PHARMACY-RELATED REGULATIONS: AN UPDATE...Pharmacy, technician training programs, health care systems, technicians, Board members, Board staff "Provides training requirement and program

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PHARMACY-RELATED REGULATIONS: AN UPDATE

MAY 18, 2013

Candice M. Fleming, R.Ph. Associate Director of Compliance Minnesota State Board of Pharmacy

Learning Objectives

§  Review technician training standards §  Review technician continuing education

requirements §  Describe continuing education reporting

process §  Outline technician compounding with

pharmacists’ responsibilities §  Define pharmacy compounding,

manufacturing, and wholesaling §  Review 2012 Statutes for pharmacy

Regulation – Technician Training Standards §  Registration is required

ú  “An individual may not, under any circumstances, perform pharmacy tasks as a pharmacy technician prior to being registered as a pharmacy technician pursuant to this part.”

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Regulation – Technician Training Standards §  Registration requirement – education

ú  “January 1, 2013, initial pharmacy technician registrant must have high school graduation or possession of a general educational development certificate equivalent.”

ú  Individual registered prior to January 1, 2013, may renew provided all other requirements for renewal are met and provided s/he maintains registration on an uninterrupted basis.

ú  Individual, who allows his/her registration to lapse more than one year, must meet registration requirements in effect at time s/he applies for reinstatement.”

Regulation – Technician Training Standards §  Registration requirement – training

ú  Effective January 1, 2014, Board shall not renew registration of technician initially registered after January 1, 2013, unless s/he has completed one:    Training program offered by Board-approved,

accredited vocational/technical institution or college;    Training program accredited by American Society of

Health-System Pharmacists (or other national accreditation organization);

   Program provided by branch of United States Armed Services or Public Health Service; or

   Employer-based training program including minimum of 240 hours in a one year period including theoretical and practical instruction.

Board-Approved Vocational/Technical College §  American Society of Health System

Pharmacists ú  Accredited program ú  Must contain pharmacist-trained experiential

component §  Accredited by agency recognized by U.S.

Department of Education ú  Accredited program ú  Students eligible for financial aid ú  Must contain pharmacist-trained experiential

component

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Board-Approved Vocational/Technical College §  Website for Accrediting Agencies

ú  U.S. Department of Education ú  www2.ed.gov/admins/finaid/accred/

accreditation)pg5.html §  Board does not maintain list of

approved institutions or colleges ú  Contact directly to determine if criteria met

§  Century College White Bear Lake

Regulation – Technician Training Standards §  Technician Training Advisory

Committee (TTAC) ú  MPhA, MSHP, NACDS, MN College of

Pharmacy, technician training programs, health care systems, technicians, Board members, Board staff

ú  Provides training requirement and program advice

Technician Training Advisory Committee §  Issues reviewed

ú  Content and development of employer-based training programs    Recommends minimum content

ú  Content and accreditation of vocational/technical institution and community college-based programs

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TTAC Board-Approved Courses

§  Pharmacies may use course materials developed by another entity in lieu of in-house program ú  Must contain “hands-on” training

Board-Approved Online Training Sites §  Pharmacy Technicians University

ú  Developed by “Pharmacist’s Letter” ú  http://

pharmacytechnicianuniversity.therapeuticresearch.com/home.aspx?cs=&s=PTU

§  National Pharmacy Training Program 7th edition ú  http://atipharmacy.com

§  Online programs without “hands on” training not approved

Employer-Based Pharmacy Technician Training §  Legal and ethical content

ú  Minimum standards    Permissible duties    Duties that may not be performed    Requirements of valid prescription    Requirements of valid controlled substance

prescription    Registration    Continuing education    Unprofessional conduct    Patient Privacy

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Employer-Based Pharmacy Technician Training §  Minimum Standards

ú  Pharmacy and medical terminology ú  Basic pharmaceutical calculations ú  Common trade and generic drug names

and dosage forms ú  Error prevention reporting and follow-up

Employer-Based Pharmacy Technician Training §  Minimum dispensing processes:

ú  Data entry ú  Retrieval of medication ú  Filling containers/packaging of

medications ú  Affixing labels ú  Pharmacist certification requirement

§  Basic knowledge of drugs ú  Proper and safe handling and storage ú  Proper disposal

Hands-On Training

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Employer-Based Pharmacy Technician Training §  Pharmacist-in-charge

ú  Ensure adequate additional training    Minimum standards    Other standards may include: ­  USP <797> sterile compounding ­  USP <795> non-sterile compounding ­  Operating automated drug counting or

distribution systems ­  Repackaging

Hands-On Training

Pharmacists and Technicians

0 1000 2000 3000 4000 5000 6000 7000 8000 9000

10000

1997 1999 2001 2003 2005 2006 2009 2010 2013

3850 3954 4167 4435 4720 4861 5417

7356 7820

0

2584

4707

5843 6581 6830

8288 8552

9918

Pharmacists

Technicians

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Continuing Education

Technician Pharmacist §  Reporting period ends

July 31, odd numbered years

§  20 hours approved §  Prorated for

registration after August, odd-numbered years

§  Reporting period ends September, even numbered years

§  30 hours approved §  Prorated for licensure

after October, even- numbered years ú  1.25 CE per month

Technician Continuing Education Pro-rated Credit Schedule §  August 2011 20 §  September 19 §  October 18 §  November 17 §  December 16 §  January 2012 15 §  February 14 §  March 13 §  April 12 §  May 11 §  June 10 §  July 9

§  August 8 §  September 7 §  October 6 §  November 5 §  December 4 §  January 2013 3 §  February 2 §  March 1 §  April 0 §  May 0 §  June 0 §  July 0

Continuing Education

Technicians Pharmacists

§  CE due prior to renewal n

§  10 % audited August of odd numbered year

§  CE certificates required

§  CE due prior to renewal §  10 % audited in October

of even numbered year §  CE certificates required

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Certify Continuing Education Completion §  Do NOT certify completion until

required hours completed §  CE certification must be completed or

registration/licensure status changes to “owe CE” ú  Registration/licensure renewal not

available if CE not completed on time

Certify Continuing Education Completion - New §  Automated online process

ú  Same log-in and password used for renewals

ú  Click on “Continuing Education review and certification”    Follow instructions

ú  Ensure CE hours completed during the reporting period

Certify Continuing Education Completion §  Mail-in certificate

ú  Form printed from website under “miscellaneous forms;” or

ú  Request form by calling Board office at 651-201-2825

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Approved Continuing Education

§  Board accepts any CE program offered by ACPE-approved or Board-approved provider ú  Program must be appropriate for pharmacy

technicians; or ú  For both pharmacists and technicians

Non-Approved Continuing Education §  Submit CE approval request for

programs not offered by ACPE-approved or Board-approved providers ú  Form on Board website ú  CE Advisory Task Force

   Reviews requests    Recommends approval or denial

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Compounding

§ Extemporaneous compounding: ú  Preparation of compounded drug product

upon receipt of prescription for specific patient

§ Bulk compounding: ú  Preparation by pharmacy of a compounded

drug product sufficient to meet short-term anticipated need for filling prescriptions

Rule Changes – Technician Compounding

Rule Changes – Technician Compounding §  MN 6800.3100 E and MN 6800.3300 §  Technicians officially allowed to assist

in hospital and community extemporaneous compounding ú  Documented prior technician training ú  Patient-specific prescriptions ú  Pharmacist establishes and validates

“initial formulation record of all compounded preparations”

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Compounding and Pharmacist Stage-Checking §  Stage-checking

ú  Implemented January 2, 2013 ú  Initial draft rule language – all drugs ú  Final draft – high risk drugs only ú  Pharmacist ensures components

accurately compounded each stage of procedure

ú  Accountability for everyone involved in procedure/recipe

Compounding and Pharmacist Stage-Checking §  Recipe includes:

ú  Drugs/ingredients ú  Quantity of each ingredient ú  Directions to make/mix ú  Final strength ú  Quantity made ú  Beyond use date source ú  Sample label

Compounding and Pharmacist Stage-Checking §  Compounding documentation:

ú  Drugs/ingredients    Manufacturer    Lot number    Expiration date    Quantity of each ingredient

ú  Final quantity made ú  Compounding technician ú  Stage-check pharmacist ú  Final check pharmacist

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High Risk/High Alert Drugs

§  Pharmacy determines institution’s high risk drugs ú  P & T Committee or equivalent

§  Drug list resources ú  ASHP ú  ISMP

High Alert Drug Examples

§  Adrenergic drugs ú  Epinephrine

§  Anesthetic drugs ú  Ketamine, Propofol

§  IV or SQ insulin §  IV Heparin §  Narcotics

ú  Morphine, fentanyl §  Neuromuscular blockers

ú  Succinylcholine §  Total parental solutions

ú  Electrolytes §  IV magnesium §  IV potassium concentrate

High Alert Examples

§  Epidurals §  Intrathecals §  Cardioplegic solutions §  Pediatric drugs/TPNs §  Neonatal drugs/TPNs

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Compounding and Pharmacist Stage-Checking USP <797> §  Each ingredient, IV and syringe viewed

by pharmacist and documented before mixed ú  Pharmacist may be required to meet USP

<797> gowning requirements ú  Pulled back empty syringe does not meet

intent

Compounding and Pharmacist Stage-Checking USP <797> §  21st century methods

ú  Electronic pictures of drug vials, syringe volumes, and IV bags

ú  Pharmacist documents before contents added to IV    Some maintain pictures as part of recipe    Some use iPads to send pictures to

pharmacist and do not maintain pictures

Compounding and Pharmacist Stage-Checking USP <795> §  Non-sterile stage-checking recipe

requirements §  USP <795> stage-checking methods

ú  Each ingredient and amount viewed and documented by pharmacist before mixed

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Compounding and Pharmacist Stage-Checking USP <795> §  21st century methods

ú  Electronic scales tied to computerized recipe ú  Drug or ingredient’s barcode scanned before

weighing ú  Next drug or ingredient scanned and weighed ú  After final drug or ingredient weighed,

pharmacist checks and documents printout ú  Contents mixed and labeled by technician ú  Final pharmacist check

Non-Sterile Compounding

Compounding, Manufacturing, and Wholesaling §  Wholesaling

ú  Pharmacy may sell drugs to physician or clinic if licensed as wholesaler

ú  Electronic scales tied to computerized recipe    MN Statute 151.44

­  (a) definition “wholesale drug distribution;” ­  (b) definition “wholesale drug distributor”

   MN Statutes 151.47 and 151.48 ­  Requiring wholesalers be licensed

   Wholesale drug distributor definition includes a pharmacy

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Compounding, Manufacturing, and Wholesaling §  Compounding

ú  USP Chapter <795>    Compounding differentiated from

manufacturing by existence of “practitioner-patient-compounder relationship”

Compounding, Manufacturing, and Wholesaling

§  Practitioner or hospital may not purchase prescription drugs from pharmacies not licensed as wholesalers ú  MN Statute 151.46

   Unlawful . . . to knowingly purchase or receive prescription drug from source other than person or entity licensed under laws of state . . . person violating provisions of this section guilty of misdemeanor

Compounding, Manufacturing, and Wholesaling

§  Compounded drugs from pharmacies sold to practitioners or hospitals without prescription is manufacturing ú  Minnesota Rules 6800.3300 requires

compounding done pursuant to United States Pharmacopeia (USP) Chapters 795 or 797 standards    USP Chapter 795 notes compounding

differentiated from manufacturing by existence of “practitioner-patient-compounder relationship”

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New England Compounding Corporation “NECC” Situation §  NECC licensed as nonresidential

pharmacy – not as wholesaler or manufacturer ú  Over 100 pharmacies, clinics, hospitals and

other healthcare facilities in Minnesota identified as customers of NECC    Prescriptions not issued    NECC selling manufactured products at wholesale

§  Board’s position: ú  Sales were illegal

New England Compounding Corporation “NECC” Situation §  Excuses:

   Facility claims purchases not at wholesale because, though drug purchased in advance, prescription was written before drug administered to patient and then sent to NECC

§  Board’s position:    Shipping drug to practitioner for office use and

having practitioner return prescription before or after use on patient is illegal because no practitioner-patient-compounder relationship exists

§  Sale to anyone other than patient is wholesaling

Possible Federal Changes to Compounding

§  Rewrite of Section 503a of FDCA ú  Under legal cloud due to series of US

Appellate and Supreme Court decisions ú  Unconstitutional provisions stricken,

remainder rewritten §  FDA given clear authority to register and

regulate facilities that: ú  Prepare sterile products ú  Ship across state lines ú  Sell at wholesale – or do anticipatory

compounding §  Possible use of state agencies to

enforce federal standards

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Possible Minnesota Changes to Compounding §  HF 1136/SF1081

ú  Apply to facilities licensed by Board ú  Non-residential facilities

   Licensed in state located    Registered, if required, by FDA    Provide inspection report < 2 years old    Provide proof any noted deficiencies corrected

§  Board to engage in rule-making ú  Set standards for compounding facilities not

required to be licensed/registered by another state or FDA

Number of Minnesota Pharmacy Licenses §  Community (Retail) 1199 §  Hospital 117 §  Parental/Enteral/Home Health 16 §  Nursing Home 19 §  Nuclear 4

Chain vs Non-Chain Pharmacies

0

100

200

300

400

500

600

700

800

1996 1998 2000 2002 2004 2006 2009 2011 2013

CHAIN Non-chain

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2012 Statutes Changes for Pharmacy §  MN Statute 151.58 §  Use of automated drug distribution

systems (ADDS) “mechanical system approved by Board” ú  Stores drugs ú  Packages drugs ú  Dispenses drugs

§  Located in ú  Licensed nursing home ú  Community behavioral health hospital

MN Statute 151.58- ADDS §  “Pharmacy may use automated drug

distribution system to fill prescription drug orders for patients of health care facility. Automated drug distribution system may be located in health care facility not at same location as managing pharmacy. When located within health care facility, system considered an extension of managing pharmacy.”

MN Statute 151.58 - ADDS

§  Notification requirements ú  60 days for first installation ú  7 days for subsequent installations

§  Board must approve ADDS and policies and procedures of machine and managing pharmacy ú  Guidance document on web site

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MN Statute 151.58 - ADDS

§  Operation requirements ú  Limited access to ADDS

   Authorized pharmacy and facility staff ú  ADDS supervised remotely ú  All other rules pertaining to ADDS must be

followed MN 6800.2600    Exceptions specified in section 151.58

Potential Benefits When Using ADDS §  Reduced pharmaceutical waste

ú  Reduced costs for payers and/or patients ú  Reduced environmental impact

§  Reduced diversion of controlled substances

§  Access to first and emergency doses §  Increased pharmacist time on clinical

activities ú  Must review and release first doses

§  More nursing time on direct patient care

Potential Problems When Using ADDS §  Safety issues

ú  Incorrect canister/cartridge filling ú  Incorrect canister/cartridge loading ú  Lack of RPh certification of correct filling and

labeling ú  Packaging mishaps

   Drug does not drop correctly    Extra drug drops    Mislabeled    Drugs damaged    Package does not seal

ú  Wrong drug removed ú  Drug incorrectly restocked ú  System malfunction

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Potential Problems of Using ADDS in Long Term Care (LTC) Facilities §  Security issues

ú  Access to drugs on “override” ú  Access to protected health information

§  Minnesota legal issues ú  Statutory definition of manufacturing includes

packaging of drugs    Except for pre-packaging within licensed

pharmacy ú  MN Statutes 151.215

   “A pharmacist must certify prescription…before prescription is dispensed, delivered, mailed or shipped to patient or patient’s caregiver.”

Licensees and Registrations

§  Pharmacists 7820

§  Interns 1512

§  Technicians 9918

Male vs Female Pharmacists; Interns

0

500

1000

1500

2000

2500

3000

3500

4000

4500

1997 1999 2001 2003 2005 2006 2009 2010 2013

3074 3072 3052 3160 3225 3240 3433 3496 3452

2032 2207

2410 2685

2954 3071

3665 3857

4355

Male RPh

Interns

Female RPh

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Minnesota Prescription Monitoring Program §  To promote public health by detecting

diversion, abuse & misuse of controlled substances ú  Information source for prescribers and

pharmacists ú  Investigative tool for law enforcement &

medical examiners §  Not intended to prevent patient from

obtaining needed drugs or to decrease their doses

Minnesota Prescription Monitoring Program (PMP)

AP RN  8.9%

DDS  3.3%

DEL EGATES  4.6%

DO  2.6%

P A  8.1%

R P H  26.2%

DPM  0.3%

ME/C ORONER  0.3%

MD  45.4%

OD  0.1%

MRR P  0.2%

System  Accounts  by  User  Type,  April  2013  Total  =  9,601

PMP Prescriber and Pharmacist Users: MD 5194 and RPh 2094

Present Use Proposed Use

§  Prescribing or considering prescribing

§  Dispensing or considering dispensing

§  Treatment allows access

§  Providing pharmaceutical care or prescriber requests consult

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PMP Basic Facts: January – March, 2013 §  Account requests:

ú  Average 11.8 per day §  Prescriptions dispensed:

ú  1,678,637 ú  7.3 million year to date

§  Queries: ú  71,031 by prescribers (incl. delegates) ú  18,151 by pharmacists (incl. delegates)

§  Other requests: ú  9 individuals’ prescription history requests ú  99 law enforcement search warrants

Prescription Monitoring Program (PMP) April’s Queries

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206

4,019

19,991

24,062

1 10 10 0 1,0 0 0 10 ,0 0 0 10 0 ,0 0 0

P R E S C R IB E R S

P HA R M A C IS T S

D E L E G A T E S

M R R P

M E /C O R O N E R S

N umb er   o f  Q uer ies   P er   C a t eg o r y

Prescription Monitoring Program (PMP)

Present Upgrades Future Updates

§  Electronic online registration

§  Credentials within 10 minutes via e-mail

§  Account holders required to update profile annually

§  Integrate PMP annual renewal with licensure renewal

§  Interstate exchange of PMP data

§  14+ states share PMP data

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Prescription Monitoring Program (PMP) Present Reporting Proposed Reporting

§  Schedules II-IV §  Outpatients, with

exceptions §  Op-in prescriber’s

name on report

§  All schedules plus butalbital and tramadol §  Nursing home and

assisted living patients §  All prescriber’s names

on report-remove op-out

PMP Top 10 Drugs: 2013 to date

§  Hydrocodone/APAP §  Oxycodone/APAP §  Amphetamines mix §  Zolpidem §  Lorazepam §  Oxycodone §  Methylphenidate §  Clonazepam §  Alprazolam §  APAP with codeine

§  424,006 21.0% §  173,967 8.6% §  171,963 8.5% §  166,411 8.25% §  139,882 6.9% §  137,979 6.84% §  112,654 5.59% §  112,046 5.56% §  112,046 5.56% §  56,385 2.79%

Contact Information

Candice M. Fleming, R.Ph. Associate Director for Compliance Minnesota Board of Pharmacy 2829 University Avenue SE

#530 Minneapolis, MN 55414 (651) 201-2834 phone (651) 201-2837 fax [email protected]

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Questions