Transcript Pharmacy Compliance in the ASC

PHARMACY
COMPLIANCE IN THE
ASC
Christopher M. Dembny R.Ph.
Nov 7, 2013
COMPOUNDING
PHARMACIES
Necessary?
Evil?
Necessary Evil?
Biography
• Christopher M. Dembny R.Ph.
• Licensed pharmacist in Texas for 30
years
• Consultant pharmacist for surgery
centers for 20 years
• Exclusively practicing in surgery centers
and surgical hospitals for 13 years.
• Currently consulting for > 70 ASC’s
• ****Feel free to ask questions!
Who has regulatory oversight?
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FDA
DEA
Texas DPS*
State Board of Pharmacy *
Texas DSHS
JCAHO (if you pay them)
AAAHC (if you pay them)
CMS
$$$ **
What does the TSBP want to see?
• 1. Annual controlled substance inventory
– notarized
• 2. CII invoices with DEA 222…or CSOS In
separate file (signed by RPh and person
receiving)
• 3. Power of attorney to sign DEA 222
• 4 CIII-V invoices (separate) (signed)
• 5. Controlled substance reproducible audit
trail ****
What does the TSBP want to see?
• Controlled substance administration records
– Date and time of administration
– Patient name
– Drug and dose administered
– Signature of person administering ***
– Waste (if any) and signature of person
witnessing waste
– Ordering practitioner
– Must be maintained separately from chart
What does the TSBP want to see?
• 6. Library is adequate:
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– B.
– C.
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– E.
– F.
Pharmacy Rules
General Reference Text (Facts & Comp)
Drug Interaction text
Injectable Products
Antidotes and poison control #
Weight conversion chart
What does the TSBP want to see?
• 7. Controlled substance documentation
• 8. Removal of stock log
• 9. Policies and Procedures(see list in TPR
291.76)
• 10. Licenses – Pharmacy, DPS, and DEA
What does the TSBP want to see?
• 11. “Adequate security”
• 12. Transfers to other registrants
• 13. Loss or theft reports – DEA 106
– Theft or significant loss
• 14. Save for 2 years
• 15. Pyxis – Omnicell??????
What does the DPS want to see?
Licenses
Adequate security
Reproducible audit trail
Secure prescription pads
Annual inventories
What does DSHS/CMS look for?
CMS – CFR 416.48
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§ 416.48 Condition for coverage—Pharmaceutical
services.
The ASC must provide drugs and
biologicals in a safe and effective manner,
in accordance with accepted professional
practice, and under the direction
of an individual designated responsible
for pharmaceutical services. (TPR 291.76)
(a) Standard: Administration of drugs.
Drugs must be prepared and administered
according to established policies
and acceptable standards of practice.
CMS – CFR 416.48
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(1) Adverse reactions must be reported
to the physician responsible for
the patient and must be documented in
the record.
(2) Blood and blood products must be
administered by only physicians or registered
nurses.
(3) Orders given orally for drugs and
biologicals must be followed by a written
order, signed by the prescribing
physician.
(b) [Reserved]
DEA
• They’ll tell you what they’re looking for.
• I’ve never seen them visit when there wasn’t
already a problem.
Questions?????
COMPOUNDING
PHARMACIES
Necessary?
Evil?
Necessary Evil?
How did we get here?
• Drug shortages are worse than ever.
• Cause (my opinion)
• A. Online ordering
– 1.
everyone orders the cheapest
product
B. Lowers price and profit for manufacturer
How did we get here?
• C. Forces some manufacturers out of
business
• D. Others make EXACTLY what they think
they will sell. With smaller profit
margins, profit disappears if you make
too much.
• E. Now we have fewer manufacturers with
less overstock.
How did we get here?
• F. Interruption of supply
– 1.
Natural disaster
– 2.
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FDA shutdown
Internal problem (strike – retooling)
G. If 1 of 10 manufacturers experiences an
interruption, no problem
H. If 1 of 2 manufacturers experiences an
interruption, BIG PROBLEM.
SHORTAGES.
Problem created
• A. Shortages of necessary drugs
1. Fentanyl
2. Midazolam
3. Propofol
B. Shortages of Crash Cart Drugs
1. Mag Sulfate
2. Sodium Bicarbonate
Are Compounding Pharmacies a
viable answer?
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Yes, but choose carefully.
Get approval from Med Exec.
The cheapest isn’t always the best.
The cheapest isn’t always the cheapest -Ask those who used NECC.
Picking a good compounder
• A. Look for accreditation:
– Pharmacy Compounding Accreditation
Board (PCAB)
– An independent accreditation
organization
– Appear to be the only one
– Very stringent
– Can’t ensure everything is perfect
Picking a good compounder
• B. Independent assessment
– Consultant pharmacist can be a resource
– International Association of Compounding
Pharmacists (IACP) http://www.iacprx.org/
• http://www.iacprx.org/associations/13421/fil
es/CPAQ%20REV%20with%20updated%20me
mber%20number%20October%202012.pdf
• This is the assessment tool from IACP
Picking a good compounder
• C. Consultant Pharmacist Assessment
• D. I would use in-state compounders
– FDA may prohibit shipping across state lines.
Picking a good compounder
• ************************************
• D. Ask for independent analysis
– 1.
Sterility
a. bacterial
b. fungal
– 2.
Quantitative Analysis
Contact Information
• Christopher M. Dembny R.Ph.
• [email protected]