Page 1 of 14 SUBJECT: PURPOSE: POLICY: Returned medications and reclamation processing To define the process for handling products returned to the Pharmacy to ensure that medications are properly destroyed or credited and returned to stock for reuse. Facilities may return stock medications and patient medications to the Pharmacy for destruction or reclaim credit. Stores clerks will follow the established procedure for processing returned medications. PROCEDURE: I. Facilities may return stock medications and patient medications to the Pharmacy for destruction or reclaim credit. A. Facilities should not return controlled substances to the Pharmacy. Facilities should use the designated reverse distributor (e.g., Genco). Patient medication orders-individual patient orders for controlled substances that have been dispensed by the Pharmacy with a patient label should not be returned to the Pharmacy by commercial carrier. These medications should be handled according to TDCJ Pharmacy Policy and Procedure 20-15. If controlled substances are received in error, they should be given to the vault immediately for proper handling. B. Returns are processed under the unit s 2 digit unit code. 1. Re-usable medication is scanned and credited to the unit. Medication is then returned to the proper inventory (i.e., 340B or non-340b inventory). 2. Expired, damaged or unusable product that cannot be reclaimed is destroyed under the unit account number (i.e., unit 2 digit code). Product will be disposed of according to the disposal policy (policy 30-45). If still in original packaging, it will be returned to the designated reverse distributor (Genco) instead. C. Items returned that were dispensed by Hospital Galveston (HG) should be recorded as destruction using ZG code. Items returned by HG that were supplied by the CMC Pharmacy will be handled as described above. D. If the source (i.e., unit) of the returned product cannot be verified, the inventory can be identified by the package marking. 1. Re-usable medication is scanned and reclaimed. The product is reclaimed to UP (340B inventory) or UW (non-340b inventory/wac) based on the package marking. Medication is then returned to the proper inventory (i.e., 340B or non-340b inventory). 2. Expired, damaged or unusable product that cannot be reclaimed is destroyed to UP (340B inventory) or UW (non-340b inventory/wac) based on the package marking. Product will be disposed of according to the disposal policy (policy 30-45). If still in original packaging, it will be returned to the designated reverse distributor (Genco) instead. II. Only medications should be returned to the Pharmacy. Non-drug items such as empty cards, empty containers, laboratory specimens, personal items, or syringes should not be returned to the Pharmacy. Exception: Empty blister pack cards of warfarin should be returned to the Pharmacy for disposition.
Page 2 of 14 Empty warfarin cards should be separate from other returns in a bag labeled Warfarin. Stores clerks should report inappropriate returns to the pharmacist coordinator. The pharmacist coordinator is responsible for notifying the facility s management team, pharmacy management team, and/or pharmacist that audits the facility. Repetitive problems will be reported to the Regional Management Teams as needed. III. IV. ALL mail received in shipping containers containing returned medications should be forwarded to the proper destination in a timely manner. A. Mail may include items such as truck mail, medication error reports, and audit responses. B. Mail from patients should be taken immediately to the administrative secretary. C. If you are unsure or do not know where it goes, please ask a Supervisor. Class C business Includes TJJD institutions and TDCJ facilities. A. Items may be reclaimed and credit issued to the facility if the following criteria have been met. 1. Items were not issued to the patient (i.e., NONKOP or KOP items not issued). 2. Unopened floor stock or pharmacy warehouse items (may reclaim partial blister pack cards) Items must be marked with the unit s name. 3. Within allowable dating for expiration date (> 60 days) on the pre-pack label and/or manufacturer s packaging. 4. Refrigerated items were returned to the Pharmacy properly packed and maintained at appropriate temperature. 5. Not subject of a mandatory recall by a state agency, federal agency or voluntary recall by a manufacturer. B. Items will be destroyed and no credit will be issued if any of the following are true. 1. Opened floor stock or pharmacy warehouse items (may give credit for partial blister pack cards) Items NOT marked with the unit s name. 2. Packaging is not complete (i.e. medication, syringes and all that was supplied in the original container). 3. Obliterated bar code on patient or prepack label (e.g., by marking, covering or removing). 4. Unsealed original manufacturer s containers (e.g., eye drops). 5. Drug has expired or is outside the allowable dating ( 60 days) on the prepack label and/or manufacturer s packaging. 6. Outside allowable quantity ( 10 dosages) and cost limit ( $0.50). 7. Drug or packaging appears to be adulterated. 8. Requires refrigeration and was not returned under appropriate temperature. 9. Compounded medications. 10. In the physical possession of the person for whom it was prescribed (issued KOP to the patient). 11. Ordered KOP and the Not Issued label was not applied to the packaging or is applied incorrectly. It is not acceptable to hand write or stamp Not Issued on the packaging. It must be the Not Issued label.
Page 3 of 14 12. Problems with package integrity For example, no credit will be given for solid dosage forms in unit dose packaging (blister pack cards) if individual cells have been broken. The individual dose(s) will be removed from the card and credit will be given for the remaining doses that are contained within sealed cells. 13. Packaging has been written on and/or contains HIPAA protected information such as patient name or patient identification number. 14. Drug for an individual patient dispensed by another pharmacy. V. Class A business Includes TJJD half way houses, Galveston Teen Center, and county jails. A. Items may be reclaimed and credit issued to the facility if the following criteria have been met. 1. Items were not issued to the patient and still in the original manufacturer s container. This includes unit of use items (e.g., eye drops, inhalers) and medications in blister pack cards (i.e., all doses must still be in the card and none removed, full cards). 2. Floor stock or pharmacy warehouse items still in the original manufacturer s containers. This includes unit of use items (e.g., eye drops, inhalers) and medications in blister pack cards (i.e., all doses must still be in the card and none removed, full cards). Items must be marked with the unit s name. 3. Within allowable dating for expiration date ( 120 days) on the pre-pack label and/or manufacturer s packaging. 4. Refrigerated items still in the original manufacturer s container that were returned to the Pharmacy properly packed and maintained at appropriate temperature. 5. Not subject of a mandatory recall by a state agency, federal agency or voluntary recall by a manufacturer and still in the original manufacturer s container. B. Items will be destroyed and no credit will be issued if any of the following are true. 1. Items no longer in their sealed original manufacturer s container. This includes unit of use items (e.g., eye drops, inhalers) and medications in blister pack cards that have missing doses (i.e., cards are not full). 2. Opened floor stock or pharmacy warehouse items Items NOT marked with the unit s name. 3. Packaging is not complete (i.e., medication, syringes and all that was supplied in the original container). 4. Obliterated bar code on patient or pre-pack label (e.g., by marking, covering or removing). 5. Drug has expired or is outside the allowable dating (< 120 days) on the pre-pack label and/or manufacturer s packaging. 6. Outside allowable quantity ( 10 dosages). 7. Drug or packaging appears to be adulterated. 8. In the physical possession of the person for whom it was prescribed (issued KOP to the patient). 9. Ordered KOP and the Not Issued label was not applied to the packaging or is applied incorrectly. It is not acceptable to hand write or stamp Not Issued on the packaging. It must be the Not Issued label.
Page 4 of 14 10. Packaging has been written on and/or contains HIPAA protected information such as patient name or patient identification number. 11. Prescription dispensed for an individual patient. VI. VII. The reclamation sorter is programmed to differentiate between class A and class C customers and returns criteria are configurable. A. This is programmed at the computer in the Reclamation room. 1. Make sure you are in the Management screen (move between this and the sorter screen by hitting the Num Lock and * keys). 2. Log in (user name and password) then choose edit tab. 3. Look under the units and select the one you want to set up and double click it. 4. Look on the right side and choose Return Rule. Choose the one that represents the unit that is selected. Choices are listed below. a. A = Class A b. C = Class C c. X = medications may not be returned for credit B. Reclamation sorter and hand scanner reads the facility code from the patient label barcode and looks up in a reference table to determine the Class of business (Class A, Class C, etc) and then follows business rules for that type of pharmacy. C. There are currently 3 fields that are configurable by the Pharmacy personnel: (1) destruction cutoff which corresponds to expiration date, (2) minimum reclamation cost which corresponds to cost, and (3) minimum reclamation quantity which corresponds to quantity remaining in package. Processing returned products A. Shipping containers that contain returned products will remain sealed unless they are being actively processed inside the reclamation room. B. Containers may not be opened on the receiving dock unless they contain refrigerated medications. Containers with refrigerated medications must be opened immediately upon receipt and placed in the refrigerator. These items should be processed first each day. C. Containers are stored in the warehouse area until they can be presorted. D. Containers will be brought inside the reclamation area and presorted as time and workloads permit. Presorted containers of blister pack cards will be marked with the presort date and PHS (340B) or WAC (non-340b) to indicate the inventory and be resealed. They will be placed back in the warehouse in the appropriate location for that specific inventory. E. Presort process 1. Blister pack cards will be sorted in the reclamation area into two main categories: reclamation and destruction. The following criteria will be used to determine the appropriate category. a. Medications will be classified as reclamation if the following criteria are met. i. Intact bar codes (i.e., patient and prepack labels) ii. Clean card
Page 5 of 14 iii. Ordered KOP and the Not Issued bar code is properly placed on the patient label. iv. Ordered Non-KOP v. Reclaimed 3 times. This can be determined by counting the number of prepack labels on the card. vi. The reclamation boxes are marked with date sorted and sealed (See VII [F]) b. Medications will be classified as destruction if the following criteria are met. i. Obliterated patient or prepack label bar code (i.e., damaged bar code). ii. Dirty, bent, creased or torn packaging iii. Ordered KOP and the Not Issued bar code was not placed on the patient label or covers the patient label bar code. iv. Reclaimed more than 3 times. This can be determined by counting the number of prepack labels on the card. v. Packages that are marked Destroy (or with a big D ) on the prescription label at the unit level. vi. The destruction boxes are marked with date sorted and sealed (See VII [F]) 2. Unit of use items (e.g., eye drops, inhalers, bottles, creams) will be presorted to one of the following containers. a. Full expired items will be sorted to the tote marked CAP PHS or CAP WAC to indicate the inventory for the reverse distributor (Genco). Items will be sent back to the manufacturer or wholesaler for credit. Since these are not in our inventory we do not scan. We will receive a list of drugs back from the reverse distributor. b. Items issued KOP or ordered KOP and the Not Issued bar code was not placed on the patient label or if it covers the patient label bar code Items will be sorted to the tote marked KOP for destruction (stored on shelf in reclamation). These will be scanned with the wireless scanner for destruction (code K) and put in the biohazard box. c. Unit of use items that may be reclaimed (full Non-KOP and KOP not issued) will be sorted into the unit of use tote. When the unit of use tote becomes full they will be run down 40 lane sorter, credited to the units and sorted into the correct station totes. The products that cannot be scanned by 40 lane sorter will be scanned with the wireless scanner, credited to the unit and returned to the correct filling station. Patient labels will be removed at the station and put in an Iron Mountain container for proper disposal. d. To set up the wireless scanner for destruction-turn the wireless scanner on (RF Terminal menu)-choose #1-enter-Log in to scanner (user name and password)- enter-#2 reclamation-enter-#2 destroy-enter-scan prepack label-scan patient labelenter-enter quantity-arrow down-enter unit-arrow down-enter destruction codeenter
Page 6 of 14 e. To set up the wireless scanner for reclamation-turn the wireless scanner on (RF Terminal menu)-choose #1-enter-Log in to scanner (user name and password)- enter-#2 reclamation-enter-#1 reclamation-enter-scan prepack label-scan patient label-enter-enter quantity-arrow down-enter unit-arrow down-enter destruction code-enter 3. Floor stock items will be sorted into small plastic containers separating the expired from those that are not expired per the criteria listed in sections IV and V above. The containers are marked with the presort date. Cards for destruction are scanned with wired scanner and placed in a biohazard box. 4. Medications dispensed by Hospital Galveston (HG) If a medication dispensed by HG is inadvertently returned to the CMC Pharmacy, it will be recorded under HG s account ZG as destruction and disposed of properly. 5. Parole and Discharge medications (medications in plastic pharmacy vials) should be hand scanned and recorded as destruction (code D). The medications should be placed in biohazard boxes.( See VIII E 2d for procedure for setting up wireless RF gun) 6. Patient s medications (from other pharmacies) 1. Medications that were brought to the intake units and county jails, that are not control, are recorded in the Prescription Drug Inventory Sheet. The unit will fill out Date Disp, Rx#, Name of Pharmacy, Name & Strength of Drug and Quantity (Attachment A).These will then be put in a biohazard box. 2. Control drugs are not returned to the CMC Pharmacy. These medications should be handled according to the TDCJ Pharmacy Policy and Procedure 20-15. 7. All medications identified for destruction will be sent down the sorter or hand scanned (see H or I). Then these medications must be placed inside biohazard boxes. Once the biohazard box is full, it should be sealed and disposed of properly (see VIII). F. The sealed presorted containers that contain blister pack cards will be stored outside the reclamation room in the Pharmacy warehouse or outside the reclamation room in the production area if there is no room available in the Pharmacy warehouse. G. Presorted containers of partial blister pack cards will be brought into the reclamation room to be processed on the reclamation sorter by inventory as time and workloads permit. Presorted containers of full blister pack cards will be processed on the 40-lane sorter by inventory as time and workloads permit. H. Reclamation sorter set up i. The appropriate receptacles will be placed at each shoot of the reclamation sorter and at the end of the sorter belt. a. Chute 1 is the error tote. All items that fall inside the error tote must be evaluated by a pharmacist. The error tote is a plastic tote. b. Chute 2 is the reclaim tote. All items that fall inside the reclaim tote may be processed further. The reclaim tote is a large yellow rolling cart. c. Chute 3 is the destruction tote. All items that fall inside the destruction tote should be placed inside biohazard boxes. Once the biohazard box is full, it should be sealed and disposed of properly.
Page 7 of 14 d. End of sorter belt Items that fall off the end of the sorter belt into the plastic tote should be rerun on the sorter or hand scanned. 2. Set up the sorter (Bernice)-Tab Control twice get into Fast Lane (sorter computer)-log in (user name and password) choose I/O Control-choose Track Statistics-start scanning I. Use of reclamation sorter 1. Each blister pack card will be re-inspected for adulteration (e.g., dirty, bent, creased, torn). If a card is determined to be possibly contaminated, then it will be placed in a biohazard box for destruction and is not scanned. All other adulterated cards are put in the KOP box and run later in the destruction run or hand scanned. 2. Each blister pack card will be re-inspected for correct inventory for each run. 3. Each blister pack card will have the empty blister card cells completely opened. If a cell is not completely open, it can be opened by pressing the empty blister card cell on the foil side. This will ensure an accurate count by the reclamation scanner. 4. Each blister pack card will be inspected for broken cells. If individual cells have been broken, the individual tablet or capsule will be removed from the cell. The integrity of individual tablets and/or capsules cannot be guaranteed if the cell is broken. 5. Each blister pack card will be loaded onto the belt one at a time. The first card must reach the mark on the belt before placing another card on the sorter. This allows the sorter to take a picture of the card before the next one is loaded. 6. Each blister pack card will be sorted to the appropriate shoot by the reclamation sorter. J. 40 Lane sorter setup for reclaim (Full Cards ONLY) 1. To set up 40 Lane sorter-tab control until in Fast Sort -Log in (user name and password)- choose wave setup-choose wave action-choose 036 - $$Return for credit by station - start wave-choose ok-run the drugs down belt while checking for pin holes-finish runchoose reports-choose summary, choose #1 (40 lane sorter)-finish report-choose wave setup-close K. Hand scanning on Reclamation sorter 1. The hand scanner is used to process unit stock, unit of use items, and blister pack cards (i.e., no reads) that would not process on the reclamation sorter. 2. Each blister card will be inspected to determine if it is possibly contaminated. If it is, it will be placed in a biohazard box for destruction and is not scanned. 3. To set up the scanner for reclamation tab control until in Management PC appearschoose reclamation, choose reclamation, enter quantity left in card (each cell in blister pack cards with a tablet or capsule will be counted), scan the bar code on the prepack label and the unit to receive credit will be entered manually. To complete this scan press ok and a new label will be printed. (Peal back the corner of the label and attach temporarily to card. Take these to pharmacy table for pharmacist to attach new label and return to unit stock). Then proceed with the next blister card. 4. To set up the scanner for destruction tab control until in Management PC appearschoose reclamation, choose destruction, choose category (destruction code see chart below - individual determines code that best describes the issue), enter quantity left in card (each cell in blister pack cards with a tablet or capsule will be counted), scan the bar
Page 8 of 14 code on the prepack label and the unit to receive credit will be entered manually. To complete this scan press ok. Then proceed with the next blister card. 5. The stores clerk must select the appropriate destruction code while processing returns on the Reclamation Screen of the Management PC. Destruction codes are listed below. Destruction Code Description A Adulterated B Barcode obliterated C Compounded medication D Discharge medication E Expired (current field parameter called destruction cutoff) K Ordered KOP, no indication Not Issued Q Minimum reclamation quantity R Subject to mandatory recall T Inappropriate temperature U Unsealed container $ Minimum reclamation value L. Disposition of reclaimed items 1. Blister pack cards will be hand sorted to a plastic tote corresponding to the correct filling station and correct inventory as determined by the tote label. 2. Patient labels must be removed from all containers of medications sorted to shoot 2 (reclaim tote) of the reclamation sorter before they are returned to stock. Labels should be placed inside an Iron Mountain container for proper disposal. Each tote is sealed and stored in the production area and separated by inventory. 3. Blister pack cards will be hand sorted to a plastic tote corresponding to the correct filling station, sealed and stored in the production area and separated by inventory. 4. Once there are 6 totes for a station or more frequently if time and workloads permit, the blister pack cards will be run down the 40-lane distribution sorter. 5. To set up 40 Lane sorter-tab control until in Fast Sort -Log in (user name and password)- choose wave setup-choose wave action-choose Reclamation station(choose station you want to run)-start wave-choose ok-run that stations drugs by inventory down belt-finish run-choose reports-choose summary, choose #1 (40 lane sorter)-finish report-choose wave setup-close 6. The 40-lane distribution sorter will sort medications by drug. After the medications are sorted by drug, the totes are labeled with the drug(s) and the inventory and they are returned to stock in the corresponding filling station for reuse. M. Disposition of shipping containers 1. Remove all labels from empty shipping containers to avoid miss shipments. 2. All plastic totes should be stored in the designated area of the warehouse.
Page 9 of 14 3. All cardboard boxes should be broken down and taken to the Recycle Box Container outside. VIII. Disposal considerations A. Personal protective equipment is available for use and safety. B. Empty cards, plastic bags, or bottles with patient labels should not be placed in biohazard waste boxes. Patient labels must be removed from all containers and the containers may be thrown away in regular trash. Patient labels should be placed inside an Iron Mountain container for proper disposal. C. All IV fluids (e.g., dextrose, sodium chloride) and enteral feeds (e.g., Osmolite) that cannot be reclaimed should be opened, contents poured out, and containers thrown away in the regular trash. If unsure, please ask. D. Hazardous medications will be identified by the sorter using the Waste Management wave that identifies the product s hazardous status using the product s barcode, and lane assignments (policy 30-45). 1. Lane 7 Medication with Sharp 2. Lane 9 Aerosol 3. Lane 11 P-Listed Waste 4. Lane 13 U-Listed Waste 5. Lane 15 D-Listed Waste 6. Lanes 17 thru 39 Non-Hazardous pharmaceutical waste E. Medications that cannot be reclaimed or returned to the reverse distributor (Genco) should be placed in biohazard waste boxes. F. Oral liquid medications that are returned without a seal or broken seal cannot be reclaimed and should be destroyed. These items should be placed in the biohazard waste boxes. G. The biohazard box is assembled and the bottom of the box taped, making sure all holes a seams are sealed. A bioplastic bag is required inside the box to prevent leaking. H. When each box is full, tie the bag closed by knotting from corner to corner. Fold the top of the box in with the handles inside. Each biohazard waste box will be taped with brown tape provided across the top making sure to go from side to side and making sure seams are sealed. The tape should not cover any writing on the box. I. Each biohazard waste box will be assigned a number from the blue UTMB label (Attachment C) J. Weigh each biohazard waste box and record the weight, date, box number (the last 5 letter/numbers on the blue label) and initials on the Hazardous Material Disposal sheet in the log book (Attachment D). The log book is kept next to the scales. Boxes should weigh between 15-20lbs. K. Write the weight, date and initials, on the UTMB yellow label and adhere the label to the side of the biohazard waste box. Make sure not to cover any writing or bar codes that are on the box. L. Stack the biohazard waste boxes in the approved area (next to the scales) until they are picked up for destruction. M. Once a week (unless we need special pickup) fill out a Medical Waste Shipping Document form. Complete the generator and primary transporter section on the form (Attachment E).
Page 10 of 14 N. Have supervisor sign Medical Waste Shipping Document and put complete form in mail box for courier. When couriers pick up boxes, they will sign and leave gold sheet in mail box.. O. File the gold sheet and a copy of the log book next to the reclamation computer. The company will send a white copy of the Medical Waste Shipping Document back to us, attach to the gold sheet and file. Reference: Rule 291.8 Return of Prescription Drugs. Texas Administrative Code Title 22, Part 15, Chapter 291, Subchapter A.
Attachment A Date: Destruction Record for Dangerous Drugs Shipped Back to Pharmacy Facility: (Prescriptions from Free World Pharmacies) Contact: This section for facility use. All information must be completed. Patient Name Patient Number Prescription # Drug Name & Strength QTY Returned Sending Person s Name Person Verifying Count This section for Pharmacy use only. All information must be completed. The completed form should be returned to the facility and the Pharmacy should keep a copy. Records should be kept for 3 years. Pharmacist: Pharmacist License #: Date: Date Dispensed RX # Name of Dispensing Pharmacy Drug Name & Strength QTY Destroyed Witness Method of Destruction Note: This form is for patient medications (individually labeled prescription) only.
Attachment D HAZARDOUS MATERIAL DISPOSAL Biohazard Waste Shipping Document #: Container Date Box # Wt. Initials Container Date Box # Wt. Initials 1 21 2 22 3 23 4 24 5 25 6 26 7 27 8 28 9 29 10 30 11 31 12 32 13 33 14 34 15 35 16 36 17 37 18 38 19 39 20 40
Attachment E