The Closed System of Controlled Substance Distribution Flashcards
What is the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970?
- Creates a closed system via registration
- Establishes national uniformity
- Enforced by DEA
- Overall goal is to reduce diversion
What is Title I of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970?
Establishes rehabilitation programs for drug abusers
What is Title II of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970?
Provides for the registration programs for drug abusers
What is Title III of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970?
Addresses the importation and exportation of controlled substances
Who has the authority to regulate controlled substances?
- Supremacy Clause
- Interstate Commerce Clause
What is the Supremacy Clause of U.S. Constitution?
Doctrine of Preemption
-Federal law preempts state law if they conflict
-State law must be stricter than federal law to not conflict
What law do pharmacists follow federal vs. state?
They should follow the stricter law
What is the Interstate Commerce Clause?
- Intrastate interactions involving controlled substances have a “direct and substantial” effect on interstate commerce
- Manufacturing and distribution of intrastate and interstate transactions cannot be distinguished from each other
What is Intrastate?
Completely within one state
What is Interstate?
Between two or more states
Marijuana and Methamphetamine fall under what schedule?
Schedule I
Anabolic steroids fall under what schedule?
Schedule III
Placement into a specific schedule depends on what?
- Abuse potential
- Degree to which drug may cause physical or psychological dependence
Do Schedule I drugs have an accepted medical use?
NO
Marijuana is a C-I drug under federal law and following the stricter law, can it be dispensed in pharmacies?
NO, even if it allowable under state law or approved medically
In terms of Marijuana what does it mean for pharmacists?
Pharmacists should be able to answer questions and provide surveillance for potential drug interactions
What drug interactions with Marijuana?
Warfarin, increased INR
What is the classification of C-I Drugs?
- Have a high potential for abuse
- Have no currently accepted medical use
What is the classification of C-II Drugs?
- Have a high potential for abuse
- Have a currently accepted medical use, with or without restrictions
- Abuse may lead to severe physical or psychological dependence
What schedule is Cocaine and why?
Schedule C-II, but is can be used for nasal surgery as a vasoconstrictor
What is the classification of C-III Drugs?
- Potential for abuse is less
- Have a currently accepted medical use
- Abuse may lead to moderate or low physical dependence or high psychological dependence
C-III Drugs may include what type of drugs in combination?
CII Drugs
APAP + Codeine
Anabolic Steroids Act of 2004 is what?
- Maintains anabolic steroids as schedule III
- Provides automatic scheduling of certain salts, esters, and ethers of anabolic steroids without need to prove muscle growth
What is the classification of C-IV Drugs?
- Potential for abuse less than CIII substances
- Have a currently accepted medical use
- Abuse may lead to limited physical or psychological dependence
What is the classification of C-V Drugs?
- Potential for abuse less than C-IV substances
- Have a currently accepted medical use
- Abuse may lead to limited physical or psychological dependence relative to C-IV drugs
What are the Federal Limits on Pseudoephedrine PSE?
- 3.6g per day
- 9g per 30 days (7.5g if by mail order)
What are the Oklahoma Limits on Pseudoephedrine PSE?
- 7.2g per 30 days
- 60g per 12 month period
If there is a patient in Oklahoma using Sudafed as a decongestant and buying it OTC continuously, they will cap out before 12 months, what is an exception?
If it is physician prescribed, the limit if OFF
What are the Federal Requirements of a Pharmacy/Pharmacist selling PSE?
- Customers cannot have direct access
- Sales must be recorded with required information
- Sellers must annually engage in self-certification
What is an OTP and what Act does it fall under?
Opioid Treatment Programs OTPs
Falls under the Drug Addiction Treatment Act DATA
What is Detoxification?
Dispensing an opioid agonist in decreasing doses incident to withdrawal
What are the concerns with Detoxification?
- Withdrawal can lead to relapse
- Important to taper down
- Detoxification outside an approved treatment program is illegal
What is Maintenance?
Dispensing of opioid agonist for period in excess of 21 days
What are the 4 drugs allowed for treatment of opioid addiction?
- LAAM (levo-a-acetylmethadol)
- Methadone
- Buprenorphine (Subutex)
- Buprenorphone/Naloxone (Suboxone)
2,3,4 are most used in the US
Methadone is indicated for pain and addiction, when is prescribing for addiction allowed?
Only allowable in treatment program
Manufacturers Voluntarily restricted 40 mg Methadone tablets to OTPs meaning?
40 mg highest strength of methadone is NOT available in community pharmacies to be dispensed
When is prescribing Methadone for pain allowed?
Must verify pain indication but can be filled at ANY pharmacy
Methadone prescriptions to a PHARMACY can only be used for what?
ANALGESIC purposes
1. Pain
2. Antitussive
What is the Drug Addiction Treatment Act?
Enacted in 2000 with intent of allowing addiction to be treated in OFFICE based settings outside of OTPs
Why was the Drug Addiction Treatment Act important?
Increased the amount of practitioners that treat this disorder, and allowed for rural access in substance abuse
What are the 2 drugs allowed for office-based treatment of addiction?
- Buprenorphine (Subutex)
- Buprenorphine/Naloxone (Suboxone)
For Office-Based treatment of addiction, treatment must be prescribed by a what?
Qualifying Physician
What are the factors that make them a Qualifying Physician?
- Board Certification in Addiction Psychiatry or Addiction Medicine (or in training)
- Limits on the number of patients on qualifying physician may treat annually
- Qualifying physician must obtain special DEA number
What is the special DEA number for Qualifying Physicians?
- X DEA Number
- Physician will also maintain regular DEA Number
Buprenorphine is indicated for pain and addiction and for addiction prescribing when should it be used?
Intended for beginning of addiction treatment (induction) and administered by qualifying prescriber
What type of Buprenorphine is more common at pharmacies?
Buprenorphine/Naloxone
Pharmacists should document what if Buprenorphine Rx is being dispensed?
Used for addiction or pain
If patient is being prescribed Buprenorphine Rx for addiction, as a pharmacist what must you do?
Watch to ensure you do not dispense them an opioid
What is Suboxone most commonly used for?
Maintenance phase of addiction treatment
What falls under the Scheduling Authority?
- Unscheduled to Scheduled
- Changing Schedules
- Remove a drug from a schedule
The Scheduling Authority falls under who?
- Secretary of DHHS
- Attorney General
Who makes the official change of a drug schedule?
Attorney General officially makes the change under the advise of the Secretary
Can the Attorney General make a change to a drug schedule without the Secretary?
YES
1. Avoid an imminent hazard to public safety
2. Abuse potential
If a drug falls with a controlled schedule, what must the manufacturing label demonstrate?
- Identification symbol of the schedule (C w/ Roman numeral)
- Clear, prominently located, large symbol
What is the role of the DEA in regulating controlled substances?
DEA Registration
Who has to register with the DEA in the process of controlled substances?
Anyone (individual or businesses) working within the closed system of controlled substances must register with the DEA
What are the registration exemptions of the DEA?
- Agents or employees of registrants
- Common carriers
- Ultimate users (patient)
- Law enforcement officers
What are examples of agents or employees of registrants?
- Pharmacists
- Medical residents (allowed to use hospital DEA)
What are examples of common carriers?
Delivery service or postal service
What are activities that REQUIRE DEA Registration?
- Manufacturing
- Distributing and Reverse Distributing
- Dispensing
What parts of Manufacturing of Scheduled Drugs requires DEA Registration?
- Production
- Preparation
- Compounding
- Processing
- Packaging/Repackaging
- Labeling/Relabeling
For pharmacies that COMPOUND control substances, does the pharmacist/pharmacy need to register as a manufacturer?
NO
For DEA Registration of a Manufactuer, how often does registration occur?
MUST register ANNUALLY
Manufacturer registration with the DEA is excludes activities of practitioners incidental to dispensing meaning?
Pharmacies are exempt if engaging in ordinary course of pharmacy practice = relabeling prescriptions ok
Distributing DEA Registration is for required for who?
Those delivering schedule drugs =
1. Wholesalers = McKesson/Cardinal
2. Reverse Distributing to wholesalers and dispensers
Do Dispensers register as a Distributor with the FDA?
NO, they are exempt provided they comply with all conditions
For DEA Registration of a Distributor, how often does registration occur?
MUST register ANNUALLY
What is a requirement of all Distributors?
Required to design and operate a system able to detect suspicious orders of CSs and inform DEA upon discovery
Wholesalers who are distributors have a system to keep track of scheduled substances and are able to what?
Say if something looks suspicious and work with the DEA or local authorities accordingly
What does Dispensing include under DEA Registration?
- Prescribing
- Administering
- Dispensing
- Packaging
- Labeling
- Compounding
Who is considered a Dispenser?
- An individual who is a dispenser must register as an individual (physician, dentist, vet)
- An individual who works under a business that has to register if an AGENT of the business may not have to register individually (pharmacist/pharmacy, hospital)
For DEA Registration of a Dispenser, how often does registration occur?
MUST register every 3 years
As a pharmacist you do not have to register with the DEA as a dispenser unless what?
- Mid-Level Practitioner based on collaborative prescriptive authority (only if permitted by state law)
What are Individual Practitioners IPs?
Individual practitioners include physicians, dentists, veterinarians, and others licensed to dispense by the state
IPs include what besides physicians, dentists, and vets?
Includes medical residents in training, does NOT include pharmacists
IPs who are AGENTS/Employees of another IP may what?
Administer or Dispense controlled substances but NOT prescribe
How do you register a pharmacy with the DEA?
DEA Form 224, initial/new
DEA Form 224 for initial and new registration application results in a certificate of registration but until then what can you do?
You CANNOT engage in activity where registration is required until registration is granted and the certificate of registration issued is in HAND
Registration cannot be assigned or terminated without what?
DEA Approval
DEA Form 224 Renewal requires email for what?
Renewal reminders 60,45,30,15, and 5 days prior to expiration
Modification or Termination of Registration must be approved by the DEA including what?
If registrant dies or business ceases legal existence, DEA must be notified and registration terminated
If there is a Discontinuance of Business, registrants must return what?
Certificate of Registration to DEA for cancellation together with any unexecuted Form 222s
For a Transfer of Business, what must be done to the DEA?
Proposal must be submitted to DEA at least 14 days prior to transfer with required information
What is the required information in a transfer of business proposal to the DEA?
- Transfer may occur unless DEA notifies otherwise
- Complete inventory of Cs must be taken on date of transfer
- C-II produced must be recorded via Form 222
Attorney General may DENY a practitioner-applicant registration if what?
- Materially falsified on application
- Felony conviction
- If ever has a state license or registration suspended, revoked, or denied
Each principal place of business where controlled substances are administered, dispensed, or stored REQUIRE SEPARATE registration meaning?
- DEA licensees are connected to a PHYSICAL Location
- Each place of business has to have their own license
What are the Security Requirements from the DEA applying to pharmacies?
- All applicants and registrants must provide effective controls and procedures to guard against theft and diversion
- OK Board of Pharmacy will ask to see your policy to prevent diversion
IPs must securely lock control substances in a Substantially Constructed Cabinet, does this apply to a pharmacy?
NO, only applies to IPs that are dispensing
Are pharmacies allowed to disperse control substances throughout the stock of non-controlled substances?
Yes
What are Penalites associated with violations of the Controlled Substance Act?
841 establishes penalties for drug traffickers and is applicable to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice
AKA Penalties can result in what?
Charged with drug trafficking
The Controlled Substance Registrant Protection Act protects pharmacies by way of Deterring Theft resulting in?
- Pharmacy Robbery is a Federal Crime
- If at least $500 in replacement costs of CSs
- Person suffers significant injury
- If interstate commerce is involved
What are the Constitutional Issues with Pharmacy Inspections?
- Fourth Amendment protects individuals from unreasonable searches and seizures, requires the issuance of a search warrant based on probable cause
Who can inspect a pharmacy?
- DEA
- State Board
In DEA Inspections, what is allowed?
DEA has the authority to inspect any place where CS records are kept or persons who are registered
What can the DEA inspect in the pharmacy?
- Examine and copy all records and reports regarding CSs, inspect within reasonable limits, and take an inventory of CSs
- Inspector not allowed to inspect financial, sales, or pricing data without consent
A new pharmacy that opens will not be granted a DEA license without what?
Inspection
Audit procedure involves inspecting records of drugs received less drugs dispensed and comparing with inventory, how do you calculate inventory?
Cs Received - Cs Dispensed = Inventory
Prior to inspection, the inspector is required to what?
Provide notice of inspection with Purpose
What is a Notice of Inspection NOI?
- Must be provided to pharmacy
- NOI is NOT the same as a warrant
- Requires consent
- Consent must be voluntary and not coerced and may be withdrawn
- PIC or owner can grant inspector limited consent
As a pharmacist/ownder can you limit consent of the NOI/Inspector?
Yes
NOI must contain what?
- Name of Owner or PIC
- Name and Address of Business
- Date and Time of Inspection
- Statement that the NOI was given
Administrative Inspection Warrant AIW is what?
- AIW created by Supreme Court as alternative to search warrant
- AIW may ONLY be served during regular business hours
What is required for AIW?
- NO consent required
- Probably cause required
State Pharmacy Board Inspections, in OK the state board may what?
Conduct on-site periodic routine inspections and investigations during reasonable business hours
