afams eo 004.01 interpret a prescription for a compound (dari) 01/09/2013

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EO 004.01 Interpret a Prescription for a Compound

(Dari)

01/09/2013

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Importance of Lesson(Dari)

• In the prior lectures you learned how to dispense prescriptions for Ready-form medications.

• Whenever possible Ready-form medications should be used.

• Ready-form medications are manufactured with Good Manufacturing Processes and to high standards.

• However, there will be times in your pharmacy careers when the right ready-form medication will not be available.

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Importance of Lesson(Dari)

• The purpose of this lecture is to introduce you to concepts of pharmacy compounding.

• In future lessons you will perform actual pharmacy compounding.

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Overview EO 004.01(Dari)

• Define pharmacy compounding• Review different compounded

dosage forms.• Describe situations when

compounding should be done.• Sterile vs non-sterile

compounding• Additional steps required upon

receipt of a prescription• Pharmacy compounding

references• Review• Scenarios (not graded)

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DefinitionDari

As you previously learned Ready-form medications are mass produced to a given standard. Therefore, they have:– A fixed quantity of active medication– A fixed recipe of non-active ingredients

(excipients)– A fixed dosage form.

•Therefore, patients requiring lower doses, changes in excipients due to allergies/ intolerances, who have difficulty swallowing tablets, or require additional active medications to those in a single Ready-form medication may require a compounded prescription.•Compounded prescriptions are patient specific.

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DefinitionDari

Sterile vs Non-Sterile Compounding:

The preparation of sterile products involves more stringent controls than the preparation of non-sterile products:•air quality evaluation•sterility-testing of products•training and testing of personnel in aseptic technique

Solutions for injection are the most commonly compounded sterile products to prevent microbial contamination which can lead to significant patient harm.

The compounding of sterile products is not within the scope of practice of Pharm Techs in the ANA

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Pharmacist’s Letter

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DefinitionDari

The following preparations MUST be sterile when they are administered to patients:

•aqueous bronchial and nasal inhalations•baths and soaks for live organs and tissues• injections (e.g., colloidal dispersions,

emulsions, solutions, and suspensions)•irrigations for wounds and body cavities•ophthalmic drops and ointments•tissue implants

These can only be compounded under the aforementioned conditions by trained personnel.

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DefinitionDari

Examples of compounding in the non-sterile pharmacy setting:

1. Preparation of oral liquids and suspensions, topicals, or suppositories

2.Conversion of one dosage form into another

3. Preparation of specific dosage forms from bulk chemicals

4. Preparation of pediatric dosage forms from adult dosage forms

5. Preparation of cassettes, syringes, and other devices with medication for administration in the home setting

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Compounded Dosage FormsDari

Commonly compounded products:

1. Ointments and creams

2. Solutions and Suspensions

3. Suppositories

4. Capsules

5. Rapid-dissolve tablets

6. Lollipops

7. Trouches

8. Powders

9. Transdermals

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Compounded Dosage FormsDari

Commonly compounded products:

1. Ointments and creams

2. Solutions and Suspensions

3. Suppositories

4. Capsules

5. Rapid-dissolve tablets

6. Lollipops

7. Trouches

8. Powders

9. Transdermals

We will look more in depth at the first two since they are the most common formulations.

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OintmentsDari

Ointments: are semi solid preparations intended to be applied to the skin or mucous membrane. Ointments soften but not melt when applied to the body; it is also used as a vehicle for external application of medicinal substances.• Pastes are "thick, stiff ointments that ordinarily do

not flow at body temperature." For this reason, pastes can serve as protective coatings over the areas to which they are applied

Three types of Ointments:

1. Oleaginous bases

2. Anhydrous or absorption bases

3. Water soluble bases

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OintmentsDari

Oleaginous bases are ointments that soothe and protect the skin from the air. Oleaginous ointments repel water and do not wash off easily with water. They commonly provide lubricating effect, do not allow moisture to escape from the skin and are greasy to the touch.

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OintmentsDari

Anhydrous or absorption bases contain no water and are similar to oleaginous bases. Anhydrous ointment base do not repel water but absorbs it and is used to soften the skin.

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OintmentsDari

Water soluble bases are non-greasy and water washable. Non-aqueous or solid medications are added to this type of ointment base.

Example: Active drug incorporated in Polyethylene Glycol Ointment base

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Common Ingredients OintmentsDari

•An ointment will involve incorporating active ingredients into prepared ointment bases, like the Vasoline (petroleum jelly). •Levigating agents help reduce particle size. Decreasing particle size helps the ingredient be evenly mixed throughout the base.– Mineral oil works well with oleaginous ointment

bases. – Depending on the formulation, water, glycerin,

alcohol, propylene glycol, or mineral oil can be used as levigating agents with absorption bases.

– Polyethylene glycol and propylene glycol are good for incorporating insoluble powders into water-soluble bases.

– Water or glycerin can also be used with water-soluble bases.

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CreamsDari

•Creams are "opaque, soft solids or thick liquids intended for external application.“•Lotions are fluids for external application. Creams can sometimes be made into lotions, with the slow addition of water.•Creams are semisolid Oil /Water or Water/Oil emulsions that may or may not contain medication. Creams are easier to apply on the skin and not greasy to touch compare to ointments.

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EmulsionDari

Emulsions are mixture of two liquids or solids that normally do not mix. In an emulsion, one liquid is broken into small particles and evenly scattered throughout the other.

To keep the two liquids from separating, an emulsifying agent is added to the formulation. The emulsifying agent prevents the small particles of the internal phase from fusing together and eventually separating from the external phase to form two distinct layers.

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EmulsionDari

Oil-in-Water (O/W)

Advantages

Improves taste of oral medications

Better absorption of oral medications in the bloodstream

Light, non-greasy feel when used topically

Water washable

Disadvantages

May easily wash off with water or if patient sweats

Does not spread easily on the skin

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EmulsionDari

Water-in–Oil (W/O)

Advantages

Spreads evenly on skin

Soften skins

Not easily washed off

Disadvantages

May stain clothing

Heavy and greasy feel

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Ingredients of Creams and LotionsDari

•Preparation of creams and lotions (or any emulsion) typically involves input of energy to break up and disperse one liquid in another

– (for example, mechanical agitation via mortar and pestle or simple shaking via the "bottle method").

•Ingredients for a compound must be mixed together in a specific order otherwise they will not go into solution or incorporate into a cream.•An emulsifier might be needed to make a cream or lotion. Emulsifying agents help make two immiscible liquids more miscible, or rather, help distribute one phase more evenly and finely though another.

– (e.g., acacia, glyceryl monostearate, polyethylene glycol [PEG], sodium lauryl sulfate, Spans, Tweens, etc)


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•Emulsifying agents are "rated" on the arbitrary numeric hydrophile-lipophile balance (HLB) system. – Agents with a lower HLB value are more oil-

soluble, and those with a higher HLB value are more water-soluble.

– The value of ten is considered to be the breaking point between oil- and water-soluble.

•An emulsifier that's oil-soluble is appropriate for preparing a water-in-oil emulsion.– For example, glyceryl monostearate has an HLB

value of 3.8. It would be best for a water-in-oil emulsion like Eucerin.

– Triethanolamine oleate has an HLB value of 12. It would be best for an oil-in-water emulsion like Dermabase.

– Often, more than one emulsifying agent is used to prepare an emulsion so all ingredients are properly mixed.\

– HLB values for substances can often be found in compounding references and texts.


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A levigating agent, like mineral oil or glycerin, or a wetting agent, like alcohol, might be needed when an active ingredient is being incorporated into a prepared or commercially available cream base. •The wetting agent helps increase contact between solid particles and liquids. •Levigating agents help reduce particle size. Decreasing particle size helps the ingredient be evenly mixed throughout the base.

•Some commercially available cream bases include Dermabase and Vanicream (both oil-in-water) and Hydrocream and Eucerin (both water-in-oil). •It's important to use the correct base when compounding so the ingredients are properly incorporated.


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SUMMARY CHART: PROPERTIES OF OINTMENT BASESDari

Oleaginous Ointment Bases

Absorption Ointment Bases

Water/Oil Emulsion Ointment Bases

Oil/Water Emulsion Ointment Bases

Water-miscible Ointment Bases

Composition oleaginous compounds

oleaginous base + w/o surfactant

oleaginous base + water (< 45% w/w) +

w/o surfactant (HLB <8)

oleaginous base + water (> 45% w/w) +

o/w surfactant (HLB >9)

Polyethylene Glycols (PEGs)

Water Content anhydrous anhydrous hydrous hydrous anhydrous, hydrous

Affinity for Water hydrophobic hydrophilic hydrophilic hydrophilic hydrophilicSpreadability difficult difficult moderate to easy easy moderate to easyWashability nonwashable nonwashable non- or poorly

washablewashable washable

Stability oils poor; hydrocarbons better

oils poor; hydrocarbons better

unstable, especially alkali soaps and natural colloids

unstable, especially alkali soaps and natural colloids; nonionics better

stable

Drug Incorporation Potential

solids or oils (oil solubles only)

solids, oils, and aqueous solutions (small amounts)

solids, oils, and aqueous solutions (small amounts)

solid and aqueous solutions (small

amounts)

solid and aqueous solutions

Drug Release Potential*

poor poor, but > oleaginous fair to good fair to good good

Occlusiveness yes yes sometimes no noUses protectants,

emollients (+/-), vehicles for

hydrolyzable drugs

protectants, emollients (+/-),

vehicles for aqueous solutions, solids, and

non-hydrolyzable drugs

emollients, cleansing creams, vehicles for solid, liquid, or non-hydrolyzable drugs

emollients, vehicles for solid, liquid, or non-hydrolyzable

drugs

drug vehicles

Examples White Petrolatum, White Ointment

Hydrophilic Petrolatum,

Anhydrous Lanolin, Aquabase™, Aquaphor®, Polysorb®

Cold Cream type, Hydrous Lanolin,

Rose Water Ointment, Hydrocream™,

Eucerin®, Nivea®

Hydrophilic Ointment,

Dermabase™, Velvachol®, Unibase®

PEG Ointment, Polybase

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Solutions and SuspensionsDari

SOLUTIONS:

1. Aqueous and viscous aqueous solutions use purified water as the vehicle. Aqueous solutions maybe ingested orally, applied externally or injected into the bloodstream.

2. Viscous aqueous solutions can be thick, sticky and sweet. Uses purified water as vehicle.

Preparation of solutions and suspensions typically involves either dissolving or mixing active drug in a vehicle. For compounding solutions and suspensions, you will need a vehicle or solvent. This vehicle could be anything from water to an aqueous liquid (e.g., syrup), to a polyhydric alcohol (e.g., glycerin, glycol, mannitol, etc). The appropriate vehicle will depend on the qualities of the active ingredient.

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SOLUTIONS:

3. Non aqueous solutions are those that use solvents or dissolving liquids in addition to or instead of water as the vehicle.

• Examples of non-aqueous solvents are alcohol, glycerin and propylene glycol.

a. Hydroalcoholic solution is a mixture of alcohol and water.

b. Alcoholic solutions are non-aqueous solutions that contain alcohol but no water.

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SOLUTIONS: contain a solvent and a solute:

• solute is a substance that creates a solution when dissolved in a solvent. – For example, when sugar (solute) is dissolved in

water (solvent).

•Solute can change its physical state but solvent and solution are of same phase.– e.g sugar is solid before get dissolved in water after

dissolution it changes its phase to liquid.

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SUSPENSIONS• Suspensions are mixtures of fine

particles of an undissolved solid distributed through a gas, or liquid.

• Suspensions are useful for administering a large amount of solid medication that is inconvenient to take as a tablet or capsule.

• Since drug particles are suspended in liquid, it is important to shake the suspension really well before using as particles may have settled in the bottom of the container during storage. Oral suspensions usually use water as the vehicle. For parenteral suspension, oil is used as the vehicle.

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TYPES OF SUSPENSIONS

1. Lotions. Lotions are suspensions intended for external application. They contain finely powdered medications to cool, soothe, dry or protect the skin. Lotions can be worked easily to cover large areas of the skin. Shake well before using.

2. Magmas and milks. Magmas and milks are thick, viscous suspensions of undissolved drugs in water. They are usually intended for oral use and must be shaken well before using.

3. Gels. Gels are similar to magmas and milk except that the suspended particle size in gels is smaller. Gel suspensions are mostly intended for oral administration. Shake well before using.

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Common Ingredients of Oral Solutions•There is a long list of commercially available vehicles for syrups. •These include:– cherry syrup; – Ora-Sweet; – Ora-Sweet SF (sugar-free); – syrup, – USP; and – wild cherry syrup.

•The pH (or measure of acidity) and alcohol content of these vehicles varies, which may be the reason that one is preferred over another for a particular recipe.

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Compounding SituationsDari

When compounding might be appropriate:

1. When a medication is discontinued or unavailable, possibly because the product is not profitable for a manufacturer (note that a drug that has been pulled from the market for safety reasons must not be compounded for dispensing)

2. When a patient is allergic to preservatives, dyes, or other inactive ingredients in commercially available products

3. When a dosage strength is not commercially available

4. When a patient can't take a commercially available product by the intended route

5. When medications require flavor additives to make them more palatable

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Populations Requiring Compounding

DariPopulations that are more likely to require compounded products:

1. Elderly patients

2. Pediatric patients

3. Patients with conditions like chronic pain, or diseases like AIDS

4. Patients who require preservative-free formulations, special flavors, or delivery systems that aren't commercially available

5. Animals under veterinary care

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Receipt of a PrescriptionDari

Steps to follow when a prescription for a compounded drug product is received:1. Check to see if there's a

commercially available product.

2. If there is a commercially available product, check to see if:

a. All the ingredients are appropriate for the condition being treated

b. The concentrations of the ingredients in the prescription are reasonable

c. The physical, chemical, and therapeutic properties of the individual ingredients are consistent with the expected properties of the drug product that was prescribed.

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• If the answers to all of the previous questions are POSITIVE, the Pharmacist should contact the prescriber to suggest a switch to the commercially available product.

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• If the answers to all of the above are NOT POSITIVE, the Pharmacist should consider asking the prescriber the following questions:– What is the purpose of the order?

(Ready-form product available?)– If a formula is provided by the

prescriber, ask where the formula originated. If possible, obtain a copy of the original formula.

– How will the compounded product be used?

– For how long will the compounded product need to be used?

– Does the patient have other conditions that must be considered?

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Compounding ReferencesDari

Two excellent references for compounding recipes are:

1.Isaac Walton Kilam (IWK) Hospital

http://www.iwk.nshealth.ca/page/iwk-compounding-formulas

2.Hospital for Sick Childrenhttp://www.sickkids.ca/Pharmacy/Compounding-Service/

Both are children’s hospitals however; many of their formulations are also appropriate for Adults. Children commonly require compounded prescriptions due to requirement for smaller dosing or inability to swallow tablets.

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http://www.sickkids.ca/Pharmacy/Compounding-Service/

http://www.sickkids.ca/Pharmacy/Compounding-Service/

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Isaac Walton Kilam (IWK) Hospital-Available online-Canadian Hospital-Non-sterile compounding only-Recipes are in PDF format for easy printing.-Updated with new formulations-Formulations reviewed by Pharmacists

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Example/ Dari

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Required Equipment

Compound and Strength

Ingredients and amount required

Directions

How it should be stored once made

How long it is good for if stored appropriately

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Hospital for Sick Children-Available online-Canadian Hospital-Non-sterile compounding only-Recipes are in PDF format for easy printing.-Updated with new formulations-Formulations reviewed by Pharmacists

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Example/ Dari

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Required Equipment

Compound and Strength

Ingredients and amount required

Directions

How it should be stored once made

How long it is good for if stored appropriately

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Checking a Compounded PrescriptionDariAdditional Steps:

Obtain compounding formula and verify with prescription:

-Drug name

-Drug strength (concentration)

-Calculate amount of ingredients required (Have calculations double checked by Pharmacist)

-Final volume or quantity required

-On “Prescription Insert” write:

oPatient Name

oDrug Name

oDrug Strength

oDirections

oPrescriber Name

oPharmacy Name

oPharmacy Phone Number

o Expiry date and storage conditions

- SIGN back of Prescription as the filler.- Pass to another Technician or Pharmacist to check. - Undercontrol Medications must be checked by a Pharmacist.

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Review(Dari)

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DefinitionDari

Sterile vs Non-Sterile Compounding:

The preparation of sterile products involves more stringent controls than the preparation of non-sterile products:•air quality evaluation•sterility-testing of products•training and testing of personnel in aseptic technique

Solutions for injection are the most commonly compounded sterile products to prevent microbial contamination which can lead to significant patient harm.

The compounding of sterile products is not within the scope of practice of Pharm Techs in the ANA

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