1989-12-30|Drug labelling in Canada
To whom it may concern
- We would like to tell you a horror story in drug labelling in Canada. In our recent experience, we were unable to determine the dosage of antibiotic drug to our child! Here is a list of what is wrong with the particular package on the prescription drug, as marked in the attached photocopy:
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- The large prescription label overlaps both English and French DOSAGE/POSOLOGIE instructions, making them extremely difficult to read, if possible at all. Are we supposed to remove the lable in a panic situation?
- The DOSAGE specifies daily dosage of 25 to 50 mg/kg in divided doses every 8 hours. What does "/kg" mean? If it should specify the infant's weight, our child who weighs 7 kg would have to take 175 mg to 350 mg in 24 hours, meaning 58.3 mg to 116.6 mg at a time? How are we supposed to measure the weight of the liquid when the bottle only provides a dropper which measures volumes of 0.5 ml or 1.0 ml?
- If we just forget about the instructions on the label and exactly follow the prescription, does the doctor's instruction "1 ML AUX 8 HEURES" mean 1 ml of raw liquid ignoring the DOSAGE, or 1 ml after adding 13 ml of water as in the DIRECTIONS?
- What do "reconstitute" in the DIRECTIONS and "prepared suspension stable" in the DOSAGE mean to the consumers?
- We presume that DIN at the top of the label stands for "Drug Identification Number" which may be very important. What is then "No 694" beside "15 ml" on the label? Also, a mysterious number "2671" shows up following the DOSAGE, only on the English side of the package.
- We presume that EXP.3-91, which shows up only on the French side, means that the drug expires in March, 1991. What does (L)1ZEW-HI following EXP.3-91 mean?
- On the prescription label, various numbers show up frantically and endlessly: "682940", "SUN100789", "4010", "1/1", etc.
- The English title of the package is unreadable because it is almost completely covered by some other adhesive labels.
- The 4 small labels attached to the English side, including the one marked "IMPORTANT", appear in French only.
- We have spent no shorter than 1 hour trying to decipher the instructions only to get further confused and to be still unable to determine the real dosage to our very sick child in an emergency situation. Incidentally, we both have master's degrees (M. Eng. from McMaster University and M. Sc. from Université Laval). How on earth can up to 10% of the Canadian population who are functionally illiterate cope with this drug labelling madness? Only absolute simplicity and consistency for the consumers would be acceptable in life-or-death situations.
- We recognise that certain aspects such as unilingual labels attached by the pharmacy may fall into provincial jurisdiction. However, if our child's health is at stake, we cannot accept it as Canadian citizens, and we are sure that you are in complete agreement with us. We wonder if you could show a strong leadership and enforce a law/regulation to avoid potential tragedies just as you have demonstrated in the Declaration of Taxpayer Rights while you were Minister of Revenue.
- Thank you very much for your attention.
- Merci de votre attention.
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