the 83rd Session of the Texas Legislature
E. Disciplinary Orders
E.1 Consideration of Proposals for Decision
E.1.1 In the Matter of Anne Akinyi Odim, Pharmacist License #40536
E.1.1.1 Executive Session Concerning the Proposal For Decision in the Matter of Anne Akinyi Odim, Pharmacist License #40536
E.2 Report on Agreed Board Orders Entered by Executive Director
E.3 Discussion of and Action on Proposed Agreed Board Orders and Default Orders
E.4 Executive Session to Consider Confidential Agreed Board Orders
F. Consideration of and Possible Action Concerning the Following Enforcement Reports
F.1 Consideration of Petition(s) to Serve as a Preceptor
F.1.1 Petition from Susan Nguyen-Thiem, R.Ph.
F.1.2 Petition from Joseph Adam Isbell, R.Ph.
F.1.3 Petition from Nancy Robin Duffle Golden, R.Ph.
F.1.4 Petition from Jaime Ponce Anaya, R.Ph.
F.2 Report on Complaints Closed and Dismissed During the Previous Quarter
F.3 Report on Status of Active/Pending Complaints
G. Miscellaneous
G.1 Items to be Placed on Agenda for February 2013 Board Meeting
G.2 Discussion of and Possible Action on Recent Conferences and Events
* National Association of Chain Drug Store (NACDS)
2012 Pharmacy & Technology Conference, Denver, CO
August 25-28, 2012
* Council on Licensure, Enforcement and Regulation (CLEAR)
Annual Education Conference, San Francisco, CA
September 6-8, 2012
* MALTA-GON
Annual Conference, Tulsa, OK
September 9-12, 2012
* Academy of Managed Care Pharmacy (AMCP)
Education Conference, Cincinnati, OH
October 3-5, 2012
* National Community Pharmacists Association (NCPA)
Annual Convention, San Diego, CA
October 13-17, 2012
* National Association of Board of Pharmacy/American
Association of Colleges of Pharmacy (NABP/ACCP)
District VI, VII, and VIII Annual Meeting, Little Rock, AR
October 21-24, 2012
G.3 Discussion of and Possible Action on Upcoming Conferences and Events
* Technician Informal Conference, Austin, November 28, 2012
(Mendoza)
* American Society of Consultant Pharmacists (ASCP)
Annual Meeting, National Harbor, MD
November 7-9, 2012
* Informal Conference, Austin, December 4-6, 2012
(Wiesner)
* Technician Informal Conference, Austin, December 13, 2012
(Stine)
* American Society of Health-System Pharmacists (ASHP)
Mid-Year Conference, Las Vegas, NV
December 2-6, 2012
* Informal Conference, Austin, January 8-10, 2013
(Tipton)
* Technician Informal Conference, Austin, January 24, 2013
(Stine)
__________
THE TEXAS STATE BOARD OF PHARMACY MAY ENTER EXECUTIVE SESSION TO CONSIDER ANY AGENDA ITEM WHEN PERMITTED BY TEXAS LAW.
Persons with disabilities who plan to attend this meeting and who may need auxiliary aids or services such as interpreters for persons who are deaf or hearing impaired, readers, large print or Braille, are requested to contact Cathy Stella at (Voice) 512/305-8000, (FAX) 512/305-8075, or TDD 1-800/735-2989. Requests for reasonable accommodations should be made five working days prior to the meeting so that appropriate arrangements can be made.
American Society for Pharmacy Law In Conjunction with the National Alliance of State Pharmacy Associations Presents 2012 Developments in Pharmacy Law Seminar XXIII
Included during this seminar is the following:
10:45 am – 12:15 pm Veterinary and Human Compounding
Since the Food and Drug Administration Modernization Act (FDAMA)
of 1997 was passed, confusion has reigned over the legal parameters
for pharmacy compounding. Contradictory court decisions, FDA’s
interpretation and enforcement of laws, and dissonance between
FDAMA and FDA guidelines, have all contributed to the confusion.
Similar factors have confounded compounders of veterinary
products. This presentation will explain the laws, regulations, and
court decisions affecting human and veterinary compounding so
attendees can better understand the law and enforcement in these
areas. Held in cooperation with the Food and Drug Law Institute.
Mark S. Brown, JD, King and Spalding LLP (1.5 credit hours)
To see the entire schedule click here
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