Substitution of Medicines not included in the HPRA (IMB) List of Interchangeable Medicines

The PSI has received a number of queries from patients, pharmacists and other healthcare professionals on the requirements for generic substitution of medicines that are not included on the Health Products Regulatory Authority (HPRA) (formerly the IMB) List of Interchangeable Medicines. The PSI has prepared the following information for pharmacists to clarify the circumstances in which generic substitution is allowed and how patients can be advised and accommodated in their choice for a generic medicine or otherwise. 

Pharmacists will be aware that under the health (Pricing and Supply of Medical Goods) Act 2013 (the Act) a system of generic substitution and reference pricing has been introduced for interchangeable medicinal products as listed by the HPRA, and which is binding on all pharmacists working in retail pharmacy businesses. It should be noted that the entitlement to substitute under this Act only arises in the case of medicinal products that are included in the List of Interchangeable Medicinal Products established and published by the HPRA. This list is available on the HPRA website. 

Depending on how a prescription is issued the following applies: 

1. Prescriptions Issued Using a Brand or Proprietary Name 

If a prescription has not been issued on a non-proprietary basis (i.e. the prescription has been issued using a brand or proprietary name) then generic substitution may only be made in the following circumstances: 

• In the case of those medicines which have been designated as interchangeable by the HPRA or 
• Where the prescribing doctor has indicated on the prescription that a generic equivalent can be provided or 
• Where the pharmacist has consulted and agreed with the prescribing doctor or 
• Where the pharmacist has an arrangement with that doctor, in writing, directing such substitution on an ongoing basis. 

It should be noted that under the Act, where the prescribed product is one that is included in a group of interchangeable medicinal products published by the HPRA, the pharmacist must offer the patient the option to accept the substitute medicinal product, from within the interchangeable group, that is in stock and is of the lowest cost to the State or to the patient, as the case may be.   

2. Issued on a Non- Proprietary Basis (‘written generically’) 

If a prescription has been issued on a non-proprietary basis (i.e. the prescription has been issued using the international non-proprietary name (INN) for the medicine) the pharmacist may dispense any equivalent medicinal product whether proprietary or non-proprietary as outlined below: 

• If the medicine is one that is included in the List of Interchangeable Medicinal Products published by the HPRA the pharmacist must offer the patient the option to accept the substitute medicinal product that is in stock from within the interchangeable group that is of lowest cost to the State or to the patient, as the case may be.
• If the medicine is not listed on the HPRA interchangeable list, pharmacists may dispense any equivalent medicinal product whether proprietary or non-proprietary, which the pharmacist has in stock and is of the lowest cost to the State or to the patient, as the case may be. In such cases, pharmacists should consult with the patient and exercise their professional judgment when selecting the product to be supplied so that any change to the patient’s usual product is safe and that efficacy will not be affected e.g. pharmacists should not substitute medicines with a narrow therapeutic index or those with differing pharmacokinetic profiles likely to impact on efficacy or safety e.g. certain anti-epileptics, anticoagulants, lithium products. (It should be noted that this guidance relates to products outside of the list of interchangeable medicines only, as the assessment carried out by the HPRA to include medicines on the interchangeable list takes account of these considerations.) 

Patient Information and Counselling

Where a patient asks about generic medicines, it is appropriate for a pharmacist to discuss generic medicines with the patient and where appropriate recommend to the patient that they ask their doctor to prescribe a generic medicine or to offer to speak to the doctor on the patient’s behalf. 
 
Pharmacists have a very important role in providing information and education to patients on medicines and that role is particularly important when supplying a substitute medicinal product. Therefore, when a medicine is substituted, pharmacists must take time to ensure that patients receive appropriate counselling so as to ensure that patients understand the correct use of their medicines. 
 
As the List of Interchangeable Medicines is subject to regular updates, all pharmacists are encouraged to subscribe to the HPRA website updates service to receive email and/or SMS alerts of changes to the list. Further information and guidance for pharmacists can also be found on the HPRA and Department of Health websites.  

Medicines authorised in Ireland   

Medicines authorised in Ireland by the Health Products Regulatory Authority (HPRA) and medicines centrally authorised by the European Medicines Agency are easily searchable on the HPRA website. This is an up-to-date reference listing of medicines that includes all prescription and over-the-counter medicines whether they are original brand-name medicines or generic versions along with their classifications, summary of product characteristics document, and in many cases providing access to the package leaflet for patient information purposes.