Over the years, the PDA has warned members about the risks associated with online prescribing of prescription-only medicines. Some of the PDA’s concerns and feedback to the General Pharmaceutical Council (GPhC) may have played a part in the updated guidance published earlier this year. The guidance sets out those medicines that should not be provided based solely on the information in an online questionnaire and which require additional safeguards.
ADHD medication monitoring requirements
NICE guidance specifies monitoring which should be carried out for patients taking ADHD medicines, including the following clauses:
Cardiovascular
1.8.9 – Monitor heart rate and blood pressure and compare with the normal range for age before and after each dose change and every 6 months.
1.8.11 – If a person taking ADHD medication has sustained resting tachycardia (more than 120 beats per minute), arrhythmia or systolic blood pressure greater than the 95th percentile (or a clinically significant increase) measured on 2 occasions, reduce their dose and refer them to a paediatric hypertension specialist or adult physician.
Case
A coroner’s inquest involved the incredibly sad case of a 28-year-old patient prescribed Elvanse by a private doctor. His treatment was stepped up twice from 30mg daily; firstly, to 50mg and then to 70mg. Following NICE guidance would have involved heart rate and blood pressure checks before and after each dose increase. The checks which were carried out did not follow NICE guidance.
- There was NO clear documentation of baseline blood pressure and heart rate before starting Elvanse.
- There was NO clear documentation of blood pressure and heart rate after increasing the dose to 50mg.
- The heart rate and blood pressure values used to inform the dose increase to 70mg were from a period when the patient was taking a 30mg dose.
- There was NO record of advice about adverse effects being provided to the patient or discussed with him.
- There was NO follow up letter sent to the patient following the dosage increase to 70mg.
The inquest record shows that the patient increased his dose to 70mg daily on the 6 August 2024. He told his family and friends that the new dose was making him ‘feel weird’, causing insomnia and exhaustion. The patient collapsed and died at home on 23 August 2024. The cause of his death was listed as: 1a) sudden arrhythmic death syndrome; 2) Elvanse treatment for ADHD.
Whilst the coroner stated that it was not possible to establish the precise cause of the arrhythmia on the balance of probabilities from the evidence before them, the failure to provide the patient with clear written advice regarding side effects of Elvanse or the actions to take if they experienced any adverse effects, deprived him of the information which could have led him to seek medical advice and which could therefore have changed the final outcome.
The coroner’s concerns included the following:
- Increasing doses (even in accordance with dosage recommendations) could cause a patient that has previously tolerated the medication to develop adverse side effects. Monitoring of heart rate and blood pressure may help identify serious side effects at an early stage.
- ADHD symptoms such as forgetfulness or inattention could result in patients not recalling advice on adverse reactions, particularly if only given at the start of therapy and not reinforced in writing.
- The practice of remote consultations may mean that prescribers are reliant upon patients providing heart rate and blood pressure data outside of the consultation. Consequently, there is the potential for clinical decisions to be based on unreliable observations.
Advice to PDA members
The PDA has members who are employed via private companies to monitor and prescribe ADHD medicines for previously diagnosed patients. This will involve up-titration of therapy. The PDA urges members to be meticulous about the monitoring of blood pressure and heart rate before and after every dose increase. If the patient develops tachycardia, arrythmia or significantly increased blood pressure, they must have their dose reduced and be referred to a physician. It is also important to provide (and ensure patients understand) information about the risks of treatment, warning signs and actions to take if they suffer apparent side effects, such as insomnia and exhaustion in this case.
The remote online model is a particular risk since measurements of heart rate and blood pressure cannot be taken directly. Other monitoring which would ideally be done directly is body weight and BMI (Body Mass Index) every 6 months.
Where the medicine provided requires patients to be monitored including measurement of weight, blood pressure, heart rate and direct examination, members should take into account guidance from the GPhC about additional safeguards which may need to be included in the service provided.
When supplying medicines for long-term conditions or conditions that require ongoing monitoring or management
The prescriber independently verifies the medical history provided by the person to make sure the supply is appropriate. By ‘independently’ we mean that the prescriber uses a different way to verify the information provided to them by the person. This should be through contacting the person’s GP, their regular prescriber, or a third-party provider, or checking the person’s clinical records, with the person’s consent, before making a supply. In addition, the prescriber takes responsibility for making sure the necessary monitoring arrangements are in place before prescribing.
Conclusion
The provision of prescription only medicines via online and remote services has been linked to numerous cases of patient harm and, sadly, a growing number of deaths. Providing medicines via an online consultation should be done to exactly the same safety standards as face-to-face in-person consultation. If this cannot be achieved, it raises the question of whether a remote consultation is appropriate or whether changes to the service should be considered.
NICE guidance sets out the monitoring requirements for a patient’s prescribed medication for ADHD. Members are advised to follow this guidance carefully wherever the service they provide is located, in particular ensuring that patents receive the monitoring checks which may help to identify cardiovascular adverse effects and prevent significant harm or death.
If members are concerned that their organisation prevents them from providing safe care, they should get in touch with the PDA for support and advice.
Learn more
- GPhC: Guidance for registered pharmacies providing pharmacy services at a distance, including online services
- ADHD Awareness Month 2024
- PDA IN THE NEWS: Dispatches highlights safety concerns around online prescribing of weight loss medication
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