Knowledge

Global Medication Database structure. Master Data

The following are elements that need to be created to form the global database. We report them as they are drwn upon in each case. They constitute additional knowledge that is required to find the errors, and we intend to associate a global approval organization with it. Then we will show the approval status.

Database structure

Active Substances in Medicines (per country)

Most databases tie the Active Substances (the ingredients) to the medicine, but they are sometimes weak when it comes to the amounts of Active Substances in "one unit" (e.g. a pill, but see below under base amounts). Especially when it comes to combination products. Also many databases are mislead by the structure of ATC codes, in that a combination has a separate code, where it should have a code for each ingredient.

Sometimes "strength" is given in databases, e.g. as "200 mg/ml", but if one unit consists of 4 ml, it contains 800 mg of the ingredient. We have assigned the correct amount of Active Substance in each unit.


Base Amounts (per country)

For pills (tablets) the base amount is one pill. But this becomes more tricky for capsules, where the content inside the capsule is a fluid. In some databases the fluid is specified with the amount of ingredient given for 1 ml, and the amount inside the capsule often differs from 1 ml. It is certain that prescriptions for medicine in capsules are given in number (of capsules), not "ml". The same goes for certain other dispensing ways (dosage forms) like glasses of powder to be added to water to create a solution etc. It is therefore important to determine what the base amount is.

Many countries allow "%" - and it must then be determined if it is "weight per weight", "weight per volume" etc. Then the base amount is given - but then the prescription is often a problem, since the amount is rarely gived (e.g. for creams, where you "apply once per... on the area...").


Codes and standardization

We have assigned RxNorm codes (and hence SNOMED CT (US) codes) for every Active Substance where available.


Weighting in Risk Classes

If an Active Substance is in a Risk Class (e.g. Anticoagulation, Opioids, NSAIDs etc. - e.g. Aspirin is in all of those mentioned), we have assigned a weight of that Active Substance in the Risk Class. They are relative to a certain reference Active Substance, and the threshold amount of this reference Active Substance is then used.

We then calculate a weighted sum, e.g. weigh together the amount of Aspirin and the amount of Clopidogrel of some form (Clopidogrel being more "heavy" than Aspirin) and determine if the weighted sum is too much in the Anticoagualnt class (using the threshold of the reference Active Substance, Warfarin Sodium, where the weights applied are relative to Warfarin Sodium).

This way we find over doses of a Risk Class - the leading cause of death and serious injury from medication errors. We have only found weights ("equivalent strengths") in Switzerland and only for some Active Substances and some Risk Classes. For the rest we have used official max dosage numbers, so that the max dosage exactly hits the threshold as it should.


Digitalization of package inserts

We have turned the following 3 important sections of the package inserts into check point that we attempt to set: (1) Contra indications, (2) Precautions, and (3) Other Medications (to tell the doctor about). The strict and literary interpretation of them has created hilarious situations (showing that they are not being read by anybody). E.g.: "If you die from a side effect, you should stop taking the medication" and "If you are a woman, you should call your doctor immediately".

Nevertheless we set (true or false) these check marks, if we can. If we know for sure how to set it, it is greyed out (e.g. for medication, where we assume we know of them all). If we are not sure, we set it as best we can, but leave it for the user to override the setting (e.g. "You drink large amounts of alcohol", where we set it, if you drink more than 4 units per day on average, but we leave it for the user to determine).


Globalization. Europe and USA

The clinical rules come out in Package Inserts and in web site applications like MicroMedex (now a oart of IBM Watson Health), MedBase (Finnish and a little Swedish, also used in Italy and other places) and Medicin.dk (used as the main source of clinical information in Denmark and in Danish). The Package Inserts are often the same (in different languages) in Europe, so they have clearly been approved by the EMA, and/or the pharmaceutical re-uses the application in all of Europe. But the Package Insert is often very different in the USA (and Canada). You can see this in Micromedex, where a US flag is shown, when they display rules from the FDA.

We have chosen to digitize the Danish and thus the European Package Inserts - but we will incoporate US (FDA) rules as well, and adopt a "least common denominator" principle, i.e. put conta-indications and warnings there, if they are in any of the countries.


Drug GPS for Clinicians

This document (click to open) explains in detail what the errors are and what knowledge the solution consists of. It goes through an example.