Safer Management of Controlled Drugs

Background for the Safer Management of Controlled Drugs

The Shipman Inquiry was set up on the 31st January 2001 and was chaired by Lady Justice Janet Smith DBE as an independent public inquiry into the issues arising from the case of Harold Shipman. The Inquiry's Fourth Report was published on 14th July 2004 and made a number of recommendations to strengthen the prescribing of controlled drugs and for monitoring their movement from prescriber to dispenser to patient. In December 2004 the Government's response, Safer Management of Controlled Drugs was published. The response accepted that the current systems can be strengthened provided that this doesn't hinder the use of controlled drugs to meet patients' needs. Details of the inquiry can be found at the following link:

http://www.the-shipman-inquiry.org.uk/

As part of wider action by the Department of Health, a project is underway in the Prescription Pricing Division to implement changes affecting the prescribing, dispensing and supply of controlled drugs. The new arrangements for private prescriptions came into effect from 1st April 2006 and were given statutory backing through amendments to the Misuse of Drugs Regulations, which were made on 12th June 2006 and came into force on 7th July 2006.The Medicines (Sale & Supply) (Miscellaneous Provisions) Amendment Regulations 2007 have also been amended to remove the requirement for dispensing contractors to retain dispensed private controlled drug prescriptions for two years. Therefore from 1st September 2007 dispensing contractors should submit original private controlled drug prescriptions for schedule 2 or 3 CDs to the Prescription Pricing Division using their private controlled drug account.

Early Action

Some early changes in the legislation governing controlled drugs were implemented by amendments to the Misuse of Drugs Regulations that came into force on 14th November 2005. The principal changes allowed:

• all details on prescriptions for controlled drugs except the signature to be computer generated;
• computerisation of controlled drugs registers for drugs listed in Schedules 1 and 2;
• extension of the list of controlled drugs which Nurse Independent Prescribers may prescribe for certain medical conditions following changes to the Prescription Only Medicines (Human Use) Order effective from 1st May 2006;
• amendment of the list of allowable drug paraphernalia to include ascorbic acid.

You can access details by clicking here.

Further Action

Further changes have taken place following amendments to the Misuse of Drugs Regulations that came into force on 7th July 2006. These include:

• Introduction of special forms for any private prescription of schedule 2 & 3 controlled drugs dispensed by community pharmacists. Records of these prescriptions will be held on a central database so that they can be monitored by local PCTs;
• Modified arrangements for the dispensing of NHS prescriptions for schedule 2 & 3 controlled drugs, including a new requirement for patients or other people collecting medicines on their behalf to sign for them;
• Validity of any prescription for schedule 2, 3 & 4 controlled drugs to be restricted to 28 days;
• Introduction of requirement that all healthcare providers holding stocks of controlled drugs should have and comply with the terms of an agreed Standard Operating Procedure (SOP);
• Strong recomendation that the maximum quantity is limited to 30 days for prescriptions of schedule 2, 3 & 4 controlled drugs;
• Re-emphasis of professional guidance that doctors should prescribe controlled drugs for themselves or family members only in exceptional circumstances.

Detailed guidance has been published by the Department of Health and is available on their website here

More changes have been made following amendments to the Misuse of Drugs Regulations; these changes come into effect from the 1st September 2007 unless otherwise specified and include:

• The requirement for dispensing contractors to retain dispensed private controlled drug prescriptions for Schedule 2 and 3 controlled drugs for two years has been rescinded allowing dispensing contractors to submit the original prescription.
• Accountable officers responsible for the monitoring and management of controlled drugs to have the authority to appoint authorized witnesses to observe the destruction of controlled drugs.
• Operating Department Practitioners to possess and supply any controlled drug in a hospital ward, theater or any other department for the purposes of administration to a patient.
• The reclassification of Midazolam from a Schedule 4 controlled drug to a Schedule 3 controlled drug from January 2008. However Midazolam will be exempt from the Schedule 3 safe custody requirements.
• New regulations covering requisitions used for the supply of Schedule 2 and 3 controlled drugs will come into effect from January 2008. Suppliers of controlled drugs (excluding wholesalers and hospitals) will be required to provide information about the supply of controlled drugs in the absence of a prescription to the Prescription Processing Division.
• Changes to the requirements covering the format of Controlled Drug Registers. From February 2008 the regulations covering the format of CDRs will be replaced with more flexible arrangements but will still require certain fields of information to be recorded including the identity of a person collecting a Schedule 2 controlled drug.