2. What are OTC drugs?
• OTC are medicines that can be bought without
a prescription from the doctor.
100,000 OTC drug products
marketed
800 significant active
ingredients
80 therapeutic categories
3. • Most OTC agents are no more than “me
too “ products.
– drug that is structurally very similar to already
known drugs, with only minor differences.
– less risky to develop.
– approved 'automatically„
– create competition and drive prices down.
– 75 % of all new drugs in the market.
4.
5. • According to Consumer Healthcare Products
Association (CHPA)
– 73% Americans would rather treat themselves at
home than to see a doctor.
• Americans buy more than 5 billion OTC drug
products each year – 60% of drugs used.
6. Advantages of OTC Drugs
• benefits outweigh risks
• low misuse & abuse potential
• consumers are able to
Self diagnose
Self treat
Self manage
• adequately labeled
• health practitioners are not needed.
7. Disadvantages of OTC Drugs
• Reduced opportunities to receive counseling
about possible lifestyle therapies (e.g. exercise &
diet),
• Poorer compliance,
• Misdiagnosis, patients won‟t benefit from the
drug but will be exposed to its risks,
• More difficult to study a drug's effects.
8. The Label
• According to the law, OTC drug labeling must include “all of
the information that an ordinary consumer needs for safe and
effective use.”
• Active ingredient
• Uses "indications"
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions or Comments
10. The Label (Cont.)
• The OTC drugs
– labeling is regulated by FDA
– advertising by Federal Trade Commission (FTC).
• But
• Prescription drugs advertising is strictly
regulated only by FDA.
11. OTC drug regulation
• May 1972, before & after.
• Ingredients fell into three categories.
Category I: GRASE
Category II: not GRASE
Category III: cannot determine if safe
and effective
12. OTC drug regulation
(Cont.)
OTC drug New Drug
monographs "recipe Application (NDA)
book" process
• "recipe book" • new ingredients
• ingredients, doses, • Rx-OTC switch
formulations,
labeling, and testing
• continually updated.
13. OTC regulation in UK
• Medication will fall into one of three
categories:
1) Prescription Only Medication (POM)
2) Pharmacy Only Medication (P), "behind-the-
counter“.
3) General Sales List(GSL).
15. Rx-to-OTC Switch (Cont.)
• The reasons for a drug to become an OTC:
1) Overall risk & potential abuse or dependency.
2) Availability for a larger population early in a disease.
• E.g. Hyperacidity & ulceration.
3) The company‟s way of extending the life of their drug
• By creating reduced strength & reduced price
product.
4) Rx drug cost has increase by 15% per year
• Financial relief.
16.
17. Recall “Tylenol”
• In 2008 McNeil company received complaints of
– an "unusual moldy musty" odor.
– nausea, stomach pain, vomiting and diarrhea.
– "2,4,6-tribromoanisole (TBA)," store packaging materials.
• The FDA has issued a warning letter to McNeil.
• In Jan. 2010 recall took place.
18. Recall (Cont.)
• Another example is phenylpropanolamine (PPA)
– used in some cold and cough remedies.
– ingredients caused serious allergic reactions.
– concern regarding strokes in young women.
19.
20. OTCs & Pregnancy
• Data are lacking.
• Some are known to cause birth defects.
• Estimated 50% of products taken during pregnancy are
OTC medications.
• According to the New England Journal of Medicine, 10-
45 % of pregnant women in 1st trimester, unaware of their
condition, use aspirin.
21. Pregnancy (Cont.)
• Aspirin & salicylate drugs should only be used under
doctor's supervision, especially during last trimester.
• Acetylsalicylate, may
– prolong pregnancy
– cause excessive bleeding before & after delivery.
• READ THE LABEL.
22.
23. OTCs & Driving
• First generation Antihistamines.
• Decongestants- speed up the
CNS.
• Night-time cold and flu
medications.
• READ THE LABEL
24. Examples of OTC drug Categories
Antacids and Acid Reducers
Antiemetic Medicines
Antidiarrheals
Antihistamines
Cough Medicine
Decongestants
Herbal Products and Supplements
Laxatives
Pain Killers
Vitamins
25. Laxatives
• Many products relieve constipation,
– bulk-forming laxatives, lubricants, stool softeners,
saline laxatives, stimulant laxatives and
combination medicines.
• Constipation usually goes away on its own or if
you make changes in diet and other habits
– e.g.. enough fiber, drinking enough fluids and
getting enough exercise.
26.
27. Pain Killers
• Two main types
– acetaminophen “paracetamol”
– NSAIDs include the following:
• Aspirin
• Ibuprofen
• If an OTC medicine doesn‟t help you may
have a more serious problem or need a
prescription medicine.
28.
29. Weight loss OTC drugs
• FDA recently banned 111 ingredients in OTC weight
control products ineffective.
– E.g. alcohol, ascorbic acid (vitamin C), caffeine, several
forms of sugar, phenacetin (a pain reliever), sodium, and
yeast.
• In February 7, 2007- (FDA) approved orlistat
capsules as an OTC.
30. Weight loss OTC drugs (Cont.)
• Orlistat was approved in 1999 as a prescription
drug for obesity
– remains a Rx drug at a higher dose.
• OTC orlistat under the name “Alli” became
available in drugstores June 15, 2007.
31. Weight loss OTC drugs (Cont.)
• Alli is indicated for
– adults ages 18 years & older
– along with a reduced-calorie, low-fat diet
– & exercise program.
• Alli is an OTC lower dose version
of prescription “Xenical”.
32.
33. OTC Drugs References
• Orange Book: The list of Approved Drug
Products with Therapeutic Equivalence
Evaluations.
– Supposed to use in pharmacy all the time in the
US.
• BNF:
– Prescription only Medication. PoM
– Controlled Drug. CD
– Preparations not available for NHS prescription. NHS
34. Misuse & Abuse of OTC drugs
• Pharming “getting high”.
• Common misconception: OTC drugs are
harmless.
• By definition:
– OTC drugs can be used safely and
effectively by reading and following the
directions on the label.
35. Misuse & Abuse (Cont.)
• The labeling is written in easily understood language
“of low comprehension”
• Recent surveys have reported that
– Consumers do not read OTC labels,
– If they do read them, they do not follow the directions on
the labels.
– In one survey, it has been found that only 16% reported
reading the entire product label.
36. Misuse & Abuse (Cont.)
• Abuse is most common in adolescents aged 12-17
years.
• Readily available, no suspicion.
• Alcohol Vs. OTCs
• Adolescents are 18 times more likely to die from an
OTC overdose than from an illicit drug overdose
– Recent data suggests that MDMA (Ecstasy) abuse has
decreased over the past two years. Yet OTC abuse is
increasing.
37. Misuse & Abuse (Cont.)
• Since reporting of this type of abuse is not
mandatory, the true incidence of OTC abuse is
unknown.
• The FDA has responded by trying to create OTC
labels that are easier to read and understand.
– However, there are no warnings against intentional
overuse of the drug to get high.
38. Facts & Numbers
• 36 million Americans use OTC pain drugs daily.
• In 2006, 3.1 million persons aged 12 to 25 had ever used
an OTC cough and cold medication to get high, and
nearly 1 million had done so in the past year.
• 30,000 people in the UK are addicted to OTC drugs.
• Only 39% of OTC drugs are now purchased in a
pharmacy.
– drug stores, supermarkets, gas stations, airports, vending
machines, and mass merchandisers.
39. OTC drugs Abused
DXM
• Antitussives (especially dextromethorphan):
• DXM is found in more than 140 OTC cough and cold
medications in the US .
– Internet sites explain how to extract DXM !!!
• When taken at very high doses, it acts as a
dissociative anesthetic, similar to PCP(angel dust)
– DXM users consume more than 100 mg per dose.
– Tolerance develops; so long-term DXM users may need
more than 1000 mg per dose to create the psychoactive
effect.
40. DXM
• Adverse effects of DXM in large doses:
– Decreased thermal regulation
– Dry mouth and body fluid losses
– Blurred vision, hallucinations & delusions
– Irregular heartbeat, high BP, numbness of fingers or toes,
flushing, headache
– Loss of consciousness
– Death (rarely)
42. Abuse
CNS Stimulants
• Stimulants are found in
– nasal decongestants, bronchodilators, appetite suppressants,
energy pills, and sports supplements.
• Examples: ephedrine, pseudoephedrine, and caffeine
43. Abuse
Ephedrine
• Ephedrine can be converted to methamphetamine
chemically
– Formulas are readily available on the Internet!!!
• In many states, it is illegal to sell single-entity
products containing ephedrine.
• In toxic doses ephedrine causes
– palpitations that sometimes progress to chest pain,
– submyocardial infarction & arrhythmia,
– Paranoia & seizures.
44. • Pseudoephedrine:
– The main nasal decongestant oral cough and cold
products today.
– Abused by sport players.
• Other abused OTC drugs:
– Antidiarrheals (loperamide)
– Antihistamines
– Caffeine
45. Role of the clinician
Help the patient select a safe &
effective product.
Limit the cost of drugs they prescribe.
Review all medications taken by the
patient.
Educate patients, community, friends, &
family about OTC medication .
Encourage people to seek guidance from
their physician or pharmacist.
Editor's Notes
Active ingredient. the chemical compound in the medicine that works to relieve symptoms. There may be more than one active ingredient in a product. The label show the purpose of each active ingredient. To reduce your risk of overdose, be sure to check that you’re not taking two medicines that contain the same ingredient.Uses "indications". This section lists the symptoms the medicine is meant to treat. Warnings. This safety information will tell you: what other medicines, foods or activities (such as driving) to avoidpossible side effectsparticular group of people, such as pregnant women. Directions. how much medicine, how often and for how long it should be taken. The directions may be different for children and adults. Other information. other important information, such as how to store the medicine. Inactive ingredients. is a chemical compound in the medicine that isn't meant to treat a symptom. This can include preservatives, binding agents and food coloring. This section is especially important for people who know they have allergies to food coloring or other chemicals. Questions or Comments. A toll-free number for the manufacturer is provided in case you have any questions or want to share your comments about the medicine.
Before 1972, OTC medications largely escaped federal scrutiny. Manufacturers were not required to institute research to prove their ingredients' safety or efficacy or that the labels were adequate for self-care. On May 11 of that year, the FDA announced in the Federal Register that it would evaluate the safety and efficacy of all OTC products marketed in the United States up until that date that were not covered by new drug applications (NDAs)._ The FDA struggled with the overwhelming task of reviewing the approximately 400,000 OTC products estimated to exist at that time, so the agency established the OTC Review Process. The review process included dividing the OTCs into one of 80 therapeutic categories (e.g., laxative, antidiarrheals, and cough medicines). Because of the large number of drugs under review, the review process was based on ingredients, doses, formulations, and labeling. The task fell to expert panels that deliberated and eventually established a drug monograph for each drug. GRASE : generally recognized as safe & effective
OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and testing. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without FDA pre-approval, while those that do not, must undergo separate review and approval through the New Drug Application2 (NDA) process. The NDA process, and not the monograph process, is also used for new ingredients entering the OTC marketplace for the first time. For example, the newer OTC drug products (previously available only by prescription) are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process.
1) Prescription Only Medication (POM) :only available with a valid prescription from a doctor .2) Pharmacy Only Medication (P), containing chemicals, strengths or sizes which require more information, personal to the person taking the medication. "behind-the-counter“.3) General Sales List(GSL), available off the shelf with no pharmacy training required to sell.
Rx: prescribed drugs
2) Using an effective drug at a lower dose earlier in a condition like the development of an ulcer (hyper-acid production) may prevent more serious conditions down the road and save money.
A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient.
It was later known to be caused by "2,4,6-tribromoanisole (TBA)," which is applied to wooden pallets that are used to transport and store packaging materials.
Benadryl = diphenydramine, a H1 histamine receptor blocker
Data on the effects of OTC medication on fetal development are lacking.
Controlled Drug: preparations that are subject to prescription requirements. The pharmacist is NOT allowed to dispense a CD drug unless all info required by law is given on the prescription such as prescriber signature, date, dose & patient’s name & address. E.g. morphineNHS: preparations included in the BNF that are not prescribable under the NHS. Those prescribable only for specificdisorders have a footnote specifying the condition(s) for which the preparation remains available.OTC drugs : no “PoM”, “CD” or “NHS” or any other signNHS:National Health Service.
Pharming :the practice of getting high by using prescription or OTC drugs in manners for which they were not prescribed or intended.
Abuse of OTCs is most common in adolescents aged 12 to 17 years. Since these drugs are readily available at any corner pharmacy, supermarket, gas station, or convenience store, they can be purchased in large quantities without raising much suspicion. The sale of alcohol to adolescents is not legally permitted, so persons who might otherwise have purchased a case of beer may choose to buy OTCs instead. MDMA: methylene-dioxy-methamphetamine.
