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Chapter 14. Prescription Drugs, Over-the-Counter Drugs, and Dietary Supplements. Categories of Medicinal Products . Three categories of medicinal substances are available for purchase: prescription drugs over-the-counter (OTC) drugs dietary supplements. Categories of Medicinal Products . - PowerPoint PPT Presentation
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Chapter 14
Prescription Drugs,Over-the-Counter Drugs,and Dietary Supplements
Categories ofMedicinal Products
Three categories of medicinal substances are available for purchase:
•prescription drugs•over-the-counter (OTC) drugs•dietary supplements
Categories ofMedicinal Products
The U.S. Food and Drug Administration (FDA) sets standards of safety, effectiveness, and honesty in labeling for prescription drugs and OTC drugs.
Dietary supplements are not regulated as drugs.
Cosmetics are also regulated by the FDA.“articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance"
What is a drug?Drug: A chemical substance which, when taken intothe body, alters the structure or functioning of the body in some way.
Problems with this definition?
…excluding those nutrients considered to be related to normal functioning. (whether the substance in question has been intended to be used primarily as a way of inducing abodily or psychological change; p. 5)
Is toothpaste a drug?
Is deodorant a drug?
Is shampoo a drug?
Is skin moisturizer a drug?
Scents—Drugs or Not?(does it make sense?)
Perfumes?
Aromatherapy?
Room deodorizers?
How the Regulation of Prescription and OTC Drugs Began
No regulation prior to 1906; “snake oil” salesmen abounded
1906 Pure Food and Drug Actensured purity and consistency of drugsactive ingredients must be identified on label
1938 Food Drug and Cosmetic Actingredients in drugs and cosmetics must be proven safebasis of modern food and drug regulations
1962 Kefauver-Harris Amendmentdrug must be proven safe and effective
_________is the basis for all present-day U.S. food and drug laws.
A. The Pure Food and Drug Act of 1906B. The Dietary Health and Education Act of 1994C. The Federal Food, Drug, and Cosmetic Act of 1938D. The Kefauver-Harris Amendment of 1962E. The Dietary Supplement Health and Education Act
of 1994
Procedures for Approving Prescription and OTC Drugs
1. animal studiesdetermine safety limits and relative toxicity
2. clinical trialsa. healthy human volunteersPhase 1: establish drug safety b. patientsPhase 2: establish effectiveness for therapeutic usePhase 3: identify optimal doses and dosing regimen;
identify side effects
LD 50,birth defects
long-term toxicity
safety
therapeutic effectiveness
dosing regimen,side effects,usage—final tweaking
(or more)
A serious problem in the development and testing of many drugs is that interactions with other drugs are not tested and may be unpredictable.There may also be unanticipated long-term effects.
Patent clock begins to run Marketing of drug
In Phase 1 clinical trials, __________.A. certain pharmacological questions are answeredB. clinical samples are not involvedC. safe dosage levels are determinedD. drug effectiveness is not consideredE. all of the above
Procedures for Approving Prescription Drugs
Very few new compounds are eventually approved by the FDA for marketing as new prescription drugs.
The process often takes several years.
Patent clock (20 years) begins to run when Phase 1 clinical trials begin.
drug companies must recover research costs
may introduce “new” drugs with minor differences to obtain a new patent (e.g. time-release version)
may obtain approval to market drug OTC (e.g. Tylenol, Benadryl, Claritin)
Table 14.2
Procedures for Approving OTC Drugs
Since 1962, all OTC drugs have been required by the FDA to be Generally Recognized As
Safe (GRAS)Effective (GRAE)Honestly Labeled (GRAHL)
Approval of OTC drugs must follow the NDA process or, more commonly, conform to existing drug monographs.
Table 14.3
Are FDA-ApprovedDrugs Safe?
Prescription and OTC drugs are FDA-approved for use when taken in the recommended dosages and under the recommended circumstances, their misuse can result in medical emergencies and fatalities.Prescription drug misuse, whether intentional or unintentional (prescription errors), is a growing public health problem as the number of available medications increases.
There have been several recent instances of drugs with similar names being incorrectly dispensed
Are FDA-ApprovedDrugs Safe?
ER visits involving prescription drugs far fewer than those involving illegal drugs
Prescription drugs are often the choice for suicide attempts
Most ER visits involving prescription drugs are for polydrug use, usually alcohol (e.g. benzodiazepines and other depressants; OxyContin and other opiates)
Doctor-shopping, lax medical oversight of multiple-prescription users (often the elderly)
Which of the following best characterizes the FDA’s approach to approving drugs for the market?
A. speedB. empathyC. caution (safety)D. need for the drugE. likely profitability of the drug
Major OTC Analgesic Drugs
OTC analgesic drugs
acetylsalicylic acid (aspirin),
acetaminophen (e.g. Tylenol)
ibuprofen (e.g. Advil, Motrin)
naproxen (e.g. Aleve)
Major OTC Analgesic Drugs aspirin, ibuprofen and naproxen are anti-inflammatory (non-steroidal anti-inflammatory drugs; NSAIDs)
acetaminophen is not anti-inflammatory
aspirin and acetaminophen are both anti-pyretic (fever-reducing)
long duration of effect makes naproxen effect for relief of menstrual cramps
NSAIDs may interact with, and reduce the effectiveness of, SSRI antidepressants.
Major OTC Analgesic Drugs
Hazards include: aspirin: gastrointestinal irritation, bleeding acetaminophen: bleeding, liver and kidney damage
especially troublesome with alcohol consumptionpotentially lethal
ibuprofen: kidney damage or failure
naproxen: gastrointestinal irritation
Analgesic Anti-Inflammatory
Anti-pyretic
Acetylsalicylic Acid(aspirin)
Acetaminophen(Tylenol)
Ibuprofen(Advil, Motren)
Naproxen Sodium(Aleve)
Other Major Classesof OTC Drugs
OTC sleep aids and cough-and-cold remedies are notable for their popularity and their potential for misuse.
sleep aids with an active ingredient of either diphenhydramine (e.g. Benadryl) or doxylamine succinate (e.g. Unisom).
these antihistamines are depressants that aretypically components of “P.M.” versions of cold medications
Other Major Classesof OTC Drugs
OTC sleep aids and cough-and-cold remedies are notable for their popularity and their potential for misuse.
antihistamines + alcohol additive
alcohol content increases abuse potential
pseudoephedrine used to make crystal methamphetaminealthough still OTC, sales are now monitored
dextromethorphan is a continuing drug abuseproblem (so-called “robo-tripping,” after “Robitussin”)
The Pharmaceutical Industry Today
Highly competitive marketadvertising in mass mediadiversification of productsprotection from generics
The Pharmaceutical Industry Today
Pressure to reduce priceshigh cost of drug researchuninsured and underinsured patientsmaintaining adequate supplies
problems regulating internet trafficking of prescription medicationscopycats masquerade as brand-name drugoften of foreign originmanufacturing unsupervisedproblems of accuracy and purity
a vitamina mineralan herb or other botanicalan amino acida dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands)a concentrate, metabolite, constituent or extract.
What is a Dietary Supplement?1994 Dietary Supplement Health and Education Act (DSHEA)
A dietary supplement is “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.
Dietary Supplements
A large number of dietary supplements are available to the public.
Unlike OTC preparations, dietary supplements are not evaluated by the FDA for safety or efficacy.
This lack of regulation should not be construed to tacit approval of either their use or safety. They may or may not be safe or effective and may interact with other drugs.
Therefore, considerable caution should be exercised when using them.
Which of the following is a dietary supplement? A. an analgesicB. a weight-loss aidC. an herbal formula to boost testosteroneD. a cough and cold remedy
Dietary supplements are considered foods, not drugs.
Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.
Pre-market review for safety data and other information is required.
Manufacturers need to register with the FDA pursuant to the Bioterrorism Act
Dietary Supplements
Dietary Supplements
What must appear on a label of a dietary supplement?
a descriptive name of the product stating that it is a "supplement" the name and place of business of the manufacturer, packer, or distributor a complete list of ingredients (active and inactive)the net contents of the product
Claims of medical benefits for supplements are often exaggerated and are difficult to verify because well-controlled scientific studies of their effectiveness are either nonexistent or incomplete.
Clearly, more scientific studies should be conducted to evaluate these supplements.
(Why AREN’T there more studies?)
Dietary Supplements
The FDAmonitors the marketplace for illegal products (products that may be unsafe or make false or misleading claims)
and obtains information frominspections of dietary supplement manufacturers and distributorsthe Internetconsumer and trade complaintsoccasional laboratory analyses of selected products adverse events associated with the use of supplements that are
reported to the agency.
Dietary Supplements
A product cannot make claims to be a treatment, prevention or cure for a specific disease or condition (only substances classified and regulated as drugs may do that).
Manufacturers MAY make health claims(links between a food substance and disease or a health-related condition)structure/function claims(intended benefits of using the product)nutrient content claims(amount of a nutrient or dietary substance in a product)
Dietary Supplements
Disclaimers are often provided to qualify claims
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”
Claims of medical benefits for supplements are often exaggerated and are difficult to verify because well-controlled scientific studies of their effectiveness are either nonexistent or incomplete.
Clearly, more scientific studies should be conducted to evaluate these supplements.
(Why AREN’T there more studies?)
Dietary Supplements
Cautionary notes:
active chemical constituents of dietary supplements need not be specifically identified
doses of active chemicals may vary by lot; actual dose will therefore vary
those taking supplements may fall victim to the “more must be better” thinking; e.g. pyridoxine (vitamin B6)
potential side effects need not be listed on the label
potential drug interactions need not be listed
Dietary Supplements
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