MEDICATION SAFETY
Meeting HFAP Accreditation
Standards for Pharmacy Services
and Medication Use
Part Two: Procurement, Preparation and Dispensing
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HFAP Chapter 25 keeps you in
compliance with the Medicare
Conditions of Participation
Medication Safety Series
1.
2.
3.
4.
5.
Prescribing challenges
Procurement in an era of drug shortages –
keeping it safe
Preparation and dispensing – includes
sterile preparation
Administration of medications – timing, unit
dose, bedside medication verification
Monitoring of therapy, Medication Use
Evaluations
Procurement, Preparation, and
Dispensing- Objectives
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Describe the supply chain for
pharmaceuticals
Discuss the challenges posed by drug
shortages
Describe the process of ensuring
adequate compounding facilities
Discuss the role and challenges of
automated dispensing systems
The Problem
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The Institute of Medicine Report revealed that
errors in medical care are responsible for
many deaths
Many health care providers are not aware of
their responsibilities
Medication errors responsible for numerous
adverse outcomes, including death
This results in high cost (emotional and
financial)
Responsibilities
Physicians Nurses
Pharmacists Respiratory
Therapists
X
Prescribing
X
Preparation
X
X
X
X
Dispensing
X
X
X
X
Administration
X
X
X
X
Monitoring
X
X
X
X
Regulatory Standards
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HFAP – Chapter 25
CMS Conditions of Participation 482.25
PROCUREMENT
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Formulary maintenance process
managed by the Pharmacy and
Therapeutics Committee and is subject
to approval by the Medical Executive
Committee
Non-formulary drugs can be obtained if
the patient’s needs cannot be met by
medications currently on the formulary
DRUG SHORTAGES
Drug Shortages: a Serious and
Widespread Problem
Annual New Drug Shortages
January 2003 to December 31, 2010
Tripled since 2006
University of Utah Drug Information Service
National Drug Shortages
77%
Injectables
211
149
166
129
120
88
73
58
74
70
Drug Information Services, University of Utah, 2010
156
Projected 2011 annual shortage
January 2001 – June 2011
Causes of Shortages
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Fewer suppliers
Manufacturer financial decisions
Enforcement of FDA
standards/regulations
Leaner inventory levels
Gray market distributors
Stockpiling by end-users
Unexpected increases in demand
Quality/availability raw material
Reasons for Shortages (Injectables)
Clinical Impact of Drug Shortages
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Adversely affect drug therapy
Compromise or delay medical
treatment/procedures
Failure to treat /progression of disease
Medication errors/adverse patient
outcomes
Near Misses, Errors and Adverse
Outcomes
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Dosing
– EPINEPHrine 1:1,000 overdose in substitution for 1:10,000
– Wrong dose of levoleucovorin substituted for leucovorin
– IV etoposide converted to oral dosing without doubling
dose
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Concentration
– Cytarabine dosing error using 1000mg vial instead of
500mg vial
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Alternative Drug
– Thrombophlebitis from Phenytoin administration
Near Misses, Errors and Adverse
Outcomes
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No Therapy/Delayed Therapy
– Treatment of PCP due to no IV Bactrim
– Death from Untreated resistant pseudomonas: no
amikacin
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Clinically significant delay in treating a patient with
PCP due to IV TMP/SMX shortage
Death from resistant pseudomonas infection due to
amikacin shortage
Drug Shortage Survey - Impact
98%
89%
80%
Guidelines for Managing Drug
Shortages
– Assessment of duration of shortage
– Analysis of threat to patient care and
cost
– Exploration of therapeutic alternatives
– Effective/Timely communication
– Patient prioritization
– Ensure external relationships
What Hospitals Experience
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Communication
– Appropriate timing
– Target audience
– Method of communication
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Ethical dilemma
– Patient prioritization
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System Limitation
– Complexity of the system
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Increased costs
What Hospitals Experience
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Compromise of safety measures
– Look-Alike drugs
– Standard concentrations
– Preparation of products
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Increased workload
– Compounding and repackaging
– Finding drug supply
– Establishing guidelines or identifying
alternatives
Shortages Summary
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Problems
– Difficult to impossible to predict
– Little to no information from manufacturers
– Increased cost and emotions
– No evidence of relief from shortages
Solutions
– Work together as a multidisciplinary team to create
guidelines for use, when possible
– Use cost-saving and resource-sparing measures
when appropriate
– ABOVE ALL, KEEP IT SAFE!
Preparation Issues
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Environment of drug preparation
– Sterile areas
– Equipment (is everyone competent to use
it?)
– Procedures for preparation
– Storage conditions
Preparation Responsibilities
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Pharmacists
Nurses
Respiratory therapists
Problems
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Drug names that sound and look alike
Use of brand names
Multiple package sizes
Outdated information
Inappropriate storage
Not reading the label
Poor labeling
APPROPRIATE LABELING
Actual vial contents are listed
APPROPRIATE LABELING
Strength per milliliter and total per
vial are listed
This can be
misleading to
indicate that each
ampoule contains
only 1 mg
This can be
misleading to
indicate that each
vial contains only
400 mg
Why Compounding?
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Shortage of commercially available
products
Custom concentrations
Compounding In-House or
Outsourcing?
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In-house OK if small quantity needed
and adequate resources are available
Cannot prepare bulk quantities in-house
– that is manufacturing
USP 797 requirements
Risk Level Classifications of
Compounded Sterile Products
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Risk level classifications are divided up
into low, medium, and high depending
on how much manipulation to the
admixture is involved
Low-risk level:
– Manually mixing no more than three
products to compound drug admixtures
– i.e. Morphine drip, Dopamine drip, KCl drip
Risk Level Classification, cont.
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Medium-risk level:
– Multiple individual doses of sterile products
are combined to prepare a product that will
be administered to multiple patients or the
same patients on multiple occasions
– Compounding includes complex aseptic
manipulations other than single volume
transfer
– i.e. TPN admixtures
– Inpatient pharmacy normally practices at a
medium-risk level
Risk Level Classification, cont.
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High-risk level:
– Measuring or mixing sterile ingredients in
non-sterile devices before sterilization is
performed
– Dissolving non-sterile bulk drug and
nutrient powders to make solutions, which
will be sterilized
– i.e. Cardioplegia drips
Handwashing
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Touching sterile products while compounding is the
most common source of contamination of pharmacy
prepared sterile products.
Scrub your hands, nails, wrists, and forearms
thoroughly for at least 30 seconds with a brush, warm
water, and appropriate bactericidal soap before
performing aseptic manipulations. Wash your hands
frequently and every time you re-enter the sterile
compounding area.
Workers who have open sores on their hands or have
an upper respiratory tract infection should inform their
supervisor and/or consult the institutions quality
assurance procedures. Wear sterile gloves and mask is
needed.
Equipment and Supplies
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Another important factor in aseptic preparation of sterile
products is the correct use of appropriate sterile
equipment and supplies, including syringes and needles.
Syringes:
- made of either glass or plastic
- most drugs are more stable in glass, so glass syringes
are most often used when medication is to be stored in
the syringe for an extended period of time.
- Composed of a barrel and plunger. To maintain sterility
of the product, do not touch the syringe tip or plunger.
Many syringes have a locking mechanism at the tip:
Leur-lock, which secures the needle within a threaded
ring.
Preparation of Intravenous
Admixtures
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Before compounding – assemble all materials and
visually inspect vials, ampules, and IV solution containers
for signs of cloudiness, particulate matter, cracks and
punctures, expiration dates, and anything else that may
indicate that the product is defective.
Preparation continued…
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Next, disinfect all injection surfaces and allow them to
dry.
- Flexible plastic bag – made of polyvinyl chloride (PVC)
are frequently used.
- Easier to store, less breakable than glass bottles, and
eliminates the need to vent the container when
removing fluid.
- The protective overwrap should not be removed from
a PVC bag until it is ready to be used.
- To minimize air turbulence in the critical area, position
the injection port of a PVC bag, which is covered by
an outside latex tip diaphragm, toward the HEPA filter
when preparing an IV admixture.
Automated Compounding
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Three primary pieces of equipment are used, sometimes
together and sometimes individually.
- An automated compounder prepares the base
components dextrose, amino acids, and possibly fat
emulsion & H20
- A second automated compounder adds most or all of the
additives or other components
- A computer with software maintains the orders of the
ingredients and controls the two compounders.
Quality assurance programs
Quality Assurance for Sterile
Compounding
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Sterility Testing
– Product
– Staff
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Potency Testing
Random samples
Pyrogen testing
Outsourcing
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Numerous companies
Not all alike
Compounding vs. manufacturing
FDA role
Buyer beware
– NECC
Outsourcing – choosing a
company
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Review their latest inspection records
Review their record with the State
Board of Pharmacy
Are they accredited? By whom?
PCAB
Ask to visit their facility
Can they supply in a timely manner?
Perform your own QA
Recent Examples
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Sodium Bicarbonate
50% Dextrose
Epinephrine
Atropine
Magnesium sulfate
Dispensing Issues
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Verification of allergies and potential
drug interactions
Verification of drug dosage
Identification of the patient (i.e.,right
name on the label)
Automated dispensing devices
– Accuracy of filling
– Accountability of controlled substances
Dispensing Responsibilities
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Pharmacists and technicians
Nurses
Physicians (i.e., anesthesiologists)
Respiratory therapists
Potential Problems
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Mathematical mistakes
Excessive floor stock
Lethal doses easily available (such as
concentrated potassium chloride – no longer
available outside the pharmacy)
Ability to bypass controls in automated
systems (OVERRIDE medications in ADC)
Solutions
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Double-check calculations (two different
people starting at opposite ends)
Use the ADC profile system
Limit floor stock and ADC override
capability
Require pharmacist review of every
order (even if no 24 hour pharmacy
available)
Remote Verification of Orders
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Essential if pharmacist not available
Available from several companies
Verify competency and licensure status
Complements the onsite pharmacy staff
Helps limit overrides
Summary
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Many challenges in procurement
No immediate relief of the shortage
situation in sight
Need careful attention to preparation
technique
Compounding can be our friend
Pharmacist verification prior to
dispensing can save lives
Next Time
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Administration of Medications
Use of technology
Direct observation