1. Medication surveillance concerning hypersensitivity reactions to drugs: the Dutch approach
Froukje Harkes-Idzinga KNMP, The Hague October / November 2016

2. Program:
G-Standaard
decision support concerning hypersensitivity reactions to drugs
guideline on registration and exchange of characteristics of hypersensitivity reactions to drugs

3. Use of the G-Standaard Manufacturer Physician Pharmacy Patient
visit
Physician
goods
Wholesaler
order
Health insurer
invoice
Pharmacy
prescription
medication
Manufacturer

4. Content of the G-Standaard (in general)
The G-Standaard contains:
all (licensed) medicines available in the Netherlands, including OTC
homoeopathic products
medical devices
and provides information on:
logistics, legal status, reimbursement (for all products)
pharmaceutical characteristics (for medicines)
decision support (for medicines)
The G-Standaard contains:
all registered medicines available in the Netherlands, including OTC, and some other OTC health products, such as St. John’s wort with it’s danger of drug-interactions.
It also contains
homoeopathic as well as anthroposophic products
and medical devices, such as catheters and bandages.
For all registered medicines, the database provides information on pharmaceutical characteristics, such as
active ingredients
pharmaceutical form, like tablets or solutions, and
route of administration,
Also for registered medicines, it contains medication surveillance data for decision support by the healthcare professional.
This information is also being provided for the other OTC health products, but not for the homoepathic and anthroposophic products.
It also contains useful information on logistics, legal status and reimbursement.
For example concerning logistics how many units one package contains,
and concerning legal status whether a product is prescription only, available only in pharmacies, or also at the chemists’ or, as we call it in the Netherlands, at the gas station.

5. File 750
File 711
File 715
File 050
File 031
File 004

6. examples niveau example SNK (basic substance) Morphine GNK (substance)
Morphine HCl-3-H2O
GPK (GeneriekeProductKode, basic product)
Morphine injvlst 10mg/ml [contains morphine HCl-3-H2O 10 mg]
PRK (PRescriptieKode, prescription product)
Morphine injvlst 10mg/ml amp 1ml
HPK (HandelsProductKode, trade product)
Morphine HCl PCH injvlst 10mg/ml ampul 1ml
ZI-number (Consumer item)
Morphine HCl PCH injvlst 10mg/ml ampul 1ml (10 st )

7. From database to clinical decision support
Clinical decision support for:
General Practitioner
Medical Specialist
(hospital) pharmacist
Information from databases incorporated in:
Prescribing system
Pharmacy System
Databases:
G-Standaard
PharmaBase

8. Hypersensitivity (e.g. allergy)
Features:
Alert
groups with possible cross-reactivity
no practical guideline
Information based on:
SPC
expert opinion

9. Guideline
National Working Group with delegates from professional organisations of both physicians and pharmacists and Nictiz
guideline on registration and exchange of characteristics of hypersensitivity reactions to drugs (concept)
characteristics in guideline:
drug (substance or product) or group with possible cross-reactivity
symptom(s) of worst hypersensitivity reaction
seriousness of hypersensitivity reaction
source
policy (can de drug be prescribed again in the future or not?
So, medication surveillance, or decision support, plays an important role in the prevention of medication errors.
I have told you about the different types of medication surveillance data that are available in the G-Standaard.
As the G-Standaard is incorporated in computerized systems for healthcare professionals, these checks can be performed during prescription and before dispensing.
Most types of alerts are accompanied by practical guidelines on how to deal with the alert.
Also, evidence is made transparant as it is provided in a data sheet.
However important, the fact remains that medication surveillance introduces alerts healthcare professionals have to deal with.
This means it takes time and effort in day-to-day clinical practice.
It is important to remain aware of this, to find a balance between getting all important alerts, but also not to create alert fatigue. (GOED OMSCHREVEN?)
Now I have told you about the advantages and challenge of medication surveillance, or decision support, using the G-Standaard,
I would like to turn you over to my collegue, Frits Elferink, who will tell you about the structural characteristics of this database.

10. Global Substance Registration System (G-SRS)
is being designed at the moment
takes into account ISO IDMP Standards
might be of use to our project
project leader: Herman Diederik (Medicines Evaluation Board, the Netherlands)

11. more information: f.harkes-idzinga@knmp.nl
Questions?
more information: