Dispensing and supply of medicines

Under Article 46 of the Regulation on Pharmacy Licences and Pharmacies, No. 1340/2022, the Icelandic Medicines Agency (IMA) shall issue guidelines on good practice in pharmacies and the distance selling of medicines.

General requirements for the supply of medicines

Medicines are not ordinary consumer goods, and their incorrect use or storage can cause serious harm to the people using them. The advice given in pharmacies and their branches aims to promote the correct and responsible use of medicines and thereby limit the risks that can arise from incorrect use.

The information and advice provided by pharmacists working in pharmacies are important in promoting the correct use and storage of medicines.

When medicines are dispensed and supplied from pharmacies and pharmacy branches, every effort must be made, through advice and guidance, to ensure that the people using the medicines are aware of the correct and safe use of the medicine in order to ensure effective treatment.

It is common for trained staff to supply medicines on behalf of a pharmacist, but only pharmacists, individuals with a BS degree in pharmacy or pharmacy technicians are authorised to provide information and advice on medicines. Trained pharmacy staff may, however, assist in the choice of over-the-counter medicines and provide the information that appears on their packaging and package leaflets.

The Regulation on Pharmacy Licences and Pharmacies contains two main rules on how medicines shall generally be dispensed and supplied in a pharmacy:

1. Medicine packs shall generally be shown

This reduces the risk of the wrong medicine being supplied. It also promotes greater communication and education about the medicines supplied.

2. Advice shall generally be provided

The recipient shall be asked whether they are familiar with the medicines and whether they have any particular questions about the use or storage of the medicines. The necessary information shall be provided on the pharmacist's initiative.

A pharmacist may delegate the task of providing this information to an individual with a BS degree in pharmacy or to a pharmacy technician, but responsibility for the advice, and for ensuring that it has been given, rests with the pharmacist who dispensed the medicine.

IMA's priorities

In addition to the general requirements that apply to the supply of all medicines, IMA considers it appropriate to place particular emphasis on certain considerations, with patient safety as the guiding principle. In its guidelines from March 2025, IMA places particular emphasis on the supply of medicines intended for children, medicines with a medical device as an integral part, unlicensed medicines (undanþágulyf), narcotic and habit-forming medicines, medicines with special safety information, and dose-dispensed medicines.

Supply of medicines intended for use in children

When medicines intended for use in children are supplied, it is important that the recipient of the medicines knows how the medicines are to be administered, the correct dose, the duration of treatment and how they are to be stored, as well as how to respond if an adverse reaction is suspected.

The pharmacist shall take particular care in the statutory review of doses. This can be done, for example, by obtaining information on the child's weight and comparing the instructions for use with standard use according to the manufacturer's information. If the instructions for use are inconsistent with standard use, it would be appropriate to contact the doctor and obtain confirmation of the instructions. In the case of young children, such an assessment should always be carried out.

Example:

An 18-month-old child is prescribed an antibiotic oral suspension for the treatment of acute otitis media. In conversation with the parent, it emerges that the child weighs 12 kg. On checking the information in the Summary of Product Characteristics (SmPC), it is clear that the doctor's instructions for use are inconsistent with standard use. The correct response by the pharmacist in this case would be to refer the prescription to the prescriber for confirmation.

Supply of medicines with a medical device as an integral part

When medicines with a medical device as an integral part are supplied, e.g. inhalers, medicine pens or transdermal patches, it is important that the patient knows how the device is used and how it is to be handled.

For example, the patient or their authorised person should be asked whether they need information on how the device is used, stored and, where applicable, maintained.

Supply of unlicensed medicines

Unlicensed medicines are, as a rule, not accompanied by any information in Icelandic. It is therefore important that the pharmacist takes the initiative and provides the necessary information to ensure correct use.

It cannot be assumed that the patient is familiar with the medicines, e.g. how they are to be used, possible adverse reactions, interactions with food or storage. This is particularly important when it is permitted to change a prescription to an unlicensed medicine.

Example:

An unlicensed medicine used to treat overproduction of thyroid hormones in cats can cause serious harm to the unborn child if pregnant women come into contact with the medicine. The unlicensed medicine is not accompanied by any information in Icelandic, and it is therefore the pharmacist's role to provide women of childbearing age and pregnant women with the necessary information.

Supply of narcotic and habit-forming medicines

When narcotic and habit-forming medicines are supplied, the pharmacist should make sure that the patient is informed about the risk of dependence and addiction associated with the medicines. Information should also be obtained on the patient's knowledge of the use and storage of the medicines.

It cannot be assumed that the patient is familiar with the medicines, e.g. how the risk of dependence and addiction can be limited.

Information could, for example, be given orally on the maximum number of days for which sleeping medicines should be used, or on how physically and psychologically addictive opioids are with repeated use.

Example:

A patient is prescribed a sleeping medicine containing zopiclone. According to the doctor's instructions for use, one tablet is to be taken before bedtime. It is important that the patient is made aware that the medicine is a narcotic and habit-forming medicine and that the risk of dependence increases with higher doses and longer duration of treatment.

IMA draws attention to the fact that a maximum of 30 days' supply of controlled medicines (eftirritunarskyld lyf) may be dispensed at a time, and not until at least 25 days have passed since the last dispensing. The pharmacist may deviate from this minimum number of days in special circumstances.

It is IMA's view that when deviating from the above minimum number of days, the pharmacist shall make a professional assessment of these special circumstances. This shall be recorded as a deviation in the pharmacy's incident log.

Supply of medicines with safety and educational material

The marketing authorisations of certain medicines are subject to conditions concerning safe use, and safety information for healthcare professionals and patients is then often published. It is essential that pharmacists dispensing the medicines concerned familiarise themselves with the guidance and inform patients or their authorised persons.

Marketing authorisation holders are responsible for distributing safety information, but it is also published in the Medicinal Product Information.

Example:

When dispensing isotretinoin capsules, the medicine's accompanying checklist for pharmacists shall be followed, as the medicine causes serious harm to the unborn child.

Supply of dose-dispensed medicines

When dose-dispensed medicines are supplied, the necessary information about the medicines shall, as a rule, be provided. Information should be obtained on the patient's knowledge of the use and storage of the medicines.

It cannot be assumed that the patient is familiar with the medicines, e.g. their main adverse reactions or interactions. The patient should be told where they can access the package leaflets for the medicines.

Example:

A patient is on simvastatin treatment through automated dose dispensing. The medicine can cause serious adverse reactions in the muscles. The package leaflet specifically states that the patient must watch for unexplained muscle pain, muscle tenderness or muscle weakness and stop taking the medicine immediately if such adverse reactions occur. Consumption of grapefruit juice should also be avoided while using simvastatin, as the juice alters how the body uses the medicine.

Legitimacy of the supply of medicines

When medicines are supplied, the legitimacy of the supply shall be verified. The main rule is that medicines are only supplied to the patient or their authorised person, or to the owner or keeper of an animal, upon presentation of proof of identity, and the ID number of the person receiving the medicine shall be recorded in a traceable manner. The information shall be kept for two years.

Proof of identity requirement

Valid proof of identity for use in Iceland includes driving licences, passports and identity cards issued by Registers Iceland (Þjóðskrá Íslands).

Other documents are not considered valid proof of identity.

Digital driving licences are equivalent to traditional driving licences.

See IMA's guidelines on digital driving licences and how they are verified.

Authorisation requirement

Under the Regulation, medicines may only be dispensed to the person to whom the prescription is issued, or to the owner or keeper of an animal, unless the holder of the prescription has authorised a specific individual. To make it unambiguous who can be considered an authorised person in this respect, it is necessary to require authorisation from anyone who collects medicines from a pharmacy for someone other than themselves. In all cases, proof of identity must be presented, whether by the holder of the prescription or the authorised person.

Further explanations and information on the page Authorisation to collect medicines.

Obligation to report incidents in the operation of pharmacies

If a serious incident occurs in the operation of a pharmacy, for example when dispensing or supplying a medicine, the pharmacy licence holder shall report it to IMA without delay and send IMA a copy of the incident log.

Legal basis

Provisions on the supply of medicines are found in the following laws and regulations:

• Medicinal Products Act, No. 100/2020

• Regulation on Pharmacy Licences and Pharmacies, No. 1340/2022

• Regulation on the Prescribing and Dispensing of Medicines, No. 740/2020

• Regulation on Dose Dispensing of Medicines, No. 850/2002

• Regulation on the Education, Rights and Obligations of Pharmacists and the Conditions for Obtaining a Licence to Practise and a Specialist Licence, No. 1090/2012

Professional requirements and responsibilities of pharmacists

The professional requirements and responsibilities of pharmacists are addressed in Chapter IV of Regulation No. 1090/2012.

A pharmacist is responsible for ensuring that assistants and students working under their direction have sufficient competence and knowledge and receive the necessary guidance and instruction to carry out the tasks the pharmacist assigns to them, cf. Article 10 of the Regulation.

Article 8 states that a pharmacist shall show respect to patients and to those to whom they provide services, and shall perform their duties with diligence and integrity and in accordance with the professional requirements placed on the profession at any given time. The pharmacist is also responsible for the handling of medicines and, as applicable, for advice, assessment and resolution of medicine-related problems of patients and those to whom they provide services. It is also provided that a pharmacist is obliged to respect their professional limitations.

The pharmacist's duty to provide information is then addressed in Article 9 of the Regulation.

Only pharmacists are permitted to dispense a prescription in a pharmacy or pharmacy branch, and the pharmacist is responsible for and oversees the correct dispensing in accordance with the prescription, cf. Article 51(2) of the Medicinal Products Act. This obligation and responsibility is reiterated in regulations issued under the Medicinal Products Act, cf. Article 8 of the Regulation on Pharmacy Licences and Pharmacies, No. 1340/2022, and Article 13 of the Regulation on the Prescribing and Dispensing of Medicines, No. 740/2020.

Duty to provide information

Under Icelandic law, a pharmacy licence holder is obliged to provide information on medicines, the use of medicines and the storage of medicines, cf. point (d) of Article 40(1) of the Medicinal Products Act. The explanatory notes state the following on the duty to provide information:

Point (d) of paragraph 1 addresses the obligation of pharmacy licence holders to provide information on medicines, the use of medicines and the storage of medicines to the general public, healthcare professionals and veterinarians. Given their education and competence, it is reasonable to place this requirement on pharmacists working in pharmacies, and no one is better suited to this than they are.

The requirements for the supply of medicines are addressed in more detail in the Regulation on Pharmacy Licences and Pharmacies, No. 1340/2022. Article 18(2) and (3) of the Regulation reiterates and sets out in detail the pharmacies' duty to advise, stating:

Medicines shall, as a general rule, be dispensed in such a way that the patient or their authorised person receives them in the pharmacy and all necessary information or advice is provided at the same time. The patient shall, as a rule, be shown their medicines when advice is provided.

Pharmacies are obliged to provide advice on medicines. It shall be asked clearly and unambiguously whether the patient or their authorised person needs further information on the medicine supplied and its use.