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Board of Registration Board of Registration

in Nursingin Nursing

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Module 5 Module 5 Guidelines: Preparing for Guidelines: Preparing for

Advanced Practice Advanced Practice Registered Nurse Registered Nurse

Prescriptive PracticePrescriptive Practice

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Prescriptive PracticePrescriptive Practice

• RequirementsRequirements• Board authorization as APRNBoard authorization as APRN• A minimum of 24 contact hours in A minimum of 24 contact hours in

pharmacotherapeutics beyond those acquired pharmacotherapeutics beyond those acquired in generic nursing education programin generic nursing education program

• Valid registration(s) to issue written or oral Valid registration(s) to issue written or oral prescriptions or medication orders from prescriptions or medication orders from Massachusetts Department of Public Health, Massachusetts Department of Public Health, Drug Control Program for schedule VI and from Drug Control Program for schedule VI and from US Drug Enforcement Administration for US Drug Enforcement Administration for schedule II – V schedule II – V

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M.G.L. 112, s. 80E, 80G, M.G.L. 112, s. 80E, 80G, 80H80H

• Legal authorization for APRN to issue written prescriptions and Legal authorization for APRN to issue written prescriptions and order tests and therapeutics pursuant to guidelines mutually order tests and therapeutics pursuant to guidelines mutually developed and agreed upon by the nurse and the supervising developed and agreed upon by the nurse and the supervising physician in accordance with regulations promulgated jointly physician in accordance with regulations promulgated jointly by the board and the board of registration in medicineby the board and the board of registration in medicine

• CNM are exempt from the requirement for supervising CNM are exempt from the requirement for supervising physician and guidelinesphysician and guidelines

• CNS do not have prescriptive authority in MACNS do not have prescriptive authority in MA

• A prescription made by an CNP, CRNA, PCNS must include the A prescription made by an CNP, CRNA, PCNS must include the name of the physician with whom such nurse has developed name of the physician with whom such nurse has developed and signed mutually agreed upon guidelinesand signed mutually agreed upon guidelines

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M.G.L. 94C – Controlled M.G.L. 94C – Controlled Substances ActSubstances Act

• ““Controlled substance” is defined Controlled substance” is defined as a drug, substance, or immediate as a drug, substance, or immediate precursor in precursor in anyany schedule or class schedule or class

• Massachusetts statute Massachusetts statute http://www.mass.gov/legis/laws/mgl/gl-94c-toc.hthttp://www.mass.gov/legis/laws/mgl/gl-94c-toc.htmm

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Title 21 – Food and DrugsTitle 21 – Food and DrugsChapter 13Chapter 13

• Drug Abuse Prevention and ControlDrug Abuse Prevention and Control

• Division of Food and DrugsDivision of Food and Drugs

• Federal statutesFederal statuteshttp://uscode.house.gov/download/pls/21C13.txthttp://uscode.house.gov/download/pls/21C13.txt

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Prescription SchedulesPrescription Schedules

• Schedule I Schedule I • (A) The drug or other substance has a (A) The drug or other substance has a

high potential for abuse.high potential for abuse.• (B) The drug or other substance has (B) The drug or other substance has

no currently accepted medical use in no currently accepted medical use in treatment in the United States.treatment in the United States.

• (C) There is a lack of accepted safety (C) There is a lack of accepted safety for use of the drug or other substance for use of the drug or other substance under medical supervision.under medical supervision.

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Schedule IISchedule II

(A) The drug or other substance has a high (A) The drug or other substance has a high potential for abuse.potential for abuse.

(B) The drug or other substance has a currently (B) The drug or other substance has a currently accepted medical use in treatment in the United accepted medical use in treatment in the United States or a currently accepted medical use with States or a currently accepted medical use with severe restrictions.severe restrictions.

(C) Abuse of the drug or other substances may (C) Abuse of the drug or other substances may lead to severe psychological or physical lead to severe psychological or physical dependence.dependence.

No prescription for a controlled substance in No prescription for a controlled substance in schedule II may be refilled. schedule II may be refilled.

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Schedule IIISchedule III

(A) The drug or other substance has a potential for abuse (A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I less than the drugs or other substances in schedules I and II.and II.

(B) The drug or other substance has a currently accepted (B) The drug or other substance has a currently accepted medical use in treatment in the United States.medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to (C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high moderate or low physical dependence or high psychological dependence. psychological dependence.

Such prescriptions may not be filled or refilled more than Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more six months after the date thereof or be refilled more

than five times after the date of the prescription unless than five times after the date of the prescription unless renewed by the practitioner.renewed by the practitioner.[[

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Schedule IVSchedule IV

(A) The drug or other substance has a low potential for (A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in abuse relative to the drugs or other substances in schedule III.schedule III.

(B) The drug or other substance has a currently accepted (B) The drug or other substance has a currently accepted medical use in treatment in the United States.medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological limited physical dependence or psychological dependence relative to the drugs or other substances dependence relative to the drugs or other substances in schedule III.in schedule III.

Control measures are similar to Schedule III. Control measures are similar to Schedule III. Prescriptions for Schedule IV drugs may be refilled up Prescriptions for Schedule IV drugs may be refilled up

to five times within a six month period.to five times within a six month period.

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Schedule VSchedule V

(A) The drug or other substance has a low potential for (A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in abuse relative to the drugs or other substances in schedule IV.schedule IV.

(B) The drug or other substance has a currently (B) The drug or other substance has a currently accepted medical use in treatment in the United accepted medical use in treatment in the United States.States.

(C) Abuse of the drug or other substance may lead to (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological limited physical dependence or psychological dependence relative to the drugs or other substances dependence relative to the drugs or other substances in schedule IV.in schedule IV.

No controlled substance in schedule V which is a drug may be No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purposedistributed or dispensed other than for a medical purpose

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Schedule VISchedule VI

Massachusetts designated schedule Massachusetts designated schedule for all prescription medications for all prescription medications

that do not fall into Scheduled I - Vthat do not fall into Scheduled I - V

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105 CMR 700.000105 CMR 700.000

• Massachusetts regulationsMassachusetts regulations• Implementation of 94CImplementation of 94C• DefinitionsDefinitions• Registration requirementsRegistration requirements• Security requirementsSecurity requirements

http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr700.phttp://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr700.pdf df

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105 CMR 721.000105 CMR 721.000Standards for prescription format and Standards for prescription format and

securitysecurity

1. the registration number of the practitioner;2. date of issuance of the prescription;3. name, dosage, and strength per dosage unit of the

controlled substance prescribed, and the quantity of dosage units;

4. name and address of the patient, except in a veterinary prescription;

5. directions for use, including any cautionary statements required; and

6. a statement indicating the number of times to be refilled.

http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr721.pdf

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In addition…….In addition…….

Paper prescriptions written by CNP, CRNA, PCNS must also contain the name of the supervising physician.

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Other RequirementsOther Requirements• Special security standards for paper Special security standards for paper

(review 105 CMR 721.000)(review 105 CMR 721.000)• Indication that “Interchange is mandated

unless the practitioner indicates ‘no substitution’ in accordance with the law”

• The name and address of the practitioner must be clearly indicated on the prescription

• A hospital or clinic prescription must have the name and address of the hospital or clinic clearly indicated on the prescription

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CNP, CRNA, PCNS Required to Have CNP, CRNA, PCNS Required to Have Prescriptive Practice GuidelinesPrescriptive Practice Guidelines

• CNM exempt from guideline requirementCNM exempt from guideline requirement

• CNS do not have prescriptive authority in CNS do not have prescriptive authority in MAMA

• Board may request at any time an Board may request at any time an opportunity to review the APRN’s opportunity to review the APRN’s prescriptive practice guidelines. prescriptive practice guidelines.

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Content of GuidelinesContent of Guidelines• identify the supervising physician and APRN;identify the supervising physician and APRN;

• include a defined mechanism for the delegation of supervision to another physician include a defined mechanism for the delegation of supervision to another physician including, but not limited to, duration and scope of the delegation;including, but not limited to, duration and scope of the delegation;

• describe the nature and scope of the APRN's prescribing practice;describe the nature and scope of the APRN's prescribing practice;

• identify any limitations on medications or intravenous therapy to be prescribed;identify any limitations on medications or intravenous therapy to be prescribed;

• describe circumstances in which physician consultation or referral is required for the describe circumstances in which physician consultation or referral is required for the pharmacologic treatment of medical conditions;pharmacologic treatment of medical conditions;

• include a defined mechanism and time frame to monitor prescribing practices;include a defined mechanism and time frame to monitor prescribing practices;

• specify that the initial prescription of Schedule II drugs must be reviewed within 96 hours; specify that the initial prescription of Schedule II drugs must be reviewed within 96 hours;

• be kept on file in the workplace and be reviewed and re-executed every two years; andbe kept on file in the workplace and be reviewed and re-executed every two years; and

• conform to M.G.L. c. 94C, the regulations of the Department of Public Health at 105 CMR conform to M.G.L. c. 94C, the regulations of the Department of Public Health at 105 CMR 700.000 700.000 et seq.et seq., 105 CMR 721.000 et seq., M.G.L. c. 112, §§ 80B, 80C, 80E, 80G, 80H, and , 105 CMR 721.000 et seq., M.G.L. c. 112, §§ 80B, 80C, 80E, 80G, 80H, and 244 CMR 4.00.244 CMR 4.00.

Audit tool located at: Audit tool located at: http://www.mass.gov/eohhs/docs/dph/quality/boards/apnaudit.pdfhttp://www.mass.gov/eohhs/docs/dph/quality/boards/apnaudit.pdf

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Educational RequirementEducational Requirement• As of January 1, 2011, pursuant to MGL 94C, Section 18(e), As of January 1, 2011, pursuant to MGL 94C, Section 18(e),

all prescribers, upon initial application for MA Controlled all prescribers, upon initial application for MA Controlled Substance Registration (MCSR) and subsequently during Substance Registration (MCSR) and subsequently during each APRN license renewal period, must complete each APRN license renewal period, must complete education relative to: education relative to: • effective pain management, effective pain management, • identification of patients at high risk for substance abuse, and identification of patients at high risk for substance abuse, and • counseling patients about the side effects, addictive nature counseling patients about the side effects, addictive nature

and proper storage and disposal of prescription medications. and proper storage and disposal of prescription medications.

• Please note that MGL 94C, Section 18(e) does not specify a Please note that MGL 94C, Section 18(e) does not specify a minimum number of contact hours to comply with this minimum number of contact hours to comply with this education requirement. All continuing education offerings education requirement. All continuing education offerings must be consistent with the Board of Registration in must be consistent with the Board of Registration in Nursing (Board) requirements at 244 CMR 5.00: Nursing (Board) requirements at 244 CMR 5.00: Continuing Continuing EducationEducation and, for this specific requirement, the Board and, for this specific requirement, the Board Advisory Ruling #0901:Advisory Ruling #0901: Management of Pain Management of Pain. .

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Read What You SignRead What You Sign

By signing the MCSR form and by your By signing the MCSR form and by your signature on your license renewal signature on your license renewal form, you attest under penalties of form, you attest under penalties of perjury that you have complied with perjury that you have complied with state tax and child support laws, state tax and child support laws, mandatory reporting laws, and all mandatory reporting laws, and all Board laws and regulations, Board laws and regulations, including continuing education including continuing education requirements. requirements.

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Changing Supervising Changing Supervising Physician?Physician?

• If guidelines have not expired, either If guidelines have not expired, either amend with new, dated signatures amend with new, dated signatures of APRN and supervising physician of APRN and supervising physician or write and sign new guidelinesor write and sign new guidelines

• Must contact MA Department of Must contact MA Department of Public Health, Drug Control Program Public Health, Drug Control Program to amend MA Controlled Substance to amend MA Controlled Substance RegistrationRegistration

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Changing Practice Changing Practice Location?Location?

• Must contact Drug Enforcement Must contact Drug Enforcement Agency (DEA) to amend formAgency (DEA) to amend form

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Prescription Monitoring Prescription Monitoring Program (PMP)Program (PMP)

• tool that supports safe prescribing and dispensing and assists in addressing tool that supports safe prescribing and dispensing and assists in addressing prescription drug misuse and abuseprescription drug misuse and abuse

• collects prescribing and dispensing information on Massachusetts Schedule II collects prescribing and dispensing information on Massachusetts Schedule II through V controlled substances dispensed pursuant to a prescriptionthrough V controlled substances dispensed pursuant to a prescription

• utilizes PMP data to determine prescribing and dispensing trendsutilizes PMP data to determine prescribing and dispensing trends

• provides patient prescription history information to prescribers and provides patient prescription history information to prescribers and dispensersdispensers

• provides educational information to health care providers and the publicprovides educational information to health care providers and the public

• provides case information to regulatory and law enforcement agencies provides case information to regulatory and law enforcement agencies concerning drug distribution and diversionconcerning drug distribution and diversion

• www.mass.gov/dph/dcp/onlinepmpwww.mass.gov/dph/dcp/onlinepmp

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Prescription Monitoring Prescription Monitoring Program (PMP)Program (PMP)

• Prescribers will be automatically Prescribers will be automatically enrolled into program upon initial enrolled into program upon initial or renewal of MA Controlled or renewal of MA Controlled Substance Registration (MCSR)Substance Registration (MCSR)

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Legal DocumentationLegal Documentation

• In all records required by federal and state In all records required by federal and state laws and regulations and accepted standards laws and regulations and accepted standards of nursing practiceof nursing practice• Must be accurate, complete, legibleMust be accurate, complete, legible• Sign name and initials as they appear on Sign name and initials as they appear on

your license (CNP, PCNS, CRNA, CNM, CNS)your license (CNP, PCNS, CRNA, CNM, CNS)

• May use certification credentials on business May use certification credentials on business cards, stationary, advertisements, and other cards, stationary, advertisements, and other similar correspondencesimilar correspondence

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MA Controlled Substance MA Controlled Substance Registration (MCSR)Registration (MCSR)

Contact the Drug Control Program Contact the Drug Control Program through the Department of Public through the Department of Public

HealthHealth

www.mass.gov/dph/dcpwww.mass.gov/dph/dcp

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Federal RegistrationFederal Registration

Contact the Contact the

Federal Drug Enforcement AgencyFederal Drug Enforcement Agency

http://www.justice.gov/deahttp://www.justice.gov/dea

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Review 4.00 and 9.00Review 4.00 and 9.00

• Go to the Board’s website to review:Go to the Board’s website to review:• 244 CMR 4.00: Massachusetts 244 CMR 4.00: Massachusetts

Regulations Governing Advanced Regulations Governing Advanced Practice Registered NursingPractice Registered Nursing

• 244 CMR 9.00: Standards of Conduct244 CMR 9.00: Standards of Conduct

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Get into the habit of Get into the habit of Checking the Board’s WebsiteChecking the Board’s Website

www.mass.gov/dph/boards/rnwww.mass.gov/dph/boards/rn

• News and UpdatesNews and Updates• Practice IssuesPractice Issues• AlertsAlerts• Regulatory GuidanceRegulatory Guidance• Advisory RulingsAdvisory Rulings• NewslettersNewsletters