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AFAMS EO 004.01 Interpret a Prescription for a Compound (Dari) 01/09/2013.

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Presentation on theme: "AFAMS EO 004.01 Interpret a Prescription for a Compound (Dari) 01/09/2013."— Presentation transcript:

1 AFAMS EO 004.01 Interpret a Prescription for a Compound (Dari) 01/09/2013

2 AFAMS 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. AFAMS Insert Dari

3 AFAMS 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. AFAMS Insert Dari

4 AFAMS 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) AFAMS Insert Dari

5 AFAMS Definition Dari 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. AFAMS Insert Dari

6 AFAMS Definition Dari 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 AFAMS Insert Dari Pharmacists Letter

7 AFAMS Definition Dari 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. AFAMS Insert Dari Pharmacists Letter

8 AFAMS Definition Dari 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 AFAMS Insert Dari Pharmacists Letter

9 AFAMS Compounded Dosage Forms Dari 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 AFAMS Insert Dari

10 AFAMS Compounded Dosage Forms Dari 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. AFAMS Insert Dari

11 AFAMS Ointments Dari 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 AFAMS Insert Dari

12 AFAMS Ointments Dari 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. AFAMS Insert Dari

13 AFAMS Ointments Dari 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. AFAMS Insert Dari

14 AFAMS Ointments Dari 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 AFAMS Insert Dari

15 AFAMS Common Ingredients Ointments Dari 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. AFAMS Insert Dari

16 AFAMS Creams Dari 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. AFAMS Insert Dari

17 AFAMS Emulsion Dari 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. AFAMS Insert Dari

18 AFAMS Emulsion Dari 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 AFAMS Insert Dari

19 AFAMS Emulsion Dari Water-in–Oil (W/O) Advantages Spreads evenly on skin Soften skins Not easily washed off Disadvantages May stain clothing Heavy and greasy feel AFAMS Insert Dari

20 AFAMS Ingredients of Creams and Lotions Dari 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) Pharmacists Letter

21 AFAMS Ingredients of Creams and Lotions Dari 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. Pharmacists Letter

22 AFAMS Ingredients of Creams and Lotions Dari 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. Pharmacists Letter

23 AFAMS SUMMARY CHART: PROPERTIES OF OINTMENT BASES Dari 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 hydrous anhydrous, hydrous Affinity for Water hydrophobichydrophilic Spreadability difficult moderate to easyeasymoderate to easy Washability nonwashable non- or poorly washable washable Stability 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) solid and aqueous solutions (small amounts) solid and aqueous solutions Drug Release Potential* poorpoor, but > oleaginousfair to good good Occlusiveness yes sometimesno Uses 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

24 AFAMS Solutions and Suspensions Dari 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. AFAMS Insert Dari

25 AFAMS Solutions and Suspensions Dari 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. AFAMS Insert Dari

26 AFAMS Solutions and Suspensions Dari 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. AFAMS Insert Dari

27 AFAMS Solutions and Suspensions Dari 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. AFAMS Insert Dari

28 AFAMS Solutions and Suspensions Dari 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. AFAMS Insert Dari

29 AFAMS Solutions and Suspensions Dari 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. AFAMS Insert Dari

30 AFAMS Compounding Situations Dari 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 AFAMS Insert Dari Pharmacists Letter

31 AFAMS Populations Requiring Compounding Dari Populations 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 AFAMS Insert Dari Pharmacists Letter

32 AFAMS Receipt of a Prescription Dari 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. AFAMS Insert Dari Pharmacists Letter

33 AFAMS Receipt of a Prescription Dari 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. AFAMS Insert Dari Pharmacists Letter

34 AFAMS Receipt of a Prescription Dari 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? AFAMS Insert Dari Pharmacists Letter

35 AFAMS Compounding References Dari 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 Children http://www.sickkids.ca/Pharmacy/Compounding -Service/ Both are childrens 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. AFAMS Insert Dari

36 AFAMS Compounding References Dari 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 AFAMS Insert Dari

37 AFAMS Example/ Dari AFAMS 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

38 AFAMS Compounding References Dari 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 AFAMS Insert Dari

39 AFAMS Example/ Dari AFAMS 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

40 AFAMS Checking a Compounded Prescription Dari Additional 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: o Patient Name o Drug Name o Drug Strength o Directions o Prescriber Name o Pharmacy Name o Pharmacy 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. Dari

41 AFAMS Questions?

42 AFAMS Review (Dari) AFAMS

43 Definition Dari 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 AFAMS Insert Dari Pharmacists Letter

44 AFAMS Definition Dari 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. AFAMS Insert Dari Pharmacists Letter

45 AFAMS Definition Dari 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 AFAMS Insert Dari Pharmacists Letter

46 AFAMS Ointments Dari 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 AFAMS Insert Dari

47 AFAMS Ointments Dari 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. AFAMS Insert Dari

48 AFAMS Ointments Dari 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. AFAMS Insert Dari

49 AFAMS Ointments Dari 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 AFAMS Insert Dari

50 AFAMS Creams Dari 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. AFAMS Insert Dari

51 AFAMS Emulsion Dari 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 AFAMS Insert Dari

52 AFAMS Emulsion Dari Water-in–Oil (W/O) Advantages Spreads evenly on skin Soften skins Not easily washed off Disadvantages May stain clothing Heavy and greasy feel AFAMS Insert Dari

53 AFAMS Receipt of a Prescription Dari 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. AFAMS Insert Dari Pharmacists Letter

54 AFAMS Receipt of a Prescription Dari 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. AFAMS Insert Dari Pharmacists Letter

55 AFAMS Compounding Situations Dari 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 AFAMS Insert Dari Pharmacists Letter

56 AFAMS Quiz (Assessment) Dari Formative Assessment: Not marked Used to assess the students understanding of lectures material. Instructors will provide descriptions of types of compounds which students must indicate type of compound. Instructor will provide a debrief at the end of the quiz. Time estimate (including debrief): 20-30 mins Insert Dari

57 AFAMS Quiz (Assessment) Dari 1.An opaque soft solid or thick liquid intended for external application. Can have a drying effect. 2.A fluid emulsion or suspension for external application. Can have a lubricating effect. 3.A semisolid preparation intended for external application to the skin or mucous membranes that softens or melts at room temperature. Insert Dari

58 AFAMS Quiz (Assessment) Dari 4.A thick, stiff ointment that ordinarily does not flow at body temperature. Can be used as a protective covering. 5.Consists of one phase dispersed in a second phase, by an emulsifying agent. 6.Liquid preparations containing one or more drug substances molecularly dispersed in a suitable solvent or mixture of mutually miscible solvents. Insert Dari

59 AFAMS Quiz (Assessment) Dari 7.Are sweetened, flavored, liquid preparations containing the active drug (or excipients, when it is prepared from commercially available drug products) as insoluble materials. Insert Dari

60 AFAMS Quiz (Assessment) Dari 1.Cream 2.Lotion 3.Ointment 4.Paste 5.Emulsion 6.Solutions 7.Suspension Insert Dari

61 AFAMS End of Lecture Dari


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