While most of Europe is enjoying the heat wave , manufacturers, wholesalers, pharmacist and RP should be living in fear and in- trepidation , how high is the temperature in our ambient storage areas going to go ? What can we do when the air conditioning is just not coping. How can we comply with Good distribution practice when we deliver our medicines in normal vans, in which the totes become warm to the touch. What will a two or three hour non compliant journey do to the core temperature of the product and indeed to the API of our medical products? Will my fridge compressor cope if the ambient temperature rises above 30 degrees ?We really do not know all the answers ? We do not have all the information we need to make informed choices so we should ” err “on the side of caution.
A hospital pharmacist told me he was worried about his medicine deliveries, as the totes were too hot on delivery. He placed a data logger in the tote and it read 29 degrees centigrade and this was after sitting for 15 minutes in their air conditioned pharmacy. His concern was justified as placing ” hot ” stock into his robot was resulting in the Tutela temperature data logger in the robot alarming as the temperature was rising above 25 degrees centigrade and he was having to record the deviations and do his root cause analysis. He contacted the two main wholesalers for advice and there was no one available to take his call so he called me for advice.
This does cause RPs a real problem, it is not acceptable behaviour for wholesalers to deliver medicines out with GDP guidelines. If the medicines have not been stored and transported within the manufacturers recommendations as stated on the packaging , they are in breach of their Wholesale dealers licence,WL , and the products marketing authority,MA, and the product is rendered ” Un-licensed “.
I did a pharmacy locum this month in a 100 hour pharmacy.I went to read the fridge temperature and found it was a ” Meat Fridge ” the plate on the front gave it away +1 to +4? Funny, I thought medicines are + 2 to + 8 if cold chain, however if it kept the medication within the correct temperature limits , I would not worry too much . So I looked at the temperature log and sure enough there were reading of 1.2 and 1.3 etc. I asked the technician what was going on and she said
” We have had problems with the fridge it is a meat fridge , however we turned it up a little and bought a new thermometer”
“What about the stock”? I asked,
” It is OK , the temperature is fine now.”
I opened the fridge and there was insulin pens in their packaging sat on the base plate of the fridge. I spoke to the pharmacy manager when she came to relieve me and alerted her to the deviations and to the insulin. I told her the insulin on the base plate should not be used as it could have frozen as “+1.2” readings can be as low as “+0.7″ as the accuracy of the fridge data logger was + or – 0.5 degrees centigrade.
She retorted ” We cannot destroy all that stock ! ”
I was a little worried at the response, do pharmacist not know they have a duty of care to their patients?
But what about the supply chain, people need their medication, we cannot just stop delivering medication when it is hot ? There are not enough vans dedicated to cold chain deliveries and the cost will soar? Who will pay the extra cost ? What are the risks to the patient if they do not get their medication? What is an acceptable deviation to one product may not be to another ? Will the wholesaler credit the pharmacy if they refuse the order on the grounds that it has been not delivered in a compliant way ? There are too many unanswered questions , but as a scientist and a professional , I feel that more evidence is required, manufacturers should carry out shipping studies and a common sense approach needs to be adopted.
We await the guidelines due to be issued by the MHRA in August to help give some clarity on the situation, however for now the responsibility rests with the RPs who must validate their supply chain, record all temperature excursions and make the final decision if a product is fit for purpose. But remember it could be you or your child whose life may depend on that drug one day ? Your child could go into a diabetic coma if their insulin does not work.