- Pharmacy Updates
ADDITIONAL COMPLIANCE REQUIREMENTS
The recent NPA announcement and update, is pertinent to your daily practice and requires immediate action.
As pharmacists and doctors at UKCC, we have been engaging with all the regulatory bodies on your behalf – including the NPA and the GPhC. It is now time for you to take careful stock of what your daily practices are – in order to remain compliant and safe.
The position outlined by the NPA is in direct parallel to the position we have held and developed since we started providing training and support to pharmacists and healthcare providers.
It is highly likely that the sale of CBD products will now become part of the GPhC inspection model.
In order to make a compliant supply of any cannabis product, your responses to the following must be true:
Has your pharmacist completed the training on CBD products? (If not, link is below.)
Is the supply chain being compliantly maintained? i.e. is your CBD coming from a pharmaceutical wholesaler (like Ethigen), or directly from the manufacturer (Like CBD UKCC)? If not, then GDP has been breached and your products could be compromised.
a) As with medicines, CBD requires to be maintained within a controlled temperature range to remain stable and has required storage conditions. We have come across examples of customers purchasing CBD products such as Cannabidiol from a 3rd party resellers (Such as Toiletries sellers and transfer order salespeople). These are not pharmaceutical wholesalers and the products do not travel through a GDP supply chain subject to controlled temperatures and storage.
b) Any products through this supply model would not be suitable for retail sale, or defensible/insurable legally if there was an event.
Does your product show 0% THC or <0.2% THC? Under the current guidance ANY THC (<0.2%) will be considered a schedule 1 Controlled Drug. UKCC can provide master certification showing no THC in existence for all products endorsed by our supply chain. (More info below).
Are you certain products are displayed for self-selection? If they are not displayed for self-selection then pharmacists could be considered to be recommending them without having been requested to do so by the patient. We have encountered multiple instances of this. If you require dummy packaging to make available for self-selection, get in touch with us straight away and we can supply free of charge.
Are the UKCC guidance and drug interaction checklists freely available to staff and obviously being used? As a pharmacist, your number 1 duty is to the patient. Selling CBD products without checking for drug interactions would be an oversight which could lead to a significant patient event.
QUICK PHARMACY AUDIT
Don’t panic, just take action as soon as practical for your business.
Current stock is not a risk to patients but may not be insurable if there is a patient event.
PLEASE NOTE VAPE PRODUCTS ARE UNAFFECTED BY THIS NPA NOTICE AND CAN CONTINUE TO BE SOLD WITHOUT ANY ALTERATION IN PRACTICE.
Vape Products are made from Crystallised Isolate or synthetic cannabidiol. Therefore, they cannot contain THC.
HOW ARE WE MAKING THIS MORE COMPLIANT FOR YOU?
1. All products provided through our supply chain will now be branded Pharmacy Exclusive under the banner Canidol.
a) All Canidol products are double tested for absence of THC (HPLC and 3rdparty GCMS)
b) All Canidol products are designed for Pharmacy retail and dispensing
c) All current pharmacy retailers of UKCC/Canidol products will be provided with a UK Cannabis Clinic online portal, with research driven protocols, backed by science and consultant level physicians. (Worth £1000).
2. All Canidol products will contain a PIL*, giving information about drug interactions and product content – this means that even if a drug interaction check is missed, or a sale takes place which is for another person, the information is available to the end patient. This does NOTdischarge your responsibility but merely strengthens the safety message and provides a needed backup. Examples of these can be downloaded here and here.
3. All products will contain a certification card – 0% THC.
a) While modern testing environments and technology are good, the actual rules on THC content from the home office are “1mg per unit”.(You should know this from the training module).
b) Laboratory tests alone cannot completely rule out THC content, however small, therefore supply chain, process control and understanding of methodology are also important
c) Using this information, Canidol Pharmaceutics – the pharmacy research brand for UKCC going forward, will provide 0% THC detectable certification to you and therefore remove vicarious liability.
d) This then removes your vicarious liability.
Canidol products are Pharmacy exclusive and are NOT available online and should not be sold online. Any online sales or retail presentations of cannabinoids on pharmacy websites should cease immediately.
We would urge you to contact either your local sales rep, or us directly. We will immediately and expediently swap all your existing stock to Pharmacy Exclusive Canidol to further align your practices compliance with the recent notices by the NPA, Home Office and coming guidance from the GPhC.
If you are currently purchasing other brands of CBD products in addition, we would seriously consider that you review their certification, product and GDP model as any retail sale of a product containing THC in any amount – could now be considered to be an offence from a legal and a regulatory standing.
Read the whole announcement from the NPA
ACCESS THE COMPULSORY CBD TRAINING MODULE: www.ukcannabisclinic.com We will then send you your certificate.
GUIDANCE/INTERACTION LEAFLETS can be ordered from us via the contact page: www.ukcannabisclinic.com/ (free of charge)
PATIENT GUDES can be ordered or downloaded directly from us.
SWAPPING EXISTING STOCK:
*Product information leaflet
REORDERING COMPLIANT PHARMACY EXCLUSIVE product could not be easier just call us on 0141 404 6255 or contact your wholesale representative.