Article Text

PDF
Other Hospital Pharmacy topics (including: medical devices)
Problems and solutions related to the storage of investigational drugs
  1. G. Saibene,
  2. M. Mazzer,
  3. E. Togliardi,
  4. L. Russo,
  5. G. Ciuffreda,
  6. S.G. Arienti
  1. 1Fondazione IRCCS Istituto Nazionale Dei Tumori, Farmacia, Milano, Italy

Abstract

Background The pharmacist has to ensure the integrity and efficacy of drug products. Proper storage of experimental drugs is of great importance in the management of clinical trials. Temperature is one of the most important parameters to control. The authors are dealing with new substances and The authors have only a little information about their stability, therefore the temperature is strictly monitored.

Purpose Increasingly, drugs are required to be stored at a temperature below 25°C and the pharmacist has to certify it. Therefore, air conditioning systems are not sufficient and control systems are needed.

Materials and methods For continuous temperature monitoring inside the pharmacy, in addition to recording on paper, The authors are using ScanTEMP, an innovative series of data loggers. They are temperature monitoring devices with RFID interface; they can record up to 6400 samples in a temperature range from -25°C and +70°C.

Results The software automatically makes charts of temperature records and indicates any ‘out of range’ parameters with an alarm. Features: easy to use, cheap, small, mobile, accurate, long battery life, large memory, difficult to falsify; reading through specific device, connected to the USB port of a PC; working parameters customisable as needed (range of data acquisition, alarm); password protected data; 12 reports per year. Paper recording, on the other hand, requires: periodic replacement of the disks, periodic calibration of the probe; is easy to fake; provides 52 reports per year. Being able to see immediately when the temperature is outside limits, and for how long, is a great quality.

Conclusions Pharmaceutical companies increasingly ask for monitoring and recording even of the room temperature. It is necessary to implement temperature measuring systems, which also have to record data. In the event of temperature excursions, however, it is important to act promptly: it would be beneficial to use devices that allow recorded data to be seen immediately, with an alarm in case the temperature is out of the allowed range.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.