MANAGING YOUR CONTROLLED SUBSTANCES

Steve Wunsch – City of Middleton EMS

Kep Anderson – City of Sun Prairie EMS

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What is Diversion Control?� When must people think of controlled substances

they think Heroin, Marijuana, Cocaine, LSD, etc.� They often don’t think of pharmaceutical drugs as

being a major part of the “drug problem” in the United States

� Unfortunately we do have a major problem of licit chemicals and pharmaceutical drugs being diverted to the illicit market

� This presentation will familiarize you with the Drug Enforcement Administration’s Diversion Control Program

� You will obtain a basic understanding of controlled substance scheduling, record keeping requirements, and basic law as it relates to management of pharmaceutical controlled substances used in the EMS industry

Why is Diversion Control Necessary?

� To prevent and detect the diversion of stolen controlled substances

� To protect the provider’s DEA Registration� To protect the honest employees with a system

of checks, balances and witnessed activities� To protect the public’s health and safety. The

practitioners treating the public should not be impaired by illegally diverted drugs and the medications the public receives should not be diluted

� In very simple terms, these records and security measures should be maintained because it’s the law

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Code of Federal Regulations - Title 21

� This is where you find all of the regulations that were written to implement the Controlled Substance Act of 1970

� Parts 1300 – 1321 apply to EMS (as well as all other Practitioners)

� Also contains the must recent lists (Schedules I to V) of Controlled Substances

� Amended and published annually

Index of Parts 1300 - 1319� 1300 Definitions � 1301 Registration of manufacturers, distributors, and dispensers of

controlled substances� 1302 Labeling and packaging requirements for controlled substances� 1303 Quotas� 1304 Records and reports of registrants � 1305 Orders for Schedule I and II controlled substances � 1306 Prescriptions � 1307 Miscellaneous � 1308 Schedules of controlled substances � 1309 Registration of manufacturers, distributors, importers and

exporters of list I chemicals � 1310 Records and reports of listed chemicals and certain machines � 1311 Requirements for electronic orders and prescriptions (Eff. 6-1-10) � 1312 Importation and exportation of controlled substances � 1313 Importation and exportation of list I and list II chemicals� 1314 Retail sale of scheduled listed chemical products � 1315 Importation and production quotas for ephedrine,

pseudoephedrine, and phenylpropanolamine � 1316 Administrative functions, practices, and procedures � 1321 DEA Mailing addresses

REGISTRATION

� Anyone who handles or intends to handle controlled substances must register with the DEA

� For EMS agencies this is typically the Medical Dire ctor� The physician must hold a state license and agree to

be ultimately responsible for accountability of the controlled substances

� Hospital owned EMS agencies may choose to use whoever is the registered agent of the hospital pharmacy

� Some states require a separate state registration before applying for a DEA number (Wisconsin does not)

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Registration Classifications

� Importer/Exporter� Manufacturer� Distributor� Narcotic Treatment Programs� Hospital� Pharmacy� Practitioner (this is where EMS falls)� Analytical Laboratory, Researcher,

Teaching Institution, Canine Handlers

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Number of DEA Registrants

� Physician/Practitioners 1,021,865� Pharmacies 65,001� Hospitals/Clinics 16,249� Researchers, Labs, etc 7,924� Pharmaceutical Distributors 823� Pharmaceutical Manufacturers 515� Importers/Exporters 362

DEA REGISTRATION CERTIFICATE

� Application may be done online� Units of local or state government are

exempt from fees� A unique number is assigned to each

legitimate handler of controlled substances (DEA number)

� At the time that the application is approved, a supply of 222 Forms will be issued

� All orders from suppliers must be shipped to the address listed on the DEA certificate

DEA REGISTRATION CERTIFICATE

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CSA = CLOSED SYSTEM FOR DISTRIBUTION

Closed System Routing� Everything is tracked as product moves

through the system� Starts with import of raw materials into the

country� Then moves to manufacturers . . .� Then to distributors and suppliers . . .� Then to pharmacies, practitioners, and other

health care providers and facilities . . .� And finally to the patient to whom the

controlled substance is dispensed� This requires detailed records to be kept

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Types of Required Records

� Inventories:� Initial � Biennial

� Purchasing and Receiving Records� Order Forms, Invoices & DEA 222 Forms

� Dispensing Records� Distribution Records� Theft and Loss Reports - DEA Form 106� Destruction Records - DEA Form 41

Common Schedule II Drugs

Form 222 is required to order these from a Pharmacy or Supplier

�Morphine Sulfate�Fentanyl Citrate (Sublimaze)�Hydromorphone (Dilaudid)�Meperidine (Demerol)

Filling out the 222 Form

� Make sure it is filled out completely

� No strike-outs or corrections are permitted

� Submit only the first two copies to the supplier or distributor (including a hospital or retail pharmacy)

� Keep the third copy - when the order is received at your facility record on that copy the date, time & quantity received

Filling out the 222 Form

� NEVER DESTROY OR DISCARD OLD OR UNUSED 222 FORMS!

� Void the form and maintain it on file

� If a form is lost report it to the DEA immediately

Schedule III Drugs (Uncommon for EMS)

�Ketamine is the only one used by EMS that is included here (it is classed as a CNS Depressant and often used as an animal tranquilizer)

�Make sure your DEA Certificate includes the authorization to order Schedule III controlled substances

Common Schedule IV Drugs

Form 222 is NOT required to order these

�Diazepam (Valium)�Lorazepam (Ativan)�Midazolam (Versed)

Invoices and packing slips are your only means to track these drugs

How Often Must An Inventory Be Conducted?

� An initial inventory must be conducted when the practitioner is first registered with the DEA

� Thereafter, complete physical inventories must be conducted at least once each year

� However, the DEA strongly recommends that EMS agencies conduct a count at every shift change with two individuals, who then record the physical inventory in some type of log book (bound if possible)

What Information Must Be Included in the Inventory

Record?� Date that the inventory was conducted� Exact time it was conducted (to provide a

reference point for any orders received or doses administered on that same day)

� Names of the controlled substances� Do not mix Schedule II drugs and Schedule

III – V drugs on the same inventory sheet� The finished form of the item (e.g. – 100 mcg

Carpuject vial)

What Information Must Be Included in the Inventory

Record?� The number of dosage units of each finished

form in a package or container (e.g. – box of 10, 3 single Carpujects, etc.)

� Include everything – even expired drugs or drugs that are set aside for destruction

What Information Must Be Included in the Inventory

Record?� Exact location where the controlled

substances are stored (e.g. – Medic 34 jumpkit, Medical Supply Room locking cabinet, etc.)

� If the inventory is being used as the annualDEA Physical Inventory the record must explicitly state that on the documents

� All inventory records must be retained for a minimum of two years

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Purchasing Recordkeeping

� Schedule II records (222 Forms) must be maintained separate from all other records

� Likewise, Schedule III and IV records must also be maintained separate from all other records

� Schedule III and IV records (invoices and packing slips) must be “readily retrievable”upon request of the DEA (highlight line items)

� All records must be maintained and be available for inspection for a minimum of 2 years following the transaction

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Dispensing Records

� Patient name and address� Date the controlled substance was

dispensed/administered� Name and strength of the controlled substance� Quantity or amount dispensed� Names/initials of the individual(s) who

dispensed or administered the controlled substance

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Dispensing Records

� There must also be a corresponding documentation of the same information in the patient care report

A physician cannot simply write a prescription to replenish

ambulance stock!

Prescriptions can only be written by a physician in order to dispense a

specific drug dose to a single patient

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Disposal of Partial Doses

� Only drugs that were opened and contaminated by patient contact may be wasted

� The drug that is being wasted must be “destroyed beyond reclamation ”

� In other words, don ’t squirt it in an empty soda can and throw it in the garbage – rather flush it down the sink and rinse it down with copious amounts of water

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Disposal of Partial Doses

� Two responsible individuals must always be present to witness the destruction of the leftover controlled substance after administering a partial dose to a patient

� The waste must also be documented� Record the amount of any waste along with

the names / initials of the individual(s) who witnessed the waste of the controlled substance (huge area for potential diversion)

� Many times it is most convenient to have the Waste Record on the same form as the Dispensing Record

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Disposal of Expired Drugs

� A practitioner may dispose of out-of-date or otherwise unused or unwanted controlled substances by transferring them to a registrant who is authorized to receive such materials

� These registrants are referred to as “Reverse Distributors” – contact DEA for a current list

� $$$$ This can be VERY costly $$$$� Essentially you become the supplier and must

obtain 222 forms from, and issue invoices to the Reverse Distributor who accepts the drugs

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Disposal of Expired Drugs� An easier method is to request

permission to conduct a destruction that is carried out by two responsible individuals on an annual basis

� First contact the Milwaukee District Office and request a DEA “Destruction Kit” to be sent out

� Create a detailed inventory of the controlled substances that you wish to dispose of by destruction

Disposal of Expired Drugs

� Determine the exact date, time and location where you will conduct the destruction

� Include all of these details in DEA Form 106 and submit it to the Milwaukee DEA office

� DEA Form 106 can be submitted online at:http://www.deadiversion.usdoj.gov

� Wait for approval – once you are approved, you may perform the disposal as planned

� A DEA Official MAY appear at the location to verify that proper disposal has occurred

What if a DEA Official Suddenly Shows Up at My Door?

When the DEA arrives to conduct a “controlled substance accountability”, you can expect the following:

� A Notice of Inspection or an Administrative Inspection Warrant will be presented

� The Diversion Investigator will conduct a Closing Inventory of all controlled substances in your possession

What if a DEA Official Suddenly Shows Up at My Door?

� Records for all purchases and deliveries will be reviewed� Copies of all 222 order forms for Schedule

II’s along with delivery receipts� Invoice copies for all Schedule III’s and

IV’s along with packing slips, etc

� Administration and Waste records will be reviewed

� Any Transfer Records will be reviewed

What if a DEA Official Suddenly Shows Up at My Door?

� Hopefully, after doing all of these reviews, the Diversion Investigator will discover that the Closing Inventory matches all of the transactions that have occurred since your last AnnualInventory was documented

� If not, an official investigation will be undertaken to determine the source of the potential diversion

How Is Secure Storage Achieved?

� Controlled substances are required to be secured in a “substantially locked cabinet” – but no clear definition exists

� This can be a challenge, especially for drugs carried in a “jump kit”

� Tamper proof sequentially numbered “break-away” seals can be useful

� Best option is a storage box that requires a code to entered with an audit trail

Knox Box Med Vault

Recommended Best Practices for EMS Agencies� Always keep the stock carried on the

ambulance to a minimum� Back stock should be kept locked up with

limited access using some type of individual ID coding system

� Don’t keep keys to secured storage areas on the ambulance in plain sight (in essence creating a situation where there is no limited access)

Recommended Best Practices for EMS Agencies� Routinely review controlled substance laws

and regulations so you are familiar with what is required

� Contact authorities when you have questions or concerns

� Implement a written policy and procedure of how and by whom controlled substances are to be handled in your agency and what steps are required

Recommended Best Practices for EMS Agencies� Conduct periodic training meetings to

ensure that your staff knows what is required and how to comply with laws and policies

� Conduct periodic reviews and self-inspections of your own service to ensure that you and your employees are consistently complying with policies and laws

Recommended Best Practices for EMS Agencies� Periodically audit and reconcile your drug

counts against the record keeping to ensure that all drugs are accounted for, drugs are not missing, and there are no record keeping errors

� Most ambulance services have the drugs on the ambulances counted with each shift change, by one employee going off duty and one employee who is coming on duty

� When possible, have all controlled drug activities performed by two people

Recommended Best Practices for EMS Agencies� The person who orders and purchases the

drugs should be a different person than the person who receives, checks them in and adds them to inventory. These should ideally not be the same people who also pay the bills. Separate the duties of ordering, receiving and paying so there are checks and balances

� Set up a calendar or reminder system so you know when it is time for an annual inventory or renewal of DEA registration

Recommended Best Practices for EMS Agencies� Review your invoices from drug companies

to make sure you authorized the drugs purchased

� The person who receives controlled substance shipments and checks them in should have a second person verify what was received and that the drugs are accurately being added to the perpetual inventory logs

Recommended Best Practices for EMS Agencies� Although not required, perpetual inventory

logs are encouraged to provide an ongoing record of what you have administered and what you have remaining

� Do not allow patients and visitors access to drug supplies. This means if drugs are missing, it is an employee who is responsible. Although you trust your employees, it is often the staff in a service that divert drugs because they are ones who have access and can falsify records

Recommended Best Practices for EMS Agencies� All employees should be comfortable with

policies and procedures that require oversight and witnesses because if there is a discrepancy in the drug count, consistent compliance with policies can protect them from false accusations

� Restrict the number of people who have access to your drugs to the fewest people possible

Recommended Best Practices for EMS Agencies� Have a policy requiring random drug testing.

Even if you do not want to conduct random drug testing on a regular basis, you should be able to demand a drug test during the course of an internal investigation if drugs are found to be missing

� Periodically review your administration and dispensing logs to make sure that an employee has not removed drugs and made up a name of a fictitious patient you don’t have a record of treating

Product InspectionExamples of Intact Seals

� Inventory requires more than just counting –integrity of seals must also be verified. Employees should be trained to check for tampering, torn packaging, or holes in packaging.

� There should be no disruption in the adhesive label seal

� Look carefully at the small curved “slices”in the label

� All cut lines should line up with no gaps or bumps noted

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Reporting Employee Diversion

� Federal Code of Regulations Title 21, Part 1301.91 states that an employee who has knowledge of drug diversion from his employer, by another fellow employee, has an obligation to report such information

� The employer is required to treat the reporting employee’s report confidentiality while the employer conducts an internal investigation and notifies the proper authorities.

Evidence of Tampered Seals

� The most common method of theft in an ambulance service is to steal the drugs and replace the drugs with water so the containers appear full

� If a theft or a loss (including evidence of tampering) is discovered you have one (1) business day to notify the local DEA office of the incident

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Evidence of Tampered Seals

� Any evidence of tampering MUST be reported to the DEA on Form 106 (this can also be submitted online at: http://www.deadiversion.usdoj.gov

� Local law enforcement should also be notified for a possible investigation

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Special Thanks to:Kathy L. Federico

Diversion Investigator(414)-336-7380

Milwaukee District Office4725 W. Electric Avenue

West Milwaukee, WI 53219

Questions?

Recordkeeping Using Image Trend Software

On to Kep . . .