What should a nurse do if a patient experiences an adverse drug reaction?

The HPRA encourages patients, carers and other members of the public to report suspected adverse reactions (side effects) to us.

It is important that you also contact your doctor or pharmacist if you think you may have experienced a side effect after using a medicine. They will tell you if you need any medical care. They will also consider if you need to change your treatment or if you need a different treatment.

The HPRA has published an information page on side effects for patients and other members of the public on side effects. 

Reporting Suspected Adverse Reactions

Most of us will not experience any problems when using medicines. However, all medicines have some risks associated with their use and so a small number of people may experience an adverse reaction (also known as a side effect).

What is an adverse reaction (side effect)?

An adverse reaction is formally defined as a ‘response to a medicinal product which is noxious and unintended’. This definition includes any harm associated with the use of a medicine including use following overdose, misuse or error.

What should I do if I think I may have experienced an adverse reaction (side effect)?

If you are concerned that you have had a suspected adverse reaction to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the HPRA on your behalf.

If you wish to directly report an adverse reaction you can use the HPRA’s online reporting service. Anyone can report issues relating to the safety of medicines to the HPRA. This includes patients, carers, other members of the public and healthcare professionals.

How do I report an adverse reaction?

You can report a suspected side effect in a number of ways:

• To your doctor, pharmacist or nurse who can then notify the HPRA.
• By using our online form.
• By downloading a copy of our adverse reaction report form (Word version). You can e-mail completed forms to [email protected]
• By printing our adverse reaction report form (Word version) and posting a completed copy to the HPRA by freepost.
• By calling us on (01) 676 4971.

How do I fill in an adverse reaction report form?

Certain mandatory fields are required to successfully submit an adverse reaction report via the online systems. These include reporter details and a contact email address. The latter facilitates return of a unique report identifier number, as a confirmation of a successfully submitted report. The confirmation email from the HPRA will also contain a PDF version of the report submitted. In addition, the following minimum criteria must be included for a ‘valid’ adverse reaction report:

• An identifiable patient (i.e. patient initials/age/sex/record number)
• An identifiable medicinal product (i.e. product name or active substance if brand is unavailable)
• An identifiable reporter
• An identifiable reaction

While the above information reflects the minimum criteria needed for a ‘valid’ adverse reaction report, additional information regarding details relating to the reaction such as relevant medical history, other medication(s) being taken, action taken with the medicine, the outcome of the reaction and any other relevant information are extremely helpful in the evaluation of the suspected adverse reaction.

Once the report is reviewed by the HPRA, the reporter may be contacted for further follow up information that is considered to be significant to the evaluation of the suspected adverse reaction. Permission may also be requested to contact a healthcare professional directly for any further relevant information.

Why is it important for me to report suspected adverse reactions?

Patients are in an ideal position to identify the impact of medicines they have taken, particularly on their quality of life. Systems for patients/consumer reporting are an important tool to facilitate and encourage ‘spontaneous reporting’, which in turn contributes to the overall knowledge of the safety of a medicine and the patient experience. The patients’ role in reporting adverse drug reactions is a key element in building an improved system of pharmacovigilance and the participation of patients is now at the core of the new medicines safety monitoring in Europe. 

An adverse event is an incident that results in harm to the patient. Adverse events commonly experienced in hospitals by patients over 70 include falls, medication errors, malnutrition, incontinence, and hospital-acquired pressure injuries and infections.

What we do or do not do to identify and respond to issues such as malnutrition, uncontrolled pain and unrecognised delirium can contribute to a patient experiencing an adverse event and, in turn, functional decline.

Why is it important?

Physical and cognitive functional decline is often unrelated to the primary reason a person presents to hospital and can have a significant impact on a person’s ability to perform activities of daily living.

• Older people are particularly vulnerable to experiencing adverse events due to inherent complexity in managing their care and a decline in physiological reserves. Approximately three in four older adults have complex multimorbidity1, and one in two older people take over four medications.2
• Approximately one in 20 patients experience an adverse event while in hospital.3
• Patients with adverse events stay about ten days longer and have over seven times the risk of an in-hospital death than those without complications.4

How can you prevent an adverse event?

Adverse events can be prevented through screening and early identification of the factors that put older people at risk.3,5

Patients aged 70 years and over should be screened to determine the risks of adverse events, and undergo a comprehensive interdisciplinary assessment where risk is identified.

Effective communication with patients, their family, carers and other healthcare professionals is important in preventing adverse events for older people in hospital.5 A lack of communication and collaboration between health professionals is a common factor in the majority of adverse events.6

All staff have a shared role in preventing harm to older patients.

Make sure you are familiar with your health service’s official policy regarding the prevention of adverse events.

Screen and assess patients to minimise the risk of adverse events

• Use validated tools to screen for the risk of adverse events such as: falls, medication errors, malnutrition, continence, delirium and hospital-acquired pressure injuries.
• Ensure screening and assessment are undertaken at admission and transition to other areas in the health service.

Engage patients, families and carers in the care plan

• Encourage patients, family and carers to ask questions when you discuss risk factors and preventative measures:
  • Consider the patient’s health literacy and their cultural and linguistic background.
  • Check the patient has all necessary aids such as glasses and hearing aids.
• Involve patients, family and carers in clinical handover processes and the care plan.
• Ensure patients, family and carers know how to identify and respond to clinical deterioration.

Respond to a patient who has a high risk of experiencing an adverse event

• Undertake a comprehensive geriatric assessment – with interdisciplinary team input – to ensure that risk is addressed and preventative strategies are included in the patient’s care plan.
• Discuss preventative strategies (such as a medication review) with the patient and their family or carer and implement any changes to reduce the risk of an adverse event.
• Communicate adverse event risk factors to other staff involved in caring for the patient, for example by using alert symbols above patient beds, during team meetings and on clinical handover.
• Ensure that critical information, such as a medication list or falls history, is transferred, acted upon, and documented during clinical handover. Many health services use the framework ISBAR (identify, situation, background, assessment and recommendation) when transferring patient information during clinical handover.

Respond to a patient who has experienced an adverse event

• Provide the necessary care to address the impact of the adverse event on the patient.
• Inform and involve the patient and their family or carers of the adverse event and the strategies used to minimise risks.
• Review all preventative strategies and assessment procedures to minimise further adverse events occurring.
• Refer to the relevant specialist for best practice advice and management.
• Monitor and evaluate the outcomes of the ongoing care plan and adjust as necessary.

Monitor a patient’s ongoing care

• Ensure you deliver person-centred care in agreement with the patient’s monitoring plan, including documenting the type and frequency of observations to be recorded for the patient.
• Engage in intentional rounding (carrying out regular checks with the patient at set intervals) and assist the patient with eating, drinking, pain relief, ambulation, regular toileting and repositioning (as required).
• Escalate the care of a patient whose condition deteriorates.

The National Safety and Quality Health Service Standards provide a useful resource for hospital staff to prevent adverse events and harm to the patients.

1. Barnett K, Mercer SW, Norbury M, Watt G, Wyke S & Guthrie B 2013, ‘Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study’, Lancet, 380(9836):37-43.

2. Morgan TK, Williamson M, Pirotta M, Stewart K, Myers SP & Barnes J 2012, ‘A national census of medicines use: a 24-hour snapshot of Australians aged 50 years and older’, Med J Aust, 196(1):50-53.

3. Australian Institute of Health and Welfare 2012, Australia's Health 2012, Australian Institute of Health and Welfare, Canberra, Australia.

4. Ehsani JP, Jackson T & Duckett SJ 2006, ‘The incidence and cost of adverse events in Victorian hospitals 2003–04’, The Medical Journal of Australia, 184(11):551.

5. Department of Health 2012, Best care for older people everywhere – The toolkit, State Government of Victoria, Melbourne.

6. Mansah M, Griffiths R, Fernandez R, Chang E & Thuy Tran D 2014, ‘Older folks in hospitals: the contributing factors and recommendations for incident prevention’, Journal of Patient Safety, 10(3):146-153

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