Repost:Criminalization of Medication Errors; Mistakes by Pharmacists

The following article appears at http://www.uspharmacist.com/content/c/16572/

Jesse C. Vivian, BS Pharm, JD

Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University
Detroit, Michigan

11/19/2009

US Pharm. 2009;34(11):66-68. Here is a sobering thought. A pharmacist makes a mistake. The error results in the death of a patient, and the pharmacist is charged with negligent homicide. He is found guilty of involuntary manslaughter and faces up to 5 years in prison and a maximum fine of $10,000. Of course, his pharmacist license is revoked and chances are he will never work in the profession again. His crime? He did not check the accuracy of calculations used by a pharmacy technician under his charge to compound the concentration of sodium chloride in a prescription for a cancer chemotherapy solution.
Negligent? Yes. Accountability and responsibility? Yes and Yes. Malpractice? Yes. Loss of license? Yes. Guilty? Yes. But a crime? Prison term? For a mistake, albeit a mistake with a worst-case outcome? That is tough medicine to swallow. More important, how is justice served by putting this pharmacist in jail? The message to pharmacists and perhaps all other health care practitioners—watch out. There may be prosecutors out there just itching to put you away.

Repost from 10/28/12; Should More State Veterinary Medical Board's Adopt Compounding Regulations

The focus lately has been on the state pharmacy board rules and regulations and the FDA rules and regulations.  However, some states have veterinary rules that address compounded medications.  For example, Texas this year adopted significantly new rules and regulations relating to the veterinary compounding word.  Click here to review blog post regarding Texas Veterinary Rules Relating to Compounding that became effective June 2012.  Should other states be doing something similar? 

Repost: More Reform Needed: State Boards Need to Increase Access to Disciplinary Information

Another Area in Need of Reform:  State Pharmacy, Medical and Veterinary Boards need to increase access to disciplinary information and make it more readily available.
How does someone know if a pharmacy, veterinarian or doctor has been disciplined?  This is not an easy task. If, for example, a pharmacy has been discplined by the FDA for a compounding issue, a warning letter will have been issued. The warning letters are available on the FDA website.
But how does one find out if that pharmacy has been disciplined in one of the 50 states?  Each state has its own disciplinary process and procedures and each has its own laws regarding whether this information has to be made available to the public.  For example, inn Michigan, the Michigan Public Health Code, P.A. 368 of 1978, as Amended, mandated that the Department of Consumer & Industry Services is required to publish the names and addresses of disciplined individuals.

In Texas, 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 Texas Veterimarian Board of Medical Examiners publishes an alphabetical list of disciplinary actions dating back to 1970. Included are the name of the practitioner, date of action, violation, summary and sanction.  Click here.  Other states, such as Oklahoma publish disciplinary actions on their web sites - either as disciplinary lists, in Board Minutes, or as licensee lookup by name. 

Repost: Who Should Monitor Compounding Pharmacies?

DECEMBER 7, 2012 BY CHERI GARVIN LEAVE A COMMENT

As an owner of a compounding pharmacy I have been closely monitoring the media coverage about the meningitis outbreak from medications prepared at the New England Compounding Center (NECC) in Massachusetts. While my heart goes out to the families affected, I implore you to not lump all compounders together. We are not like NECC.

Our compounding pharmacy is PCAB accredited, and we take great care to ensure the quality of every compound we prepare, as do many other pharmacies across the nation. Compounders fill an important void in our healthcare system; if we were not able to prepare customized medications for our patients it would jeopardize the health of millions of people.

Because of the severity of the issue, I understand the need for lawmakers to “fix” the problem, but it is imperative that we avoid knee jerk reactions. A familiar old saying comes to mind, ‘don’t throw the baby out with the bathwater’. In other words, it is imperative that we fully assess the situation to gain an understanding of what went wrong and why. Once all the issues are identified, we must then address them to prevent another tragedy like this from occurring.

Repost: 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