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Richard Hough discusses what the reclassification of five drugs by the Home Office means in practice

The Advisory Council on the Misuse of Drugs (ACMD) has recently made recommendations to the Home Office following its review into the potential for misuse and harm of a number of medicines. The result of its recommendations is a new statutory instrument, the Misuse of Drugs Act 1971 (Ketamine etc) (Amendment) Order 2014, which came into force on June 10. Under the provisions of the Order and further to the ACMD's conclusion that the commonly prescribed medicines, tramadol, zopiclone and zaleplon, have the potential to be misused, they have now been classified as Class C controlled drugs under the Misuse of Drugs Act 1971. The less commonly prescribed lisdexamfetamine €“ a drug that converts to dexamfetamine when administered orally and which is used as second-line treatment for ADHD €“ becomes a Class B controlled drug. Ketamine has been reclassified from Class C to Class B.

The classification of a drug has relevance predominantly to restrictions on its use, the severity of any offences committed, and the imposition of sanctions relating to it, for example in relation to any unauthorised production, possession or supply of the drug. The drugs named in the Order have been scheduled as follows, according to the Misuse of Drugs Regulations 2001, to ensure that they remain available for legitimate and regulated healthcare purposes:

€¢ Zopiclone and zaleplon are now listed in Part 1 of Schedule 4 (CD Benz POM) alongside zolpidem
€¢ Tramadol is listed in Schedule 3 (CD No Reg POM) but is exempted from the safe custody requirements, which normally apply to Schedule 3 drugs
€¢ Lisdexamfetamine is listed in Schedule 2 (CD POM) alongside dexamfetamine.

Ketamine is not being rescheduled immediately. In line with the ACMD's advice, the Home Office will carry out a public consultation later this year to assess the impact of rescheduling ketamine to Schedule 2. A final decision on the appropriate schedule for ketamine will be made after the consultation. Until then, it will remain a Part 1 Schedule 4 drug.

The new rules

Pharmacists should make themselves familiar with the new classifications and scheduling of these medicines to ensure that they deal with them legally in the course of their business activities. General guidance is set out below:

"Supporters of the Bill hope that, if adopted, it will make provision for responsible innovation in the treatment of patients"

As Schedule 4 drugs, zopiclone and zaleplon are not subject to safe custody or controlled drug prescription requirements. Prescriptions for these drugs are only valid for 28 days. Prescribers can only issue quantities for these medicines that do not exceed 30 days' supply. Prescribers may issue repeatable prescriptions for these medicines if clinically appropriate. Pharmacists may make emergency supplies of these medicines if they believe such a supply is warranted. However, a licence will now be required for the import or export of these medicines and suppliers will need to keep a record of any imports or exports made. Private prescriptions must use the standardised format for prescribing.

As a Schedule 3 drug, tramadol will be subject to controlled drug prescription writing requirements, but notably it is not subject to afe custody requirements. Tramadol may no longer be prescribed on NHS repeat prescriptions. As for Schedule 4 above, prescriptions for the supply of tramadol will only be valid for 28 days and the 30-day maximum supply requirements will apply. The address of the prescriber must also be within the UK. Emergency supplies of tramadol will not be permitted. The new classification of tramadol means that it can no longer be supplied via EPS/EPS R2, as the prescriber's signature will be required on the prescription. It will be an offence for a pharmacist to dispense tramadol where the relevant statutory requirements have not been met.

As a Schedule 2 controlled drug, lisdexamfetamine is subject to particularly stringent regulation, with all of the Schedule 3 requirements stated above as well as the requirement for safe custody. Lisdexamfetamine must therefore be stored safely in the pharmacy's CD cabinet and locked in such a manner that prevents unauthorised access. Record keeping requirements apply and details of receipt and supply must be recorded in the CD register.

Medical Innovation Bill

On June 5, the Medical Innovation Bill was introduced into the House of Lords by Lord Saatchi, who lost his wife to ovarian cancer and who expressed frustration at the lack of treatment options available to her. While its provisions relate to the clinical actions of doctors, the Bill has received media coverage and should be of interest to pharmacists as it impacts on the law of negligence as applied to healthcare professionals. Supporters of the Bill hope that, if adopted, it will make provision for responsible innovation in the treatment of patients by doctors, who might otherwise risk being sued under existing law for negligence for not following generally accepted medical practices.

Under the Bill, doctors would be given legal protection from negligence claims if, subject to certain safeguards, they try out novel treatments on patients who have little chance of survival using accepted medical treatment. When departing from accepted treatment practices, doctors would be required to first consult with appropriately qualified colleagues, notify their responsible officer, obtain patient consent and act at all times in the patient's best interests.

Richard Hough is senior associate, pharmacist, and head of healthcare at Brabners LLP.

Contact him on 0151 600 3302, or at richard.hough@brabners.com.