DERM Exam I

What are the seven pillars of self-care?

knowledge & health literacy; self-awareness; physical activity; healthy eating; risk avoidance/mitigation; good hygiene; rational use of products & services

What are some general exclusions to self-care?

persistent or prolonged symptoms; CI to therapy; health conditions or status; no qualifying indication; previous self-treatment ineffective

What are the functions of the skin?

temperature regulation (sweat, vasodilation); sensory; synthesizes vitamin D; route of drug administration; protection

the ingredient in a formulation that has the desired pharmacological activity

active pharmaceutical ingredient (API

ingredients in a formulation that do not have the desired pharmacological activity

excipients

the combination of excipients and API

vehicle

the amount of API released from the formulation that penetrates into or through the skin

skin penetration

What are the different occlusion methods?

formulation with hydrophobic excipients or covering application site with bandage or dressing

Hydrated skin is ____ permeable than dry skin

more

The site of application matters: In general, the thicker the stratum corneum, the _____ the penetration of a compound into the skin

lower

dispersions made up of two immiscible liquid phases which are mixed using mechanical shear

emulsions

What is added to an emulsion to help stabilize the internal phase?

surfactant

oil in water (O/W)=

cream

water in oil (W/O) =

ointment

Most APIs penetrate through the skin by ______

passive diffusion

Rate of diffusion through the skin is called

flux

Fick’s law of diffusion =

J = P x (C donor - C receiver)

Fick’s law of diffusion: J =

flux from the donor to receiver

Fick’s law of diffusion: P =

permeability coefficient; a natural property of the API based on its chemical structure

Fick’s law of diffusion: C donor - C receiver =

concentration gradient

Fick’s law of diffusion: to increase flux

increase permeability of increase concentration of API (C donor)

Chemicals that enhance drug transport across the skin by increasing the thermodynamic prosperity of drug in the patch system or by altering the stratum corneum

permeation enhancers

a measurement of barrier properties of the stratum corneum; measures the rate of water evaporation

transdermal epidermal water loss test

What are the advantages of transdermal drug deliver over oral?

avoids hepatic first pass metabolism; eliminates GI side effects due to local effects; longer duration of activity

What are the advantages of transdermal drug delivery over parenteral?

easily self-administered with no needles; longer duration of activity

What are the limitations of transdermal delivery?

poor skin permeation of most APIs; skin irritation; individual variation; dosing limitations

What are the ideal API properties for transdermal drug delivery?

dail dose <20 mg; half-life suitable for once daily dosing; MW <1000 Da; balance of lipophilicity/hydrophilicity; non-irritating and non-sensitizing to skin

Components of transdermal patches: drug impermeable membrane prepared with plastic polymers and metal foils

backing membrane

Components of transdermal patches: silicone or acrylate polymers

pressure sensitive adhesive

Components of transdermal patches: drug impermeable protecting layer that is peeled off before use

release liner

Components of transdermal patches: matrix or reservior

formulation

What is used for in vitro release tests for topical formulations?

Fraz Cell Apparatus

Fraz Cell Apparatus: to determine the rate of release of the API from the vehicle through non-rate limiting membrane

drug release

Fraz Cell Apparatus: to determine the rate of penetration of the API through skin sample or synthetic membrane

drug penetration/skin permeability

Fraz Cell Apparatus: barrier or no barrier to diffusion

difference is type of membrane used in test

What are some examples of penetration enhancers?

solvents, surfactants, terpenes, cyclodextrins, keratolytics, phospholipids, fatty acids and alcohols

refers to the written, printed or graphic matter appearing on the immediate commercial container of a drug product

label

information printed on the label AND outside package of a drug product

labeling

labeling includes:

package insert, patient insert and MedGuide

What required all consumer products in interstate commerce to be honestly and informatively labeled?

1966 Fair Packaging and Labeling Act

For prescription drugs, the manufacturer’s duty is to provide prescribing physicians with information, so that the prescriber is then better equipped to educate the consumer/patient; this is called

learned intermediary doctrine

What are the two formats of a package insert?

physician labeling rule (PLR) and old (non-PLR) format

What are the two main components of a package insert?

highlights of prescribing information (HPI) and full prescribing information (FPI)

provides immediate access to the information to which practitioners most commonly refer and regard as most important

HPI section of a package insert

What are the indications for using a drug off-label?

practitioners find promising uses for drugs much faster than they can be approved; manufacturers often seek NDA approvals with minimum number of indications for faster approval

promoting off-label use of a drug to the public is ______

illegal

T/F: manufacturers can promote off-label use of a drug to providers

True

A document, provided by the manufacturer and written in lay language that is intended to educate the patient about the proper use and potential dangers inherent in the use of product

patient package insert (PPI)

____ MUST be provided to the patient by anyone dispensing this drug; failure to do so is considered _______

PPIs; misbranding

What is an example of a drug that has to be dispensed with a PPI?

oral contraceptive

What are some factors that go into determining if a drug needs a MedGuide?

labeling could help prevent serious AEs; serious risk relative to benefit that pt should be aware of to decide whether to use; pt adherence to directions is critical to the drugs’s effectiveness

written information provided by the pharmacy for all drugs =

consumer medication information (CMI)

What patient drug information is NOT federally mandated and NOT approved by FDA before distribution?

CMI

The process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual patient

drug compounding

compounded preparation are ____ FDA approved

NOT

______ pharmacy compounding is considered a practice of pharmacy regulated by state boards of pharmacy, NOT regulated by FDA

traditional

Pharmacy compounding vs manufacturing: medication is NOT commercially available

compounding

Pharmacy compounding vs manufacturing: made for individual patients

compounding

Pharmacy compounding vs manufacturing: cannot be sold in bulk for resale

compounding

Pharmacy compounding vs manufacturing: cannot advertise specific drugs

compounding

Pharmacy compounding vs manufacturing: medication is commercially available

manufacturing

Pharmacy compounding vs manufacturing: made in mass production

manufacturing

Pharmacy compounding vs manufacturing: can be sold in bulk for resale

manufacturing

Pharmacy compounding vs manufacturing: can advertise specific drugs

manufacturing

What granted the FDA more authority to regulate and monitor manufacturing of compounded drugs?

Drug Quality and Security Act

Drug Quality and Security Act 503A =

traditional compounding pharmacy that compounds in accordance to patient specific prescription and is regulated by the state boards of pharmacy

Drug Quality and Security Act 503B =

outsourcing facility that may produce large batches with or w/o prescriptions to be sold to healthcare facilities as office use or shipping out of state and is regulated by FDA

USP 795 =

non-sterile compounding

USP 797 =

sterile compounding

USP 800 =

hazardous drugs

Xerosis =

dry skin

What is the most common cause of pruritus?

dry skin

Dry skin affects ______ more frequently

older adults

How does the epidermis change as we age, leading to dry skin?

decreased ceramides in the skin results in water loss; abnormal maturation and adhesion of keratinocytes results in a superficial, irregular layer of corneocytes; hormonal decline = less sebum production

Eczema craquele =

cracked appearance

Ichthyosis =

fish-scaling appearance

When should oil-based emollients be applied for dry skin?

immediately after bathing while skin is damp

contains salts of long-chain fatty acid + alkai metal

soaps/cleansers

Colloidal oatmeal baths should be used with caution in older adults because

it makes the bath and floor very slippery; risk of falls

emollients =

softeners

maintains skin water content by creating a hydrophobic barrier over the skin and blocking trans-epidermal water loss

occlusives

Which occlusive can reduce water loss more than 98%?

petrolatum

hygroscopic substances which help the stratum corneum absorb water by attracting water from the dermis and a humid environment into the epidermis

humectants

deposits within the stratum corneum to make the skin soft and smooth by reestablishing stratum corneum integrity

emollients

What are the different formulations of moisturizers?

lotions, creams, gels, ointments

lotions =

oil in water; non-greasy; great for hairy areas; cooling effect

Creams =

W/O or O/W; made of heavier lipids, use at nighttime

Gels =

W/O or O/W; smooth finishing, non-oily, non-comedogenic; good for intertriginous areas

Ointments =

W/O; greasy/glossy looking; useful when high degree of occlusion required; CI in intertriginous areas

Topical Hydrocortisone often includes _____ which is a possible skin irritant for some people

aloe

What are the complications of dry skin?

itching, inflammation, development of secondary infections

What are the two types of drug-induced dermatologic reactions?

irritant and allergic

Irritant or Allergic drug induced dermatologic reactions: localized

irritant

Irritant or Allergic drug induced dermatologic reactions: allergens

irritant

Irritant or Allergic drug induced dermatologic reactions: IV drug extravasation

irritant

Irritant or Allergic drug induced dermatologic reactions: immune response

allergic

Irritant or Allergic drug induced dermatologic reactions: may be systemic

allergic

Irritant or Allergic drug induced dermatologic reactions: first rxn may be dermal but subsequent exposures may become systemic

allergic

What are some risk factors for developing drug-induced dermatologic reactions?

prior drug reaction; multiple drug therapy; viral illness; dosage/serum drug level increases; topical route; genetic factors; comorbidites

Which type of allergic dermatologic reaction is IgE mediated?

type I