Chapter 14 into to compounding Flashcards

1
Q

Definition of compounding

A
  1. To mix or combine, 2. To make by combining parts, 3. To intensify by adding new elements
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2
Q

Compounding is the

A

Practice of extemporaneously preparing medications to meet unique need of an individual patient according to specific order of a prescriber

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3
Q

Incense in compounding comes from

A

Discontinuation of drugs by manufacturers, removal of drugs from market by FDA, unavailability of drugs in a strength or dose, allergies,

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4
Q

Valuable resources of compounding

A

Remingtons pharmaceutical sciences, Merck Manual, Merck veterinary manual, trissel’s stability of compounded formulations, drugs facts and comparisons, united stats pharmacopeia, vertically drug handbook, internal journal of compounding pharmacists.

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5
Q

USP

A

Imports states pharmacopeia

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6
Q

USO regulates

A

Compounding pharmacy by setting standards for compounding, under guidance of volunteer pharmacy compounding experts, offers resources and support for compounder

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7
Q

USP standards for sterile and non sterile preps are available in chapters

A

797 and 795

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8
Q

USO 795 provides guidance on

A

Applying good compounding practices in preparation of non sterile compounded formulations

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9
Q

USP 795 was recently revised to include

A

Categories of compounding (simple, moderate, complex), new definitions for terms (beyond use date, hazardous drug, stability) criteria for compounding each drug preparation (suitable compounding environment and use of appropriate equipment)

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10
Q

PBCA was founded when

A

8 of the nations leading pharmacy organizations joined together to create a voluntary quality accreditation designation for compounding

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11
Q

Goals of PCAB

A
  1. Improve quality of compounding operations and preps.
  2. Provide a competitive edge in the marketplace and ability to secure new business.
  3. Offer validation for compounding pharmacies to meet national standards
  4. Strengthen community confidence
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12
Q

First step in compounding

A

Obtain a formula/recipe prepared by a pharmacist that include all necessary ingredients and explicit instructions for the preparer

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13
Q

From the formula/recipe the technician creates a

A

Worksheet containing a list of active ingredients and excipients and exact amounts needed of each.

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14
Q

Geometric dilution

A

Technique of starting with the ingredient of the smallest amount and doubling the portion b adding the other ingredients in order of quantity until fully mixed

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15
Q

Procedure 1 & 2 of general compounding process

A
  1. Obtain the recipe or formula

2. Write up a compounding worksheet based on the formula

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16
Q

Procedure 3 & 4 of general compounding

A
  1. Collect all ingredients and equipment necessary to prepare the compound
  2. Weigh each ingredient and have the measurements verified by the pharmacist
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17
Q

Procedure 5 & 6 of general compounding process

A
  1. Following direction of the formula, prepare the compounded medication
  2. Package and label the compounded medication in an appropriate container
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18
Q

Procedure 7 & 8 of compounding process

A
  1. Have the pharmacist do a final check on the compound

8. Clean the workstation and equipment used

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19
Q

Estimated _% of all prescriptions dispensed in the United States are compounded, thus making this a niche market.

A

1%

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20
Q

Geometric dilution should mean that the final product is

A

Even distribution of the active ingredient throughout the final product

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21
Q

Most appropriated dosage form will depend on

A

The drug and the patient

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22
Q

The patient is probably the most important factor in?

A

Dosage form

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23
Q

Common dosage forms

A

Capsules. Liquids, transdermal gels, creams, ointments, suppositories, chewables

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24
Q

Even though compounded are prepared on individual basis the pharmacy still must have a good

A

Quality assurance

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25
Q

Quality assurance (QA)

A

A program of activities used to ensure that the procedures used in preps of compounds lead to products that meet certain specifications and standards

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26
Q

Typical components of a good QA program include

A

SOPs, formulation records, compounding worksheets, ingredient record forms, material safety data sheets, documented training, and QA tests for each compound

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27
Q

Standard operating procedures (SOPs) are

A

A step by step written instructions on how to do a certain task. All important tasks should be covered by a SOP

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28
Q

SOPs should be developed for

A

Facility maintenance, equipment calibration and maintenance, personnel training and validation, and preparation, packaging, and storing of compounded items.

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29
Q

SOPs can assure that

A

Equipment is properly maintained and calibrated, supplies and chemicals are received, inventoried, compliant with compounding standards, stored properly and disposed of correctly, all procedure and tasks are performed consistently and documented

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30
Q

SOP general format follow

A
  1. SOP number - unique assigned number
  2. Date effective
  3. Author
  4. Author signature
  5. Purposes of procedure
  6. Equipment/ materials listed for each task
  7. Detailed procedure
  8. Documentation forms
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31
Q

PCAB accreditation requires SOPs to regard

A

Cleaning, maintenance, calibration and verification of each piece of equipment

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32
Q

Capsules:

A

Oral dosage, been used for more than a century. Offers broad range of dosage options for patients.

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33
Q

Tablets:

A

Solid dosage form administered orally, sublingually, vagina lily or as an implant under the skin. Compressed tables made by manufacturers are most commonly prescribed dosage form.

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34
Q

Sublingually means

A

Under the tongue, preparations may be administered by placing them under the tongue and allowing them to dissolve.

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35
Q

Powder is a

A

Solid dosage form made from blended active ingredients and excipients.

36
Q

Lozenge is a

A

Solid dosage form administered orally to be dissolved in the mouth

37
Q

Trachea is a

A

Interchangeable term for lozenge but sometimes prepared in soft form

38
Q

Suppository is a

A

Solid dosage form used to administer medication by way of the rectum, vagina, or urethral tract

39
Q

Aqueous solutions are

A

Water soluble

40
Q

Powders are a solid dosage that may be used

A

Either internally (BC powder) or externally (talcum powder). Use of powders has declined, but still an occasional need.

41
Q

Some advantages of using torches and lozenges are that they

A

Easily to handle and administer to a variety of patients, base is made of sugar torches generally have a pleasant taste which makes them popular with pediatric, geriatric, and hospice patients.

42
Q

Sticks :

A

Unique dosage form used for topical application of local anesthetic, sunscreens, antivirals, antibiotics, and cosmetics. Convenient, relatively stable and fairly easy to repair but time consuming.

43
Q

A suppository dissolves

A

At body temperatures, allowing absorption of medication into surrounding tissues. Can have a systemic effect or local effect depending on desired effect expected by prescriber or on the drug being used.

44
Q

Common bases for suppositories

A

Battibase, poly base, cocoa butter

45
Q

Drug in a suppository can either be

A

Dissolved or suspended

46
Q

Solutions:

A

Water soluble chemical dissolved in the water phase of compounding. May contain just enough water to dissolve the drug or may be as much as 50% of the final volume.

47
Q

Suspensions:

A

Preparation that contains insoluble solid particles uniformly dispersed though-out a vehicle. Must be shaken prior to administration.

48
Q

Suspensions need a suspending agent such as

A

Ora plus or Karo syrup

49
Q

Emulsions:

A

Liquid or semisolid preparation that can be taken orally or applied topically.

50
Q

Emulsions are prepaired when

A

Two immiscible liquids must be dispensed in the same preparation

51
Q

Emulsions are held together by a

A

Emulsifying agent

52
Q

Emulsions are either

A

Water-in-oil or oil-in-water
Internally oil-in-water
Topical could be both

53
Q

Ointments:

A

Semisolid, usually applied to skin or mucosal tissue. Doe not penetrate into the skin, should be soft and easily spreadable and smooth in texture.

54
Q

Common ointment bases are

A

Hydrophilic petrolatum, aquaphor, hydrous ianolin, and PEG ointments.

55
Q

Comminuting or triturating

A

Process of reducing particle size to a fine powder

56
Q

Pastes:

A

Stiff or very viscous, do not melt or soften at body temp. Intended as protective covering over areas where applies. (Diaper rash)

57
Q

Cream:

A

Soft, opaque solid applied externally. Dissipate into skin healing the affected area from inner layers of dermis. Medications are usually dissolved or suspended in water soluble base.

58
Q

Some cream bases available include

A

Vanishing cream, HRT base, cetaphil, Eucerin, lubriderm

59
Q

Gels:

A

Semisolid system consisting of suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid.

60
Q

Transdermal gel

A

Unique, semisolid dose that becoming increasingly popular. Have special absorption enhancers that “push” medication though the layers of skin so it can be absorbed into the blood stream.

61
Q

Most common form of transdermal gel is a

A

Two phase vehicle made from plutonic lecithin organogel (PLO) consists of both oil phase and an aqueous phase. Making it suitable for many chemicals/

62
Q

Poloxamer gel is a

A

Liquid stored in the fridge. When brought to room temp it will form a gel. Final product should be stored at room temp.

63
Q

Ophthalmic preps:

A

For the eye. May be a solution, suspension, or ointment. Must be sterile.

64
Q

Ophthalmic solutions must be

A

Clear and particulate free, and is the most commonly prepared in compounding

65
Q

The eye generally tolerates a pH rang of

A

4 to 11

66
Q

Buffers are used to

A

Maintain the pH of a product

67
Q

Preservatives are necessary when

A

Prep is intended for multiple uses. They prevent contamination of preparation from microbial growth.

68
Q

Optic preps:

A

For the ear, (otic) made in liquid, powder or ointment form.

69
Q

Vehicles most often used for otic liquids are

A

Propylene glycol, glycerin, polyethylene glycol, vegetable oil, mineral oil. Necessary to use viscous liquid because medication should adhere to the ear canal.

70
Q

Nasal preps:

A

Solutions, suspensions, gels, or ointments. Used locally or systemically.

71
Q

Excipients used in nasal preps could be

A

The vehicle, buffers, preservatives, tonicity adjusting agents.

72
Q

Two common vehicles used for nasal solutions are

A

Sodium chloride 0.9% and sterile water for injection

73
Q

Veterinary compounding:

A

One of the fastest growing areas of compounding. Doses are usually calculated on milligrams per kilogram of body weight. Making for a more accurate dose.

74
Q

Successfully _____ medication is a critical step in the process, especially when a drug is bitter.

A

Flavoring

75
Q

A psychological impact for medication is

A

Flavor and color

76
Q

Individuals are usually more sensitive to the

A

Aroma of a prep then the actual taste. Older patients may require added amounts of flavor. Females tend to be more sensitive to smell then males.

77
Q

Pediatric flavoring

A

Children have more taste buds, meaning more sensitive to taste. Infants and children tend to prefer sweet tases and do not respond well to bitter flavors. Flavors could include raspberry, bubblegum, marshmallow, butterscotch, citrus, berry and vanilla. The younger the patient the more mild the flavor should be.

78
Q

Adult flavoring

A

More tolerant of bitter flavors such as coffee, chocolate, cherry, anise, grapefruit, mint.

79
Q

Four taste types

A

Sour, sweet, bitter, salty and a new fifth sense call umami

80
Q

Sweet, salty and sour taste receptors are in a region

A

Just inside the outer edge of the tongue.

81
Q

Salary and sour receptors are located

A

Along the back of the tongue

82
Q

Sour only receptors are located

A

In the center of the tongue

83
Q

There is an area in the tongue where no sensation are experienced

A

Toward the center and front. (Center section)

84
Q

The brain is not able to distinguish different tastes components rather

A

Perceives taste as a composite sensation

85
Q

Most used flavor enhancer is

A

Vanilla