From Dosing to Destruction:
Best Practices - Controlled Medications
Rob Shulman R.Ph. CGP FASCP
Director of Consulting Services
Remedi SeniorCare
William M. Vaughan, RN
Vice President, Education and Clinical Affairs
Remedi SeniorCare
Disclosure / Contact
• Rob Shulman has no relevant disclosures
• William Vaughan is a shareholder at Remedi
SeniorCare, a consultant to CMS currently
working on QAPI and on the advisory board of the
Institute for Safe Medication Practices’ long-term
care newsletter
• Rob.Shulman@Remedirx.com
• William.Vaughan@Remedirx.com
Objectives
• Address best practices related to the prescribing,
administration, monitoring, and storage of controlled
substances from both a clinical and regulatory
perspective.
• Provide an overview of the Drug Enforcement Agency's
final rule on disposal of controlled substances and its
potential implications for long term care communities
Diversion Case Studies
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Vomiting Phenobarbital
The case of the “weak” foil
Some drugs will surprise you
Its often those who you would least expect
Regulatory Pearls – Controlled Drugs
Federal Nursing Home Regulations:
(what about assisted living facilities?)
• Acknowledge diversion  policy/procedures
• Include pharmacist in development / ongoing review
• Consistency: pharmacy/facility
• Consistency: log/MAR
• “The facility must provide separately locked, permanently
affixed compartments for storage of controlled drugs …
other drugs subject to abuse …” (F 431)
• Permanently affixed  intent
• Other drugs  proactively define
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Medical Director, Consultant Pharmacist, NIDA
Regulatory Pearls – Controlled Drugs
• Drug diversion: Duty to report to survey agency?
• Neglect = failure to provide goods and services necessary to
avoid physical harm, mental anguish, or mental illness
• Misappropriation of Resident Property = The deliberate
misplacement, exploitation, or wrongful, temporary or permanent
use of a resident’s belongings or money without the resident’s
consent. (Ref: CMS S&C-05-09)
• Drug diversion: Duty to report to law enforcement?
• The Affordable Care Act requires reporting of “any reasonable
suspicion of a crime” to local law enforcement:
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Serious bodily injury  2 hours, otherwise within 24 hours
Reference: CMS S&C: 11-30-NH
Regulatory Pearls – Controlled Drugs
“Counting” Liquid Medications
• Deficiency Allegation: “… the facility failed to ensure
narcotic medications for Resident #25 were properly
secured and accounted for …”
• Narcotic medication = Morphine Sulfate (100 mg/5ml)
Regulatory Pearls – Controlled Drugs
• Surveyor observes 30 mls.
• Narcotic reconciliation record = 28 mls
• DON estimates between 29 and 30 mls
“Failure to properly account for narcotic medications”
Regulatory Pearls – Controlled Drugs
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Informal Dispute Resolution
Minimal volume administered via dropper (.25ml)
Bottle calibrated in 1-5 ml increments
Manufacturers routinely overfill by up to 10%
(label = 30 mls, actual volume 31-33 mls)
Removing morphine each shift creates more risk
Staff was estimating the amount … just like the surveyor
Intent F 431: “Identification of loss or diversion of
controlled medications so as to minimize the time between
actual loss or diversion and the detection and
determination of the extent of loss or diversion”
Controlled Substance Diversion
Diversion of drugs:
Unlawful channeling of regulated pharmaceuticals, including
the misuse of prescription medications
• Symptom of the disease of addiction
• Addiction is a treatable disease
Healthcare Professionals and Drug Abuse:
Healthcare Professions with higher rates of drug use:
• Nurses
• Dentists
• Pharmacists
• Anesthesiologists
• Veterinarians
Preferred Medications:
• Benzodiazepines
• Opiates
Healthcare Professionals and Drug Abuse:
Types of drugs preferred:
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60% use an opiate
45% use a benzodiazepine
11% use sedatives
3.5% use amphetamines
1.9% use inhalants
Early intervention is vital for both patient care concerns and
health care employee professional recovery
A visible program is a major deterrent to diversion
(Lillibridge, Cox & Cross, 2002)
Drug Diversion Issues: Nursing Staff
• 10 –20% of nurses have substance abuse issues
• ANA estimates approximately 6% to 8% of nurses are
practicing while impaired
• Substance abuse is the number one reason named by
state boards of nursing for disciplinary action
• Recidivism rates by nurses from diversion and
rehabilitation programs are lower when compared with
the general population
(Griffith, 1999); (Trinkoff& Storr, 1998) (Sullivan & Decker, 2001).
Staff Risk Factors:
In the workplace:
• Stress
• Belief in medications
• Caregiver burnout
• “Nurses’ knowledge can ward off substance abuse”
• Access to controlled substances
At high risk : Nurses who administer drugs daily and perceive poor
to non-existent workplace controls have 2 x the risk of drug misuse
Physical Signs of Use/Withdraw
• Physical signs of use or withdrawal:
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Hand tremors
Headache
Diaphoresis
Abdominal/muscle cramps
Nausea/ Diarrhea
Irritability or Restlessness
• Signs may disappear with use
• Non-descript: can also be signs of psychological problems.
• Behaviors impair clinical judgment and put residents at risk
(Smith et al., 1998).
Drug Diversion: Staff Indicators
Staff Behavioral Indicators:
 Isolates self from others, eats meals alone, avoids staff social
events
 Frequent, unexplained disappearances during shift
 Often shows up on days off to finish work or retrieve forgotten
items
 Frequently volunteers to work extra shifts
 Volunteer to hold the narcotics keys/ perform count
 Frequently spills or wastes narcotics
 Chaotic home/personal life
 Refuses to comply with narcotic diversion investigational
procedures
 implausible excuses for behavior or become defensive
Drug Diversion: Staff Indicators
Resident Care Indicators:
 Inconsistent or incorrect charting
 Displays inconsistent work quality with times of high and low
efficiency
 Offers to medicate other nurses’ patients on a regular basis
 Obtains larger dose of narcotics when the ordered dose is
available, documents the remaining amount as wasted
 Requests to care for specific patients
 His/her patients reveal consistent pain scale patterns or complain
that narcotics are not effective only on that shift
Prevention and Recognition of Diversion and
Drug Use/Abuse
Early intervention is vital for both patient care concerns and
health care employee professional recovery
A visible program is a major deterrent to diversion
To prevent drug diversion:
• Adequate controls in place- Policies & Procedures
• Use proactive approach for early detection and
intervention
• Discourage diversion through education and awareness
• Intervene as appropriate
• Rapid closure on diversion cases
Preventing Drug Diversion: Best Practices
Staff Prevention Strategies:
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Only remove medications for your assigned patients
Only remove current dose of medication for your patient
Properly document medication administration and pain scores
All wastes of medications must have a documented witness
Don’t be a “virtual witness” to medication wasting
Don’t loan your ID badge or pass-codes to anyone
Return unused medications according to procedure
Report medication discrepancies promptly to pharmacy (on-line reporting available)
Report attempted inappropriate access to medications to pharmacy
Report witnessed or suspected medication diversion to pharmacy
Preventing Drug Diversion: Best Practices
Policies, Procedures and Controls
• Procurement
• Storage and security
What areas need
the most
reinforcement with
Administration and
Staff?
• Prescribing
• Preparation/Administration of CDS
• Handling wastage
• Documentation
• Follow-up if diversion is suspected
What do you do if
diversion is
suspected, or if CDS
are missing?
Policies & Procedures Addressing Drug
Disposition
Examples of procedures addressing the disposition of
medications include:
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Controlled substance receipt/ reconciliation
Shift counts/ongoing accountability
Timely identification and removal of medications
Identification of storage method for medications awaiting final
disposition
Control and accountability of medications awaiting final disposition
Documentation of actual disposition of medications
Method of destruction consistent with applicable state and federal
requirements
Procedures for discrepancies, theft or loss
Drug Diversion Investigation
Rapid internal investigation and closure of diversion incidents
Reasons to contact pharmacy:
• Unresolved discrepancies
• Questionable resolutions
• Tampered syringes or vials
• Misplaced narcotics
• Missing narcotics
• Records of dispensing, refills
Investigation
Checklist
Controlled Substance Drug Disposal
In Ohio…
For every unintentional opiod overdose death in 2010, there
were 733 non-medical users.
ER visits from pharmaceutical abuse with no other type of
drug or alcohol involvement doubled between 2004-2010.
70% of younger people using Rx drugs get them from family
or friends. One in four teens admit to having used Rx drugs
More Americans abuse Rx drugs than the number of
cocaine, hallucinogen methamphetamine and heroin users
combined
OhioPMP.gov
Cocktail Hour…
Opiate + Benzo + Muscle relaxant
“Trinity” = hydrocodone + alprazolam + carisoprodol
“Holy Trinity” = oxycodone + alprazolam + carisoprodol
Hydrocodone, prior to becoming a C-II was #1 drug of abuse
in Ohio
OhioPMP.gov
OARRS
Ohio Automated Rx Reporting System
All controlled dispensing data on one website
Researched by patient name
Detects multiple prescribers
Checked by Prescribers prior to writing for CDS
Checked by Pharmacies prior to filling Rx for a CDS
(OAC 4729-5-20) – prospective DUR
Ohio Board of Pharmacy
“Deter & Detect”
Drug destruction at the facility :
• Witnessed by the DON or Administrator and a Pharmacist
Complete and accurate record of the drugs destroyed shall be
made:
• Record of destruction shall be signed and dated by the persons
witnessing the destruction
• Maintained at LTCF for a period of two years.
• Copy goes to Board of Pharmacy
White House Office of National Drug Control Policy (ONDCP) Federal
Guidelines for the Proper Disposal of Prescription Drugs
Take your prescription drugs out of their
original containers:
• Mix drugs with an undesirable substance,
such as cat litter or used coffee grounds
• Put this mixture into a disposable container
with a lid or into a sealable bag.
• Place the sealed container with the mixture,
and the empty drug containers, in the trash.
Food and Drug Administration
DEA- Disposal of Controlled Substances
Safe and Secure Drug Disposal Act of 2010 allows DEA to
develop regulations to allow non-DEA registrants to dispose
of unused controlled medications.
• Mail-back programs
• Take-back events
• Secured on-site receptacles
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Centers for Medicare and Medicaid Services
Centers for Medicare and Medicaid Services F-Tag 425
Policies and procedures for disposal of medications.
• Timely identification and removal of medications for disposition
• Identification of storage method for medications awaiting final
disposition
• Control and accountability of medications awaiting final disposition
consistent with standards of practice
• Documentation of actual disposition of medications
• Method of disposition consistent with applicable state and federal
requirements and standards of practice
Destruction of Fentanyl Patches:
Additional Guidance
CMS:
“The remaining fentanyl in a used patch is a potential vehicle of abuse
and warrants implementation of adequate disposal policies”
• Staff should dispose of fentanyl patches in the same manner as wasting of
any other controlled substances, particularly because the active ingredient is
still accessible.
• Wasting must involve a secure and safe method, so diversion and/or
accidental exposure are minimized.
Occupational Safety and Health Administration (OSHA)
In verbal discussions with OSHA, ASCP was told that OSHA has no
guidance about medication disposal other than to say medications (in
particular Fentanyl patches) should not be put into sharps containers.
Cactus “Smart Sink”
2014 Drug Diversion: DEA Final Rule
Disposal of Controlled Substances
The Disposal Act amendment to the Controlled Substances Act
• 9/9/14 - Expands the entities to which ultimate users may
transfer unused/unwanted/expired pharmaceutical CDS
for disposal.
• Expands the methods by which CDS may be collected.
• Encourage public and private entities to develop a variety
of methods of collection
• Voluntary
* 21 CFR Parts 1300, 1301, 1304, 1305, 1307, and 1317
DEA Final Rule : Disposal Options
Who can collect:
Manufacturers, distributors, reverse distributors,
narcotic treatment, hospital pharmacies, retail
pharmacies
How:
• Mail-back Programs
• Take-Back Events
• Collection Receptacles:
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At DEA registrant’s location
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Hospitals/ clinics and retail pharmacies may
also maintain collection receptacles at longterm care facilities.
Drug Destruction: “Ultimate User”
“Ultimate User” :
“A person who has lawfully obtained, and who possesses, a CDS for
his own use /for the use of a member of his household “
Voluntary options for “ultimate user” disposal:
(1) Take-back events
(2) Mail-back programs
(3) Collection receptacles
Exceptions: “Ultimate User” Destruction
Exceptions:
(1) Individuals lawfully entitled to dispose of an ultimate user
decedent’s property are authorized to dispose of the ultimate
user’s pharmaceutical controlled substances by utilizing any of
the three disposal options.
(2) LTCFs may dispose of pharmaceutical controlled substances on
behalf of an ultimate user who resides, or has resided, at that
LTCF.
Operational Challenges- Structure
A collection receptacle shall be located in a secured area
regularly monitored by LTCF employees.
• Securely fastened to a permanent structure
• Securely locked, substantially constructed container with a permanent
outer container and a removable inner liner
• Outer container shall include a small opening that allows contents to
be added to the inner liner, but does not allow removal of the inner
liner's contents.
• Small opening in the outer container shall be locked when the
collection receptacle is not being regularly monitored by long-term
care facility employees.
Operational Challenges- Coordination
• When disposing into a collection receptacle, disposal shall occur no
longer than three business days after the discontinuation of use by the
ultimate user.
• Supervisor-level employee of the LTCF (e.g. a charge nurse,
supervisor, or similar employee) to install, remove, store, or transfer
inner liners with one employee of the collector.
• Filled liners may be stored in a securely locked for up to three
business days until the liners can be transferred for destruction.
• Collectors may not transfer sealed inner liners from LTCFs to their
primary registered location (i.e., the pharmacy location).
Facility Implications
• Take-back programs:
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Touchstone for this disposal method is the individual nature of the disposal
activity
Institutional facilities such as LTCFs should ensure that the individual patient
is the disposer
• Release of controlled substances to individuals lawfully entitled to dispose
of an ultimate user decedent’s property
• Placement of disposal receptacles within a long-term care facility renders
the facility a "controlled premises" under the Controlled Substances Act
• Cost!
Operationalizing Diversion Prevention
Ensure your facility has adequate policies, procedures and
that they are held accountable for following these guidelines.
Audits and observations will ensure ongoing compliance to
procedures
• MedPass Observations
• MedCart Audits
• Documentation Audits
Controlled Substances: Storage and Access
• Drugs listed in Schedules II-V are not to be accessible to other than:
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Licensed nursing personnel
Pharmacy personnel
Medical personnel
Those designated by the facility /as allowed by regulations
Note: Medication Aides may have access/administer controlled substances per
facility policy if state regulations allow.
• All Schedule II controlled substances are to be stored under double
lock, separate from other medications.
• Depending on state regulations, ALL controlled substances may
require a double lock and shift count- Check your state regulations
regarding the storage for CIII- V medications.
Controlled Substances: Accounting
Procedures
 Declining Inventory sheets must be signed by the accepting nurse
upon receipt of the med in the facility
 Verifying the quantity received matches the quantity sent.
 Schedule II medications must be counted by an oncoming nurse and
an offgoing nurse at the change of each shift
 Documented on the Shift Count Form for Controlled Substances.
Count all medications storage areas, including the refrigerator.
 Controlled substances other than Schedule II’s may be added to the
accounting procedures.
 The pharmacy can provide the individualized records for Schedule III-V’s
upon request if not already provided.
Controlled Substances: CII Record Procedures
Separate records (individual controlled substance record) need to be
maintained on all Schedule II drugs in the form of a declining inventory
Pharmacy will provide these individual records for each Schedule II
prescription sent.
Each record must be accurately maintained and shall include:
 Name of the resident
 Name of the prescriber
 Prescription number
 Drug name
 Form of the medication (tablet, capsule, liquid, suppository, etc.)
 Strength and dose administered
 Date and time of administration
 Signature of the person administering the drug
 Remaining number of doses
Controlled Substances: Emergency Supply
Staff should only sign-out and remove one (1) dose at a time,
at the time you are actually administering the drug.
If two (2) doses are due on your shift, you still must sign and
remove each dose at designated time of administration.
Ensure the MAR and Declining Inventory Sheet match
Controlled Substances: Incorrect Count
Incorrect Count- What to do?
 Determine whether the medication was given and not charted.
 Determine if the medication may have been ‘lost’ or discarded.
 Document on the individual count form that “count is incorrect”
 Sign the shift count record in the usual manner, indicating that the
count was not correct
 The nurse on the shift on which the count was identified as being
incorrect must fill out an Incident Report indicating the action that was
taken to locate the medication
 Forward the report to the Nursing Office; the DON /Administrator need to
be notified (or follow facility policy)
Thank You
References
Narcotic Use and Diversion in Nursing
Mandy L. Hrobak, University of Arizona College of Nursing
http://juns.nursing.arizona.edu/articles/Fall%202002/hrobak.htm.
1.
2. Nurse Drug Diversion and Nursing Leader's Responsibilities: Legal, Regulatory, Ethical,
Humanistic, and Practical Considerations. Tanga, H. JONA's Healthcare Law, Ethics, and Regulation
Jan 2011 Vol 13(1) pg 13 –16. http://www.nursingcenter.com/lnc/static?pageid=1193263 .
3. Impaired healthcare professional Marie R. Baldisseri, MD, FCCM. Crit Care Med 2007 Vol. 35, No.
2 (Suppl.) http://www.csamasam.org/sites/default/files/pdf/misc/16_article_Baldisseri_Impaired_healthcare_prof_2007.pdf.
4. A Multidisciplinary Approach to Proactive Drug Diversion Prevention. Jerry Siegel Pharm.D. FASHP
The Ohio State University Medical Center Columbus, Ohio, 2009.
5. Disposal of Controlled Substances. Federal Register / Vol. 79, No. 174 / Tuesday, September 9,
2014 / Rules and Regulations