CHAP 12: CONTROLLED SUBSTANCES Patient Safety

Federal State Laws and Regulations Institute of Safe Medication

Drug Enforcement Administration
(DEA) / PDEA
- Charged with enforcing &
implementing the Controlled
Substances Act
- Code of federal regulations
US DEA Schedules:
Practices (ISMP)
- Non profit organization with the
mission of enhancing patient
safety
- Designed controlled substances
as High Alert Medications
- USP-ISMP Medication Errors
Reporting Program (USP-
MEDMARX)

Schedule I
Heroin The Joint Commission
Lysergic acid diethylamide (LSD) Selection of Controlled Substances
Marijuana (Cannabis)
Peyote Formulary
Schedule II - Must consider the ff:
Narcotics o Location w/in health
- hydromorphone system
- methadone o Storage
- Meperidine o Physical security
Stimulants o Appropriate stocking
- amphetamine levels
- metamphetamine o Authorized access to
- methylphenidate medications
Schedule III o Prescribing restrictions
Narcotics o Medication ordering
- products containing n.m.t. 90 o Health care staff and
mg of codeine per dosage unit patient education
Non-narcotics Risk Assessment
- benzphetamine o Failure mode & effects
- phendimetrazine analysis
- ketamine - examines the potential for
Schedule IV failures by identifying,
Diprazolam clarifying & assessing the
Lorazepate impact of failures on the
Diazepam system
Lorazepam Failure modes any
Midazolam errors or defects
Schedule V Effects analysis
Cough preparations containing studying the
n.m.t. 200 mg of codeine per 100 consequences
mg or per 100 g Procurement of Controlled Substances

JFMC 2FPH
 Federal Registration
Requirements
- Registered w/ DEA (renewed
every 3 years) DEA Form 224
Application for New Registrant
- DEA Form 222 (Sched II)
- RPh with complete
understanding of federal
requirements for procurement
and processes
Inventory & Storage Management
Inventory & Record Requirements
- Audit trail of complete and
Administration
accurate documentation
(procurement to administration)
- Maintained for 2 yrs
- Records for Sched II are
segregated
- Biennial inventory is conducted
following the initial inventory
Evaluation
Physical Security and Storage
- securely locked, substantially
constructed cabinet
- Pharmacies are allowed to place
controlled substances among
non-controlled medications as
long as there are BARRIERS TO
THEFT
- Minimal stock levels
- Limited access to health care
staff
Policies and Procedures
Disposal
- Segregated and inventoried
separately from all other drugs
Ordering & Dispensing
JFMC 2FPH
Medication orders
- Specific requirement for
controlled substances dispensed
in institutions may be covered
within state law and regulations
Electronic prescribing
o Facsimile Sched II
- authorized with original
prescription presented at the
time of dispensing
o Facsimile Sched III
- no need for original
prescription
Risk reduction techniques
1. Limited access
2. Limited availability of SALAD
3. Double check system
4. Health care staff and patient
education
5. Patient monitoring
Medication Utilization Evaluation
(MUE)
- Provide pharmacists with a
mechanism for examining the
utilization of controlled
substances
Controlled Substances
Surveillance Program
Clinical Practice Guidelines
- Authorized personnel to procure
- Normal and emergency
procurement procedures
- Receiving process
- Inventory management and
accountability
- Distribution procedure