Transcript Managing Drug Shortage - Remote

5th Annual PBM Pharmacy Informatics Conference
Managing Drug Shortages
Kathy 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
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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.”
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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.
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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
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• Manufacturer
Discontinuation
• Industry Consolidations
• Market Shifts
• Unexpected Demand
• “Grey “ Market Vendors
• Prime Vendors Just In Time
Inventory
• Unexplained or Unknown
• Inventory Practices
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Managing Shortages
Sourcing Product
Clinical Intervention
• 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
• Available forms
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• Available strengths
• Similar agents within
therapeutic class
• Other agents
• Formulary vs Non-Formulary
• 30 Day fills
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Opportunities
Inventory Management
• Learn to anticipate need
• Evaluate purchase history
• Buy ahead
• Utilize reporting tools
• Use technology to your advantage
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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
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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
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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
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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.
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Notification to Patients
• Letter of notification – generic form or
individual
• Aux label
• Notice on Rx label –
“ Replaces xxxxx – Do Not
Take Both “
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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
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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
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Factors to consider
•
•
•
•
Convert from Rx refill labels
UNmark from CMOP?
Convert from suspended Rx’s ahead of fill
Inpatient med orders
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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
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New OP Order (COPY)
ZZTEST,PATIENT
PID: 000-00-2720
DOB: MAR 27,1977 (35)
Orderable Item:
(1)
CMOP Drug:
(2) Patient Status:
(3)
Issue Date:
(5) Dosage Ordered:
Verb:
Dispense Units:
Noun:
Route:
Schedule:
(6)Pat Instruction:
Other Patient Inst.:
SIG:
(7)
Days Supply:
Apr 26, 2012@17:00:33
Page:
1 of
2
<A>
Ht(cm): 157.48 (03/01/2012)
Wt(kg): 102.27 (03/01/2012)
AMLODIPINE ORAL TAB <DIN>
AMLODIPINE 10MG TAB (NORVASC) <DIN>
SERVICE-CONNECTED
APR 26,2012
(4) Fill Date: APR 26,2012
10 (MG)
TAKE
1
TABLET
ORAL
DAILY
FOR BLOOD PRESSURE/HEART.
TAKE ONE TABLET EVERY DAY FOR BLOOD PRESSURE/HEART.
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(8)
QTY (TAB): 30
(9)
# of Refills: 2
(10) Routing: WINDOW
(11)
Clinic:
(12)
Provider: PROVIDER, ONE
(13)
Copies: 1
(14)
Remarks: New Order Created by copying Rx # 7831642.
Entry By: PROVIDER, ONE
Entry Date: APR 26,2012 17:18:28
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Rx Conversions steps
– Filling Rx
• Aux labels to identify change
• Include notification letter
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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
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Print Suspended Rx
Select ADPAC FileManager Menu Option: Print File Entries
OUTPUT FROM WHAT FILE: PRESCRIPTION//
SORT BY: STATUS["SUSP"//
WITHIN STATUS["SUSP", SORT BY: DRUG//
* Previous selection: DRUG from PHENYTOIN 100MG CAP EXTENDED (DILANTIN) to PHE
NYTOIN 100MG CAP EXTENDED (E
START WITH DRUG: PHENYTOIN 100MG CAP EXTENDED (DILANTIN)
Replace
GO TO DRUG: PHENYTOIN 100MG CAP EXTENDED (E Replace
WITHIN DRUG, SORT BY: LAST DISPENSED DATE//
* Previous selection: All LAST DISPENSED DATE (includes nulls)
START WITH LAST DISPENSED DATE: @//
GO TO LAST DISPENSED DATE: LAST//
WITHIN LAST DISPENSED DATE, SORT BY:
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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:
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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
P0001
P0002
P0003
1234567E
2345678A
3456789
4567890C
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
100MG
100MG
100MG
100MG
CAP
CAP
CAP
CAP
TAKE
TAKE
TAKE
TAKE
TWO CAPSULES
EVERY EVENING
THREE CAPSULES
EVERY DAY FOR SEI
ONE CAPSULE
THREE TIMES A DAY FO
ONE CAPSULE
THREE TIMES A DAY FO
MAY 11,2012
MAY 26,2012
JUN 2,2012
JUN 20,2012
* LAST DISPENSED DATE = SUSPENSE DATE
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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
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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]
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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) Y// ES
Prescription List for Drug Warnings
* Previous selection: DIVISION from A to Z
START WITH DIVISION: A//
GO TO DIVISION: Z//
* Previous selection: DRUG from MOR to MORZ
START WITH DRUG: MOR//
GO TO DRUG: 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)
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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
2
3
4
5
NDC
DISPENSE DRUG AND LOT NUMBER
DISPENSE DRUG
VA GENERIC NAME
ORDERABLE ITEM
Dispense Drug:
BUPRENORPHINE 2MG/NALOXONE 0.5MG SL
Lot # : ABC123
Exclude Deceased Patients? YES//
** To avoid undesired wrapping of the output
** please enter '0;512;999' at the 'DEVICE:'
** You may need to set your Terminal Session
**
Settings to 512 columns.
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TAB
data,
prompt.
Display
CN101
**
**
**
**
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\\HEADER\^RX #^DRUG NAME^PATIENT^SSN^ADDRESS 1^ADDRESS 2^ADDRESS
3^CITY^STATE^ZIP^PHONE (HOME)^PHONE (WORK)^PHONE (CELL)^DECEASED?
\\ORIGINAL\^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
\\REFILL\^RX #^REFILL DATE^RELEASED DATE/TIME^QTY PER DAY^LOT#^NDC^
DIVISION^RETURNED TO STOCK^PROVIDER^PARMACIST NAME^MAIL/WINDOW
\\PARTIAL\^RX #^PARTIAL DATE^RELEASED DATE/TIME^NDC^LOT #^QTY PER DAY
^DIVISION^ RETURNED TO STOCK^PROVIDER^PHARMACIST NAME^FILLING PERSON^
REMARKS^MAIL/WINDOW
\\CMOP\^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\^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
\\REFILL\^301188^11/14/07^11/14/07 11:09:40^2^^^TROY^^PHARNAM,DAVID^
DOCNAM,SUZY^W
\\CMOP\^301188^179^1^11/18/07 10:22^11/18/07 11:17^2^TRANSMITTED^^^^
11/19/07^^
\\HEADER\^100002832^PREDNISONE 20MG S.T.^TRAPATNM,STEVE^ 666000187^12345
^^^TROY^NEW YORK^12180^518-472-4307^^^N
\\ORIGINAL\^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
\\PARTIAL\^100002832^
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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 (2.60 MB)
PDF (2.36 MB)
• “Change Pages” (patches PSO*7*348 and PSO*7*371)
http://www.va.gov/vdl/documents/Clinical/PharmOutpatient_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]
[email protected]
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