D.27- ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCE PROCESSING, INPATIENT AND OUTPATIENT PRESCRIBING AND DISPENSING.pdf

ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCE PROCESSING

SOP 119-010

Syracuse VA Medical Center Syracuse, NY 13210

Signatory Authority:

Chief of Staff

Responsible Owner:

Chief, Pharmacy Service

Service Line(s):

Pharmacy

Effective Date:

July 2021

Recertification Date:

July 2026

1. PURPOSE AND AUTHORITY

a. The purpose of this standard operating procedure (SOP) is to establish duties related to Electronic Prescriptions for Controlled Substance (EPCS) processing. This SOP must be followed by Syracuse VA employees who help facilitate electronic prescribing access for authorized staff providers, resident physicians, and Certified Registered Nurse Anesthetists (CRNAs).

b. There is no governing document.

2. PROCEDURES

a. Establishing authorization.

(1) Once the staff provider/resident physician has a functioning PIV card, the Integrated Care Community (ICC) Administrative Officer or their designee will send an e-mail to the “VHASYR Electronic Prescribing Of Controlled Substances” e-mail group with the name(s) of VA Staff Provider(s) or VA Resident Physician(s) requiring medication writing ability.

(2) VA Staff Providers:

(a) The Credentialing representative for VA staff providers will verify provider Drug Enforcement Agency (DEA) number using the DEA Registration Validation website:

https://apps.deadiversion.usdoj.gov/webforms/validateLogin.jsp.

(b) Once Credentialing verifies that the VA staff provider has a valid DEA number, they will open the ePCS GUI app and check the box “Authorized to Write Med Orders”, enter the DEA number, enter the DEA expiration date and check only the II-V schedules the provider is permitted to prescribe.

(c) Credentialing will then reply to the initial email when complete.

(3) For Residents/ Fellows/ Trainees:

(a) The Human Resource representative for VA resident physicians will verify that

Attachment D.27 RFP 36C24224R0049 https://apps.deadiversion.usdoj.gov/webforms/validateLogin.jsp

July 2021 SOP 119-010 the resident physician has been cleared to begin working at the Syracuse VA Medical Center.

(b) Once Human Resources verifies that the resident physician is cleared to work, they will open the ePCS GUI app and check the box “Authorized to Write Med Orders”, enter the provider VA number (suffix number), and check the box “Select all Schedules” (permitting to prescribe all schedules II-V).

(c) Human Resources will then reply to the initial email when complete.

(4) Credentialing and Human Resources will utilize the secure SharePoint document on the Pharmacy Service SharePoint Site (“Electronic Prescribing of Controlled Substances”) to list providers with med-write access and document:

(a) The provider’s valid DEA number/suffix number.

(b) The provider’s valid DEA expiration date.

(c) That the provider has been credentialed/cleared to prescribe and information has been entered into the ePCS GUI app.

b. Enabling Access.

(1) Once the provider has been credentialed/verified and all pertinent information has been entered into the GUI app, Credentialing/Human Resources will “Reply to All” on the initial email string sent to the ‘VHASYR Electronic Prescribing of Controlled Substances’ group by the Administrative Officer or designee, notifying Pharmacy that the provider is ready to be “enabled” to prescribe controlled substances.

(2) The Pharmacy service will utilize the secure SharePoint document on the Pharmacy Service SharePoint site (‘Electronic Prescribing of Controlled Substances’) to verify the provider’s valid DEA number/suffix number and expiration date have been entered into the ePCS system, and that the individual is credentialed/cleared to prescribe controlled substances.

(3) Pharmacy will “enable” the provider’s access to prescribe controlled substances in the ePCS system (VistA) after verifying that Credentialing or Human Resources has entered the required information as outlined above.

(4) Pharmacy will update the SharePoint document to reflect that the provider has been enabled and will “Reply to All” on the email sent from Credentialing or Human Resources once the provider has been enabled in VistA.

3. ASSIGNMENT OF RESPONSIBILITIES.

a. Integrated Care Community (ICC) Administrative Officer. The Integrated Care Community (ICC) Administrative Officer or designee is responsible for:

(1) Ensuring the VA staff physician or VA resident physician has a valid PIV card.

And emailing the ‘VHASYR Electronic Prescribing of Controlled substances’ group with the name(s) of provider(s) requiring medication writing ability, as outlined above.

b. Credentialing. The Credentialing representative for VA staff providers is responsible for:

(1) Verifying VA staff provider DEA information, updating the ePCS GUI app, updating the ePCS SharePoint document, and notifying the VHASYR Electronic Prescribing of Controlled Substances group, as outlined above.

c. Human Resources. The Human Resources representative for VA resident physicians is responsible for:

(1) Verifying VA resident physician DEA suffix number, updating the ePCS GUI app, updating the ePCS SharePoint document, and notifying the VHSYR Electronic Prescribing of Controlled substances group, as outlined above.

4. DEFINITIONS

None.

5. REFERENCES

U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Division, Electronic Prescriptions for Controlled Substances (EPCS), accessed June 4, 2021, https://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html.

6. REVIEW

At minimum at recertification, when there are changes to the governing document (for example, national policy or a health care accreditation body mandate).

7. RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of July 2026.

In the event of contradiction with national policy, the national policy supersedes and controls.

8. SIGNATORY AUTHORITY

S. ASIF ALI, MD

Chief of Staff Date Approved: July 27, 2021

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

https://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html

DISTRIBUTION: SOPs are available at: Syracuse Medical Center Document Control SharePoint (DCS). https://dvagov.sharepoint.com/sites/VHASYR/svdc.

https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/

DEPARTMENT OF VETERANS AFFAIRS

VA HEALTHCARE NETWORK

UPSTATE NEW YORK @ SYRACUSE

Medical Center Professional Memorandum June 2018 Chief of Staff 11-031

INPATIENT AND OUTPATIENT PRESCRIBING AND DISPENSING MEDICATIONS

I. PURPOSE :

To ensure the ordering of medications and pharmacist processing of medication orders is safe and efficacious. Medications needed to treat a patient’s condition will be ordered.

Non-medication protocols intended for use by non-providers such as registered dieticians (RD), pharmacy technicians, and registered nurses (RN) may be utilized in the outpatient setting only when approved through the Local Pharmacy & Therapeutics (P&T) Committee and Medical Staff Executive Committee (MSEC).

II. POLICY :

A. All orders for medications and treatment must originate from a physician, dentist, or nurse practitioner, or from a provider (physician assistant, clinical pharmacist and certified nurse anesthetist) who operates under a scope of practice that grants prescribing privileges as defined in the Medical Staff Bylaws.

B. Providers will enter all orders for medications into the hospital computerized patient medical record. Electronic orders will be considered valid when the electronic signature is placed.

C. All orders for medications will include the date and time written, and a complete expression of each prescription including: drug name, dose, route of administration, and dosing frequency.

D. The use of non-medication protocols to allow non-providers (such as registered dieticians, pharmacy technicians and registered nurses) may be utilized in the outpatient setting to improve the provision of care and must be agreed upon and approved by the Local P&T Committee, corresponding Service Chiefs, and the appropriate approving body such as the Medical Executive Committee (MEC) or Clinical Executive Board (CEB).

E. Registered Dieticians may prescribe nutritional supplements for outpatients once they have an approved scope of practice and have completed the credentialing process.

Medical Center Professional Memorandum June 2018 Pharmacy 11-31 Page 2

F. Acting Interns (Medical Students) : All orders for treatment and/or medications must be signed by the supervising resident before they are carried out. No verbal orders will be accepted. It is the responsibility of the acting intern to get all orders signed by his/her supervising resident or attending physician.

III. RESPONSIBLITIES :

A. The Chief, Pharmacy Service or designee is responsible for the policy and procedures related to pharmacy functions delineated in this document.

B. The Careline Managers are responsible for the adherence to this policy by their providers.

C. The Associate Director for Patient Care Services is responsible for the adherence to this policy of nursing service.

D. The Health Informatics Specialist or designee will be responsible to train providers on ordering medications through the computerized patient record.

E. The Pharmacy Supervisors or designee will be responsible to train providers on specific prescribing criteria or ordering requirements developed to ensure the medications are ordered safely and appropriately.

IV. PROCEDURES :

A. Medication Orders – general information

1. Medication orders will not be acted upon by a pharmacist until electronically signed by an authorized provider or when written on a prescription blank as defined below.

2. High-Risk /High-Alert Medication orders will be processed as outlined in MCPM 11-153 and will document that the pharmacist provided an additional review of the medication order.

3. Medications will be listed on the patient’s medication profile under the generic name for the drug.

4. Sound-alike/look-alike drugs have been identified by the Network Pharmacy Advisory Board. Providers will be able to determine if the drug selected in the ordering process is a sound-alike/look-alike through the Medication Order

Pharmacy 11-31 Page 3

Dialogue box which will have on the screen in blue bolded letters either “Sound A-Like/Look A-Like” or “Display Restrictions/Guidelines”.

5. Directions for Use. Directions must be specified and complete.

1. All PRN Medication orders must include qualifiers/indication for use.

Notations such as “as needed (PRNs)” or “as directed” without qualifiers will not be accepted without further explanation. These orders will require clarification by the provider.

2. All topical medication orders must include location of application. Topical medication orders without location of application will not be accepted. These orders will require clarification by the provider.

3. Orders which are not approved to be accepted by pharmacy include: resume all previous medication orders, range orders, orders for herbal medications.

4. Non-formulary drugs may be ordered using the electronic non-formulary process. A non-formulary request should only be approved where it has been demonstrated that all formulary options have been exhausted, no formulary options exist, or there are contraindications or documented adverse events to the formulary options. See MCPM 11-094 Selection and Procurement of Mediations (Formulary Management) for further details.

i. Non-formulary orders will be evaluated by pharmacy staff prior to processing to ensure criteria for use are met and a formulary alternative cannot be utilized. Approval must be obtained prior to dispensing by pharmacy.

ii. Approval and receipt of a non-formulary drug for inpatients will be processed within 24 hours, and for outpatients within 96 hours and the use of formulary agents should be continued until a decision is made and until the desired item can be obtained and provided to the patient. Urgent/ STAT requests must be communicated verbally to one of the clinical pharmacists.

iii. If a provider wishes to appeal a non-formulary denial, the provider will communicate to the pharmacy manager (or designee) the wish to appeal a specific denial. The requesting provider will provide documentation supporting the appeal. The appeal will be adjudicated by the Local Pharmacy & Therapeutics Committee.

Pharmacy 11-31 Page 4

5. Providers may order compounded drug items and supply items (outpatient prescriptions only) using the non-formulary drug request and these will be approved if a commercially available and/or formulary alternative is not available.

6. Verbal medication orders will be accepted by registered professional nurses or a registered pharmacist, only in emergency situations when a patient’s condition is critical, when a delay impacts the continuum of care in the critically ill patient or during surgical/invasive procedures. Verbal orders will not be accepted from Acting Interns.

i. The registered professional nurse or the registered pharmacist accepting a verbal/telephone order (for non-CODE BLUE situations) will write it down or enter into CPRS, then do a complete read-back of the order to the physician to verify correctness.

ii. The registered professional nurse receiving the order will place an electronic order for co-signature by the physician. The registered pharmacist receiving the order will enter it into the computer as a verbal telephone order. The order must include the name of the prescribing provider giving the verbal order.

iii. The read-back of orders is not exclusive to medication orders and includes all verbal orders given.

iv. In an emergent situation (i.e. Code Blue) or during a surgical/ invasive procedure, the verbal order will be repeated back by the provider before the medication is administered or placed on the field and recorded on the appropriate document.

7. Written medication orders will not be honored by pharmacy personnel if the order contains an abbreviation which is on the “Do Not Use Abbreviation List”. Electronic abbreviations on orders will only be accepted if the abbreviation is hard coded into the electronic medication order software.

8. Medications order through the double chevron functionality (free text) will not be accepted by pharmacy personnel. Parenteral nutrition orders utilizing the double chevron functionality approved order set will be accepted. The provider will be contacted to place the medication order correctly.

Pharmacy 11-31 Page 5

9. Investigational Medication Orders: medication orders for investigational or clinical trial medications will be ordered pursuant to MCMP 11-221 Investigational Drugs and/or Clinical Trial Drug.

10. Standing Orders: the facility only allows standing orders to be used for specific initiatives pursuant to approval by the facility local pharmacy & therapeutics committee and Chief of Staff.

11. Titration Orders: all orders requiring titration will include the following elements:

Medication name Medication route Initial or starting rate of infusion (dose/min) Incremental units the rate can be increased or decreased Frequency for incremental doses (how often dose[rate] can be increased or decreased) Maximum rate (dose) of infusion Objective clinical endpoint (RASS score, CAM score, etc.)

B. Non-Medication Orders – Outpatients

1. Although medications may only be prescribed by providers authorized by law or VA regulation, which includes physicians, dentists, advanced practice registered nurses (APRNs), physician assistants (PA), or clinical pharmacists with an SOP that contains prescriptive authority for medications, non-medication protocols intended for use by non-providers (such as registered dieticians (RD), pharmacy technicians, and registered nurses (RN) may be utilized in the outpatient setting

2.

i. The term ‘non-medication’ refers to non-medication products such as oral nutritional supplementation, expendable supplies, wound care and ostomy products that would not be defined as a drug per the

FDA.

ii. The VA medical facility must have a policy that outlines the use of non-medication protocols and contains elements related to their use and oversight.

3. Registered Dieticians: Registered Dieticians will be permitted to prescribe nutritional supplements for outpatients once they have an approved scope of practice and have completed the credentialing process. See MCPM 11-218 (Clinical Dietician Scope of Practice)

Pharmacy 11-31 Page 6

i. Ordering will be completed through the Dietician Nutritional Supplement ordering menu in CPRS

ii. Quality Assurance Monitoring will be conducted on a regular basis by the Clinical Dietician Manager as part of the Scope of Practice Renewal Process.

C. Medication Orders – Inpatients

1. Inpatient Medication orders will be valid for 30 days except for the following:

a. Schedule II Narcotics and alcoholic beverages:

i. 7 days: Acute Care Inpatient Wards

ii. 14 days: CLC

b. Orders for Narcotic Epidurals and Patient Controlled Analgesia will be valid for 72 hours.

c. Antibiotics – 7 days unless otherwise specified.

d. Warfarin – 7 days unless otherwise specified.

e. Heparin infusions – 24 hours.

f. Clozapine – 14 days

g. Respiratory inhalation treatments – 5 days.

h. The provider will be informed of the impending expiration of a drug order according to OPNP 003-001 Medication Administration.

2. Medications shall not be continued beyond the stop order date unless a new order is written.

3. Medication orders must be rewritten for patients transferred between care lines, services, post-operatively or when there is a change in the level of care.

D. Ordering of Outpatient Prescriptions

Pharmacy 11-31 Page 7

1. All Outpatient prescriptions will be ordered electronically. Controlled substances must be ordered by secure Electronic Prescribing for Controlled Substance (EPCS) pursuant to MCPM 11-194 Electronic Prescriptions for CS Processing. EPCS is Special software approved for VA use by the Drug Enforcement Administration (DEA). The Federal DEA requires that EPCS software meet certain requirements. It must contain internal controls to prevent diversion and alteration of controlled substance prescriptions that are entered electronically.

2. Prescription blanks will be issued to the using ward/clinic area upon request. The provider or designee who signs for and receives the prescription blanks for an area will ensure that only authorized personnel have access to prescription blanks. All prescription blanks are serially numbered. Pharmacy will maintain a log of blanks issued by using area/individual for accountability purposes.

3. When a written prescription is required, during contingency mode, using prescription blank (VA Form 10-2577f), the following elements must be completed in a legible manner:

i. Patient’s full name, social security number, and current address.

ii. Name of medication (generic preferred), dosage form, strength metric and specific directions for use. (“As directed” or “prn” by themselves are not acceptable.)

iii. Quantity and maximum # of refills.

iv. Signature, title of prescriber, and DEA or suffix number where required. In addition, all prescriptions must bear the printed name of the prescriber.

v. Date written.

4. Prescription orders will be filled in quantities of 30-90 days for up to 12 month’s duration. Prescription orders for employees must be ordered by employee health provider and will be limited quantities of 3 days unless the order is for an antibiotic in which the order will be valid for the full course of therapy. Prescriptions for contracted federal bodies will be dependent on the contract.

Pharmacy 11-31 Page 8

5. To increase the safety of patients receiving oral chemotherapy, orders will be non-refillable requiring a new prescription for each course of therapy and limited only to hematology/oncology providers. In addition, Pulmonary, Renal and rheumatology may order cyclophosphamide. Rheumatology, Dermatology, Pulmonary and Nephrology may order methotrexate.

Mercaptopurine may be ordered by GI. Additional changes permitting other specialties to prescribe oral chemotherapy agents will be identified and approved through the Network P&T Committee.

6. To increase the safety of patients receiving Intravenous Chemotherapy, orders for these agents are limited to the hematology/oncology providers. The hematology/oncology fellow and NP may order IV chemotherapy orders to continue a regimen (subsequent cycles) but they are not permitted to order the initial cycle-dose. Oral Chemotherapy agents are restricted to hematology-oncology providers with exceptions as outlined in MCPM 11-153/High- Risk/High-Alert Medications.

7. Providers will indicate when an outpatient medication order is to treat a patient’s service connected condition.

8. Pharmacy will be authorized to convert outpatient medication orders to conform to the Network Tablet Splitting policy if the patient is considered appropriate for the program.

9. Discharge prescriptions are to be ordered for processing as soon as a provider determines patient is ready for discharge. A discharge pharmacist is available for provider consults and to provide the medication education to the patient on discharge. Prescriptions will be automatically mailed to patients with the exception of patients that present to pharmacy for pickup.

i. Patients being mailed medications will receive education from patient medication information sheets and the ordering provider.

ii. Outpatient Pharmacists will counsel all patients picking up prescriptions in the pharmacy on medication information as indicated. Patient will also be provided patient medication information sheets.

Pharmacy 11-31 Page 9

E. Ordering of Controlled Substances for Outpatients

1. Schedule II Narcotic Controlled Substances will be dispensed pursuant to MCMP 11-194, Electronic Prescribing of Controlled Substances for a quantity not to exceed a 30-day supply for any one patient at any time.

2. Ethanol and alcohol-containing beverages cannot be ordered for Outpatients.

3. Outpatient medication orders for Schedule III through V controlled substances will be ordered electronically for a quantity not to exceed 30 days of therapy and may be refilled up to 5 times within a six-month period from the date the original prescription was ordered.

4. Schedule III, IV and V controlled substances are normally dispensed in 30-day quantities. Providers may request approval to prescribe up to a 90-day quantity of these controlled substances in certain circumstances based with approval granted by the Local Pharmacy & Therapeutics Committee and/or Chief, Pharmacy Service or designee. Approval will be based on patient’s medical condition (see list below), extenuating circumstances and medication refill history. The approval will be documented in a CPRS note by the Chief, Pharmacy Service or their designee. Patient compliance will be monitored at each prescription renewal by the Pharmacist completing the order. Any compliance issues may be reason for rescinding the approval.

5. Practitioner may prescribe up to a 90-dy supply of a controlled substance for the following conditions. The provider must include on the outpatient prescription the name of the condition or Code designating the condition.

i. Panic disorders, designated as code A;

ii. Attention deficit disorder, designated as code B;

iii. Chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity, designated as code C;

iv. Relief of pain in patients suffering from conditions or diseases known to be chronic or incurable, designated as code D;

v. Narcolepsy, designated as code E; or

Pharmacy 11-31 Page 10

vi. Hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, metastatic breast cancer in women, anemia and angioedema, designated as code F.

6. Written prescriptions for controlled substances may only be used during approved contingency periods as outlined in MCPM 11-194, Electronic Prescriptions for Controlled Substance Processing (EPCS).

7. Providers will query the NYS Prescription Drug Monitoring Program (I- STOP/PMP – Internet System for Tracking Over-Prescribing-Prescription Monitoring Program) and enter a disclosure note using the template in CPRS titled “State Prescription Monitoring Program” prior to prescribing a Schedule II through IV Controlled Substance and upon any subsequent prescription renewal.

i. The following are excluded from the requirements for checking NYS PDMP based on VHA directive 1306 and NYS PDMP regulation:

i. Any patient whose only controlled substance prescription is for a 5-day supply or less without refills prescribed through the emergency department

ii. Any patient enrolled in Hospice Care.

F. Pharmacist Review of Medication Orders

1. A medication profile will be maintained in the computerized medical record for each patient receiving medication through VISTA/CPRS to ensure that the profile is available to all staff responsible for the patient’s care.

2. Minimum information maintained on the profile will include the patient’s name, date of birth, sex, pertinent problem(s)/diagnosis, current medication therapy to include VA dispensed medications and non-VA dispensed medications or herbals, allergy and adverse drug reaction data.

3. All medication orders will be reviewed by a registered pharmacist against the medication profile. This review will be accomplished prior to dispensing. The review will be to determine:

Pharmacy 11-31 Page 11

i. Review patients’ medication profile to assure rational drug therapy and avoid adverse drug reactions, drug-drug and drug -food interactions.

ii. Adequacy of dose ordered, proper mode of administration, contraindications, therapeutic incompatibilities, duplication of therapy, polypharmacy.

iii. Pharmacists will contact the prescribing provider to resolve problems identified during the review process with recommendations for modifications to the ordered medications.

V. REFERENCES :

VHA Handbook 1108.05. “Outpatient Pharmacy Services”, June 16, 2016.

VHA Directive 1108.06 entitled “Inpatient Pharmacy Services”, February 8, 2017.

VHA Directive 1108.08 “VHA Formulary Management Process”, November 2, 2016

VHA Directive 1306 “Querying State Prescription Drug Monitoring Programs (PDMP)”, October 19, 2016.

NYS Prescription Monitoring Program Requirements, Frequently Asked Questions dated February 2014 (http://www.health.ny.gov/professionals/narcotic/prescription_monitoring)

VISN 2 Pharmacy & Therapeutics Committee Policy & Procedures: Tablet Splitting, 10N2-177-14, May 7, 2014

OPNP 003-001 Medication Administration

38 C.F.R. Part 17§33a (e) Medication

MCPM 11-218, Clinical Dietician Scope of Practice

VHA Handbook 1109.02, Clinical Nutrition Management, February 14, 2012 http://www.health.ny.gov/professionals/narcotic/prescription_monitoring

Pharmacy 11-31 Page 12

VI. RESCISSION:

Medical Center Professional Memorandum 11-31 Inpatient and Outpatient Prescribing and Dispensing Medications dated July 2017.

VII. REVIEW DATE :

June 2020

VIII. FOLLOW-UP RESPONSIBILITY :

119 Pharmacy

S ASIF ALI, MD

CHIEF OF STAFF