Pseudoephedrine - HPRA Implement Risk Minimisation Measures

The Health Products Regulatory Authority (HPRA) has implemented the following two risk minimisation measures surrounding the sale and supply of pseudoephedrine containing medicines:

  1. Impose a maximum quantity per pack of 720mg pseudoephedrine. Packs containing more than 720mg would not be marketed for pharmacy sale without a prescription.
  2. Limit pharmacy sales of all pseudoephedrine containing medicines to one pack per transaction.

The HPRA has stated that conditions have been added to the licenses of all relevant pseudoephedrine containing medicinal products. Pharmacies will be permitted to run down existing stocks that do not meet the conditions; there will be no recall of stock at this time.

Full details are provided in the HPRA Medicinal Products Newsletter, January-April 2016.

We ask that all relevant staff members are alerted to these changes and pharmacy procedures are updated to reflect these controls.

The issue of illegal use of pseudoephedrine has been highlighted previously through the PSI newsletter along with points to assist pharmacists in dealing with requests for pseudoephedrine, which you may find of use.

(This update was included in Issue 3 of the PSI Newsletter (May) 2016)