4 Labelling ‘The labels on dispensed medicines thould— LL Give the patient clear and complete instructions on pow w take or use the preparation. 2. Indicate the storage conditions necessary 10 ensure fall potency the period of treatment. 4. Be neatly written and carefully displayed on the con~ tainer, thus strengthening the patient's confidence in the preparation Conventional labels are backed with water-acti- vated gum and are moistened with a label dampener (ot the tongue!); they are satisfactory on glass or paperboard surfaces but they quickly separate from plastics or metals. Adhesion to'the last two can be achieved with suitable glues (eg, Fastik, which is available in # pen) but self-adhesive labels, which can be obtained in reels (used in special dispensers) or on sheets, are a more acceptable alternative. Labels are purchased ready-printed with the name and address of the pharmacy and, if desired, with cer- tain common directions to the patient. Conventionally, the printing is red for labels of external preparations, the association of red with danger helping to prevent a cidental ingestion of the medicine. Information Given on the Label A. NAME AND STRENGTH OF PRESCRIBED PREPARATION 1, NALS. Prescriptions The pharmacist automatically gives the name and strength of the prescribed preparation unless— (a) The prescriber has lecters dg te cuetineitn ee Sosa Printed in & box in the top right-hand corner prescribing rea fal NLM. prescripion lores Dare “ dicates that the patient is not to know the nature son neat th tt mci smpy tate the spe of preparation, 8. The ture, ules etc, Minture Tpresciber hes tndicated on the form that he prefers another description, such as “The Sedative Tablets’. ration has a special formula for which stares es cee nee nor a proprietary product). To NP label this type of preparation, all of the ingredients would have to be stated and, therefore, only the type of product, ¢.g. The Ointment, is indicated. : (d) The product is a Controlled Drug, in which case the prescriber must write his initials alongside the printed letters NP if proper-name’labelling is required. Should the prescriber not want the proper name for some of several items on a prescription he must cross out the printed letters NP and write them agdinst those items he wishes to have identified. ‘A problem arises when a medicine requires dilution to raise the dose to $ ml or a multiple thereof. In these circumstances the container is labelled with the percen- tage of undiluted preparation, For example, if 50 ml of Chloral Mixture B.P.C. has been diluted to 100'ml itis labelled ‘Chloral Mixture B.P.C, $0 per cent’. This statement is imprecise when the diluent is other than water but in the unlikely event of this knowledge being important it can be obtained from the B.P.C. or a, diluent directory (p. 68). uh 2 Private Prescriptions Prescriber writes NP or an alternative descriptive wording (see (8) above) against those items he wishes labelled with their proper names or 1 description, Proper-name labelling. was introduced for manyan lead to delayed treatmem, which con be . For example. overdosage with iron : Freparable hi im. mediately treated. ee (@)/No other record of treatment may be available toa cannot be relied up- (on, because the container may have been emptied. _(@) Proper-name labelling prevents confusion when the Patient is receiving several medicaments. ) The patient should be his Lf ons ‘ehcouraged to understand is BS os © Asitagonists 0° tue system argue that— ‘The patient may recognise the drug.as one given to an, tance with a dangerous disease, draw the sian, and worry unnecessarily. ~ » Hemay lead to self-medication. Refusal by the phar- Macist to supply could be embarrassing for him and ‘the customer. ‘Medical advice may be given by lay ‘experts Patients are known to anaes Sees tice one coms to another. crgsions tore p24). L we From the rules outlined above itis ‘name labelling is limited to— Preparations included BP.C., BP. etc.)s Préparations described by a proprietary name. Preparations containing a single drug. in an official book (B.N.F. The strength need not be stated where it is obvious from the name of the Preparation. For example, many “ial preparations are-of,one Strength only and the name, followed by the appropriate letters, BNF, BPC. BP. etc. defiges the strength. Similarly, the strength is unnecessary for " Preparations. However, it ‘could be in doubt as, for e products such as many tabl . DIRECTIONS FOR USE Generally, the prescriber wr heading ‘Label’ (below the formula for the preparation) oF at the head of the section to which the product belongs (€.g. Mixtures), are used, For example, at the beginning of the section on Mixtures is the statement: “In the absence of instructions by the presi, the dose given below the she i teen od dose i piven Hae Two 5 ml spoons o be taken three times a day in water’. Itis advisable to add : otherwise6 DISPENSING FOR PHARMACEUTICAL STUDENTS ‘characteristic reference number. e.g. B.77.2, that is ‘written on the prescription and on the container: this allows the record to be traced easily if the patient brings the container and not the prescription when a further supply is needed. (N.B. In some cases prescriptions can- not be repeated unless the form is available or a new prescription is obtained from the prescriber; for details, See a textbook-of forensic pharmacy.) The reference fnumber is conveniently written at the left-hand side of the label on the,same level as the patient's name; followed by the date of dispensing, N.H.S, prescriptions are not recorded in the prescrip- tion book and only the date is given on the label, Presentation of Information The label must not be too small or the information will not be clearly legible. For tiny containers it may have to over the complete depth of the body of the container bbut it. must not project above, because the free collar thus greated may be caught by a finger and.torn awe; with loss of important information. If necessary it should be carefully cut to size. The size of the label should also be related to the size of the container. A small Iabel, even though it is big enough to display the information legibly, will look out of place on a large bottle, Handwritten labels are most easily read if written in black ink, such as Fount India which is suitable for fountain pens. Ball point pens that do not write clean lines are unsuitable. 4 typewriter is valuable for those whose haidwriting is untidy but the type should be clear and the ribbon regularly replaced. Special label-writing \ypewriters are available with condensed typefaces (e.g. 17 characters to an inch) and an attachment that takes several spools of different sizes of gummed or adhesive labels. Its easier to type evenly over all ofthe label area ‘with a spool than with a single label. c Numbers, except when they occur in statements strength or in the term’S ml spoonful’ should be given in words to avoid confusion and incorrect dosage. For example, TWO 5 ml spoonfuls’ is free from the mis- interpretation that might arise with 2 5 ml spoonfuls’ ¥ passive voice, e.g. "Two to be taken’, is preferable to the rather brusque active form, ‘Take two’. Information shoyld be well-balanced, with the name Me meeigicn 2f the preparation placed symmetrically to the top, followed by the when relevant ‘nd then the directions. oe : _ ip connection with the statement of strength, vice given in the BNF. regarding the nee of ab. and a zero before the decimal point, which in detail in tion with inject Examples of Labels Private Prescription. Not NP —ss THE MIXTURE TWO 5 ml spoonfuls to be taken THREE times a day in water, unless otherwise directed 5.3 (7.7.74) Mrs C Jones Name and Address of Pharmacy” N.H.S. Prescription. NP 50 FERROUS GLUCONATE TABLETS 300 mg One to be taken three times a day 1.7.94 Miss A Brown Name and Address of Pharmacy N.B. The use of 300 mg and not 0-3 g (see p. 32). It is useful to state themumber of tablets since. in a case of poisoning, this might give an indication of the dose ingested. Additional Labels ‘These may be— 1. Required by law. i 2, Necessary for pharmaceutical reasons, ¢.¢— (@) To indicate. restrictions on’ the use: of the preparation. (6) To give special instructions on the method of use. (©) To specify storage conditions and shelf life. ‘Sometimes these can be written on the main label ‘and, whenever possible, this is desirable for instructions ‘on the method of use. Alternatively, separate labels may be used; the common ones can be purchased ready- Printed and have the advantage that they are more ey®- Catching than the equivalent written labels. te aneLee Os arranged carefully on the container ‘backs’ Never attached to closures (see p. 20), INSTRUCTIONS REQUIRED BY LAW The word ‘Poison’ is not used on dispensed ‘ations unless the prescriber specifically requests { Ifthe preparation is a poison one of two labels may be necessary in certain circumstances — 2 ‘ur External Use Only" : This, together with a description of the preparation, such as ‘The Liniment’, is required in the case of liquid ‘medicines for external application, (In law, articles for Application to mucous membranes are not regarded as aor for external application, e.g. mouthwashes, ‘gargles, throat sprays, ear and nasal drops, eye drops and lotions, douches and inhalations.) 2. ‘Not 10 be Taken’ wad This is used if the liquid is @ preparation other than a medicine and is contained in bottle of not more than 120 1 o2 (3 litres) capacity. Antiseptic and disinfectant Solutions are examples, = INSTRUCTIONS RESTRICTING USE OF PREPARATION 1 > 1 a ‘solutions, 5 ore Sib: *. Tete tote cass of pons describes above Batis relape eere LABELLING . (d) Solution tabiets, (6) Unit-dose forms not intended essaries, suppositories and vitrelae. used to prepare disinfectant and antiseptic solutions. , ‘A patient might be worried by the use of ‘Not to be Taken’ for preparations in groups (b) and (c) because he ‘might feel he was ‘taking’ nasal drops, enemas, sup. Positories ete. Therefore, altern have been suggested for these groups. One possibility is ‘Nor 1o be taken by mouth’ but this is not entirely satisfactory for nasal sprays and drops; another is to use precise, although not particularly elegant wording, such as— ‘For nasal use only’—for nasal sprays and drops. ‘For rectal use only'—for enemas and suppositories. ‘For vaginal use only'—for pessaries. Choice is largely a matter of opinion. INSTRUCTIONS FOR USING THE PREPARATION ‘Shake the bottle’ This is necessary on all liquid disperse systems, such as suspensions and emulsions, because, if the dispersed phiase separates and the container is not shaken before ‘use, the patient will take low doses of medicament at first and high doses towards the end of the bottle. Both effects are particularly serious with oral medicines ‘because the patient might not benefit from low dosage and might be harmed by overdosage. _ Several applications, liniments and lotions are’dis- Derse systems and require this label. Its needed also on ‘any medicine in which precipitation or separation could ‘occur on storage: examples are mixtures containing vegetable extracts (such as tinctures) from which con- stituents may be precipitated in fine suspension (often rather slowly) as a result of the change of solvent when the extract is added to water. " Special nsiructons ‘These are relevant to particular classes of pre- Cachets because of their large size and sharp edges (wet-seal type) or angles (dry-seal type) are hard 10 ee ee ak be in water, fw a Mati de mite oe pests gee acoENEMAS : Because the rectal administration of cold liquids is un- —— enemas of large volume should be labelled ‘To warmed 10 body temperature before use’. GARGLES AND MOUTHWASHES ‘These require directions for dilution with warm water before use. Additionally, exept for those gargles in- tgnded to be swallowed, they should be labelled /Not 10, be taken’ or, preferably, because it is less like}y 0 worry the patient if he swallows a little by accidgat ‘Not 10 be swallowed in large amounts’. e INHALATIONS a Althauah inhator- * ¢ uséd in more than one way : ‘hat are most often met in . ng (Menthol and Benzoin and Eucalyptus Inhalation) tructions on the prescription, poonfiul to a pint of hot, not the vapour’. Use of boiling ingredients to quickly and sens wo see patient. SINSUFFLATIONS AND SPRAYS “In the absence of contrary instructions from the prescriber, these should be labelled ‘To be used in a sulrable atomiser as directed’ and the pharmacist should confirm that the patient has an atomiser and knows how to use it correctly (see p. 8). LNcTUSES H ‘As these are intended to soothe the throat they should not be diluted or swallowed quickly. The appropriate in- struction is ‘To be sipped and swallowed slowly without the addition of water’. -<\. MIXTURES FOR ADULTS As these are relatively concentrated preparations they nay be unpleasant to take unless diluted with water. Adult mixtures are always taken in water (see p. 25) unless the prescriber directs otherwise. MIXTURES POR CHILDREN Paediatric mixtures are usually given undiluted but some contain ingredients that itritate the stomach or in- testine and may cause vomiting and diarrhoea unless the preparation is well-diluted with water before ad- ministration, Examples ‘are Chloral Mixture, Ferrous Sulphate Mixture, Paediatric and Ferric Ammonium Citrate Mixture, Paediatric. The omission of a direction, to dilute well with water is a serious error. i TABLETS Special directions apply to certain types of tablet. For DISPENSING FOR PHARMACEUTICAL STUDENTS (a) Tablets that require mast Daas isintegration in the gut are labelled "To be thened before swallowing’ (e.g. Calcium Glucongte, Compound Magnesium Carbonate and Compoung Magnesium Trisiljcate Tablets). : GB) Wheh disintegration does not readily take place in the alimentary tract the tablets are labelled To be rushed before swallowing’ (e.8- Caleium and Vitamin ets). : ete drugs that are more effectively absorbed frase the buccal mucosa than from the stomach the direction ‘To be dissolved slowly in the mouth’ is used (eg, Glyceryl Trinitrite Tablets and Oxytocin Tablets) i) The direction ‘To be dissolved in water before taking’ applies to. substances. such as potassium chloride. that are very irritant to the gastric mucosa un- fess taken in very dilute solution. This instruction is also hecessazy for effervescent tablets: as these contain a Garbondte of bicarbonate and citric and/or tartaric acid they effervesce with water and this assists disintegration - of the tablet and produces a solution that is relatively pleasant to take. YITRELLAE, These require the instruction ‘To be crushed between the ; (finger and thumb and the vapour inhaled’ (see p. 11). INDIVIDUAL PREPARATIONS TO WHICH SPECIAL IN. STRUCTIONS ARE RELEVANT Watch must be kept for directions peculiar to a par- ticular preparation. For example— () The directions for using Benzyl Benzoate Application. (i) The warning, relevant to Phenol Ear Drops, that ‘Dilution with water renders these drops caustic’. i) The warning applicable to Podophyllum Paint and Dithranol Paste that “This preparation is very irri- tant to the eyes and tender parts of the skin. Clayton (1972) has drawn attention to, the frequent need for special instructions to ensure that patients take medicines in a manner that produces. maximum therapeutic effect. For example, when tettacyclines af administered with milk, or cloxacillin is taken on a full stomach, absorption is impairec. Since verbal advice may be forgotten, itis advisable to provide this informa- tion by labelling. Clayton lists almost 100 drugs to which one or more of twelve dosage i and he suggests that, as a reminder, stock bottles in the dispensary should carry a copy of the warning label necessary when a prescription for the contents i$ dispensed.SHELF LIFE ‘Store ina cool place’ Storage in a cooltplace, ie. at not more than 15°C, is necessary for many products, e.g ‘Capsules—loss of moisture makes the Shells brittle, Creams—to prevent ‘drying-out’ “Collodions, Paints and Vit in vont een ‘itreiiae—they contain volatile Emulsions—high temperatures ‘creaming. Ointments—to prevent (a) loss of water (when present), (6) loss of volatile ingredi breakdown, mile ingredients, and (c) structural Moulded ‘suppositories and 37°C or slightly below. : tions containing thermolabile medica- ments—to prevent loss of potency. volatile ingredic . Tur eral sometimes I potaneonat mite tome this label on exten Fe tf ‘contain ingredient | rts es ete foe remeron ce Although few patients will know the meaning of ‘coo! place’, the warning should ensure that the preparation is | Rot kept on a radiator shelf or on the mantelpiece. % “thine lil : This label is unnecessary when a light-sensitive prepara- - tion is packed in iisehaan ‘container but is Tequired if such a container is not available or ifit is con- sidered advisable not to use one (see p. 367). Although sugar-coating usually gives adequate light protection to the ingredients of tablets, itis advisable to pack these visually-attractive products in a coloured ‘container in which they are ess obvious tachildren. For the same reason, capsub's, even if they have shells coloured with a light-resistant substance, should be Packed in the same way. The thells of-cachets are ert ned let sewn pees Set ‘A few medicaments, e.g. paraldehyde, must be stored in complete darkness “and a label to this effect is necessary. A light-resistant container is not enough. ‘Inflammable’ . - ‘The Pharmaceutical Society of Great Britain’ has made the following recommendations— i‘ _1, When scalp lotions and shampoos containing $0 ‘cent or more of alcohol, or containing a more in- ble solvent, either alone or in combination, are d, they should be labelled ‘Caution, this oe ae jay encourage essaries—some melt at 3 LABELLING INSTRUCTIONS INDICATING STORAGE CONDITIONS AND* ww reparation is inflamniable. Do not use it or dry the hair near a fire or naked flame’. °° 2. When any other preparatton containing 50 per cent or more of alcohol, or containing anothé&ijafiam Mable solvent, is dispensed or sold, it should carry the word ‘Inflammable’. Examples to which one or other of these labels apply, depending on the intended use of the preparation, are Salicylic Acid Lotion B.P.C., which contains about 90 per cent of alcohol, and Coal Tar Paint B.P.C., which is a solution of crude coal tar in acetone and benzene. EXPIRY DATE It may be necessary to dilute official mixtures. elixirs and linctuses to raise fractional doses to 5 ml or a multi ple thereof (see p. 68). In addition, certain creams and lotions, particularly those containing corticosteroids, * are more concentrated than is necessary for many pur- poses; therefore requests for dilution are received, The stability of these five classes of preparation is lowered by dilution and, singe the concentration of any antimicrobial. ingredient will also be diluted, their protection against microbial contamination is reduced. ‘Consequently, if the diluted preparations are not used within a specified period they must be discarded. The period is usually two weeks for diluted mixtures, elixirs and linctuses (phenethicilin, phenoxymethylpenicillin ‘and propicillin elixirs are exceptions —one week period) «and one monift for ereams and lotions. This should be indicated on the label by stating the expiry date; this is preferable to giving the storage life, which involves the patient in a calculation. z Protection of Children All dispensed medicines should dicating the importance of storage in’a place inaccessi ble to children. A suitable wording is ‘For safety's sake, keep owt of the reach of children’ and this should appear on a separate label or as part of the text of the main bel. Warning Cards Patients under treatment with certain drugs may have Serious reactions if they eat particular foods or take cer- © tain other drugs. For example— ms (a) Amine-containing foods should not be eaten by” patients taking: monoamine-oxidase inhipitors (MAO}s). () Aspirin-containing preparations should be avoided completely by patients under treatment with coumarin anticoagulants, oral antidiabetic drugs or, the antineoplastic drug, methotrexate. In these instances, patients can be in difficulty through not knowing which foods contain amines or