LABEL for Diazepam, roll
Valid Article
LABEL for injectable drugs
Definition
Pre-printed label (according to ISO standards) for correct identification of injectable medicines in the perioperative area, in order to reduce medication errors.
Specifications
Quality Standards Comment
ASTM D4267 - 07(2015): Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers.
ISO 26825:2020: Anaesthetic and respiratory equipment -- User-applied labels for syringes containing drugs used during anaesthesia -- Colours, design and performance.
Technical specifications
- The label must be self-adhesive.
- If the labels are supplied in tape form, the area where the tape should be cut between labels must be perforated or clearly marked.
- If there is backing material, the label must be easily detachable from it and from adjacent labels.
- The label material should allow additional information (e.g. drug concentration) to be written with a ball-point pen, without smudging or blurring.
- Background colours and patterns should adhere ISO specifications. The background colour must not impair the legibility of any additional information on the label when using a black ball-point pen.
- To designate a drug with opposite actions (including antagonists), use 1 mm wide diagonal stripes of the designated colour, alternating with 1 mm wide white stripes. At least the top 20 % of the label should have diagonal stripes. The top of the drug name must be separated from the diagonal stripes by at least 0.5 mm.
- Each label should measure between 25 mm and 40 mm in length and between 10 mm and 15 mm in width.
- The height of the letters of the drug name should be as large as possible, but not less than 2.5 mm. The font should be a plain sans-serif style, with similar proportions of line and space within the letters (bold or semi-bold style):
- lowercase letters with an initial uppercase letter
- lowercase letters with distinctive parts of similar drug names in uppercase (so-called 'tall-man' lettering)
- all-uppercase lettering should not be used
- Except for drugs with opposite actions (including antagonists), the drug name should be printed in the upper half of the label, leaving space to write the drug's strength.
- All letters should be black, except for the labels for suxamethonium and adrenaline, which should be printed on the background colour with inverted bold letters in a black bar running from one edge of the upper half of the label to the other, with the rest of the label showing the coloured background.
- The concentration unit can be pre-printed at the bottom right corner of the label.
Note on Tall Man Lettering:
Due to the lack of standardisation regarding the name pairs and the uppercase letters to use, it is recommended to follow the list provided by the FDA and IMSP (Institute for Safe Medication Practice): DOPamine, diazePAM, ePHEDrine and fentaNYL.
Others are proposed by the CCWG: KETAmine, PROPofol, THIOpental, MIDAzolam, ATRAcurium, VECUronium, SUXAmenthonium (= succinylcholine), NEOstigmine, MORPhine, NALoxone, LIDOcaine, BUPIvacaine, ONDAnsetron, DEXAmethasone, aTROPine, PHENylephrine, ADREnaline, ANTIbiotic, OXYTocin.
Packaging & Labelling
Presentation in rolls. The number of labels per roll varies depending on the manufacturer: 400 to 1000 labels per roll.
The quantity to be ordered should be based on the number of rolls, not the number of labels.
Some rolls are presented in dispenser boxes, while other manufacturers offer different models of label dispensers that can hold 6 to 24 rolls.
To be Ordered Separately
Dispensor for syringe labels
Instructions for use
Storage
- Below 25°C - Protect from sunlight - Protect from humidity
- Keep the labels in their protective packaging, away from dust, until their use.
MSF requirements
The purpose of these recommendations is to standardise the labelling and facilitate the identification and differentiation of syringes and containers (bags, bottles, etc.) containing injectable medicines used in anaesthesia, in order to reduce the risk of medication errors within MSF projects.
These recommendations are applicable in operating theatres, recovery rooms, and anaesthesia or sedation areas outside of the operating rooms in MSF projects.