Pharm: Controlled drugs
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Questions and Answers

Which law regulates controlled substances in the United States?

  • Food, Drug, and Cosmetic Act
  • Controlled Substances Act (CSA) of 1970 (correct)
  • Veterinary Practice Act
  • Federal Drug Administration Act

Which agency regulates controlled substances under the CSA?

  • Food and Drug Administration (FDA)
  • Drug Enforcement Administration (DEA) (correct)
  • Centers for Disease Control and Prevention (CDC)
  • Department of Agriculture (USDA)

How are controlled substances classified under the CSA?

By their potential for abuse or misuse

Which of the following is true regarding the classification of controlled substances?

<p>The lower the class number, the higher the potential for abuse (B)</p> Signup and view all the answers

What can cause a change in the control level of a drug?

<p>A decision by the DEA if the abuse potential has changed (B)</p> Signup and view all the answers

Which of the following is a general requirement for controlled substances?

<p>They must be stored securely (A)</p> Signup and view all the answers

How often must controlled substances undergo inventory checks at a minimum?

<p>At least biennially (C)</p> Signup and view all the answers

What must veterinarians do to legally purchase, administer, or dispense controlled substances?

<p>Register with the DEA (B)</p> Signup and view all the answers

How do storage and record-keeping requirements for controlled substances vary?

<p>They vary between states and follow the most stringent guidelines (C)</p> Signup and view all the answers

Describe the characteristics of Class 1 controlled drugs.

<p>highest abuse potential, severe liability, no therapeutic agents in the US, DVM are NOT allowed to prescribed or dispensed</p> Signup and view all the answers

What are the two examples of class 1 controlled drugs?

<p>LSD and heroin</p> Signup and view all the answers

Describe the description of a class II controlled drug

<p>High abuse potential, severe liability</p> Signup and view all the answers

What are examples of a class II drugs?

<p>Morphine, codeine and amphetamines</p> Signup and view all the answers

describe what a class 3 controlled drug is.

<p>Abuse potential is less than Class 1 and Class 2 and moderate liability</p> Signup and view all the answers

What are examples of a class 3 drug?

<p>Anabolic steroids and buprenorphine</p> Signup and view all the answers

Describe what a Class IV drug is?

<p>Abuse potential is less than C1, C2 and C3 and moderate liability</p> Signup and view all the answers

What are examples of Class 4 drugs?

<p>Butorphanol and diazepam</p> Signup and view all the answers

Describe the class 5 drug

<p>Least abuse potential and limited liability</p> Signup and view all the answers

Under what condition is the use of opioids permitted in food-producing animals?

<p>If an adequate withdrawal interval can be determined (B)</p> Signup and view all the answers

Which act allows the use of opioids in food-producing animals under specific conditions?

<p>Animal Medicinal Drug Use Clarification Act (AMDUCA) (C)</p> Signup and view all the answers

What resource should be consulted to determine the most current withdrawal interval recommendations for opioid use in food-producing animals?

<p>Food Animal Residue Avoidance Databank (FARAD) (D)</p> Signup and view all the answers

What schedule classification does tramadol fall under as a controlled drug?

<p>Schedule IV</p> Signup and view all the answers

Is tramadol currently FDA-approved as a veterinary medication?

<p>No, it is not FDA-approved as a veterinary medication (C)</p> Signup and view all the answers

Where would you NOT find tramadol listed as a veterinary-approved medication?

<p>Both A and C (D)</p> Signup and view all the answers

Under the Animal Medicinal Drug Use Clarification Act (AMDUCA), the FDA can prohibit the use of an entire class of drugs in selected animal species if:

<p>An acceptable analytical method has not or cannot be established (B)</p> Signup and view all the answers

What is another reason the FDA may prohibit the extra-label use of a drug or drug class?

<p>If its extra-label use presents a public health risk (B)</p> Signup and view all the answers

Can the FDA restrict extra-label drug use only for specific species, indications, or routes of administration?

<p>Yes, the FDA can limit the prohibition to certain species, indications, dosage forms, or routes of administration (D)</p> Signup and view all the answers

What should happen if a prohibited drug is mistakenly used in a food animal?

<p>The animal and its by-products should never enter the human food chain (A)</p> Signup and view all the answers

What does current law say about compounding animal drugs from bulk drug substances?

<p>It is not permitted, but FDA allows limited exceptions (C)</p> Signup and view all the answers

Which FDA guidance document outlines conditions where the agency does not intend to take action against compounding drugs from bulk substances for animals?

<p>GFI #230 (B)</p> Signup and view all the answers

Match the groups to its correct description

<p>Group 1 = Drugs with no Allowable extra label uses in any food producing animal species Group 2 = Drug classes with prohibited ELDU or with restricted ELDU in food producing animal species Group 3 = Drugs with special restrictions for Grade “A” Dairy Operations Free bee = Free Bee</p> Signup and view all the answers

What are the group 1 drugs?

<p>Chloramphenicol, clenbuterol, diethylstilbesterol, fluroquinolone-class antibiotics, glycopeptides (including vancomycin), medicated feeds, nitromidazoles and nitrofurans</p> Signup and view all the answers

What are the group 2 dugs?

<p>Adamantane and Neuraminidase inhibitors, cephalosporins, gentian violet, indexed drugs, phenylbutazone and sulfonamide class antibiotics</p> Signup and view all the answers

Which animals are included in the prohibition of extra-label use for Group I drugs?

<p>All food-producing animals, including horses intended for human consumption (B)</p> Signup and view all the answers

Why is chloramphenicol prohibited in food-producing animals?

<p>It can cause fatal aplastic anemia in humans exposed to residues</p> Signup and view all the answers

Which drug is a synthetic member of the chloramphenicol family that lacks the para-nitro group and is approved for use in pigs and cattle?

<p>Florfenicol (B)</p> Signup and view all the answers

What is true about thiamphenicol?

<p>It is not approved for use in the United States (C)</p> Signup and view all the answers

Florfenicol is effective for treatment of bovine and swine _____ disease

<p>Respiratory</p> Signup and view all the answers

What are the restrictions for florfenicol treatment?

<p>Do not administer to dairy cows older than 20 months, Don’t administer to veal calves, Don’t administer to calves under 1 month of age, Don’t administer to calves on all milk diet</p> Signup and view all the answers

What is the FDA-approved use of clenbuterol?

<p>Treatment of airway constriction in horses (C)</p> Signup and view all the answers

Why is clenbuterol illegal for use in food-producing animals?

<p>It poses a health risk to humans through food residues (B)</p> Signup and view all the answers

Clenbuterol residues in food products are particularly dangerous for which group(s) of people?

<p>Pregnant women and people with heart conditions (D)</p> Signup and view all the answers

What has the TFDA established regarding clenbuterol residues in food products?

<p>A &quot;zero tolerance&quot; policy (C)</p> Signup and view all the answers

Why is cooking ineffective in removing clenbuterol residues from food?

<p>The compound is highly resistant to heat degradation (A)</p> Signup and view all the answers

What was diethylstilbestrol (DES) originally prescribed for?

<p>Prevention of miscarriage in pregnant women (B)</p> Signup and view all the answers

What reproductive effects were observed in female offspring of DES-treated patients?

<p>Development of reproductive tract abnormalities and tumors (B)</p> Signup and view all the answers

What reproductive issues were detected in male and female offspring of DES-treated patients?

<p>Subfertility and infertility (A)</p> Signup and view all the answers

Why was DES used in food animal production?

<p>To promote growth (B)</p> Signup and view all the answers

DES use in food producing species has been prohibited although it is still marketed in the U.S.

<p>False (B)</p> Signup and view all the answers

What was the first group of antimicrobials prohibited from extra-label use by the FDA?

<p>Fluoroquinolones (C)</p> Signup and view all the answers

Why was the use of fluoroquinolones restricted in poultry?

<p>They were linked to an increase in fluoroquinolone-resistant Campylobacter spp. in humans (C)</p> Signup and view all the answers

In which food-producing animals is the use of enrofloxacin still legal?

<p>Beef cattle and calves (excluding veal calves) (B)</p> Signup and view all the answers

What change was made to the label of enrofloxacin?

<p>It was expanded to include nonlactating dairy cattle and swine (C)</p> Signup and view all the answers

What is required when using enrofloxacin and danofloxacin?

<p>They must be used strictly according to label directions, any deviation from the label directions is prohibited (A)</p> Signup and view all the answers

What was the primary use of nitroimidazoles in turkeys?

<p>Treating histomoniasis (B)</p> Signup and view all the answers

Why was the use of nitroimidazoles prohibited in food animals?

<p>They were linked to mutagenicity and carcinogenicity in cattle (C)</p> Signup and view all the answers

Which of the following nitroimidazole drugs has been linked to in vivo and in vitro potential carcinogenesis?

<p>All the above (D)</p> Signup and view all the answers

What was nitroimidazoles' recommended use in bulls before being prohibited?

<p>Treatment of trichomoniasis (C)</p> Signup and view all the answers

What is the current legal status of nitroimidazoles in food animals?

<p>The use of any member of this drug class is illegal in food animals (C)</p> Signup and view all the answers

What were nitrofurans originally approved to treat in poultry and swine?

<p>Protozoal and bacterial infections (B)</p> Signup and view all the answers

Why were systemic nitrofuran products banned from use in food-producing species in 1991?

<p>They caused carcinogenic effects in laboratory animals (C)</p> Signup and view all the answers

For what conditions were topical nitrofuran products still available for food animals after the 1991 ban?

<p>Surface wounds and infectious keratoconjunctivitis (pink eye) (B)</p> Signup and view all the answers

What led to the complete prohibition of nitrofurans in food animals in 2002?

<p>Reports of systemic absorption and residue detection in meat and milk (B)</p> Signup and view all the answers

What is the current legal status of nitrofurans in food animals?

<p>All members of this drug class are illegal in food animals (C)</p> Signup and view all the answers

Which is the only glycopeptide used in veterinary medicine?

<p>Vancomycin</p> Signup and view all the answers

Why has vancomycin use been necessary in veterinary medicine?

<p>To treat resistant enterococcal or staphylococcal infections (B)</p> Signup and view all the answers

What concern has been linked to glycopeptide use in poultry and swine?

<p>Development of Enterococcus spp. resistant to vancomycin (A)</p> Signup and view all the answers

Vancomycin is considered a last-resort treatment for which type of infection?

<p>MRSA infections</p> Signup and view all the answers

What is the legal status of vancomycin in food animals?

<p>Completely prohibited due to the lack of approved veterinary products (C)</p> Signup and view all the answers

Why are antiviral drugs used in poultry in some countries outside the United States?

<p>To treat or prevent avian influenza (D)</p> Signup and view all the answers

What is the legal status of antiviral drugs for poultry in the United States?

<p>None of these drugs are labeled for animal use (C)</p> Signup and view all the answers

The prohibition of antiviral drugs in poultry in the U.S. extends to which species?

<p>Chickens, turkeys, and ducks (A)</p> Signup and view all the answers

How do adamantane antiviral drugs work?

<p>They inhibit viral replication</p> Signup and view all the answers

Why is extra-label use of cephalosporins prohibited in food-producing animals?

<p>To preserve their efficacy for humans and prevent resistance (B)</p> Signup and view all the answers

Which zoonotic foodborne pathogen is of particular concern regarding cephalosporin resistance?

<p>Salmonella spp. (B)</p> Signup and view all the answers

In which food-producing animals are cephalosporins legally marketed for use?

<p>Cattle, sheep, dairy goats, and swine (A)</p> Signup and view all the answers

What formulations of cephalosporins are available for use in livestock?

<p>Injectable formulations and intramammary preparations (A)</p> Signup and view all the answers

Why is ceftiofur of particular concern, despite not being used in human medicine?

<p>There is concern about the movement of foodborne bacteria between animals and humans and cross-resistance (C)</p> Signup and view all the answers

What is the general rule regarding the extra-label use (ELDU) of indexed drugs in food-producing animals?

<p>It is strictly prohibited (B)</p> Signup and view all the answers

What is the exception to the prohibition of indexed drug use in food-producing animals?

<p>Their use is allowed in minor-use animal species that are not used as food for humans or other animals (A)</p> Signup and view all the answers

What was the original purpose of adding gentian violet to poultry feed?

<p>To promote growth by increasing dietary absorption of methionine and glucose (B)</p> Signup and view all the answers

How did gentian violet help prevent growth retardation in poultry?

<p>By inhibiting mold growth and reducing aflatoxin exposure (B)</p> Signup and view all the answers

What is the FDA’s stance on the use of gentian violet in food animals?

<p>It was never approved for use in food animals (C)</p> Signup and view all the answers

Why is gentian violet no longer permitted for use in poultry feed?

<p>The impact of its residues on human health has not been fully assessed (C)</p> Signup and view all the answers

What are some alternatives to gentian violet as a mold inhibitor?

<p>Propionic acid and other organic acids (A)</p> Signup and view all the answers

Phenylbutazone in humans can induce ______ disorders like _____

<p>Phenylbutazone in humans can induce blood disorders like aplastic anemia</p> Signup and view all the answers

The use of Phenylbutazone has been prohibited in female dairy cattle older than :

<p>20 months of age (C)</p> Signup and view all the answers

What NSAID is used for lactating dairy cattle instead of Phyynylbutazone?

<p>Flung in meglumine</p> Signup and view all the answers

Flunixin meglumine should only be used IV excluding veal calves and swine

<p>True (A)</p> Signup and view all the answers

Why are sulfonamides generally prohibited in adult dairy cattle?

<p>They have been observed to cause cancer in laboratory animals. (A)</p> Signup and view all the answers

Which of the following statements accurately describes the legal use of sulfadimethoxine and sulfaethoxypyridazine in adult dairy cattle?

<p>Their use is permitted strictly according to label instructions, but extra-label drug use (ELDU) is prohibited. (B)</p> Signup and view all the answers

What is the primary concern regarding the use of sulfonamides in sheep and goats?

<p>They can result in drug residues in milk, despite not being expressly prohibited. (B)</p> Signup and view all the answers

Which factor is most critical in determining the legality of sulfonamide usage in adult dairy cattle?

<p>The specific type of sulfonamide used; only sulfadimethoxine and sulfaethoxypyridazine are conditionally permitted. (A)</p> Signup and view all the answers

Why did the FDA withdraw approval of metamizole (dipyrone) for human products?

<p>Concerns over prolonged bleeding time and agranulocytosis. (B)</p> Signup and view all the answers

In what animal species and for what purpose has the FDA approved dipyrone injection?

<p>Horses, but not for animals intended for human consumption. (C)</p> Signup and view all the answers

Which of the following animals is dipyrone specifically prohibited from being used in?

<p>Lactating dairy animals (D)</p> Signup and view all the answers

What is the primary concern regarding the use of colloidal silver in animals?

<p>The possibility of delaying appropriate treatment for serious illnesses. (D)</p> Signup and view all the answers

Why is the use or storage of dimethyl sulfoxide (DMSO) and colloidal silver prohibited on dairy operations involving lactating dairy cattle?

<p>They pose a potential risk of contamination in the milk supply. (D)</p> Signup and view all the answers

What is argyria, and which substance is it associated with?

<p>A permanent skin discoloration caused by silver accumulation. (D)</p> Signup and view all the answers

While DMSO gel is suggested for reducing acute swelling due to trauma, what is a significant health concern associated with its use?

<p>Potential for inducing carcinogenic diseases with prolonged or repeated exposure. (D)</p> Signup and view all the answers

Flashcards

Controlled Substances Act (CSA)

Regulates controlled substances in the United States.

Drug Enforcement Administration (DEA)

Regulates controlled substances under the CSA.

Potential for abuse or misuse

Controlled substances are classified by this under the CSA.

Higher

Lower class number means its abuse potential is this.

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Change in abuse potential

This can cause the DEA to change a drug's control level.

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Securely

They must be stored this way.

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Biennially

Controlled substances must have inventory checks at least this often.

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Register with the DEA

Veterinarians must do this with the DEA to handle controlled substances legally.

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Vary between states

Storage and record-keeping requirements for controlled substances do this.

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Class 1 Controlled Drugs

Highest abuse potential, not for US therapeutic use. DVM can't prescribe.

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Examples of Class 1 drugs

LSD and heroin

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Class II Controlled Drug

High abuse potential, severe liability.

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Examples of Class II drugs

Morphine, codeine, and amphetamines

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Class III Controlled Drug

Abuse potential less than Class 1 and 2, moderate liability.

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Examples of Class III drugs

Anabolic steroids and buprenorphine.

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Class IV Drug

Abuse potential less than C1, C2 and C3 and moderate liability

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Examples of Class IV drugs

Butorphanol and diazepam

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Sulfonamides

A group of drugs banned in adult dairy cattle due to observed carcinogenicity in lab animals.

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Sulfonamide ELDU in Dairy Cattle

Sulfadimethoxine and sulfaethoxypyridazine are permitted for labeled use but extra-label drug use (ELDU) is prohibited.

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Prohibited Sulfonamide Use

Using any sulfonamide besides sulfadimethoxine and sulfaethoxypyridazine in adult dairy cows.

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Sulfonamide Use in Sheep/Goats

Use is discouraged due to concerns about drug residues in milk.

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Definition of Adult Dairy Cattle

Adult dairy cattle include any dairy cattle older than 20 months of age, regardless of milking status.

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Dipyrone's Human Use

A drug with human use concerns due to bleeding time and agranulocytosis risks; FDA approval removed for human products.

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Metamizole FDA Status

FDA approval was removed for human products containing metamizole due to safety concerns.

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Dipyrone Use in Horses

FDA approved dipyrone injection for horses in 2019, but not for food-producing animals.

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Dipyrone Restrictions

Dipyrone is not approved for animals intended for human consumption or food-producing animals, including lactating dairy animals.

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Dipyrone Safety Concerns

Prolonged bleeding time and agranulocytosis were the teratogenic concerns for human use of Dipyrone.

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DMSO (Dimethyl sulfoxide)

Topical gel to reduce acute swelling due to trauma.

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Argyria

A potential side effect from human consumption of silver resulting in permanent ashen-gray or blue discoloration of the skin and organs.

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DMSO/Colloidal Silver - Dairy Ban

Not for use or storage on dairy operations or feeding to lactating dairy cattle.

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Colloidal silver concerns

Using these products to treat a serious illness in animals (including pets) could potentially endanger the health of the animal by delaying timely, appropriate treatment.

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Colloidal silver side effects

Consumption may result in argyria (permanent ashen-gray or blue discoloration of the skin, conjunctiva, and internal organs)

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Study Notes

  • Sulfonamides are banned in adult dairy cattle, defined as any dairy cattle older than 20 months, regardless of milking status.
  • Sulfonamides have demonstrated carcinogenicity in lab animals

Sulfadimethoxine and Sulfaethoxypyridazine

  • Sulfadimethoxine and sulfaethoxypyridazine are currently labeled for use in adult dairy cattle.
  • Using sulfadimethoxine and sulfaethoxypyridazine according to the label is permitted.
  • Extra-label drug use (ELDU) of sulfadimethoxine and sulfaethoxypyridazine is prohibited.
  • Using any other sulfonamide in an adult dairy cow is a violation.

Sheep and Goats

  • Sulfonamide use is discouraged in sheep or goats due to potential milk residues, despite not being expressly prohibited.

Dypirone

  • Concerns exist regarding human use of dypirone due to potential teratogenic effects, prolonged bleeding time, and agranulocytosis.
  • The FDA removed approval of metamizole for human products.
  • In 2019, the FDA approved dypirone injection for use in horses.
  • Dypirone is not approved for animals intended for human consumption.
  • Dypirone is not approved for food-producing animals, including lactating dairy animals.

Dimethyl Sulfoxide and Colloidal Silver

  • Dimethyl sulfoxide and colloidal silver are not to be used or stored on dairy operations or fed to lactating dairy cattle.

Dimethyl Sulfoxide (DMSO)

  • Dimethyl sulfoxide gel is recommended as a topical application to reduce acute swelling due to trauma.
  • It raises concerns about carcinogenic diseases.

Colloidal Silver

  • Human consumption of silver may result in argyria (permanent ashen-gray or blue discoloration of the skin, conjunctiva, and internal organs).
  • Colloidal silver use to treat a serious illness in animals may endanger the animal's health by delaying timely, appropriate treatment.

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