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

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

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

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.

File 750 File 711 File 715 File 050 File 031 File 004

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 )

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

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

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.

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)

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