Electronic Prescribing In New York State

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Electronic Prescribing In New York State"

Transcription

1 Electronic Prescribing In New York State Joshua S. Vinciguerra, Director Bureau of Narcotic Enforcement October 28, 2015

2 October 28, Overview Review the problem & e-prescribing mandate Describe the practitioner EPCS registration process Describe the exceptions to the e-prescribing mandate & waiver application process Discuss implications for prescription drug crimes & investigative techniques

3 October 28, The Connection

4 States with more opioid pain reliever sales tend to have more drug overdose deaths Death rate, 2013, National Vital Statistics System. Opioid pain reliever sales rate, 2013, DEA s Automation of Reports and Consolidated Orders System

5 October 28, Official Prescription Program NY issues forge-proof official prescription forms to all registered practitioners within the State Contain a number of security features Trackable From issued ~1.4 B prescription forms At a cost of $78.7 M 5

6 October 28, Prescription Drug Reform Act 2012 Part A: Part B: I-STOP Electronic Prescribing Part C: Schedule Changes Controlled Substance Part D: Part E: 3309 Work Group Safe Disposal Program

7 October 28, Definition of Electronic Prescribing A prescription issued with an electronic signature and transmitted by electronic means in accordance with regulations of the commissioner of health and the commissioner of education and consistent with federal requirements. A prescription generated on an electronic system that is printed out and manually signed or transmitted via facsimile is NOT considered an electronic prescription. Electronic prescribing is a paperless process. Public Health Law 3302

8 October 28, Why Electronic Prescribing? Next step in medical technology Curtail forged and counterfeit prescriptions Reduce medication errors associated with bad handwriting Improved workflow

9 October 28, Reducing Fraud & Forgery Easier to track and review records. Originate from one place with unique identifiers. Should reduce the volume of paper scripts in circulation that may be lost/stolen/forged.

10 October 28, Benefits of Electronic Prescribing Secure method of prescribing outside the practice site Patients no longer have to come to the office to pick up their prescription Reduction in office staff responsibilities Eliminates the two-step procedure for follow-up prescriptions

11 October 28, Electronic Prescribing Non-controlled Substances Controlled Substances

12 October 28, Electronic Prescribing DEA Interim Final Rule (IFR) Background Effective June 1, 2010, allows for electronic prescribing of controlled substances. The federal security requirements are included in the IFR regarding electronic prescriptions for controlled substances. The rule may be accessed via the U.S Department of Justice, DEA Office of Diversion Control website.

13 October 28, EPCS DEA Rule Background 21 CFR Part 1300 Definitions and 21 CFR Part 1311 Requirements for Electronic Orders & Prescriptions Provides practitioners with the option of signing and transmitting prescriptions for controlled substances electronically Permits pharmacies to receive, dispense and archive electronic prescriptions Maintains a closed system for controlled substance prescribing and dispensing through rigorous security requirements and audit trails CII-V can be prescribed electronically

14 October 28, Electronic Prescribing DEA Interim Final Rule (IFR) Background Use a certified application (software) that records, stores and transmits controlled substance information required under Parts 1306 and 1311 of 21 CFR. Note: BNE does not certify software applications.

15 October 28, Electronic Prescribing DEA Interim Final Rule (IFR) Background Identity-proofing - the process by which a credential service provider or certification authority validates sufficient information to uniquely identify a person Obtain and use a two factor authentication credential Something you have (token) Something you know (password, PIN) Something you are (biometric) Ensures prescription integrity and non-repudiation

16 October 28, EPCS Pharmacy Application Requirements Must meet DEA s requirements May only process controlled substance prescriptions using a certified pharmacy application Application must be able to set access controls Application must be able to import, store and display prescription requirements and verify the practitioner s digital signature Application must allow for pharmacist annotations and be maintained electronically

17 October 28, EPCS Pharmacy Application Requirements Be capable of retrieving controlled substance prescriptions by practitioner name, patient name, drug name and date dispensed. Allow downloading of prescription data into a database or spreadsheet that is readable and sortable. Maintain an audit trail of a number of actions (e.g., receipt annotation, alteration, changes in logical access). Conduct internal audits and protect records. Retain archived records electronically.

18 October 28, EPCS Transmission Copies of EPCS transmitted prescription must state Copy only not valid for dispensing. EPCS application must not allow for electronic transmission if original was printed prior to electronic transmission At no time may an intermediary convert the electronic prescription to another form (e.g., facsimile) for transmission

19 October 28, EPCS Transmission EPCS application must transmit the electronic prescription as soon as possible after signature by the practitioner Electronic prescription may be printed only if practitioner has been notified of transmission failure Printed version must contain information relating to original electronic transmission failure

20 October 28, Electronic Prescribing NYS Regulations Effective March 27, 2013, NYS Regulations allow for electronic prescribing of controlled substances (EPCS). Electronic prescribing of controlled and non-controlled substances becomes mandatory for all practitioners as of March 27, Additional information pertaining to electronic prescribing of noncontrolled substances is available on the NYSED Office of the Professions Website

21 October 28, NYS Regulations Electronic Prescribing Electronic prescriptions must be preserved for a period of five years Such records that are maintained electronically shall be made available to the DOH upon request, in a hardcopy format that is readily understandable, at the premises where the licensed activities are conducted.

22 October 28, NYS Regulations Electronic Prescribing Requires all practitioners and pharmacists engaging in electronic prescribing and dispensing of controlled substances to utilize computer applications that meet federal security requirements and to register such computer applications with the NYS DOH/BNE

23 October 28, Registration of Controlled Substance Software All practitioners should complete the registration of their EPCS software with BNE after the application has been installed by their vendor and the practitioner has completed all the necessary steps to begin transmitting controlled substance prescriptions.

24 October 28, Registration of Controlled Substance Software Re-registration is required, whichever occurs first: At least every two years, or Whenever functionality related to controlled substance prescription requirements is altered with the computer application.

25 October 28, EPCS NYS Regulations Registering Certified Application with BNE Current Process forms are available online Or online registration process Once Registration Form is Received About one week to process Registrant will receive an advising that application has been registered with NYS

26 October 28, Registration of Controlled Substance Software Physicians register online through the HCS using an application called ROPES = Registration for Official Prescriptions and E-prescribing Systems Facility Single Practitioners Nearly 30,000 practitioners have registered their certified EPCS software Official Prescription Program registration can be renewed at the same time Registration itself does not activate the software, this is a software vendor function.

27 October 28, ROPES EPCS Registration Screen

28 October 28, Information Required to Register Name of software company (ie. Microsoft) Name of the software application (ie. Windows) Version of the software (ie. 10)

29 October 28, Prescriber Responsibilities Safeguard credentials An electronic prescription may ONLY be reviewed and signed by the prescribing practitioner. Practitioners must retain sole possession of hard tokens, if used, and must not share passwords, other knowledge factors, or biometric information with any other person.

30 October 28, Prescriber Responsibilities Practitioners must notify the Bureau immediately upon discovery that the hard token has been lost, stolen, or compromised or the authentication protocol has been otherwise compromised. Failure to comply with this provision may result in prescribers being held responsible for any controlled substance prescriptions written using their two-factor authentication credential.

31 October 28, What Are We Telling Prescribers? Contact your software vendor to determine if the e-prescribing software meets all the federal security requirements for controlled substances If you have implemented EPCS software where you practice and registered it with BNE, start using it now If an institution: understand the federal rules associated with credentialing and logical access For practitioners, pharmacies and institutions ensure that your EPCS certified software is registered with BNE Check BNE s website often for more information BNE Newsletter and EPCS FAQ document

32 October 28, EPCS Take Aways Permissive now--mandated for ALL prescriptions March 27, 2016 Practitioners and pharmacists are required to use a certified software application for issuing and dispensing electronic prescriptions for controlled substances Certified software application must be registered with BNE If the prescription starts electronically, it remains electronic. Fax does NOT equate to electronic Proper safeguarding of credentials *** Token = Signature***

33 October 28, Electronic Prescribing Exceptions Technological or electrical failure; Use of EP would impact the patient s medical condition (up to 5 day supply for controlled substances); Prescriptions issued by a practitioner to be dispensed outside of New York State; Veterinarians; Practitioners who have received a waiver from the Department of Health. 33

34 October 28, Electronic Prescribing Waivers Practitioners may apply for a waiver from the requirement to electronically prescribe controlled substances. BNE is developing an online application for requesting a waiver. Waivers will be granted upon a proper showing of economic hardship, technological limitations outside of the practitioner s control or other exceptional circumstances. By statute, waivers are good for one year, after which a practitioner may apply for a renewal. 34

35 October 28, The Waiver Process Waiver timeline; What must be submitted to complete a waiver request; How we intend to review waivers under our interpretation of the statutory criteria; What situations may constitute exceptional circumstances.

36 October 28, Implications: Prescription Drug Crimes Pill Mills Identity Theft/Forgery Computer Trespass Diversions New Methods

37 October 28, Implications: Investigative Techniques Search Warrants Computer Forensic Analysis Subpoena Practice/ISP s, Software Providers Witness Interviews

38 October 28, Implications: Investigative Techniques Search Warrants - Search and Seize - What Does Token Control? - Describe with Particularity - Instrumentality of Crime

39 October 28, Implications: Investigative Techniques Computer Forensic Analysis - Are there two sets of records? - Access Logs

40 October 28, Implications: Investigative Techniques Subpoena Practice/ISP s, Software Providers Witness Interviews

41 October 28, Resources Federal Rule Electronic Prescriptions for Controlled Substances 10 NYCRR Part 80 Rules Click on the link to New York State Regulations related to Electronic Prescribing of Controlled Substances State Education Department Office of the Professions

42 October 28, Bureau of Narcotic Enforcement Joshua S. Vinciguerra, Director (518) Toll Free (866) Website: Riverview Center 150 Broadway, 6 th Floor Albany, New York 12204

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES EPCS Revised: October 2014 NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement 1-866-811-7957 www.health.ny.gov/professionals/narcotic

More information

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES EPCS Revised: August 2014 NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement 1-866-811-7957 www.health.ny.gov/professionals/narcotic

More information

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES EPCS Revised: April 2015 NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement 1-866-811-7957 www.health.ny.gov/professionals/narcotic

More information

EPCS FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES. Revised: January 2016

EPCS FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES. Revised: January 2016 FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES EPCS Revised: January 2016 NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement 1-866-811-7957 www.health.ny.gov/professionals/narcotic

More information

E-Prescribing of Controlled Substances (EPCS) New York State Board for Podiatry

E-Prescribing of Controlled Substances (EPCS) New York State Board for Podiatry E-Prescribing of Controlled Substances (EPCS) As of March 27, 2015 it will be mandatory for practitioners, excluding veterinarians, to issue electronic prescriptions for controlled and non-controlled substances.

More information

California State Board of Pharmacy and Medical Board of California

California State Board of Pharmacy and Medical Board of California California State Board of Pharmacy and Medical Board of California Transmission and Receipt of Electronic Controlled Substance Prescriptions Pursuant to DEA Interim Final Rule (IFR): Electronic Prescriptions

More information

UPDATE I-STOP and E-Prescribing

UPDATE I-STOP and E-Prescribing UPDATE I-STOP and E-Prescribing Tracy Russell PSSNY Executive Director Learning Objectives State the statistics regarding the success of the I-Stop regulations Define electronic prescribing in NYS regulations

More information

DEA's New Proposed Regulations For E-Prescribing

DEA's New Proposed Regulations For E-Prescribing Portfolio Media, Inc. 648 Broadway, Suite 200 New York, NY 10012 www.law360.com Phone: +1 212 537 6331 Fax: +1 212 537 6371 customerservice@portfoliomedia.com DEA's New Proposed Regulations For E-Prescribing

More information

The Prescription Drug Abuse and Heroin Crisis: New York s Response

The Prescription Drug Abuse and Heroin Crisis: New York s Response The Prescription Drug Abuse and Heroin Crisis: New York s Response Joshua S. Vinciguerra, Director Bureau of Narcotic Enforcement October 28, 2015 October 28, 2015 2 The Connection States with more opioid

More information

Everything s Going Electronic, Including Your Prescription for Vicodin (But Not Likely Anytime Soon)

Everything s Going Electronic, Including Your Prescription for Vicodin (But Not Likely Anytime Soon) Everything s Going Electronic, Including Your Prescription for Vicodin (But Not Likely Anytime Soon) Article Date: Tuesday, December 07, 2010 Written By: Jennifer B. Markham Effective June 1, 2010, physicians

More information

Electronic Prescribing of Controlled Substances

Electronic Prescribing of Controlled Substances Electronic Prescribing of Controlled Substances (EPCS) This document, as well as the software described in it, is provided under a software license agreement with STI Computer Services, Inc. Use of this

More information

FALCON EPCS INTERNAL POLICIES AND PROCEDURES

FALCON EPCS INTERNAL POLICIES AND PROCEDURES FALCON EPCS INTERNAL POLICIES AND PROCEDURES Falcon Physician will be audited by a third party* before it is used to create, sign, transmit, or process controlled substance prescriptions to ensure that

More information

TABLE OF CONTENTS Storage and Retrieval of Prescription Information for Controlled Substances

TABLE OF CONTENTS Storage and Retrieval of Prescription Information for Controlled Substances Department of Consumer Protection Sec. 21a-244 page 1 (2-98) TABLE OF CONTENTS Storage and Retrieval of Prescription Information for Controlled Substances Computer systems requirements... 21a-244-1 Refill

More information

Re: The Drug Enforcement Administration interim final rule on the Electronic Prescriptions for Controlled Substances

Re: The Drug Enforcement Administration interim final rule on the Electronic Prescriptions for Controlled Substances May 26, 2010 Michele M. Leonhart Deputy Administrator Drug Enforcement Administration DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, Virginia 22152 Re: The Drug Enforcement

More information

Electronic Prescribing of Controlled Substances: Establishing a Secure, Auditable Chain of Trust

Electronic Prescribing of Controlled Substances: Establishing a Secure, Auditable Chain of Trust Electronic Prescribing of Controlled Substances: Establishing a Secure, Auditable Chain of Trust Imprivata Confirm ID and the DEA Interim Final Rule on EPCS Technology requirements to comply with the DEA

More information

2015 Annual Convention

2015 Annual Convention 2015 Annual Convention Date: Saturday, October 10, 2015 Time: 11:45 am 12:15 pm Location: Gaylord National Harbor Resort and Convention Center, Chesapeake 7/8/9 Title: Activity Type: Speaker: Update on

More information

Pharmacy Leads the Way with eprescribing of Controlled Substances. March 24, 2015 Pharmacy Town Hall Series

Pharmacy Leads the Way with eprescribing of Controlled Substances. March 24, 2015 Pharmacy Town Hall Series Pharmacy Leads the Way with eprescribing of Controlled Substances March 24, 2015 Pharmacy Town Hall Series Presentation Description The majority of pharmacies are now capable of receiving electronic prescriptions

More information

BEYOND IDENTITY PROOFING: How EHRs Can Become More Than Just Vendors

BEYOND IDENTITY PROOFING: How EHRs Can Become More Than Just Vendors BEYOND IDENTITY PROOFING: How EHRs Can Become More Than Just Vendors INTRODUCTION The implementation of electronic prescribing, or e-prescribing, is one of the most the groundbreaking changes in healthcare.

More information

Re: Docket No. DEA-218, Electronic Prescriptions for Controlled Substances

Re: Docket No. DEA-218, Electronic Prescriptions for Controlled Substances American Society of Health-System Pharmacists 7272 Wisconsin Avenue Bethesda, Maryland 20814 (301) 657-3000 Fax: (301) 664-8877 www.ashp.org Drug Enforcement Administration Attention: DEA Federal Register

More information

FREQUENTLY ASKED QUESTIONS

FREQUENTLY ASKED QUESTIONS FREQUENTLY ASKED QUESTIONS for the Revised: February 2014 NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement 1-866-811-7957 www.health.ny.gov/professionals/narcotic Online PMP Q: What is

More information

FREQUENTLY ASKED QUESTIONS ABOUT ELECTRONIC DATA TRANSMISSION

FREQUENTLY ASKED QUESTIONS ABOUT ELECTRONIC DATA TRANSMISSION FREQUENTLY ASKED QUESTIONS ABOUT ELECTRONIC DATA TRANSMISSION for the Revised: July 2014 NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement 1-866-811-7957 www.health.ny.gov/professionals/narcotic

More information

May 21, 2010. Docket No. DEA-218. Dear Drug Enforcement Administration;

May 21, 2010. Docket No. DEA-218. Dear Drug Enforcement Administration; May 21, 2010 Drug Enforcement Administration Attention: DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, VA 22152 dea.diversion.policy@usdoj.gov Re: Docket No. DEA-218 Dear Drug

More information

VASCO: Compliant Digital Identity Protection for Healthcare

VASCO: Compliant Digital Identity Protection for Healthcare VASCO: Compliant Digital Identity Protection for Healthcare Compliant Digital Identity Protection for Healthcare The proliferation of digital patient information and a surge in government regulations are

More information

Pursuant to the authority vested in the Commissioner of Health by Article 33 of the

Pursuant to the authority vested in the Commissioner of Health by Article 33 of the Electronic Prescriptions and Records for Hypodermic Needles and Hypodermic Syringes Effective date: 10/9/13 Pursuant to the authority vested in the Commissioner of Health by Article 33 of the Public Health

More information

A Planning Guide for Electronic Prescriptions for Controlled Substances (EPCS)

A Planning Guide for Electronic Prescriptions for Controlled Substances (EPCS) A Planning Guide for Electronic Prescriptions for Controlled Substances (EPCS) The Federal Drug Enforcement Administration (DEA) regulates prescriptions of controlled substances that have risks for abuse.

More information

SAML for EPCS (Electronic Prescription of Controlled Substances)

SAML for EPCS (Electronic Prescription of Controlled Substances) SAML for EPCS (Electronic Prescription of Controlled Substances) Discussion Slides for review in the OASIS Security Services (SAML) TC August, 2014 DEA Regulation Compliance with New York s istop law-

More information

Department of Justice Drug Enforcement Administration Attention: DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, VA 22152

Department of Justice Drug Enforcement Administration Attention: DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, VA 22152 May 28, 2010 Department of Justice Drug Enforcement Administration Attention: DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, VA 22152 Docket No. DEA-218 21 CFR Parts 1300,

More information

Re: Docket No. DEA-218, Electronic Prescriptions for Controlled Substances, Interim Final Rule with Request for Comment

Re: Docket No. DEA-218, Electronic Prescriptions for Controlled Substances, Interim Final Rule with Request for Comment American Society of Health-System Pharmacists 7272 Wisconsin Avenue Bethesda, Maryland 20814 (301) 657-3000 Fax: (301) 664-8877 www.ashp.org Drug Enforcement Administration Attention: DEA Federal Register

More information

What Every Practitioner Needs to Know About Controlled Substance Prescribing

What Every Practitioner Needs to Know About Controlled Substance Prescribing What Every Practitioner Needs to Know About Controlled Substance Prescribing New York State Department of Health Use of Controlled Substances Controlled substances can be effective in the treatment of

More information

Narcotic Treatment Programs

Narcotic Treatment Programs This is a copy of two small segments of the DEA Pharmacist Manual, April 2004. This material is absent from the DEA Practitioner s Manual. Narcotic Treatment Programs The Narcotic Addict Treatment Act

More information

How Real-Time Data Integration is Changing the Face of Healthcare IT

How Real-Time Data Integration is Changing the Face of Healthcare IT How Real-Time Data Integration is Changing the Face of Healthcare IT INTRODUCTION The twin goals of the Affordable Care Act reducing costs and improving quality have triggered sweeping changes to the way

More information

Drug Diversion. Controlled Substance Prescribing and Diversion

Drug Diversion. Controlled Substance Prescribing and Diversion Drug Diversion Provider Presentation Controlled Substance Prescribing and Diversion Angela Wallace, R.Ph. Coastal District Inspector, PMP Law Enforcement Officer DHEC Bureau of Drug Control Presentation

More information

Re: Docket No. DEA-218I, Electronic Prescriptions for Controlled Substances, Interim Final Rule with Request for Comment

Re: Docket No. DEA-218I, Electronic Prescriptions for Controlled Substances, Interim Final Rule with Request for Comment June 1, 2010 Drug Enforcement Administration Attention: DEA Federal Register Representative/ODL 8701 Morrisette Drive Springfield, VA 22152 [Submitted electronically at: www.regulations.gov] Re: Docket

More information

E-Signature. The Pharmacy Perspective

E-Signature. The Pharmacy Perspective E-Signature The Pharmacy Perspective Prescriptions arrive at a pharmacy today... Written by a prescriber ( not always on a prescription pad). Do not always know the prescriber s s handwriting legibility

More information

Colorado Prescription Drug Monitoring Program. Department of Regulatory Agencies Division of Professions and Occupations State Board of Pharmacy

Colorado Prescription Drug Monitoring Program. Department of Regulatory Agencies Division of Professions and Occupations State Board of Pharmacy Colorado Prescription Drug Monitoring Program Department of Regulatory Agencies Division of Professions and Occupations State Board of Pharmacy DORA is dedicated to preserving the integrity of the marketplace

More information

MEDICAL ASSISTANCE BULLETIN

MEDICAL ASSISTANCE BULLETIN ISSUE DATE April 8, 2011 EFFECTIVE DATE April 8, 2011 MEDICAL ASSISTANCE BULLETIN NUMBER 03-11-01, 09-11-02, 14-11-01, 18-11-01 24-11-03, 27-11-02, 31-11-02, 33-11-02 SUBJECT Electronic Prescribing Internet-based

More information

RULES OF THE TENNESSEE BOARD OF NURSING CHAPTER 1000-04 ADVANCED PRACTICE NURSES AND CERTIFICATES OF FITNESS TO PRESCRIBE TABLE OF CONTENTS

RULES OF THE TENNESSEE BOARD OF NURSING CHAPTER 1000-04 ADVANCED PRACTICE NURSES AND CERTIFICATES OF FITNESS TO PRESCRIBE TABLE OF CONTENTS RULES OF THE TENNESSEE BOARD OF NURSING R 1000-04 ADVANCED PRACTICE NURSES AND CERTIFICATES TABLE OF CONTENTS 1000-04-.01 Purpose and Scope 1000-04-.07 Processing of Applications 1000-04-.02 Definitions

More information

E-Authentication Risk Assessment for. Electronic Prescriptions for Controlled Substances

E-Authentication Risk Assessment for. Electronic Prescriptions for Controlled Substances E-Authentication Risk Assessment for Electronic Prescriptions for Controlled Substances RIN 1117-AA61, Docket No. DEA-218 I. Introduction The Office of Management and Budget s E-Authentication Guidance

More information

Department of Justice

Department of Justice Wednesday, March 31, 2010 Part II Department of Justice Drug Enforcement Administration 21 CFR Parts 1300, 1304, 1306, and 1311 Electronic Prescriptions for Controlled Substances; Final Rule VerDate Nov2008

More information

NOTICE REQUIREMENTS FOR PRESCRIPTION MONITORING PROGRAMS

NOTICE REQUIREMENTS FOR PRESCRIPTION MONITORING PROGRAMS NOTICE REQUIREMENTS FOR PRESCRIPTION MONITORING PROGRAMS This project was supported by Grant No. G1299ONDCP03A, awarded by the Office of National Drug Control Policy. Points of view or opinions in this

More information

Electronic Signature Guidance

Electronic Signature Guidance National Council for Prescription Drug Programs White Paper Electronic Signature Guidance Version 1.0 February 2014 This document provides clarification and guidance to the industry for the use of electronic

More information

"Electronic Prescribing of Controlled Substances: Addressing Health Care and Law Enforcement Priorities" Before the Senate Judiciary Committee

Electronic Prescribing of Controlled Substances: Addressing Health Care and Law Enforcement Priorities Before the Senate Judiciary Committee DEA Congressional Testimony December 4, 2007 Statement of Joseph T. Rannazzisi Deputy Assistant Administrator Office of Diversion Control Drug Enforcement Administration "Electronic Prescribing of Controlled

More information

State of New York Executive Chamber Andrew M. Cuomo Governor

State of New York Executive Chamber Andrew M. Cuomo Governor State of New York Executive Chamber Andrew M. Cuomo Governor For Immediate Release: August 27, 2012 GOVERNOR CUOMO SIGNS LEGISLATION TO HELP NEW YORK STATE FIGHT PRESCRIPTION DRUG ABUSE Governor Andrew

More information

ALABAMA STATE BOARD OF PHARMACY ADMINISTRATIVE CODE CHAPTER 680-X-3 ALABAMA UNIFORM CONTROLLED SUBSTANCES TABLE OF CONTENTS

ALABAMA STATE BOARD OF PHARMACY ADMINISTRATIVE CODE CHAPTER 680-X-3 ALABAMA UNIFORM CONTROLLED SUBSTANCES TABLE OF CONTENTS Pharmacy Board Chapter 680-X-3 ALABAMA STATE BOARD OF PHARMACY ADMINISTRATIVE CODE CHAPTER 680-X-3 ALABAMA UNIFORM CONTROLLED SUBSTANCES TABLE OF CONTENTS 680-X-3-.01 680-X-3-.02 680-X-3-.03 680-X-3-.04

More information

Why should I report issues directly through my pharmacy management system vendor and not Surescripts?

Why should I report issues directly through my pharmacy management system vendor and not Surescripts? E-Prescribing FAQ Table of Contents p.4 How do I work with my pharmacy management system vendor to enable my pharmacy for e-prescribing via the Surescripts network? Why should I report issues directly

More information

Report on Electronic Prescribing in Medicaid and the Children s Health Insurance Program (CHIP)

Report on Electronic Prescribing in Medicaid and the Children s Health Insurance Program (CHIP) Report on Electronic Prescribing in Medicaid and the Children s Health Insurance Program (CHIP) As Required By S.B. 59, 83 rd Legislature, Regular Session, 2013 Health and Human Services Commission March

More information

USER S GUIDE - PHYSICIAN. Life Matters. Paula Escalante - PMP Educator (405) Kelly Couch - PMP Helpdesk 1-(877)

USER S GUIDE - PHYSICIAN. Life Matters. Paula Escalante - PMP Educator (405) Kelly Couch - PMP Helpdesk 1-(877) Paula Escalante - PMP Educator (405) 530-3105 Kelly Couch - PMP Helpdesk 1-(877) 627-2674 Don Vogt - PMP System Administrator (405) 521-2885 2016 Life Matters USER S GUIDE - PHYSICIAN OKLAHOMA BUREAU OF

More information

12 LC 33 4683S. The House Committee on Health and Human Services offers the following substitute to HB 972: A BILL TO BE ENTITLED AN ACT

12 LC 33 4683S. The House Committee on Health and Human Services offers the following substitute to HB 972: A BILL TO BE ENTITLED AN ACT The House Committee on Health and Human Services offers the following substitute to HB 972: A BILL TO BE ENTITLED AN ACT 1 2 3 4 5 6 7 8 9 10 11 12 13 To amend Chapter 34 of Title 43 of the Official Code

More information

Statement of the Federation of State Medical Boards of the United States

Statement of the Federation of State Medical Boards of the United States Statement of the Federation of State Medical Boards of the United States Introduction Drug Enforcement Agency Hearing on Electronic Prescriptions for Controlled Substances Presented by Lisa A. Robin Vice

More information

HOUSE OF REPRESENTATIVES STAFF ANALYSIS REFERENCE ACTION ANALYST STAFF DIRECTOR. 1) Health Care Mitchell Collins 2) 3) 4) 5)

HOUSE OF REPRESENTATIVES STAFF ANALYSIS REFERENCE ACTION ANALYST STAFF DIRECTOR. 1) Health Care Mitchell Collins 2) 3) 4) 5) HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: HB 103 Medicinal Drug Prescriptions SPONSOR(S): Quinones TIED BILLS: IDEN./SIM. BILLS: SB 132 (i) REFERENCE ACTION ANALYST STAFF DIRECTOR 1) Health Care

More information

The Impact of 21 CFR Part 11 on Product Development

The Impact of 21 CFR Part 11 on Product Development The Impact of 21 CFR Part 11 on Product Development Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical

More information

Oracle WebCenter Content

Oracle WebCenter Content Oracle WebCenter Content 21 CFR Part 11 Certification Kim Hutchings US Data Management Phone: 888-231-0816 Email: khutchings@usdatamanagement.com Introduction In May 2011, US Data Management (USDM) was

More information

21 CFR Part 11 Implementation Spectrum ES

21 CFR Part 11 Implementation Spectrum ES 21 CFR Part 11 Implementation Spectrum ES INFRARED SPECTROSCOPY T E C H N I C A L N O T E Introduction Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell

More information

D R A F T SUMMARY. prescription monitoring information submitted under ORS 431A.860 to

D R A F T SUMMARY. prescription monitoring information submitted under ORS 431A.860 to LC 0 Regular Session // (SCT/ps) D R A F T SUMMARY Requires Oregon Health Authority to disclose prescription monitoring information to practitioner or pharmacist or member of practitioner s or pharmacist

More information

Prescription Drug Monitoring Program Administrators Guide for Training Law Enforcement

Prescription Drug Monitoring Program Administrators Guide for Training Law Enforcement Prescription Drug Monitoring Program Administrators Guide for Training Law Enforcement 2013 Telephone: (781) 609-7741 Fax: (888) 705-8053 Email: info@pdmpassist.org Website: www.pdmpassist.org INTRODUCTION

More information

E-Prescribing FAQ s for Independent Pharmacies Table of Contents

E-Prescribing FAQ s for Independent Pharmacies Table of Contents Table of Contents How do I work with my software vendor to enable my pharmacy for e-prescribing via the Surescripts network?...2 Why must I report issues directly through my software vendor and not Surescripts?...2

More information

November 2009 Special Edition

November 2009 Special Edition NOVEMBER 2009 MEDICAID UPDATE Volume 25, Number 14, www.nyhealth.gov DAVID A. PATERSON GOVERNOR State of New York RICHARD F. DAINES, M.D. COMMISSIONER New York State DOH DEBORAH BACHRACH DEPUTY COMMISSIONER

More information

A ChemoMetec A/S White Paper September 2013

A ChemoMetec A/S White Paper September 2013 NucleoCounter NC-3000, NucleoView NC-3000 Software and Code of Federal Regulation 21 Part 11; Electronic Records, Electronic Signatures (21 CFR Part 11) A ChemoMetec A/S White Paper September 2013 ChemoMetec

More information

CALIFORNIA controlled substance prescription pads FAQ s

CALIFORNIA controlled substance prescription pads FAQ s CALIFORNIA controlled substance prescription pads FAQ s Q: Where can I find the regulations for the controlled substance prescription pads for the state of California? A: http://law.onecle.com/california/health/11162.1.html

More information

SECTION.1800 - PRESCRIPTIONS

SECTION.1800 - PRESCRIPTIONS SECTION.1800 - PRESCRIPTIONS 21 NCAC 46.1801 EXERCISE OF PROFESSIONAL JUDGMENT IN FILLING PRESCRIPTIONS (a) A pharmacist or device and medical equipment dispenser shall have a right to refuse to fill or

More information

NH Laws / Rules Regarding Limited Retail Drug Distributors

NH Laws / Rules Regarding Limited Retail Drug Distributors NH Laws / Rules Regarding Limited Retail Drug Distributors 318:1, VII-a. "Limited retail drug distributor'' means a distributor of legend devices or medical gases delivered directly to the consumer pursuant

More information

Prescription Drug Monitoring Program. A Powerful Tool

Prescription Drug Monitoring Program. A Powerful Tool Prescription Drug Monitoring Program A Powerful Tool September 16, 2015 No reportable financial interest. Controlled Substance Utilization Review and Evaluation System >16,000 Prescription Painkiller Overdose

More information

Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy

Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy Legislative changes PDMP program changes 503B outsourcing facilities Rules changes Ph800 review Ph300 Ph400 Ph700 Current issues

More information

- 1 - First Time Pharmacy Managers (Revised 02/02/2011)

- 1 - First Time Pharmacy Managers (Revised 02/02/2011) State of Connecticut Department of Consumer Protection Commission of Pharmacy 165 Capitol Avenue, Room 147 Hartford, CT 06106 - Telephone: 860-713-6070 ALL FIRST-TIME PHARMACY MANAGERS ARE REQUIRED TO

More information

NOTICES OF PROPOSED RULEMAKING

NOTICES OF PROPOSED RULEMAKING NOTICES OF PROPOSED RULEMAKING Unless exempted by A.R.S. 41-1005, each agency shall begin the rulemaking process by first submitting to the Secretary of State s Office a Notice of Rulemaking Docket Opening

More information

McKesson Practice Choice TM Electronic Prescribing of Controlled Substances (EPCS) Frequently Asked Questions

McKesson Practice Choice TM Electronic Prescribing of Controlled Substances (EPCS) Frequently Asked Questions Overview McKesson Practice Choice TM Electronic Prescribing of Controlled Substances (EPCS) Frequently Asked Questions What is EPCS? EPCS stands for Electronic Prescribing of Controlled Substances. Our

More information

E-PRESCRIBING OF CONTROLLED SUBSTANCES

E-PRESCRIBING OF CONTROLLED SUBSTANCES E-PRESCRIBING OF CONTROLLED SUBSTANCES WELCOME Anthony Pudlo, PharmD, MBA, BCACP Vice President, Professional Affairs Iowa Pharmacy Association Outline of Today s 2/2/2 PRESENTER Ken Whittemore, Jr., R.Ph.,

More information

Review of Maine Pharmacy Rules. An update of new rules adopted 12/11/2013

Review of Maine Pharmacy Rules. An update of new rules adopted 12/11/2013 Review of Maine Pharmacy Rules An update of new rules adopted 12/11/2013 This review is meant to highlight important changes and additions to the rules as adopted on 12/11/2013. We will cover the rules

More information

Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries

Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries White Paper No 01 I December 2010 Implementation of 21 CFR Part 11 in the epmotion Software Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device

More information

COMPILATION OF STATE PRESCRIPTION MONITORING PROGRAM MAPS

COMPILATION OF STATE PRESCRIPTION MONITORING PROGRAM MAPS MTION OF STATE PREPTION NITONG PROGRAM PS This project was supported by Cooperative Agreement No. 202-DC-BX-K002 awarded by the Bureau of Justice Assistance. The Bureau of Justice Assistance is a component

More information

STATE PLAN TO PREVENT AND TREAT PRESCRIPTION DRUG ABUSE RECOMMENDATION SUMMARY Governor s Prescription Drug Abuse Prevention Council

STATE PLAN TO PREVENT AND TREAT PRESCRIPTION DRUG ABUSE RECOMMENDATION SUMMARY Governor s Prescription Drug Abuse Prevention Council STATE PLAN TO PREVENT AND TREAT PRESCRIPTION DRUG ABUSE RECOMMENDATION SUMMARY Governor s Prescription Drug Abuse Prevention Council PRIORITY AREA: PRESCRIBERS Recommendation: The Council recommends that

More information

POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM

POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM W H I T E P A P E R POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM This white paper is written for senior executives

More information

Second Annual Florida 2008 Electronic Prescribing Report

Second Annual Florida 2008 Electronic Prescribing Report Second Annual Florida 2008 Electronic Prescribing Report FLORIDA CENTER FOR HEALTH INFORMATION AND POLICY ANALYSIS AGENCY FOR HEALTH CARE ADMINISTRATION JANUARY 2009 Better Health Care for All Floridians

More information

Full Compliance Contents

Full Compliance Contents Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex

More information

SUBSTITUTE FOR HOUSE BILL NO. 5326

SUBSTITUTE FOR HOUSE BILL NO. 5326 SUBSTITUTE FOR HOUSE BILL NO. 5326 A bill to amend 1978 PA 368, entitled "Public health code," by amending sections 7333a, 7422, 17708, and 17757 (MCL 333.7333a, 333.7422, 333.17708, and 333.17757), section

More information

Controlled II Substance Rules & Regulations. Controlled II Substance Rules & Regulations

Controlled II Substance Rules & Regulations. Controlled II Substance Rules & Regulations North Carolina Board of Pharmacy Controlled Substance Pocketcard A brief summary of pertinent rules and regulations impacting the practice of pharmacy ~ Controlled II Substance Controlled II Substance

More information

SCOPE OF PRACTICE FOR ARNPS

SCOPE OF PRACTICE FOR ARNPS FLORIDA'S PROHIBITION ON ADVANCED REGISTERED NURSE PRACTITIONERS (ARNPs) PRESCRIBING CONTROLLED SUBSTANCES AND THE REQUIREMENTS TO REPORT SUCH ACTIVITY Florida is one of the two states that does not allow

More information

Electronic Prescribing System (EPCS)

Electronic Prescribing System (EPCS) Electronic Prescribing System (EPCS) In order to use EPCS in Wells Px3, the following steps must be completed: 1. Each prescriber who wants to use EPCS completes the signup process 2. Practice sets the

More information

Technical Safeguards is the third area of safeguard defined by the HIPAA Security Rule. The technical safeguards are intended to create policies and

Technical Safeguards is the third area of safeguard defined by the HIPAA Security Rule. The technical safeguards are intended to create policies and Technical Safeguards is the third area of safeguard defined by the HIPAA Security Rule. The technical safeguards are intended to create policies and procedures to govern who has access to electronic protected

More information

Alaska Prescription Drug Monitoring Program

Alaska Prescription Drug Monitoring Program Alaska 1. What is a PDMP? PDMP stands for. This is a commonly used term for the programs implemented by various states to monitor the dispensing of controlled substances within their borders. For this

More information

Thank you for choosing Rcopia, the award-winning e-prescribing system from DrFirst! This packet contains all the registration forms needed to get

Thank you for choosing Rcopia, the award-winning e-prescribing system from DrFirst! This packet contains all the registration forms needed to get Thank you for choosing Rcopia, the award-winning e-prescribing system from DrFirst! This packet contains all the registration forms needed to get your practice up-and-running with Rcopia. Registration

More information

Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.

Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title

More information

Fourth Annual Florida 2010 Electronic Prescribing Report

Fourth Annual Florida 2010 Electronic Prescribing Report Fourth Annual Florida 2010 Electronic Prescribing Report FLORIDA CENTER FOR HEALTH INFORMATION AND POLICY ANALYSIS AGENCY FOR HEALTH CARE ADMINISTRATION JANUARY 2011 Better Health Care for All Floridians

More information

American Indian Health Commission for Washington State October 1, 2015

American Indian Health Commission for Washington State October 1, 2015 American Indian Health Commission for Washington State October 1, 2015 States with more opioid pain reliever sales tend to have more drug overdose deaths Death rate, 2011, National Vital Statistics System.

More information

Implementation of 21CFR11 Features in Micromeritics Software Software ID

Implementation of 21CFR11 Features in Micromeritics Software Software ID Implementation of 21CFR11 Features in Micromeritics Software Software ID PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A General Provisions Sec. 11.1 Scope. 11.2 Implementation. 11.3 Definitions.

More information

SASKATCHEWAN COLLEGE OF PHARMACISTS Electronic Transmission of Prescriptions. Policy Statement and Guidelines for Pharmacists

SASKATCHEWAN COLLEGE OF PHARMACISTS Electronic Transmission of Prescriptions. Policy Statement and Guidelines for Pharmacists SASKATCHEWAN COLLEGE OF PHARMACISTS Electronic Transmission of Prescriptions PREAMBLE This document replaces the Operational Guidelines - Facsimile Transmission of Prescriptions Current legislation allows

More information

How do I work with my pharmacy management system vendor to enable my pharmacy for e-prescribing via the Surescripts network?

How do I work with my pharmacy management system vendor to enable my pharmacy for e-prescribing via the Surescripts network? Table of Contents How do I work with my pharmacy management system vendor to enable my pharmacy for e-prescribing via the Surescripts network?...1 Why should I report issues directly through my pharmacy

More information

Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures

Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures Subpart A General Provisions Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria

More information

Electronic Prescribing of Controlled Substances Technical Framework Panel. Mark Gingrich, RxHub LLC July 11, 2006

Electronic Prescribing of Controlled Substances Technical Framework Panel. Mark Gingrich, RxHub LLC July 11, 2006 Electronic Prescribing of Controlled Substances Technical Framework Panel Mark Gingrich, RxHub LLC July 11, 2006 RxHub Overview Founded 2001 as nationwide, universal electronic information exchange Encompass

More information

Adopted Rule - 11/19/14 1

Adopted Rule - 11/19/14 1 Adopted Rule - 11/19/14 1 CHAPTER Ph 800 PHARMACY TECHNICIANS Statutory Authority: RSA 318:5-a, X, XI Adopt Ph 801 & Ph 802, previously effective 7-25-01 (Doc. # 7535) and expired on 7-25-09, to read as

More information

INSTRUCTIONS FOR USE: OA-RX

INSTRUCTIONS FOR USE: OA-RX P a g e 1 INSTRUCTIONS FOR USE: OA-RX Welcome to Office Ally s Electronic Prescription module, called OA-Rx. This web-based program has been designed to integrate into Office Ally s Practice Mate and EHR

More information

What is an e-prescription?

What is an e-prescription? Page 1 of 6 patient medical records and eligibility available at the moment of prescribing and dispensing the medication. Serving the insured population in Dubai What is an e-prescription? It is the computer-based

More information

Federal Regulations For Prescribing Scheduled Controlled Substances

Federal Regulations For Prescribing Scheduled Controlled Substances Federal Regulations For Prescribing Scheduled Controlled Substances HEIT TEMPLATE.PPT 1 Central Principle of Balance With the Use of Controlled Substances Dual imperative of government Establish a system

More information

Electronic Prescriptions for Controlled Substances (EPCS)

Electronic Prescriptions for Controlled Substances (EPCS) Electronic Prescriptions for Controlled Substances (EPCS) Michael Burger Director, Clinical Product Management Director, Strategic Clinical Initiatives Washington, DC July 12, 2006 Emdeon Corporation WebMD

More information

September 25, 2008. Dear Acting Administrator Leonhart:

September 25, 2008. Dear Acting Administrator Leonhart: September 25, 2008 Michele M. Leonhart Acting Administrator Drug Enforcement Administration DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, Virginia 22152 Re: The Drug Enforcement

More information

FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER

FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER Copyright 2012 FileHold Systems Inc. All rights reserved. For further information about this manual or other FileHold Systems products,

More information

State Advocacy Guide to Prescription Drug Monitoring Program Legislation and Regulations

State Advocacy Guide to Prescription Drug Monitoring Program Legislation and Regulations State Advocacy Guide to Prescription Drug Monitoring Program Legislation and Regulations There is currently an epidemic of prescription opioid abuse, misuse and diversion in the U.S. Numerous federal,

More information

Florida Electronic Prescribing Annual Report for 2012

Florida Electronic Prescribing Annual Report for 2012 Florida Electronic Prescribing Annual Report for 2012 FLORIDA CENTER FOR HEALTH INFORMATION AND POLICY ANALYSIS AGENCY FOR HEALTH CARE ADMINISTRATION JANUARY 2013 Better Health Care for All Floridians

More information

Technical Assistance Guide No Additional Data Fields for PDMPs to Consider Collecting from Dispensers

Technical Assistance Guide No Additional Data Fields for PDMPs to Consider Collecting from Dispensers Technical Assistance Guide No. 01-14 Additional Data Fields for PDMPs to Consider Collecting from Dispensers March 12, 2014 Introduction Prescription Drug Monitoring Programs (PDMPs) are important tools

More information

21 CFR Part 11 Electronic Records & Signatures

21 CFR Part 11 Electronic Records & Signatures Gap Analysis - Checklist 21 CFR Part 11 Electronic Records & Signatures his document is a proposal and starting point only. he type and extent of documentation depends on the process environment. he proposed

More information