Over The Counter OTC

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Over The Counter (OTC) Prescription Drugs

• Chap 15

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OTC Drugs

• Each year over 4 billion is spent on OTC
  products.
• Most are very effective for mild/moderate relief
• OTCs are poorly understood by the public
• Herbal medicines are generally exempt from FDA
  regulation

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OTC Drugs

• Each year over 14 billion is spent on OTC
  products.
• Over 300,000 different OTC products are available
  for any aliment you may have.

4
OTCs

• Make up of the annual drug purchases in this
  country.
• Estimated that 3 out of 4 people self-medicate
  with these drug products.

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• OTC drugs are nonprescription drugs that can be
  bought and used without physician/health
  professional supervision.
• OTCs can be dangerous when not used as
  recommended or combined with other drugs.

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OTCs

• Most are very effective for mild/moderate relief
  from uncomplicated health problems.
• But some have questionable therapeutic value.

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Abuse of OTC Drugs

• Herbal medicines are generally exempt from FDA
  regulation and are available as OTC products.
• have the ability to be extremely dangerous and
  should be taken with caution

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Abuse of OTC Drugs

• Because OTC drugs are available on demand they
  are perceived as being exceptionally safe.
• OTCs are poorly understood by the public and
  their abuse pattern is different from the hard
  core drugs.

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Abuse of OTC Drugs

• However, they can be just as harmful when
  misused.
• Even though their margin of safety is greater
  than Rx drugs, there is still a safety issue.

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• Many OTC drugs can cause physical and
  psychological dependence.
• Those that can be severely habit-forming include
• nasal and ophthalmic (eye) decongestants
• Laxatives
• Antihistamines
• sleep aids
• antacids.

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• OTCs that are of major concern are stimulants
  like , which can be severely toxic or can be
  used to synthesize dangerous amphetamines.

ephedrine
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• Its impossible to determine abuse patterns
  because sales of OTC products are unrestricted.
• These products are more likely to be abused by
  the general public because someone inadvertently
  becomes dependent due to excessive
  self-medication. ???

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Federal Regulation of OTC Drugs

• The FDA is responsible for regulating OTC drugs
  in the US.
• Active ingredients in OTC drugs are evaluated and
  classified according to their effectiveness and
  safety.
• Most principal ingredients in nonprescription
  drugs are category I
• considered safe and effective

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• FDA is trying to make more drugs available to the
  public by switching some frequently used and safe
  Rx medications to OTC status.
• This is in response to the publics demand to
  have access to effective drugs for
  self-medication. ???

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• This has helped to cut medical costs by
  eliminating the need for costly doctor visits.
• Notable drugs that have gained OTC status
• naprosyn (Aleve)
• ketoprofen (Orudis)
• diphenhydramine (Benadry)
• hydrocortisone (Cortaid)
• lperamide (Imodium)
• cimetidine (Tagamet)

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• Concern of health professionals is the overuse or
  misuse of these drugs.
• People self-medicate when they need to be seeking
  medical care for a potentially serious situation.
• Also an increased risk of dangerous interactions
  from taking multiple drugs at one time.

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OTC Drugs and Self-Care

• Over a 1/3 of time people treat their routine
  health problems with OTC medications to relieve
  symptoms from their illness.
• We are very open to self-care.

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• Proper self-care assumes that the individual has
  made a correct diagnosis of the health problem
  and is informed enough to select the correct OTC
  drug.

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• If used correctly, these drugs can provided
  relief form minor ailments at minimal cost.
• Misuse occurs when people do not know what OTCs
  can and cannot do, and their potential side
  effects.
• It is very important that those using OTCs be
  fully aware of their proper use.

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OTC Labels

• FDA requires information about proper use of OTC
  products to be cited on the label.
• Required label information includes
• approved uses of product
• detailed instructions on safe and effective use
• cautions or warnings to those at greatest risk
  when taking the medication

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• People experience negative side effects because
  they ignore or do not read the warnings on the
  labels.
• Some people unknowingly become addicted to OTC
  and experience withdrawal symptoms when they stop
  using the product.

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Rules for Proper OTC Drug Use

• Always know what your are taking
• know active ingredients
• Know the effects
• know potential desired and undesired effects of
  the active ingredients

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• Read and heed warnings and cautions
• warnings are not intended to scare but to protect
• Dont use anything for more than 1 to 2 weeks
• if a problems lasts longer than a week seek
  medical advice

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• Be particularly cautious if also taking
  prescription drugs
• serious interactions can occur
• If you have questions, ask a pharmacist
• they have up-to-date knowledge on OTC products
  and can assist in selecting proper medication
• If you dont need it, dont use it.

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Common OTCs

• Internal Analgesics
• The largest sales category of OTC drugs in the
  US.
• Most of the money is for salicylates (aspirin
  products--Bayer, Anacin), acetaminophen (Tylenol,
  Pamprin, etc), ibuprofen (Advil, Nuprin), and
  ibuprofen-like drugs (Alleve) and ketoprofen
  (Orudis).

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• Internal Analgesics
• effective in treating several common ailments
• relieve mild to moderate somatic pain associated
  with musculoskeletal structures such as bones,
  skin, teeth, joints, and ligaments

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• Internal analgesics
• used for treating headaches, toothaches,
  earaches, muscle strains
• not effective in treating severe pain or pain
  associated with internal organs (heart, stomach,
  intestines)

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• Internal Analgesics
• High doses (2 to 3 times the analgesic dose) of
  salicylates and ibuprofen relieves inflammation
  associated with arthritis.
• But even at high doses, acetaminophen has little
  anti-inflammatory action.

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• Internal Analgesics
• Antipyretic Effect
• aspirin and acetaminophen reduce fever but does
  not alter normal body temp? called antipyretics
• use of these drugs to reduce fever is very
  controversial ??? ?

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• interfering with fever may hamper the bodys
  ability to rid itself of infection-causing
  microorganisms
• because no serious problems are associated with
  fevers below 102o, they are probably better left
  alone

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• Internal Analgesics
• Side Effects
• Salicylates (asprin) are frequently used, but can
  cause problems for children and adults
• Common side effects -- GI irritation, interferes
  with blood clotting, can cause ringing of the
  ears and Reyes syndrome

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• Because of side effects salicylates are not
  recommended for
• children
• people with GI problems (ulcers)
• those with bleeding problems
• those scheduled for surgery or near term in
  pregnancy

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• Side Effects of
• Acetaminophen
• Liver
• High acute doses or chronic exposure can cause
  severe damage

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• Ibuprofen
• Gastrointestinal
• irritation, bleeding , aggravation of ulcers
  (less severe than salicylates)
• Blood
• interference with clotting (less severe than
  salicylates)

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• Ibuprofen
• Kidneys
• damage in elderly or those with existing kidney
  disease

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Caffeine and Other Additives

• Several OTC analgesics contain caffeine
• evidence supports that caffeine relieves some
  types of pain
• may also relieve the perception of pain due to
  stimulant effect
• combination of caffeine with OTC analgesics may
  enhance pain relief and may be very useful in
  treating vascular headaches

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Cold, Allergy, and Cough Remedies
Common cold

• is single most expensive ailment in
  the U.S.
• More time is lost from work and school from
  common cold than all other elements combined.

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• Common cold has 2 stages
• Stage 1throat and nose are dry and scratchy
• Stage 2 secretions accumulate in air passages,
  nose , throat, and bronchial tubes

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Decongestants

• Cold and allergy products we use are formulated
  with drugs such as decongestants, antihistamines,
  analgesics, and other vitamins and minerals.

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• Antihistamines
• reduce congestion caused by allergies but their
  use for virus-induced colds is controversial

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• Antihistamines may also cause
• dizziness
• drowsiness
• impaired judgement
• constipation
• dry mouth

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• Because of their limited usefulness and side
  effects, decongestant products without
  antihistamines are usually preferred for viral
  infections.
• However, antihistamines are very effective in
  relieving allergy-related congestion and symptoms.

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• Decongestant (sympathomimetic) drugs cause nasal
  membranes to shrink because of their
  vasoconstrictive effect.
• Reduce congestion caused by colds and allergies.

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• Can be used in spray, drops, or oral form.
• FDA-approved sympathomimetics include
• pseudoephredrine, phenylpropanolamine,
  phenylephrine, naphazoline, oxymetazoline, and
  xylometrazoline

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• Use of nasal sprays frequently causes congestion
  rebound due to tissue dependence.
• This is withdrawal from excessive use of a
  decongestant resulting in congestion.
• Can be prevented by using nasal sprays sparingly
  and for no longer than the recommended time.

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• Orally ingested sympathomimetic drugs give less
  relief form congestion than topical medications
  but doesnt cause rebound effects.
• However, these drugs may cause cardiovascular
  problems.
• Heart arrhythmia, increased blood pressure, and
  stroke

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Antitussives

• Used to treat symptoms of coughing from common
  cold.
• Coughing helps clear the lower respiratory tract
  of foreign matter.

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• Two types of cough
• Productive --helps remove foreign matter so that
  breathing is made easier
• Nonproducitve --dry cough that causes sore throat
  and irritation

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• Cough suppressants can be used to treat
  nonproductive (dry) cough, but should not be used
  to suppress productive coughs.

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• Two kinds of OTCs available to treat coughing
• Antitussives -- codeine, dextromethorphan, and
  diphenhydramine (antihistamine) act on the CNS to
  raise the threshold of cough-coordinating center
  --decreases coughing

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• Expectorants --guaifenesin and terpin hydrate,
  theoretically increase and thin the fluids of the
  respiratory tract
• Dont appear to be very effective.

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• Commonly used OTC Antitussives
• Cheracol plus
• Cheracol D
• Novahistine DMX
• Robitussin CF
• Vicks NyQuil

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Antacids and Anti-Heartburn Medication

• Estimated that as much as 50 of US population
  has had one or more gastritis attacks.
• referred to as acid indigestion, heartburn, upset
  stomach, and sour or acid stomach
• often due to acid rebound occurring one to two
  hours after eating

• Inflammation or irritation of the gut

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• After stomach contents have emptied, the gastric
  acids that are left irritate or damage the lining
  of the empty stomach.
• Heartburn, or gastroesophegeal reflux occurs
  after lower esophagus is exposed to irritating
  gastric chemicals.

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• Severe cases of acid indigestion may progress to
  peptic ulcer disease.
• This situation is serious, but can be treated
  with antacids combined with other OTC or Rx
  drugs.

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• Drugs used to treat peptic ulcers and chronic
  acid indigestion
• cimetidine --Tagament
• ranitidine -- Zantac
• famotidine -- Pepcid

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• Someone experiencing sever stomach pain, chronic
  gastritis, blood in the stool, diarrhea, or
  vomiting should see physician immediately and
  should not try to self-medicate.

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• Most bouts of acid rebound are caused by
  overeating or consuming irritating foods or
  drinks.
• Usually effectively treated with OTC medications
  such as sodium bicarbonate, calcium carbonate,
  aluminum salts, and magnesium salts.

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• In general, OTC antacids are safe for occasional
  use at low recommended doses, but excessive use
  can cause serious problems.

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• These drugs can interact with other drugs and
  affect gastrointestinal absorption or renal
  elimination of other medications.
• Example these drugs inhibit the absorption of
  tetracycline antibiotics and should not be taken
  together.

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FINAL EXAM

• TBA