Pharmacy Practice Updates and Notices - Overview

• Expert task force gov - Expert Taskforce to support the expansion of the role of pharmacists in Ireland (www.gov.ie) 

• Open disclosure  
• Employers responsibilities under health and safety legislation

• Opioid Substitution Therapy – Introduction of Buprenorphine or Buprenorphine/Naloxone

   

Preparing for the Children First Act for pharmacists and pharmacies from 11 December (child protection and safety legislation)  

• Professional Indemnity Insurance for Pharmacists  

• Substitution of medicines not included in the HPRA (IMB) List of Interchangeable Medicines
• Transparency in the Pricing of Prescription Medicines 

• PSI position on electronic cigarettes  

Regulatory notice 03/2018   Issued: 29 January 2018
Circulation list: All registered pharmacists and pharmacy owners  
Responsibility for action: Superintendent pharmacist and pharmacy owner 

The Health Products Regulatory Authority (HPRA) published a Medical Devices Information Notice on Food Intolerance Testing on Monday, 29 January 2018.

The HPRA has undertaken a review of the types of food intolerance tests available on the market and has consulted with clinical experts. Following this review, the HPRA has clarified that, as the cause of food intolerance is unknown, any test which claims to indicate an intolerance to food is of little clinical validity and confirms that there is no single test available to diagnose food intolerance. The HPRA is advising the public and healthcare professionals not to rely on food intolerance tests for the purpose of a diagnosis or as the basis for dietary change.

The HPRA states that products being promoted as food intolerance tests, cannot diagnose food intolerance and the results of such tests should not be acted on without expert advice from a medical doctor or registered dietician.

As regulated healthcare professionals, pharmacists are a trusted source of advice for the public on medicines and health matters in the community. In order to uphold that trust, the PSI expects that all information and services provided by pharmacists is accurate, clinically valid and in line with current evidence and best practice.

Therefore, the PSI wishes to advise superintendent pharmacists and pharmacy owners that offering food intolerance testing in pharmacies, to diagnose food intolerance, is not appropriate.

Background information

The following provides some information for pharmacists on food intolerance from the Health Products Regulatory Authority (HPRA) and the Food Safety Authority of Ireland (FSAI) as well as information for pharmacists on requirements under the Code of Conduct and providing testing services in pharmacies.

Information from the HPRA and FSAI on food intolerance

The Health Products Regulatory Authority (HPRA) published a Medical Devices Information Notice on Food Intolerance Testing on Monday, 29 January 2018, following a notice also in 2015.

The Food Safety Authority (FSAI) has also published an information leaflet on food hypersensitivity.

The HPRA notice and FSAI leaflet clarify some important information on food intolerance testing that is relevant for pharmacists and pharmacies. Both resources highlight the important distinction between a food allergy and a food intolerance. Pharmacists should be familiar with the advice from both agencies in the area of food intolerance.

Diagnosing food intolerance

The FSAI advises that diagnosis of either a food allergy or food intolerance should involve medical consultation and that changes to a person’s diet should only be undertaken in consultation with suitably qualified experts. The HPRA provides a similar statement, and is informing the public that the only clinically valid method for the diagnosis and treatment of food intolerance is an elimination diet. The HPRA states that elimination diets must be undertaken in close consultation with an experienced clinician or registered dietician, who can provide specialist advice on maintaining a balanced diet throughout the elimination test.

The FSAI outlines that an incorrect diagnosis of food intolerance can result in the cause of a health problem being overlooked and in unnecessary dietary restrictions.

Providing Testing Services in Pharmacies

In the provision of a testing services, it is essential that patients’ expectations of the standard of care provided by their pharmacist are met and that they can be assured of the quality, accuracy and reliability of such testing.

Any tests or health checks should only be performed by pharmacists or offered in pharmacies where there is an established clinical and scientific evidence base and for which the validity, accuracy and reliability of the test(s) can be assured. The purpose, health benefit and clinical need for the use of a particular test must be established prior to its introduction and re-evaluated at regular intervals. Where available, relevant national healthcare strategy, health promotion campaigns, clinical guidelines and best practice should be observed in the provision of testing services.

Any testing service in a pharmacy should only be provided in line with PSI guidance on providing testing services in pharmacies.

Code of Conduct for Pharmacists

Under the Code of Conduct pharmacists are expected to:

• provide a proper standard of care to those for whom they provide professional services
• use their professional knowledge, competence and specialised knowledge about medicines, health related products and medicinal and non-medicinal therapies for the benefit of patients
• provide honest, accurate, current and appropriate information to patients regarding the nature, cost, value and benefit of medicines, health-related products and services provided by them.

Conclusion

In accordance with the information provided above and the conclusions of the HPRA review, any test which claims to indicate an intolerance to food is of little clinical validity, and therefore the PSI wishes to advise superintendent pharmacists that offering food intolerance testing services to diagnose food intolerance is not appropriate.

Members of the public that purchase a self-test should be made aware of the limitations of such products and the HPRA advice that they should not rely on food intolerance tests for the purpose of a diagnosis or as the basis for dietary change.

The resources referred to above should be consulted for correct and accurate information on food allergies and food intolerance.

Pharmacists and pharmacies are important sources of information and advice for members of the public, so it is important that all pharmacists and pharmacy staff who may be dealing with queries from the public in relation to food intolerance are familiar with the advice of the HPRA and the FSAI and current best practice. Pharmacists continue to have an important professional role in assisting the public in managing any symptoms they may have, including referral for medical assessment as appropriate.

Regulatory notice 01/2017   Issued: 23 October 2017
Circulation list: All registered pharmacists and pharmacy owners  
Responsibility for action: Superintendent pharmacist   

Background

The Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008) has been amended by S.I. No. 80 of 2016 and Regulation 5(1)(ea) has been inserted. Under this regulation the pharmacy owner and the superintendent pharmacist shall, inter alia, ensure that pharmacy-only medicines “are stored in a part of the premises to which the public does not have access”.

Professional role in supply of pharmacy-only medicines

Pharmacists, through their interaction with patients, play an important role in ensuring that medicines are used rationally, responsibly and safely in our society, as well as referring patients to other healthcare professionals where necessary. Pharmacists have a professional role and statutory duty to carry out, or personally supervise, the sale and supply of all non-prescription medicines from the pharmacy to ensure that the patient/purchaser is made aware of the safe and appropriate use of the product and that it is not intended for misuse or abuse. It is essential when supplying medicines that relevant information and advice is provided to establish the medical needs of the patient and to support them and ensure the appropriate selection and use of these medicines.

Medicines are categorised in national law into three categories; namely, medicines requiring a medical prescription, pharmacy-only medicines and general sale medicines (which may also be sold from non-pharmacy outlets). Pharmacy-only medicines are a category of medicines which are only available to the public under the personal supervision and guidance of a pharmacist.

Storage of pharmacy-only medicines

As per the amended legislation (S.I. 80/2016), pharmacy–only medicines must be stored in an area of the pharmacy to which the public does not have access. The PSI is aware that there are a number of ways in which pharmacies can comply with the requirements of the legislation including:

• Storage of pharmacy-only medicines behind the medicines counter/OTC counter
• Any other arrangements within the premises that ensures that the public does not have direct or physical access to pharmacy-only medicines

If a member of the public is able to self select (i.e. physically access / pick up) a pharmacy-only medicine from a publicly accessible part of the pharmacy, then it is the view of the PSI that the medicine is not stored in a part of the premises to which the public does not have access.

Please note that:

• pharmacy-only medicines do not need to be stored in the dispensary
• medicinal products on the general sales list are not affected by this legislation

Compliance

Many pharmacies already store pharmacy-only medicines in the manner described above. However, if any pharmacy has pharmacy-only medicines stored in an area of the pharmacy that is accessible to the public, it is the responsibility of the pharmacy owners and superintendent pharmacists to review their storage arrangements, to ensure that compliance with these legislative provisions is achieved. There are various ways in which pharmacies can comply with these legislative provisions and it is open to each pharmacy to adopt an approach which is appropriate to their pharmacy and ensures compliance with the legislation.

As of 1 April 2018, the PSI will expect that all pharmacies will demonstrate full compliance with this legislation.

Failure to comply with this regulation constitutes an offence under section 18(3) of the Pharmacy Act 2007.

The PSI will shortly update the “PSI Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business” to reflect the amended legislation and above information.

You can read the amended legislation here.

Information about this amendment was previously communicated to pharmacists in the PSI newsletter in March 2014 and April 2016.

Regulatory notice 02/2017   Issued: 6 November 2017
Circulation list: Pharmacy owners, superintendent pharmacists and supervising pharmacists
Responsibility for action: Pharmacy owner

Background

Under the Pharmacy Act 2007 a pharmacy must be registered with the PSI in order to operate. However, certain changes in the ownership of a pharmacy may automatically cancel the registration of the pharmacy with the PSI. If this occurs, and the pharmacy intends to continue to operate, you must apply for a new pharmacy registration.

If you are considering any change in the ownership structure of your pharmacy, it is imperative that you contact the PSI before the changes takes place, so that we can advise you if your registration will be affected by this change.

Changes in Ownership

Some examples of the most common changes in the ownership of a pharmacy, which require a new pharmacy registration, include situations where:

1. A company transfers more than 50% of its shares in one transaction or a series of transactions to: (a) an existing shareholder/(s), and/or (b) a new shareholder/(s).
2. A company transfers its shareholding to a holding company. Under the Act a change in ownership may occur even where the beneficial ownership remains the same.
3. The pharmacy ownership is changing from the existing trading company to a different trading company.
4. A sole trader transfers the ownership of the pharmacy to a company.

Failure to notify the PSI of a change in ownership, which cancels the pharmacy’s registration, will result in the closure of the pharmacy until a new registration is processed. In addition, it is an offence under the Act to operate a pharmacy which is not registered.

In order to ensure that there is no interruption of a pharmacy’s service and that continuity of care is maintained for patients, as well as the appropriate insurance arrangements remaining in place, you are required to give sufficient notice to the PSI of any proposed change in the ownership of your pharmacy. Applications for registration must be received in sufficient time so that each component of the application process can be carried out, as specified in the legislation.

Where sufficient notice is given, the PSI will work with you to ensure that the pharmacy can continue to trade through this process. Section 17 of the Pharmacy Act sets out the relevant legislative requirements, and additional information is available in the pharmacy registration section of the website.