IMP temp monitoring

We routinely monitor temperature of IMP but once we have dispensed it to a patient then storage is not our concern. Can anyone advise on if we need to temp monitor IMP on the ward if it has been dispensed to a patient ???? :confused:

Clinical Study subjects should know the acceptable storage conditions (temperature range) for drug that are dispensed to them. Typically, this is printed on the bottle labels or provided in ancillary information provided to them. Subjects should be reminded at each visit regarding the acceptable storage condition and why storing the drug at these temperatures is important (viz. product stability and potency, which affects efficacy and safety). The staff should encourage subjects to tell them when excursions from the accepted temperatur range have occurred, so the study staff can replace the drug, if necessary.
I have never known of a sponsor which was required subjects to maintain logs of storage temperatures once the drug has left the clinic.

Thanks for responding, very true ,so then I would assume that if the patient is on the ward then we should continue to temp monitor the IMP regardless of the IMP being allocated?

Hi Susie,

If the patient is still on the ward and the ward is in the sponsor designated hospital, then I think it is responsibility of the hospital to maintain the IMP at the right temperature and usual responsibility of the sponsor applies.
When the IMP is dispensed to a patient to take away with them, then as Gfn said, all staff should strongly encourage the patients to follow the information given and to keep the IMP at the right temp and to report any excursions.

I hope this helps.

Hi Susie

Definately. The MHRA will expect it to be kept in a secure location (e.g. lockable cupboard) and separate from standard ward drug stock. Also, the temp monitor should be calibrated and re-calibrated as advised by the manufacturer (e.g. anually). I have found is it ofen cheeper to buy new thermometers rather than pay for re-calibration.

Best
John

Thanks John yes it is crazy that new thermometers cost less isnt it.

It's also worth being aware that most medications can be stored at up to 30 degrees even if the SmPC says 25 degrees. That knocks out many of the problems and one should request approval for up to 30 degrees in the SmPC.

How important this is should also surely depend on the study rather than being an arbitrary rule? It's a nonsense to waste time temperature monitoring wards for a few days at the start of a trial if you're dealing with a drug that has been on the market for 40 years and where each patient is dosed over 18 months - whereas a novel compound given for only 7 days while an inpatients might be important to monitor closely.

I don't understand why the risks of temperature excursions cannot be debated and agreed at study start and protocols written to say it will be ignored completely in low risk situations or study designs.

Has anyone seen that done? How would the MHRA feel about that? Perhaps it should form part of the CTA application?

CTU

On the note of thermometers - we have recently bought electronic data loggers for temperature and I have checked with the MHRA regarding 're-calibration'. For non-trial loggers we usually get one logger externally recalibrated then use that one to 'validate' the use of the others in the department therefore getting around paying for recalibration of all loggers. I have been assured by the MHRA CT helpline that this is fine to do for loggers used for clinical trial stock :-) another cost saving for R&D and the NHS!!!

Susie,

You definitely need to monitor IMP if stored in clinic or on the ward - the MHRA picked this up at our recent inspection, and I know they have done at other Trusts. In our case, we weren't even aware the drug was being kept for long periods of time. We now have a rule that if drugs are to be kept overnight they need temperature monitoring - and strongly discourage this practice unless absolutely necessary. Each area has a thermometer, supplied and maintained by us, but they are responsible for recording the temperature and reporting any deviations - each area has a deviation procedure to follow. A member of the pharmacy team conducts monthly audits to ensure compliance - if they don't comply, we threaten the removal of the remote storage option! I'd be happy to share our paperwork with anyone who wants it. Kate

Hi pgamble,
We are in similar situation.New web based system installed in Pharmacy.As backup system can we calibrate min/max thermometer? Some of these thermometers are due calibration next month and some are due next year.Can we calibrate Min/max thermometers using one which are due next year or we need to calibrate using a brand new calibrated thermometer?

Good post CTU - I think the MHRA are very reasonable in their expectations for IMP temp monitoring when the risks of not temp monitoring are demonstrably very low. We have a CTIMP running in which the IMP is a well established drug dispensed as per routine practice from hospital stock and used in it's licensed indication. We stated in the protocol and in the CTA application that the IMP will be stored as per routine practice; we don't maintain any temperature logs as part of the trial documentation therefore. That said, the trial is very much a 'Type A' trial.

Hi All,

My understanding about importance of temperature monitoring is that, as the product is in investigation use, every single thing they take as serious. And I think that if MHRA is linear with temperature control then people might misuse that phrase and start storing at any places.

Dear skumar,

It might not be a good idea to use any thermometer to use as reference point. Normally this responsibilities lies with QC department. If you want to calibrate some thermometer, you must have one reference thermometer which normally calibrated by manufacturer. Using that manufacturer calibrated thermometer you can calibrate other thermometers.........

Just realised in my post above I should have said apply for 30 degrees in the CTA application even if the SmPC says store at 25 degrees, not to apply for 30 degrees in the SmPC....obviously!!