Exam 1 Content

What did the Pure Food & Drug Act of 1906 do?

Prohibited adulteration & misbranding

What did the Harrison Narcotics Act of 1914 do?

Required prescription-only status for opium & other narcotics

What did the Food, Drug, & Cosmetic Act (FDCA) of 1938 do?

Mandated safety standards for foods, drugs, & cosmetics

What did the Durham-Humphrey Amendment of 1951 do?

Provided for 2 classes of drugs: prescription & nonprescription

What did the Kefauver-Harris Drug Amendment of 1962 do?

Required proven efficacy for marketed products

What did the Dietary Supplement Health & Education Act (DSHEA) of 1994 do?

Defined & regulated dietary supplements

What did the Food & Drug Modernization Act of 1997 do?

Established inactive ingredient labeling requirements

What are the aspects of nonprescription status?

• Used w/o medical supervision

• Consumer can:

  • Self-diagnose

  • Self-treat

  • Self-manage

• Low potential for abuse & misuse

What are some nonprescription medications that are also available as prescription drugs?

• Ibuprofen: 200 mg (non), higher strengths (Rx)

• Meclizine: motion sickness (non), vertigo (Rx)

What is a full prescription-to-nonprescription switch?

Formerly prescription drug is only available OTC

• Naloxone nasal spray

What is a partial prescription-to-nonprescription switch?

Switching only some indications to OTC

What are some other examples of prescription-to-nonprescription switch?

Narcan, Opill, Nasonex 24 HR Nasal Spray, Pataday, Flonase Allergy Relief, Allegra, MiraLax, Mucinex D ER Tablet, Prilosec OTC, Claritin-D 24 Hour, Voltaren Arthritis Pain, Excedrin Migraine, Imodium Advanced, Gyne-Lotrimin 3, Aleve, Nix, Diphenhydramine, Advil, Miconazole, Hydrocortisone, Pseudoephedrine

What is adulteration?

Contains a substance that may make the product harmful to consumers

What is misbranding?

• Labeling is false or misleading

• Does not contain required labeling information

What are the labeling aspects & requirements?

• Regulated by FDA

• Drug fact label

• Low-level reading comprehension (5-6th)

• Font size: 6 point or larger

• Headings:

  • Active ingredient(s)

  • Purpose(s)

  • Use(s)

  • Warning(s)

  • Directions

  • Other information (ex. temp)

  • Inactive ingredients

  • Frequently asked questions

What is the “Flag the Label” Program?

• Alerts consumers to changes in currently marketed products or labels

• “Flag” should be on the label for at least 6 months after the change is made

What are packaging requirements for nonprescription drugs?

• Tamper-resistant

  • Feature of the product packaging is created to prevent access to the product

• Tamper-evident

  • Features that make previous unauthorized access to the product easily detectable

• Expiration date

  • Determined by stability testing (outside manufacturer’s warrenty)

What are the advertising aspects to nonprescription drugs?

• Regulated by Federal Trade Commission (FTC)

• Prohibits false advertisements

What are De Facto Third Class of Drugs?

• Prescription-status products supplied to patients w/o a prescription

• “Behind the counter”

• Ex. Pseudoephedrine, NPH & recombinant (R) U-100 insulin, syringes, needles

What are aspects of nonprescription homeopathic drugs?

• Treat symptoms of a disease w/ substances that product symptoms of the disease in healthy subjects

• “Like cures like”

• Not approved by FDA

• Not required to show safety or efficacy before marketing

• Ingredients listed in terms of dilution (1X, 6X)

What are aspects of dietary supplements?

• Regulated by FDA as foods, not drugs, under DSHEA of 1994

• Vitamins, minerals, herbs or other botanical, amino acid

• Not approved by FDA

• Not required to show safety or efficacy before marketing

• Premarket petition must be filed

• Supplement Facts label must say “dietary supplement”

What is the liability for advice on nonprescription drugs?

Pharmacists can be sued for negligence & malpractice for inaccurate advice that harms the patient

What is the Pharmacists’ Patient Care Process (PPCP)?

• Systemic, standardized process

• Patient-centered

• Collect, assess, plan, implement, follow-up: monitor & evaluate

What is the expectation for time spent on nonprescription consultations?

Pharmacist: <3-10 minutes

Patient: 1-5 minutes

What is used to quickly & accurately assess the patient?

QuEST/SCHOLAR-MACO

What are aspects of the SCHOLAR?

• Symptoms

• Pt reports

• Subjective

What are aspects of the MACO?

• Objective

• Report

• Observed

What is QuEST/SCHOLAR-MACO?

• Symptoms; what are the main & associated symptoms?

• Characteristics: what is the situation like? Is it changing?

• History: what has been done so far? Has this ever happened before, & if so, what was done then? What was successful? What wasn’t?

• Onset: when did it start?

• Location: where is the problem?

• Aggravating factors: what makes it worse?

• Remitting factors: what makes it better?

• Medications: prescription & nonprescription, as well as complementary & alternative products

• Allergies: to medication & other substances, & reactions experienced

• Conditions: coexisting health conditions

• Other: age, weight, sex, pregnancy, lactation, dietary habits, occupation

When do you establish that the patient is an appropriate self-care candidate?

• No severe symptoms

• No symptoms that persist or return repeatedly

• No self-treating to avoid medical care

When do you suggest appropriate self-care strategies?

• Medications

• Alternative treatments

• General care

When do you do when talking w/ the patient?

• Counsel on medication actions, administration, & adverse effects

• Describe what to expect from treatment

• Discuss appropriate follow-up

What part of the PPCP is the Qu, SCHOLAR-MACO?

Collect

What part of the PPCP is the E?

Assess

What part of the PPCP is the S?

Plan

What part of the PPCP is the T?

Implement & Follow-up

What does QuEST stand for?

• Quickly & accurately assess the situation

• Establish that the patient is a candidate for self-care

• Suggest a nonprescription product &/or nonpharmacologic therapy. List product, dosing, & other relevant information

• Talk/counseling

What are the special populations?

• Pediatric patients

• Geriatric patients

• Pregnant patients

• Lactating patients

What are the ages of different pediatric patients & what is different about them?

• Newborn: 0-27 days

• Infants & toddlers: 28 days-23 months

• Children: 2-11 years

• Adolescents: 12 to 16-18 years

• Differences in pharmacokinetics & pharmacodynamic profiles

What are the aspects of geriatric patients?

• 65 years of age & older

• Heavy consumers of both prescription & nonprescription medications

• Decline in the function of many organ systems

• Multiple chronic disorders

• Difficulty

What are the aspects of pregnant patients?

• Many medications cross the placenta to some extent

• Never presume a nonprescription product is safe to use during pregnancy

• Ask all women of childbearing age if pregnancy is possible

• Recommend nonpharmacologic therapy first

• Discourage the use of homeopathic & natural products

What are the aspects of lactating patients?

• Nursing mothers’ use of medication has the potential for adverse effects on the infant

• Ask about breastfeeding status

• Recommend nonpharmacologic therapy first

• Choose a medication w/ the shortest half-life

• Discourage the use of homeopathic & natural products