South Dakota Board of Pharmacy Update 2017

Kari Shanard-Koenders, Executive DirectorMelissa DeNoon, PDMP Director

South Dakota Pharmacists Association Annual MeetingSeptember 22, 2017

PRESENTATION OBJECTIVES AND DISCLOSURESThis CPE activity will ensure that pharmacists and technicians in attendance will :

1. Employ effective strategies on how to be compliant with Federal and State laws and how changes affect them;

2. Identify what can and cannot be changed on a CII prescription and on an EPCS;

3. Explain the requirements for USP <800> and how it affects a pharmacy

4. Describe how Senate Bill 1 changed SD PDMP;5. Describe how the DEA’s Disposal of Controlled Substances final

rule effective October 9, 2014, impacts pharmacy practice;**None of the presenters has any direct financial relationship to disclose.

2

WHAT’S NEW?

CARA Comprehensive Addiction and Recovery Act of 2016

Board Policy Statements1. DEA Transfer of Unfilled CII prescriptions2. What can be changed on a CII prescription

USP <800> Senate Bill 1DRUG TAKE BACK Program

3

CARAJuly 22, 2016, Comprehensive Addiction and Recovery Act (CARA) signed in to law – among many things, includes:1. Improve access to overdose treatment2. Improve access to overdose reversal (naloxone)3. Improve Medication-Assisted Treatment (MAT) for

recovery from addiction – buprenorphine Expands prescribing privileges to CNP’s and PA’s for five years

until 10/1/2021 They must complete 24 hours of training to become a “data

waived” prescriber of buprenorphine and will have an X-DEA number

CNP’s and PA’s can treat a maximum of 30 patients

CARA CONT’D

4. CARA also amends the Controlled Substances Act to allow a pharmacist to partially fill a prescription for a schedule II controlled substance (such as an opioid) if:

such partial fills are not prohibited by state law, a partial fill is requested by the patient or prescribing practitioner, and the total quantity dispensed in partial fillings does not exceed the quantity prescribed

SD Rules20:51:05:16. Prescription for Schedule II controlled drug requires date and signature of prescriber --Not refillable. No pharmacist may dispense a Schedule II controlled drug for which a written prescription is required under federal or state law until a prescription bearing the date of issue and the written signature of the prescriber has been delivered to the pharmacy or issued and signed electronically where permissible by law. No pharmacist may refill a Schedule II controlled drug prescription.

20:51:05:18. Partial filling of prescription for Schedule II controlled drug. A pharmacist may partially fill a prescription for a Schedule II controlled drug according to the procedure set out in §§44:58:08:18 and 44:58:08:18.01.

44:58:08:18. Partial filling of prescriptions for Schedule II substances. A pharmacist may partially fill a prescription for a controlled substance listed in Schedule II, if unable to supply the full quantity called for in a written or emergency oral prescription, and a notation of the quantity supplied is made on the face of the prescription. The remaining portion of the prescription may be filled within 72 hours of the partial filling; however, if the remaining portion is not filled within the 72-hour period, the pharmacist shall notify the practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

BOARD POLICY STATEMENT

The Board worked with DEA to complete this document. Jenna Heyen, Pharm D., completed this document on her P4 rotation with the BOP

What Can be Changed on a CS Rx?The following may be added or modified without consulting the practitioner if information can be reliably obtained:

Patient’s address Practitioner’s address Practitioners telephone number 1Quantity may be modified ONLY in conjunction with change of Strength.

6

WHAT CAN BE CHANGED ON A CS RX? (CONT’D)

The following may be added or modified after consulting with a practitioner (may not be an agent of the practitioner). The pharmacist should document all consultations and note any changes on the face of the Rx.

Date of issue may be added but not changed. A pharmacist may not change a “do not fill until date” even if the provider is consulted. A pharmacist may fill prior to a “do not fill until” date in extenuating circumstances and after consulting the provider.

Example: A prescription bears a “do not fill until 3/29” notation. Today’s date is 3/26. The patient is leaving for a two week vacation and requests that it be filled. After obtaining approval by the provider, you may fill the Rx.

The pharmacist must document the date, reason for early fill, “prescriber consulted”, and pharmacist initials on the face of the prescription

Drug Quantity and Strength unless it falls under the example previously discussed1 This includes situations where the acetaminophen strength is missing or incorrect in hydrocodone combinationproducts. The prescriber should be contacted to verify strength of acetaminophen.

Directions for use unless it falls under the example previously discussed1

Dosage form (capsules and tablets are not interchangeable)

Refill instructions for controlled substances III-IV

Practitioners printed name (NOT practitioners signature)

Indication on prescription for buprenorphine containing products

WHAT CAN BE CHANGED ON A CS RX? (CONT’D)

A pharmacist may never change: Patient’s name Name of controlled substance (except where generic substitution permitted) Signature of the practitioner

Finally, a pharmacist is expected to use their professional judgment and knowledge to determine when it is appropriate to make changes to any prescription including a prescription for a controlled substance. Policy Statement approved by SD Board 6/9/17

BOARD POLICY STATEMENTTwo Part Policy Statement on Transferring E-prescribed or Written prescriptions

Part I - “Is a prescription, including a CII prescription, which has never been filled, allowed to be transferred?”

The Board wishes to provide clarity on this issue. DEA has been consulted. We asked the DEA the above question. In an email from Sarah Boblenz, Group Supervisor of the Des Moines DEA Field office, her response to the question was: “The practice is currently under review by DEA headquarters for a potential CFR change and that if the state allows it, DEA accepts the practice as long as it follows 21 CFR 1306.15, 1306.25 and 1306.27.”

The state’s regulation is listed in ARSD 20:51:23:01 and states: For the purpose of dispensing refills of prescriptions, a pharmacy may transfer prescription information to another pharmacy, subject to the following requirements:

(1) The transfer is limited to the number of refills authorized on the original prescription; (2) The transfer is communicated directly between two licensed pharmacists; and (3) Both the original and the transferred prescriptions are kept for two years from the date of the last refill.

Since the prescription has never been filled, and per ARSD 20:51:23:01, the purpose of the transfer would not be for “refills” but would be for an original fill; therefore, review of our rule may conclude that it should not be standard of practice. In fact many chain drug stores have recently enacted policies and procedures that prohibit this practice to or from their store.

The Board feels strongly that prohibiting a transfer of an unfilled prescription is contrary to timely and proper patient care and could contribute to diversion as there is a chance that there would be two active prescriptions that could be filled for the patient. While our rules state “for the purpose of dispensing refills”, this is not to be taken literally and a transfer may be for the purpose of an original fill as well. Until administrative rules can be changed, the Board clarifies that the practice of transfer of a prescription prior to fill is acceptable in South Dakota.

Please reference ARSD 20:51:23 and 20:51:20:04 for further transfer regulations. 9

BOARD POLICY STATEMENT

Part II - “Is an e-prescribed prescription for a CIII – CV allowed to be transferred?”

We asked the DEA the above question. Sarah Boblenz, DEA, responded, yes, as long as the transfer is allowed in the state and it meets the requirements of 21 CFR 1306.25(a)(4) and (5). The Board agrees and this is allowed by South Dakota and is authorized in ARSD 20:51:23:04.

Please reference ARSD 20:51:23 and 20:51:20:04 for further transfer regulations.

10

UNITED STATES PHARMACOPEIAL CONVENTION (USP) <800> Hazardous Drugs (HD) – Handling in Healthcare

Settings Released February 2016 Chapter to become effective July 1, 2018 This chapter applies to all healthcare personnel who handle

HD preparations and all entities that store, prepare, transport or administer HD

https://www.readyfor800.com/download-ready-800-checklist/ is the link to an excellent checklist for USP <800> in healthcare facilities

11

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY & HEALTH (NIOSH)

Under Center for Disease Control (CDC) Document maintains a list of antineoplastics and other

HD’s used in healthcare Entity must maintain a list of HD Entity’s list must be reviewed at least every 12 months Website = www.cdc.gov/NIOSH

12

USP CHAPTER <800> WHAT IS IT? AND DOES IT APPLY TO MY PHARMACY?

USP <800> Hazardous Drugs – Handling in Healthcare Setting will become official July 1, 2018 for allHealthcare settings including retail pharmacies.

DOES THIS APPLY ONLY TO COMPOUNDING PHARMACIES?No. USP <800> applies to all healthcare personnel who handle hazardous preparations, and entities that transport, store, prepare or administer hazardous drugs (HDs). For example: pharmacies, hospitals, patient treatment clinics, physicians offices, and veterinarians offices.

WHO MUST COMPLY?Compliance with all containment strategies and work practices listed is required for ALL healthcare settings utilizing HDs. An entity may perform an Assessment of Risk (AoR) for certain HDs to determine which drugs may be handled with an alternative containment strategy or work practice.

WHO WILL ENFORCE USP <800>?State Boards of Pharmacy, Occupational Safety and Health (OSHA), and possibly [FDA]

ARSD 20:51:16:03. The pharmacist's relation to the public. In relation to the public, the pharmacist: Upholds the approved legal standards of the U.S. Pharmacopeia…Uses every precaution to safeguard the public when dispensing any drugs or preparations. Being legally entrusted with the dispensing and sale of these products, the pharmacist assumes responsibility by upholding and conforming to the laws and regulations governing the distribution of these substances;(4) Holds the health and safety of the pharmacist's patrons to be of first consideration…(5) Keeps the pharmacy clean, neat, and sanitary…

13

USP <800>Information: USP Chapter <800> Official document - Purchase copy here : https://store.usp.org/OA_HTML/usp2_ibeCCtpSctDspRte.jsp?section=12587&minisite=10020

USP <800> Frequently Asked Questions http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

Center for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH 2016 document) List of Antineoplastic & Other Hazardous drug in the Healthcare Setting

http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf

Center for Disease Control and Prevention, National Institute for Occupational Safety and Health

(NIOSH Alert – 2004 document) Preventing Occupational Exposure to Antineoplastic & Other Hazardous Drugs in a Health Care Setting

https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

Controlling Occupational Exposure to Hazardous Drugs https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html

Resources:

USP <800> Hazardous Drugs-Handling in Healthcare Settings Preparation Checklist http://CompoundingToday.com/Compliance/IJPC_USP_800_Preparation_Checklist.xlsx

USP Chapter <800> Consensus Statement on Hazardous Drugs (Adobe .pdf, 1,716 KB) http://CompoundingToday.com/Compliance/HDCS_Consensus_Statement.pdf

Risk Assessment Templates (MS Excel, .xlsx, 125 KB) http://CompoundingToday.com/Compliance/Risk_Assessment_Templates.xlsx

Perform an Assessment of Risk to Comply with USP <800> https://www.pppmag.com/article/2012

Best Practices for Handling Hazardous Drugs – Training http://www.criticalpoint.info/course/hazardousdrugs/ ; https://www.pppmag.com/documents/V8N10/CC/PDFs/HazDrugRisk_Acknowledg.pdf

Supplies:

Health Care Logistics Inc. , Hazardous drug supplies http://shop.gohcl.com/default.aspx?page=item%20detail&itemcode=18595

http://www.medtronic.com/covidien/products/hazardous-drug-protection

Hazardous Drug Spill Kit components

http://www.medtronic.com/content/dam/covidien/library/us/en/product/hazardous-drug-protection/chemosafety-spill-kit-instructions.pdf

14

THE UNITED STATES’ OPIOID EPIDEMIC BY THE NUMBERS:

CDC reported that 52,404 persons in the US died of a drug overdose in 2015

Of these deaths, 33,091 involved an opioid and among these approximately 15,000 involved a prescription opioid

Drug overdose is the leading cause of injury death in the US and in every year since 2009 has outpaced deaths by firearms, motor vehicle crashes, homicide, and suicide

Additionally, in 2015 an estimated 2 million persons in the US had opioid use disorder associated with prescription opioids

HOW IS SOUTH DAKOTA DOING? Enough doses of opiates were prescribed to South Dakotans in 2015 to medicate every

SD adult around-the-clock for 19 straight days Between 2004-2011: 82 Opioid Deaths (approximately 10 per year) 2013: 17 Opioid Deaths 2014: 16 Opioid Deaths (including one death where heroin was present) CDC’s Analysis of Mortality Data from the National Vital Statistics System

SD 2013 Age-adjusted rate: 6.9 deaths per 100,000; Number of deaths: 55 SD 2014 Age-adjusted rate: 7.8 deaths per 100,000; Number of deaths: 63 SD 2015 Age-adjusted rate: 8.4 deaths per 100.000; Number of deaths: 65

Compared to the rest of the US for 2015: Age-adjusted rate: SD (8.4) ranks 50/51 with WV first at 41.5 deaths per 100,000 Number of deaths: SD (65) ranks 50/51 with CA first with 4,659 deaths and OH second with 3,310

deaths Opioid Prescribing Rates for 2016 from the CDC Vital Signs:

SD ranks 43/51 with a prescribing rate of 54.8 prescriptions per 100 residents AL is the top state with a prescribing rate of 121 prescriptions per 100 residents District of Columbia is at the bottom with a prescribing rate of 32.5 prescriptions per 100 residents Overall US rate is 66.5 prescriptions per 100 residents ** lowest rate in more than 10 years **

Prescription Drug Monitoring Programs (PDMPs) continue to be

among the most promising state-levelinterventions to improve opioid prescribing,inform clinical practice, and protect patients

at risk.

THE ROAD TO MANDATORY REGISTRATION

SUBSTANCE ABUSE PREVENTION 2016 INTERIM STUDY

“The study of substance abuse prevention at the earliest stages and options available to South Dakota communities.”

The scope of the study was to explore the problem of substance abuse, specifically meth and prescription drug use, and possible community prevention or intervention for pre-teens, teens, and young adults.

Committee membership of 11 SD State Legislators SD PDMP presentation on October 11, 2016

21

PROPOSED LEGISLATION

Senate Bill 1 SDCL 34-20E-1-(9) defines “Integration” SDCL 34-20E-2 changes the electronic reporting

standard to the 2011 ASAP V4.2 SDCL 34-20E-3 changes the submission frequency

to at least every 24 hours SDCL 34-20E-7-(1) allows the board to provide data

in the central repository to prescribers and dispensers via integration with electronic medical records

22

PROPOSED LEGISLATION

Senate Bill 2 “An Act to require prescribers to access the

Prescription Drug Monitoring Program database prior to issuing a prescription for certain controlled substances.” AKA “Mandatory Use”

23

2017 SD LEGISLATIVE SESSION

Senate Bill 1 was amended to add a new section to SDCL 34-20E requiring any person with a SD Controlled Substance Registration (CSR) to register with the program; this bill was signed by the Governor on March 8, 2017 making SD a Mandatory Registration state

Senate Bill 2 (Mandatory Use) was thereby tabled for this session

A good compromise

24

THE ROAD HAS HAD A FEW BUMPS…

Partnership with SD’s Division of Controlled Substances

Challenges of the “Master List” Partnerships with SD’s Professional Licensing

Boards Lessons learned and still learning

25

ARE WE THERE YET?

SD PDMP REGISTRATION PROCESS

Website for the SD PDMP, known as PMP AWARxE, and initial account set up: https://southdakota.pmpaware.net

Click “Create an Account” on the login screen to request a new account in PMP AWARxE

Complete the following steps: enter a user-unique email address for the account user name and create a password, select a user role, click on the link in the verification email sent to the registered email address, enter personal and employer demographics, and click on “Submit Your Registration” to complete the process

The program will provide a notification page and link to print the additional document our program requires, a data requestor notary form; this information will also be sent in an email, once this form is completed it may be uploaded into the created account or faxed as indicated on the form

The created account will go through a credentialing and approval process and when the account is approved, an email will be received stating the account is active and ready for access

SD PDMP RESOURCES

Quick User Guide – How to Register for a New Account in PMP AWARxE: http://doh.sd.gov/boards/pharmacy/assets/AWARxE-RegistrationNewUsers.pdf

Quick User Guide – Making a Request in PMP AWARxE: http://doh.sd.gov/boards/pharmacy/assets/Request-AWARxE.pdf

PMP AWARxE Requestor User Support Guide: http://doh.sd.gov/boards/pharmacy/assets/UserSupportGuide.pdf*Delegate information in Sections 2.2, 4.1, and 4.2*

SD PDMP website: http://doh.sd.gov/boards/pharmacy/pdmp.aspx

SD PDMP email: sdpdmp@state.sd.us

NEXT STEPS

Ongoing approval of accounts Compliance

Letters mid to late July Notifying Professional Licensing Boards Future hope to link SD CSR with SD PDMP

registration Consequences of non-compliance

29

THE FUTURE OF PDMPS

Integration of PDMP data into health system’s electronic health records (EHR) and pharmacy’s software systems

• Addresses a major concern of prescribers and pharmacists which is accessing the PDMP requires additional steps that are not in the clinical workflow

• Integration benefits include: Immediate improvement in the patient care process User workflows were streamlined and improved Pharmacist and prescriber satisfaction was highest when technology automated the

majority of workflow tasks

Integration of SD PDMP data into Avera Health System’s EHR went live May 25, 2016

Future Health System EHR/PDMP Integrations: Sanford Health and Regional Health Systems

DRUG TAKE-BACK PROGRAM

One of the goals of the PDMP is to deter and reduce diversion of controlled substances in South Dakota

Occasional nonmedical users of prescription pain relievers are most likely to obtain their drugs for free from a relative or friend

A disposal program for unused, unwanted, and expired drugs decreases this avenue of diversion

The SD Board of Pharmacy is beginning its partnership with SD pharmacies in a statewide drug take-back program

FINAL RULE OF THE DISPOSAL OF CONTROLLED SUBSTANCES

Became effective on October 9, 2014 and can be found in Title 21 of the Code of Federal Regulations (CFR) Part 1317

These regulations implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances (CS) from ultimate users for the purpose of disposal, including collection receptacle locations at retail pharmacies

With this final rule, the DEA is implementing a standard of destruction, “non-retrievable”

HOW DOES MY PHARMACY BECOME A COLLECTION SITE?

Modify your current DEA registration to obtain authorization to be a collector. This authorization is subject to renewal.

Collectors may install, manage, and maintain collection receptacles located at their authorized collection location.

Only CS listed in Schedule II, III, IV, or V may be collected. Controlled and non-controlled substances may be collected

together and co-mingled. Collectors can only allow the ultimate user to deposit their

medications into the collection receptacle at a registered location.

Once a substance has been deposited into a collection receptacle, the substance shall not be counted, sorted, inventoried, or otherwise individually handled.

HOW DOES MY PHARMACY BECOME A COLLECTION SITE? CONT’D Collection receptacles need to be securely placed and

maintained in the immediate proximity of the pharmacy, i.e. can be seen from inside the pharmacy.

The collection receptacle must meet certain design specifications including being securely fastened to a permanent structure so it can not be removed*, be securely locked, and display a sign indicating what substances may be deposited. (*The opening to the receptacle must be inaccessible to the public when an employee is not present such as when the pharmacy is closed.)

The sealed containers may be delivered or picked up as set forth by the contracted agency.

ASSURED WASTE SOLUTIONS’ MEDDROP PROGRAM

POST-TEST

When federal laws like the CARA becomes effective, which contradicts state law, which law do you follow?A. The state law because it is least restrictiveB. The one that is most restrictiveC. The Federal Law because it is Least restrictive and is the Federal LawD. Always the state law

When an EPCS arrives and changes are required, you must tell the prescriber that you cannot fill it and you would like a new EPCS.A. Yes, there is no way to change something on an EPCSB. You may make all required changes after contacting prescriber and documentingC. You can print the prescription and make only certain changes after contacting prescriber and

documentingD. You must send a copy of the prescription with the patient.

36

POST-TEST (CONT’D)USP <800> should be enacted as soon as possible as the focus of the document is protecting pharmacy staff, nursing staff, and patients.

A. TrueB. False

Senate Bill 1, which became effective July 1, 2017, made the following changes to the SD PDMP;

A. Data submission frequency is at least every 24 hoursB. “Integration” is defined and the board is allowed to provide data to prescribers and C. dispensers via integration with electronic health recordsD. The electronic reporting standard is the 2011 ASAP V4.2E. Registration with the program is mandated for all holders of a SD Controlled Substance

RegistrationF. All of the above

Retail pharmacies registered with the DEA as a Collector can provide a receptacle to accept controlled substances from ultimate users for disposal; .

A. True B. False

37

QUESTIONS?

38