Landing Gear Is Down And Locked!
PHARMACY LAW UPDATE 2014
Hollywood Casino
September 6, 2014
Gregory Cameron, R.Ph
Assistant Professor of Pharmacy Practice
Husson University
Field Coordinator, Community Sites
OBJECTIVES
• Changes in DEA status of Tramadol & Vicodin
• Updates on “Drug Take back” regulations
• PIC responsibilities
• New Maine Pharmacy Law Updates
Pharmacy Law Update 2014- G. Cameron
Electronic Prescriptions for Controlled Substances Notice
of Approved Certification Process
• Before any electronic prescription or pharmacy application
may be used to transmit prescriptions:
o a third party must audit the application for compliance
with the requirements of 21 CFR part 1311, or
o a certifying organization whose certification process has
been approved by DEA must verify and certify that the
application meets the requirements
Pharmacy Law Update 2014- G. Cameron
Electronic Prescriptions for Controlled Substances Notice of Approved
Certification Process (Cont.)
• A Notice by the Drug Enforcement Administration on
8/20/2014
• The Drug Enforcement Administration (DEA) is
announcing one new DEA-approved certification process
for providers of Electronic Prescriptions for Controlled
Substances (EPCS) applications
• Certifying organizations with a certification process
approved pursuant to 21 CFR 1311.300(e) are posted on
DEA's Web site upon approval.
Pharmacy Law Update 2014- G. Cameron
Electronic Prescriptions for Controlled Substances Notice
of Approved Certification Process (Cont.)
On July 25, 2014, DEA approved the certification
process developed by Comply Smart, LLC.
Relevant information has been posted on DEA's
Web site:
http://www.deadiversion.usdoj.gov/ecomm/e_rx
/thirdparty.htm
o The following list provides the names of certifying
organizations whose certification processes have been
approved by DEA.
Pharmacy Law Update 2014- G. Cameron
Electronic Prescriptions for Controlled Substances Notice of
Approved Certification Process (Cont.)
InfoGard Laboratories, Inc. (October 19, 2011)
Drummond Group Inc. (August 1, 2012)
iBeta LLC (August 1, 2012)
Global Sage Group, LLC (March 26, 2013)
ComplySmart, LLC (August 20, 2014)
The list of certifying organizations for EPCS does not constitute an endorsement by the
DEA of these companies or their products or services.
Pharmacy Law Update 2014- G. Cameron
National Prescription Drug Take
Back Day September 27, 2014
Pharmacy Law Update 2014- G. Cameron
• May 8, 2014 - DEA’S National Prescription Drug TakeBack Days Meet a Growing Need for Americans by
dropping off more prescription pills than ever on
April 26, 2014
• 780,158 pounds (390 tons) of pills were brought in
• 6,072 collection sites that DEA and its 4,423 state,
local, and tribal law enforcement partners set up
• When added to that collected at previous DEAcoordinated Take-Back events
• 4.1 million pounds (2,123 tons) of prescription
medications have been removed from circulation.
Pharmacy Law Update 2014- G. Cameron
Tramadol
• Moved to a CIV on August 18, 2014
• Every DEA Registrant who possesses any quantity
of Tramadol must take an inventory
• Any person who becomes registered after
8/18/14 must take an initial inventory of all stocks
of controlled medication, including Tramadol
• Included in Biennial Inventory
• Records must be maintained
• All prescriptions must comply with 21 U.S.C. 829
and 21 CFR part 1306 & part 1311
Pharmacy Law Update 2014- G. Cameron
RESCHEDULING OF HCPs
•
DEA to Publish Final Rule Rescheduling Hydrocodone
Combination Products
•
AUG 21, 2014 (WASHINGTON)–On Friday
(08/22/2014) the U. S. DEA will publish in
the Federal Register the Final Rule moving
hydrocodone combination products (HCPs) from
Schedule III to the more-restrictive Schedule II
•
This Final Rule imposes the regulatory controls and
sanctions applicable to Schedule II substances on
those who handle or propose to handle HCPs
Pharmacy Law Update 2014- G. Cameron
RESCHEDULING OF HCPs (cont.)
• It goes into effect in 45 days
• October 6, 2014
Pharmacy Law Update 2014- G. Cameron
HOW DID HCP GET TO CII STATUS
• The rescheduling of HCPs was initiated by a petition
from a physician in 1999
• The DEA submitted a request to HHS for a scientific
and medical evaluation of HCPs and a scheduling
recommendation
• In 2013, the U. S. FDA held a public Advisory
Committee meeting on the matter, and the
committee voted to recommend rescheduling HCPs
from Schedule III to Schedule II by a vote of 19 to 10
Pharmacy Law Update 2014- G. Cameron
HOW DID HCP GET TO CII STATUS (Cont.)
• Consistent with the outcome of that vote, in
December of 2013 HHS sent such a recommendation
to the DEA
• Two months later, on February 27, the DEA informed
Americans of its intent to move HCPs from Schedule III
to Schedule II by publishing a Notice of Proposed
Rulemaking
• Public comments on the proposal, of which almost
600 were received
• Small majority of the commenters supported the
proposed change.
Pharmacy Law Update 2014- G. Cameron
HOW DID HCP GET TO CII STATUS (Cont.)
• Orders for HCPs. Every DEA registrant who distributes HCPs must
comply with order form requirements, pursuant to 21 U.S.C. 821,
828, 871 and in accordance with 21 CFR parts 1305 and 1307 as of
October 6, 2014
o In other words DEA Form 222
• Prescriptions. All prescriptions for HCPs must comply with all the
CII requirements as of October 6, 2014
• No prescription for HCPs issued on or after October 6, 2014 shall
authorize any refills
• Any prescriptions for HCPs that are issued before October 6,
2014, and authorized for refilling, may be dispensed in
accordance with 21 CFR 1306.22-1306.23, 1306.25, and 1306.27,
if such dispensing occurs before April 8, 2015
Pharmacy Law Update 2014- G. Cameron
Theft or Drug-Related Misconduct of Pharmacy Intern
The preceptor shall notify the board via letter, fax or email of any
resignation or discharge from an internship program or termination
of employment for any of the following reasons, provided that the
report shall be made by a pharmacist in charge or supervising
pharmacist if the reason for the resignation, discharge or
termination arose outside of the IPPE/APPE
•
Notice shall be provided within 48 hours after the termination:
o Any drug-related reason, including but not limited to
 adulteration, abuse, theft or diversion;
 Theft of non-drug merchandise; or
 Theft of cash or credit/debit card data.
Pharmacy Law Update 2014- G. Cameron
Pharmacist in Charge
• Responsibilities
o The pharmacist in charge is responsible legally and
professionally for all activities related to the practice
of pharmacy within the retail pharmacy for which the
licensee is registered as pharmacist in charge
o For the pharmacy’s compliance with the provisions of
the Maine Pharmacy Act, the rules of the board, and
the federal laws and rules
Pharmacy Law Update 2014- G. Cameron
• The responsibilities of the pharmacist in
charge include, but are not limited to:
o The pharmacy’s procedures for the
procurement, storage, compounding and
dispensing of drugs;
o The recordkeeping systems required in the
practice of pharmacy for the purchase, sale,
possession, storage and repackaging of drugs;
o The security of the prescription filling area and
its contents;
Pharmacy Law Update 2014- G. Cameron
The responsibilities of the pharmacist in charge include, but are
not limited to: (Cont.)
o Ensuring that the prescription filling area is
operated in conformance with good
pharmaceutical practices;
o Notifying the board of termination of status as
pharmacist in charge via letter, fax or email within
7 days of the termination;
o The supervision of pharmacy technicians and
performance of administrative responsibilities
o Ensuring that each pharmacist employed at the
pharmacy for which the pharmacist in charge is
responsible is licensed with the board.
Pharmacy Law Update 2014- G. Cameron
Maine Board of Pharmacy Actions
• Pharmacist had a Misfill of a prescription (Error)
o Letter of Warning & $250 Fine
• Technician- Passing a worthless instrument
o Letter of Warning & $250 Fine
• Pharmacist - Substance Abuse
o License on Probation
o Substance Abuse Monitoring Program
• Pharmacist - Answered YES on renewal of license for
conviction OUI
o Denied renewal
o Offered consent agreement
Pharmacy Law Update 2014- G. Cameron
Maine Board of Pharmacy Actions (Cont.)
• Pharmacist - Unprofessional Conduct
o Missing Medications
o 36,487 hydrocodone/APAP
o Probation for a year
o $1,500 Fine
Pharmacy Law Update 2014- G. Cameron
Pharmacy Technician
Notice of Change of Work Site or Contact Address
A pharmacy technician shall notify the board of a
change in work site, cessation of employment as a
pharmacy technician or a change of contact address
via letter, fax or email within 10 days after the
change.
Pharmacy Law Update 2014- G. Cameron
Pharmacy Technician Duties
•
No person other than a pharmacist or pharmacy intern may
perform any of the following duties unless a valid pharmacy
technician license is held:
o Acceptance of an original or renewal prescription drug
order;
o Receipt of a transferred prescription for a noncontrolled
drug
o Prescription data entry;
o Prescription drug selection from inventory; or
o Counting, packaging and labeling of prescription drugs
for delivery
o The assignment of any of the above duties to a
pharmacy technician lies within the discretion of the
pharmacist on duty.
Pharmacy Law Update 2014- G. Cameron
Notice of Employment and Non-Employment of Pharmacy Technicians
• The pharmacist in charge shall notify the board via letter, fax, email
or on line within 10 days after the commencement or cessation of
employment of any pharmacy technician at a pharmacy for which
the pharmacist in charge is responsible
• Notice of Termination of Employment For Drug-Related
Reasons or Theft
• The pharmacist in charge or a designee of the pharmacist in charge
shall notify the board of the termination of employment of a
pharmacy technician for any of the following reasons and shall
include in the notice the reason for the termination. Notice shall be
provided within 7 days after the termination:
o adulteration, abuse, theft or diversion;
o Theft of non-drug merchandise; or
o Theft of cash or credit/debit card data.
Pharmacy Law Update 2014- G. Cameron
Security Cameras
• A retail pharmacy shall deploy security cameras
sufficient in number to monitor the critical areas of the
pharmacy department, including, at a minimum
o prescription filling area
o self-service customer kiosks
o dispensing machines that are part of an automated
pharmacy system
o controlled drug storage areas
o checkout area
o compounding area (if applicable)
o Shall operate continuously 24 hours per day
o Requirement of security camera coverage of the
compounding area (if applicable) and controlled drug storage
areas goes into effect on July 1, 2014.
Pharmacy Law Update 2014- G. Cameron
Reporting of Theft, Loss and Unresolved Inventory
Discrepancies of Controlled Drugs
•
A pharmacist shall report any significant theft, loss or
unresolved inventory discrepancy of C/S no later than 7
days after discovery
•
When determining if a theft, loss or unresolved inventory
discrepancy is “significant,” a pharmacist should consider,
among others, the following factors:
Pharmacy Law Update 2014- G. Cameron
When determining if a theft, loss or unresolved inventory
discrepancy is “significant,” a pharmacist should consider,
among others, the following factors:
•
The actual quantity of controlled substances lost in
relation to the type of business
•
The specific controlled substances lost
•
Whether the loss of C/S can be associated with access by
specific individuals
•
A pattern of losses over a specific time period
•
Are these C/S likely candidates for diversion
•
Local trends
Pharmacy Law Update 2014- G. Cameron
For Administration of Influenza Vaccines
• Pharmacist who holds a certificate of administration
shall verify as necessary that the patient is 9 years of
age or older
• For administration of all other vaccines pursuant to a
prescription, the pharmacist shall verify
o That the patient is the person to whom the
prescription was issued
o That the patient is 18 years of age or older.
Pharmacy Law Update 2014- G. Cameron
Administration of Drugs and Vaccines by Pharmacy Intern
A pharmacy intern who is under the direct supervision
of a pharmacist holding a certificate of administration
and has obtained the drug administration training
required by 32 MRSA §13832(3) may administer drugs
and vaccines to a person 18 years of age or older.
Pharmacy Law Update 2014- G. Cameron