Steps to be followed during compounding of any drug preparation 1. Interpretation of the Prescription or Medication Order S.O.A.P.

re: RI hospital Carefully read the prescription or medication order and identify the dose, dosage form, and route of administration. What doesnt belong and why ! Whene"er necessary clarify any doubts or #uestions either consulting the physician or patient. $lan a preliminary compounding procedure. a. DINFO: i. Ingredient synonyms, intended use, pharmacology, chemical structure, melting point, hardness, "iscosity, specific gra"ity% osmolarity, p&a, partition coefficient, solubility, stability, organoleptic properties'. ii. Where do loo( to get this information with least e)penditure of time iii. What should it loo( li(e *a"ent I done this before somewhere i". Where am I going to get this from +ubstitution of manufactured product or alternate salt form will affect stability, etc. b. LAW: i. +hould I say ,o-! to the physician or customer Is this "alid Is this legal ii. .oes this ma(e sense for patient What substitutions, additions and or deletions ma(e professional sense iii. DEA, can this doctor prescribe this type of therapy i". ./. interactions, dosage form interactions ". CS: $atient age, d)0s1, allergies, and condition "i. 2re there refills "ii. $recautions, contraindications, warnings, STOK: $erform necessary calc lations 0with a colleague chec( and unit analysis1. 4he 5etric +ystem Calculation of .oses Reducing and 6nlarging 7ormulas i. *ow much of this should/can I ma(e ii. Can I weigh/measure this 5 et di" or dtd iii. Clarity: label in best units i". 8ist unit operations% be specific: *9W I mi)ed, *9W I sie"ed, etc'! .ensity, +pecific :ra"ity, and +pecific ;olume $ercentage and Ratio +trength Calculations .ilution and Concentration Isotonic +olutions 6lectrolyte +olutions: 5illie#ui"alents, 5illimoles, and 5illiosmoles Constituted +olutions, Intra"enous 2dmi)tures and Rate of 7low <=nits,< <>mu?g/mg,< and 9ther 5easures of $otency =se of $refabricated .osage 7orms in Compounding $rocedures .rug 2"ailability and $harmaco(inetics Radioacti"e $harmaceuticals 4he Common +ystems and Intersystem Con"ersion $harmacoeconomic Calculations +tatistical Concepts $roof +trength +olubility Ratios 6mulsion ,ucleus and *8@ +ystem 6)ponential and 8ogarithmic ,otation @uffer +olutions Chemical Con"ersion +ubstitution of $harmaceutical .osage 7orms and .rug .eli"ery +ystems *6R@al, nutraceuticals, in"estigational products

3.

A.

P!" #$%&: +elect the appropriate acti"e and inacti"e ingredients, compounding e#uipment and prepare the product using proper techni#ue. a. E'CIPients: i. Chemical/physical/microbiological preser"ati"e0s1 ii. 7la"oring, color 0dye "s pigment "s la(e1% wetting agent% surfactants% antio)idants iii. *as any changes I made going to ha"e a ripple effect ! i". .ont rein"ent. +implify. &I++! ". SOP: .ocument a repeatable compounding process. b. PACKaging: +elect the appropriate container and pac(age the preparation. i. 4ypes of plastic/glass that is best for multiple "s unit dose ii. 5odify pac(aging operation to promote stability/safety 0hermetic/heat sealing, sparging, blister wrap, color/shape dressing!, security for narcotics, childproof1. c. (A: $erform #uality control procedures within constraints of accuracy and precision. i. STA)ility* .etermine an appropriate beyondBuse date. ii. Calculate or predict 0by 2rrhenius1% empirical "ersus laboratory data% apply +SP guidelines for microbiological )+D iii. InBhouse! 0weight "ariation, "isual inspection or p* measurement1 or CONTract out for lab assistance i". ASSA, considerations: Can you measure what you Cthin( you can% positi"e and negati"e controls% standards% -ALIDation. ". Instruct patients to watch for any change in the preparation. .ispense your handiwor( a. LA)EL the container, including recommended au)iliary labels. E1F% GHICI b. .eli"er the product to the patient with appropriate consultation. c. P"ICE, promote, ad"ertise d. Rechec( all wor(

D.

Remember, all problems consist of (inetic and thermodynamic considerations and these are separate from one another. 2ll problems ha"e legal and economic 0as well as science1 related issues that ha"e great bearing on your critical thin(ing decision0s1. 4ry to gi"e I of #uestions directed at therapeutics to tell if they came to class, I from reading and I from homewor( and the rest from handouts.