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PHARMACY LAW UPDATE 2014

Gregory Cameron, R.PhAssistant Professor of Pharmacy Practice

Husson University Field Coordinator, Community Sites

Hollywood CasinoSeptember 6, 2014

Pharmacy Law Update 2014- G. Cameron

OBJECTIVES

• Changes in DEA status of Tramadol & Vicodin

• Updates on “Drug Take back” regulations

• PIC responsibilities

• New Maine Pharmacy Law Updates


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

http://www.deadiversion.usdoj.gov/21cfr/cfr/2111cfrt.htm


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.

https://www.federalregister.gov/select-citation/2014/08/20/21-CFR-1311.300



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.

http://www.deadiversion.usdoj.gov/ecomm/e_rx/thirdparty.htm






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.


National Prescription Drug Take Back Day September 27, 2014

http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html

http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html


• May 8, 2014 - DEA’S National Prescription Drug Take-Back 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 DEA-coordinated Take-Back events

• 4.1 million pounds (2,123 tons) of prescription medications have been removed from circulation.


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


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


RESCHEDULING OF HCPs (cont.)

• It goes into effect in 45 days

•October 6, 2014


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


• 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.

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

HOW DID HCP GET TO CII STATUS (Cont.)

http://api.fdsys.gov/link?collection=uscode&title=21&year=mostrecent&section=821&type=usc&link-type=html

https://www.federalregister.gov/select-citation/2014/08/22/21-CFR-1305

https://www.federalregister.gov/select-citation/2014/08/22/21-CFR-1306.22


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.


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


• 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;


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.

The responsibilities of the pharmacist in charge include, but are not limited to: (Cont.)


• Pharmacist had a Misfill of a prescription (Error)o Letter of Warning & $250 Fine

• Technician- Passing a worthless instrumento Letter of Warning & $250 Fine

• Pharmacist - Substance Abuseo License on Probationo Substance Abuse Monitoring Program

• Pharmacist - Answered YES on renewal of license for conviction OUIo Denied renewalo Offered consent agreement

Maine Board of Pharmacy Actions


• Pharmacist - Unprofessional Conducto Missing Medicationso 36,487 hydrocodone/APAPo Probation for a yearo $1,500 Fine

Maine Board of Pharmacy Actions (Cont.)


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 Technician

• 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

drugo Prescription data entry;o Prescription drug selection from inventory; oro Counting, packaging and labeling of prescription drugs

for deliveryo The assignment of any of the above duties to a

pharmacy technician lies within the discretion of the pharmacist on duty.

Pharmacy Technician Duties


• 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; oro Theft of cash or credit/debit card data.


Notice of Employment and Non-Employment of Pharmacy Technicians

Security Cameras• A retail pharmacy shall deploy security cameras

sufficient in number to monitor the critical areas of the pharmacy department, including, at a minimumo prescription filling areao self-service customer kioskso dispensing machines that are part of an automated

pharmacy systemo controlled drug storage areaso checkout areao 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.


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:


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


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 verifyo That the patient is the person to whom the

prescription was issuedo That the patient is 18 years of age or older.


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.


Landing Gear Is Down And Locked!

Documents

pharmacy application

dea registrant

certification processes

previous deacoordinated

prescription pills

ibeta llc

deas web site

tons of pills