Medication Guides Update

1. Medication Guides Update

2. Background The FDA requires the distribution of Medication Guides, FDA-approved patient information, for selected prescription drugs that pose a serious and significant public health concern. The FDA lists the products that require Medication Guides at the following web site: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm Medication Guides are required when the FDA determines that one or more of the following circumstances exist: • Patient labeling could help prevent serious adverse effects • The drug product has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product • The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness

3. Background - Continued While the FDA supplies the PDF documents it does not supply a process to automate the distribution of the products. The list of medications needing FDA Medication Guides Continues to grow and manual processes are no longer sufficient to ensure that patients receive this valuable information. Lack of an automated distribution of FDA Medication Guides increases the work flow process for the pharmacist. The look-up and retrieval processes are manual, creating a break in the rhythm of the work flow process. The FDA has a sharing agreement with the National Library of Medicine (ELM) to maintain a library for medication guides and to provide easy access to them.

4. Increment 1 (PSN*4*108) • Provides the capability to link FDA Medication Guides to VA Product entries. This information will be distributed via monthly National Drug File updates. • Provides the Display FDA Medication Guide option within the main National Drug File Menu. This option will remain dormant until the Medication Guides links are distributed via the monthly data updates. • Provides software interface to be utilized by Outpatient Pharmacy when Increment 2 is released. • No local testing

5. Increment 2 • Increment 2 will provide features to Outpatient Pharmacy to print medication guides along with the automated printing of labels and PMI sheets. • Increment 2 will provide additional features in Outpatient Pharmacy which will enable the user to manually display the associated medication guide for a specific prescription, if one is available, through the activity/label log. There will also be an option to reprint the medication guides associated with specific prescriptions.

6. NDF Updates • NDF will place medication guides on a SharePoint site. • The URL will be linked to a VA product. • Each version of a medication guide will be stored with a unique URL. Which will enable the to process to track history. • All documents will be in PDF format.

7. NDF Updates Continued • For generic products NDF will edit the document to remove the references to a particular manufacture. • Some products such as Antidepressants and NSAIDS have a class document. The class document will be used for generics. • May require the addition of a few more trade name specific entries or indication specific entries (EPO for Chemotherapy patients)

8. Local Sites • Outpatient parameters will include a new field for a FDA Med Guide default printer. • When a user signs on they will be asked for a med guide printer. The user can accept the default or edit. • The printer could be the label printer, dual tray printer, or separate printer.

9. Automated Printing • When the label is queued the system will make a call and retrieve the medication guides based on the URL. • VistA will cache the PDF document of the local users machine and it will be stored for 24 hours. If the document is needed again it will use the cache document which will improve system performance. • The prescription label, PMI, and Medication Guide will be held as a group so they will print at approximately the same time. • If your site has a separate Medication Guide printer collating the documents will be required.

10. On Demand Printing • Users must have “Display FDA Medication Guide” option. • User must have a PDF reader (Adobe) installed. • User must have VistA PDF applet installed on PC. • When user uses Display FDA Medication Guide option the applet will open PDF reader. The user can view or print the document. • If user does not have VistA applet they can copy the URL into their internet application.

11. National Drug File Menu WELCOME TO THE NATIONAL DRUG FILE VERSION 4.0 Select National Drug File Menu Option: ?    REMA   Rematch / Match Single Drugs    VER    Verify Matches    SVER   Verify Single Match    MERG   Merge National Drug File Data Into Local File    AUTO   Automatic Match of Unmatched Drugs    RPRT   National Drug File Reports Menu ...    INQ    Inquiry Options ...    PMIS   Print a PMI Sheet    FDA    Display FDA Medication Guide Select National Drug File Menu Option: Display FDA Medication Guide

12. National Drug File Select National Drug File Menu Option: FDA Display FDA Medication Guide Select VA PRODUCT NAME: PACLITAXEL 1 PACLITAXEL 100MG/17ML INJ,CONC 2 PACLITAXEL 300MG/50ML INJ,VIL,50ML 3 PACLITAXEL 30MG/5ML INJ,CONC 4 PACLITAXEL 6MG/ML INJ,CONC,IV 5 PACLITAXEL PROTEIN-BOUND 100MG/VIL INJ CHOOSE 1-5: 3 PACLITAXEL 30MG/5ML INJ,CONC There is no FDA Medication Guide associated with this medication.

13. National Drug File Select VA PRODUCT NAME: ABACAV 1 ABACAVIR SO4 100MG/5ML SOLN,ORAL 2 ABACAVIR SO4 300MG TAB 3 ABACAVIR SO4 300MG TAB,UD 4 ABACAVIR SO4 300MG/LAMIVUDINE 150MG/ZIDOVUDINE 300MG TAB 5 ABACAVIR SO4 600MG/LAMIVUDINE 300MG TAB CHOOSE 1-5: 4 ABACAVIR SO4 300MG/LAMIVUDINE 150MG/ZIDOVUDINE 300MG TAB The following URL provides the link to the FDA Medication Guide associated with this medication. https://devportal.cdco.va.gov/FDA/Documents/Abacavir-lamivudine-zidovudine%20(Tr izivir)%20(2009).pdf Retrieving the Medication Guide...  (This may take several seconds) If the FDA Medication Guide does not automatically open in a .PDF format, this desktop may not have the required software installed. Contact your local technical support for assistance. Press Enter to continue <Enter>

14. PDF Document

15. FDA Med Guide Default Printer (part 1)Outpatient System Parameters [PSO SITE] Select OPTION NAME: PSO SITE PARAMETERS Site Parameter Enter/Edit Select SITE NAME: ALBANY 500 Would you like to see all site parameters for this division? Y// YES ... PRESCRIPTION # LOWER BOUND: 100000999 PRESCRIPTION # UPPER BOUND: 500000000 LAST PRESCRIPTION # ISSUED: 100001899 FDA MED GUIDE DEFAULT PRINTER: PRINTER1$PRT IB SERVICE/SECTION: PHARMACY RELATED INSTITUTION: ALBANY ... NAME: ALBANY// MAILING FRANK STREET ADDRESS: 114 HOLLAND AVE// AREA CODE: 518// PHONE NUMBER: 472-4307// ... PROCESS AUTO REFILLS FOR INPAT: PROCESS AUTO REFILLS FOR CNH: FDA MED GUIDE DEFAULT PRINTER: PRINTER1$PRT // ?

16. FDA Med Guide Default Printer (part 2)Outpatient System Parameters [PSO SITE] FDA MED GUIDE DEFAULT PRINTER: PRINTER1$PRT// ? Enter the default printer used to print FDA Medication Guides for the Division. Answer with DEVICE NAME, or LOCAL SYNONYM, or $I, or VOLUME SET(CPU), or SIGN-ON/SYSTEM DEVICE, or FORM CURRENTLY MOUNTED Do you want the entire DEVICE List? FDA MED GUIDE DEFAULT PRINTER: PRINTER1$PRT// PRINTER2$PRT

17. FDA Med Guide Printer SelectionOutpatient Pharmacy Manager [PSO MANAGER] Select PHARMACY MASTER MENU Option: PS Outpatient Pharmacy Manager Outpatient Pharmacy software - Version Division: ALBANY 500 You are logged on under the ALBANY division. Select PROFILE PRINTER: HOME// GENERIC INCOMING TELNET Select LABEL PRINTER: HOME// GENERIC INCOMING TELNET OK to assume label alignment is correct? YES// Select FDA MED GUIDE PRINTER: PRINTER2$PRT// PRINTER3$PRT Bingo Board Display: OUTPATIENT//

18. Label Printing (Window Rx’s) Patient Prescription Processing [PSO LM BACKDOOR ORDERS] Label Printer: TELNET-IN FDA Med Guide Printer: PRINTER3$PRT LABEL: QUEUE/CHANGE PRINTER/SUSPEND or '^' to bypass Q// CHANGE PRINTER Select PROFILE PRINTER: TELNET-IN// GENERIC INCOMING TELNET Select LABEL PRINTER: TELNET-IN// GENERIC INCOMING TELNET OK to assume label alignment is correct? YES// Select FDA MED GUIDE PRINTER: PRINTER3$PRT// PRINTER4$PRT Label Printer: TELNET-IN FDA Med Guide Printer: PRINTER4$PRT LABEL: QUEUE/CHANGE PRINTER/SUSPEND or '^' to bypass Q//

19. Label Sample (“Read FDA Med Guide”) 19

20. FDA Med Guide Label Log Patient Prescription Processing [PSO LM BACKDOOR ORDERS] OP Medications (ACTIVE) January 6, 2010@11:10:38 Page: 1 of 1 TEST,PATIENT PID: 666-00-5555 Ht(cm): _______ (______) DOB: MAR 6,1935 (71) Wt(kg): _______ (______) Rx #: 100001901$ Orderable Item: DOXORUBICIN INJ,SOLN Drug: DOXORUBICIN 10MG S.P ... Label Log: # Date Rx Ref Printed By =============================================================================== 1 01/12/10 ORIGINAL USER,PHARMACIST Comments: From RX number 100001901 FDA Med Guide URL: http://devportal.cdco.va.gov/FDA/Documents/Doxorubicin(2008). pdf ... DC Discontinue PR Partial RL Release ED Edit RF Refill RN Renew Select Select Action: Next Screen//

21. FDA Med Guide CMOP Event Log Patient Prescription Processing [PSO LM BACKDOOR ORDERS] OP Medications (ACTIVE) January 6, 2010@11:10:38 Page: 1 of 1 TEST,PATIENT PID: 666-00-5555 Ht(cm): _______ (______) DOB: MAR 6,1935 (71) Wt(kg): _______ (______) Rx #: 100001901$ Orderable Item: DOXORUBICIN INJ,SOLN CMOP Drug: DOXORUBICIN 10MG S.P ... CMOP Event Log: Date/Time Rx Ref TRN-Order Stat Comments =============================================================================== 02/21/00@08 Orig 1-1 TRAN NDC: 1234-4444-33 FDA Med Guide URL: http://devportal.cdco.va.gov/FDA/Documents/Doxorubicin(2008). Pdf ... DC Discontinue PR Partial RL Release ED Edit RF Refill RN Renew Select Select Action: Next Screen//

22. FDA Med Guide Reprint (On-demand)Patient Prescription Processing [PSO LM BACKDOOR ORDERS] OP Medications (ACTIVE) January 6, 2010@11:10:38 Page: 1 of 1 TEST,PATIENT PID: 666-00-5555 Ht(cm): _______ (______) DOB: MAR 6,1935 (71) Wt(kg): _______ (______) Rx #: 38338845 (1) *Orderable Item: SIMVASTATIN TAB (2) Drug: SIMVASTATIN 80MG TAB Verb: TAKE (3) *Dosage: 1 TABLET *Route: ORAL *Schedule: D (4)Pat Instructions: SIG: TAKE 1 TABLET BY MOUTH (5) Patient Status: SC (6) Issue Date: 01/06/10 (7) Fill Date: 01/06/10 Last Fill Date: 01/06/10 (Window) Last Release Date: (8) Lot #: Expires: 01/06/11 MFG: DC Discontinue PR Partial RL Release ED Edit RF Refill RN Renew Select Select Action: Next Screen// OTH

23. Display FDA Medication Guide (OTH hidden actions)Patient Prescription Processing [PSO LM BACKDOOR ORDERS] --- Other OP Actions --- PN Progress Note (OP) AP Action Profile (OP) MI Print Medication Instructions DO Display Orders' Statuses MG Display FDA Medication Guide Select Item(s): MG Display FDA Medication Guide The following URL provides the link to the FDA Medication Guide associated with this medication: http://devportal.cdco.va.gov/FDA/Documents/Amphetamine-Dextroamphetamine%20(Adde rall)%20(2008).pdf If the FDA Medication Guide does not automatically open in .PDF format when you press <Enter> below, this desktop may not have required software installed. Contact your local technical support for assistance. Enter RETURN to continue or '^' to exit:

24. Questions?