Transcript Managing Drug Shortage - Remote
5 th Annual PBM Pharmacy Informatics Conference
Managing Drug Shortages
Kat hy Walker, CPhT, Coatesville VA Bruce McIntosh, PharmD, VA National Center for Patient Safety Daphen Shum, RPh, VA Maryland Health Care System Robert Silverman, PharmD, PBM Clinical Informatics
DATE/MONTH 2012
Objectives
• • • • Identify issues to consider in managing drug shortages Identify patient safety issues associated with changing medication therapies Identify process issues to consider in changing medication therapies (converting prescriptions) Be familiar with the VistA tools available for identifying patients affected by drug shortages VETERANS HEALTH ADMINISTRATION 1
Drug Shortages: A Problem on the Rise A VA Guide For Survival Kathy Walker, CPhT
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Definition of Drug Shortage
A product shortage occurs when: “[Total] supply does not meet demand for a drug on a nationwide or regional basis for a period of time that necessitates changing the practice of treating the patient.” VETERANS HEALTH ADMINISTRATION
The Healthcare Supply Chain
• • • • • Every day more than nine million prescription medicines and healthcare products are delivered to nearly 200,000 pharmacies, hospitals, nursing homes, clinics and other healthcare locations nationwide.
A single product shortage is likely the combination of numerous factors The healthcare supply chain is becoming increasingly complex Manufacturers are operating in a global model for sourcing ingredients and developing branded and generic pharmaceuticals.
Supply chain efficiency has continued to increase over the past decade, while total supply chain inventory has decreased.
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Key Facts about Drug Shortages
• • • • The number of reported drug shortages annually has tripled from 61 in 2005 to 178 in 2010. Of the 127 studied shortages in 2010-11, 80 percent involved drugs delivered to patients by sterile injection, including oncology drugs, antibiotics, and electrolyte/nutrition drugs. The leading reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).
Manufacturing quality problems that have resulted in shortages can be serious, including findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients. VETERANS HEALTH ADMINISTRATION 6
Taken from FDA U.S. Food and Drug Administration: Protecting and Promoting Public Health http://www.fda.gov
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Why Do Shortages Occur?
• • • • • • • • • Natural Disasters Raw Material Shortages Regulatory Non-Compliance Voluntary Recalls Recalls Manufacturer Allocation Restricted Distribution Shift in Clinical Practice Economics • • • • • • • • Manufacturer Discontinuation Industry Consolidations Market Shifts Unexpected Demand “Grey “ Market Vendors Prime Vendors Just In Time Inventory Unexplained or Unknown Inventory Practices VETERANS HEALTH ADMINISTRATION 9
Managing Shortages
• • • • • • •
Sourcing Product
Contact PPV check other DC’s Check other manufacturers Place an order direct with manufacturer Network with other VA’s Check with local healthcare institutions Outsource to other compliant vendors Compounding through a certified compounding pharmacy VETERANS HEALTH ADMINISTRATION • • • • • •
Clinical Intervention
Available forms Available strengths Similar agents within therapeutic class Other agents Formulary vs Non-Formulary 30 Day fills 10
Opportunities
• • • • •
Inventory Management
Learn to anticipate need Evaluate purchase history Buy ahead Utilize reporting tools Use technology to your advantage VETERANS HEALTH ADMINISTRATION 11
Drug Substitution & Effect on Patients Bruce McIntosh, PharmD
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Drug Substitution & Effect on Patients
•
Patient safety concerns:
– Patient may take both medications – Patient may take neither medication – ADEs and Med Events (errors) – Therapeutic substitution • Dose conversion and follow-up – Example: Coreg to Toprol XL – Withdrawal syndrome VETERANS HEALTH ADMINISTRATION 13
Drug Substitution & Effect on Patients
•
Communication Breakdown:
– Look Alike / Sound Alike (LASA) • Example- Amlodipine vs. Felodipine – Rx Sig. changes due to change • Example- ISDN vs. ISMN – Patient may not be taking medication anymore • Active status in CPRS – Communication to clinicians and health care team VETERANS HEALTH ADMINISTRATION 14
Drug Substitution & Effect on Patients
• • • • • • Mass letters vs. telephone call Patient literacy (for letter and Rx label) No replacement available/suitable Alternative too expensive and low risk medication (e.g. Nasal Steroid Inhalers) High Risk medications Medication use process VETERANS HEALTH ADMINISTRATION 15
Resources
• • • • http://www.fda.gov/Drugs/DrugSafety/DrugShort ages/ucm050792.htm
http://www.ashp.org/shortages?WT.ac=hp%5FPo pLinks%5FDrug%5FShortages http://www.ismp.org/newsletters/acutecare/arti cles/20100729.asp
http://www.cshp.org/uploads/file/Newsroom/20 12/hosp_pharm_dec_2011_drug_shortages.pdf
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Processing Medication Changes - Converting Rx
Daphen Shum, RPh
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What to do?
• •
Identify alternative Communication to providers, pharmacy staff & patients
•
Change/convert Rx / med orders
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Alternatives
• • •
Availability & costs Timeliness – short or long-term backorder?
P&T authorization to change
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Communication
• • • •
Notify Providers Notify Pharmacy staff Notify Patients Notify Nurses
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Notification to Providers
•
General communication /email announcement
•
Patient list to providers to change Rx
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Notification to Providers
VAMHCS Prescribers: Please note the following changes related to product availability which may affect the way you prescribe certain medications.
VARDENAFIL to SILDENAFIL CONVERSION
In response to the November 2011 National Formulary changes, Pharmacy Service continues the therapeutic substitution of sildenafil for vardenafil. After the VAMHCS conversion began the MAP/PBM Chairmen issued a memo announcing the mandatory use contract and suggesting, “as a safety precaution, patients currently taking a 20mg dose of vardenafil should be converted to sildenafil 50mg (or lower), not sildenafil 100mg.” Pharmacy Service conversions have been modified to limit sildenafil dose conversion to a maximum dose of 50mg. The potential VAMHCS annualized cost savings for the vardenafil to sildenafil conversion is in estimated to exceed $1,300,000.
Testosterone Patches
Watson Pharmaceuticals, the manufacturer of testosterone patches no longer manufactures 2.5mg and 5mg patches. They now manufacture 2mg and 4mg patches. Because transdermal testosterone is a controlled substance, Pharmacy Service cannot perform a therapeutic substitution. Patients with active prescriptions for 2.5mg or 5mg patches and their prescribers have been notified of this change. The drug file has been updated to reflect availability of the 2mg and 4mg products. VETERANS HEALTH ADMINISTRATION 22
Notification to Patients
• • • Letter of notification – generic form or individual Aux label Notice on Rx label – “ Replaces xxxxx – Do Not Take Both “ VETERANS HEALTH ADMINISTRATION 23
Notification to Patients
Dear Veteran, Our VA Maryland Health Care System Pharmacy records show that a refill request has been made for flunisolide (Nasalide ®) or fluticasone (Flonase ®) NASAL inhaler. These inhalers are not available from the manufacturer and the VAMHCS pharmacy is unable to purchase them. To continue to provide treatment to you it is necessary to replace your prescription for either fluticasone or flunisolide with mometasone (Nasonex ®) nasal inhaler. All of these inhalers contain corticosteroids and are prescribed for similar conditions.
The prescription label for mometasone provides you with the directions on how to use this medication. READ THE LABEL CAREFULLY because the directions may be different. We do not expect that you will notice any difference in the effects of the medications. If you notice any change in your nasal symptoms please discuss them with your provider.
If you have any questions or concerns about this change in medication please contact the Telephone Liaison Care Program (TLCP) Pharmacist at 1-800-865-2441 Monday – Friday, 8:00 am until 4:00 pm.
Sincerely, Xxx,Xxxxxx Co-chairperson, Pharmacy & Therapeutics Committee VETERANS HEALTH ADMINISTRATION 24
Notification to Pharmacy Staff
• •
Details of conversion process Notification via email
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Factors to consider
• • • Dosage equivalence Pharmacist conversion or Provider change Local vs CMOP fill of the new Rx – Volume of prescriptions – Patient notification VETERANS HEALTH ADMINISTRATION 26
Factors to consider
• • • • Convert from Rx refill labels UNmark from CMOP?
Convert from suspended Rx’s ahead of fill Inpatient med orders VETERANS HEALTH ADMINISTRATION 27
Rx conversion steps – Drug File issues / CPRS
• • • • •
Inactivate (original) Orderable Item UNmark from CMOP Mark non-renewable / not refillable Enter new/ replacement drug Not renewable / not refillable
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Rx Conversion steps – Converting active Rx
• • • • • • • Copy original Rx to create new Rx Edit dispense drug (field #2) Edit Dosage Ordered (field #5) & QTY (field #7) Edit Patient Instructions (field #6) – include Aux info Adjust refills (field #9) Nature of Order: Policy or Service correction **Discontinue original Rx VETERANS HEALTH ADMINISTRATION 29
New OP Order (COPY) Apr 26, 2012@17:00:33 Page: 1 of 2
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Rx Conversions steps – Filling Rx
• • Aux labels to identify change Include notification letter VETERANS HEALTH ADMINISTRATION 32
Automating Conversion Process
• • • Use Fileman to identify Rx needing conversion (suspended Rx list vs Refill labels printing when unmarked for CMOP) May set up menu of FM routine Use VBA Macro for Reflection to convert VETERANS HEALTH ADMINISTRATION 33
Print Suspended Rx
Select ADPAC FileManager Menu Option: Print File Entries OUTPUT FROM WHAT FILE: PRESCRIPTION// SORT BY:
STATUS["SUSP"
Replace // WITHIN STATUS["SUSP", SORT BY: NYTOIN 100MG CAP EXTENDED (E WITHIN DRUG, SORT BY:
DRUG
// * Previous selection: DRUG from PHENYTOIN 100MG CAP EXTENDED (DILANTIN) to PHE START WITH DRUG: PHENYTOIN 100MG CAP EXTENDED (DILANTIN) GO TO DRUG: PHENYTOIN 100MG CAP EXTENDED (E Replace
LAST DISPENSED DATE
START WITH LAST DISPENSED DATE: GO TO LAST DISPENSED DATE:
LAST @
// // WITHIN LAST DISPENSED DATE, SORT BY: // * Previous selection: All LAST DISPENSED DATE (includes nulls) VETERANS HEALTH ADMINISTRATION 34
Print Suspended Rx
(cont’d) FIRST PRINT FIELD:
PATIENT;L20
// THEN PRINT FIELD:
PATIENT:1U4N;L6
// THEN PRINT FIELD:
RX #;L10#
// THEN PRINT FIELD:
DRUG;L20
// THEN PRINT FIELD:
SIG1
// (multiple) THEN PRINT SIG1 SUB-FIELD:
SIG1;L40;L45
// 1 SIG1 2 SIG1 CHOOSE 1-2:
1 SIG1
THEN PRINT SIG1 SUB-FIELD: // THEN PRINT FIELD:
LAST DISPENSED DATE
// THEN PRINT FIELD: Heading (S/C): PRESCRIPTION LIST// STORE PRINT LOGIC IN TEMPLATE: VETERANS HEALTH ADMINISTRATION 35
Print Suspended Rx
(cont’d) Select Outpatient Pharmacy Special Reports Option: Suspend RX by Drug * Previous selection: DRUG from RISPERIDONE 0.5MG TAB to RISPERIDONE 3
START WITH DRUG:
RISPERIDONE 0.5MG TAB Replace
GO TO DRUG :
RISPERIDONE 3// DEVICE: qUEUE TO PRINT ON DEVICE: p-mess 1 P-MESSAGE-HFS Message Output 2 P-MESSAGE132 MAIL 132 Choose 1-2> 2 P-MESSAGE132 MAIL 132 Subject: <= type in the email subject The report can be queued to a printer or VISTA email (P-mess).
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Rx’s on Suspense
LAST DISPENSED PATIENT PATIENT:1U4N RX # DRUG SIG1 DATE ----------------------------------------------------------------------------------------------------------------------- PATIENT,ONE PATIENT,TWO PATIENT,THREE PATIENT,FOUR P0000 1234567E PHENYTOIN 100MG CAP TAKE TWO CAPSULES EVERY EVENING MAY 11,2012 P0001 2345678A PHENYTOIN 100MG CAP TAKE THREE CAPSULES EVERY DAY FOR SEI MAY 26,2012 P0002 3456789 PHENYTOIN 100MG CAP TAKE ONE CAPSULE THREE TIMES A DAY FO JUN 2,2012 P0003 4567890C PHENYTOIN 100MG CAP TAKE ONE CAPSULE THREE TIMES A DAY FO JUN 20,2012 * LAST DISPENSED DATE = SUSPENSE DATE VETERANS HEALTH ADMINISTRATION 37
VBA Macro for Reflections
• • Link: \\vhabalpbm\Informatics Education\LiveMeeting and Camtasia Recordings\VBA Macro for Reflections\Excel Converter Link: \\vhabalpbm\Informatics Education\LiveMeeting and Camtasia Recordings\VBA Macro for Reflections\Excel Converter HTML VETERANS HEALTH ADMINISTRATION 38
Informatics Help & Notifications Robert Silverman, PharmD
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VistA Reports
• As a result of issues regarding the disclosure of patient safety information about Chantix (varenicline), 2 VistA options were released: – Prescription List for Drug Warnings [PSO RX LIST] – List of Patients/Prescriptions for Recall Notice [PSO RECALL LIST] VETERANS HEALTH ADMINISTRATION 40
VistA Reports
• • These reports can be useful in finding a current list of patients on a selected drug Note: there are continued reports of discrepancies with these two options –
The more they are used, the more these issues will be identified and can be corrected!
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Prescription List for Drug Warnings
PSO RX LIST
Prescription List for Drug Warnings ** Users unfamiliar with sort templates should review ** ** sort template documentation before continuing. ** ** To avoid undesired wrapping of the output data, ** ** please enter '0;512;999' at the 'DEVICE:' prompt. ** ** You may need to set your Terminal Session Display ** ** Settings to 512 columns. ** EXCLUDE DECEASED PATIENTS (Y/N) START WITH DIVISION: GO TO DIVISION: GO TO DRUG:
Z
// START WITH DRUG:
MORZ A
//
MOR
// //
Y
// ES Prescription List for Drug Warnings * Previous selection: DIVISION from A to Z * Previous selection: DRUG from MOR to MORZ * Previous selection: FINISH DATE/TIME from Oct 1,2011 to Nov 30,2011@24:00 START WITH FINISH DATE/TIME:
Oct 1,2011
// (OCT 01, 2011) GO TO FINISH DATE/TIME:
Nov 30,2011
// (NOV 30, 2011) VETERANS HEALTH ADMINISTRATION 42
List of Patients/Prescriptions for Recall Notice
PSO RECALL LIST
List of Patients/Prescriptions for Recall Notice You may select a single or multiple Divisions,or enter ^ALL to select all Divisions.
Division:
^ALL
From Release Date:
T-90
// (JAN 14, 2012) To Release Date:
T
// (APR 13, 2012) Select one of the following: 1 NDC 2 DISPENSE DRUG AND LOT NUMBER 3 DISPENSE DRUG 4 VA GENERIC NAME 5 ORDERABLE ITEM Dispense Drug:
BUPRENORPHINE 2MG/NALOXONE 0.5MG SL TAB
Lot # :
ABC123
Exclude Deceased Patients?
YES
// ** To avoid undesired wrapping of the output data, ** ** please enter '0;512;999' at the 'DEVICE:' prompt. ** ** You may need to set your Terminal Session Display ** ** Settings to 512 columns. ** CN101 VETERANS HEALTH ADMINISTRATION 43
\\ \\
HEADER
\^RX #^DRUG NAME^PATIENT^SSN^ADDRESS 1^ADDRESS 2^ADDRESS 3^CITY^STATE^ZIP^PHONE (HOME)^PHONE (WORK)^PHONE (CELL)^DECEASED?
\\ \\ \\
ORIGINAL REFILL PARTIAL CMOP
\^RX #^ISSUE DATE^FILL DATE^RELEASED DATE/TIME^EXPIRATION DATE^LOT #^NDC^DIVISION^PHARMACIST^PROVIDER^RETURNED TO STOCK^PATIENT STATUS^QTY PER DAY^# OF REFILLS^MAIL/WINDOW \^RX #^REFILL DATE^RELEASED DATE/TIME^QTY PER DAY^LOT#^NDC^ DIVISION^RETURNED TO STOCK^PROVIDER^PARMACIST NAME^MAIL/WINDOW \^RX #^PARTIAL DATE^RELEASED DATE/TIME^NDC^LOT #^QTY PER DAY ^DIVISION^ RETURNED TO STOCK^PROVIDER^PHARMACIST NAME^FILLING PERSON^ REMARKS^MAIL/WINDOW \^RX #^TRANSMISSION NUMBER^SEQUENCE #^NDC SENT^NDC RECEIVED^RX INDICATOR^STATUS^CANCELLED DATE/TIME^CANCELLED REASON^RESUBMIT STATUS^ DATE SHIPPED^CARRIER^PACKAGE ID \\ \\ \\
HEADER
\^301188^PREDNISONE 20MG S.T.^SURPAT,RODNEY^666000148^123 ^^^TROY^NEW YORK^12180^^^^N \\
ORIGINAL REFILL CMOP
11/19/07^^ \^301188^9/25/07^9/25/07^9/25/07 15:10:33^9/25/08^^^TROY^ PHARNAM,DAVID^DOCNAM,SUZY^^SC LESS THAN 50%^2^11^W \^301188^11/14/07^11/14/07 11:09:40^2^^^TROY^^PHARNAM,DAVID^ DOCNAM,SUZY^W \^301188^179^1^11/18/07 10:22^11/18/07 11:17^2^TRANSMITTED^^^^ \\ \\ \\
HEADER
\^100002832^PREDNISONE 20MG S.T.^TRAPATNM,STEVE^ 666000187^12345 ^^^TROY^NEW YORK^12180^518-472-4307^^^N
ORIGINAL PARTIAL
\^100002832^2/8/10^2/8/10^2/8/10 15:16:51^2/9/11^^00009-0165-02 ^EXT^TESTMAN,PHARM^TESTMAN,PROV^^SC LESS THAN 50%^1^11^W \^100002832^ 44
Documentation References
• Virtual Documentation Library • http://www.va.gov/vdl/application.asp?appid=90 User Manual - Manager - Outpatient Pharmacy V.7.0 Posted March 07, 2012 DOC PDF
(2.60 MB) (2.36 MB)
• “Change Pages” (patches PSO*7*348 and PSO*7*371) http://www.va.gov/vdl/documents/Clinical/Pharm Outpatient_Pharmacy/pso_7_p348_man_um_cp.pdf
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Questions???
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QUESTIONS?
Please use the Q&A Function on Live Meeting OR Email: [email protected]
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