Presentation by PSI to the Oireachtas Committee on Health and Children

Date: 11 October 2006

Oireachtas Committee on Health & Children
Sub-Committee on the Adverse Side Effects of Pharmaceuticals

Presentation by the Pharmaceutical Society of Ireland, Tuesday 10th October 2006.

Opening Address by Mr. Ronan A. Quirke MPSI, President

Chairman, Deputies and Senators

The Pharmaceutical Society of Ireland is the statutory body which regulates the profession and practice of pharmacy in this country in the public interest.

As the Society’s President, I would like to thank the Sub-Committee for affording me and my colleagues the opportunity to address it on the important matter of the adverse side effects of pharmaceuticals.

The adverse side effects of pharmaceuticals is an issue of considerable importance to patient welfare and safety. The Society answered this Sub-Committee’s call for submissions because of the important and significant contribution that pharmacists can make to preventing and dealing with adverse effects of pharmaceuticals and critical incidences relating to medication errors.

Pharmacists are highly trained in medicines, therapeutics and technologies and are a unique health resource. Pharmacists have a comprehensive knowledge and understanding of drugs: their uses and actions; why they act in the way they do; how to best deliver them into the body for optimal effect.

Medicines can harm patients as well as help them, particularly when not used appropriately. Adverse effects can arise in a number of ways: overdose; adverse interaction with another drug; being taken by someone for whom it is not appropriate etc.

The professional practice of pharmacists has developed significantly to add value and safety to the supply of medicines. Whether working in a community pharmacy, in a hospital pharmacy, in a nursing home or prison, whether dispensing a medicine on foot of a prescription or making an over the counter recommendation, pharmacists ensure that the medicine supplied is appropriate and safe for the particular person in light of their health status, age, current medication history and previous pharmaceutical history. By so doing, pharmacists provide important protection from patients experiencing adverse side effects. Not a day passes in my pharmacy that I or one of my staff does not make an intervention with regard to the supply of a medicines either on prescription or OTC, which if it did not occur would very likely result in that person experiencing an adverse effect. For example diabetics require specialist advice at this time of year when choosing simple, over the counter cough and cold remedies as a number of them are not suitable for use by them.

Adverse effects can arise with the use of OTC medicines, particularly where they are misused or abused or are supplied without the benefit of professional advice. For example ibuprofen, the anti-inflammatory painkiller found in Nurofen® if not appropriately used can cause gastric ulceration and haemorrhaging and increased incidences of heart attack. It is for this reason that the Society is concerned about the application currently being considered by the IMB to have this product supplied through non-pharmacies without any professional advice available and the likely increase in adverse effects that will arise as a result.

In our submission we refer to the modern philosophy of pharmacy practice as one of pharmaceutical care and treatment. Pharmaceutical care is the responsible provision of pharmaceuticals for the purpose of achieving definite outcomes that improve or maintain a patient’s quality of life. It embodies a continuous quality improvement process for the use of medicinal products. The scope of pharmacy practice is ever expanding in a number of ways, all of which impact directly on reducing and preventing the adverse effects of pharmaceuticals. These include formal medicines management and review, where the pharmacist collaborates with the patient, medical practitioners and other healthcare professionals in identifying changes to improve a patient’s drug therapy; formulary development and health promotion campaigns such as how to safely dispose of unwanted medicines.

Modern pharmacy practice requires that the current legislative framework governing the profession and practice of pharmacy in Ireland be reformed and updated. It currently operates under Pharmacy Acts dating back to 1875 and is in need of reform. The new pharmacy bill should not just regulate pharmacists but it must also include parallel and complementary provision to regulate pharmacies and the provision of pharmacy services in all locations, be it a pharmacy on the Main St, in a hospital, in a privately owned clinic, in a prison, in a nursing home or a residential home for those with mental disability The Minister has committed to introducing two new Pharmacy Bills and the Society welcomes the Minister’s initiatives. However, it believes that a single comprehensive bill should be introduced to address the totality of issues involved.. To attempt to regulate pharmacists in one Bill, with the promise of a second bill in the future to regulate pharmacies and pharmacy services will not protect the welfare of patients or maximise the value of such legislation to the public. The Society will host a Pharmacy summit on 16th October next which will be addressed by the Minister. The summit will be addressed by a number of speakers whose experience will support the call to regulate all aspects of pharmacy service delivery. 

The Society’s submission highlights other areas where action could contribute to reducing and preventing the incidence of adverse effects with pharmaceuticals.

Effective communication can play a very important role at a number of levels:
with patients and users themselves; Effective communication of professional advice and support by the pharmacist with the person using the medicines or their representative with respect to need, dosage, other medicines being taken, other conditions, expected or common side effects etc. plays an important role in reducing the incidence of adverse effects while taking the medicinal product in question. 400,000 people visit pharmacies every day in this country. This together with open access to a highly trained pharmacist demonstrates the resource this is in reducing and preventing adverse effects.
With Prescribers: where a pharmacist in his or her professional opinion considers that a particular prescribed drug regimen is likely to give rise to adverse effects in the patient, he or she needs to be able to communicate his or her concerns to the person prescribing the therapy with a view to ensuring that adverse effects are avoided where possible;
With the Irish Medicines Board (IMB); prompt notification to the IMB of suspected incidences of adverse drug reactions are very important in alerting the IMB to their incidence in order to minimize their re-occurrence in the future.

The internet supply of medicines is an area of grave concern. The public has no assurance as to the safety and appropriateness of medicines supplied via the internet. With internet supply, there is an absence of direct contact with a pharmacist to give advice and guidance. As a result internet supply of medicines has the potential to greatly contribute to patients experiencing adverse effects with pharmaceuticals. Effective action to enhance and enforce controls on the internet supply of medicines must be prioritised.

The global increase in the production and supply of counterfeit medicines is alarming. It is no longer a problem confined to developing countries. Already in 2006, there have been 130 incidents in Europe involving the supply of counterfeit medicines. Counterfeit medicines have entered the legitimate supply chain in the UK and elsewhere in Europe.  This is a major threat to human health and welfare and requires action both at national and EU level to combat it.

Thank you for your attention. My colleagues and I would be pleased to answer any questions that you may have.

Click to view the submission to the Sub-Committee on the Adverse Side Effects of Pharmaceuticals