Over The Counter Drugs (OTC)

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Over The Counter Drugs(OTC)

• Dina R. Utter
• MSN Student
• Viterbo University

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Prescription vs. Non Prescription (OTC) Drugs

• Determined by the U.S. Food and Drug
  Administration (FDA).
• FDA also decides when a prescription drug can be
  used as an OTC drug.
• Center for drug evaluation and Research (CDER), a
  branch of FDA oversees OTC drugs and prescription
  drugs.

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OTC Drug History

• 1938 Federal Food Drug Cosmetic Act (FFDCA) drug
  safety requirement.
• 1951 Durham-Humphrey Amendments to Federal Food,
  Drug and Cosmetic Act (FFDCA)
• designated drugs that cannot be used safely
• without professional supervision as prescription
• drugs and all other drugs as OTC.

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OTC Drug History

• 1962 Drug Amendments to FFDCA added
• efficacy requirement. Drug Efficacy Study
  Implementation (DESI) retrospective review of
  efficacy of 1938 - 1962
• New Drug Application (NDA) began in 1966.
• 1972 FDA established OTC drug review procedures
  for classification of all OTC drugs on the
  market.

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OTC Drug History

• In order for an OTC drug active ingredient to be
  included in an OTC monograph it must have been
  marked prior to May 11, 1972.
• Two legal pathways for OTC drug marketing post
  1938.
• Marketing in compliance with drug monograph
• Marketing under the authority of an approved New
  drug application (NDA).
• Any medication proposed for OTC availability
  after May 11, 1972 must undergo the new drug
  application (NDA) process.

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OTC Drug Review Process

• Designed to produce OTC monographs
• (regulatory standards) for marketing of
  nonprescription drug products not covered by NDA
• OTC monographs describe ingredients,
• indications, and labeling requirements for OTC
  products that are recognized as safe and effective

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OTC Drug Review ProcessPhase I

• First Phase Accomplished by advisory review
  panels
• These advisory panels
• Review the ingredients to determine safety and
  effectiveness for self treatment.
• Appropriate labeling including therapeutic
  indications, dosage instructions and warnings
  about side effects and preventing misuse

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OTC drug review Phase I cont.

• Advisory panel Classifies drug ingredients into
  three categories
• Category I safe and effective for the claimed
  therapeutic indication
• Category II not as safe and effective or
  unacceptable indications
• Category III Insufficient data available to
  permit final classification.

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OTC Drug ReviewPhase II

• The agency reviews ingredients in each class of
  drugs based on.
• The panels findings, public comment, and any new
  data that may have become available.
• The agency publishes conclusions in the Federal
  Register in the form of a proposed monograph.
• Time is allotted for objections to the proposal
  or for request for a hearing before the
  commissioner of the FDA.

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OTC Drug ReviewPhase III

• The publication of the final drug monograph.
• The monographs establish conditions under which
  certain OTC drugs are recognized as safe and
  effective.

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OTC Drug Monograph

• Final OTC monograph establishes the acceptable
• active ingredients
• concentration of the active ingredients
• therapeutic claims
• indications
• labeling/warning requirements
• directions for use

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Sample OTC Labeling (Monograph)

• Drug FactsActive ingredient
  
  Purpose
• XXXXXXXXXXXXXX....................................
  .........................................Antifunga
  l
• Uses ? cures most athletes foot (tinea pedis) ?
  relieves itching, burning, cracking, and scaling.
  
• WarningsFor external use only Do not use on
  children under 2 years of age unless directed by
  a doctorWhen using this product do not get into
  eyes. If contact occurs, rinse eyes thoroughly
  with water.Stop use and ask a doctor if
  irritation occurs or if there is no improvement
  within 4 weeks.Keep out of reach of children. In
  case of overdose, get medical help or contact a
  Poison Control Center right away.
• Directions? wash the affected area and dry
  thoroughly. ? apply a thin layer of the product
  over affected area twice daily (morning and
  night) or as directed by a doctor? supervise
  children in the use of this product. ? for
  athletes foot ? pay special attention to
  spaces between the toes wear well-fitting,
  ventilated shoes, and change shoes and socks at
  least once daily.? use daily for 4 weeks. If
  condition persist longer, ask a doctor.? This
  product is not effective on scalp or nails
• Other information XXXXXXXInactive ingredients
  XXXXXXXQuestions or comments? Call
  1-800-XXX-XXXX.

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Prescription to OTC switch

• Examples of OTC switch

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OTC Switch

• Occurs when NDA holder of approved prescription
  drug files NDA or supplement for approval of OTC
  product.
• The NDA holder may gain 3 years of marketing
• exclusivity for OTC conditions of use if
  switch is
• based on
• New clinical investigation(s)
• Conducted or sponsored by the applicant
• Essential to approval

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OTC Switch Candidates

• Acceptable margin of safety based on prior
  prescription
• marketing experience.
• OTC dosages/indications are relatively safe
• low misuse potential
• minimal abuse potential
• reasonable therapeutic window of safety
• Self treatment and monitoring with minimal
  physician
• supervision.
• Adequately labeled to allow safe and effective
  use of the
• OTC drug and benefits from the switch clearly
  outweigh the risks.

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OTC Switch
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Final Thoughts

• Imagine what it would be like if OTC medications
  were not so rigoursly monitored.
• Wouldnt you love to call your primary care
  provider (PCP) every time you had a cold,
  headache or a fever.

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References

• Federal Food and Drug Administration.
  http//www.fda.gov. Retrieved February 22, 2005.
• Rules and regulations. Federal Register, 67 (15).
  Retrieved February 22, 2005, http//www.fda.gov.