Labelling of dispensed medicines
Reasons for labelling dispensed products
Standard details required on labels
Introduction
All dispensed medicines, whether extemporaneously prepared, repackaged from a manufacturer’s pack or a manufacturer’s patient pack, should be individually labelled for the patient. The label on a dispensed medicine has several main functions:
To identify the contents of the container
To provide clear and concise information which will enable the patient to take or use their medicine in the most effective and appropriate way
To identify clearly the patient for whom the medicine is dispensed
Most countries have both legal and professional requirements for the labelling of dispensed medicines. It is the pharmacist’s responsibility to ensure that these requirements are satisfied and that all labelling is accurate and comprehensible. Normally, there are standard details which must appear on every label. However, some medicines may require additional details. The provision of an adequate label, however, does not remove the need to give advice and counselling to the patient (see Ch. 25).
Standard requirements for labelling dispensed medicines
All labels should be in printed form and so the information should be legible. However, it is good professional practice to check each label for legibility (including size of print) before handing the product to the patient.
The details which should appear on the label of a dispensed medicine are:
Name of the preparation, strength and form (if more than one available)
Precautions relating to the use of the product
Name and address of the pharmacy
‘Keep out of reach of children’ or similar
The phrase ‘For external use only’ for certain formulations.
Additional labelling requirements
Warning or advisory labels should be attached to the container, where appropriate
A batch number should be indicated if the preparation has been prepared extemporaneously
An expiry date should be indicated if the preparation has been prepared extemporaneously or the shelf-life has been shortened, e.g. a diluted preparation
Additional legal requirements, e.g. ‘For animal treatment only’ on veterinary prescriptions
The name of the preparation, strength and form
The name which appears on the label must be the same as the one which appears on the prescription. The preparation may be prescribed generically but only be available as a proprietary or branded product; however, the prescribed name must be used. The reason for this is to avoid the patient becoming confused with a variety of names.
The name may be omitted only when the product is prepared to a prescriber’s own formula and contains several active ingredients and has no official name. In these instances, it may be difficult to list all the ingredients on the label and so the pharmaceutical form is used, e.g. ‘the ointment’, ‘the mixture’.
If the preparation is available in more than one strength, e.g. amoxicillin 250 mg and 500 mg capsules, the strength must be included on the label. Such information clearly identifies the medicine.
Similarly, the form of the medicines should be included on the label. This is especially important if the product is available in more than one form (e.g. capsules, syrup, suspension, sachets, injection). The inclusion of the form identifies the medicine and may give an indication of how it is to be used/taken (e.g. suppositories, inhalations, enemas).
Quantity and multiple packs
Normally, the quantity which appears on the label will be the quantity which has been prescribed. Nowadays, many medicines are supplied in the manufacturer’s patient packs, which will be labelled according to the legal requirements. If the quantity on the prescription requires more than one of these patient packs to be dispensed, e.g. two patient packs each containing 28 tablets of the same medicinal product (a total of 56 tablets), then the quantity on the label should be the amount in each container. One of the packs should be labelled as ‘1 of 2’ and the other pack labelled ‘2 of 2’. The patient should be directed to use the pack labelled 1 of 2 and when the contents have been used, the patient should use the pack labelled 2 of 2.
Instructions for use
No patient should leave a pharmacy without knowing how much, how often and how to use/take his or her medication (see Ch. 25). Although the label should be seen as a back-up to the verbal counselling and advice given by the pharmacist, it is still essential to ensure that the wording on the label is clear, concise and comprehensible to the patient. If the prescriber’s instructions are missing or incomplete on the prescription, it is the pharmacist’s professional duty to obtain instructions from the prescriber or use professional discretion to interpret BNF statements.
The way in which instructions are worded is very important and will greatly influence how easily a patient understands the message. Pharmacists should therefore give serious consideration to the wording on medicine labels.
The Royal Pharmaceutical Society Working Party Report (1990) on ‘The Labelling of Dispensed Medicines’ made several recommendations. The use of active verbs is preferred, e.g. ‘take’ instead of ‘to be taken’; ‘apply’ instead of ‘to be applied’. The reason is that research has shown that active verbs are more easily understood and remembered than passive verbs. It is bad practice to have two numbers appearing together in instructions, e.g. ‘take two three times daily’. It is easy for a patient to mentally transpose the position of the numbers so that the previous instruction becomes ‘three twice daily’ in the patient’s mind. To avoid this, the numbers should always be separated by using the formulation name, e.g. ‘take two tablets’, ‘two capsules’, ‘two powders three times daily’. Other recommendations in the report can be seen in Table 31.1.
Table 31.1
Recommended wording for directions
| Recommended wording | Wording to be replaced |
| Do not swallow | Not to be taken |
| Put two drops in the affected eye | Instil two drops into the affected eye |
| For creams or ointments: Spread thinly | Use sparingly |
| For pessaries or suppositories: Gently put one into the vagina/rectum | Insert one into the vagina/rectum |
Numbers which are part of an instruction must always be written as words, except in the case of, e.g. 5 mL, when referring to a 5 mL spoonful, or oral syringe quantities, e.g. a 2.5 mL dose using the oral syringe provided.
Many manufacturers’ packs of medicines contain a patient information leaflet. These normally give detailed instructions (with illustrations) of how to use a medicine, along with other details about the medicine. Patients should be told to read the patient information leaflet before using the medicine. This is a back-up to the label.
Precautions relating to the use of the product
Labelling the product with precautions relating to its use, is for safety reasons. Such labels will be specific to the product and can include: ‘Caution flammable: keep away from fire or flames’ or ‘Not to be consumed by mouth’.
The patient’s name
It is a legal requirement that the name of the patient for whom the medication has been prescribed must appear on the label of all dispensed medicines. If possible, the status of the patient, i.e. Mr, Mrs, Miss, Master, Child or Baby, should be included in order to clearly differentiate from other members of a household, where there may be other persons with the same name. For the same reason, a full first name should also be included if possible, rather than an initial, e.g. Mr James Burnett instead of J. Burnett.
The date and name and address of the pharmacy
The majority of pharmacies use computer systems for prescription labelling and this information will normally appear automatically, with the date being re-set daily. This information is a legal requirement, and enables the source of the medicine and date of dispensing to be traced, if necessary. For example, in the case of possible overdose or poisoning, the label would assist any investigation.
Additional labelling requirements
In addition to the standard details required on all dispensed medicines, there are several extra details which are required in certain circumstances. Some information may be specific to a particular type of formulation.
Storage
General information for different types of preparation can be found in the relevant chapters in this book. Some formulations require special storage and this information should be attached to the label, e.g. transdermal patches should be stored in a cool place. Other labels relating to storage include: ‘protect from light’ and ‘store in a fridge’. Any specific pharmaceutical precautions relating to storage should always be indicated, e.g. glyceryl trinitrate tablets should be labelled with ‘Store the tablets in this bottle with the cap tightly closed. Get a new supply 8 weeks after opening’.
The British Pharmacopoeia (and other pharmacopoeias) uses the terms ‘freshly prepared’ and ‘recently prepared’ for extemporaneously prepared products with a short keeping time. ‘Freshly prepared’ is defined as having been made no more than 24 h before issue for use, but there is no indication of when it should be discarded. In this case, it is usual to give a 1 week discard date. The term ‘recently prepared’ is used for products which should be discarded 4 weeks after issue when stored at 15–25°C.
Information on proprietary medicines can be accessed in the Association of British Pharmaceutical Industries’ (ABPI) Medicines Compendium.
Warnings for patients
Many drugs cause side-effects about which the patient should be informed. It is a professional requirement, subject to the pharmacist’s discretion, that if indicated, these special warnings should be affixed to the container. The BNF contains a list of Cautionary and Advisory labels for dispensed medicines. Nowadays, most computer systems will automatically print these warnings when a label for a particular drug is being produced. However, there are instances when use of this information is inappropriate and professional discretion should be used. For example, the antihistamine, chlorphenamine, requires the warning: ‘Warning. This medicine may make you sleepy. If this happens do not drive or use tools or machines. Do not drink alcohol’. Young children may be prescribed a drug such as this but this warning would be inappropriate. Obviously, it is important to draw attention to the problem of sedation and in this case, a more suitable warning, e.g. ‘Warning. This medicine may make you sleepy’, could be used.
A batch number
When a product has been prepared extemporaneously it is good practice to award it a batch number and incorporate this onto the label. When preparing an extemporaneous product, details of the ingredients used should be recorded (see Ch. 30). The batch number allows referral back to this information.
Expiry date
It is not normally necessary to put an expiry date on the label of a dispensed medicine, although with the increasing dispensing of manufacturers’ original packs, this information will be part of the patient pack labelling. Manufacturers’ expiry dates relate to ideal storage conditions but, unfortunately, when a product has been dispensed and given to the patient there is no longer any control over how it is stored. For this reason, under current legislation, when a product is repackaged for dispensing, no expiry date is stated. Patients should be encouraged to complete the course of medication or, if for any reason a supply is not finished and is no longer required, to bring any remainder back to the pharmacy.
There are, however, specific occasions when an expiry date must be added to the label:
An expiry date should always be put onto any extemporaneously prepared item
An expiry date should always be used when a product has been diluted, thereby affecting its stability and shelf-life
An expiry date should always be indicated when the preparation is sterile, e.g. eye drops. Once opened the product is no longer sterile and if used beyond a certain timescale, there is a serious risk of infection. It is therefore recommended that eye drops and eye ointment, unless otherwise specified by the manufacturer, should be discarded 4 weeks after opening. This instruction should be indicated on the label (see Ch. 42 for further details).
Although the majority of patients will understand what ‘expiry date’ means, it is important to express the information in a clear and unambiguous way. ‘Any unused … to be discarded on … (date)’ or ‘Do not use after … (date)’ are preferred methods of expressing expiry dates.
Legal requirements in certain circumstances
Veterinary dispensed products
The words ‘For animal use only’ or similar, must always be added to the label of a dispensed veterinary product. Instead of the patient’s name, the name of the animal’s owner should appear, along with the owner’s address or address where the animal is kept (see Ch. 28).
Labels for vulnerable patients
Some patients may have difficulty in reading the normal print size of a label due to failing eyesight or blindness. In such cases, consideration should be given to providing additional support to these patients, in the form of large print size on labels or the provision of large print size copies of the labels. In all cases, the medicinal products should be labelled. Additionally, consideration should be given to providing Braille labels for those patients able to read Braille.
Some patients may not be able to read the language on the label due to either illiteracy or being a non-native language reader. It may be possible to provide such a patient with a picture or series of pictures to illustrate the instructions. Many pictograms (a symbol representing a concept, object, activity, place or event by an illustration) have been developed for labelling medicines with instructions on how often and how to take medicines. Similarly, many toxic chemicals are labelled with pictograms to avoid harm to the public. The Risk-benefit Assessment of Drugs-analysis and Response (RAD-AR) Council of Japan, FIP and the USP all have websites showing pictograms for use on pharmaceutical packaging.
Clearly any patient with difficulty reading or understanding a label on a dispensed medicine should be given advice and counselling by the pharmacist before leaving the pharmacy.
Errors in labelling
The potential for making errors when producing a label is considerable and it is important that constant checking is carried out. Practice procedures should be such that the chances of errors occurring are minimized.
Key Points
A label is used to identify and instruct on the use of a medicine, so simple language should be used
All labels must be typewritten or computer-generated
All labels must state the name and quantity of the preparation, patient’s name and instructions, name and address of pharmacy, date of dispensing and ‘Keep out of reach of children’ or similar wording
Warning labels may also be required
Active verbs should be used on the label
Adjacent numbers should be separated by the formulation name (e.g. ‘take two tablets three …’) on a label
As full a name of the patient as possible should be included on the label
The BNF contains details of side-effect warnings which should be used, unless there is a good reason not to do so
Some warning labels may require verbal explanation
It is good practice to give an extemporaneous preparation a batch number
Expiry dates are required on the label when dispensing diluted, sterile and extemporaneous preparations