Modern Pharmacy Regulation
The Pharmacy Act, 2007 updated and regulated pharmacists and pharmacy businesses on a modern basis. The Pharmaceutical Society of Ireland was reincorporated.
The Council of the Society was established. It is given certain key functions. The Council consists of individuals appointed by the Minister and nominated by the pharmacy profession, those representing the HSE, educational bodies, users and various other interests. It is intended that the majority are not members of the pharmacy profession.
The functions of the Society include
- the regulation of the pharmacy profession,
- promotion of the education and training of pharmacists,
- ensuring that pharmacists maintain appropriate experience and comply with professional development requirements
- ensuring that pharmacists comply with professional and legal obligations,
- supervising compliance with obligations.
Admission and Membershp
The Society may draw up the registers, provide codes of conduct, approve and review programmes of education and training and act as the authority for recognition of EU pharmacists.
The Council maintains registries of pharmacists, druggist, pharmaceutical assistance and retail pharmacy businesses. The registrations of both premises and persons are maintained in written and online forms.
The requirements for qualifications entered in the register are prescribed. A person must have certain qualifications, have the requisite experience and comply with ongoing requirements. The requisite qualifications are set out in legislation and are recognised by the Society.
EU pharmacists are entitled to recognition under EU law. There is requirement both for the holding of qualifications and having the requisite experience including three years of practising as a pharmacist in the State.
Register of Premises
The register of retail businesses registers the premises and specifies the person in charge. Regulations may be made regarding the retail pharmacy business in relation to
- the manner in which products are prepared,
- physical characteristics of the premises,
- separation from the rest of the premises,
- physical characteristic,
- conditions including temperature, humidity, cleanliness and sanitation, in which products are prepared, stored, supplied and dispensed,
- disposal of products,
- the manner of sale,
- physical characteristics of premises which are provided for members of the public,
- the facilities to be provided,
- records to be kept in connection with the sale and supply of products and dispensing,
- retention of records and custody,
- the use of apparatus,
- safekeeping of products.
A certificate of registration is issued for registered premises which lasts for 12 months and must be renewed. There is provision for appeal to the High Court in the case of refusal registration. Premises may be inspected and authorised officers may take appropriate steps to ensure compliance.
The provisions apply to pharmacies, medical stores, drug stores, drug hall, medical hall and medical supplies stores and chemists.
Pharmacists must not practice in partnership with a non-pharmacist. Certain conditions apply including that
- the business is under the personal control of a registered pharmacist with ceratin post registration experience,
- that the sale of medicinal products is conducted under the personal supervision of the registered pharmacist,
- where the business is carried on by a company or representative, a registered pharmacist must be personally involved.
It is an offence for any person to dispense controlled medicines who is not a pharmacist or registered pharmaceutical assistant. It is an offence to hold oneself or another out or to cause or permit the public perception to arise or occur, that a peson is a pharmacist, dispensing chemist, a pharmaceutical chemist or member of the Pharmaceutical Society, wo is not so registered.
There are prohibitions on certain economic relationships between pharmacists and doctors. They arose from practices whereby doctors and pharmacists engineered certain proximity in return for financial benefits. A pharmacist may not have an interest in a medical practice. Similarly, a medical practitioner may not have an interest in a pharmacy business.
An interest is defined as including benefits consisting of financial benefits accruing to the other. This may include subsidised rents or rents referable to turnover.
There is a prohibition on registered pharmacists and medical practitioners carrying on pharmacy business or medical practice being carried on in the same premises or with shared access if there are arrangements whereby there is benefit from the co-location. There are obligations on pharmacists and doctors to report contraventions.
Conduct and Standards
The Council may draft codes of conduct which must be approved by the Competition Authority. The Council has powers to investigate breach including powers to search and enter premises. There are powers in relation to taking samples
The provisions in respect of enquiries and misconduct are broadly similar to other professions. There is a preliminary proceedings committee and a professional conduct committee. The majority of the members of the disciplinary committee are non-pharmacist. At least one represents the public interest.
Complaints may range from poor professional misconduct, poor professional performance, impaired ability and breach of codes and membership conditions.
After a complaint is received it is sent to the preliminary proceedings committee for advice on whether it is sufficient to warrant further action. If there is a recommendation for further action, it may be referred to mediation or to a committee of enquiry to either the professional conduct or health committee.
The council may devise guidelines in relation to the resolution of disputes by mediators. The consent of each party is required. A complaint referred for mediation may be referred to a committee of enquiry if not so resolved.
The proceedings of the professional conduct committee are broadly similar to other medical professions. The committee has the powers of a Judge of the High Court to enforce evidence from witnesses. It is as an offence not to co-operate. A pharmacist may be suspended from the register on an interim basis while the hearing is ongoing.
On completion of the enquiry, a written report is made to the Council. If the complaint is substantiated, sanctions ranging from admonishment, imposition of conditions on practice, suspension , cancellation or prohibition for a period may be applied.
The pharmacist conscerned may appeal to the High Court on the basis of evidence adduced or arguments made. A decision to impose sanctions other than admonishment does not take effect until it is confirmed by the High Court.
The High Court shall confirm unless there are good reasons not to do so. If no appeal is made, the Council may apply to the High Court for confirmation of its decision. The High Court may but need not confirm the Council’s decision.