1 SAMPLE MEDICATION PROTOCOL Policy Number: CLIN. 25 Goal: Provision of sample medications with proper documentation and proper storage, handling, and disposal of sample medications. Scope: This protocol applies to all HDI sites where sample medications are used for patient care. Responsibility: Providers, Nursing staff Protocol: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Medication samples are received by designated staff from pharmaceutical representatives and via the mail through pharmaceutical companies. Drug samples are accepted according to center need and availability. Due to the transient nature of sample medication stock, no formulary is kept. Upon arrival to the site, the samples are counted, logged on the “Sample Log Sheet”, and grouped according to drug category in the storage area. All sample storage areas are locked - access to the sample areas is controlled/limited to providers and nursing support staff. Expiration dates are marked with felt marker on outside of sample box. Samples with short expiration dates are placed in the front of the storage shelf to be used first. Expiration dates of samples are checked on a monthly basis by designated site staff. Documentation of this check is recorded on the “Monthly Check Sheet”. Sample storage areas are checked yearly by the Pharmacist to assure quality control. Controlled substances samples are stored in a double-locked area. Expired sample medications are sent to the Administrative Coordinator in the Purchasing/Finance Department where they are boxed as bio-hazard waste and disposed of through the medical waste management vendor. Sample medications are provided (when available) to patients who: a) Do not have prescription coverage from their insurance company or the required medication is not on the formulary from the insurance company/managed care organization. b) Are uninsured. c) Are “trialing” the new medication to see if it is effective for their condition. d) May not be compliant with filling a prescription at an outside pharmacy. The provider writes an order for the sample medication on the progress note (paper chart process) or orders the medication in the electronic health record and chooses “Samples given” as the Prescribing Method. The provider or nursing staff fill the prescription from the sample medication supply. Expiration date is checked for each sample. Expired samples are not dispensed. Paper Chart process: A. A sample medication form is completed by the provider or nursing staff. The form is filled out completely, including the medication lot number, any instructions, and 2 14. 15. 16. the provider’s signature. The nurse/medical assistant may complete the form, signing their name and title after the provider’s name. B. The completed sample medication form is handled in the following way: a. The white copy is retained in the designated location per center and kept in alphabetic order by prescription name. b. The yellow copy is given to the patient with the sample medication(s). c. The blue copy is attached to the back of the progress note or shingled onto the prescription copy sheet kept beneath the Med List tab on the left side of the chart. 13. Electronic Health Record process: A. The sample medication form is completed in the EHR B. Choose Print function at top of chart – Letters – Common Letters – Sample Rx Letter C. Select Customize and complete the following: Sample name of medication Amount of medication dispensed Directions Lot # Expiration Date Other instructions (“Take” and “Caution”) Other directions D. Check the box before “Save as document in chart” E. Print the sample medication letter F. Sign the letter and give to the patient with the sample medications Samples are stored for patient pick-up in the designated area per site. The staff member preparing the samples documents the patient name and the date the samples are placed into the storage area on the “Sample Pick-Up Sheet” - attached. The patient or person sent to pick up the samples must sign the form and the date of pickup. The staff member who gives the samples to the patient/pick-up person initials the form after the samples are distributed. The sample pick-up area is checked monthly by designated staff for samples that have not been picked up. Patients are contacted with a reminder phone call to pick up the sample meds previously prepared. Sample meds not picked up within 7 days of the reminder call are placed back into stock. The yellow patient copy of the sample med is returned to the chart with a notation that the samples were not picked up. Related Policies: Reviewed By: Effective Date: Revision Date: Review Date: Pharmacy Protocols Quality Improvement Committee November 20, 2000 Dec. 4, 2003; November 21, 2006; November 24, 2011; May 30, 2014 November 20, 2001; December 4, 2003; November 21, 2006 November 21, 2008; November 24, 2011; May 30, 2014 Approval: Douglas Saylor, MD Chief Medical Officer