Pharmaceutical Compounding And Dispensing

2Pharmaceutical Compounding and Dispensing5.6.a.b.c.d.e.f.g.7.Choice of containerLabelling considerationsTitleQuantitative particularsProduct-specific cautions (or additional labelling requirements)Directions to patient – interpretation of Latin abbreviationswhere necessaryRecommended British National Formulary cautions whensuitableDiscard dateSample label (you can assume that the name and address of thepharmacy and the words ‘Keep out of the reach of children’ arepre-printed on the label)Advice to patientIn all the worked examples, the information provided in thistext has been fully referenced. Wherever possible, the followingreference texts have been used: British Pharmacopoeia (2004, London: TSO).British National Formulary, 51st edn (2006, London: BMJPublishing Group and RPS Publishing).Martindale, The Extra Pharmacopoeia, 33rd edn (London:Royal Pharmaceutical Society).For some information (e.g. solubility data) it has been necessaryto use older reference sources. Where this has happened, detailsof the references used have been fully annotated within the text.However, it should always be remembered that wherever possible,compounders should use the most up-to-date reference sourceavailable.In addition to the product-type chapters, this chaptercontains a summary of the key storage, labelling and packagingrequirements for extemporaneous dosage forms.OverviewUpon completion of this chapter, you should be able to: understand the key principles behind labelling of pharmaceuticalpreparations including:– How to label products for both internal and external use.– The importance of auxiliary labels.– The rationale behind choosing an appropriate discard date. identify the different pharmaceutical packaging available select appropriate packaging for different pharmaceutical formulations.

IntroductionTipsStorage and labelling requirementsStorageAll products dispensed extemporaneouslyrequire some form of additional storageinstructions to be detailed on the label. Thisinformation can be the addition of just aproduct expiry date through to a number ofimportant additional auxiliary labels.The summary list given in Table 1.1 isto be used as a guide in the absence of anyguidance from the official pharmaceuticaltexts. It should be remembered that theinformation in this table is to be used onlyas a guide. Any information on additionallabelling or expiry dates in the official textswill supersede the information provided inTable 1.1.All suggested expiry dates included inTable 1.1 and other sections of this book areto be used as a guide only and are based onhistorical practice.General principles of labellingNowadays it is common practiceto assign a maximum of a 2-weekdiscard to any extemporaneouslyprepared product. Considerationshould always be given toassigning a shorter discard date.KeyPointsThe label of a pharmaceuticalproduct has many functions: To indicate clearly the contentsof the container To indicate clearly to patientshow and when the medicinalproduct should be taken orused To indicate clearly to patientshow the product should bestored and for how long To indicate clearly to patientsany warnings or cautions ofwhich they need to be madeaware.Every extemporaneously preparedpreparation will require a label to beproduced before the product can bedispensed or sold to the patient. The accuracyof the label is paramount as it conveys essential information to thepatient on the use of the preparation.Although the pharmacist or other healthcare practitioner maycounsel patients when the medication is handed over, it is unlikelythat patients will be able to remember all the information thatthey are given verbally. The label therefore acts as a permanentreminder of the key points that patients need to know.Table 1.1 A guide to auxiliary labels and discard dates for ortant auxiliary labelsSuggesteddiscard dateApplicationsAmber flutedbottle with CRCFor external use only4 weeksCapsulesAmber tablet bottlewith CRCSee BNF for advisory labelsrecommended for activeingredient3 monthsCreamsand GelsAmber glass jar orFor external use onlycollapsible metal tube4 weeks3

4Pharmaceutical Compounding and DispensingPreparationContainerImportant auxiliary labelsSuggesteddiscard dateDustingPowdersPlastic jar preferablywith a perforated,reclosable lidFor external use onlyNot to be appliedto open wounds orraw weeping surfacesStore in a dry place3 monthsEar DropsHexagonal amberfluted glass bottlewith a rubber teatand dropper closureFor external use only4 weeksElixirsPlain amber medicinebottle with CRC4 weeksEmulsionsPlain amber medicine Shake the bottlebottle with CRC4 weeksEnemasAmber fluted bottlewith CRCFor rectal use only*Warm to body temperaturebefore use4 weeksGargles andMouthwashesAmber fluted bottlewith CRCNot to be taken*Do not swallow in largeamounts4 weeksInhalationsAmber fluted bottlewith CRCNot to be taken*Shake the bottle4 weeksLinctusesPlain amber medicinebottle with CRCLinimentsand LotionsAmber fluted bottlewith CRCMixtures andSuspensionsPlain amber medicine Shake the bottlebottle with CRC4 weeksNasal DropsHexagonal amberNot to be taken*fluted glass bottle witha rubber teat anddropper closure4 weeksOintmentsAmber glass jarFor external use only3 monthsPastesAmber glass jarFor external use only3 monthsPessariesWrapped in foil andpacked in an amberglass jarFor vaginal use only*3 monthsPowders(individual)Wrapped in powderStore in a dry placepapers and packed in Dissolve or mix witha cardboard cartonwater before takingSee BNF for advisorylabels recommendedfor active ingredient3 monthsSuppositoriesWrapped in foil andpacked in an amberglass jar3 months4 weeksFor external use onlyShake the bottleAvoid broken skinFor rectal use only*See BNF for advisorylabels recommendedfor active ingredientBNF – British National Formulary; CRC – Child Resistant Closure* – See General principles of labelling below4 weeks

IntroductionAppearance ––––– – –Correct positionMedicine bottles: The label should be on the front of amedicine bottle about a third of the way down the container.The front of an internal bottle is the curved side and the frontof a fluted bottle is the plain side.Cartons: The label should be placed on the large side of thecarton. If there is not enough room on a single side of thecarton for the entire label, it should be placed around thecarton, ensuring that all the information is visible.Ointment jars: The label should be placed on the side of thejar, ensuring that the contents of the label are visible when thetop is placed on the jar.Ensure that the patient can open the container withoutdestroying the label (e.g. when labelling cartons).Ensure the label is positioned with care and is straight, notcrooked.CleanEnsure the container is clean before packing the product, thenclean the outside before affixing the label. Never pour anyliquids into a pre-labelled container as this risks spoiling thelabel with drips of the medicament.SecureEnsure that the label is secure before dispensing the product tothe patient. The main reason for labels not sticking to productcontainers is because of a dirty or greasy container.Information – – –LegibleAlways check label print size and quality to ensure that it canbe read clearly. If there is too much information to place onone label, consider placing the additional information on asecondary label, rather than reducing the size of the print ortrying to include too much information on one label.ConciseAlthough it is important that sufficient information is placedon the label, it must be remembered that it is important not toconfuse the patient by placing too much information on thelabel. If the label contains too much information, rather thanassisting patients, they may feel overwhelmed and as a resultthey may read none of the information.AdequateEnsure that sufficient information is given. For example, theterm ‘when required’ raises the questions how much? Howoften? When required for what?5

6Pharmaceutical Compounding and Dispensing – –IntelligibleThe wording of the information on the label must be in plainEnglish, be easily understandable and use unambiguousterms. It must always be remembered that patients may feelembarrassed to ask for further clarification on the meaning ofcomplicated words used on the label.AccurateIt is important that the title is accurate, the instructions areaccurate and that the patient name is complete and accurate.Dispensed type labelsIn the UK, detailed requirements for labelling of medicinal productsare contained in the Medicines Act 1968 and in amendments to thatAct made by Statutory Instrument. The legislation distinguishesbetween labelling of a medicinal product for sale and labelling for adispensed product when lesser requirements apply.1.All labels for dispensed medicines must have the name of thepatient – preferably the full name, not just initials – and ifpossible the title of the patient (Mr, Mrs, Miss, Master, Ms etc.) asthis helps to distinguish between family members. The date andthe name and address of the pharmacy are also legally required.This will normally automatically appear on most computerlabelling systems with the date being reset automatically.The words ‘Keep out of the reach of children’ are also legallyrequired, but most labels used for dispensing purposes arealready pre-printed with these words.2. All labels must state the name of theproduct dispensed, the strength whereappropriate, and the quantity dispensed.Remember, the label of apharmaceutical product must be3a. Products for internal usein the right place and containThe title of an extemporaneousthe right information. Thepreparation should be given if it is anfollowing need to be taken intoofficial product (i.e. one with an acceptedconsideration:formula that can be found in an officialtext). The title should be as quoted in theAppearanceofficial text (for example, ‘Ammonia and Correct position CleanIpecacuanha Mixture BP’). SecureIf it is an unofficial product (thatis, a product made from an individualInformationformula, for example, a doctor’s own Legibleformula) it may be labelled ‘The Mixture’ Conciseor ‘The Solution’ etc. Unofficial products Adequatemust state the full quantitative particulars Intelligible Accurateon the label (i.e. the formula must bestated on the label). For preparationsKeyPoints

Introductionintended for internal use, this is expressed as the amount ofingredient per unit dose.For example, the quantitative particulars for a SodiumChloride BP solution 4% with a dose of 10 ml bd could belabelled as:The SolutionEach 10 ml dose contains:Sodium Chloride BPFreshly boiled and cooled purified water400 mgto 10 ml3b. Products for external useLabels for preparations not intended for oral use requireslightly different labelling. If the product being made is official,the official title should be used (e.g. ‘Sodium Bicarbonate EarDrops BP’ or ‘Sodium Chloride Mouthwash BP’).If the product is an unofficial product the label title mayreflect the type of external product:e.g. ‘The Nose Drops’‘The Ear Drops’‘The Mouthwash’‘The Lotion’‘The Enema’ etc.As with preparations intended for oral use, unofficial productsfor external use need to be labelled with the full quantitativeparticulars. In the case of products for external use, thequantitative particulars are expressed as the complete formula.Therefore, the quantitative particulars for 100 ml SodiumChloride BP Lotion 4% would be labelled:The LotionContaining:Sodium Chloride BPFreshly boiled and cooled purified water4gto 100 mlorThe LotionContaining:Sodium Chloride BPFreshly boiled and cooled purified water4%to 100%Similarly, the quantitative particulars for 200 ml of SodiumChloride BP Lotion 4% would be labelled:7

8Pharmaceutical Compounding and DispensingThe LotionContaining:Sodium Chloride BPFreshly boiled and cooled purified water8gto 200 mlorThe LotionContaining:Sodium Chloride BPFreshly boiled and cooled purified water4%to 100%4.Labels must also include an expiry date. See Table 1.1 forguidance. The Medicines Act 1968 (as amended) requiresmedicinal products to specify a month and year after whichthe product should not be used. However, in practice this cancause confusion and an alternative format is to show expiry asa single discard date: for example, ‘Discard after 31.01.07’.5. Warning labels may also be required. These may bepharmaceutical or pharmacological warnings (see labellingappendix in the British National Formulary). Generally ifthere is a choice between two warning labels with equivalentmeaning, the positive one should be chosen (e.g. ‘For rectal useonly’ is preferable to ‘Do not swallow’ for suppositories).Table 1.1 gives guidance on the use of additional auxiliarylabels. Within the UK, the term ‘For external use only’ is usedon any preparation intended for external use. The MedicinesAct 1968 defines products for external use as embrocations,liniments, lotions, liquid antiseptics, other liquids or gels forexternal use.However, traditionally, for the following dosage forms,alternative labels have been employed insteadof ‘For external use only’ to reflect moreclosely the intended purpose of the product.These alternative labels are (indicated on TableRemember, the label of a1.1 by ‘*’):pharmaceutical product willneed to indicate the contents. Enemas: ‘For rectal use only’ For official preparations, it will Gargles and mouthwashes: ‘Not to bebe sufficient to put the officialtaken’title (as this indicates the Inhalations: ‘Not to be taken’contents). Nasal drops: ‘Not to be taken’ For unofficial products, the Pessaries: ‘For vaginal use only’formula will need to be detailed Suppositories: ‘For rectal use only’.on the label. For internalKeyPointsproducts this information isgiven per dose; for externalproducts, per container.Pharmacists should use their professionaljudgement when deciding which auxiliarylabels should be applied to different

Introduction6.7.8.9. pharmaceutical dosage forms. As it is accepted practice withinthe UK to use the terms outlined above, these will be the termsused within each of the product chapters.All directions on labels should use active rather than passiveverbs. For example, ‘Take two’ (not ‘Two to be taken’), ‘Useone’ (not ‘One to be used’), ‘Insert one’ (not ‘One to beinserted’), etc.Where possible, adjacent numbers should be separated bythe formulation name. For example, ‘Take two three times aday’ could allow for easy misinterpretation by the patient.Therefore, ideally, the wording on this label would includethe formulation, e.g. ‘Take two tablets three times a day’.The frequency and quantity of individual doses are alwaysexpressed as words rather than numerals (i.e. ‘two’ not ‘2’).Liquid preparations for internal use usually have their doseexpressed as a certain number of 5 ml doses. This is becausea 5 ml spoon is the normal unit provided to patients tomeasure their dose from the dispensed bottle. Therefore if aprescription called for the dosage instruction 10 ml tds, thiswould be expressed as ‘Take two 5 ml spoonfuls three times aday’. Paediatric prescriptions may ask for a 2.5 ml dose: in thiscase, the label would read ‘Give a 2.5 ml dose using the oralsyringe provided’. Note here the use of the word ‘Give’, as thepreparation is for a child and would be given to the patient bythe parent or guardian.Remember the label on a medicine is included so that the itemcan be identified, and the patient instructed as to the directionsfor use. Therefore, simple language should always be used.Never use the word ‘Take’ on apreparation that is not intended for theoral route of administration.Remember, labels forextemporaneous products needUse ‘Give’ as a dosage instruction onto contain the following:products for children as a responsible Full name (including title) of theadult should administer them.patientOnly use numerals when quoting the Name of the productnumber of millilitres to be given or taken. Quantitative particulars (forAll other dosage instructions should useunofficial products)words in preference to numerals. Appropriate expiry date Additional warnings (whereAlways be prepared to give the patient aappropriate)verbal explanation of the label. Directions for usePharmaceutical packagingAll dispensed medicinal products willneed to be dispensed to the patient in asuitable product container. The function of aKeyPointsThese are in addition to the nameand address of the pharmacy andthe words ‘Keep out of the reach ofchildren’.9

10Pharmaceutical Compounding and Dispensingcontainer for a medicinal product is to maintain the quality, safetyand stability of its contents.Although different pharmaceutical preparations will bepackaged in different containers depending on the product type,pharmaceutical packaging can largely be grouped into a fewmain types.KeyPointsThe ideal container should be:1. Robust enough to protect thecontents against crushing duringhandling and transport2. Convenient to use in orderto promote good patientcompliance (i.e. encouragepatients to take their medicationat the correct times)3. Easy to open and close,especially if the medication isfor an elderly or arthritic patient4. Constructed of materials whichdo not react with the medicine,so the materials of constructionshould be inert5. Sufficiently transparent to allowfor inspection of the contents inthe case of liquid preparations.Tablet bottlesTablet bottles come in a variety of shapes andsizes and are usually made of either glass orplastic (Figure 1.1). Generally, tablet bottlesare coloured amber to reduce the likelihoodof the contents reacting with light. They areused for solid, single-dose preparations thatare intended for oral use (i.e. tablets andcapsules).In normal circumstances, all tablet bottleswould be fitted with child-resistant closures.Although not child-proof, these closuresreduce the possibility of access to medicationby children. There are a number of differenttypes of child-resistant closures on themarket. Consideration should be given to thepatient when using child-resistant closures,as some patient groups (e.g. the elderly andarthritic patients) may not be able to openthe container to access their medication.This can lead to non-compliance or reducedcompliance.Figure 1.1A selection of tablet bottles.w

IntroductionMedical bottlesPlain amber medicine bottlesPlain amber medicine bottles can be used to package all internalliquid preparations. Traditional amber medicine bottles used inthe UK have two different sides, o

as a guide. Any information on additional labelling or expiry dates in the offi cial texts will supersede the information provided in Table 1.1. All suggested expiry dates included in Table 1.1 and other sections of this book are to be used as a guide only and