NABP Comments on ISMP Published Survey Results on Compounding Practices

Feb. 6, 2013
A majority of respondents to a survey on compounding practices indicated that pharmacy technicians who work in sterile compounding should be certified or licensed. The survey, conducted by the Institute for Safe Medication Practices (ISMP), also indicated that respondents believe technicians should be required to demonstrate proficiency in sterile compounding as a requisite for such licensure. Further, of the 412 pharmacists and pharmacy technicians surveyed, 13% reported that contamination of high risk compounded sterile products had occurred in their facility in the past year. “Only half (50%) of all staff pharmacists and 38% of pharmacy technicians were confident that contamination had not occurred,” as stated in a news release (PDF) summarizing the survey results. The complete ISMP survey results were published in the January 24, 2013 issue of the ISMP Medication Safety Alert! newsletter. 

Source found here

NABP Member Boards Take Action to Strengthen Regulation of Compounding Practice

Feb. 6, 2013

With the multistate meningitis outbreak linked to unsafe compounding practices at the New England Compounding Center, state and federal lawmakers, regulators, government officials, and stakeholders, including NABP, are seeking to clarify the law and put in place new systems. Information on actions taken by state boards of pharmacy, including details about the compounding action plan implemented by NABP member boards, is available in the February 2013 NABP Newsletter article “State Boards and NABP Take Action to Clarify Regulations and Bolster State Regulatory Systems Specific to Compounding Pharmacies” (PDF).

Drug Topics: NABP action plan created to help enforce compounding regulations

Jan 15, 2013 By: Julia Talsma, Content Channel ManagerDrug Topics

Last month NABP Executive Director Carmen Catizone, MS, RPh, unveiled an action plan to inspect nonresident compounding pharmacies and create a database to share regulatory information about these pharmacies with the state boards of pharmacy nationwide. This was in response to the fungal meningitis outbreak that took the lives of 39 individuals and injured more than 600.
Catizone spoke to attendees of the American Society of Health-System Pharmacists (ASHP) Midyear meeting in Las Vegas.
These patients had received contaminated compounded steroid injections that were produced and distributed by the New England Compounding Center, Framingham, Mass.
"This is a tragedy like no other that NABP has faced," said Catizone who has served the association for 27 years. "This issue has totally consumed NABP and the state boards of pharmacy. This will change pharmacy regulation like no one has anticipated."
NABP's action plan began in November during the meeting of the board of pharmacy executive directors. The Iowa Board of Pharmacy had already requested that NABP develop an inspection plan for all of its nonresident pharmacies dispensing compounded drugs that were licensed by Iowa.
"Based upon that agreement, we will be acting as an agent of the state of Iowa and going into all the other states where these pharmacies are located and physically inspecting those pharmacies. We will do so with the cooperation of the resident states," Catizone said. The state boards have been supportive and cooperative in providing a list of pharmacies for inspection, the first part of NABP's action plan, he said.
The week of December 10, NABP started implementing the second part of its action plan to inspect these facilities that are compounding and to determine whether the pharmacies are compounding pursuant to a prescription in compliance with state regulations, or are engaged in manufacturing.
The third part of the action plan involves the creation of a database with information pertaining to compounding pharmacies identified by the Iowa Board as well as those indicated by other state boards.
"Initial data collected from the boards and the inspection reports will be stored in an NABP Pharmacy e-Profile, allowing the NABP to disseminate pertinent public information among state boards," NABP reported on its website. "Ultimately, states will be able to submit inspection reports and other related information to NABP for inclusion in pharmacies' e-Profiles."
NABP also plans to provide training and education of board of pharmacy inspectors via Web seminars and field training, according to its website. State boards are supportive of these efforts. "They have said, 'We can't sit back and we can't argue this for 20 more years—what is the definition of compounding versus manufacturing. Too many patients have been killed or injured. We have to act. And we will do so in the best interest of the patient,' " Catizone said.
Source found here 

NABP Implements Action Plan to Assist States in Regulating Compounding Pharmacies

Supporting state board of pharmacy efforts to enforce compounding
regulations, NABP is implementing a four-part action plan centered
around inspection of nonresident compounding pharmacies and creating
an information-sharing network of regulatory details on such pharmacies.
Focusing on inspections of nonresident compounding pharmacies and
sharing this data among boards of pharmacy nationwide was determined
by NABP and its member state boards of pharmacy to be key to preventing
future tragedies like the current meningitis outbreak.
NABP developed the action plan at a November 2012 meeting of board
of pharmacy executive directors where the attendees expressed a strong
commitment to correcting system failures that allowed the meningitis
outbreak to occur, and implementation began quickly thereafter. The Iowa
Board of Pharmacy recently requested NABP to develop an inspection
program for entities that are licensed by the state as nonresident pharmacies
and dispensing compounded drugs in Iowa. Those in attendance expressed
their support of this inspection initiative, which became a cornerstone of
the four-part action plan.
In the first part of its action plan, NABP shared the list of nonresident
compounding pharmacies provided by the Iowa Board with other NABP
member boards of pharmacy and began coordinating the collection of
information on these pharmacies. The boards’ collaboration on this data
helped NABP identify the initial pharmacies to inspect. NABP believes that
the list provided by Iowa represents a significant number of nonresident
pharmacies dispensing compounded drugs across the country.
Implementing the inspection program is the second part of the action
plan and is currently underway. Initial results will reveal whether the selected pharmacies are compounding pursuant to a prescription in compliance
with state regulations, or instead are engaging in manufacturing. Entities
that refuse inspection may be subject to disciplinary action by the Iowa
Board and such actions will be shared with all of NABP’s member boards.
The third part of the action plan includes NABP collecting and maintaining data on the compounding pharmacies identified by the Iowa Board
and by other boards of pharmacy. Initial data collected from the boards
and the inspection reports will be stored in an NABP Pharmacy e-Profile,
allowing the Association to disseminate pertinent public information
among state boards. Ultimately, states will be able to submit inspection
reports and other related information to NABP for inclusion in pharmacies’
e-Profiles. The network will be made available at no cost to boards for use
in making licensure and registration determinations for pharmacies, and
may also help to identify pharmacies whose operations are more akin to
manufacturing than compounding.
As the final part of the action plan, NABP plans to schedule immediate
and ongoing training of board of pharmacy inspectors and compliance officers via Webinar and field training opportunities. NABP will also continue
cooperative efforts with Food and Drug Administration and legislators to
address the regulatory quagmire that exists when traditional compounding
is exceeded and manufacturing may be occurring.

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.

NABP Leads the Charge as States Tighten Ranks Around Compounding Pharmacies - National Association of Boards of Pharmacy® (NABP®)

http://www.nabp.net/news/nabp-leads-the-charge-as-states-tighten-ranks-around-compounding-pharmacies/

Continued NABP Actions Vital to Protecting Public from Rogue Internet Drug Outlet Dangers, Task Force Advises

Originally published in the August 2012 NABP Newsletter

Applying for the .pharmacy generic Top-Level Domain (gTLD), supporting relevant legislation, and educating consumers, health care providers, and law enforcement, are among the many actions NABP should continue to undertake in order to protect the public health from Internet drug outlets, as agreed by the 2011-2012 NABP Task Force on Internet Pharmacy Practice. Task force members discussed the complex network of operations behind rogue Internet drug outlets to determine how such entities can be shut down, and made several recommendations in this regard. Further, members discussed the importance of continuing to share NABP’s research findings on rogue Internet drug outlets with both United States and international regulators, law enforcement, and other stakeholders. Members also agreed that the Association should take additional actions to support boards of pharmacy efforts to help shut down rogue Web sites illegally selling drug products.

The Task Force on Internet Pharmacy Practice met March 6-7, 2012, at NABP Headquarters and accepted their charge as follows:

1. Review existing Internet pharmacy practices;
2. Review current state laws and regulations, Verified Internet Pharmacy Practice Sites^CM (VIPPS^®) program standards, and NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy language; and
3. Examine future opportunities and challenges in an emerging global environment.

The full article includes a summary of the task force recommendations, as well as background information, and is available in the August 2012 NABP Newsletter (PDF) (page 151).

What Information is Available

The NABP August 2012 Newsletter deals with Information on What's Available, written by Dale J. Atkinson, J.D.  The article addresses open records act and pharmacy boards.  To view the article, click here. 

 

State Boards of Pharmacy Reported 4324 disciplinary actions in 2011

The April 2012 Newsletter of the National Association of Board of Pharmacy reports that state boards of pharmacy reported 4,324 disciplinary actions to the NABP Clearinghouse in 2011.  The percentages of the disciplinary actions report are as follows:

Probation of License (19.7%)
Administrative or Publicly Available Fine/Monetary Penalty (14.8%)
Revocation of License (12.5%)
Suspension of License (11%)
Voluntary Surrender of License (10.7%)
Miscellaneous* (10%)
License Restored or Reinstated,
Complete and Conditional (9.2%)
Reprimand or Censure (9%)
Summary or Emergency Suspension of License (3%)

To view the entire article, click here.