Dispensing of Prescriptions (Continued)

In 2008, NABP convened the task force on Medication Collection Programs. Based on research conducted and task force recommendation, NABP developed a position statement and model rules for the safe return and resuse of prescription medications in community pharmacy settings.6,13 CVS Health commends the Board of years ago for incorporating many of the recommendations set forth by NABP in 18VAC110-20-355(E) which are paramount for ensuring the integrity and stability of the medications are maintained. While it is not recommended in the NABP position statement and model rules, we acknowledge the best practices reasoning for 18VAC110-20-355(E)(2) and requiring restocked drugs to be dispensed as soon as possible. However, we believe the current rule does not account for automated counting device and dispensing processes which are stocked with medications that would qualify as fast-moving or high volume and therefore meet the intentions of current community pharmacy restock and reuse best practices.

• We request the Board amend 18VAC110-20-355(E)(2) to permit using returns of dispensed medication that never left the pharmacy or the control of the pharmacy delivery agent to be restocked for resuse in an automated counting device.

Suggested Language:

18VAC110-20-355. Pharmacy repackaging of drug; records required; labeling requirements.

D.E. A pharmacy may return a dispensed drug to stock for redispensing that has never left the pharmacy premises or the control of the pharmacy delivery agent pursuant to § 54.1-3411.1 A 3 of the Code of Virginia under the following conditions:

1. An expiration date shall be placed on the label prior to returning the drug to stock. In the absence of stability data to the contrary, the date on the label may not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier.

2. The restocked drug shall be used to fill the next prescription received for that product, unless the restocked drug is used to fill automated counting devices and dispensers. In the event that the drug is not dispensed prior to the new assigned expiration date, it shall be removed from working stock as expired, and disposed of in accordance with 18VAC110-20-210.

3. If there is no lot number on the label of a drug returned to stock or on the prescription records that can be cross-referenced from the prescription label, the drug shall be removed from stock upon any recall of that drug product and returned to the manufacturer or otherwise disposed of in accordance with 18VAC110-20-210.

Transmission of Prescriptions and Chart Orders

CVS Health, along with our subsidiary Omnicare, Inc commends the Board for the proposed changes eliminating the 5% pharmacy robotics systems daily random checks in 18VAC110-20-425(5) and adding the first dose immediate drug supply allowance in 18VAC110-20-530(B)(1-2). We believe pharmacies providing first dose services to long-term care facilities through common ownership or written contract will enhance patient care by decreasing delays in therapy from the lag time between the patient’s admission and the time it takes the pharmacy to receive new orders. Further, the Board’s recommended changes dovetails nicely with the research and recent recommendations of the 2017 NABP task force on long-term care pharmacy rules.14 CVS Health again commends the Board of years ago for addressing chart order provisions for long-term care pharmacies well before national recommendations were put forth. We believe permitting chart orders in long-term care facilities and correctional facilities streamlines patient care and aligns with the current NABP model rules and task force on long-term care rules recommendations.6,14

CVS Health supports the 18VAC110-20-420 unit dose dispensing systems rules as they provide patients necessary access to pharmacy services in long-term care facility settings. We believe 18VAC110-20-420(B) was written pursuant to federal law that has changed since the implementation of the Affordable Care Act (ACA). The ACA mandates caused Centers for Medicare and Medicaid Services (CMS) to promulgate regulations permitting pharmacies to dispense up to a 14-day cycle of medications.15 Further, CMS regulations exclude antibiotics and drugs that must be dispensed in their original container as indicated in the Food and Drug Administration (FDA) Prescribing Information and drugs that are customarily dispensed in their original packaging to assist patients with compliance.

• We request the Board amend 18VAC110-20-240(C)(1) to align with the NABP model rules and task force on long-term care recomendations by permitting chart orders in correctional facilities.
• We request the Board amend 18VAC110-20-530(B)(1) to additionally align with the NABP model rules and task force on long-term care recomendations by allowing shared pharmacy services for immediate need between pharmacies with common ownership or written contract.
• We request the Board amend 18VAC110-20-420(B) to a maximum of 14-days pursuant to current CMS regulations.

Suggested Language:

18VAC110-20-240. Manner of maintaining records, prescriptions, inventory records.

C. Chart orders.

1. A chart order written for a patient in a hospital, a correctional facility or long-term care facility, a patient receiving home infusion services, or a hospice patient pursuant to § 54.1-3408.01 A of the Code of Virginia shall be exempt from having to contain all required information of a written prescription provided:

Suggested Language:

18VAC110-20-530. Pharmacy's responsibilities to long-term care facilities.

B. The pharmacy providing services to the long term care facility may share a copy of a Schedule VI prescription or order with another pharmacy for the purpose of dispensing an immediate supply of drugs, not to exceed a seven-day supply, without transferring the prescription pursuant to 18VAC110-20-360 if the following conditions are satisfied:

1. The pharmacy providing services to the long term care facility has common ownership or a written contract with the other pharmacy outlining services to be provided, the recordkeeping associated with the dispensing, and the responsibilities of each pharmacy; and,

2. The pharmacy providing services to the long term care facility provides a valid oral or written prescription or order to the other pharmacy.

Suggested Language:

18VAC110-20-420. Unit dose dispensing system.

B. In providing unit dose systems to hospitals or long-term care facilities where only those persons licensed to administer are administering drugs, the pharmacy shall dispense not more than a sevenfourteen-day supply of a drug in a solid, oral dosage form at any one given time.

CVS Health appreciates and understands the ongoing effort since 2016 the Board has committed to in order to amend these rules and regulations to reflect the current and evolving practice of pharmacy. We are supportive of the allowance of patient drop boxes, pharmacist professional judgment decisions, removal of the 5% robotic pharmacy systems random checks, first dose for long-term care pharmacies, along with clarifying language that has been added throughout the rules. In order to continue to further the highest order of pharmacy practice, we have proposed suggested amendments to align the language with current trends across the nation which include but are not limited to allowance of pharmacy technician roles that enhance medication dispensing support, emergency temporary pharmacies, restock and resuse of medications, and chart orders in correctional facilties.

CVS Health appreciates the opportunity to submit comments for this periodic review of regulations in chapter 20 and 50. If you have any questions, please contact me directly at (401)601-1968.

Sincerely,

Mark Johnston, PharmD

Senior Director, Pharmacy Regulatory Affairs

CVS Health

200 Highland Corporate Drive

Woonsocket, RI 02895

(401)601-1968

Mark.Johnston@CVSHealth.com

References:

1. Gaither CA, et al. Final report of the 2014 National Sample Survey of the Pharmacist Workforce to determine contemporary demographic, practice characteristics and quality of work-life. 2014. Available from: https://www.aacp.org/sites/default/files/finalreportofthenationalpharmacistworkforcestudy2014.pdf (Accessed February 20, 2019).
2. Zellmer WA, et al. Toward uniform standards for pharmacy technicians: Summary of the 2017 Pharmacy Technician Stakeholder Consensus Conference. Am J Health Syst Pharm. 2017;74(17):1321-1332.
3. Adams AJ. Advancing technician practice: Deliberations of a regulatory board. Research in Social and Administrative Pharmacy. 2018;14(1):1-5.
4. Frost TP, Adams AJ. Expanded pharmacy technician roles: Accepting verbal prescriptions and communicating prescription transfers. Res Social Adm Pharm. 2017;13(6):1191-1195.
5. Florida Board of Pharmacy. Florida Administration Code 64B16-27.4001. 2019. Available from: https://floridaspharmacy.gov/resources/ (Accessed February 20, 2019).
6. National Association of Boards of Pharmacy. The Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act). 2019. Available from: https://nabp.pharmacy/publications-reports/resource-documents/model-pharmacy-act-rules/ (Accessed February 20, 2019).
7. CVS Health. CVS Pharmacy Deploys Additional Pharmacy Resources to Impacted Communities Following Hurricane Harvey. 2017. Available from: https://cvshealth.com/newsroom/press-releases/cvs-pharmacy-deploys-additional-pharmacy-resources-impacted-communities (Accessed February 20, 2019).
8. Drug Topics. Pharmacists Tackle Hurricane Harvey. 2017. Available from:  https://www.drugtopics.com/editors-choice-drtp/pharmacists-tackle-hurricane-harvey (Accessed February 20, 2019).
9. Drug Enforcement Agency. A Pharmacist's Guide to Prescription Fraud. 2000. Available from: https://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm (Accessed February 20, 2019).
10. Drug Enforcement Agency. Pharmacist’s Manual An Informational Outline of the Controlled Substances Act. 2010. Available from: https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf (Accesed February 20, 2019).
11. Adams, Alex J. Prescription adaptation services: a regulatory and practice perspective. Annals of Pharmacotherapy 52.7 (2018): 700-703.
12. Adams, Alex J. Medication synchronization: A regulatory approach to “short fills”. Journal of the American Pharmacists Association 57.3 (2017): 299-300.
13. National Association of Boards of Pharmacy. National Association of Boards of Pharmacy Position Statement on the Return and Reuse of Prescription Medications in the Community Pharmacy Setting. 2009. Available from: https://nabp.pharmacy/wp-content/uploads/2016/07/Return-Reuse-Rx-Community-Pharm-07-2009.pdf (Accessed February 20, 2019).
14. National Association of Boards of Pharmacy. Report of the Taskforce on Long-Term Care Pharmacy Rules. 2017. Available from: https://nabp.pharmacy/wp-content/uploads/2018/01/2017-Report-of-Task-Force-on-Long-Term-Care-Pharmacy-Rules.pdf  (Accessed February 20, 2019).
15. Department of Health and Human Services. 42 CFR Parts 417, 422 and 423 Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Changes; Final Rule. 2011. Available from: https://www.govinfo.gov/content/pkg/FR-2011-04-15/pdf/2011-8274.pdf (Accessed February 20, 2019).

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