PHARMACY PROCUREMENT OF DRUG AND NON-DRUG PRODUCTS. Pharmacy Procurement of drug and non-drug products.

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1 Page 1 of 11 SUBJECT: PURPOSE: POLICY: Pharmacy Procurement of drug and non-drug products. To establish the policy and procedures governing the procurement and control of pharmaceuticals and other supplies by the Pharmacy. The Pharmacy procures all pharmaceuticals through a prime vendor wholesaler, secondary wholesalers or other vendors. The Department will make reasonable efforts to purchase not less than ninety percent (90%) of all dollars spent on Pharmaceutical Products by using its prime vendor. Any item not available through the prime vendor or secondary wholesalers will be procured by special order through other vendors. The Pharmacy procures non-drug products and supplies through various vendors. DEFINITIONS: The Department will implement controls to ensure an effective and efficient control environment for all pharmaceutical and non-drug products. 340B Drug Pricing Program Section 340B of the Public Health Service Act (1992) requires drug manufacturers participating in the Medicaid Drug Rebate Program to sign an agreement with the Secretary of Health and Human Services. This agreement limits the price manufacturers may charge certain covered entities for covered outpatient drugs. The resulting program is called the 340B Program. UTMB qualifies as a disproportionate share hospital. PIPS Pharmacy Inventory Pricing System is the name of the drug inventory pricing system used by the Pharmacy. Primary Vendor The prime vendor is the Department s preferred wholesaler for pharmaceuticals. WAC WAC is wholesaler acquisition cost. WAC is used to purchase medications for employees at 340B facilities and patients not eligible for 340B pricing such as Texas Tech patients, county jail patients, and MTC unit patients. GPO A group purchasing organization (GPO) is an entity that helps pharmacies realize savings and efficiencies by aggregating purchasing volume and using that leverage to negotiate discounts with manufacturers, distributors and other vendors. Currently, CMC patients are not eligible for GPO pricing.

2 Page 2 of 11 PROCEDURE: I. Purchasing Pearls A. All requirements of the 340B Drug Pricing Program must be followed at all times. The following are requirements for participation in the 340B Drug Pricing Program B prices may change every 3 months, sometimes sooner. Consider using the pricing information from various Morris and Dickson reports to identify products and their pricing from the previous quarter. 2. The 340B Prime Vendor Program managed by Apexus also provides current and historical 340B pricing on covered products. 3. GPO (e.g., Premier) contracts may not be used to purchase medications for any customer, 340B eligible or ineligible. Under no circumstances will an exception be made. 4. Changes in items carried by specific NDC number should be minimized to take full advantage of the 340B program. The goal is to limit changes to one NDC per quarter for generics at the best possible price for each contract. Switching from one manufacturer to another requires administrative approval. Different generics may be used for each account (i.e., 340B and non-340b); however brand utilization on one account and generic utilization on another is not permitted. Different brand utilization is currently limited to albuterol HFA inhalers and insulin products. B. All products must be generic if available or approved brands. C. Consider purchases through tertiary wholesalers (e.g., Auburn, Top Rx, Harvard Drug Group, Anda, Independent Pharmaceutical, Smith Medical Partners, Winston Pharmacy or ParMed Pharmaceuticals) for purchases of items below wholesaler prices. D. Purchases through tertiary wholesalers are limited to $5,000 per item and must be procured through assistance from the Purchasing group at the Medical Warehouse. High volume or high cost items should be considered for an annual bid. E. Consider using independent contracts obtained and loaded in the wholesaler s catalog to lower the cost of products. F. Keep wholesalers aware of product needs and ask them to stock items if needed and transfer items from other divisions if needed (e.g. AmerisourceBergen). G. Product selection at Morris and Dickson (M&D) may be limited. Review other catalogs at AmerisourceBergen and tertiary wholesalers for product selection. Requests should be submitted to M&D for the addition of products that are identified as a better value and are not on the current M&D catalog. H. Items currently not available from Morris and Dickson include the flu vaccine, Tracleer,Veletri, Stivarga, Promacta, Monoclate P, Mononine, Nexavar, Tasigna, IVIG, Somavert, Albumin, Prolastin, full listing of IV fluids and sets (Baxter), custom TPN, Varizig, Imbruvica, Rhogam, Revlimid, Cyclosporine eye drops, Letairis, Xtandi, Humate P, and various other specialty drugs.

3 Page 3 of 11 I. Koate-DVI or Monoclate P and Factor 9 may be bought directly from the manufacturer to take advantage of 340B pricing. Koate DVI is also available at ASD with 340B pricing. J. All tertiary wholesalers must be an authorized UTMB vendor and their purchases submitted through the purchasing department. Vendors who are not approved can be authorized if the appropriate forms are completed and tax information is supplied. Separate accounts for WAC purchases and 340 B purchases are required. Compliance with DSCA requirements and EDI transfer is also required. K. When placing drop shipments, the appropriate account # must be referenced to ensure correct pricing. All drop shipments must go to the pharmacy. L. Purchase the least expensive generic for multi-source products (i.e., products that have a commercially available generic). Exceptions include narrow therapeutic drugs such as digoxin, levothyroxine, phenytoin and other seizure drugs, cyclosporine, mycophenolate, warfarin, and tacrolimus and products which have a registry such as clozapine. 1. Use the web site to identify new generics and utilize generic products whenever possible. 2. Generics must be FDA approved and AB rated. 3. If a contract dictates that a brand must be supplied, the brand product may be used. The Assistant Director of Pharmacy must be notified of these requirements. M. Brand product will only be purchased for single-source products (i.e., products that are only available as a branded product). 1. Products must be FDA approved. 2. The Assistant Director of Clinical operations should be notified when a generic becomes available. The decision to switch from a branded product to a newly approved generic requires administrative approval. 3. Informatics pharmacy personnel responsible for the maintenance of pharmacy systems (e.g., EHR, HCC, and MPT) must also be notified when a generic will replace a brand name so that all computer systems can be updated accordingly. II. III. The Department will make reasonable efforts to purchase not less than ninety percent (90%) of all dollars spent on Pharmaceutical Products by using its prime vendor as its first choice for the purchase of such products normally purchased through wholesale pharmaceutical distributors, except to the extent that the prime vendor is unable to supply such products, those purchases shall be excluded from the ninety percent (90%) calculation. The Pharmacy s prime vendor is Morris & Dickson. A. Orders or inquires can be placed through Morris & Dickson s online web portal B. Placing orders 1. Go to the web portal at 2. From the main menu (Order s tab), click on new orders and add an order.

4 Page 4 of Pick the appropriate department and account (e.g., WAC, 340B) and name the purchase order. 4. Items can be searched by description, NDC number, last 5 digits of NDC, Morris and Dickson catalog number, and state commodity code number (SCC#). 5. Clicking on the item will offer generic alternatives if available. 6. Items can only be ordered if a SCC# is available. 7. Items never ordered before require a SCC#. A SCC# can be obtained from Trisha McGhee, Sheri Diehl, Michaela Slimp or Bill Toney. 8. Highlighting existing SCC# allows the selection of a default generic or product tied to a specific SCC#. 9. Tying one catalog # to one SCC number allows tracking of usage. 10. Clicking on the Morris & Dickson catalog # reveals pricing on different contracts. 11. After adding the quantities desired of the selected product send the order and review for shortages at the order acknowledgements page. 12. The quantities ordered should reflect established par levels. 13. The order acknowledgement tab allows all current day orders to be printed at once. All order acknowledgements must be printed and signed off by the appropriate supervisor. 14. All purchase orders on the order acknowledgement page must be approved within 5 days. 15. Orders must also be electronically signed off by the appropriate supervisor. IV. AmerisourceBergen is a secondary wholesaler A. Orders or inquires can be placed through the online ordering system. B. Placing orders 1. To place an order at the web portal ( ) 2. After signing in, use the tab option ordering to create a new purchase order. 3. Make sure the correct account (e.g., WAC, 340B) is chosen. The account can be changed by using the change customer option. 4. In the PO number field, name the PO and save it by using the Update PO function. 5. Items can be searched by item #, description or NDC #. 6. After selecting the desired quantities, the purchase order is allocated and then sent. 7. The purchase order (PO) must be printed for approval by the appropriate supervisor. 8. Supervisor must sign and date the purchase order within 5 days and forward it to the accounting department.

5 Page 5 of 11 V. Special Orders A. Any item not available through the prime vendor wholesaler or secondary wholesaler must be approved through the People Soft System which will create a purchase order. B. A purchase request is turned into the Accounting Department. The Finance Specialist I will type up a Requisition form after verifying the cost of the product, availability and cost of shipping. C. The Requisition form is turned into the Assistant Director for approval. D. The Requisition is returned to the Finance Specialist I and entered into the PeopleSoft system. E. The Finance Manager will review the requisition in PeopleSoft and verify the correct budget and accounting numbers. F. When the Finance Manager approves the requisition, it will be turned into a purchase order and faxed to the vendor. G. When the product arrives, the senior informatics technologist ensures invoice data was correctly entered into PIPS, the receiving stores clerk signs and dates each page of the packing slip and/or invoice, and the invoice is turned into the Finance Specialist I. H. The Finance Specialist I will receive the product in the PeopleSoft system and follow through the procedure for getting the invoice paid. VII. VIII. VII. Procedures for Ordering IV Solutions A. IV solutions are obtained through Morris and Dickson on the appropriate 340B or non-340b account. B. IV solutions may be ordered directly from Baxter if product is not available from Morris & Dickson. Ordering from the Prison Store which requires approval per Assistant Director. A. Supplies such as paper goods are obtained from the Prison Store. B. Order should be faxed to John Peak at C. Keep fax confirmation and file with order. D. This MUST be completed by TUES before 12noon in order to receive order by the following Tuesday. At the current time we are not on a delivery schedule. Ordering from the Medical Warehouse which requires approval per Assistant Director A. Supplies such as office supplies are obtained from the Medical Warehouse. B. Enter IV00;LIS;REQ in the Inventory Management System (IVS) on the TDCJ Mainframe C. Type CHA;WAR; , then <ENTER> D. Type REQ;then TAB E. Type state commodity code for item requesting. F. On the following line, type the quantity need for that item. G. When ordering is complete, type SUB; on action line. H. Type Pharmacy, Reference #, THANKS, your name, then <ENTER>.

6 Page 6 of 11 I. Note document #, then PRINT document # (PRI ;ORD ;#) J. Keep for files for verification of order upon receipt. VIII. IX. Procedures for Loaning Items to Other Institutions A. Do not loan items from the 340B inventory under normal circumstances. Only in the case of an emergency medical situation and with Director of Pharmacy approval will 340B drugs be loaned. B. Provide the following information on the Charge Ticket: located in the Supervisor s Office (Attachment B) 1. Date of transaction. 2. Name of institution borrowing products from us. 3. Description of item(s). 4. Quantity loaned. 5. Pharmacist involved in transaction B. Get a signature from the person picking up the item(s). C. Make a copy of the signed charge ticket. D. Give the copy to the carrier and file the original in the Medication Borrow/Loan Log which is located in the Supervisor s Office (Attachment A). E. Fill out the log with the above information. F. Indicate the date resolved (in the log), when the borrowing institution has repaid the loan. Repaying the loan should be done on an exact item for item basis. G. Final verification of the transaction must be noted by the Pharmacy Supervisor. Procedures for Borrowing Items From Other Institutions A. Do not borrow items for a 340B eligible patient under normal circumstances. Only in the case of an emergency medical situation and with Director of Pharmacy approval will drugs be borrowed for a 340B eligible patient. B. Provide the following information on the Medication Borrow/Loan Log which is located in the supervisor s office (Attachment A): 1. Date of transaction. 2. Name of institution we are borrowing from. 3. Description of the item(s). 4. Quantity borrowed 5. Pharmacist involved in transaction B. Obtain a charge ticket from the loaning institution, signed by the UTMB Pharmacy employee receiving the package (Attachment B). C. File the charge ticket in the Medication Borrow/Loan Log. D. Indicate the date resolved (in the log), when we have repaid the loan. The process is as follows: Repaying the loan should be done on an exact item for item basis. Final verification of the transaction must be noted by the Pharmacy Supervisor X. Controls A. There will be segregation of duties for individuals involved in the purchasing process.

7 Page 7 of 11 B. All invoices, as well as purchase approvals, are maintained by the Accounting Department. C. All incoming shipments of medications and/or supplies should be reconciled to the original invoices/packing slips. D. Accounting staff will reconcile the original order to the invoice. E. Drug Orders from Prime Vendor 1. Original PO (blanket or individual) is approved by the Assistant Director of Pharmacy. 2. Orders are placed daily as needed. a. Orders are entered on the M&D system by the responsible person in each area. b. The Senior Pharmacist responsible for purchasing will review all orders for appropriateness and then submit the order electronically. c. All order acknowledgements will be printed. d. An Assistant Director of Pharmacy will review the order that was placed for appropriateness and indicate the review was completed by signing and dating the order acknowledgement. 3. Packing slip and/or invoice will be reconciled by the receiver. a. This will be indicated by the receiver by signing and dating each page of the packing slip and/or invoice. b. The receiver will acknowledge the receipt of goods by scanning each item in the M&D receiving system. c. Once complete, M&D will transfer the records electronically to UTMB for download into the PIPS system. d. All completed documentation will be forwarded to the Accounting Department. 4. The Assistant Director-PIC will approve the invoice and indicate the review was completed by signing and dating the invoice. All completed documentation will be forwarded to the Accounting Department. 5. The senior informatics technologist will ensure invoice data was correctly entered into PIPS (pricing system) and a Finance Specialist I will verify that the information (reconcile each line item and total value of invoice). 6. Accounting staff will ensure that the quantity and dollar value entered in the receiving database (PIPS) is the same as the quantity and dollar amount on the purchase order for individual products and total for the invoice. 7. Accounting staff will monitor the process to ensure all steps are complete for each order and that all necessary signatures and dates have been obtained. 8. The Finance Manager will submit the memorandum to authorize payment to UTMB Accounts Payable. F. Drug-orders from other vendors

8 Page 8 of Original PO (blanket or individual) is approved by the Assistant Director of Pharmacy. Exception: Secondary wholesalers PO s are approved on an annual basis. 2. Orders are placed daily as needed. a. Orders are entered on the AmerisourceBergen platform by the Senior Pharmacist responsible for purchasing. The vault orders will be reviewed for appropriateness by the Senior Purchasing pharmacist or the vault pharmacist and then submitted. b. All order acknowledgements will be printed. c. An Assistant Director of Pharmacy will review the order that was placed for appropriateness and indicate the review was completed by signing and dating the order acknowledgement. d. Orders placed from outside vendors will be submitted in Peoplesoft by the Finance Specialist I. This initial requisition will become an order once Purchasing in Galveston faxes the PO to the vendor. 3. Packing slip and/or invoice will be reconciled by the receiver. a. This will be indicated by the receiver by signing and dating each page of the packing slip and/or invoice. b. All completed documentation will be forwarded to the Accounting Department. c. Finance Specialist I will reconcile the original order to the invoice for drug orders placed with outside vendors. d. Finance Manager will review the packing slip and or invoice that was placed for appropriateness and indicate the review was completed by signing and dating each page of the packing slip and /or invoice. Finance Specialist I will prepare the Memorandum Authorization Form for final signature by Finance Manager and Assistant Director-PIC and then submit for payment by UTMB Accounts Payable. 4. The Assistant Director-PIC will approve the invoice (secondary wholesaler) and indicate the review was completed by signing and dating the invoice. All completed documentation will be forwarded to the Accounting Department. 5. The senior informatics technologist will ensure invoice data is correctly entered into PIPS (pricing system) and an accounting clerk will verify the information (reconcile each line item and total value of invoice). 6. Accounting staff will ensure that the quantity and dollar value entered in the receiving database (PIPS) is the same as the quantity and dollar amount on the purchase order for individual products and total for the invoice. 7. Accounting staff will monitor the process to ensure all steps are complete for each order and that all necessary signatures and dates have been obtained.

9 Page 9 of The Finance Manager will submit the memorandum to authorize payment to UTMB Accounts Payable. G. Non-drug (Supplies) Orders 1. Original PO (blanket or individual) is approved by the Assistant Director of Pharmacy. 2. Finance Specialist I submits the requisition in PeopleSoft. 3. Order is placed by Finance Specialist I once Purchasing in Galveston faxes the PO to the vendor. 4. Packing slip and/or invoice will be reconciled by the receiver. This will be indicated by the receiver by signing and dating each page of the packing slip and/or invoice. 5. Finance Specialist I will reconcile the original order to the invoice for nondrug orders (i.e., supplies). 6. Finance Manager will review the packing slip and/or invoice that was placed for appropriateness and indicate the review was completed by signing and dating each page of the packing slip and/or invoice. 7. Finance Specialist I will prepare the Memorandum Authorization Form for final signature by Finance Manager and Assistant Director-PIC and then submit for payment by UTMB Accounts Payable. 8. Accounting staff will monitor the process to ensure all steps are complete for each order and that all necessary signatures and dates have been obtained. References: Health Resources and Services Administration. Office of Pharmacy Affairs. 340B Drug Pricing Program & Pharmacy Affairs B Prime Vendor Program -

10 Page 10 of 11 Attachment A Medication Borrow/Loan Log Date Inventory (P=340B, W=WAC) Borrowing or Loaning Institution Medication, Strength & Quantity Transaction Signature Person From Institution Name of Pharmacist Date Repaid Supervisor

11 Page 11 of 11 Attachment B Charge Ticket UTMB CMC Department of Pharmacy Date: 2400 Avenue I Huntsville, TX Loaned to: Name of Pharmacist: Picked Up by: Supervisor: Quantity Medication & Strength Product Size Comments

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