All practitioners have a duty to raise concerns where they believe that patient/public safety or care is being compromised by the practice of colleagues or the systems, policies and procedures in the organisations in which they work. They must also encourage and support a culture where staff can openly and safely raise concerns.
Practitioners must not enter into contracts or agreements with an employing or contracting body that seeks to prevent them from or restrict them in raising concerns about patient safety. Contracts or agreements are void if they intend to stop an employee from making a protected disclosure.
Obstacles to sharing information
Due to time pressures or limited resources, it is sometimes difficult to give consumers as much information or support in making decisions as would be liked. To assist in this, practitioners should consider the role that other members of the healthcare team might play, as well as what other sources of information and support are available. For example, this may be patient/client information leaflets, advocacy services, expert patient programmes, expert advisory groups (such as Aesthetic Complications Expert (ACE) Group World) or support groups for people with specific conditions.
Overcoming obstacles to reporting
Practitioners may be reluctant to report a concern for a number of reasons. For example, fearing that nothing will be done or that raising the concern may cause problems for colleagues; has a negative effect on working relationships or one's career; or results in a complaint about you.
If you are hesitating about reporting a concern or a complication arising from a procedure that you may have performed, you should bear the following in mind:
- You have a duty to put patients'/clients' interests first and act to protect them, which overrides personal and professional loyalties
- The law provides legal protection against victimisation or dismissal for individuals who reveal information to raise genuine concerns and expose malpractice in the workplace
- Practitioners do not need to wait for proof—raising a concern can be justified if it is done so honestly, on the basis of reasonable belief and through appropriate channels, even if mistaken. For advice on such channels, please visit www.nmc.org.uk/standards/guidance/raising-concerns-guidance-for-nurses-and-midwives/whistleblowing and https://improvement.nhs.uk/resources/freedom-speak-guidance-nhs-trust-and-nhs-foundation-trust-boards.
» Prior to the UK's departure from the EU, the Medicines and Healthcare products Regulatory Agency was part of the European system of approval; however, since January 2021, it has been a standalone body, with the exception of Northern Ireland, which, under protocol, the authorisation of medicines marketed in Northern Ireland continues to be the responsibility of the European Medicines Agency «
Leadership and management for all practitioners
Early identification of problems or issues with the performance of individuals, teams or services is essential to help protect patients. Practitioners must take part in regular reviews and audits of the standards and performance of any team they work in, taking steps to resolve any problems. They should be familiar with, and use, the clinical governance and risk management structures and processes within the organisations they work for or to which they are contracted. Practitioners must also follow the procedure for reporting adverse incidents and near misses as dictated at their workplace. This is because routinely identifying adverse incidents or near misses at an early stage can allow issues to be tackled, problems to be put right and lessons to be learnt.
Practitioners must be conversant with all relevant national and local guidance set down by employers, professional bodies and professional associations that relate to raising and acting on concerns about patient safety when they have reason to believe that systems, policies, procedures or colleagues are, or may be, placing members of the public at risk of harm.
Practitioners must tell patients/clients if an investigation or treatment might result in a serious adverse outcome, even if the likelihood is very small. They should also tell patients/clients about less serious side effects or complications if they occur frequently and explain what the person should do if they experience any physical, emotional or psychological symptoms or complications as a consequence of the intervention.
Practitioners must share and provide information about risk in a balanced and proportionate way. They should avoid bias and explain the expected benefits, as well as the potential physical, emotional and psychological challenges and risks of any proposed investigation or treatment.
Practitioners must use clear, simple and consistent language when discussing risks with patients/clients. Practitioners should be aware that the service user might understand information about risk differently from them. Clinicians should check that the person understands the terms that are used, particularly when describing the seriousness, frequency and likelihood of an adverse outcome. They should use simple and accurate written information or visual or other aids to explain risk if they will help the individual to understand and make an informed decision about their choice of treatment and how to engage with the treatment and aftercare process in a safe and participatory manner.
Defining an adverse event or incident
Adverse events or incidents occur with medical treatment and can include medication side effects, injury, psychological harm or trauma or even death. Adverse events or incidents can be either preventable or unpreventable and are often associated with medication errors.
Any health problem that occurs after a treatment or procedure is considered an adverse event, either a true adverse reaction, also known as a side effect, or a coincidental event.
Adverse reactions or side effects have usually been identified in clinical trials and may range from mild to moderate or severe. Often resolving on their own, they may or may not require medical intervention. Dependent on the severity, an adverse reaction may also be considered a serious adverse event.
Coincidental events are health problems that occur following a treatment or procedure that would have happened regardless of whether a procedure or treatment had been carried out and are unrelated.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care, and it is responsible for ensuring that medicines and medical devices work and are acceptably safe. Prior to the UK's departure from the EU, the MHRA was part of the European system of approval; however, since January 2021, it has been a standalone body, with the exception of Northern Ireland, which, under protocol, the authorisation of medicines marketed in Northern Ireland continues to be the responsibility of the European Medicines Agency (MHRA, 2022).
A suspected problem (‘adverse incident’) with a medicine or medical device should be reported as soon as possible using the Yellow Card Scheme. For example, if:
- A medicine causes side effects
- Someone is injured (or almost injured) by a medical device, either because its labelling or instructions are not clear, it is broken or it has been misused
- A patient's treatment is interrupted because of a faulty device
- Someone receives the wrong diagnosis because of a medical device
- A medicine does not work properly
- A medicine is of a poor quality
- You think a medicine or medical device is fake or counterfeit (Gov. uk, 2022).
The Yellow Card scheme is vital to the MHRA, as it allows them to monitor the safety of all healthcare products in the UK. Anyone can report a problem, and reports should be made for suspected adverse reactions (ADRs) to all medicines, including:
- Vaccines
- Blood factors
- Herbal medicines
- Homeopathic remedies
- All medical devices available on the UK market
- Defective medicines (not of an acceptable quality).
Where to find the Yellow Card
By far the easiest way to report an adverse event is via the Yellow Card app, which is available to download from Google Play for Android or the Apple Store for iPhone. Reports can also be filed via the Yellow Card website (https://yellowcard.mhra.gov.uk).
ACE Group World encourages members to report adverse events or incidents by completing a form in the members' section of the website (https://uk.acegroup.online/report-a-complication) or via the app for iPhone users. ACE Group World reports to the MHRA on behalf of members.
What to include
The following should be included in the report:
- Details about the patient, using their initials, age and gender
- Details about the drug(s)/vaccine(s) they were taking, including self-medication and complementary remedies
- Details of the ADR they experienced
- Details of the individual completing the report (i.e. their contact details).
What happens to the data
The information is submitted to the MHRA alongside reports submitted from pharmaceutical companies (when an incident or faulty device is reported to the manufacturer, they are also required to report this information in to the MHRA). Where appropriate, the MHRA will take action to communicate safety notices, which may include:
- Changes or warnings in the product information or on the package label
- Changing the information on how the medicine should be used
- Changes in the specified dose of the medicine
- Restricting the indications for use of a medicine, for example, advising that it should not be used by particular groups of patients
- Changing the legal status of a medicine, for example, from over-the-counter to prescription-only
- In rare circumstances, removal of the medicine from the market, if the risks of a medicine are found to outweigh the benefits.
Information provided to healthcare professionals (HCPs) and the public on the nature of benefit and risk enables informed choices to be made about treatment options and in the management of ADRs should they occur. Sometimes, this information or training may come from pharmaceutical companies directly to HCPs, patients or carers (Royal Pharmaceutical Society, 2022).