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Possibly confused Reflections on an EAHP Seminar

Possibly confused Reflections on an EAHP Seminar

After une petite IT glitch in le matrix the session “Compounding without frontiers, cooperation over country borders” commenced with Professor Koch outlining some of her research in the area of Therapeutic Drug Monitoring (TDM) and Model Informed Precision Dosing (MIPD) and the benefits of collaborating with other global experts. TDM and MIPD are tools to allow personalised dosing/pharmaceutical care which is a holy grail of clinical pharmacists. Apart from the clinical benefits of optimal dosing to match the unique physiology and biochemistry of a patient there are also financial and sustainability benefits too. Instead of one (or repeated) doses for every patient, as recommended by the manufacturer/ SmPC, tailored doses can result in less medication being administered for the same benefit and a reduced side-effects burden. This can mean increased patient access to rare and/or expensive medications and financial savings. Brilliant! you say, why aren’t we all using TDM? Well, interestingly, the good professor also shared with us two studies that showed no benefits in primary and secondary outcomes between patients treated sans TDM (apart from adjustments for eGFR) and those who were. Some of the details can be found in the Dolphin Trial conducted in the Netherlands). However, collaboration came to the rescue. Other experts and researchers were able to contribute to the discussion and it seems there are important benefits to be obtained in subsets of the patients involved in the study. Professor Koch indicated that larger studies are required to verify the benefits of TDM and MIPD. TDM, According to the professor TDM may become more easily accessible to clinical pharmacists as there are now biosensors for medicines that could simplify the sampling/ analytical aspect of TDM but further validation of the benefits of expanded TDM services is required. Professor Koch also spoke about the EU’s ambition “to create new knowledge and scientific evidence and to codesign new solutions and support their transfer and scale-up across countries and regions while also fostering capacity building.” (EU text and my italics). Interested parties can also liaise directly with the professors university at COST.bEU.PREPAREDNESS@ ERASMUSMC.NL

The professor at the outset, it should be noted, protested that she was not a compounder but a collaborator but her esteemed co-presenter Professor Pascal Odou was an exquisite compounder. The author waited with bated breath to hear of his daring exploits in the field of compounding and based on the EUs desire for cross-border collaboration I was anticipating a geopharmaceutical gallop across Europe. Professor Odou did not disappoint. He recounted that during the pandemic stocks of cistracurium injections ran critically low. However he knew a “guy”. Actually it was a Belgian pharmaceutical broker who could supply him with the API. The Professor’s hospital pharmacy in Lille (France), had manufacturing facilities that could produce ampoules. Normally it was authorised to do small batch manufacturing but during the crisis the ministry of health approved the production of much larger batches (tens of thousands instead of some hundreds). Obviously this necessitated the procurement of a large quantities of ampoules. So off to the Spanish border we go (for reasons not disclosed) and the professor gets his supply of ampoules and the manufacture of vital cistracurium amps commences. All the rigorous tests and standards of GMP were complied with and the pharmacy in Lille produced about 60,000 ampoules, if my memory is correct. So many units in fact that there was a surplus. The professors Belgian colleagues (some only 30km away) wondered if they could have some. The professor was willing and ran it by the French authorities who said Non! You can import but you can’t export. Vive la bureaucracy !! Well at least he knew he could import, that has to count for something. Well.. encore Non!

The beleaguered professor has an automated anticancer compounding device that has a very specific palate when it comes to water. As you can imagine my fatigued reader, said water became unavailable. The resourceful professor found out that an alternative supply of water was produced by a French company. Magnifique! you cry, the patients are not inconvenienced. Unfortunately for the professor the water was produced and licensed for the Belgian market only. The same authorities as before, deemed it unsuitable for French patients because it was not marketed in France. The professor is not taking that lying down and we await developments. In defence of the French officials, their counterparts in Belgian also hindered a cross-border initiative that the professor described, on the basis that Belgians don’t cross the border for healthcare!

Professor Odou believes that the EU should authorise pharmacists to exchange goods. (And this would seem to echo the EU THCS initiative). He also believes there is a need for a compendia that would harmonise compounding practises. This presumably would simplify cross-border transfers, if authorised.

Please do not hold Professor Kock or Professor Odou to account on the basis of these meagre scribblings. Other people’s recollections may be more accurate!

Written by Declan P O’Sullivan, Head of Pharmacy, Cherry Orchard Hospital

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