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Limitations

A number of known device limitations are set out in this section to inform the Intended Use and Contraindications.

The limitations described in this section represent residual risks identified through Dosium's risk management process under BS EN ISO 14971. The clinician must take them into account when using Touchdose and when interpreting the recommendations it provides.

Availability​

As with all products of the nature of the Device, it is possible for the Device to be temporarily unavailable. If Touchdose is unavailable you should refer to the BNF, your local guidelines or any other resources you usually make use of when prescribing.

Automation complacency​

Touchdose presents dose recommendations in a clear, structured, and authoritative-looking format. There is a recognised risk that clinicians may accept these recommendations with reduced scrutiny because of the way they are presented, rather than applying the same level of clinical judgement they would when using a non-software reference. Touchdose's recommendations are decision support only; the clinician retains responsibility for evaluating whether each recommendation is clinically appropriate for the specific patient, taking into account the patient factors and clinical considerations that Touchdose does not have visibility of (see Limitations relating to exchanged data below).

Limitations relating to exchanged data​

Limited patient information​

The Device operates only on selected patient demographic and anthropometric inputs. A full list of patient parameters which can be taken as inputs by Touchdose are:

  • Date of birth
  • Sex at birth
  • Total bodyweight
  • Body length / height

These inputs form the exclusive basis for Touchdose's medication-related suggestions. Touchdose uses these inputs to calculate other patient information such as:

  • Body surface area
  • BMI
  • Ideal body weight
  • Obesity status

This patient information will also be considered by Touchdose when presenting dose recommendations.

It is important to note that additional patient characteristics, which could be pertinent to medication use but are not supported by Touchdose will not be factored into its responses. As such, Touchdose's suggestions must be supplemented with clinical judgment to ascertain their clinical appropriateness.

The Device does not accommodate several patient characteristics that might necessitate alterations in medication-use decisions. These include, but are not limited to:

  • Other medications a patient may be receiving thus the system cannot consider drug interactions or cumulative dose maxima
  • Patient allergies
  • Corrected gestational age (only date of birth is taken as an input)
  • Patient comorbidities
  • Considerations regarding medication side-effects
  • History of adverse drug reactions
  • Pharmacokinetic considerations including but not limited to:
    • Malabsorption states
    • Liver function
    • Kidney function
    • Serum/plasma drug concentration values
  • Pregnancy status
  • Breast feeding status
  • Overall clinical condition
  • Any other clinical consideration that would dictate any dosing modification

Note that Touchdose does not take any of the above information as inputs. It's crucial to understand that EP Systems integrated with Touchdose might include extra patient data not shared with Touchdose. Simply because data is available for a patient in the EP System doesn't mean Touchdose can utilise it for dose recommendations.

In addition, each dose recommendation is presented independently and as such no consideration is made to other dose recommendations made. This means that Touchdose is not aware of other prescriptions made using Touchdose or otherwise. It is the responsibility of the clinician to appraise each prescribing decision using Touchdose considering a patient’s other medications at the time of prescription.

Limitations relating to the underlying formulary​

Touchdose relies upon third party formulary reference data.

The formulary content surfaced within Touchdose for a given organisation is governed by the data contained within that organisation’s formulary, which the application interfaces with directly. The breadth, completeness, and accuracy of the formulary content are controlled by the organisation’s formulary managers and are subject to:

  • The scope, structure, and limitations of any third-party reference data incorporated into the local formulary, and
  • The breadth and depth of any additional content provided by the site.

Accordingly, formulary content available within Touchdose may vary between organisations and may be subject to certain constraints, including but not limited to:

Missing content​

Touchdose is unable to offer suggestions for any medication, condition, or patient group lacking corresponding data in the underlying formulary.

Incorrect content​

The content in any underlying formulary onto which Touchdose provides an interface must be approved by the Client or other relevant data supplying organisations. It is possible, however, that this formulary may be incorrect, and in such cases, recommendations based on that content would be incorrect.

Incomplete content​

Medication-use suggestions generated by Touchdose may be limited if the medication content in an underlying formulary is incomplete for any medication, condition or patient group, as such, responses received from the Device should never be considered to be a reflection of all possible use cases for a particular medication.

Unstructured content​

The data model of the formulary onto which Touchdose provides an electronic interface contains unstructured (free-text) fields to enable detail or nuanced explanations to be communicated to the clinician. Such explanations may contain advice suggesting modifications to the use of a medication in certain clinical situations. Touchdose will pass this information to the Clinical End User if available but will not directly modify the medication-use suggestions. Medication-use suggestions generated by Touchdose may need to be modified by clinicians based on free text information.

Temporal considerations of the treatment plan​

The Device is not designed to incorporate broader drug records for a patient as input. Consequently, it does not consider any past, ongoing or future medication regimens that a patient might be prescribed or have received. This means that Touchdose will not modify its medication-use suggestions based on other medications a patient has received or will go on to receive.

However, when underlying formularies contain temporal dosing guidelines (such as maximum doses per course or per day), this information will be presented by Touchdose. It is the responsibility of the healthcare provider using the Device's guidance to make appropriate adjustments to the medication order when necessary. This includes potentially modifying the suggested duration of treatment based on the available dosing guidelines.

Independent recommendations​

Each query is treated independently. Touchdose does not maintain state across prescribing sessions for a patient, does not detect duplicate or similar prescribing within or across sessions, and does not adjust its recommendations on the basis of any prior recommendation presented to the user — for example, where the user has previously viewed a drug that may interact with, or act as a substitute for, the currently selected drug. The clinician is responsible for checking each prescribing decision against the patient's wider medication profile.

Drug drug interactions​

Touchdose does not integrate with databases containing information on interactions between medications and will not modify any response based on any potentially relevant drug-drug interaction.

User information and prescribing rights​

Touchdose does not receive data regarding the end users of Touchdose. Consequently, the usage of Touchdose is not limited based on user-specific information. It is the responsibility of the relevant parties within the organisation where Touchdose is deployed to ensure that any prescribing restrictions are adhered to.

Funding considerations​

Touchdose does not alter suggestions based on the cost of a medication or its availability within the organisation in which it is deployed. For example, a medication may not be covered by a health service in a certain country or region, but if dosing data is present in the integrated formulary, dosing recommendations will still be returned by Touchdose. If a medication is not available an alternative medication may need to be selected. Clients have the ability to choose the included drugs in their underlying formulary.

Licensing status of medications​

Touchdose provides medication-use suggestions based on the content available in the Client-approved formulary, regardless of whether this content relates to the licensed or unlicensed use of a particular medication. This means that Touchdose does not differentiate between medications approved for specific uses and those used off-label, basing its recommendations solely on the information contained within the dataset.

Limitations relating to order writeback into the EP System​

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Touchdose does not authorise, sign, or commit any medication order. Where order writeback is used, the recommendation is placed into the host EP System's pre-signature draft only. The clinician must independently review every field of the order — both those populated by Touchdose and those completed manually — and authorise the order within the EP System before it reaches the patient record.

Where the integration with the EP System supports it, Touchdose can transfer the dose recommendation that the clinician has built within Touchdose into the EP System's pre-signature order form. This is referred to as order writeback. The clinician must then review the order in the EP System, complete any field that Touchdose was unable to populate, and act on any clinical decision support presented by the EP System before signing.

Availability of order writeback​

Order writeback is not supported by every integration. Where it is supported, it may only be available for a subset of medications, and may only be available from particular launch contexts within the EP System. For example, in some integrations order writeback is only available when Touchdose is launched from within an active medication ordering workflow (an "in-order launch", in which the medication context is already set). When Touchdose is launched from another context — for example, a patient-context launch where Touchdose has access to patient data but not to an existing order — order writeback may not be available, and the recommendation must be entered into the EP System manually.

When order writeback is not available for a given prescribing event, the Add order button will not be active.

Order writeback may also be intentionally blocked for specific orders that cannot be safely or correctly transferred into the EP System's order form, even where the integration otherwise supports writeback and all decisions have been completed. An example is a continuous infusion, where the dose is expressed as a rate that the order form cannot represent. When writeback is blocked for an order in this way, the Add order button remains inactive and the clinician must enter the order into the EP System manually using the standard order form. This is distinct from the case where an individual field simply has no equivalent in the EP System (see Field coverage of order writeback below): there, the order is still written back with that one field left blank, whereas a blocked order is not written back at all. Which orders are blocked is determined by each organisation's configuration.

Field coverage of order writeback​

When order writeback is performed, Touchdose typically populates key prescribing fields including medication, indication, brand, dose quantity, dose unit, frequency, duration, duration unit, route of administration, formulation, special administration instructions, and PRN status.

Not every order will contain values for all of these fields. In some cases, even where data exists in Touchdose, the value may not be transferable to the EP System — for example, certain frequency options in Touchdose may not have a direct equivalent in the EP System. Where this happens, the field will be left blank in the EP System's order form and must be completed manually by the clinician before signing.

Some EP System fields are mandatory and may not always be populated by Touchdose (for example, formulation in some integrations). The clinician is responsible for completing any mandatory field that Touchdose has left blank before signing the order.

Transcription and completion errors after writeback​

Any field that order writeback leaves blank must be completed manually by the clinician within the EP System before signing. Any manual completion or amendment carries an inherent risk of transcription or entry error. The clinician must therefore review every field of the order in the EP System — both those populated by Touchdose and those completed manually — and confirm its accuracy before signing.

Opt-in use​

Where Touchdose is available with order writeback as a prescribing tool, its use is opt-in. The clinician may revert to the standard EP System prescribing workflow at any time.