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Clinical Safety Risk – Drug Dosage Changing on Copying Repeat Prescriptions or Converting Serial/CMS Script to Repeat

Cegedim Healthcare Solutions would like to clarify Vision 3 prescribing functionality that results in drug dosage information changing, without user action, when copying repeat prescriptions or converting Serial/CMS to a standard repeat prescription. In these scenarios the dosage will change to the default for that product, if a default exists, or the dosage instructions will be removed if there is no default.

Examples of both outcomes are provided below showing this occurring for the conversion of a Serial/CMS Prescription to a standard repeat prescription.

This will also occur when copying a standard repeat in both scenarios – an example for a repeat is shown for scenario 1.

Scenario 1: Where a default dosage exists for the product

Original Serial/CMS Prescription 1-1

Converted to standard repeat where a default dosage for the product exists – the dosage has been changed 2

Original Standard Repeat Prescription 3

Copied standard repeat where a default dosage for the product exists – the dosage has been changed 4

Scenario 2: Where no default dosage exists for the product

Original Serial/CMS Prescription5

Converted to standard repeat where a default dosage for the product does not exist – the dosage field has been cleared6

There is a clinical safety aspect to this, whereby the prescriber may not notice that the dosage has changed, and therefore there is a risk that patient may be issued with a higher or lower dosage than intended.

Should the prescription containing the changed dosage be dispensed to the patient, this may result in actual patient harm or adverse effects experienced by the patient. These include overdose, which can cause serious, life-threatening adverse drug events, or underdose, which may lead to diminished therapeutic effects of a drug (possibly resulting in a relapse or exacerbation of a patient's condition).

Note that any current content of the 'Information for Patient' and 'Information for Dispenser' fields included using the ‘Additional Information’ option on the Vision 3 Therapy - Add screen, may also be affected by this issue. Changing a prescription from a Serial/CMS to a standard repeat prescription removes any text in these fields. These additional information fields are separate to the dosage field.

Cegedim Healthcare Solutions is currently investigating what action can be taken to further mitigate any clinical safety risk as soon as possible. In the interim, we would request that prescribers using Vision 3 always confirm/edit the dose and other information as required, to ensure the prescription accurately reflects the prescriber’s intent when copying a repeat script or converting a Serial/CMS script to a standard repeat. Alternatively, users can cancel the existing Serial/CMS script and create a new standard repeat.

Many thanks for your co-operation with this.