PHARMACY COMPLIANCE IN

THE ASCChristopher 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?• 1. FDA• 2. DEA• 3. Texas DPS*• 4. State Board of Pharmacy *• 5. Texas DSHS• 6. JCAHO (if you pay them)• 7. AAAHC (if you pay them)• 8. 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:– A. Pharmacy Rules– B. General Reference Text (Facts & Comp)– C. Drug Interaction text– D. Injectable Products– E. Antidotes and poison control #– F. 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?

LicensesAdequate securityReproducible audit trailSecure prescription padsAnnual inventories

What does DSHS/CMS look for?

CMS – CFR 416.48

• § 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• (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

productB. 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. FDA shutdown– 3. 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. Fentanyl2. Midazolam3. Propofol

B. Shortages of Crash Cart Drugs1. Mag Sulfate2. Sodium Bicarbonate

Are Compounding Pharmacies a viable answer?

• 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/files/CPAQ%20REV%20with%20updated%20member%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. bacterialb. fungal

– 2. Quantitative Analysis

Contact Information

• Christopher M. Dembny R.Ph.• cdembny@tx.rr.com