Stability of Solutions: Decanting off the Truth

Manish Khullar, BSc PharmInterior Health Pharmacy Resident

October 3, 2013

Learning Objectives

• To understand some of the current issues in the dispensary

• To recommend a method to dating products in the dispensary

• To describe the various issues that occur with best possible medication histories

Outline

• Issue behind the dating of decanted products • Drug information question• Drug distribution project

• Best possible medication histories

Decanting of Solutions

What is Currently Done in the Dispensary

• Products that are currently decanted into stock bottles are given an expiration date

• After the expiration date is up, the product is discarded and new product is dispensed

• Sometimes from the same stock bottle! • ex. Chlorhexidine and its 30 day expiration date

Drug Information Question…

• Is the current method used for expiration dating of solutions in the dispensary the most appropriate, efficient and cost effective way to dispense these medications?

Why Do We Care?

• Wasting product• Wasting money• Takes time away from the nursing staff• Takes more time away from the pharmacy

department • Staff is confused on what to do!

Why Not Just Use Manufacture’s Date?

• Need to consider:• Stability of product(s)• Stability data of the compounds outside

of manufacturer’s bottle • Possible contamination of stock bottles?• Types of ingredients in compounds

Currently in the Dispensary…

• No guideline is currently being employed or followed in the dispensary to come up with a proper expiration date for decanted solutions

• No standard for Interior Health currently exists

My Approach• United States Pharmacopoeia (USP) 795 (non-sterile products) 797 (sterile

products):

– For non-aqueous formulations• The beyond use date is not later than the time remaining until the earliest expiration date of any

ingredients or 6 months, whichever is earlier.

– For Water-Containing Oral Formulations (ie reconstituted products) • The beyond use date is not later than 14 days when stored at controlled room temperatures.

– For Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations• The beyond use date is not later than 30 days.

*The beyond use date shall not be later than the expiration date on the container of any component.

Search

• Literature search (pubmed, medline)• no relevant articles

• References• United states pharmacopoeia (USP), Trissel's Stability of

Compounded Formulations, Remington

• BC College of Pharmacists • referred me to USP 795 and 797

• Health Canada • referred me to USP 795 and 797

• Manufacturer…

Commonly Decanted Solutions/Suspensions at KGH

Response received Response not received

BenzydamineFerrous SulfateFurosemide Morphine SulfateChlorhexidine GluconateSucralfate SuspensionRanitidine

DigoxinDiphenhydramineSodium Hypochlorite 6%Acyclovir SuspensionCodeine Syrup

Response

• Varied from 6 months, 1 year, manufacturer’s expiry date on bottle to don’t do it at all

• Not very clear on what the approach should be or who to trust!

Potential Changes to Current Practice? Drug USP 795/797 Manufacturer’s

Recommendations Currently

Benzydamine 6 months Product date or 1 year whichever is shorter

Decanted as single doses PRN

Ferrous Sulfate 6 months Product date or 1 year whichever is shorter

Decanted as single doses PRN

Furosemide 6 months Not recommended Decanted as single doses PRN

Morphine 6 months Product date or 1 year whichever is shorter

Manufacturer’s date

Chlorhexidine 6 months Manufacturer’s date 30 days Sucralfate 6 months Not recommended Manufacturer’s date

Ranitidine 6 months Not recommended Decanted as single doses PRN

Creams/Ointments 30 days max - 30 days

Conclusion

• Recommendations for expiration dates on decanted solutions should be a judgment call and recommendations from both the USP and manufacturer should be considered

BPMH: When Best Isn’t Good Enough

Manish Khullar, BSc PharmInterior Health Pharmacy Resident

October 3, 2013

Background

• Best possible medication histories (BPMH) are conducted upon admission to the hospital

• Majority received are from ER

• They are used as a physician order form for the first time and physician order forms or pre-printed orders (PPOs) are used thereafter

• In order to process BPMHs as physician orders, all areas must be filled out appropriately and accompanied by a physician signature

Importance of Proper BPMHs

• There are a high number of discrepancies (84.3%) between gold standard BPMHs and medication profiles found in Pharmanet

• Canadian studies have shown that 40-50% of patients have experienced unintentional medication discrepancies upon admission to an acute care facility

• 46% of medication errors occur on admission or discharge

http://www.bcpsqc.ca/ccm-public/documents/fernandes.pdfJ Crit Care 2003; 18(4): 201-5BMC 2012; 12(42): 17

Importance of Proper BPMHs

• Allows pharmacy staff to know proper medication history was taken from the patient

• Proper BPMHs frees up more time for pharmacy staff and provides more efficient workflow

• Prevents having to contact the physician, nursing staff and unit clerks

• does not take time away from them

• If properly done, the chances of mistakes and harm to the patient could be prevented or minimized

Project• Randomly selected 100 BPMHs from the emergency department

ER scanners• A randomization table was used and gathered 200 BPMHs from August 1/2013,

onwards• From the 200, 100 were selected using the odd numbers from the

randomization table

• For each BPMH: • All pages received? • Home Medication Report included? • Was it the initial scan?• Verification column filled out?• Physician order column filled out?• Was there a physician signature?• Total number of issues

Results

• 63/100 did not meet all or some of the criteria • 51/63 did not have the bare minimum

requirements:• Verification column • Physician order column • Physician signature

• 12/63 “incomplete” BPMHs could still be used and processed based on the current dispensary practice

Breakdown of Errors

514

23

30

37

26Missing HMR

Not First Scan of BPMH

Missing at least one page

No Verification

No Physician Order

No Signature

Results

• 37 total BPMHs were considered complete based on this criteria

• These 37 completed BPMHs were then looked at in detail…

Errors Identified • Therapeutic Interchange*• Order to continue completed antibiotic therapy• Order to continue completed therapy• Missed drug order• Incomplete order (ie no dose and/or route and/or frequency) • Patient’s own medication (POM)*• Duplicate drug order• Continue medication without verifying dose• Continue medication when patient not taking therapy• Did not use PPO (fentanyl and insulin)• New physician order came before BPMH

*workload measure (ie. not true errors)

ResultsLegend

A Therapeutic interchange

B Order to complete continued therapy (Abx)

C Order to complete continued therapy (Rx)

D Missed order

E No Dose, No Route, No Frequency

F POM

G Duplicate Drug Order

H Patient takes checked, continued verified dose checked

I Patient not taking, continue verified dose

J Did not use PPO

K New Physician order came before BPMH

A11.32%

B1.89%

C1.89%

D1.89%

E11.32%

F37.74%

G7.55%

H16.98%

I3.77%

J3.77%

K1.89%

Distribution of Common Errors on 'Complete' BPMHs

Limitations of the project

• Only obtained data from ER scanners• Only looked at a 2 week interval

• August 1st-15th

• Strict criteria for BPMHs • Did not look at BPMHs from patients from

direct admit or pre-surgical screening

How Can we use this data?

• Allows us to know what issues are most common in the dispensary

• Helps us as an education tool for physicians and nurses

• Able to improve in this area and increase workflow efficiency

• With more free time, pharmacists in the dispensary could be available to do BPMHs in the future

QUESTIONS?!