The accountable officers in charge of safeguarding the storage and release of controlled drugs work hard to ensure safe warehousing and management in the UK. But changes in the way healthcare is delivered mean that some of these traditional boundaries are starting to blur.
One way this is having an impact is on the granting of controlled drugs licences. In order to comply with the issuing of a licence there are some strict criteria that must be followed. When considering the suitability of a company to hold a licence or registration, no single security measure will be determinative. The Home Office Drugs and Firearms Licensing Unit considers sites holistically and location, physical security, business type, procedures, practices and personnel are all included in the evaluation.1
Site and building security in particular are affected by location and wider environment, scale of the business, size of premises, staff numbers, the nature of business and the amounts of CDs/PCs held on the premises.2
This was the case for Clarity Pharma, a prominent UK headquartered distribution partner servicing mid-market pharmaceutical companies around the world, when it was granted its Home Office Controlled Drugs license. The accreditation is an attractive addition to Clarity’s range of services for both existing and new clients.
“An important factor to highlight is that each licensee, or prospective licensee’s premises and the business conducted will carry different and specific risks which security measures should seek to mitigate,” says Mark Simpson GM & RP ‑ Distribution & Quality Services at Clarity Pharma. “The application process for the Controlled Drugs Licence requires the submission of an application to the DFLU (Home Office) Enhanced CRB checks for all staff working in the confines of the controlled drugs operation, from goods-in, to final despatch. Finally, a
compliance audit, site assessment by an DFLU inspector for suitability to store and distribute narcotics is conducted.
“Due to COVID-19 there was a delay in obtaining a compliance inspection at Clarity Pharma as virtually no Home Office inspections were taking place, but we are excited to announce that an on-site licence, valid for one year has now been issued,” he notes. “During the audit it was determined that Clarity’s facilities, procedures and security measures are adequate to allow licencing to store Schedule 2, which includes products such as diamorphine, to Schedule 5 Controlled drugs, including codeine and morphine.”
The impressive warehousing capacity includes a state-of-the-art controlled drug vault and 578ft2 of controlled drugs space.
The facility also boasts excellent security with 24-hour CCTV and a direct-to-police alarm system. It is fully compliant with good distribution practices and MHRA. All the prescribed schedule drugs are fully secured behind a two-ton safe door. The vault itself carries an independent alarm, vibration sensors and requires dual ID to access. A diesel backup generator can maintain full operation 24/7, 365 days a year.
Schedule 2 Controlled Drugs are subject to the full Controlled Drug requirements relating to prescriptions, safe custody (except for quinalbarbitone (secobarbital) and some liquid preparations). Clarity Pharma is required to keep a Controlled Drug register, (unless exempted in Schedule 5). Possession and the supply and procurement is authorised for pharmacists and other classes of persons named in the 2001 Regulations and includes products such as opiates e.g. diamorphine hydrochloride (heroin), morphine, methadone, major stimulants such as amphetamines, quinalbarbitone (secobarbital), cocaine, ketamine, and cannabis-based products for medicinal use in humans.
Schedule 3 drugs are subject to the special prescription requirements. Safe custody requirements do apply, except for any 5.5 disubstituted barbituric acid (e.g. phenobarbital), gabapentin, mazindol, meprobamate, midazolam, pentazocine, phentermine, pregabalin, tramadol hydrochloride, or any stereoisomeric form or salts of the above. Records in registers do not need to be kept (although there are requirements for the retention of invoices for two years).
Schedule 4 is broken into two parts. Part I includes drugs that are subject to minimal control, such as benzodiazepines (except temazepam and midazolam, which are in Schedule 3), non-benzodiazepine hypnotics (zaleplon, zolpidem tartrate, and zopiclone) and Sativex®.
Part II includes androgenic and anabolic steroids, clenbuterol, chorionic gonadotrophin (HCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin. Controlled drug prescription requirements do not apply and Schedule 4 Controlled Drugs are not subject to safe custody requirements. Records in registers do not need to be kept, except in the case of Sativex).
When looking at Schedule 5, it includes preparations of certain Controlled Drugs (such as codeine, pholcodine or morphine) which due to their low strength, are exempt from virtually all Controlled Drug requirements other than retention of invoices for two years.”
“The issuing of this licence is further evidence of our focus on supplying industry leading facilities with these products. The ability to offer a full suite of ambient, chilled and controlled drugs storage under one roof, coupled with our dedicated telesales team, will assist in delivering products into the primary healthcare space, which means that we can offer an unrivalled service,” Simpson points out.
With the lucrative UK market becoming more challenging to penetrate post-Brexit, customers are looking for industry experts to help them access the UK and navigate the registration process. To be able to find all of this in addition to gaining access to a ready-made infrastructure on offer from Clarity, means that even the smaller and aspirational entrants can be confident of being successful.
To discover more about Clarity Pharma, please visit www.clarity-pharma.com.