AZ Prescription Compounding Task Force

Prescription Compounding Task Force
The recent tragedy caused by contaminated compounded
prescription drugs distributed across the country by a pharmacy
in Massachusetts has probably been the “biggest story” in
pharmacy in the last decade. Unfortunately, it is not the kind
of news that pharmacy as a profession is proud of. Any time
a patient suffers a negative outcome is a “failure” both for the
professional involved and for the profession as a whole. In
this extreme case, there were at least 656 cases where patients
were infected by various organisms in the products and 39
deaths in 19 states.
On October 6, NECC [the New England Compounding
Center] expanded its recall to include all products
in circulation that were distributed from its facility in
Framingham, Mass. As part of the ongoing investigation,
FDA [Food and Drug Administration] and CDC
[Centers for Disease Control and Prevention] have
been testing various NECC products for evidence of
contamination. Laboratory testing at CDC and FDA has
found bacterial and/or fungal contamination in unopened
vials of betamethasone, cardioplegia, and triamcinolone

Arizona Board of Pharmacy Looking At Task Force To Review Compounding Regulations

AGENDA ITEM 14 – Definition of Compounding and Regulation of Compounding
Pharmacies
President Milovich asked Mr. Wand to address this agenda item.
Mr. Wand stated that in the Board book the following information was included: the definition of
compounding, the NABP model rules, NABP update of legislation affecting compounding, and
PCAB accredidation.[sic]
Mr. Wand stated that the Board could establish a task force to review the regulations.
Dr. Foy stated that he has concerns about recent complaints with questionable compounding and
proper training. Mr. McAllister stated that Texas has recently revised their rules.  Dr. Musil stated that the Texas
Board has regulations concerning testing but has not been able to fulfill their obligations in that
respect.
Dr. Musil stated that he is in favor of a task force to review the laws.   Dr. Musil stated that the
Board may want to look at accreditation.
Mr. McAllister stated that it is the Board’s responsibility to also protect our residents form
non-resident compounders.
Mr. Wand stated that he could research compounding regulations and that he could bring
back names of individuals willing to serve on a task force at the next meeting.

Source found here

Recent Disciplinary Action Against Pharmacists in Arizona

Disciplinary Actions
Notice: Before making a prescription-dispensing or other decision pursuant to information in this issue, you are encouraged to verify the current condition of a license with the appropriate
licensing agency (Board).
Pharmacists
Alnoah, Fahad (S015734) – Placed on probation for two
years; fined $2,000. Required to retake Multistate Pharmacy
Jurisprudence Examination®
. Effective September 21, 2012.
Boel, Eric (S018886) – Probation terminated. Effective November 14, 2012.
Coppola, Thomas (S017161) – License revoked. Effective
September 21, 2012.
Hannibal, Jeffrey (S011674) – Probation terminated. Effective
September 19, 2012.
Hodges, James (S009569) – Fined $500 and required to complete six additional hours of CE within 90 days. Effective
September 27, 2012.
Hunter, Lisa (S013072) – License reinstated; no additional
conditions. Effective September 19, 2012.
Makai, Gerwyn (S016844) – Board agreed at November 14,
2012 meeting to terminate Pharmacists Assisting Pharmacists of Arizona (PAPA) contract. Effective upon signing of
revised consent.
Martinez, David (S015190) – Probation terminated. Effective
November 14, 2012.
Merkel, D. Steven (S009366) – License reinstated with five
years of probation. Effective September 27, 2012.
Oxford, Sherri (S009874) – Suspended for a minimum of six
months, followed by five years of probation and a five-year
PAPA contract.
Tobin, Robert (S016952) – Placed on probation for one year,
fined $6,000, both due within 90 days. Effective September
27, 2012.

Source found here
 

Arizona Board of Pharmacy Prescription Compounding Task Force Comments on NECC

Prescription Compounding Task Force
The recent tragedy caused by contaminated compounded
prescription drugs distributed across the country by a pharmacy
in Massachusetts has probably been the “biggest story” in
pharmacy in the last decade. Unfortunately, it is not the kind
of news that pharmacy as a profession is proud of. Any time
a patient suffers a negative outcome is a “failure” both for the
professional involved and for the profession as a whole. In
this extreme case, there were at least 656 cases where patients
were infected by various organisms in the products and 39
deaths in 19 states.

Continue reading in the Arizona Board of Pharmacy January 2013 Newsletter here

Arizona's Veterinary Administrative Rules Regarding Drug Dispensing

Arizona's Veterinary Administrative Rules, which should be read in conjunction with the statutes discussed in the previous blog, relating to drug dispensing have a requiring that the veterinarian notify the animal owner that some prescription-only drugs and controlled substances may be available at a pharmacy.

ARTICLE 8. DRUG DISPENSING
R3-11-801. Notification that Prescription-only Drugs or Controlled Substances May Be
Available at a Pharmacy
A.  A dispensing veterinarian shall notify an animal owner that some prescription-only drugs and 
     controlled substances may be available at a pharmacy by:
     1.  Stating the availability at or before the time of dispensing;
     2.  Posting a written statement that is visible to the animal owner; or
     3.  Providing the animal owner with written notification.
B.   A dispensing veterinarian may provide a written prescription to the animal owner if requested by
an animal owner.
R3-11-802. Labeling Requirements
A veterinarian shall dispense a prescription-only drug or a controlled substance in a container
bearing a legible label that sets forth all of the information in A.R.S. § 32-2281(A)(1), and the name
and telephone number of the veterinary medical premises from which the prescription-only drug or
controlled substance is dispensed.
R3-11-803. Packaging Requirements
A.   A veterinarian shall dispense four ounces or less of a prescription-only drug in a childproof
container unless the animal owner waives this requirement.
B.   A veterinarian shall dispense a controlled substance in a childproof container.  
C.   A veterinarian may dispense more than four ounces of a bulk prescription-only drug in a nonchildproof container.
D.   A veterinarian may dispense a prescription-only drug in the manufacturer's original dispensing
package without repackaging the prescription-only drug in a childproof container.
R3-11-804. Reserved 28
R3-11-805. Storage
A.   A dispensing veterinarian shall store controlled substances under lock and key except for
controlled substances that are authorized by a responsible veterinarian to be administered by
personnel.
B.   A dispensing veterinarian shall store prescription-only drugs in an area to which members of the
public are not allowed access unless accompanied by a veterinarian or a member of the
veterinarian's staff.
C.   A dispensing veterinarian shall store prescription-only drugs and prescription-only devices in
compliance with state and federal laws and in compliance with the manufacturer's requirements.
R3-11-806. Reserved
R3-11-807. Dispensing a Controlled Substance or Prescription-only Drug
A.   When dispensing a controlled substance:
1.  A dispensing veterinarian or personnel who are not veterinarians but who
     are authorized by a veterinarian may:
           a. Select the controlled substance,
           b. Count the quantity of the controlled substance, and       
           c. Place the controlled substance in a prescription container.
         2.  Licensed or unlicensed personnel may:
           a. Prepare labels,
           b. Prepare drug containers for controlled substances, or          
            c. Record information required by state and federal laws.
3.   A dispensing veterinarian shall review the label of a repackaged controlled substance and
the patient's medical record and ensure that the label complies with R3-11-502 and state and
federal laws before the controlled substance is dispensed.
B.   When dispensing a prescription-only drug:
1.   A dispensing veterinarian or personnel who are not veterinarians but who are                          
authorized by a veterinarian may:
            a. Repackage prescription-only drugs,     
            b. Prepare labels,            
            c. Prepare containers for prescription-only drugs, or   
            d. Record information required by state or federal laws.
      2.  The dispensing veterinarian authorizing the dispensing shall ensure that records are 
maintained according to R3-11-502(K) and R3-11-502(L) and all state and federal laws are
followed.

These statutes can be found here.

Arizona Board of Pharmacist Disciplinary Action

The Arizona Board of Pharmacy has  its disciplinary actions located here.  The website is easy to use if you know the name of the pharmacist who was disciplined or the case number of the action.

2012 Developments in Pharmacy Law Seminar XXIII

The American Society for Pharmacy Law in conjunction with the National Alliance of State
Pharmacy Associations will host the 2012 Developments in Pharmacy Law Seminar XXIII on November 15-18, 2012,  at the Ventana Canyon Resort - Tucson, Arizona.  The current CE offered includes specific information regarding human and veterinary compounding laws:

8:15 am -  9:15 am 2012 Regulatory Enforcement Update
This past year has seen new and bold actions by law enforcement and
regulators to challenge the practices of pharmacies.  The prescription
drug abuse problem continues to cast a pall on the legitimate practice
of pharmacy, and the federal government, through the DEA and FDA,
have stepped up regulatory enforcement actions at pharmacies.  It will
be the aim of this presentation to review these legal developments
and to provide guidance regarding measures that can be undertaken
by pharmacies and their counsel to protect the pharmacy and offset
the actions of the regulators. 
William E. Fassett, PhD, RPh, Washington State University College of
Pharmacy; Ronald Friedman, JD, Lane Powell (1 credit hour)
9:15am – 10:15 am Developments in Controlled Substances
Regulation and a Foggy Crystal Ball
This presentation will provide additional details about the history of
DEA regulatory interpretation and reaction to judicial decisions, the
rationale for DEA enforcement actions, and some predictions about
the future directions for DEA rule-making and enforcement. 
D. Linden Barber, JD; Larry P. Cote, JD, Quarles & Brady LLP (1 credit
hour)
10:15 am – 10.30 am Break
10:30 am – 12:00 pm Social Media Land Mines for Pharmacists
The growth of social media has challenged attorneys to apply
traditional legal principals to new technology.  This program will briefly
describe the various forms of social media and explain application
of legal principals related to defamation, privacy, trade secret,
employment, the litigation process, and attorney ethics to the still
evolving world of social media. 
Randy Dryer, JD, Parsons, Behle & Latimer (1.5 credit hours)
12:00 pm – 1:00 pm Lunch - ASPL
1:00 pm –  3:00 pm Case Law Update
Again this past twelve months, courts, including the U.S. Supreme
Court, have made far reaching decisions that will impact pharmacies,
pharmacists, and the pharmaceutical industry.  This annual
presentation will discuss the Supreme Court’s decisions to uphold
PPACA, as well as court decisions that address the scope of pharmacists’
duty to warn, the reach of the DEA authority, employee and employer
rights, privacy and patient communications, conscientious objection
sanctions, and other topics. 
Roger Morris, RPh, JD, Quarles & Brady LLP; William J. Stilling, RPh, JD,
Parsons Behle & Latimer (2 credit hours)
3:15 pm – 4:45 pm HIPAA and HITECH: More Privacy and
Security Regulations and Their Impact on Pharmacy Compliance,
Patient Counseling, and Law Firms
The passage of the Health Information Technology for Economic
and Clinical Health (HITECH) Act in 2009 heralded new privacy and
security requirements and more onerous penalties and enforcement
of HIPAA.  HHS has issued several versions of rules to implement
the security breach, business associate, and penalty provisions. 
This presentation will explain how these provisions affect how
pharmacies must comply, the impact of HIPAA and HITECH on patient
counseling, and how lawyers must comply with privacy and security
requirements as business associates. 
Kevin N. Nicholson, RPh, JD, NACDS; Susan A. Buckna, JD, Shopko
Stores Operating Company (1.5 credit hours)
6:30 pm – 9:30 pm Reception/Dinner -  ASPL/NASPA
Saturday, November 17, 2012
7:00 am – 8:00 am Breakfast - ASPL/NASPA
8:00 am– 9:30am Legislative & Regulatory Update
This annual session will provide an overview of recently enacted and
proposed laws and regulations that affect pharmacy.  
Brian Gallagher, BS Pharm, JD, American Pharmacists Association 
(1.5 credit hours)
 9:30 am – 10:30 am Ethical Decision Making for Attorneys
and Pharmacists
As professional both pharmacists and lawyers face times in their day
when ethical decisions need to be made.  In this program we will
explore selected parts of the legal Code of Professional Responsibility
and the Pharmacist Code of Ethics as principles that can be applied
to ethical decision making for both professions.  We will explore
teaching from Aristotle to General Patton and others to construct
an ethical decision making algorism. 
Kenneth R. Baker, RPh, JD, Ken Baker Consulting  (1 credit hour)
10:30 am – 10:45 am Break
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)
1:30 pm– 4:00 pm Pharmacy Law Educators
This years pharmacy law education session will include a presentation
and workshop component.  The presentation will discuss active
learning in and outside of the classroom while the workshops will
include groups developing potential exercises and assignments that
can be used for pharmacy law professors.Sunday, November 18, 2012
7:00 am – 8:00 am Breakfast ASPL
8:00 am– 9:00 am Trends in the Regulation of Automation
This session will examine the types of automation available and
application in patient care settings.  The speakers will review select
states’ regulation of automation, including an examination of the five
W’s – Who can utilize automation, What medications may be stored,
Why automation is used, Where automation is permitted, and When
automation can be used; as well as potential federal Anti-Kickback
Statute, Stark Law, and DEA issues. 
Anne M. O’Brien, JD; Edward D. Rickert, BPharm, RPh, JD, Krieg
DeVault (1 credit hour)
9:00 am – 10:00 am Drug Manufacturer Coupon Co-Pay
Programs: Legal, Policy and Business Considerations
As drug manufacturers face rigorous formulary reviews for their
products, stern generic and brand competition, and loss of
exclusivity, the advancement of coupon co-pay programs have given
them a new and forceful tool in their armamentarium to increase
market share and drive profit.  The presentation will review the legal,
policy, and business aspects of Drug Manufacturer Coupon Co-Pay
Programs and assess the value for the relevant stakeholders.
Matthew Seamon,  PharmD, JD,  Association Professor Nova
Southeastern University College of Pharmacy, Of Counsel Fuerst Ittlmen
(1 credit hour)
10:00 am – 10:15 am Break
10:15 am – 11:15 am Medication Therapy Management:
Nuts, Bolts, and Legal Considerations
Medicare Part D requires prescription drug programs to provide
Medication Therapy Management (MTM) for Medicare beneficiaries. 
This presentation will discuss the requirements for MTM, how
pharmacists carry out MTM programs, recent changes in the Part
D regulations governing MTM, the legal requirements and risks of
MTM as this type of monitoring and intervention spreads to the
private sector. 
Doug Burgoyne, PharmD, RPh, VRx Pharmacy Services (1 credit
hour)
11:15 am – 12:15 pm Challenges to Compliance in Current
Regulatory Framework
As the regulatory environment becomes more complex, pharmacies
are more frequently being investigated by administrative agencies.  
This program will discuss the ten most common compliance
issues that are being faced by pharmacies before state boards of
pharmacy, state controlled substance authorities, the Food and
Drug Administration, and the Drug Enforcement Administration.
It will also provide a framework for conducting self-audits of
pharmacy operations practices and strategies for responding to
agency investigations.    
Laura Carpenter, RPh, JD, LLM, Carpenter Law Firm PC; Michael
Simko, JD, Walgreens (1 credit hour)


 Register Today at www.aspl.org

The Arizona Veterinary Newsletter published in January 2012 contains an article in question and answer format regarding veterinary compounding in Arizona.  To read this newsletter, click here.