Never assume that everyone is fully informed, especially when there is new information informatie. Provide a knowledge environment in which everyone can make his or her decisions. Check the position of the other stakeholders and consider what knowledge they need.

Intention

Before a drug comes on the market, extensive research is being conducted into the effect and side effect of the drug. When there are indications for new safety information after market launch (which is not yet in the package insert) a re-evaluation study of the drug will follow by governments. Especially with major changes, it is important that healthcare providers and pharmacists receive this information and that all users are informed gebruikers.

Approach

If re-evaluation studies show that the package leaflet needs to be updated with additional risk information about the medicine, then the Medicines Evaluation Board issues a Direct Healthcare Professional Communication (DHPC) out to all doctors and pharmacists. A DHPC is a one-time, additional risk minimization measure used to promptly and fully notify healthcare providers.

Result

It is not self-evident that the most current information actually reaches the users of medication, despite the strict procedures described above. An example where this didn't happen, is the story of a woman who probably ended up in hospital with a double pulmonary embolism as a result of side effects of the contraceptive Nuvaring.

It concerns a biomedical woman who, because of ease of use, switches from the regular pill to a Nuvaring in her thirties. (containing a third-generation contraceptive). The switch was done easily. The GP complies with the request and prescribes the Nuvaring without examination or additional advice. The lady does check any risks herself and finds no reason for concern here.

After years of use without complaints, arise in 2017 vague complaints of fatigue and shortness of breath after a long flight. Her smart watch also indicates that her resting heart rate is too high. Because madam is always healthy, Is she so worried after a few days that she goes to the doctor, followed by immediate admission to hospital with a double pulmonary embolism. Fortunately, the treatment is successful, but madam is going through a rehabilitation process 6 months in, can only do her job 50% and will have to keep taking blood thinners for a long period of time.

The side effects of the Nuvaring (and other contraceptives) came in 2013 renewed in the publicity: two thousand women in America accuse the manufacturer MSD that the Nuvaring thrombosis, has caused pulmonary embolisms and strokes. Four hundred women then filed a claim. There followed in 2013 a European reassessment of the newer generation of contraceptives whose core was: as a healthcare provider, pay attention to thrombosis symptoms and make the connection between risk profile (that changes during a woman's life, the older the higher the risk) and use of contraception.

On 28 January 2014 the Medicines Evaluation Board issued a DHPC to all doctors and pharmacists with the text:
‘It is very important to properly assess the individual risk factors of the woman and to reassess them regularly. More awareness must also be given to the signs and symptoms of thrombosis and cerebral infarctions; these should be clearly explained to women who are prescribed a combined hormonal contraceptive.”

Unfortunately, the lady from the example doesn't get much from the fuss in 2014 around the Nuvaring, despite keeping normal news communication channels. She cannot remember being actively contacted by her GP or pharmacist of. Ms also used a Nuvaring adherence app on her phone, but also this one has not given any signal about new safety information.

Lessons

The assumption that our safety systems are designed in such a way that important information about medication reaches end users adequately, may not be made yet, as is evident from this case.

The ambition to link all available information even better, has been an important foundation of the in 2018 founded start-up pharmacare.ai, who develops “24/7-your-pharmacist-in-your-pocket solutions”. The first product is expected in the first half of 2019. The dream of this startup is to facilitate circular pharmaceutical care concepts, that prevent personal and financial harm from drug use through integrated use of personal (digital) healthcare data and proactive communication about it.

Insights that pharmacare.ai uses in product development are:

1. The current digital communication possibilities on mobile platforms enable a patient to be actively informed about drug updates relevant to her. This is a huge opportunity for pharmacist and doctor to be able to actively inform the patient at all times "in the pocket".
2. Products that measure health-related information, like watches that track heart rate, are widely used. There are now more and more doctors and also pharmacists, who will link this data to their medical or pharmaceutical information systems, which can contribute to the earlier recognition of serious side effects of medication.
3. It is desirable that package leaflet information is even more structuredgestructureerd, so that personalized advice can be given to a patient in the future regarding the effect and side effects of risks.

Name: Claudia Rijcken
Organization: pharmacare.ai

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