Law And Ethics Pt 1 - 24% Flashcards
The Drug Enforcement Administration (DEA) was established in 1973. What is the main function of the DEA?
The DEA is the primary federal law enforcement agency charged with the responsibility of combatting the abuse of controlled substances.
*The Controlled Substance Act requires that anyone who manufactures, distributes or dispenses a controlled substance must register with the DEA.
What are the rules in place by the DEA for veterinarians that work at more than one location?
A DVM can prescribe (write a prescription to dispensed at a pharmacy) Phenobarbital to a seizing dog (for example) at four different locations owner by the same business owner, but that same DVM can not administer or dispense the Phenobarbital unless they are an employee of the practice
OR they are registered at that specific location.
What is the interpretation of the federal law provided by the DEA in regards to administration of controlled drugs by non veterinary staff?
1.) Must be agents or employees of the registered practitioner
2.) They are performing the task in the usual course of business
3.) They are acting under the direction of a licensed veterinarian ( refers to a tech administering a controlled drug while a DVM directly instructs or observes).
4.) They are under the direct supervision of a licensed veterinarian. (Veterinarian on premises and knows what is going on)
Administration of controlled drugs by independent contractors…
If any doubt exists,
It is better to require that independent contractor veterinarians maintain a separate DEA registration. This assures compliance with the Controlled Substance Act, and also helps to support the independent contractor status to the tax authorities who may consider challenging the relationship.
If a veterinarian dies, goes out of business, ceases professional practice, or no longer is licensed or practicing veterinary medicine for any reason. How much time is given before the DEA must be notified?
The DEA must be notified immediately so the registration can be terminated. Any unused drug order forms must be returned to the DEA so the registration can be terminated.
When it comes to ordering controlled substances , no special order form is needed to order drugs in schedule III , IV, or V
What form is needed for all controlled substances in schedule II ?
All controlled substances in schedule II must be ordered with the federal triplicate order form DEA-222.
When completion DEA forms, which copies of the DEA-222 must be submitted to the supplier.
Copies 1 and 2 of the DEA-222 must be submitted to the supplier.
Copy 3 of the form is retained by the registrant (the registered DVM).
**The supplier retains copy 1 and send copy 2 to the DEA.
When it comes to the DEA-222 form copy 3 (the copy retained by the registered DVM) what should written on that form when the shipment arrives?
When the shipment arrives; the date of receipt and the number of containers of each drug should be documented on the copy 3 of the original order form that was retained when ordered.
Describe a DEA schedule I drug -
Has a high potential for abuse. Has no current accepted medical use for tx in the US. Lack of accepted safety for use of the drug or other substance under medical supervision.
Describe DEA schedule II
Has a high potential for abuse. Has a currently accepted medical use in tx in the US or a currently accepted medical use with severe restrictions.
Describe DEA schedule III
Has a potential for abuse less than the drugs or substances in schedules I and II. Has a currently accepted medical use in tx in the US. Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence.
Describe DEA schedule IV
Has a low potential for abuse relative to the drugs in schedule III. Has a currently accepted medical use in tx in the US. Abuse of the drug may lead to limited physical dependence relative to the drugs in schedule III.
Describe DEA schedule V
Has a low potential for abuse relative to the drugs or other substances in schedule IV. Has a currently accepted medical use in tx in the US. Abuse of the drug may lead to limited physical dependence.
When lending a scheduled III, IV or V drug to another practitioner, what steps must be taken ?
1.) Transfer the quantity of drug to another registrant.
2.) Obtain a signed receipt/Invoice from the registered veterinarian who received the drug.
3)Store the invoice in your controlled drug record keeping system.
*The receiving veterinarian should keep keep copies of the receipts showing the drug was received from another veterinarian rather than a supplier.
*Drugs can be returned to the veterinarian from who they were borrowed using these same record keeping methods.
When lending a scheduled 2 drug to another veterinarian, what steps must be taken?
Must use the DEA 222 form. Copy 3 of the form stays with the veterinarian who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.
When a veterinarian acquires an existing practice, an initial inventory of controlled substance must be taken. The practitioner transferring the drug should prepare an invoice of all drugs being delivered, what should be on the invoice by both parties?
It should be dated and signed by both the transferor and the receiver and indicate whether it was taken at the beginning of the day or the close of the day.
*Estimated counts for Scheduled III, IV, V are permitted unless the container holds more than 1000 tablets or capsules, then an exact count is needed. (An exact count of all Scheduled II substances is required.)
*These records must be maintained along with all receipts from distributors.
**Every 2 years following the initial inventory date, the registrant must take new inventory of all controlled drugs and maintain the records at the location for 2 years.
What should you do if you have had a loss , spillage, breakage or theft of a controlled substance?
Notify the regional office of the DEA using a DEA form 106. Notify your local police department.
True or False;
A practice cannot employ an individual who has had their DEA application or license revoked or denied if, as a result of their employment , they will have access to controlled drugs.
True.
It is the employees responsibility to report drug diversions like theft by any fellow employees. You 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. Who is responsible for informing all employees about this policy?
Employers.
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 .
However, they cannot without our permission inspect any financial records, sales, and pricing data.
What is required from the DEA representative prior to the inspection taking place?
Inspectors must identify themselves, state their purpose, present their credentials, and the written notice of their authority to inspect with informed consent of the business owner or their representative and if that is not obtained, they can inspect via an administrative warrant.
*The inspection must be at reasonable times and conducted in a responsible manner.
Employees working in a controlled substance environment may be screened and rejected for reasons described by the DEA. What are a couple of pre - employment questions permissible to ask surrounding controlled drugs?
*Within the last 5 years, have you been convicted of a felony/ Or a misdemeanor in the last 2 years/ or a you presently charged?
*In the past 3 years, have you ever knowingly used any narcotics, amphetamines, or barbiturates, other than those prescribed to you by a physician?
What is the Controlled Substance Act (CSA) 1970 ?
It is title II of the Comprehensive Drug Abuse Prevention and Control act both of 1970.
The CSA will have the most relevant information about creating a closed system for the legitimate handling of controlled substances in veterinary medicine.
*Regulates by way of federal registration, all persons involved in the legitimate chain of manufacture, distribution, or dispensing of controlled drugs.
*Was designed to provide a “closed system” for legitimate handlers of controlled drugs and reduce opportunities for controlled drugs entering into the illlicit drug market.
Why must Veterinarians always be aware of their state drug control laws.
*In the event the state drug control regulations are more stringent than the federal law, the STATE regulations will take precedence.
*Practitioners can contact their state boards of examiners or state veterinary associations regarding the individual state requirements
The Controlled Substance Act divides controlled substances into five schedules. What do you know about Schedule I ?
Highest potential for abuse and severe dependence.
Lowest potential for accepted medical use.
Examples include heroin and LSD.
The Controlled Substance Act divides controlled substances into five schedules. What do you know about Schedule II ?
High potential for abuse and severe dependence.
Currently accepted medical use in the United States.
Examples include Morphine and Oxymorphone
The Controlled Substance Act divides controlled substances into five schedules. What do you know about Schedule III ?
*Less potential for abuse than schedules I & II and abuse may lead to low to moderate dependence.
*Currently accepted medical use in the United States.
*Examples include compounds that contain limited quantities of the narcotic drugs such as Tylenol with codeine and Nalline
The Controlled Substance Act divides controlled substances into five schedules. What do you know about Schedule IV ?
Low potential for abuse relative to drugs in schedule III and may lead to limited dependence.
*Currently accepted medical use in the United States.
*Examples include Diazepam and Tramadol.
The Controlled Substance Act divides controlled substances into five schedules. What do you know about Schedule V ?
*Lowest potential for abuse
* Currently accepted medical use in the United States
* Examples include Robitissin A-C and Lomotil
Who has the powers to reschedule a drug, bring an unscheduled drug under control, or remove the controls on a drug?
A section of the controlled substance act states that the Drug Enforcement Agency and the Attorney General have broad powers to reschedule a drug, bring an unscheduled drug under control, or remove the controls on a drug.
Who gives authority to the Food and Drug Administration Center for Veterinary medicine also known as the FDA CVM to govern the manufacturing , distribution and use of veterinary drugs that are distributed between states?
The Food and Drug and Cosmetic Act (or FD&C Act)
True or False:
The FDA is relevant when it comes to reporting adverse events related to FDA approved products?
True.
True or False;
The FDA CVM (Food and Drug Administration - Center for Veterinary medicine) is responsible for regulating animal feed and foods and most animal health products.
True.
What are drugs that contain unsanitary components, lack of adequate control in manufacture, differ in strength from official compendium, or that are mixed with another substance.
**Example - A practitioner takes two or more FDA approved drugs and mixes them in one syringe or bottle. In doing this the drugs have been adulterated and administering such a drug is a violation of the FD&C ACT (Food and Drug and Cosmetic Act).
These are known as adulterated drugs.
_________________ Drugs include drugs in which the labeling is false or misleading, including any drug in a package form that does not bear a label that contains the name and place of business of the manufacture/packer/ distributor, and an accurate statement on quantity.
**Label must include adequate directions for use (defined as directions, by which, a lay person can use a drug safely and for the purpose for which it was intended).
Misbranded Drugs.
________________drugs are used only by or under the supervision of a veterinarian.
*Is in the possession of a person (or agent of) who is regularly and lawfully engaged in the manufacture, transportation, storage or sale of veterinary drugs - or - on the prescription or order of a licensed veterinarian.
*Is in the possession of a licensed veterinarian for use in lawful business.
Prescription/Legend Drugs.
What are the label requirements for prescription drugs?
*The statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
*Recommended dose and route of administration
*Quantity or proportion of each active ingredient
*Names of all inactive ingredients if drug is for non oral use.
*Identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.
What are “Over the counter drugs” -
Drugs that you can purchase in a store. Directions for use can be readily understood and followed by the lay individual. Example…Essential fatty acid products or joint supplements.
Explain “Extra Label Use” -
The use of FDA approved drugs in a manner other than what is approved on the label.
**Think of the many human drugs we use for animals in our profession.
Explain what are “Generic Drugs” -
FDA approved, which requires a demonstration of bioequivalence of safety and efficacy with the original pioneer drug product.
Example - Carprofen vs Rimadyl
Differentiate EXTRA LABEL use of “approved drugs” from the use of “unapproved drugs”.
The key difference between these two is that extra label drugs have been approved by the FDA for at least one purpose but have not been approved for the specific use or for the manner employed by the veterinarian.
Unapproved drugs, on the other hand, are drugs that are not generally recognized as safe and effective by experts and never have been subjected to the FDA approval process.
An unapproved drug is an illegal drug according to the FD&C Act (Food and Drug and Cosmetic Act)
Most often, unapproved drugs are generic copies of drugs that are legally approved and on the market.
Unless the drugs have a __________________, they are illegal under the FD&C Act.
NADA —- A NADA is used to seek approval of a generic new animal drug.
True or False:
All new animal drugs (and copies) must be approved by the FDA to be sold legally?
True.
New animal drugs that are marked without NADAs violate the ____________ Act, and that violation can carry civil and criminal penalties.
FD&C Act (Food and Drug and Cosmetic Act)
What four conditions do most state laws and FDA regulations allow the compounding of drugs for animal use?
1.) The veterinarian believes that there is a need to alter the approved drug to adequately medicated a non-food animal with a diagnosed medical condition.
2.) There is an established Veterinary Client Patient Relationship (VCPR).
3.) The individual patient has a medical condition for which prescribed medication is needed.
4.) The veterinarian determines that a compounded drug is needed for the animal
True or False;
Veterinarians cannot purchase compounded drugs from a pharmacy and then resell that compounded drug to a client.
True. Veterinarians may either compound the drug themselves, or the pharmacy can sell the compounded drug directly to the client via a prescription from the veterinarian.
Adverse drug event reporting - By law, drug companies in the United States must inform the FDA/CVD of any adverse events involving their marketed products. Drug companies typically receive adverse event information from professionals and consumers.
An event can be reported via a phone call to the FDA (1-888-FDA-VETS) or by filling out FDA Form 1932a and mailing it in. What must the report include?
1) The reporter or person familiar with the event who can provide additional information.
2.)Clinical sign or symptom occurring right after product exposure, regardless of perceived causality.
3.) Product name and lot number if available.
4.) Patient, an identifiable animal or human.
Is there a mandatory reporting of adverse events involving unapproved or off label drugs for manufactures?
No - there is no mandatory reporting in place for unapproved or off label drugs. In order to provide data for unapproved product safety profiles, adverse events involving these products should be reported directly to the manufacture or distributor. THIS HELPS BUILD A DATABASE ON NON-FDA APPROVED PRODUCTS FOR PRACTITIONERS’ REFERENCE.
To report an adverse event or defect associated with the use of an Animal Medical Device it is recommended to contact the device manufacturer or report the case directly to the FDA.
What is considered an Animal Medical Device?
An instrument, apparatus, implement, machine, implant, in - vitro reagent, or similar article that is intended for the diagnosis of disease or other conditions, or to cure, mitigate, treat, prevent disease, or affect the structure or any function of the body of humans or animals and that does not achieve its primary intended purposes through chemical action or metabolism.
**Needles, syringes, surgical instruments , prosthetic devices, x-ray equipment, certain diagnostic test kits, and dental appliances are considered medical devices.
