5 th annual pbm pharmacy informatics conference managing drug shortages date/month 2012 kat hy...

5th Annual PBM Pharmacy Informatics Conference

Managing Drug Shortages

DATE/MONTH 2012

Kathy Walker, CPhT, Coatesville VABruce McIntosh, PharmD, VA National Center for Patient SafetyDaphen Shum, RPh, VA Maryland Health Care SystemRobert Silverman, PharmD, PBM Clinical Informatics

VETERANS HEALTH ADMINISTRATION

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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Kathy Walker, CPhT

Drug Shortages: A Problem on the Rise

A VA Guide For Survival

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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.”


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.


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


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

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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

Clinical Intervention• Available forms• Available strengths• Similar agents within

therapeutic class• Other agents• Formulary vs Non-Formulary• 30 Day fills

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Opportunities

• Learn to anticipate need• Evaluate purchase history• Buy ahead• Utilize reporting tools • Use technology to your advantage

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Inventory Management


Bruce McIntosh, PharmD

Drug Substitution & Effect on Patients

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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 syndrome14



• 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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• 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/DrugShortages/ucm050792.htm

• http://www.ashp.org/shortages?WT.ac=hp%5FPopLinks%5FDrug%5FShortages

• http://www.ismp.org/newsletters/acutecare/articles/20100729.asp

• http://www.cshp.org/uploads/file/Newsroom/2012/hosp_pharm_dec_2011_drug_shortages.pdf

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http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

http://www.ashp.org/shortages?WT.ac=hp_PopLinks_Drug_Shortages

http://www.ashp.org/shortages?WT.ac=hp_PopLinks_Drug_Shortages

http://www.ismp.org/newsletters/acutecare/articles/20100729.asp

http://www.ismp.org/newsletters/acutecare/articles/20100729.asp

http://www.cshp.org/uploads/file/Newsroom/2012/hosp_pharm_dec_2011_drug_shortages.pdf

http://www.cshp.org/uploads/file/Newsroom/2012/hosp_pharm_dec_2011_drug_shortages.pdf


Daphen Shum, RPh

Processing Medication Changes - Converting Rx

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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

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VAMHCS Prescribers:

Please note the following changes related to product availability which may affect the way you prescribe certain medications.VARDENAFIL to SILDENAFIL CONVERSIONIn 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 PatchesWatson 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.


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

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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


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) Apr 26, 2012@17:00:33 Page: 1 of 2 ZZTEST,PATIENT <A> PID: 000-00-2720 Ht(cm): 157.48 (03/01/2012) DOB: MAR 27,1977 (35) Wt(kg): 102.27 (03/01/2012) Orderable Item: AMLODIPINE ORAL TAB <DIN> (1) CMOP Drug: AMLODIPINE 10MG TAB (NORVASC) <DIN> (2) Patient Status: SERVICE-CONNECTED (3) Issue Date: APR 26,2012 (4) Fill Date: APR 26,2012 (5) Dosage Ordered: 10 (MG) Verb: TAKE Dispense Units: 1 Noun: TABLET Route: ORAL Schedule: DAILY (6)Pat Instruction: FOR BLOOD PRESSURE/HEART. Other Patient Inst.: SIG: TAKE ONE TABLET EVERY DAY FOR BLOOD PRESSURE/HEART. (7) Days Supply: 30 (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


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

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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 PHENYTOIN 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:


Print Suspended Rx (cont’d)

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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:


Print Suspended Rx (cont’d)

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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 ONDEVICE: p-mess 1 P-MESSAGE-HFS Message Output 2 P-MESSAGE132 MAIL 132Choose 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).


Rx’s on Suspense

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LAST DISPENSEDPATIENT PATIENT:1U4N RX # DRUG SIG1 DATE------------------------------------------------------------------------------------------------------------------------

PATIENT,ONE P0000 1234567E PHENYTOIN 100MG CAP TAKE TWO CAPSULES EVERY EVENING MAY 11,2012PATIENT,TWO P0001 2345678A PHENYTOIN 100MG CAP TAKE THREE CAPSULES EVERY DAY FOR SEI MAY 26,2012PATIENT,THREE P0002 3456789 PHENYTOIN 100MG CAP TAKE ONE CAPSULE THREE TIMES A DAY FO JUN 2,2012PATIENT,FOUR P0003 4567890C PHENYTOIN 100MG CAP TAKE ONE CAPSULE THREE TIMES A DAY FO JUN 20,2012

* LAST DISPENSED DATE = SUSPENSE DATE


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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Robert Silverman, PharmD

Informatics Help & Notifications

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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

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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// ESPrescription List for Drug Warnings* Previous selection: DIVISION from A to ZSTART 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)


List of Patients/Prescriptions for Recall Notice

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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: ^ALLFrom 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 CN101 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. **

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\\HEADER\^RX #^DRUG NAME^PATIENT^SSNÂDDRESS 1ÂDDRESS 2ÂDDRESS3^CITY^STATE^ZIP^PHONE (HOME)^PHONE (WORK)^PHONE (CELL)^DECEASED?\\ORIGINAL\^RX #ÎSSUE DATE^FILL DATE^RELEASED DATE/TIMEÊXPIRATIONDATE^LOT #^NDC^DIVISION^PHARMACIST^PROVIDER^RETURNED TO STOCK^PATIENTSTATUS^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^RXINDICATOR^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^^00009-0165-02ÊXT^TESTMAN,PHARM^TESTMAN,PROV^^SC LESS THAN 50%^1^11^W\\PARTIAL\^100002832^


Documentation References

• Virtual Documentation Libraryhttp://www.va.gov/vdl/application.asp?appid=90• User Manual - Manager - Outpatient Pharmacy V.7.0

Posted March 07, 2012DOC (2.60 MB)PDF (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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http://www.va.gov/vdl/application.asp?appid=90

http://www.va.gov/vdl/documents/Clinical/Pharm-Outpatient_Pharmacy/pso_7_man_um_r0312.doc

http://www.va.gov/vdl/documents/Clinical/Pharm-Outpatient_Pharmacy/pso_7_man_um_r0312.pdf

http://www.va.gov/vdl/documents/Clinical/Pharm-Outpatient_Pharmacy/pso_7_p348_man_um_cp.pdf

http://www.va.gov/vdl/documents/Clinical/Pharm-Outpatient_Pharmacy/pso_7_p348_man_um_cp.pdf


Questions???

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QUESTIONS?

Please use the Q&A Function on Live Meeting

OR

Email: [email protected]@va.gov

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mailto:[email protected]

mailto:[email protected]

5 th annual pbm pharmacy informatics conference managing drug shortages date/month 2012 kat hy...

Documents

drug administration

cpht drug shortages

reported shortages

studied shortages

healthcare supply chain

pbm clinical informatics

public health http

total supply chain inventory