The supply of medicinal products by way prescriptions by way is regulated under regulations made under the Health Products Regulatory Authority Acts and successor legislation.
Prescription may be made by doctors, dentists, and registered nurses in Ireland and equivalents in other EU States exercising EU community rights. The controls apply to supplies made in the State and from outside the State from another EU State.
For reasons that are readily apparent, many medicines may be supplied only on prescription. Medicines must be authorised under the appropriate authorisation regulations or under very limited exceptions to time. The supply of prescription medicine must be undertaken by a registered pharmacist or a person under his personal supervision. A list of medicines is controlled by regulation. The detailed list is amended from time to time.
A doctor or dentist may administer medicinal products subject to the regulations, and the relevant conditions that apply to the medicine concerned. A non-doctor may administer prescription products, provided it is done in accordance with the directions of a doctor or a dentist. There is exemption from prescription control in respect of a wide range of medicines which are prescribed subject to certain quantities and conditions.
Veterinary medicines are excepted provided they are clearly labelled, “for animal treatment only.”
Medicines which are exempt because of their size, dimensions, indications etc., may be sold from a retail pharmacy under the supervision of a pharmacist. Other general medicines may be sold in any retail outlet.
Medicines are classified in accordance with whether they require a prescription are pharmacy only or are general. The relevant classification is applicable to each medicine. The general position is that the medicines that are not subject to supply by prescription can be supplied by pharmacies.
There is provision for a general sale category, whereby regulations may be made permitting general of sale medicines in accordance with conditions and criteria prescribed by the Health Products Regulatory Authority. The products must be lawfully on the market in accordance with proper marketing authorisations.
Nurses and midwives may prescribe many medicines. They must be employed by the health service provider in a public or private health service setting, it must be one normally provided as part of the health service setting where the nurse is employed and the prescription must be issued in the usual course of the health service.
A health service provider may restrict the authority to prescribe. The pharmacist must be satisfied that the relevant conditions apply.
Prescriptions must be in writing in ink and be signed by the prescriber. They must set out the name, address and certain other particulars. They must specify the address of the patient and age, if under 12.
There are rules in relation to the dispensing of prescriptions. Separate rules apply to ordinary medicinal products and controlled drugs. Prescriptions are valid for six months.
A specific repeat direction may be included. This must be specifically provided for. It is available in respect of certain types of medicines only whereby a pharmacist may repeat prescription for up to 12 months, unless directed to the contrary. Dentist may not give repeated prescriptions with limited exceptions.
Certain types of medicines are subject to additional rules. Certain other classifications, such as radiopharmaceuticals, specialist diagnostic medicines may only be dispensed by a hospital.
When dispensing is complete without repeats or at six-months expiry, the pharmacy must cancel the prescription by writing the word “dispensed” and the date. It must be retained for two years.
There is provision for the emergency supply of medicines at the request of the doctor, dentist or nurse. The pharmacist must be requested to supply a particular patient. If the prescriber is unable to complete a prescription immediately, he undertakes to do so within 24 hours. The provision does not apply to certain categories of medicines.
There are provisions for the emergency supply of medicines at the request of a patient. The pharmacist must have interviewed the person requesting the medicine and be satisfied as to the immediate needs. Other detailed conditions apply, in particular in relation to the quantity and dosage. It not applicable to all medicines. The product must be labelled with certain particulars including the words, \”emergency supply.\”
There is legislation applicable to the labelling of medical products which have been dispensed. This includes medicines supplied by doctors or dentists, patients under his care and to dispensing by pharmacist in exercise of their own judgment.
Information on the label includes
- the name of the patient,
- name of the pharmacy, doctor or dentist,
- date of dispensing,
- name, whether generic or brand name, unless otherwise directed by the prescriber directions for use,
- warnings as specified.
Certain of the information need not be included if it is provided in the manufacturer\’s original pack.
Pharmacies must keep a register of prescriptions including all transactions of prescription only medicines to the public. A counterpart of the label may be retained. The records may be in electronic form.
Detail of the information to be recorded in the prescription register include particular information on supply including
- name of prescriber,
- name of prescribee,
- date of prescription.
- in the case of repeat, prescription dates and certain other particulars;
- in the case of an emergency supply, details similar to above including details of the emergency concerned.
There are provisions in respect of wholesale transactions, including in particular
- names of person supplied,
- purposes etc.
All relevant records must be kept in the premises and are open for inspection. They must be retained for at least two years.
There are limited exceptions to the requirements to enter details on the prescription register. They include
- health prescriptions under the GMS scheme where a preprinted prescription is used. A duplicate only may be a retained.
- sale and supply of controlled drugs which require a separate register,
- certain wholesale supplies where the invoice is simply retained,
- certain samples.
Certain other drugs are subject to specific requirements. For example, there are special regulations on the control of paracetamol which are incorporated in the general regulations. It may only be supplied without prescription from pharmacy subject to restrictions on quantities. The pharmacist must be satisfied as to safety. There are limits on the amount that may be satisfied. Provisions are made to prevent purchase of multiple pharmaceutical paracetamol.
Labels and package leaflet\’ information is required in respect of paracetamol, and paracetamol containing tablets. There are provisions as to what may include particular warnings regarding dosage,requirement for independent immediate medical advice in certain cases.
Medicinal products must not be supplied after their expiry dates. The Health Products Regulatory Authority may extend expiry dates, if it is satisfied as to certain factors.
It just not permitted to supply prescription medicines by mail-order. Mail-order is broadly defined as most remote sales, including purchases over the internet. It is not permitted to permits the receipt, collection or transmission of such orders or for premises to be used for collection of such orders. Medicines may not be sold from vending machines.
Prescriptions are not required for supplies to
- higher education institutes or scientific research institutes for research and education,
- sampling to regulator and public analyst officers
- persons required by law to provide medical treatment to employees for the purpose of such treatment and
- persons involved in testing quality or amount of drugs,
Some medicinal products may be supplied to registered optometrists and dispensing opticians in the course of their practice subject to certain conditions. Signed orders must be provided in respect of such supplies.
Pharmacists and nurses may supply prescription medicines in hospitals under a written direction of a registered medical practitioner or dentist without being obliged to comply with full requirements of prescription regulations. This allows use of medication charts and case sheets in lieu of prescription.
Doctors and dentists may supply medicinal and non-prescription medicinal products to their patients in the course of professional practice.
Certain medicinal products may be given by ambulance, personnel, pre-hospital emergency care providers, certain paramedics and emergency medical technicians in the course of their duty. The medicines are prescribed, and authorisation must be in accordance with clinical practice guidelines published by The Pre-Hospital Emergency Care Council or on instructions of a doctor.
There are exceptions in respect of certain emergency supplies of medicines outside the terms of normal conditions. Medicines may be supplied outside normal authorisation in certain emergency circumstances.
The Health (Miscellaneous Provisions) Act 2017 allowedthe HSE disapply the criterion regarding prescription only medicines when considered appropriate in the interests of patient safety or public health.
Medicinal products must have a marketing authorisation. Over-the-counter medicinal products, including emergency contraception and nicotine replacement products, can continue to be reimbursed after June 2016. Otherwise, medical card patients will have no way to access such products without charge (other than the prescription charge).