Controlled Substances in the Institutional Setting

NYS Council of Health-system Pharmacists

May 3, 2009

Victoria A. Hanson, R.Ph., B.S.Pharmacy Consultant

Bureau of Narcotic EnforcementNYS Department of Health

Questions to Ask Yourself…

1. How do I handle patients who are admitted on methadone or buprenorphine?

2. What are the inventory requirements?

3. Am I handling emergency kits correctly?

4. Can I spot signs of diversion…and if I do, what next?

5. Do I understand my legal responsibilities?

Bureau ResponsibilitiesNew York State Controlled Substances Act

Protects NYS citizens by combating the illegal use and trafficking of prescription Controlled Substances (CSs)

while allowing the legitimate use of CSs.

Through administration and enforcement of Public Health Law, Article 33 the Bureau:

• Regulates CS from manufacture/distribution prescribing dispensing possession destruction;

• Manages the PMP including analysis;• Conducts case investigations that can result in civil or

criminal actions; and• Provides the Official NYS Rx (ONYSRx) to prescribers.

“To Methadone or not to Methadone…”

Question #1:

A pt admitted to hospital w/acute condition (broken leg) and was previously obtaining methadone from Methadone Maintenance Treatment Provider (MMTP). Can the hospital administer methadone to pt if hospital not an MMTP? What about buprenorphine?

“To Methadone or not to Methadone…”

Question #1: A pt admitted to hospital w/acute condition (broken leg) and was previously obtaining methadone from Methadone Maintenance Treatment Provider (MMTP). Can the hospital administer methadone to pt if hosp not an MMTP? What about buprenorphine?

Answer #1: Yes, for both drugs, provided pt was not admitted solely for detox. With methadone, hospital must get orders from original MMTP provider. Can’t or dosage/strength w/o consult from original MMTP.

*Per 21CFR 1306.07(c).

“To Methadone or not to Methadone…”

Question #2:

Can hospital that detox’s administer buprenorphine to detox /rehab if pt previously obtaining it from an approved MD? What about methadone?

“To Methadone or not to Methadone…”Question #2:

Can hospital that detox’s administer buprenorphine to detox /rehab if pt previously obtaining it from an approved MD? What about methadone?

Answer #2:

BUPR: No; in this case, pt is admitted for detox therefore MD needs “X” # or can be admin as emergency txt x3 days, per CFR.

METD: Must be lic’d by OASAS as MMTP to administer methadone for detox.

“To Methadone or not to Methadone…”

Question #3:

Who is authorized to issue Rxs for methadone? What about buprenorphine?

“To Methadone or not to Methadone…”

Question #3:Who is authorized to issue Rxs for methadone? What about buprenorphine?

Answer #3: NO Rxs for addiction for methadone —methadone cannot be dispensed for addiction txt—can only dispense for pain txt. If unsure of diagnosis- Call MD!

Methadone issued for addiction pursuant to order from MMTP. Buprenorphine Rxs for addiction only by those MDs authorized by DEA (‘X’ number).

PHL 3320 Authorized Distribution

1. Controlled substances may be lawfully distributed within this state only to licensed distributors or manufacturers, practitioners, pharmacists, pharmacies, institutional dispensers, and laboratory, research or instructional facilities authorized by law to possess the particular substance distributed.

2. A person authorized to obtain a controlled substance by distribution may lawfully receive such substance only from a distributor licensed pursuant to this article.

Class 3 vs. Class 3a

• Class 3– Article 28– Pharmacy on-site– CSs administered pursuant to medical order– Can NOT obtain CSs from outside source

• Class 3a– No pharmacy on site (use ‘vendor’ pharmacy)– CSs administered pursuant to prescriptions

Emergency Kits in Class 3a

• §80.11: exempts distribution from pharmacy practitioner

• §80.47: authorizes administration of CS to pt by means other than from an Rx.

• §80.49: authorizes admin of CS to pt in an emergency situation pursuant to medical order

• §80.49: recordkeeping requirements• §80.50: authorizes possession of CS by Class

3a-specific amounts, specific safeguarding

Types of Orders in Class 3

1. Oral emergency orders

2. PRN Orders

3. Routine Orders

4. Standing Orders

Types of Orders in a Class 3

1. Oral emergency orders* Administer ONCE only

* Practitioner must sign within 48hrs

2. PRN Orders* No specific time

* Good for 72hrs only

* Administer ONCE only

Types of Orders in a Class 3

3. Routine Orders * No specific written order (i.e. after heart cath, give 40mg)NOT allowed for controlled substances!

4. Standing Orders* CS to be administered at specific time* Good for 7 days only, must rewrite every 7 days* Except: if patient in:

(1) RHCF; or(2) stabilized pt in Class 3 and has :

Convulsive Disorder; orChronic Spasticity; orMinimal Brain Dysfunction.

Such order may be for 30 days and rewritten every 30 days.

80.112 Inventory

Who?

What?

When?

How?

80.112 InventoryWho?: All who procure CSs

What?: Separate entry for ea kind of substance or preparation, & ea. pkg size.

When?: After initial inventory, every 2yrs on May 1st of odd years. (After close of business 4/30 or prior to opening 5/1).

How?: Ea entry shall include: name, qty & content of CS & size of indiv pkg, # of pkgs, & total content of all pkgs on hand as of date of inventoryTrue count of CSs- not estimate.

Legal Responsibilities

• PYL

• Know the Law & Regulations

• Documentation

• Safeguard

• Losses of CSs

• Suspected Diversion

NYS PHL Article 3374

• Notification by licensee

– Persons licensed . . . pursuant to this article shall be under a continuing duty to promptly notify the department of each incident or alleged incident of theft loss or possible diversion of controlled substances manufactured, ordered, distributed or possessed by such person.”

Reporting Suspected DiversionNYS Public Health LawArticle 33, Section 3374: 'Notification by licensee'

http://public.leginfo.state.ny.us/menugetf.cgi

10NYCRR, Part 80Title 10, Section 80.110: 'Notification by licensee'

http://www.health.state.ny.us/nysdoh/phforum/nycrr10.htm

Code of Federal RegulationsTitle 21, Section 1301.91: ‘Employee Responsibility to Report Drug

Diversion’http://www.deadiversion.usdoj.gov/21cfr/1301_91.htm

Case History

Bureau of Narcotic Enforcement433 River Street, Suite 303

Troy, NY 12180Phone: (518) 402- 0707 or (866)- 811-7957Fax: (518)- 402-0709

www.health.state.ny.us/professionals/narcotic/E-mail: narcotic@health.state.ny.us

Regional Offices:NYC: (212) 417-4103

Buffalo: (716) 847-4532Syracuse: (315) 477-8459Rochester: (585) 423-8043