Lec. 1 Controlled Substances Flashcards
Federal Regulations: The Drug Enforcement
Administration (DEA) - general information
- Established in 1973 to serve as the primary agency responsible
for enforcement of federal drug laws
—– To prevent diversion and abuse of controlled substances…
—– While ensuring an adequate and uninterrupted supply is available
to meet the country’s legitimate medical, scientific, and research needs
Fed Reg. Schedules of Controlled Substances - schedule I - V general description
1.) Schedule I
—- High potential for abuse, no currently accepted medical use in the US
2.) Schedule II
—- High potential for abuse, may lead to severe psychological or physical
dependence
3.) Schedule III
—- Potential for abuse less than substances in I or II and abuse may lead to moderate or low physical dependence or high psychological dependence
4.) Schedule IV
—- Low potential for abuse relative to substances in schedule III
5.) Schedule V
—- Low potential for abuse relative to substances listed in schedule IV and
consist primarily of preparations containing limited quantities of certain
narcotics
Fed Reg: Section 3- Registration Requirements (part 1)
1.) New pharmacy registration
—- In addition to a state controlled substances license, every
pharmacy that dispenses a controlled substance must be registered with the DEA (need for every single location!! every pharmacies’/ must be reg with DEA)… Separate registration for each location
2.) DEA Form 224 -> Online, Renewal every 3 years (224a, No more than 60 days prior to current expiration date, 224b (Retail Pharmacy Registration Affidavit for Chain Renewal))
3.) Duplicate Certificate of Registration – DEA Form 223
Fed Reg: Section 3- Registration Requirements (part 2) transfer of business
Transfer of business
- Submitted at least 14 days in advance
- Complete inventory must be taken on day of CS transfer and copy must be included in records of both
- Use DEA Form 222 to transfer schedule II drugs (form cannot be toss or shredded! must be returned to DEA!)
- Records don’t need to be sent unless requested
Fed Reg: Section 3- Registration Requirements (part 3)
Change of business address
- Modification of registration
- Proper state license, if change in state, prior to
- Maintain new certificate with old one until expiration
.
Registration termination
- Return certificate and any unused DEA 222 forms
- Controlled substance records need to be kept for at least 2 years
- Dispose of unwanted controlled substances in accordance with DEA regulations
Fed Reg: Section 3- Registration Requirements (part 4)
- DEA can deny, suspend or revoke registration
- Denial of registration in public interest
—- State recommendation
—- Experience or conviction record of applicant
—- Compliance with laws
—- Conduct that may threaten public health and safety
Fed Reg: Section IV – Transfer or Disposal of Controlled Substances: Transfer of controlled substances
- Can transfer to another pharmacy or to original supplier/manufacturer
- Pharmacy may hire outside firm to arrange transfer; pharmacy is ultimately responsible
- Records kept for 2 years
- Receiving registrant must issue DEA Form 222 (Controlled substances III‐V must document dosage, strength, quantity and date of transfer)
Fed Reg: Section IV – Transfer or Disposal of Controlled Substances: Disposal of controlled substances
DEA registered reverse distributor
- Local DEA office for current list
- DEA Form 222 – record of destruction for schedule II
- III‐V – pharmacy maintains record of distribution with drug name,
dosage form, strength, quantity and date transferred
- DEA Form 41 (Registrants Inventory of Drugs Surrendered) – reverse
distributor submits to DEA when drugs destroyed
Fed Reg: Section V - Security Requirements
- Shall provide effective controls and procedures to guard against theft and diversion
- The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration
revoked or has surrendered a DEA registration for cause (Waiver from DEA to employ an individual who meets this definition) - Notify the DEA Field Division Office and local police of theft or significant loss within one business day of discovery, in writing (DEA Form 106!!! If investigation finds no theft or loss, no need to complete DEA Form 106 but must report to DEA why not filed)
.
NOTE: significant - no definition… defined by the individual pharmacy and the stock/ amount they have!! a lots of med in stock? we loss a bottle? not a significant amount… play by ear.
Fed Reg: Section V – Security Requirements: Theft or significant loss
Registrants responsibility to identify significant loss
- Quantity in relation to type of business
- Specific controlled substance
- Pattern of loss over a period of time
- Control substance likely for diversion
- Local trends of diversion potential
Fed Reg: Section V - Security Requirements: in-transit loss, breakage/ spill, robbery
1.) In‐transit loss from central fill pharmacy
- Pharmacy is responsible not the carrier
- Purchaser completes DEA Form 106
.
2.) Breakage/spillage
- Dispose accordingly
- DEA Form 41
.
3.) Robbery
- Potential for federal investigation
- Penalties upon conviction (Below!)
- Max $25,000 fine and/or 20 years imprisonment
- If dangerous weapon used, max $35,000 and/or 25 years
imprisonment
- If death resulted, max $50,000 and/or life imprisonment
Fed Reg: Section VI - Record Keeping ( v important!)
- Complete and accurate records
- Maintained for at least 2 years
- Separate CII from CIII‐V
- Must be readily retrievable
- Can be filed electronically or in paper form
——- If conflict between federal and state requirements for filing
prescriptions, the DEA recognizes that the pharmacy must choose a filing system that would comply with both federal and state law
Fed reg: Section VI - Record Keeping: Required records which must be maintained:
Fed Reg: Section VII – Inventory Requirements
1.) Initial inventory
- Date
- Whether inventory was taken at beginning or close of business
- Name of the controlled substance inventoried
- Finished form of each substance (e.g. 10mg tablet)
- Number of dosage units of each finished form in the commercial container (e.g. 100 tablet bottle)
- Number of commercial containers of each finished form (e.g. four
100 tablet bottles)
- Count of the controlled substance – exact if schedule II, estimate for
schedule III, IV or V unless container holds more than 1000 tabs or capsules, then exact count required
2.) Biennial inventory (every other year)
- Same process as initial
3.) Newly scheduled controlled substance inventory
- Inventoried on effective date
Fed Reg: Section VIII – Ordering Controlled Substances
1.) DEA Form 222
- Schedules I and II
- Number of packages
- Size of the package
- Name of the controlled substance
- Must be signed by authorized person
- Pharmacist must document date and actual number of packages received
- File once complete
.
2.) Lost or stolen forms
- Must be reported to the local DEA office immediately
- Must provide serial numbers of each lost/stolen form, or the
approximate date of issue
.
3.) Schedules III‐V
- Registrant must keep a receipt (invoice or packing slip) that contains the name of each controlled substance, form, number of dosage units in each container, and the number of commercial containers ordered and received
—– Record date of receipt
—– Confirm accurate order
—– Readily retrievable
Fed Reg: Section IX – Valid Prescription Requirements: Prescription
- Dated and signed on the date when issued
- Patient’s full name and address, and the practitioner’s full name, address and DEA registration number
- Drug name
- Strength
- Dosage form
- Quantity prescribed
- Directions for use
- Number of refills authorized (if any)
Fed Reg: Section IX – Valid Prescription Requirements: Who may issue..
A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid‐level provider, or other registered practitioner who is:
- Authorized to prescribe controlled substance by the jurisdiction
in which the practitioner is licensed to practice, AND - Registered with DEA or exempted from registration (e.g. Public
Health Service, Federal Bureau of Prisons, military practitioners),
OR - An agent or employee of a hospital or other institution acting in
the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered, provided that additional requirements as set forth in the C.F.R. are met
Fed Reg: Section IX – Valid Prescription Requirements (other)
- Issued for legitimate medical purpose by practitioner acting in the usual course of professional practice
- Pharmacist is required to exercise sound professional judgement when making a determination about the legitimacy of a controlled substance prescription
- Pharmacist must verify practitioner and valid DEA number
Fed Reg: Section IX – Valid Prescription Requirements: Hospital prescriber DEA number
- Practitioners (e.g. intern, resident, staff physician, mid‐level
practitioner) who are agents or employees of a hospital or other
institution - Current list of internal codes and corresponding individual
practitioners is to be maintained by hospital or institution (Example: AB1234567‐012) - Pharmacist to contact hospital for verification if needed
DEA Number Validation… Is this a valid DEA number? How do you check?
BF6428522
- Add together the 1st, 3rd and 5th digits.
- Add together the 2nd, 4th and 6th digits. Double it.
- Add the two totals together.
- The second digit in that total is the check digit
.
THIS IS NOT VALID!!! (Lc)
Section IX – Valid Prescription Requirements: Schedule II substances require a written prescription
- Manually signed or meets all DEA requirements for electronic prescriptions
- While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30‐day supply, there are no express federal limits with respect to the quantities of drugs dispensed via a prescription
- Amount dispensed must be consistent with requirement that the
controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice - Refills prohibited
Fed Reg: Section IX – Valid Prescription Requirements…
- Practitioner can write 90‐day supply of CII if separate prescriptions are used
- Must comply with laws
- Must ensure it is for medical use
- Must indicate earliest date of fill
Fed Reg: Section IX – Valid Prescription
Requirements: Can fax CII if original prescription is available at pick‐up unless:
- Long‐term care
- Hospice care
- Compound for direct administration
Fed Reg: Section IX – Valid Prescription Requirements…
- Schedule III‐V
- Call in, fax, electronic
- Refilled up to 5 times within 6 months after the date of issue
- When controlled substance III or IV is refilled must include
….. Dispensing pharmacist’s initials
….. Date the prescription was refilled
….. Amount of drug dispensed on the refill
