Regulatory Agencies Flashcards
Primary federal law enforcement agency charged with the responsibility of combating the abuse of controlled substances
DEA Drug Enforcement Administration (1973)
The DEA was established to more effectively control narcotic and dangerous drug abuse through a nationally organized enforcement and prevention system
DEA cooperates with other federal agencies, as well as state and local governments, private industry and other organizations
regulates, by way of federal registration, all persons involved in the legitimate chain of manufacture, distribution or dispensing of controlled drugs
It is title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Designed to provide a “closed system” for legitimate handlers of controlled drugs and reduce opportunities to enter into the illicit drug market
CSA Controlled Substance Act (1970
Under Title 21 of the US Code, also known as the FD&C act, the ___ CVM has been given the authority to govern the manufacture, distribution, and use of vet drugs that are distributed between states. The federal code also give ___ the authority to write regulations on how it will enforce the FD&C Act. The ___CVM (Center for Veterinary Medicine) is responsible for regulating animal foods/feeds and most animal health products
FDA Food and Drug Administration
Created to enact and enforce safety rules for the american workplace
Applies to all workplaces in the US & Territories
Many states have their own version, most are more stringent
Hospital Safety Manual (HSM) is required
OSHA Occupational Safety and Health Administration
The controlled Substance Act requires that anyone who manufactures, distributes or dispenses a CS must register with the ___?
DEA
Drug Enforcement Administration
True/False
Vets working at more than one location may PRESCRIBE controlled drugs if they are registered at some principal place of business.
True
True / False
To Administer or Dispense each vet must be classified as an employee of a registrant, or they must register at each location where they are employed
True
Cannot legally prescribe any drug under state practice act laws
NON vet staff
Many states allow employees to administer drugs at the direction and under the direct supervision of a licensed vet under the following conditions
They are under the direct supervision of a licensed vet - vet is on the premises
If they are agents or employees of the registered practitioner
They are performing the task in the usual course of business
They are acting under the direction of a licensed vet - directly observes them
How should this situation be handled? Administration of controlled drugs by independent contractors
Should contact DEA divisional office for guidance
If any doubt exists, it is best to require independent contractor vets to maintain separate registrations. This will assure compliance with the CSA and tax authorities.
Whatis it called if a registrant dies, goes out of business, discontinues in professional practice or ceases legal existence, the DEA must be notified immediately so the registration can be terminated. Any unused drug order forms must be returned to the nearest DEA office.
Practitioners or representatives of their estates having controlled substances in their possession at the time the practice is discontinued should contact their regional DEA office to determine how to dispose of unused controlled substances. These substances should not be sent to the DEA unless specific instructions have been received to do so.
Termination of Registration
What form is needed to order Schedule II Drugs
DEA Form 222
True / False
Practitioners do not need to be licensed in the states where they are practicing or have a valid DEA registration to order CS from distributors
False
What special form is needed for orders of drugs in Schedules III, IV, V.
No special form needed, order direct from distributor or manufacturer
What do you do if DEA Forms are lost or stolen?
Used or unused order forms that are stolen or lost by the registered vet the DEA should be notified immediately with the serial numbers of the missing forms. If not known, the DEA should be contacted for instructions.
Who may sign a DEA Form 222
Only a registered vet or a person with a valid POA may legally sign the order forms
On DEA Form 222, who gets copies 1, 2 and 3?
Federal regulations require that copies 1 and 2 of Form 222 be submitted to the supplier. Copy 3 is retained by the registrant.
When Schedule II drug orders are received, where should the receipt be recorded?
When drug shipments arrive from the distributor, the date of receipt and the number of containers of each drug received should be recorded on Copy 3 of the original order form.
How do you cancel a Schedule II drug order
You may cancel part or all of an order by notifying the supplier in writing. The supplier indicates the cancellation by drawing a line through the items and printing “canceled” in the space provided for the number of items shipped.
What can be produced to allow veterinarians who are agents of the principal veterinarian to order CS under the registration of the principal. (Schedule II drugs)
Power of Attorney
True/False
POA for ordering Schedule II drugs also applies to prescribing, agents do not need to have their own DEA registration number.
False
True / False
For POA’s the people ordering must be agents or employees of the registrant in order to administer or dispense CS. It may be restricted to a certain time frame.
True
The rationale for maintaining records regarding drugs received from suppliers and drugs dispensed to patients is to complete the DEA’s “_______” for monitoring possibilities of diversion into illicit channels
Closed System
True/False
Schedule II drugs must be recorded and stored separately from the medical record of the patient
True
For which scheduled drug(s) can the records be stored in the medical record or separate but must be stored in a fashion where they can be readily retrieved.
Schedule III, IV, V
Two options for record keeping of Controlled Substances
- Form that allows for running totals of drugs to be maintained but requires a separate record for each drug (1 drug per form)
- Form that minimizes the number of separate record forms but makes it more difficult to produce running totals of controlled drug inventories (multiple drugs on 1 form)
What is the process for Lending controlled drugs to other practitioners
For schedule III, IV, V
Transfer the quantity of drug to another registrant and obtain a receipt signed by the registered vet who received the drug. Store the invoice in your controlled drug record keeping system.
The receiving vet should keep copies of the receipts showing the drug was received from another vet instead of a supplier
Drugs can be returned to the vet from whom they were borrowed, using the same record keeping methods
What is the process for Lending controlled drugs to other practitioners
For schedule II
Must use the DEA 222 Form. Copy 3 of the form stays with the vet who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.
Inventory of CS in a new practice
According to the CSA When a vet acquires an existing practice, an initial inventory of CS must be taken
When should this inventory take place?
DEA regulations require that this be done as of the date practitioners first engage in dispensing or administering CS.
True/False
An estimated count of Schedule II can be performed when transferring inventory to a new owner
False It must be an exact count
Estimated counts for substances in Schedule III, IV, V are permitted unless the container hold more than _____ tablets or capsules, in which case an exact count is needed when transferring inventory to a new owner
1000
Every ___ years following the initial inventory date the registrant must take a new inventory of all CS on hand. The records of these inventories are to be kept with other DEA records at the registrant’s business location and retained for ___ years.
2 years
2 years
How many employees should have access to the drug safe?
Absolute minimum
Which Scheduled drugs may be stored with other NON controlled drugs so long as they are securely locked in a cabinet.
Schedule III, IV, V
Where should Schedule II drugs be stored?
In a securely locked, substantially constructed cabinet or safe.
Registrants are required to notify the _________ and ______ of the theft or significant loss of any CS upon discovery loss/theft.
Regional Office of the DEA and Local Police Department
Fill out DEA Form ____ at the time of the notification of stolen or lost controlled drugs to DEA
106
True / False
Any breakage or spillage of CS bottle should also be reported to DEA
True
Prescriptions for which Scheduled drug(s) must be written and must bear the full name and address of the patient, plus the name, address, and registration number of the practitioner
Schedule II
Try/False
A Schedule II drug prescription can be digitally signed by the practitioner
False, it must be manually signed
How many refills can be given on Schedule II drug prescriptions?
None, It is prohibited to refill schedule II Drugs.
True/False
Prescription orders for schedules III, IV, V may be provided in writing or they may be issued to pharmacists orally.
True
How many times can prescriptions be refilled for Schedule III, IV, V drugs?
Schedule III, IV, V may be refilled up to 5 times within 6 months after the date of issue.
What is it called when A practice cannot employ an individual who has had their DEA application revoked or denied if, as a result of their employment, they will have access to controlled drugs.
Employee Prohibition Required
Employees working in a controlled substance environment may be screened and rejected for reasons described by the DEA. What questions are permissible by law to ask a candidate?
Within the past 5 years have you been convicted of a felony.
In the last 2 years a misdemeanor?
Are you presently charged? If yes, they need to furnish the details of conviction
In the past 3 years have you knowingly used any narcotics, amphetamines, or barbiturates, other than those prescribed to you by a physician? If yes, furnish details.
When screening a candidate for Controlled Substance Abuse/Violations prior to hiring, Does An employer have to have an authorization in writing that allows inquiries to be made of courts and law enforcement agencies for possible pending charges or convictions
Hell Yes
True / False
Employees are responsible for reporting drug diversions of any fellow employees
True: The employer will treat all such information confidential. Failure by the employee to report drug diversions by fellow employees will be considered a determining factor in the feasibility of the employee continuing to work in a drug secure area.
Employers are responsible for informing all employees about his policy
True / False
The Code of Federal Regulations states that a representative of the DEA is authorized to enter Controlled premises and conduct inspections for the purpose of copying and verifying accuracy of records, reports and other documents related to controlled substances
True
True / False
During a DEA inspection the Compliance Officer can inspect, without permission of the practice owner, any financial, sales and pricing data
False, They must receive permission to inspect these records from the practice owner.
True / False
A DEA inspection can be performed at any time of the day and is permissible to disrupt workflow and staff duties.
False: The inspection must be at reasonable times and in a reasonable manner
What primary factor does the CSA divide controlled substances into schedules?
primarily according to their potential for abuse:
Controlled Substance SCHEDULE ____
Highest potential for abuse and severe dependence
Lowest potential for accepted medical use (currently none)
Lack of accepted safety for use of the drug or other substance under medical supervision
Ie: heroin and LSD
SCHEDULE I
Controlled Substance SCHEDULE ___
High potential for abuse and severe dependence
Currently accepted medical use in the US - with severe restrictions
Abuse of drug may lead to severe dependence
Ie: Morphine, Oxymorhone
Schedule II
Controlled Substance SCHEDULE ___
Less potential for abuse than I and II and may lead to low to moderate dependence
Currently accepted medical use in the US
Ie: Tylenol with Codeine, Nalline
Schedule III
Controlled Substance SCHEDULE ___
Low Potential for abuse, may lead to limited dependence
Currently accepted medical use in US
Ie: Diazepam and Tramadol
Schedule IV
Controlled Substance SCHEDULE ___
Low potential for abuse and may lead to limited dependency
Currently accepted medical use in the US
Ie: Robitussin A-C, Lomotil
Schedule V
A section of the CSA states the ___ and ____ have broad powers to reschedule a drug, bring an unscheduled drug under control or remove the controls on a drug.
DEA and the Attorney General
Drugs that contain unsanitary components, lack adequate control in manufacture, differ in strength from official compendium, or that are mixed with another substance.
Adulterated Drugs
DVM takes 2 or more FDA approved drugs and mixes them into one syringe or bottle. Now the drugs have been adulterated and administering such a drug is a violation of the FD&C Act (Food Drug & Cosmetic)
This is an example of what kind of drug
Adulterated Drug
True / False
Under current law an unapproved drug is in itself, adulterated.
True