Prescription and Record Keeping Requirements

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• 1. Is a prescription written by a doctor registered in another European Economic Area (EEA) country legally valid to dispense in Ireland?

  A prescription written by a registered doctor practising in another EEA Member State may be dispensed in Ireland provided it meets the legal requirements.  In 2015, there were amendments to the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (amended), which detail the requirements for such prescriptions to be legally valid in Ireland. This update should be read in full (it was originally published in issue 2 of the PSI newsletter in 2015).

  Under this legislation, prescriptions from other practitioners, for example dentists and nurses, registered in another EEA Member State may also be legally valid in Ireland. 

  In accordance with the Code of Conduct for Pharmacists, the practice by a pharmacist of his/her profession must be directed to maintaining and improving the health, wellbeing, care and safety of the patient at all times. As well as the requirements detailed in the legislation, the pharmacist must be satisfied as to the authenticity, content and their understanding of the instructions on the prescription, and more importantly, that it is safe and appropriate to dispense the medicine for the individual patient. If the prescription does not meet the legal requirements or you are not satisfied that the medicine is appropriate for the patient, you should explain this to the patient and refer them to another appropriate healthcare professional or service for further care.   

  In addition, please note:
  

  • The original prescription must be presented in the pharmacy. A fax or scanned copy of a prescription is not a legally valid prescription. Electronic prescriptions are not currently supported by the current legislation in Ireland. 
  • Products classified as schedule 2, schedule 3 or schedule 4 part 1 controlled drugs may not be prescribed by practitioners registered in another EEA Member State for dispensing in Ireland, and such prescriptions may not be used to authorise the supply of any such controlled drug.
  • The product prescribed must be licensed in Ireland.

• 2. Is a prescription written by a doctor registered in a country outside the EEA valid for dispensing in Ireland?

  Prescriptions written by doctors outside of the EU/EEA are not legally valid in Ireland and legislation does not facilitate emergency supplies of medicines to these patients.  If presented with such a prescription, you should explain this to the patient and refer them to another appropriate healthcare professional or service for further care.

• 3. How long is a high tech prescription valid for?

  A prescription issued for a high tech medicine is subject to the same legal controls as any other prescription. The maximum validity period for any prescription issued (excluding schedule 2 and 3 controlled drugs) is six months from the date of issue. This ensures that the patient receives ongoing clinical review at appropriate intervals and is central to ensuring the safe use of these medicines. Some high tech prescriptions may specify an earlier date of patient review and care must be taken to ensure the prescriber’s instructions are correctly interpreted and followed. A prescription dispensed outside its expiry date can result in the patient not receiving the necessary clinical review, which could potentially result in harm to the patient.

  This information is contained in Section 2.1 Prescription Requirements of the PSI’s guidance Good Dispensing Practice – High Tech Scheme.

• 4. Is a prescription for a high tech medicine written by a GP valid for dispensing?

  The high tech scheme is a government reimbursement scheme which falls under the jurisdiction of the HSE. Any pharmacist participating and delivering care to a patient under this scheme must ensure that they adhere fully to the operational requirements provided by the HSE.

  Under this scheme the HSE requires that high tech medicines are initiated by a consultant doctor, who is responsible for overseeing the patient’s therapy and care, and therefore their review at appropriate intervals, depending on the clinical particulars.

  If the date of review of therapy specified by the consultant on the high tech prescription is for a period that exceeds 6 months and the GP is satisfied that it is appropriate for the patient to continue to take the medicine, they can issue a prescription for the high tech medicine provided that the product is for use within the specified review date.  The GP would be accepting responsibility for this supply and must be satisfied that it is safe and appropriate for the patient when each prescription is issued.

  This is set out in Section 2.1 Prescription Requirements of the PSI’s guidance Good Dispensing Practice – High Tech Scheme.

• 5. How long do I have to keep records at the pharmacy such as prescriptions, invoices and the duty register?

  The PSI’s Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business contains relevant information on how long records must be retained under legislation. The requirements for some other important records that promote safe pharmacy practice are also included.

• 6. How long do I have to retain the patient medication record (PMR)?

  The PSI’s Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business sets out the legal requirement to maintain a patient medication record (PMR). The legislation does not specify a minimum or maximum time period for the maintenance of this record. However, data protection legislation applies to all patient related pharmacy records. Section 5 of the Guidance on Data Protection for Pharmacists provides guidance on the eight principles of Data Protection, including;
  

  • Principle 7: Retain it for no longer than is necessary for the specified purpose or purposes, and
  • Principle 8: Give a copy of his/her personal data to an individual, on request.

  When developing and maintaining policies on the retention of records, as well as complying with the requirements set out in legislation, it is important to consider whether it is necessary to retain the record for a longer period to ensure the provision of safe services to patients, or for other legal or insurance purposes. Data protection requirements also require that there be a defined retention period for all records, which is clearly documented.

  Pharmacists and pharmacy owners should seek the advice of the Data Protection Commissioner and/or their legal advisors if they have questions regarding specific issues.