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. 1
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 2
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 employerbased training programs Recommends minimum content ú Content and accreditation of vocational/ technical institution and community college-based programs 3
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.therapeuticr esearch.com/home.aspx?cs=&s=ptu National Pharmacy Training Program 7 th 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 4
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 5
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 10000 9000 8288 8552 8000 7820 7356 7000 6581 6830 6000 5843 5417 4720 4861 5000 4707 4435 3850 3954 4167 4000 3000 2584 2000 1000 0 0 9918 1997 1999 2001 2003 2005 2006 2009 2010 2013 Pharmacists Technicians 6
Continuing Education Technician Reporting period ends July 31, odd numbered years 20 hours approved Prorated for registration after August, odd-numbered years Pharmacist Reporting period ends September, even numbered years 30 hours approved Prorated for licensure after October, evennumbered 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 CE due prior to renewal n 10 % audited August of odd numbered year CE certificates required Pharmacists CE due prior to renewal 10 % audited in October of even numbered year CE certificates required 7
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 8
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 ACPEapproved or Board-approved providers ú Form on Board website ú CE Advisory Task Force Reviews requests Recommends approval or denial 9
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 10
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 11
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 12
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> 21 st 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 13
Compounding and Pharmacist Stage-Checking USP <795> 21 st 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 14
Compounding, Manufacturing, and Wholesaling Compounding ú USP Chapter <795> Compounding differentiated from manufacturing by existence of practitionerpatient-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 15
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 16
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 800 700 600 500 400 300 200 100 0 1996 1998 2000 2002 2004 2006 2009 2011 2013 CHAIN Non-chain 17
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 18
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 19
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 4500 4000 3857 3665 3433 3496 3452 3500 3074 3072 3052 3160 3225 3240 2954 3071 3000 2685 2410 2500 2207 2032 2000 1500 1000 500 0 4355 1997 1999 2001 2003 2005 2006 2009 2010 2013 Male RPh Interns Female RPh 20
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) System Accounts by User Type, April 2013 Total = 9,601 RPH 26.2% APRN 8.9% DDS 3.3% DELEGATES 4.6% PA 8.1% OD 0.1% MRRP 0.2% DP M 0.3% DO 2.6% ME/C OR ONER 0.3% MD 45.4% PMP Prescriber and Pharmacist Users: MD 5194 and RPh 2094 Present Use Prescribing or considering prescribing Dispensing or considering dispensing Proposed Use Treatment allows access Providing pharmaceutical care or prescriber requests consult 21
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 Number of Queries Per C ategory PRESC RIBERS 24,062 PHARMAC ISTS 19,991 DELEGATES 4,019 MRRP 206 ME/CORONERS 31 1 10 10 0 1,0 0 0 10,0 0 0 10 0,0 0 0 Prescription Monitoring Program (PMP) Present Upgrades Electronic online registration Credentials within 10 minutes via e-mail Account holders required to update profile annually Future Updates Integrate PMP annual renewal with licensure renewal Interstate exchange of PMP data 14+ states share PMP data 22
Prescription Monitoring Program (PMP) Present Reporting Schedules II-IV Outpatients, with exceptions Op-in prescriber s name on report Proposed Reporting All schedules plus butalbital and tramadol Nursing home and assisted living patients All prescriber s names on report-remove opout 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 Candice.Fleming@state.mn.us 23
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