FDA Looking to Overhaul Compliance Approach

Visit www.drugregulations.org for the latest in Pharmaceuticals.

An article published in Regulatory Focus gives FDA's latest thinking on the relationship between Compliance and Quality.

In a presentation to the Regulatory Affairs Professionals Society's (RAPS) San Francisco membership chapter on 27 July 2012, Roh, regional food and drug director for FDA's Pacific Region, said the US Food and Drug Administration (FDA) is heading towards a significant change in compliance policy in the coming years. This is a result of rapidly surging imports of pharmaceutical, medical device and biologics products. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies.

The rate at which products were being imported from overseas manufacturing facilities was fast outstripping FDA's ability to effectively exercise oversight. Some of the largest US trading partners are projected to experience enormous growth trends in imports, Roh said in his presentation. China in particular is expected to experience a 426% growth in exports by 2020, while India (+465%) and Mexico (+159%) are projected to exhibit similar percentage increases, though on a smaller overall scale. This could have huge ramifications for the US, which already imports approximately 10% of all products regulated by FDA. The US is expected to see growth rates between 5% and 8% during most years, with estimations going as high as 15% during some years.

To read rest of this article, click here.

Is Reform of Veterinary Boards Disciplinary Actions and Access to that Information Needed?

If disciplinary actions of veterinarians were more easily accessed, it would not necessarily prevent compounding incidents such as Franck's, but it would make the public more aware of whether a veterinarian has previously been disciplined in relation to compound preparations.  Aligus is an organization founded to advocate against veterinary malpractice, incompetence and negligence and to educate the public about how state veterinary boards handle citizens' complaints. The following article address some of the deficiencies in this area.  The article can be found at www.ALIGUS.COM

Veterinary Boards

Each state veterinary board is responsible for licensing veterinarians and regulating the practice of veterinary medicine for the State.

Their mission is to safeguard against unqualified practitioners and to protect the public against veterinary malpractice, incompetence and negligence by carrying out their regulatory duties. State statutes and rules, generally called the Veterinary Practice Act, stipulate the regulation and enforcement of veterinary medicine. 

A performance audit of the Arizona Veterinary Medical Examining Board conducted by The Office of the Auditor General pursuant to a May 29, 1995, resolution of the Joint Legislative Audit Committee detailed deficiencies so serious as to jeopardize the continued existence of the Board.  The audit stated that if the Board did not rectify these problems after a five-year time period, the Legislature should consider other alternatives to ensure that the State's regulatory 
Sources:  http://www.auditorgen.state.az.us/PAD/97-7s.htm; http://www.auditorgen.state.az.us/Reports/State_Agencies/Agencies/Veterinary_Examining_State_Board_of/Performance/97-07/97-7.pdf

THESE DEFICIENCIES RAISE QUESTIONS ABOUT ALL STATE BOARDS.

1.   Do Boards discipline when warranted?

2.   Do Boards adequately investigate most complaints?

3.   Are disciplinary hearings conducted in a timely manner?

4.   Is there a need for uniform disciplinary guidelines?

5.   Do Boards need to increase public access to information?

6.   Do Boards adequately inspect veterinary facilities?

7.   Is there adequate public representation?

8.   What is the influence of Veterinary Medical Associations?

9.   Are disciplinary actions reported to the national database?

10. Do state performance audits need conducted?

1. DO BOARDS DISCIPLINE WHEN WARRANTED?

In the Arizona audit,  the dismissal rate of complaints had been as high as 90 percent. Veterinary consultants retained by the Auditor General of the State of Arizona reviewed complaints from fiscal year 1996 and found that as many as one out of every six complaints dismissed should have resulted in some discipline. The Board dismissed a complaint against a veterinarian who inserted a feeding tube into a cat's lungs instead of its stomach. The cat died when food was injected through the tube. The Board dismissed a complaint against a veterinarian who euthanized a dog without the proper consent. In a Board meeting, even though the veterinarian admitted making the error, the Board still dismissed the complaint. 
Source: http://www.auditorgen.state.az.us/PAD/97-7s.htm.
Since January 1, 1998 more than half of the complaints before the Arizona Board were dismissed. In an average year, one license is revoked and usually this is for drug abuse by the DVM, not animal mistreatment.  Most penalties are for failure to notify the board of an address change. Only two Tucson-area veterinarians faced probation or more serious discipline in the past five years for animal care or client interaction.  The board's own records are incomplete, inconsistent and inaccurate 
Source:  http://www.azstarnet.com/star/sun/30629VETS2f2fdst-jmd.html, June 29, 2003
The Minnesota biennial report for 2004 - 2006 shows of the closed complaint cases 73% were dismissed for fiscal year 2005; 64% dismissed for 2006.
Source: www.asu.state.mn.us/LinkClick. aspx?link=26_Vet_Med.pdf&mid=2868
An August 1, 2005 article in the Ohio newspaper, Toledo Blade, states that the Ohio Veterinary Medical Licensing Board doesn't keep a running total of disciplinary actions. Disciplinary actions and the complaints that prompted them are only recorded in the files of veterinarians and complaints are removed from the files after two years. According to the article, a review of the Board’s online meeting minutes revealed 56 disciplinary actions and 479 complaints between January, 2002, and May, 2005. But a review of the individual files for Ohio's 2,378 veterinarians found that only 45 of them have ever had disciplinary action taken against them through a disciplinary order or a settlement involving a suspension or fine.
Source: http://www.toledoblade.com/apps/pbcs.dll/article?AID=/20050801/NEWS08/508010309
In Texas 8% or only 17 out of 212 of complaints received in 2006 resulted in discipline - 92% did not. The TVBME Strategic Plan, 2007-2011, states that the agency did not have sufficient funds for State Office of Administrative hearings in fiscal year 2006. The TVBME cites the results were having two cases that had to be postponed until funding could be acquired and that it was forced to settle several cases and reduce sanctions on other cases where it felt prosecuting them would be in the "best interest of the public".
Sources: http://cbs11tv.com/topstories/local_story_080203249.html;http://www.tbvme.state.tx.us/07-11%20Strat%20Plan.pdf
In North Carolina 52.8% of the 53 complaints considered were dismissed in 2009. Between 1995 to 2008 the dismissal rate ranged from 58 to 91%.
Source:  Compilation of complaints from NCVMB Board Minutes, 1995 - 2009.
In California, 420 complaints were filed in 2000. The board issued fines and citations in only 53 cases. Six resulted in probationary measures, and four in license revocations.  85% of the complaints filed did not result in disciplinary actions.  Most of the disciplinary actions involved police matters, such as drug abuse. Malpractice allegations are rarely disciplined. 
Source:  http://classic.sacbee.com/ourtown/pets/vets.html
In the State Board Report published by the Missouri Veterinary Medical Board September 2001, 39 official veterinary complaints were received, 11 investigations were initiated, 9 investigations were completed, 10 cases were referred to the Attorney General's office and 7 stipulation agreements were signed,  
Source:  http://www.ded.state.mo.us/regulatorylicensing/professionalregistration/vet/pdfs/vetvolume1iss4.pd
The Louisiana Board of Veterinary Medicine logged 24 complaints for July 2002 - June 2003. During that period 31 cases were considered and closed, with 2 cease and desist notices issued. There were two consent orders signed. There were 48 open complaints under investigation.  
Source:  http://www.lsbvm.org/news_02_12.htm#Complaint Statistics FY2003
In 2001 the Nevada State Board of Veterinary Medical Examiners dismissed 29 of 50 formal complaints filed (58%). There were 9 disciplinary settlement agreements.  In 2002, 31 of 39 formal complaints filed were dismissed (79%).  There were 6 disciplinary settlement agreements with 1 administrative hearing held/pending. 
Source: http://vetboard.nv.gov/brdupd.htm
In Colorado the totals for 1/1/00 - 12/31/2001: Dismissed Cases = 115 (74%);
Letters of Admonition = 18; Cease & Desist Orders = 7; Stipulation/Final Agency Orders = 16. 
Source:  http://www.dora.state.co.us/veterinarians/images/PDFsUsedAsImages/VetNwsltr2001.pdf
The Rhode Island Board of Veterinary Examiners reports issuing ONLY A TOTAL OF EIGHT SANCTIONS (including simple reprimands) between 1993-2003. 
Source:  http://www.health.ri.gov/hsr/professions/vets.htm
"When disciplinary action is taken without following prescribed guidelines, the Board is perceived by some to be like the proverbial fox guarding the chicken coop if the sanction is deemed too lenient or otherwise inappropriate." 
Source: http://www.state.oh.us/watchdog/investigations\vetbrd.pdf

2. DO BOARDS ADEQUATELY INVESTIGATE MOST COMPLAINTS?

Veterinary boards' records of weak disciplinary actions may be partly attributable to their failure to adequately investigate most consumer complaints. When a complaint is received, boards routinely request the medical records and a response from the veterinarian involved. However, despite most now having investigators, basic investigative steps such as interviewing the complainant and other involved parties, such as the doctor's staff, are generally not performed.  In fact, a complainant was interviewed in only 3 of the 102 cases the Arizona performance audit.
Another problem with Board's complaint processes is that Boards often inappropriately limit the extent of the investigation performed on each complaint.  In the Arizona performance audit, rather than allowing the Board's investigators to fully pursue each complaint and present the findings to the Board for adjudication, the Board heard each complaint in a public meeting and set limits on what the investigator should do. A review of the 22 complaints in fiscal year 1996 in which the Arizona Board directed the investigation found that the Board, on average, gave the investigator 2 directives per complaint. These directives involved limited actions, such as obtaining the names of the veterinarians who worked on a given day, or photographing a veterinary facility's sign.
Boards often expend only a small percentage of their budget on investigating complaints.

In the fiscal year 2002,  Tennessee reported percentage of revenues expended as: Licensing 89.72%, Legal Services 2.54%, and Investigations 7.74%.  
Source:  http://www2.state.tn.us/health/Boards/Veterinary/funding.htm

Between 1994 -2002, the NCVMB expended less than 1% of total revenues on investigations.  In some years, there were no line item expenditures for investigations at all. North Carolina did not have a full time investigator until December 2001.  Prior to that time "investigations" were conducted by the Executive Director and Board members with a private detective being engaged on a few rare occasions. Other percentages of revenues expended were:  Examination expenses (for licensing) 10%;  Legal. accounting and audit fees 15%; and Facilities inspections - travel  3%. 
Sources:  Minutes of the North Carolina Veterinary Medical Board 1995-2003;  
1994-2002 Annual Financial Audits prepared by Shelton L. Hawley, C.P.A. for the NCVMB

3. ARE DISCIPLINARY HEARINGS CONDUCTED IN A TIMELY MANNER?

In 1997 the Ohio State Inspector General's Office investigated three allegations regarding  the Ohio Veterinary Medical Board.  Although the first two allegations were filed under a petition from the "Community at Large",  allegation three, was the result of the Inspector General's own initiative. The findings were that although the Board's investigation of the given complaint against a veterinarian was completed within a reasonable time period, five unreasonable delays totaling 197 days contributed to the overall length of time needed to complete the adjudication process.  One specific finding was that after completion of the investigation, too much time elapsed before the Notice of Opportunity for Hearing was mailed. -- 56 days had been allowed to elapse between the Board's initial vote to issue the Notice and when the Notice was actually mailed.  The report also found these delays even more troublesome in light of the Board's disinclination to pursue injunctive relief pending final administration and found that such unreasonable delays feed the perception that government is overly bureaucratic and unresponsive to citizens. 
Source: www.state.oh.us/watchdog/investigations\vetbrd.pdf
In North Carolina, 207 days elapsed between the NCVMB's vote to issue a Letter of Reprimand regarding a citizen's complaint and when it actually mailed the reprimand.  Upon receipt, one of the veterinarians reprimanded requested an Administrative Hearing. Thereafter, 343 more days elapsed before the Notice of Hearing was actually mailed.
In North Carolina,   492 days elapsed between the NCVMB's vote to issue a Notice of Hearing and when the Notice was mailed in an NCVMB initiated complaint consolidated with a citizen's complaint.  Attorneys for the NCVMB and the veterinarian jointly requested the Administrative Law Judge for three delays prolonging the start of the hearing an additional  91 days thus further contributing to the overall length of time to complete the adjudication process.  The hearing never occurred. The NCVMB and the veterinarian entered into a negotiated discipline settlement, 36 days prior to the start of the hearing. 
Sources:  NCVMB Minutes and Other Public Records Documents of the NCVMB 

4. IS THERE A NEED FOR UNIFORM DISCIPLINARY ACTION GUIDELINES?

Although the statutes and regulations between states are comparable, the discipline issued for similar violations often varies. As an example, in 2003 three Texas veterinarians failed to have valid DEA permits for handling controlled substances. Each was  fined $250.00, issued a formal reprimand and required to take and pass the TBVME's Jurisprudence Examination.  Although North Carolina has an equivalent law, in 2002 a North Carolina veterinarian found by DEA inspectors with controlled substances without a valid permit as documented to the NCVMB by the DEA was issued a Letter of Caution. 
Sources:  http://www.state.tx.us/tbvme/downloadables/03-2003BoardNotes.pdf;  NCVMB Public Records files
In 2002, the Florida Veterinary Board, in reviewing a complaint, found that a veterinarian's medical records were unclear as to which anesthetic was used or how much IV fluids were used during the surgery. The Board's Stipulation imposed a $250.00 fine, costs of $849.88, and additional continuing education in record keeping.  In North Carolina, the NCVMB found that medical records of a veterinarian were poor, that he billed for some things that were not in the record and did not provide adequate medical care following surgery and again that same night -- total discipline imposed was a Letter of Reprimand with no fine or continuing education requirements.  
Sources: http://www.state.fl.us/dbpr/pro/vetm/meet/minutes/min_june.pdf;  NCVMB Public Records files
Disparity can also exist between discipline issued to different respondents by the same Board. The North Carolina Veterinary Medical Board disciplined two veterinarians for practicing veterinary medicine in  uninspected facilities without required prior approval of the practice name or requesting a required facility inspection.  Both were disciplined via Consent Orders without administrative hearings and fined $5000.00.  One veterinarian was given a 6 months suspension (3 months active) and 2 years probation; the other was given a 30 day suspension ( no days active) and 1 year probation even though his consent order stipulated an additional violation of practicing as an entity not permitted by state statute. 
Source:  NCVMB Public Records Files
In 1997, Ohio Inspector General Richard G. Ward released a 14 page report of investigation into allegations of wrongdoing involving the investigation of a Columbus veterinarian by the Ohio Veterinary Medical Board. While the OVMB investigation itself was found to be thorough, the Inspector General recommended that the board establish written policies and procedures to ensure that appropriate decisions are reached and are consistent with prior cases.  
Source:  http://www.state.oh.us/watchdog/oigpress/1997/121097.htm 

5. DO VETERINARY BOARDS NEED TO INCREASE PUBLIC ACCESS TO INFORMATION?

According to the Arizona audit, the Board needs to do more to help ensure that the public has access to veterinarian licensing and complaint information. The public needs this information to make informed decisions when choosing medical care for their animals. Although the Board revised its public information policy in June 1996, it needed to ensure that the policy is carried out.  Auditors acting as pet owners telephoned the Board on five occasions to test whether Board staff would provide information. In four of the phone calls, Board staff failed to provide complete information about complaints and previous disciplinary actions, including a license revocation. Currently, Arizona will give telephone verification of licensure and discipline actions.  If disciplinary action has been taken, a copy will be mailed to the requester.  The full disciplinary file is available for inspection or a copy may be obtained at $0.25 per page.
In Michigan, it is mandated  pursuant to the Michigan Public Health Code, P.A. 368 of 1978, as Amended, that the Department of Consumer & Industry Services is required to publish the names and addresses of disciplined individuals.
As a result of the April 2004 Sunset Commission recommendation that the Texas board should post information about disciplinary orders and sanctions on its web site in a format that consumers can easily access, the TVBME published an alphabetical list of disciplinary actions dating back to 1970. Included are the name of the practitioner, date of action, violation, summary and sanction
Sources:http://www.sunset.state.tx.us/79threports/sbvme/sbvme.pdf; http://www.tbvme.state.tx.us/Docket%20-%20website%20M-Z.pdf; http://www.tbvme.state.tx.us/Docket%20-%20website%20A-L.pdf
Although Tom Mickey, Executive Director of the North Carolina Veterinary Medical Board, stated that anyone looking for a new vet should find out about the vet's prior disciplinary record, as of 2010 the NCVMB still does not publish disciplinary actions on its web site, nor does it even have a veterinarian lookup so the public can verify a veterinarian's license. This is in contrast to the North Carolina Medical Board's web site that makes available to the public via lookup the doctor's age, address, educational background and disciplinary history. As a result of a new 2007 law, the Medical Board is now required to also publish felony convictions, hospital sanctions, malpractice payments and discipline by other state medical boards. Having been criticized for years about its lack of openness, the N.C. Medical Board supported the legislative changes that previously prohibited sharing information about malpractice suits and hospital discipline.
Sources: http://www.ncvmb.org; http://www.charlotte.com/162/story/253713.html; http://www.journalnow.com/servlet/Satellite?pagename=WSJ%2FHTML Page%2FWSJ_HTMLPage&c=HTMLPage&cid=1031769511726
California,  Colorado, Georgia, Hawaii, Illinois, Maine, Michigan, Minnesota, Missouri, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Vermont, and Virginia are among state veterinary boards that publish disciplinary actions on their web sites - either as disciplinary lists, in Board Minutes, or as licensee lookup by name. Those that publish a compiled list, like Texas, rather than look-up by name or scattered among years of archived news letters or board minutes make this information most easily accessible to the public.
Accurate licensing AND disciplinary information should be easily available to the public.  Disclosing license status (i.e., "active license") is inadequate and may be misleading.  MANY ACTIVELY LICENSED VETERINARIANS HAVE HISTORIES OF SERIOUS COMPLAINTS AND DISCIPLINARY ACTIONS AND MAY EVEN BE UNDER CURRENT SANCTIONS.

6. DO BOARDS ADEQUATELY INSPECT VETERINARY FACILITIES?

The Arizona audit also presented findings recommending that the Board increase inspections of veterinary facilities. Performing routine inspections would help ensure a minimum standard of care at veterinary facilities.
According to a 1999 audit, Virginia's facility inspection program under the auspices of the Department of Health Professionals, failed to meet its goals for completing inspections of pharmacies, veterinary facilities, and funeral homes (although inspection standards were apparently met for the 9 other health professions).  Many had not been inspected for over eight years. The audit also raised some drug law enforcement concerns, because a primary purpose of both pharmacy and veterinary inspections is to ensure that the distribution of drugs is properly controlled. The failure to meet these goals appeared to be due in part to the assumption by inspectors of some investigative responsibilities and to a shortage of inspector positions.  
Source:  Virginia, http://jlarc.state.va.us/Summary/Rpt233/health.htm
When the complainants in North Carolina complaint  were told by the NCVMB that the veterinarian's practice facility had never been inspected, it was anticipated that the NCVMB would immediately inspect it to assure compliance with minimum standards.  Instead nine months later the NCVMB issued a written complaint against the veterinarian which contained a cease and desist statement.  The veterinarian responded by requesting an  inspection of a different facility acquired subsequently.  The Board inspector passed the newly acquired facility including certification that the veterinarian met all requirements for handling of controlled drugs. However, the veterinarian did not have a valid DEA controlled drug permit -- it had expired a year earlier and had been retired by the DEA.
Source:  Public Records documents of the North Carolina Veterinary Medical Board

7. IS THERE ADEQUATE PUBLIC REPRESENTATION?

The Arizona audit recommended that the Legislature increase public membership on the Board from three to four members. Changing a veterinarian position on the Board to a public member position would result in 50 percent public representation as recommended in the Auditor General's 1995 Special Study of Arizona's Health Regulatory System. In 2007 the Arizona Board had 4 public members and 5 veterinarians. A former president was a public member.  As far as could be determined Arizona was the only state with near numerically equitable public membership in 2007. 
Source: http://www.vetbd.state.az.us/administrative.html.
Equally important as the numerical representation on a Board, is whether the public member, sometimes also known as the consumer representative, represents the interests of the consumer or serves in a token position.  How Board members are selected is paramount.

8. WHAT IS THE INFLUENCE OF VETERINARY MEDICAL ASSOCIATIONS?

Most members of veterinary medical boards are appointed by the Governor or other elected state officials.  In many instances, these appointments appear to have a political basis, whether in conjunction with the state veterinary medical association - the professional organization representing veterinarians - or otherwise.
In Mississippi, the governor appoints the veterinarian member from a written list of three recommendations submitted by the Mississippi State Veterinary Medical Association; 
Source:  http://www.mscode.com/free/statutes/69/015/0001.htm
In Oregon, the Governor may select appointments suggested by the Oregon Veterinary Medical Association (OVMA). 
Source:  http://www.ovmeb.state.or.us/board.htm. 
Participants of the Federation of Associations of Regulatory Boards February 1999 forum drafted codes of conduct for board members.   One code of conduct drafted was that Board members shall not hold an office in a professional or trade organization of the regulated profession. From one FARB member's Code of Ethics adopted April 17, 1999: "A board member should not serve as an officer or board member of a state professional trade association or state or provinicial professionally-related trade group.:
Source: http://www.fclb.org/ethics.pdf
Until 2007, the N. C. Medical Society (the group that lobbies on behalf of doctors) nominated seven of the 12 members to the N. C. Medical Board (the state board that licenses and disciplines doctors).  The governor then ratified the nominations as appointments in a statutory practice that had been the target of criticism from patients that believed the board was more interested in protecting doctors that it was in protecting patients who raised claims of negligence or misconduct and raised the questions: (1) Is it proper for a trade group to stack the board that regulates its members, particularly where the mission is patient protection?  (2) Do boards dominated by medical organization appointees aggressively police practitioners? and (3) Do close ties between medical organizations and regulatory boards result in lax punishments for problem practitioners? This changed in 2007 as response to a lawsuit filed by a doctor and three patients who claimed the state had given control of a public job to a private entity. A new statute now mandates that a nine-member review panel - with four Medical Society members - will recommend seven doctors and a physicians assistant or nurse practitioner to the board.
Sources: http://archives.newsbank.com (April 19, 2003, Record Number: hdk85089); The News and Observer, August 9, 2007, page 5B.

9. ARE DISCIPLINARY ACTIONS REPORTED TO THE NATIONAL DATABASE?

The American Association of Veterinary State Boards maintains VIVA^® (Veterinary Information Verifying Agency) as one of its services to its members that include 57 veterinary medical licensing boards in the U.S. and Canada. The VIVA^® database, originally named the "Disciplinary Database" includes licensure and disciplinary information supplied by AAVSB Member Boards that is cross-referrenced because many veterinarians are licensed in more than one state.
Source: http://www.usvet2005.com/pdf/107.pdf
Until AAVSB finished compiling the national disciplinary database in late 1994, there was no simple way for officials of one state to tell whether a vet who applied for licensing there had been disciplined by another state or even had his license revoked.  In 1997 it was reported that while all 50 states participated voluntarily, it was up to each state to determine how many years of historical data to include.  Charlotte Ronan, Executive Director of AAVSB, estimated that  a quarter of the states provided fewer than five years of records for the database. 
Source:   http://www.smartmoney.com/consumer/index.cfm?Story=tenthings-may97
Between October 2002 and May 2003,  the AAVSB received disciplinary reports from only about 29 jurisdictions. North Carolina was not one of them although the NCVMB had previously reported discipline to AAVSB.  From the June 18, 2003 NCVMB Minutes, "Dr. Gordon [Board member Joseph K. Gordon, DVM] discussed with the Board the reporting of disciplinary actions to the American Association of Veterinary State Boards' (AAVSB). disciplinary database. Following the report from the Executive Director [Thomas M. Mickey] Dr. Marshall [Board member David T. Marshall] made a motion to not participate in the National Disciplinary Database until such time that the administrative issues within the office of the AAVSB are resolved. Dr. Lewis [Board member Amy J. Lewis, DVM] seconded the motion. The motion passed unanimously."
Sources:  http://www.aasvb,org; Information obtained from AAVSB Program Administrator May 5-6, 2003;  Minutes of the NCVMB June 2003 - November 2007
The August 5, 2009 Minutes of the North Carolina Veterinary Board state: "The Board discussed the history of the Board's relationship with the American Association of Veterinary State Boards (AASVB). Mr. Mickey [Thomas M. Mickey, Executive Director] reviewed recent administrative and other changes intended to improve the efficiency and accountability of AAVSB staff operations. The Board determined that is should confirm whether AAVSB had established sufficient security measures for confidential information and correct operational issues so as to justify this Board's resuming active participation in AAVSB. Following discussion, upon motion of Mrs. Robinson [Board member Nancy K. Robinson, RVT], seconded by Dr. Davidson [Board member Michael G. Davidson, DVM], the Board unanimously voted to authorize the necessary expenses for Mrs. Robinson and Mr. Mickey to travel to the AAVSB headquarters in Kansas City, Missouri to investigate administrative and staff changes and to report back to the Board." 
Source: Minutes of the NCVMB November 5, 2009
The accuracy and validity of the AAVSB national discipline database as a resource to all State Boards is dependent upon ALL state members reporting disciplinary actions - censures, reprimands, fines, suspensions and revocations.  

10. DO STATE PERFORMANCE AUDITS NEED CONDUCTED?

The Arizona audit clearly stated the need to remedy the identified deficiencies found against the Arizona Veterinary Medical Board. Louise Battaglia, administrator for the Arizona Board, reporting on their audit and Sunset Review, stressed that boards must be thorough in their record keeping. She suggested that boards conduct a self-audit annually to identify and correct any areas that may need improvement.  
Source:  http://www.aavsb.org/news/spring98.html

The Texas State Board of Veterinary Medical Examiners last underwent Sunset Review during the 2004 79th Legislature — as part of a regular, cyclic event for all Texas occupational regulatory agencies. Some recommendations made and later enacted by law included:

• requiring at least two veterinarian members of the Board to review and decide whether a complaint should be dismissed or moved to an informal settlement conference. Staff would be permitted to resolve cases involving nontechnical and administrative violations, subject to review by the Board at its public meeting.
• requiring a public member to participate in all informal settlement conferences as opposed to only the Board Secretary, who is a veterinarian
• providing for restitution authority to allow a complainant to receive a refund for some or all of what was lost as a result of the act that caused the complaint
• making all enforcement information, such as final disciplinary actions and sanctions, readily available to the public on its web site.

Source: http://www.sunset.state.tx.us/79threports/sbvme/sbvme.pdfIn 2001, The Colorado State Board of Veterinary Medicine's statutes were reviewed through the  Sunset process.  Some of the notable changes were:  increase the number of Board members; reflect the fact the veterinarians are required to take a national exam prior to becoming licensed for the first time; revised veterinarian recordkeeping requirements; granted immunity to veterinarians who report suspected incidents of animal cruelty in good faith; and permits the discipline of registrants for non-felony crimes.  It was reported that most crimes coming before the Board involve alcohol or substance abuse that resulted in traffic tickets or complaints of impaired ability by consumers. 
Source: http://www.dora.state.co.us/veterinarians/images/PDFsUsedAsImages/VetNwsltr2001.pdf

An inquiry to the North Carolina State Auditor's office for a copy  of ANY audit -  investigative, performance, or fiscal financial -  of the North Carolina Veterinary Medical Board netted this reply: 

"My check of our records indicate we have not done an audit of the Veterinary Medical Board, or at least one that is stored in our digital files. There was no record back at least 10 years. A lot of smaller agencies and nonprofit boards escape our notice on a regular basis". 

The response from the Governor's office in 2002 for an investigation and full performance audit of the NCVMB was that the Governor did not have statutory authority.
Sources:  N. C. State Auditor's Office, N.C. Governor's Office of Legal Affairs

North Carolina does not have any mechanism to regularly review the North Carolina Veterinary Medical Board's performance.

It would seem that periodic performance audits, in some states known as Sunset Reviews - whether conducted as required by statute or as the result of an investigation - would help promote the accountability, integrity and reliability of veterinary medical boards.

If deficiencies of veterinary medical boards in regulating practitioners were remedied, perhaps there were be fewer incidents of veterinary malpractice, veterinary negligence, veterinary incompetence and veterinary abuse.

The Need for Reform in Compounding Laws: The Alabama Accident

The Need for Reform in Compounding Laws

The article below appeared on the Institute for Safe Medicine Practice(ISMP) website.  It addresses the Alabama Total Parenteral Nutrition (TPN) bags that were contaminated, infected 19 patients and resulted in 9 patients' deaths.  The article addresses the lack of enforcement of laws, regulations and pharmacy board standards relating to compounding.  For example, any sterile activity should be undertaken with great care and in compliance with the United  States Pharmacopeia (USP) Chapter 797, Pharmaceutical Compounding: Sterile Preparations. The National Association of Boards of Pharmacy (NABP) has incorporated the 797 requirement into its Model State Pharmacy Act and Model Rules. As the article points out the NABP does not have authority to enforce its recommendations. State boards of pharmacy, who could enforce such laws, vary as to their position on 797.  Some states have adopted the entire chapter into laws, regulations or board policies and procedures, some have incorporated only portions of 797, and some have not taken any action and do not require compliance with 797. Another point made in the article is that most state boards have insufficient funding to send experienced and trained inspectors to pharmacy operations to ensure compliance with 797.  Deaths such as those resulting in Francks, ApotheCure, and the Alabama case, show that change in enforcement of compounding standards needs to occur before anymore deaths occur.  The question is how to best implement the reforms needed.

TPN-related deaths call for FDA guidance and pharmacy board oversight of USP Chapter <797>

From the April 7, 2011 issue
Last week, the Alabama Department of Public Health (ADPH) reported an ongoing investigation of an outbreak of Serratia marcescens bacteremia associated with contaminated total parenteral nutrition (TPN) bags in six Alabama hospitals.(1-4) The outbreak was identified after two of the six hospitals reported an unusual number of cases of Serratia marcescens bacteremia to the ADPH and the Centers for Disease Control and Prevention (CDC). An investigation was immediately started.
A total of 19 patients from six hospitals were adversely affected after receiving the contaminated TPN. The CDC determined that all six hospitals had received TPN produced by a single compounding pharmacy, Meds IV. Nine of the 19 affected patients have died, although the CDC has not confirmed that the deaths were directly caused by the contaminated TPN.(3) Meds IV was notified about the contaminated TPN and is fully cooperating with the investigation.
To date, the investigation has uncovered traces of Serratia marcescens in the compounding room at Meds IV, although genetic testing will be required to determine whether the organisms found in the pharmacy caused the TPN contamination. Health officials also reported that seven newborns received TPN supplements from Meds IV in March, along with 41 adults. While 19 of those 41 adults got sick, none of the babies became ill.(4) Thus, the investigation is focusing on differences between compounding TPN for adults vs. neonates.
At this time, Meds IV has discontinued all production and has recalled all of its compounded preparations.
USP Chapter <797>
Any type of sterile compounding activities must be undertaken with great care and in compliance with the United States Pharmacopeia (USP) Chapter <797>, Pharmaceutical Compounding: Sterile Preparations. It is tragic events like this that compelled USP to first establish <797>, which was initially published in 2004 and revised in June 2008. Chapter <797> describes a network of systems and processes “to prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations (CSPs).”(5)
Increased use of compounding pharmacies for sterile preparations
In the past, most sterile compounding was completed in-house in hospital pharmacies. However, this trend has shifted over the years,(6-7) particularly after the 2008 revision of <797>, as many pharmacies found it difficult to meet all the requirements of the standard. A recent (1st quarter of 2011) survey conducted by Pharmacy Purchasing & Products showed that 66% of pharmacies outsource at least some portion of their sterile compounding. Reliance on compounding pharmacies has continued to rise due to an unprecedented escalation in shortages of parenteral drugs, including recent shortages of vitamins, electrolytes, and other pharmaceutical components of TPN.
From a safety perspective, it makes sense to outsource the compounding of CSPs. It is difficult and costly for hospitals to comply with all of the <797> standard if they prepare just a few parenteral CSPs each day. As a general rule, compounding pharmacies that prepare large quantities of CSPs may be better equipped to employ, enforce, and monitor ongoing compliance with all of the <797> standard. But should hospitals be wary of using a compounding pharmacy in light of this latest infection outbreak?
While it’s true that contamination of CSPs from a compounding pharmacy can result in large and serious outbreaks, ISMP believes the use of compounding pharmacies should not be summarily dismissed as a result of this tragic outbreak. However, we must state unequivocally that the real issue to be learned from this event is that better oversight and licensing and/or registration requirements for compounding pharmacies are required.
Enforcement of <797>
Compounding pharmacies frequently prepare very complex CSPs, many with high-alert medications intended for parenteral administration. Jay Mirtallo, A.S.P.E.N. president elect, noted in a March 30, 2011 press release on this latest infection outbreak (www.nutritioncare.org/Index.aspx?id=6174) that, “Parenteral nutrition by nature is one of the most complex sterile preparations to prepare, relying on a specific order of mixture as well as method of preparation to assure sterility, compatibility, and stability.” Thus, one might expect the Food and Drug Administration (FDA) to subject compounding pharmacies to the same strict current good manufacturing practices (cGMPs) that are routine for drug manufacturers. Or one might expect all state boards of pharmacy to hold compounding pharmacies accountable for meeting the <797> standard in its entirety. However, there is often little or no required regulatory or licensing/registration oversight of compounding pharmacies to ensure and enforce compliance with <797>.
Chapter <797> is enforceable by the FDA; the agency clearly has the authority to inspect pharmacies and enforce the standard in the interest of public health.(5) However, FDA defers to the individual states to regulate the practice of pharmacy and to perform inspections.5 In the 1970s, the National Coordinating Committee on Large Volume Parenterals (NCCLVP) of USP emerged to ensure high quality CSPs. But with the dissolution of this group in the 1980s, FDA turned to the profession of pharmacy to address problems with sterile preparation. Since the early 1990s, FDA has been aware of multiple problems with compounded preparations that have resulted in recalls, patient injuries, and deaths.(5) However, when we communicated with the FDA recently to discuss this event, no one could clearly articulate how the agency regulates compounding pharmacies.
The National Association of Boards of Pharmacy (NABP) has incorporated the <797> requirement into its Model State Pharmacy Act and Model Rules, noting that, “The board’s Good Compounding Practices Applicable to State Licensed Pharmacies, and the current USP-NF chapters on compounding and sterile pharmaceutical preparations” are to be adhered to by compounding pharmacies and pharmacists.(6) However, the Model Rules or requirements of the Model State Pharmacy Act are only enforced to the extent that they are adopted by individual states, as the NABP does not have authority to enforce its recommendations.
Individual state boards of pharmacy vary in regard to the position taken with respect to <797>. Some states have adopted the chapter in its entirety, but most have chosen to incorporate only portions of <797> into laws, regulations, or board policies and procedures.(5) Some states have taken no action and do not require compliance with <797>. In addition, most state boards have insufficient funding to send experienced and trained surveyors to actually inspect pharmacy operations to ensure compliance with <797>.
While The Joint Commission (TJC) requires organizations to comply with portions of <797> that are similar to its standards, TJC views <797> as a best practice and expects organizations to review best practices for the purpose of improving systems (MM.08.01.01). Thus, surveyors may expect an improvement plan based on <797>, but it is left to the accredited organization as to what they need to improve. TJC expects organizations to comply with <797> in states that require such compliance. However, most surveyors have not been adequately trained regarding <797> and would simply ask to see the latest state inspection results.
Lessons learned: Need for future oversight
As we move forward and learn from the most recent outbreak, we are calling upon all state boards of pharmacy to expect compounding pharmacies to comply with all aspects of <797>, and to survey these pharmacies regularly to enforce compliance. To do this, state pharmacy boards must be provided with additional resources to adequately train and deploy surveyors to assess compliance. Today, many pharmacy boards are ill equipped to take on this responsibility; without additional resources, the assignment of responsibility will not result in improved oversight. The pharmacy boards that choose a limited set of criteria from the <797> standard for enforcement in their states are ill-advised regarding its benefit to public safety; partial compliance will not even partially protect patients from the risk of infection from contaminated CSPs. The <797> standard is not set out as an incremental improvement plan; it’s a bundle that must be implemented in its entirety and on an ongoing basis to be effective. Each of the state boards of pharmacy must demand and expect their licensees to comply with <797>.
We are calling upon FDA to work collaboratively with the state boards of pharmacy to provide them with the necessary support and training to survey compounding pharmacies for compliance with <797>. Further, we believe compounding pharmacies that distribute sizeable quantities (to be defined by FDA) of preparations, and those operating interstate, should be registered with FDA and subject to periodic inspections. We also encourage FDA to move forward with plans to publish guidances on Good Pharmacy Compounding Practices for Sterile Drug Products, and Outsourcer Pharmacy Operations Compliance Policy Guide (www.ismp.org/sc?k=ucm079647), to clearly articulate requirements for registration with FDA, periodic inspections, support available to the state boards of pharmacy, and expectations regarding the state boards’ role in regulating compounding pharmacies.
We are calling upon TJC to consistently survey compliance with applicable parts of the <797> standard as it relates to the type of CSPs being prepared in accredited facilities in all states.
We are calling upon all pharmacies and pharmacists/technicians who compound sterile preparations, regardless of where they work, to know and comply with <797> to the fullest extent possible. Pharmacy staff should use commercially available ready-to-use products when available, or start with sterile products whenever possible if preparing CSPs. This applies to the smallest hospitals up to the largest compounding pharmacies. We also recommend establishing an internal quality surveillance and review team to regularly monitor compounded preparations, the environment, compounding equipment, and personnel for compliance with key aspects of <797>, much like an internal peer-review process. An April 2011 supplement to Pharmacy Purchasing & Products on the state of pharmacy compounding is an excellent resource to help guide the surveillance and improvement process.(8) Any problems uncovered during surveillance require immediate stoppage of compounding, investigation, corrective action, and revalidation before resumption of activities. All pharmacy staff have a moral and legal obligation to compound preparations using the least risky processes while adhering to the highest standards possible.
We don’t have all the details about this recent outbreak, but a crucially important lesson we can take away from this tragedy is that we all need to make improvements based on the outcome of this investigation. Unfortunately, there are too many in healthcare who feel that, if it hasn’t happened to them, the adverse experiences of others do not apply. If investigation into this event uncovers some aspect (e.g., frequency of testing staff samples and environmental samples) of compounding that was overlooked in either the <797> standard or in staff practices, then let’s learn from it, incorporate necessary changes, and provide leadership and oversight to assure our patients are kept safe.
ISMP thanks Eric S. Kastango, MBA, RPh, FASHP, CEO of ClinicalIQ, for his contribution to this article.
References
1) US Food and Drug Administration (FDA). Meds IV pharmacy, IV compounded products recall: outbreak of Serratia marcescens bacteremia in Alabama hospitals. March 30, 2011. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249099.htm
2) US Food and Drug Administration (FDA). CDC and ADPH investigate outbreak at Alabama hospitals; products recalled. March 29, 2011. www.fda.gov/Safety/Recalls/ucm249068.htm
3) Watkins T. Contaminated IV solution suspected in 9 patient deaths in Alabama. CNN Health. March 29, 2011. www.cnn.com/2011/HEALTH/03/29/alabama.hospitals.deaths/index.html?hpt=T2
4) Wolfson H. Investigators piecing together tainted IV puzzle after deaths in Alabama hospitals. The Birmingham News. April 3, 2011. http://blog.al.com/spotnews/2011/04/investigators_piecing_together.html
5) American Society of Health-System Pharmacists (ASHP). The ASHP discussion guide on USP Chapter <797> for compounding sterile preparations. www.ashp.org/s_ashp/docs/files/DiscGuide797-2008.pdf
6) National Association of Boards of Pharmacy. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Mount Prospect, IL. August 2007.
7) Seres D, Sacks GS, Pederssen CA, Johnson D, et al. Parenteral nutrition safe practices: results of the 2003 American Society for Parenteral and Enteral Nutrition Survey. J Parenteral and Enteral Nutrition. 2006;30(3):259-65.
8) Pharmacy Purchasing & Products (PP&P). 2011 state of pharmacy compounding; PP&P’s 4th annual national survey. April 2011.