Module 6

TOPRA 20 2 2 ©

CASE STUDY

“ OTC SWITCH ” WORKSHOP

INTRODUCTION This workshop provides you with an opportunity to explore how you might convert the EU patient information leaflet for a prescription product into one that would be suitable for OTC supply.

Remember that the consumer is using the product without medical supervision. The only source of advice that they have is their local pharmacy , and the PIL .

BACKGROUND One of the EU regulatory agencies has taken the unprecedented step of permitting the use of the antibiotic co - trimoxazole for OTC supply in the treatment of cystitis (severe bladder infection).

A copy of the current approved Patient Information Leaflet is attached.

WHAT YOU NEED TO DO

Review the attached EU Patient Information Leaflet, which is for a Prescription-Only medicine, and provide the following feedback: 1. Using a score of 1 (simple) to 10 (very complicated), how complicated is the wording at the moment? 2. Review the INDICATIONS section of the PIL and DELETE anything that is not relevant. How would you re-word the indication for OTC use? 3. What are the really important messages that you will need to include to help ensure that the product is used safely? 4. Provide examples of current wording that is not patient friendly enough (for example, saying “ redness generalising to the whole body ” ) If you were recommending this product for OTC use, what is the main advantage of the product, for the consumer ? W hat could the “ strapline ” be? (for example, if this was for headache , you might say “ fast, effective relief …” ). What name would you give the product?

CASE STUDY 3 – TOPRA MODULE 6