Implementing a Pharmacy Policies and Procedures Manual Toolkit

Organizing Your Policies and Procedures Manual: Organizational Tips

Developed by Joe Cunningham, RPh

• The manual should be functionally organized to make it be usable. Any member of the pharmacy should be able to utilize this!
• It’s a collection of policies and procedures for your pharmacy, so customize and organize your manual to fit your pharmacy’s needs and to address challenges specific to your practice.
• Use a simple binder with alphabetically indexed inserts; these are available at drug stores and office supply stores.
• Include a table of contents first, and then a preface that describes the scope of the practice, a mission statement, a policy review, the purpose, and how pharmacy employees with be notified of policies.

Table of Contents

Preface

A. Scope of Practice
Mission Statement
B. Purpose of Policy and Procedures Manual
C. Documentation of Policy Review/Frequency of Policy Review
D. Policy Notification by Memo

I. Administrative Policies
A. Development, Revision and Retention of Policies
B. Patient Billing Policies (Under Development)

• Insurance/Third Party Billing
• Medicare Billing (Part B and D)
• Medicaid Billing
• Store Charge Accounts
• Credit/Debit Card Charging
• Collection Policies
• Cash Transactions involving the Pharmacy
• Returns

C. Pharmacy Personnel Orientation/Training

• Personnel Training, Pharmacist
• Personnel Training. Technicians
  • Technician Training Materials (Sources)
  • Documentation of Competencies
  • Retention of These Records
• Personnel Registration/Certification
• Licensure
• Personnel Training, Secretary/Bookkeeper, Delivery, and Other Personnel
• Pharmacy Orientation
  • Pharmacist Check List
  • Technician Check List
  • Ancillary Personnel Check List
• Documentation of Each Employee’s Understanding of All Policies and Procedures in this Manual

D. Job Descriptions
E. Personnel Policies/Employee Handbook (Short List)

• Personal Time Policy
• Holidays
• Scheduling and Employee Time Off Requests
• Reliability Expectations
• Abuse of Privileges
• Employee Honesty Expectations

II. Operations Policies
A. Governance, State and Federal Laws
B. Security

• Pharmacy Department
• Controlled Substances

C. Record Keeping

• Controlled Substances
• Medicare Part D
• Retention of Other Records

D. Pharmacy Safety Policies

• Crisis Management Plan (Disaster Plan)
• Employee Call List

E. Computer Competency
F. Cash Register Operating Procedures (under development)

III. Purchasing Policies
A. Responsibility for Ordering
B. Receiving orders Both Rx & OTC
C. Receiving Controlled Substances

• Signing off on Invoices
• Filing Separate of CII verses C111-CV Invoices
• Sales to and From Other Pharmacies

D. Inventory Control Procedures
E. Returns

• Outdates
  • Removal From Active Inventory
  • Disposition of Outdates
  • Recalls
  • Destruction
  • Perpetual Inventory

IV. Drug Distribution
A. Prescription Dispensing Outpatient Area (Workflow)

• New Rx Dispensing Procedure
  • Receipt of Prescription From Patient
  • Drug Utilization Review (DUR)
  • Filling of Prescription
  • Final Verification of Prescription
  • Counseling of Patient by Pharmacist
  • New Prescription by Phone/IVR
    • Refill Prescription Dispensing in Outpatient AreaEnter refill prescription into workflow
    • Perform DUR
    • Fill Prescription
    • Final Verification of Refill Prescription
    • Set aside in RX pick-up area
    • Offer Counseling
• Outpatient Prescriptions Requiring Special Handling
  • Mail Out Prescriptions
  • Delivery Prescriptions
  • Medication Requiring Refrigeration
  • Medications Requiring Reconstitution
  • Medications Requiring Special Handling
    • Clozapine
    • Isotretinoin
    • Others
• Schedule V Medications
• Compounding
• Automated Medication Dispensing Systems
• Long Term Care Policies and Procedures

V. Continuous Quality and Performance Improvement Program
A. Reportable Events
B. Quality Assurance Officer (PIC or delegate)
C. Quality Improvement Program
D. Customer Satisfaction Surveys (Under Development)

VI. HIPPA Privacy Compliance and Documentation

VII. Clinical Services
A. Clinical Services

• Immunization Programs
• Blood Born Pathogen Policies
• Collaborative Practice Agreements
• Patient Monitoring Services
• Blood Pressure Monitoring
• Blood Lipid Monitoring
• Laboratory Policies and Procedures (CLIA Waiver)
• Medical Devices and Supports

VIII. APPENDIX
A. Forms
B. References

Preface

Scope of Practice: <Pharmacy Name> <City> <State> is a full service pharmacy whose purpose is to provide comprehensive pharmacy service to customers in our trade area. In addition to maintaining a well-stocked pharmacy department, <Pharmacy Name> provides many home health products such as durable medical equipment and diabetic testing supplies. Customers may frequent the pharmacy or have purchases delivered or mailed for their convenience.

Mission Statement: <Pharmacy Name> and its staff strive to offer its customers and patients comprehensive pharmacy service and home health products in a professional and consumer friendly setting.

Policy Review: No less than annually shall this manual be reviewed for the timeliness and appropriateness of content. A notation shall be made on each page by the reviewing pharmacist as to the date the policy was reviewed and any changes made to the policy. The reviewing pharmacist shall affix his/her initials to the page. Pages will be reprinted as necessary to be legible and neat. Occasionally a complete rewriting may occur and a cover sheet to be located after this preface stating the date of completion and a date of acceptance by the reviewing pharmacy shall be sufficient to facilitate the review. Additions shall be dated as they are added to the manual.

Purpose: The purpose of this manual shall be to state the policies of this company and to set forth procedures for the implementation and fulfillment of said policies. All pharmacy employees shall become familiar with those polices that govern their roles and functions within the pharmacy. To that end, this manual is also a teaching tool to acquaint employees with the way certain things are accomplished in the pharmacy. Compliance with these polices and procedures is a condition of employment and noncompliance may lead to termination of employment.

Policy Notification by Memo: Occasionally a memo shall be circulated in the pharmacy to notify of new or changed policies and procedures. This memo will be posted in a common place for all to read. After reading the memo each employee shall affix the date the memo was read and their unique identifying mark (usually initials). Initialed memos will be retained in the appendix of this manual.

Schedule V Medications Policy

This pharmacy will make available to customers who meet screening criteria, substances restricted to sale by a pharmacist for legitimate health reasons in quantities allowed under state and federal law.

• The following procedures shall be followed; These screening criteria shall be utilized to determine the appropriateness of the transaction: 
  • Age
  • Identification
  • Product request
  • Quantity
  • Use
  • Previous purchases
• All sales will be recorded in a Schedule V Controlled Substance Log or a Pseudoephedrine Log Book
• The Customer will record his/her signature as required by law.
• The pharmacist must complete transactions. A sales clerk or pharmacy technician may ring out the sale at a cash register
• All log book entries shall be legible, and all log books shall be kept so as to be retrievable for review by the Board of Pharmacy staff or other authorized legal entity.

Resources for Getting Started with Polices & Procedures

• Iowa Pharmacy Law Manual or your state’s manual
• QA reports and data
• Notes from store or department meetings
• Magazine articles
• Friends
• Board of Pharmacy Website/Newsletter
• Pharmacists Mutual Website/Newsletter
• Third party contracts and newsletters
• IPA Technician Manual (or one from your state association)
• Health Market Franchise
• NCPA Disc
• Pharmacist’s Guide to Pandemic Preparedness (APhA, ASHP, NACDS)
• MTM Management in Pharmacy Practice (APhA)
• Disaster Preparedness Checklist (America’s Pharmacy Nov. 2006)