Dispensing of Controlled Substances

Comprehensive Drug Abuse Prevention and Control Act of 1970

  • Commonly referred to as the “Controlled Substance Act”

  • Federal policy created to combat and control drug abuse and to supersede previous federal laws regarding drug abuse

  • Strictly controls the manufacture, importation, possession, use and distribution of certain controlled substances:

    • Narcotics, Stimulants, Depressants, Hallucinogens, Anabolic Steroids

Drug Enforcement Administration

  • Prevents the diversion and abuse of controlled substances (CS) and regulated chemicals

  • Responsible for enforcing the CSA

  • Any entity who handles, stores, orders or distributes CS must be registered with the DEA and given a DEA number

  • Determines who has the authority to prescribe CS. They must be authorized and monitored by the DEA and have a license to prescribe.

A controlled substance is a drug with potential for abuse. They are restricted because of a risk for abuse and dependence.

The Five Schedules of Controlled Substances

Schedule I:

  • Illegal

  • No medical value

  • Severe safety concerns

  • Most abuse potential

ex) heroin (dextromorphine/dope), LSD, ecstasy, cannabis (marijuana), mescaline

Schedule II:

  • Legal

  • High potential for abuse, which can lead to severe dependence

  • Medical value

  • Used under severe restrictions; no refills

ex) opioids, amphetamines, barbiturates, cocaine, methylphenidate, hydrocodone, morphine (MSiR), codeine/hydrocodone with aspirin, lortab, oxycodone, vicodin, oxycodone/acetaminophen, fentanyl citrate (duragesic)

Schedule III:

  • Legal

  • High potential for abuse, but less abused and safer than CII

  • Lower potential for abuse and dependence than CII

  • Prescriptions can be refilled up to 5 times within 6 months of written date if authorized by physician

ex) anabolic steroids, low-dose opioids (codeine) combined with ASA or APAP, testosterone, pregabalin, butalbiltal (fiorcet), ketamine (ketaset)

Schedule IV:

  • Legal

  • Lower potential for abuse than CII and CIII

  • Associated with less abused and dependence

  • Refills same as CS III

ex) tranquilizers, sleeping medications, benzodiazepines, tramadol (ultram), carisoprodol, phenobarbital, alprazolam (xanax), lorazepam (ativan), diazepam (diastat), clonazepam (klonopin), eszopiclone, zolpidem (ambien), phentermine (adipex-p)

Schedule V:

  • Legal

  • Lowest potential for abuse

  • Certain drugs in this schedule are considered exempt narcotics by some state laws and can be sold without a prescription. In these situations, purchasers must be over 18, have a valid driver’s license and are required to sign a log to obtain the drug

ex) liquid codeine combination cough preparations and diphenoxylate/atropine

DEA Registration

  • Restricts access to CS and requires all entities that prepare, handle, or distribute CS to fill out an application for DEA registration. When approved the entity is then given a DEA Registration Number.

  • The following must apply for registration: physicians, pharmacies, drug distributors, drug manufacturers, drug importers, and drug exporters

  • The application form for DEA registrants is the DEA Form 224

  • Once the entity registers with the DEA they receive a unique DEA Number

  • The DEA # is necessary for the dispensing and distribution of CS

  • DEA # also used in pharmacy billing

Prescription Requirements by Schedule

CII

  • Signed manually in ink by prescriber

  • Prescription becomes invalid 6 months after it is written

  • Can only be written for a 30 day supply

  • No refills

CIII - CV

  • Signed manually in ink by prescriber

  • May be refilled up to 5 times

  • Prescription is valid for 6 months from the date written

  • Check the date of last refill on all CS. Early refill request may suggest patient is abusing the medication and not complying with the directions for use. Do not fill early unless MD authorizes.

  • Transfer to another pharmacy only once

Electronic Prescriptions

Transmitting an electronic prescription is called e-prescribing

E-prescribing:

  • Allows pharmacies, nurses, and physicians to communicate and send prescriptions through computer-based transmissions

  • Helps provide more accurate information with less errors and tampering

  • In 2010 the DEA issued new rules on e-prescribing CS. CII - CV prescriptions could be transmitted electronically only if both physician and pharmacy software systems were certified to do so by a third-party auditor

Dispensing of Controlled Substances

Verify Patient and Prescription Information

  • Date prescription is written

  • Patient’s full name and address

  • Practitioner’s name, full address, phone number, DEA #

  • Directions for use

  • Quantity

  • Number of refills (if allowed)

  • Manual signature of prescriber

Verify DEA Number

Check the Patient Profile

  • Look for any duplicate therapy when dispensing CS: might be on another CS for a different reason

  • Look prescription history: might be dependency issues; multiple prescriptions from different physicians

Fill Process of Controlled Substances

  • CIIs are stored in a locked narcotics cabinet that can only be assessed by the pharmacist

  • Most pharmacies will double count CS, and often initial the amount, in order to insure the inventory is correct

CS labels have specific requirements:

  • Pharmacy name, address, phone number

  • Date of fill

  • Prescriber’s name

  • NDC #

  • Patient’s name, address

  • Order number

  • Directions for use

  • Quantity

  • Auxiliary labels

Federal law requires all CS labels state “Caution: Federal Law prohibits the transfer of this drug to any person other than the patient to whom it was prescribed”

Emergency Dispensing of CII RXs

  • May be called in by physician if:

    • CII drug is required as soon as possible

    • No other alternative treatment is available

    • Filled on “good faith” that the physician will send a written and signed prescription within 7 days or less “Authorization for Emergency Dispensing” written on it

    • If not received in 7 days, notify DEA

    • No more than 3 days supply

Partial Fills of Controlled Drugs

  • When not enough drug is in stock to fill the full quantity

    • CII must be able to provide remaining quantity within 72 hours or contact MD for new rx for remainder

    • CII-V patient pays for what they get and calls in refill when out, or pays all up front and picks up remainder when available

    • Document everything on the prescription hard copy

Comprehensive Addiction and Recovery Act 2016

Enacted in an effort to combat the opioid epidemic. Allows partial fills on CSII medications if requested by the prescriber or patient. The following conditions must be met:

  • State law does not prohibit partial fills of CSII medications

  • The total quantity dispensed over all the partial fills does not exceed the original quantity prescribed

  • The partial fill is not dispensed later than 30 days after the original prescription was written

Federal law allows faxing and calling in prescriptions for residents in long-term care facilities, for hospice patients, and for parenteral narcotics from a home infusion pharmacy. The prescriber must follow with an original prescription within 7 days.

Three Filing Systems

Pharmacies must keep all records that pertain to CS, including receipts, inventories, prescriptions, documentation of theft or loss, and disposition, for at least two years

  1. Three-File System: pharmacy keeps 3 files

  • Exclusively CII prescriptions

  • CIII - CV

  • Noncontrolled

  1. Two-File System: pharmacy keeps 2 files

  • One file only contains CII and other file contains all other prescriptions

  • Because the 2nd file contains CS and non-CS prescriptions the DEA requires identification of controlled drugs with a red C stamp on lower right hand corner of CIII - CV

  1. Alternative Two-File System: pharmacy keeps 2 files

  • All CS are in one file and noncontrolled are in another. The CIII - CV must still have a red C stamp.

CS Inventory

  • Pharmacies must perform an inventory of all CS every 2 years after their initial inventory, keeping accurate and complete records of their entire stock of CS

  • The records must be kept for 2 years at the location that appears on the DEA registration certificate

  • DEA requires all pharmacies to keep an exact count of CII drugs (perpetual inventory), but may estimate inventories of CIII - CV drugs

  • Dispensing records of CII must be kept separately from other medications. CIII - CV dispensing records can be kept with the prescriptions, or create a third file

  • CII drugs must be in a double-locked narcotics cabinet that is tamper-proof, with secure, permanent attachment of the cabinet to the wall or floor. Automated dispensing systems are also acceptable.

  • In retail stores and hospitals, pharmacies may store CIII, CIV, and CV drugs openly on storage shelves within the pharmacy

Narcotics Cabinets: Storage and Security

  • Electronic alarm systems

  • Self-closing and automatic locking doors

  • Key and/or password-control systems

  • Allowing authorized personnel only

  • Using security officers in high-crime areas

Ordering Schedule 2 Medications

  • Pharmacists must use DEA-Form 222 to order CSII drugs. The form must be filled out in triplicate and signed by the pharmacist.

  • The first copy goes to the supplier, the second goes to the DEA and the third stays in the pharmacy

  • When the pharmacy receives the shipment, the pharmacist must note on the third copy the amount and date they received it, and retain the copy for 2 years

  • This is the form used when a pharmacy distributes to another pharmacy

  • The other option is to use the electronic DEA Controlled Substance Ordering System (CSOS). This system allows pharmacists to order CSII medications on an electronic DEA-222 and sign with an online certificate

  • DEA-222 Forms are only valid for 60 days once they are written

DEA Form 222

A pharmacy distributing controlled substances or dangerous drugs to another pharmacy (or doctor) must adhere to the following procedures. Either the Controlled Substances Ordering System (CSOS) or the DEA Order Form (222) must be used for distributing Schedule II controlled substances.

  • Order/transfer/ship CII drugs

  • 10 medications ordered on one form

DEA 222 Form:

  • Company name and address

  • Order date

  • Name of drug

  • Order number or item

  • Quantity

  • Package size

  • Purchaser’s (pharmacist) signature

  • Pharmacy DEA number

  • NOTE: no patient or doctor appear on this form

Disposal of CS

  • If a pharmacy needs to dispose of a CS, the pharmacist must fill out and submit a DEA Form-41

  • Reasons for disposal include expired or damaged medications or having excessive amounts on hand

  • Pharmacies can dispose of them by returning them to the manufacturer or wholesaler or using a reverse distributor service to pick them up

  • If the pharmacy destroys them they will need to fill the DEA Form 41 and keep it on file for two years, but they only need to submit it to the DEA if requested. Destruction must be witnessed by two people (pharmacist).

DEA Form 41

DEA Form 41 is used to request permission from the DEA to destroy controlled substances

  • To dispose/destroy outdated or damaged controlled substances

Destruction of Controlled Substances

  • Destruction is most often completed by a reverse distributor:

    • Registered with the state and federal government to manage the removal and disposal of controlled substances for the pharmacy by transferring it back to the manufacturer to facilitate disposal. The pharmacy will use DEA form 222 to transfer CSII to the reverse distributor.

  • Destroying substances should only be done if reverse distributors are unable to accept the medications for destruction. In this case, the pharmacy must complete a DEA Form 41. A pharmacy can request DEA authorization to destroy controlled substances once a year.

Expired Controlled Drugs

  • Reverse distributor collects and destroys unsalable controlled substances

  • DEA Form 41 is used to destroy controlled substances in the pharmacy

  • Must be kept on file for 2 years

  • Must be witnessed by 2 people (pharmacist, nurse, law enforcement, other healthcare practitioners)

Theft or Loss of CS

  • Any loss or theft of a CS must be documented

  • The pharmacist must contact their local DEA office

  • Significant losses are reported immediately

  • The pharmacist will fill out a DEA Form 106 then send it to the State Board of Pharmacy, local police, and DEA

DEA Form 106

The DEA-106 is for reporting any theft or loss of controlled substances

Theft or Loss of Controlled Drugs

  • Report significant losses immediately to DEA

  • DEA Form 106

    • Date of loss

    • List of items

    • Local police department information

    • Costs of medications

  • Copies sent to BOP, local police, and DEA

DEA Inspections

  • When a DEA inspector identifies him or herself, the pharmacy technician must refer the DEA agent to the pharmacist-in-charge. Otherwise the DEA agent will give the pharmacy a negative mark for noncompliance during the DEA inspection

  • DEA inspections are mandated by the CSA and require administrative search warrants. They must state their purpose of the inspection and identify themselves.

  • The DEA checks the accuracy of CS record keeping and a BOP representative is usually present. They will check for up-to-date DEA registrants, certifications and registrants. They will look at all invoices for CS and receipts for orders, inventory, DEA-222 forms, filing systems

Prescription Monitoring

  • Prescription Drug Monitoring Programs (PDMP) identify possible abuse and diversion of CS

  • The PDMP is a statewide electronic database used by statewide regulatory, administrative and law enforcement agencies. The DEA is not involved.

  • Database contains:

    • Patient history of controlled substance drug use

    • Medications

    • Prescribing physicians

    • Pharmacies where they were filled

  • It identifies discrepancies within a patient’s CS prescription history. It also helps find discrepancies within prescribers and pharmacies in the dispensing CS.

  • The National Alliance for Model State Drug Laws (NAMSDL) states that PDMP’s support access to legitimate medical uses of CS; identify and deter or prevent drug abuse and diversion; facilitate and encourage the identification of, intervention of and treatment of persons addicted to prescription drugs.