1. Pharmacy Administration Issues and thoughts Jürgen Brandstätter

2. Can we confirm this? A Pharmacy Administration documents one single administration event. Answer: YES – E.g. the taking of a pill – E.g. applying a creme – E.g. get an injection – E.g. get an infusion To what a Pharmacy Administration is related to? – Q: Can it be stand-alone? Answer: YES! – Q: Should it be possible to reference to a DIS? Answer: YES! – Q: Should it be possible to reference a PRE item instead of a DIS (means: we jump over the step of dispensing)? Answer: YES! – In future: Also to Medication Therapy Plan Item (In the same manner like PRE and DIS) A Pharmacy Administration does not need to be „managed“ by PADVs (what happened that happened) – But PADVs might refer to ADMs in case of issues -> will be extended by a CP Pharmacy Administration Items shall be able to be part of the PML document

3. Sections Additional sections, Answer: needs more thinking! – The usual ones as in all documents: Authorization, Patient Contacts, Payers – Coded Vital Signs [O] The Coded Vital Signs section should contain at least the height and weight of the patient. – Allergies [R] Allergies, Intolerances and Adverse reactions observed as a consequence of the recorded administration SHALL be documented in this section. If no such issues have been observed, the section shall remain empty or contain a narrative description declaring that no such issue has been observed. – Other sections necessary? What about Allergies the patient reports during the event?

4. Hierarchy (example) PRE item Injection 2 times a day for 1 week 5 injections in a package 3 packages to dispense DIS item 1 package with 5 injections ADM item (1 inj) DIS item 1 package with 5 injections DIS item 1 package with 5 injections ADM item (1 inj) : Note: ADMs may also be stand-alone or organized in another hierarchy

5. Data-elements Right HL7 structure: substanceAdministration with moodCode=EVN – Not „supply“ as it is in DIS -> that means, we derive the structure from PRE Data-Elements – Medicine All as in PRE, except Packaging and Generic Equivalent – Administration item (derived from PRE-item) Rename – Dosage Instructions -> Dosage administered – Prescriber -> Administering person – Fulfillment Instructions -> Administering Notes – Amount of units of the consumable to dispense -> Quantity administered Delete – Number of repeats – Patient Medication Instructions – Substitution Handling – Precondition Add – Reference to DIS item – Other data-elements to add?

6. Other thoughts Which data-container to use for the use-case „Patient tells the physician that he takes this or that medication“? – It is not really a PRE, because a PRE is an order – It is not really a DIS, because a DIS documents what the patient got dispensed. This is usually taken piece-per-piece for a longer period of time – It is not really an ADM, because an ADM documents on single administration event – Is it a „Medication Statement“? How does a Medication Statement look like? Do we need another profile for that or can we use the standard PCC Medication template?

7. Other thoughts What happens to exceptions, like „Patient gets the medication administered, but throws it up again“? How to deal with „Missed administrations“ – Should be in scope How to deal with „Adverse reactions“? In scope? How to deal that the patient himself reports an administration? – Are the header constraints allowing that (Patient has no ID)? How to deal Medical Devices are reporting an administration? – Are the header constraints allowing that?

8. Other thoughts What about infusions where the parameters change during executing (drop rate, etc.)? – Are those several administration events or is still one with tapered dosage? – It is still the same medicine, just the dose changes – Sometimes additional medication is added to the infusion in the middle of the process, because of some effects appearing – Possibilities are very complex, it‘s recommended to record those in separate events – Solution: ADM document represents the „Administration“ (containing 1..* „Administration events“) ADM may contain 1..* ADM entries – By this „splitted“ administration events can be handled Implication: One ADM document may contain the administration of … – … the administration of 1 medication with change parameters over time – … the administration of several medications at the same time

9. Other thoughts How to deal with administrations, where several medications are taken at the same time, but … – … come from different DIS or PREs?