Controlled Drugs Study Pack 2024-25

4PY019 Controlled Drugs Learning Outcomes This pack considers the management of drugs which are subject to extra controls under the Misuse of Drugs Regulations (as amended). On completion of this study pack you should: • • • • • • • • • • be familiar with the use of ‘Medicines, Ethics and Practice’ as a professional guide for pharmacists in practice, in particular its use with respect to controlled drugs have an awareness and understanding of the legislation which governs the regulation of controlled drugs be able to explain why some drugs are subject to tighter controls understand the prevalence and effects of drug misuse be able to list the classes of controlled drugs and provide examples of drugs within these be able to describe the Schedules that controlled drugs are allocated to and provide examples of these be able to explain and describe the laws relating to: o the possession and supply of controlled drugs o the obtaining of controlled drugs (requisition requirements) o prescription requirements for Schedules 2, 3, 4 and 5 controlled drugs o the collection of dispensed controlled drugs o the destruction of controlled drugs o record keeping o the use of controlled drugs registers o emergency supplies for controlled drugs o and be able to explain the implications of these for pharmacy practice explain how controlled drugs are supplied by instalment for the treatment of drug addiction and the laws relating to these understand the implications of the New Psychoactive Substances Act 2016 understand the legislation on drugs and driving and the advice that you might need to give to patients 4PY019 Controlled Drugs Contents How to use this study pack................................................................................................... 4 Drug misuse and social norms ............................................................................................. 4 Legal uses of controlled drugs ............................................................................................. 7 Habituation ........................................................................................................................... 7 Treatment of addiction ......................................................................................................... 7 Where the law on controlled drugs originates from .............................................................. 9 The law on controlled drugs ............................................................................................... 10 The Misuse of Drugs Act 1971 ........................................................................................... 10 Advisory Council on the Misuse of Drugs........................................................................... 12 Classes of controlled drugs ................................................................................................ 13 Penalties ............................................................................................................................ 14 The Misuse of Drugs Regulations 2001 (as amended) ...................................................... 14 Schedules .......................................................................................................................... 15 Controlled drugs prescriptions ............................................................................................ 15 Private prescriptions for controlled drugs ........................................................................... 18 Using the BNF as a reference source ................................................................................ 19 Cannabis ............................................................................................................................ 21 Obtaining controlled drugs – controlled drugs requisitions ................................................. 21 Midwife supply orders ........................................................................................................ 24 Emergency supplies of controlled drugs............................................................................. 24 Possession ......................................................................................................................... 25 Collecting dispensed controlled drugs ................................................................................ 26 Safe custody ...................................................................................................................... 27 Destruction of patient-returned and stock-controlled drugs ................................................ 28 Record keeping and the controlled drugs register .............................................................. 30 Accountable Officer ............................................................................................................ 33 Instalment dispensing ........................................................................................................ 33 Supervised consumption .................................................................................................... 38 New Psychoactive Substances Act 2016 ........................................................................... 39 Drugs and driving legislation .............................................................................................. 40 Paramedics and Therapeutic Radiographers – prescribing of controlled drugs ........................ 42 Supply of medicines by registered chiropodists and podiatrists (supply of codeine) ................. 43 Original Pack Dispensing in England – from January 2025………………………………………44 4PY019 Controlled Drugs How to use this study pack This study pack does NOT cover everything that you need to know. It MUST be read in conjunction with the required reference sources listed on the front page. This is to help you move towards becoming an independent learner. All activities in the pack should be completed using the advised reference sources. This will help to provide you with further material which you can use to aid your revision. Where a reference source has been recommended, the answer to the activity can be found within it. It is important to note that the purpose of studying this pack is not just to pass your exams. Learning about controlled drugs, their potential for abuse, the laws governing them and their application to every day practice are vital to you in your role as a future healthcare professional. Not only will this learning help you to provide a safe and effective service for your patients, but it will also help to protect your ongoing registration as a future pharmacist by ensuring that you work within the legal limitations of your role. Please be aware that while every effort has been made to ensure that the material in this study pack is up-to-date at the time of release, the law is ever-evolving and the most recent reference sources should always be consulted. Legal and practice updates may be found using a number of different reference sources: • • • • • • • General Pharmaceutical Council news page: https://www.pharmacyregulation.org/news Royal Pharmaceutical Society latest news: https://www.rpharms.com/ Pharmaceutical Services Negotiating Committee (PSNC) news page: https://psnc.org.https//www.pharmacyregulation.org/news NHS England news page: https://www.england.nhs.uk/news/ Significant changes made to the BNF: https://bnf.nice.org.uk/about/changes.html o You can also register to receive BNF updates here: https://info.medicinescomplete.com/bnf-newsletter-signup MHRA Drug Safety updates can be found here: o https://www.gov.uk/drug-safety-update You can search for changes to Government legislation here: https://www.legislation.gov.uk/changes 4PY019 Controlled Drugs Drug misuse and social norms As well as medicinal value, some drugs can cause harm via misuse and addiction, sometimes leading to patient harm. As a consequence, these drugs are subject to tighter controls than others. However, we need to understand that society’s attitude to drugs is not entirely based on evidence and reason and has changed many times over the years. Drug misuse can be defined as the use of a substance for a purpose which is inconsistent with legal or medical guidelines. It has a detrimental effect on health or normal functioning. It may present as drug dependence or be part of a wider spectrum of problematic behaviour. 1 0F We readily accept that, in our society, today alcohol, nicotine and caffeine are all legal and easily available. All of these are drugs with pharmaceutical effects, all are addictive and all can cause harm, even death. Almost all societies have some abusable drug substances that they find acceptable. For many societies these are alcohol, nicotine and caffeine, other societies use cocaine, khat, psilocybin, peyote, betel nut, mescal and others. It is easy for us to believe that the drugs that are currently viewed as a problem and controlled always were. However, historical attitudes to drugs such as cocaine and Heroin were very different. For example, Sherlock Holmes was a regular cocaine and intravenous morphine user. Although Sherlock is, of course, a fictional character he was written in a way which was recognisable to readers at the time that his adventures were supposed to have taken place, approximately 1880 – 1904. Open use of cocaine was very common at that time, particularly amongst the wealthy. 1 National Collaborating Centre for Mental Health (UK). Drug Misuse: Psychosocial Interventions. Leicester (UK): British Psychological Society; 2008. (NICE Clinical Guidelines, No. 51.) 3, INTRODUCTION TO DRUG MISUSE. Available from: https://www.ncbi.nlm.nih.gov/books/NBK53217/ (accessed 27/01/23) 4PY019 Controlled Drugs Coca-Cola Until 1903, Coca-Cola™ (originally created by an American pharmacist named Pemberton as an analgesic after he sustained a sabre wound) included both cocaine and alcohol amongst its ingredients. Figure1: Coca-Cola™ advertising 1886-1899 (image available at: https://www.adbranch.com/coca-cola-advertising-1886-1899/coca-cola_syrup_and_extract_1880s/ (accessed 22/01/23)) Heroin The name ‘Heroin’ is a brand name for diacetyl morphine or diamorphine, an opioid drug first synthesised by Bayer as an antitussive (look it up). It was originally widely used for coughs and in pastilles for sore throats. During the First World War (1914 -18) it was not unusual for people at home to buy Heroin kits to send to soldiers in the trenches. They were sold openly in big department stores including Harrods and Harvey Nichols, as well as by mail order, not for pain relief but for recreational use. 4PY019 Controlled Drugs Figure 2: Bayer Heroin cough syrup and marketing material (image available at: https://unbelievable-facts.com/2017/12/historic-medical-treatments.html/bayer-heroin-cough-syrupand-marketing-material (accessed 14/07/21)) It can be argued that the drugs which are controlled most tightly are selected for social and political reasons rather than because of a sound evidence base. Professor David Nutt of Imperial College was removed from his position as Chair of the Advisory Council on the Misuse of Drugs because he pointed out that this was not a sensible approach to minimising harm. He said that alcohol is, by any measure, more harmful than cannabis and that the harm caused by people taking ecstasy is at a similar level to that caused by riding horses. In fact, horse riding is the more dangerous activity. However, whilst this is a sound scientific and logical position and it might be better if we had an evidence-based approach to policy, politics got in the way, so he lost his job. Drug misuse is now a widespread problem and despite more than 40 years of the ‘war on drugs’ and billions of pounds and dollars spent (the US alone spends approximately $50 Billion a year), drug addiction is a significant problem in most developed countries. Some definitions Definition Examples Opiate Any of the natural opioid analgesic alkaloids found in the opium poppy plant. Morphine, codeine Opioid Any chemical that resembles opiates in its pharmacological effects Diamorphine Psychotropic A chemical substance that changes brain function and alters perception, mood or consciousness. LSD 4PY019 Controlled Drugs Legal uses of controlled drugs (CDs) Some controlled drugs such as morphine, diamorphine, fentanyl, dihydrocodeine and codeine are extremely powerful pain killers and are used to treat severe pain such as post-operative pain or pain in certain types of cancer. They are available in a number of different formulations, the commonest are oral, transdermal patches and injectable formulations. In palliative care it is common to use drugs in a syringe driver. This allows the drug to be infused at a constant rate over a 24-hour-period to provide a base level of pain relief. If the patient’s pain gets worse, they can be given oral medication to manage any ‘breakthrough’ pain. Transdermal patches are applied to the skin and the drug is absorbed directly through the skin. This gives a roughly constant rate of administration to achieve a base level of pain relief. Amphetamines and similar substances are also used to treat narcolepsy and, paradoxically, ADHD. See the section on cannabis and cannabis-based medicinal products below for further examples. Habituation When drugs such as heroin or other opiates are used repeatedly, there is a risk of tolerance developing. This tolerance occurs when the body becomes habituated to the presence of the drug and, as a result, the user must take a higher dose to produce the same effects. The resulting tolerance will lead to a need for the user to use it more frequently or take larger doses of the opiate in order to produce the same effect. This is sometimes described as a shift to the right in the doseresponse curve which can mean that patients taking opiates for pain relief can sometimes take apparently very large doses in safety. The same is, of course, true for drug misusers, they need higher doses to achieve the same effect. Treatment of addiction Opioids are recognised as being highly addictive. If a person stops taking an addictive drug such as an opioid, benzodiazepine, amphetamine, nicotine or alcohol (other drugs are available), they will normally suffer from withdrawal symptoms, in the case of diamorphine this happens within a few hours. The withdrawal symptoms for opiates include restlessness, muscle and bone pain, insomnia, diarrhoea, vomiting, cold flashes with goose bumps ("cold turkey"), and leg movements. Major withdrawal symptoms peak between 24–48 hours after the last dose and subside after about a week. Addiction can be causally linked directly to a number of problems for the person addicted, their family and friends and society as a whole. 4PY019 Controlled Drugs Harms include: Personal Family and friends Society • • • • • • • • • • • • Health, diet and exercise seem less important Increased risk of bloodborne diseases if taking the drug by injection Accidental overdose Increased risk of accidents whilst under the influence Harm caused by other substances added to the drugs to bulk them out (cutting) Employment, it can be very difficult to hold down a job Financial, no job and the cost of a drug habit often leads to homelessness, drug dealing and prostitution Legal proceedings, arrests, fines, imprisonment Damaged relationships Child neglect Stealing from family and friends • • • • Increased levels of crime to fund the drug habit (typically theft, burglary, drug dealing or prostitution) Massive profits made by organised criminal gangs who smuggle and distribute the drugs Cost of treatment (NHS) Loss of tax income Loss of civic responsibility Government policy in this area has been inconsistent over the years. Sometimes it has focused on imprisoning people, other times on getting misusers to stop using illicit substances and at other times on minimising harm from drug use. Patients who are addicted to diamorphine (Heroin) are often treated with substitution therapy. This involves prescribing another medicine as a replacement for their diamorphine. This allows them to stop the illicit drug without suffering withdrawal symptoms. The substitutes we use do not give patients the same ‘high’ as injecting or inhaling fumes (chasing the dragon) from diamorphine. There are two rationales for substitution therapy: 1. to get the patient to give up using diamorphine or substitutes completely 2. to minimise harm from drug addiction. Taking a prescribed heroin substitute orally is less likely to cause harm to the patient and to society than them buying and injecting street diamorphine The two most widely used drugs for substitution therapy are buprenorphine and methadone. When used for this purpose, they are often prescribed in instalments. This means that the patient may have to collect a supply daily, every few days or once a week as determined by their prescriber. This system is designed to make substitution therapy safer for the patient as well as to reduce the amount of prescribed drugs being sold illegally. See the section on ‘instalment dispensing’ for more information on this. 4PY019 Controlled Drugs One approach to harm minimisation, relatively new to the UK but widely used elsewhere, is to provide addicts with pharmaceutical grade Heroin and safe facilities to inject it. See the link below to find out more: https://www.theguardian.com/society/2019/nov/26/pioneering-glasgow-clinic-offers-addictspharmaceutical-grade-heroin (accessed 14/07/21) Where the law on controlled drugs originates from The law in this area is based on two main sources: international treaties and the reports from the official inquiries into the activities of Harold Shipman, a GP and prolific serial killer. You can read more about Harold Shipman and his crimes here: https://www.britannica.com/biography/Harold-Shipman (accessed 28/07/21) International treaties In 1961, all the United Nations member countries signed up to the Single Convention on Narcotic Drugs: • United Nations Single Convention on Narcotic Drugs, 1961 The principle of this convention is that the possession, use, trade in, distribution, import, export, manufacture and production of certain drugs should be exclusively limited to medical and scientific purposes. Each member country, once signed up, had to pass its own legislation to bring these restrictions into effect. The 1961 convention was followed by further two further treaties: • United Nations Convention on Psychotropic Substances, 1971 • United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 The Gosport Report The importance of pharmacists as medicine safety advocates and the need to follow best practice guidelines and professional standards is illustrated by this report which was published in June 2018. 450 patients are believed to have died following the administration of dangerous doses of opioids between 1988 and 2000 at Gosport War Memorial Hospital. The Gosport Independent Panel found that, ‘There is no evidence available to the Panel to suggest that either the pharmacists or Portsmouth HealthCare NHS Trust’s Drugs and Therapeutics Committee challenged the practice of prescribing which would have been evident at the time’. You can read more about this report on the RPS website: https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Hospital%20P harmacy%20Hub/Learnings%20from%20Gosport%20February%202019.pdf?ver=2019-02-13100902-563 4PY019 Controlled Drugs The law on controlled drugs Two of the main pieces of legislation that you need to understand and apply to your practice in relation to controlled drugs are: • • Misuse of Drugs Act 1971 Misuse of Drugs Regulations 2001 These have both been amended by a number of Statutory Instruments and other Acts of Parliament. The other important pieces of legislation which you need to understand are: • • • The Misuse of Drugs (Safe Custody) Regulations 1973 (as amended) – these will be referred to as the Safe Custody regulations The Health Act 2006 Controlled Drugs (Supervision of Management and Use) Regulations 2013 The Misuse of Drugs Act 1971 This Act was passed to fulfil the UKs obligations under the Single Convention on Narcotic Drugs. The aim of the act is to control ‘dangerous or otherwise harmful drugs.’ As a result of this Act all activities associated with controlled drugs are rendered unlawful UNLESS they are permitted in Regulations made under the Act. There are, however, some limited provisions for licences for importation and exportation which exist under section 3 of the Act. You can access the Act here: https://www.legislation.gov.uk/ukpga/1971/38/contents (accessed 14/07/21) This Act introduced a number of important legislative changes. These may be summarised as follows: 1. established the Advisory Council on the Misuse of Drugs 2. introduced a classification system for controlled substances 3. placed restrictions on the importation, exportation, production, prescribing and supply of controlled drugs 4. created a series of offences and penalties in relation to controlled drugs 5. gave powers to the Secretary of State to make regulations for preventing the misuse of controlled drugs Offences under the Misuse of Drugs Act include: • • • • • unlawful possession of a controlled substance possession of a controlled substance with intent to supply it supplying or offering to supply a controlled substance (even if no charge is made for the drug) manufacturing a Controlled Drug import or export of a Controlled Drug 4PY019 • Controlled Drugs Allowing premises individuals occupy or manage to be used unlawfully for the purpose of producing or supplying controlled drugs. Advisory Council on the Misuse of Drugs The Advisory Council on the Misuse of Drugs was established by the Misuse of Drugs Act 1971. Its role according to the legislation is to: 1. keep under review drugs which are being or are likely to be misused and the misuse of which is or is likely have harmful effects which may constitute a social problem 2. advise ministers on the actions to be taken as described below: a) for restricting the availability of such drugs or supervising the arrangements for their supply; b) for enabling persons affected by the misuse of such drugs to obtain proper advice, and for securing the provision of proper facilities and services for the treatment, rehabilitation and aftercare of such persons; c) for promoting co-operation between the various professional and community services which in the opinion of the Council have a part to play in dealing with social problems connected with the misuse of drugs; d) for educating the public (and in particular the young) about the dangers of misusing such drugs and for giving publicity to those dangers; and e) for promoting research into, or otherwise obtaining information about, any matter which in the opinion of the Council is of relevance for the purpose of preventing the misuse of such drugs or dealing with any social problem connected with their misuse.’ The Advisory Council must also consider any matter relating to drug dependence, or the misuse of drugs, which may be referred to it by ministers. The Home Secretary is obliged to consult the Advisory Council prior to making any amendments to the Regulations to the Misuse of Drugs Act (including changing the classification of any drug). 4PY019 Controlled Drugs Classes of controlled drugs The act created three classes of controlled substances, referred to as A, B, and C. Each class has a range of criminal penalties associated with it. An offence involving a Class A substance is considered to be more serious than one involving Class B or C substances and the penalties that a court can impose are therefore greater. The substances within each class can be amended by order, so the Home Secretary can list new drugs and upgrade, downgrade or delist previously controlled drugs with less of the bureaucracy and delay associated with passing an act. In theory, the class which a drug substance is placed in is directly associated with the harm that is or could be caused by that substance. In practice this is not always the case and drugs are often classified or reclassified for political reasons rather than on the basis of evidence of harm. Activity 1 The government has produced a guidance document on the most commonly encountered drugs currently controlled under the Misuse of Drugs legislation. This list, which is not exhaustive, details the class and schedule to which each of the drugs belongs and can be accessed below: https://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonlyencountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation (accessed 14/07/21) Use the link above to provide examples of drugs in each of the three classes in the table below. Class Includes Class A Give examples here Class B Give examples here Class C Give examples here 4PY019 Controlled Drugs Penalties Activity 2 Use the link below to help you complete the following table: https://www.gov.uk/penalties-drug-possession-dealing (accessed 27/01/23) Offence Class A Possession Up to 7 years in prison, an unlimited fine or both Class B Supply and production Class C Up to 14 years in prison, an unlimited fine or both The Misuse of Drugs Regulations 2001 (as amended) These are regulations made under the Misuse of Drugs Act 1971 and they are concerned with the day-to-day practicalities of the therapeutic use of these drugs. The regulations define the categories of persons who are authorised to prescribe, supply and possess controlled drugs whilst acting in their professional capacities as well as laying down the conditions under which these activities must be carried out. The regulations impose controls on all of the following: • • • • • • import and export production possession safe custody supply o extra prescription requirements o requisitions record keeping o CD register o retaining invoices destruction of drugs • inspection • 4PY019 Controlled Drugs Schedules Under the regulations, drugs are placed into five Schedules. These govern the degree of control they are placed under. The abbreviations used below also appear in the BNF. Schedule 1 (CD Lic POM) • • • • • These are the most tightly controlled. This Schedule includes hallucinogenic drugs such as ‘LSD’, ecstasy-type substances and raw opium. They have potential for abuse and most have no therapeutic use. Production, possession and supply are generally prohibited without specific Home Office approval. The Home Office may grant licences for these drugs to be possessed and supplied in accordance with the terms of the licence e.g. for research or industrial purposes. Schedule 2 (CD POM) • • • This Schedule includes opiates e.g. diamorphine, major stimulants e.g. amphetamines, quinalbarbitone and ketamine. These are drugs that have medicinal uses as well as a significant potential for misuse. Schedule 2 drugs are subject to controls on import, export, manufacturing and compounding although they may be compounded or manufactured by a pharmacist when acting in the course of their profession. These drugs are subject to additional prescription requirements, safe custody, controls on their destruction and the need to maintain registers relating to their acquisition and supply. All of these are explained later in this study pack. Schedule 3 (CD No Reg POM) • • • This Schedule includes minor stimulants and other drugs e.g. buprenorphine and temazepam. These drugs have a potential for misuse but are considered less harmful than those in Schedule 2 so the regime is relaxed a little. There is no requirement for them to be recorded in a CD register and no special destruction requirements. These drugs do not need to be kept under safe custody unless exempted under the Misuse of Drugs (Safe Custody) Regulations 1973 (as amended). Please see page 117 of the MEP 45th edition for a list of exemptions. Schedule 4 (CD Benz POM and CD Anab POM) • • • Part I contains most of the benzodiazepines (e.g. diazepam), non-benzodiazepine hypnotics and Sativex. Part II contains most of the anabolic and androgenic steroids as well as clenbuterol and growth hormones. They are not subject to safe custody or special prescription requirements. Although Sativex (spray containing cannabis extract) is a Sch 4, Part I CD and no safe custody and prescription requirements apply, its possession, supply and destruction should be recorded in the CD register. 4PY019 Controlled Drugs Schedule 5 (CD Inv POM or CD Inv P) • • • These are preparations that include small amounts of controlled drugs. Examples include codeine linctus (an antitussive cough linctus) or co-codamol (paracetamol and codeine) tablets. Due to their low strength they are exempt from most of the controlled drug requirements. However, pharmacies must retain invoices for these drugs for a minimum of two years. Controlled drugs prescriptions Pharmacists MUST purchase controlled drugs for prescriptions from a licensed wholesaler. Prescribing restrictions for controlled drugs Not all prescribers can prescribe controlled drugs. The following table outlines the prescribing restrictions for different prescribers for Sch 2 to 5 drugs. Note that this list is not exhaustive and more information on prescribing restrictions can be found on pages 85-89 of the MEP 45th edition. Prescriber Can prescribe Schedule 2 to 5 CDs? • • Doctor Dentist Yes - a Home Office licence is required to prescribe cocaine, diamorphine or dipipanone for addiction • Veterinary surgeon Yes - prescriptions for Sch 2 and 3 CDs don’t need to be on the standardised forms but must include the RCVS registration no. of the prescriber • • • Nurse/midwife independent prescriber Pharmacist independent prescriber Supplementary prescriber Yes – but not cocaine, diamorphine or dipipanone for treating addiction • Community practitioner nurse prescriber No Most controlled drugs are POMs although a few in Schedule 5 are available over the counter. As POMs they are subject to the usual POM prescription requirements. There are additional requirements for prescriptions for drugs in Schedules 2 and 3. These apply whether the prescription is private or NHS. 4PY019 Controlled Drugs Activity 3 Use pages 111-112 of the MEP 45th edition to help you complete the table below. Once complete this will provide you with a useful revision aid. Prescription requirements for schedule 2 and 3 controlled drugs Legal Details of legal requirement requirement Signature Date Must be within the UK Clearly defined Form Strength Total quantity Must be written in words AND figures Name of patient Dental prescriptions ‘for dental treatment only’ must be written on the prescription Instalment direction Additional requirements for a Schedule 2 and 3 controlled drugs prescription • • • Mark the prescription with the date of supply at the time the supply is made Prescription MUST be written in indelible ink and can be computer generated Only supply sugar free and/or colour free products when specified by the prescriber as these have a greater potential for abuse 4PY019 Controlled Drugs Writing the dose correctly It is important to be aware of what is and what is not legally acceptable when writing a dose, please see MEP 46th edition for further examples: Examples of legally acceptable doses Examples of doses that are NOT legally acceptable • • • • • • • One as directed One PRN One or TWO when required As directed When required PRN Weekly (frequency NOT a dose) Technical errors Pharmacists are able to amend a CD prescription where there is a minor typographical error, spelling mistake or where the total quantity of the drug or the number of dosage units, as the case may be, is specified in either words or figures but not both. Pharmacists have to exercise due diligence and be satisfied on reasonable grounds that the prescription is genuine and that they are supplying in accordance with the intentions of the prescriber. The pharmacist will need to amend the prescription in ink or otherwise indelibly to correct the error or omission and date and mark the prescription so that the amendment is attributable to him / her. Private Prescriptions for CDs Private prescriptions requirements for Schedule 2 and 3 drugs 1. Private prescriptions for controlled drugs in Schedule 2 or 3 must be written on a standardised form (in England this is an FP10 PCD) which looks very much like an NHS prescription form. 2. The prescription must include the prescriber’s unique identification number which is not the same as their GMC registration number. The number is issued by the NHS Business Services Authority. The prescriber can obtain this number from their local primary care organisation. 3. The original prescription must be submitted to the NHS Business Services Authority which is done on a monthly basis. However, it is good practice to keep a photocopy of the original prescription. No other non-CDs should be written on this form because the original needs to be submitted and the pharmacist would then be unable to comply with the requirement to keep all private POM prescriptions for two years. 4. Veterinary prescriptions do not need to be written on standardised forms or submitted to the relevant NHS agency. They must, however, be retained for 5 years. 4PY019 Controlled Drugs Repeatable private prescriptions for controlled drugs Drug Schedule Repeatable private prescriptions 2 Not permitted although prescriptions to be supplied by instalment are allowed. 3 Not permitted although prescriptions to be supplied by instalment are allowed. 4 Permitted as for POMs except that the first dispensing must happen within 28 days of the appropriate date. There is no legal time limit on the repeat supplies. 5 Permitted as for POMs and the first dispensing must happen within 6 months of the appropriate date. There is no legal time limit on the repeat supplies. Using the BNF as a reference source Activity 4 What useful information can the BNF provide you with in relation to controlled drugs prescriptions? Write your answer in the box below. Use the following links to help you with your answer: https://bnf.nice.org.uk/guidance/controlled-drugs-and-drug-dependence.html (accessed 27/02/23) https://bnf.nice.org.uk/drug/morphine.html (accessed 27/02/23) 4PY019 Controlled Drugs Activity 5 Use the information above and the MEP to complete the table below. This table, when complete, will provide you with a useful revision aid. Schedule 2 Designation Schedule 3 CD POM Schedule 4 (Part 1) Schedule 4 (Part 2) CD Benz POM Schedule 5 CD INV P or CD INV POM Prescription requirements No Prescription valid for 6 months Address of prescriber required to be within the UK EEA and Swiss healthcare professionals can legally prescribe No No Prescription is repeatable* Yes Emergency supply Yes Requisition necessary No Yes Yes Yes Requisition to be marked by the supplier Yes No Invoices to be retained for 2 years?** Yes Yes Licence required to import or export Yes * See MEP for further information ** See MEP for further information No 4PY019 Controlled Drugs Cannabis Please be aware that there are now a wide range of cannabis-based products used for medicinal purposes which are categorised as licensed products, synthetic compounds and cannabis-based products for medicinal use (CBPMs). This is beyond the scope of what will be covered in this study pack, however, if you wish to learn more about this topic you can read MEP Obtaining controlled drugs: controlled drug requisitions Students often get confused about what a requisition is, so it is important to note the following: 1. a requisition is NOT a prescription 2. no patient details will be present on a requisition 3. a requisition in the community allows a pharmacist to purchase controlled drugs from another pharmacist or supply controlled drugs to another healthcare professional indicated in the table below 4. a requisition MUST be obtained by the supplying pharmacist before any drugs are supplied A pharmacist can supply drugs in Schedules 2 or 3 against a requisition in writing from any of the following: A practitioner The master of a foreign ship in a port in Great Britain A person in charge of a hospital, organisation providing an ambulance service or care home A supplementary prescriber A person in charge of a laboratory A nurse independent prescriber The owner/master of a ship which does not carry a doctor A pharmacist independent prescriber The installation manager of an off-shore installation A person who holds a certificate of proficiency in ambulance paramedic skills (issued by or with approval from the Secretary of State) or a registered paramedic Controlled drugs requisition form (FP10CDF) From 30 November 2015 amendments to the Misuse of Drugs Regulations came into effect, making the use of an approved form for the requisitioning of Sch 2 and 3 controlled drugs in the community mandatory. This was one of the recommendations which came out of the Shipman inquiry in order to ensure that the purchase of Sch 2 and 3 drugs in the community are monitored. This form can be accessed here. 4PY019 Controlled Drugs The Royal Pharmaceutical Society has produced the figure below explaining when these requisition forms must be used: Figure 3: diagram to show when an approved mandatory requisition form must be used to request stock of Schedule 2 and 3 controlled drugs (https://www.rpharms.com/resources/quick-referenceguides/controlled-drugs-requisition-requirements#approved (accessed 22/01/23)). Note that if the request received by a community provider is from a prison or a hospice the standard approved form does not have to be used. In prisons hospital-style requisition forms are usually used instead. Legal requirements for a controlled drugs requisition form 1. Signature of the recipient 2. Name of the recipient 3. Address of the recipient 4. Profession or occupation 5. Total quantity of the drug 6. Purpose of the requisition 22 4PY019 Controlled Drugs Processing requisition forms • It is a legal requirement that all requisitions should be marked with the supplier’s name and address (in ink or otherwise indelibly). If a pharmacy stamp is used this must be clear and legible. The original requisition must be copied and sent to the relevant NHS agency. It is good practice to retain a copy in the pharmacy for 2 years from the date of supply. • • • These requirements (to mark on receipt, copy and send to the relevant NHS agency) do not apply: • where the supply is made by a hospital, care home, hospice, prison or organisation providing ambulance services. They must mark and retain the original requisition for 2 years • to supplies made by pharmaceutical manufacturers • to supplies made by wholesalers • to supplies made against veterinary requisitions. In this case the original requisition must be kept for 5 years • to supplies made against a midwife supply order. These are not treated as requisitions for the purposes of these regulations Important practice points The Royal Pharmaceutical Society has issued the following practice points in relation to the use of controlled drugs requisitions: • • • • • supplies made against a faxed or photocopied requisition are not acceptable. a licence would be required for any healthcare professional to possess Schedule 1 CDs; pharmacists cannot requisition Schedule 1 CDs. legislation requires that a requisition in writing must be obtained by the supplier before delivery of any Schedule 2 or 3 controlled drugs, to most recipients. Some recipients (such as GPhC registered pharmacies) are not included in this legal requirement. However, the Home Office advise that supplies from one registered pharmacy to another should only be made after receiving a written requisition on an approved requisition form. in an emergency, a doctor, dentist, veterinary practitioner or veterinary surgeon can be supplied with a Schedule 2 or 3 controlled drug on the assurance that a requisition will be supplied within the next 24 hours. Failure to do so would constitute an offence on the part of the requester. where stock is collected by a messenger on behalf of a purchaser, a written authorisation must be provided to the supplying pharmacist that empowers the messenger to receive the medicines on their behalf. The supplying pharmacist must be reasonably satisfied that the authorisation is genuine and it must be retained for two years. 23 4PY019 Controlled Drugs Midwife supply orders A registered midwife can obtain the following controlled drugs using a midwife supply order: • • • diamorphine morphine pethidine Activity 6 Using page 110 of the MEP 45th edition to help you, list the legal requirements for a midwife supply order below. 1. 2. 3. 4. 5. 6. Emergency supplies of controlled drugs • • • Emergency supplies at the request of a prescriber or patient are NOT permitted for any Schedule 2 or 3 drug EXCEPT o medicines containing phenobarbital or phenobarbital sodium for epilepsy Emergency supplies for a Schedule 4 or 5 drug are allowed A maximum of 5 days’ supply can be dispensed 24 4PY019 Controlled Drugs Possession It is unlawful to be in possession of a controlled drug (except possession of poppy-straw, any drug in Part II Schedule 4 and any drug in Schedule 5) unless the regulations allow it. The table below shows the classes of person who can possess and supply certain CDs. You can find a full list of these in Dale & Applebe’s Pharmacy and Medicines Law. Class of person Possession and supply A practitioner • Can possess, manufacture, compound, administer, supply or offer to supply and Sch 2, 3, 4 or 5 drug. A pharmacist • Can possess, manufacture, compound, supply or offer to supply any Sch 2, 3, 4 or 5 drug. A nurse or pharmacist independent prescriber or supplementary prescriber • Can compound any Sch 2, 3, 4 or 5 drug, for the purposes of administration Can possess, administer supply or offer to supply any Sch 2, 3 4 or 5 drug. • Other lawful means of possession • Home Office licence Persons who have a Home Office Licence to do so may lawfully possess CDs. • Home Office group authority Persons who are covered by an applicable Home Office licence group authority can lawfully possess and supply CDs in accordance with its terms. • Patients If you have been prescribed a CD by a prescriber you can lawfully possess a CD. Possession of Schedule 1 CDs Activity 7 Under what circumstances is a pharmacist permitted to take possession of Schedule 1 CDs? Use page 106 of the MEP 45th edition to help you answer this question. 25 4PY019 Controlled Drugs Collecting dispensed controlled drugs The legal requirements for the collection of dispensed controlled drugs depends upon the Schedule to which the controlled drug belongs to. Collecting a Schedule 2 drug The pharmacist is legally required to establish whether the collector is a patient, patient’s representative or a healthcare professional. Activity 8 Using page the current MEP to help you, complete the table below with the actions that are required when a dispensed Schedule 2 CD is collected. Person collecting Action Notes Patient or patient’s representative It is at the discretion of the supplying pharmacist whether to supply, using their professional judgment Healthcare professional on behalf of the patient Collection of a dispensed CD by a representative of a drug misuse patient Person collecting Action Notes Representative of a drug misuse patient • • • • • Pharmacist must obtain a letter of consent which authorises a named individual Representative should bring identification Contact the prescriber before supplying if the dose is to be supervised (verbal confirmation is sufficient but a record of the conversation should be made) Details of the representative should be included in the CD register 26 • A separate letter should be obtained each time It is good practice to see the patient in person at least once a week 4PY019 Controlled Drugs Good practice points • • It is good practice for the person collecting a Sch 2 or 3 CD to sign the space on the back of the prescription A pharmacist can make a supply if this is not signed, subject to their professional judgment Safe custody The Safe Custody Regulations require pharmacists, private hospitals and care homes to ensure certain controlled drugs are kept securely. This means that they must be kept in a ‘locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs.’ Further details on the structural requirements of safes etc can be found in the MEP. Note that the Safe Custody Regulations do NOT apply to any drug in Schedules 4 or 5 AND 1. any liquid preparations apart from injections which contain certain exempted medications e.g. methylphenidate 2. any of a list of exempted drugs which include midazolam and tramadol Activity 9 Complete the following table below relating to safe custody requirements for Sch 1, 2 and 3 drugs. You can use the current MEP edition to help you. Safe custody requirements? Schedule 1 Details Yes Schedule 2 Schedule 3 Exemptions include gabapentin, midazolam, phenobarbital, pregabalin, tramadol Safe custody important additional practice points • • • • • When CDs that require it are not kept in safe custody they must be kept under ‘the direct personal supervision’ of a pharmacist. Access to CDs and the handling of CD keys must be documented within a policy and there should be a clear audit trail identifying who has had access to them e.g. through the use of electronic or paper logs. It is common for the pharmacist to hold the CD keys in a community pharmacy. Safe custody also applies to patient-returned and out-of-date or obsolete controlled drugs. These should be clearly segregated from other stock and clearly marked. Note that in most hospital pharmacies Schedule 3 CDs (as well as drugs in lower Schedules) are kept in the CD cupboard and records of their supply are made in the CD register. This is to ensure that all stock is accounted for. Although this is not a legal requirement it is considered to be good practice. 27 4PY019 Controlled Drugs Destruction of patient-returned and stock-controlled CDs Activity 10 Read paragraphs 1.8.7 to 1.8.10 of the 2016 NICE guidelines, ‘Controlled Drugs: safe use and management’. Make some notes below on what you have read. Return of controlled drugs from patients Under the NHS Community Pharmacy Contractual Framework, disposal of unwanted medicines from households and individuals which require safe disposal is classed as an essential service. Note that ‘household’ includes residential homes, but medicines cannot be accepted from nursing homes. They must themselves arrange for their waste medicines to be disposed of appropriately. Legally, a pharmacist or practitioner does not have to record any prescribed CD returned by a patient for destruction, whether it is has been returned because they have died or because they no longer need to take the drug. Most SOPs and guidelines, however, recommend that their disposal is recorded in a separate book. The record should include: • • • • the date of receipt of the drug the date of destruction the signature of the person destroying the drug and any witness it also makes sense to record the name, strength and quantity of the CD 28 4PY019 Controlled Drugs Denaturing The RPS has issued guidance that unwanted CDs returned from patients’ homes in Schedule 2, Schedule 3 and Schedule 4 (Part I) should first be rendered irretrievable by denaturing before being disposed of in appropriate containers (see figure 4 below). To do this, denaturing kits should be used, but where this is not possible cat litter is used instead as the drugs will adsorb onto it. Drugs returned by a patient can be denatured and disposed of without an authorised witness, but it is good practice to have a registered healthcare professional as a witness. For methods of denaturing different dosage forms of CDs, please refer to the current MEP edition for guidance Denaturing kit https://www.phs.co.uk/products/con trolled-drugs-kit-cd-kit/ (accessed 30/07/21) CDs added, then the required amount of water before shaking thoroughly. Whole container then placed in an appropriate waste bin. Medical waste disposal https://www.yvedametric.top/index.php?main_ page=product_info&products_id=540165 (accessed 30/07/21) Figure 4: CD denaturing and disposal process Date expired pharmacy stock It is a legal requirement for pharmacy contractors to have stocks of obsolete, expired and unwanted Schedule 1 and 2 CDs destroyed in the presence of an authorised witness. It is good practice to have another member of staff witness the denaturing for Schedule 3 CDs. 29 4PY019 Controlled Drugs Activity 11 Using page the current MEP edition to help you, complete the following table summarising the denaturing and witness requirements for CDs. Required to denature? Patient returned CDs Expired/obsolet e/unwanted stock Authorised witness required? Record keeping requirements No, but preferably witnessed by a registered health professional Yes, for Sch 2, 3 or 4 Part I CDs Record keeping and the controlled drugs register Pharmacies must keep records of Schedule 1 and Schedule 2 controlled drugs that they have obtained and supplied. Although Sativex (spray containing cannabis extract) is a Sch 4, Part I CD and no safe custody and prescription requirements apply, its possession, supply and destruction should be recorded in the CD register. For CDs received by the pharmacy (see yellow highlights on the next page) the pharmacy must record the following (as a minimum): • • • the date the supply was received the name and address from whom they were obtained (e.g. wholesaler) the quantity obtained i.e. the number of dose units (tablets, capsules, patches etc) Where the drug is not in discrete units such as a liquid or powder, the number of ml or grams should be recorded For CDs supplied, (see green highlights on the next page) the following must be recorded (as a minimum): • • • • • • the date the supply was made the name and address of the person or organisation supplied details of authority to possess (prescriber details) quantity supplied whether the person collecting the Schedule 2 CD was the patient, their representative or a healthcare professional acting on their behalf if the person was a healthcare professional, their name and address 30 4PY019 • Controlled Drugs if it was the patient or their representative, whether ID was asked for (yes/no) and whether it was provided (yes/no) The pharmacist may add additional information to the register but should remember that it is open to inspection. Entries in CD registers must comply with the following: • • • be in chronological order. be recorded promptly be in ink, indelible or computerised (backed-up and protected) (see MEP for further requirements for electronic registers). Therefore, CD registers may be a hard copy or electronic. must NOT be cancelled, obliterated or altered (corrections must be made by signed, dated marginal notes (GPhC number must be added where appropriate)) the register must be kept at the premises and must be kept for two years from the date of the last entry it is good practice to keep a running balance (this is likely to become mandatory at some point) • • • Electronic register A number of pharmacy computer suppliers have integrated electronic registers onto their systems which are becoming more and more widely used. If the register is kept electronically: • • • • • • • the author of each entry must be identifiable best practice must be followed it must not be possible to amend or alter the register at a later date it must be possible to recall all data for audit the register must be accessible from the premises that it relates to and capable of being printed the register must be secure and minimise access or unauthorised access adequate backups must be made Persons authorised by the secretary of state e.g. GPhC and Home Office inspectors can inspect and request a copy of the register be made. Asking for ID As referred to above, you must record whether you asked for ID before making a supply of a Schedule 2 CD. If you have never met the patient or their representative before, you may feel that you want to see ID but it is not compulsory to ask, you must use your judgement. If you ask and they have no ID you must then use your judgement in deciding whether to make the supply. If the person collecting the Schedule 2 CD is a healthcare professional (e.g. a doctor or nurse), unless you already know them, you must ask for ID and their name and address must be recorded in the CD register. Again, if they have no ID, you must use your judgement about whether to supply. 31 4PY019 Controlled Drugs Example of a CD register page Form: Sugar Free Oral Solution Drug Class: Methadone Date 20/02/24 21/02/24 Obtained Strength 1 mg/ml Supplied Name, address of person or firm from whom obtained Amount Obtained A Wholesaler The Warehouse B6 9NG 500 ml Name, address of person or firm supplied Balance Authority to possess – prescribe or license holder details Person collecting Schedule 2 controlled drug. (Patient/Patient’s representative/healthcare professional) and if healthcare professional, name and address Was proof of identity requested of patient/patient’s rep (Yes/No) Was proof of identity of person collecting provided (Yes/No) Amount Supplied Brought forward 120 620 ml J Jones Dr Smith 396126 Patient No No 60 ml 560 ml Activity 12 1. Make a record above for the supply of 80 mL of this solution to a John Smith of 3 High St, Wolverhampton against a prescription from his GP, Dr Adrian Jones (611119). You can decide whether you asked for proof of ID. 2. Now make a record of receiving a supply of another 500 mL of solution from A Wholesaler. 32 4PY019 Controlled Drugs Accountable Officer The Controlled Drugs (Supervision of Management and Use) Regulations 2013 provide for the appointment of an Accountable Officer; this role was introduced under the Health Act 2006 as a result of recommendations which came out of the Shipman inquiries. The role of the Accountable Officer is to ensure the safe, appropriate and effective management and use of CDs within their organisation. The Regulations state that bodies providing healthcare are required to appoint an Accountable Officer, who should be a fit, proper and suitable experienced person. The person appointed must NOT routinely supply or handle CDs as part of their job within the organisation. The Accountable Officer is responsible for ensuring: • • • • • • • • • every aspect of the journey of CDs within the organisation, or by services provided for which the designated body is responsible, are set out in appropriate and up–to–date standard operating procedures. adequate destruction and disposal arrangements are in place. relevant individuals receive appropriate training. monitoring and auditing the management and use of CDs. effective systems for reporting concerns, incidents or complaints are in place. adequate records are maintained regarding concerns or complaints. concerns or complaints are assessed and investigated. appropriate action is taken to protect patients and/or the public where concerns or complaints are well-founded. sharing of information with other responsible bodies regarding the management and use of CDs. Local Intelligence network • The Health Act 2006 act creates a statutory duty for healthcare organisations, police services, social services, the National Clinical Assessment Service and relevant inspection bodies to work together in local networks to share intelligence on CD issues where there are concerns. Authority to enter and inspect • The Health Act 2006 gives a Police Constable or an authorised person the right to enter premises during reasonable hours and to demand and inspect records relating to controlled drugs. Instalment dispensing Only controlled drugs in Schedules 2 and 3 can be prescribed in instalments. Typically, this facility is used for the supply of methadone or buprenorphine as substitution therapy for diamorphine addiction, as discussed above. Patients who are new to substitution therapy will usually collect their medicine in daily instalments. Most patients will progress onto less frequent instalments. 33 4PY019 Controlled Drugs Instalment direction An instalment direction must specify the following pieces of information separately: 1. the amount of medicine to be supplied per instalment (in addition to the dose) 2. the interval between medication supplies **Please see the MEP and activity 15 below for further details on Home Office approved wording for instalment prescribing** FP10 (MDA) The NHS has prescription forms specifically designed to permit prescribing in instalments. In England the form is the FP10 (MDA) which is issued by drug treatment centres and some GPs. Important points to notes • • • • • • • It is only valid for a maximum of 14 days’ supply. The first instalment must be dispensed within 28 days of the appropriate date. The rest of the instalments should be dispensed in accordance with the directions of the prescriber, even if this runs beyond 28 days after the appropriate date. Each supply against an instalment prescription may only be dispensed on the date specified. Appropriate date – this is the signature date or treatment start date (whichever is the later). The date of each supply of medication must be marked on the prescription. A prescriber can add an instruction, using Home Office approved wording, to allow the supply of CDs for the remainder of an instalment when the person has failed to collect on the specified day e.g. if a patient is due to collect 2 days’ supply on Monday but fails to collect, he could collect Tuesday’s supply on Tuesday if the instruction is added. A prescriber can add an instruction, using Home Office approved wording, to allow a pharmacist to supply treatment before the start date if the pharmacy is closed e.g. on a bank holiday if the relevant approved wording is used. Note that: • All the usual CD prescription requirements must be complied with • Supplying methadone in large bottles and expecting the patient to measure a day’s supply can pose a serious risk to the patient and to any children living with them. You should therefore measure each day’s supply out into a separate container. 34 4PY019 Controlled Drugs Activity 13 Using page the current MEP edition, note down in the table below the Home Office approved wording which is used for instalment directions on instalment prescriptions. The first one has been done for you. 1 Please dispense instalments due on pharmacy closed days on a prior suitable day. 2 3 4 5 35 4PY019 Controlled Drugs Example of a FP10 (MDA) prescription As you can see, the FP10 (MDA) is twice as wide as a normal FP10 form. The right-hand side of the form is for recording each supply made or missed. The prescriber can decide how much drug is to be supplied on each day during the course of the treatment. So, the patient may get a supply daily, every few days or weekly. 36 4PY019 Controlled Drugs Pharmacy Stamp Age Title, Forename, Surname 28 A N Other NFA Wolverhampton, West Midlands Date of birth 26/05/1993 Please don’t stamp over age box Number of day’s treatment NB Ensure dose is stated Endorsements NHS Number Date Methadone 1mg/1ml SF Oral Solution 40 mL daily 30/01/2024 31/01/2024 01/02/2024 02/02/2024 03/02/2024 04/02/2024 05/02/2024 80 mL 0 mL 80 mL 0 mL 120 mL 0 mL 0 mL Total 280 mL (Two hundred and eighty millilitres) Supervise consumption on collection days. Please dispense instalments due on pharmacy closed days on a prior suitable day. Signature of Prescriber A Jones For dispenser No. of prescriptions on form Date 30/01/2024 Prescriber’s name and address Dr A Jones 698352 The practice, 123 High St Wolverhampton WV1 1LY Tel 01902 4567000 37 Quantity Supplied Pharmacist’s initials 30/01/24 Methadone SF Oral Solution 1mg/mL 80 mL RP 01/02/24 Methadone SF Oral Solution 1mg/mL 80 mL RP 1234567812 7 Item Controlled Drugs Sugar/ colour-free preparations • You must only dispense sugar-free/colour-free preparations if directed to do so on the prescription since these products have a greater potential for abuse. Note that dental caries is a frequent problem for drug misusers. Missed doses • If a patient misses three days, then they may have lost their tolerance to the drug and it could be dangerous to supply any more. They must be referred back to their prescriber. Records for instalment dispensing For each supply: • • an entry in the controlled drugs register. Note that there will be a separate register for sugarfree and with sugar solutions. an entry on the right-hand side of the prescription, as per the previous page. If a supply is missed, this should also be recorded on the right-hand side of the prescription. Supervised consumption When patients are started on substitution therapy the prescriber will normally require supervised consumption until the prescriber is confident that the patient is stable and likely to comply with their instructions. This is commonly for a period of 3 months or more. Supervised consumption means that the pharmacist or a suitably trained member of staff must supervise the patient taking their daily dose and ensure that it has been taken. This is commonly done by watching them and then requiring them to drink a glass of water. The reasons for supervised consumption are: • • to ensure the patient’s safety to prevent the medicine being sold on the illegal drugs market to finance other activities If the prescriber requires supervised consumption, they will add this onto the prescription. This is not a legal requirement, but the Department of Health recommends that any deviations from the prescriber’s instructions are recorded. 38 Controlled Drugs New Psychoactive Substances Act 2016 • In the Queen’s speech of May 2015, the government announced new legislation to ‘ban the new generation of psychoactive substances’. The Psychoactive Substances Act came into effect in May 2016. The aim of the legislation was to tackle the growth in use of ‘legal highs’. These were substances such as: amphetamines with a minor chemical modifications such as the addition of a functional group, spice or other synthetic cannabinoid receptor agonists. • The chemical difference took them out of the control of the Misuse of Drugs Act but retained their psychoactive effects and sometimes gave them some unpredictable effects too. Government attempts to control these were ineffective because as fast as they were being made illegal under the Misuse of Drugs Act, new compounds were being created. The 2016 Act controls all psychoactive substances; this has a very wide definition: Meaning of “psychoactive substance” etc (1) In this Act “psychoactive substance” means any substance which— (a) is capable of producing a psychoactive effect in a person who consumes it, and (b ) is not an exempted substance (see section 3). (2) For the purposes of this Act a substance produces a psychoactive effect in a person if, by stimulating or depressing the person’s central nervous system, it affects the person’s mental functioning or emotional state; and references to a substance’s psychoactive effects are to be read accordingly. This definition would, of course include nicotine, alcohol, tea, coffee, cola, energy drinks, chocolate, cheese and many other foods and drinks. The Act therefore has a list of exemptions for these substances. The legislation can be found at: https://www.legislation.gov.uk/ukpga/2016/2/contents (accessed 27/01/23) Guidance for retailers can be found at: https://www.gov.uk/government/publications/psychoactive-substances-act-guidance-forretailers/psychoactive-substances-act-2016-guidance-for-retailers (accessed 27/01/23) The act makes it an offence to produce, offer to supply, supply, possess with intent to supply, possess on custodial premises, import or export psychoactive substances and the maximum penalty for an offence under the act is seven years in prison. 39 Controlled Drugs Further reading • • The legislation is poorly drafted and has already proved inadequate to secure convictions in at least two cases. Click here for more information. For a guide to the Act click here Drugs and driving legislation More information on this topic can be found using the following links: • • • • • • • PSNC briefing on drug driving legislation changes RPS guidance on drugs and driving legislation On the 2 March 2015 legislation came into effect to control driving whilst impaired through drugs. Previously this was controlled by Section 4 of the Road Traffic Act 1988 under which a person could be prosecuted if their driving was impaired, even if they were taking prescribed medicines as directed or as recommended by the product information. The Road Traffic Act required the police and prosecutors to prove that the accused person’s driving was impaired by the medicine. The Drug Driving legislation means that it is illegal in England, Scotland and Wales to drive with certain specified drugs in excess of specified levels in the blood unless the drugs have been prescribed and taken in accordance with advice from a healthcare professional. Police use a roadside screening test which assesses a saliva sample to identify whether a driver has taken one of the listed drugs or a drug that is metabolised in the body to become one of these. A prosecution would be based on blood or urine levels. Under the legislation there is a statutory ‘medical defence’ for patients who are taking their medicines as prescribed. A medical defence can be raised at any time provided the drug was lawfully prescribed, supplied or purchased for medical or dental purposes and was taken in accordance with advice given by the prescriber or supplier and any accompanying written instructions. The RPS has suggested that pharmacists must be aware that their advice could be used as the basis of a defence in these cases. They go on to say, ‘In addition to this, patients who are taking medicines that are affected by the legislation should also receive the following information and advice: • • there is new legislation in place which places limits on the amounts of certain drugs that you can have in your blood stream whilst driving. There is a “medical defence” for those who are taking medicines in line with a healthcare professional’s advice, provided that their driving is not impaired. keep some suitable evidence with you when driving to show that you are taking your medicine as prescribed or supplied by a healthcare professional. Examples of evidence could include a repeat prescription slip for a prescribed medicine or the patient information leaflet for a P or GSL medicine. 40 Controlled Drugs The drugs covered by this legislation are separated into two groups. The first group are drugs which are commonly abused, rarely prescribed and which have low limits. The second group are licensed medicines which have a significant potential for abuse and have higher limits. Group 1 Group 2 Cannabis (THC) Amfetamine e.g. dexamfetamine or selegiline MDMA Clonazepam Ketamine Diazepam Methylamfetamine Lorazepam Cocaine (and its metabolite, BZE) Oxazepam LSD Temazepam 6-MAM – a diamorphine metabolite Flunitrazepam Methadone Morphine or opiate or opioid-based drugs including codeine, tramadol or fentanyl It is important to note that if the individual’s driving is impaired, they can still be prosecuted under the existing offence of driving whilst impaired through drugs, for which there is no statutory ‘medical defence’. It remains the responsibility of all drivers to consider whether their driving is or could be impaired by their medicines. ‘ Driving and New Psychoactive Substances Note that the consumption of NPS may have an impact on drug-driving laws. Although NPS are not included on drug-driving lists, if, for example an NPS increases the level of a Schedule 2 drug in the blood stream which is greater than that permitted while driving this could lead to the arrest of the individual. 41 Controlled Drugs Paramedics and Therapeutic Radiographers Prescribers Paramedic Independent Prescribers and Therapeutical Radiographer Independent Prescriber have recently (dec 2023) have made changes the law regarding the prescribing supply and administration of certain controlled drugs. Paramedic independent prescribers to prescribe and administer five specified controlled drugs, as follows: • • • • • Morphine sulphate by oral administration or by injection; Diazepam by oral administration or by injection; Midazolam by oromucosal administration or by injection; Lorazepam by injection; and Codeine phosphate by oral administration. Therapeutic radiographer independent prescribers to prescribe and administer six specified controlled drugs, as follows: • • • • • • Tramadol by oral administration; Lorazepam by oral administration; Diazepam by oral administration; Morphine by oral administration or by injection; Oxycodone by oral administration; and Codeine by oral administration. The law was amended as follows: The Misuse of Drugs (England and Wales and Scotland) (Amendment) (No. 2) Regulations 2023 dangerous drugs amendment 2023 (paramedics and radiographers).pdf 42 Controlled Drugs Supply of Medicines by Registered Chiropodists and Podiatrists Amendment have been made to enable podiatrists to supply the following controlled drugs: • • • Co-codamol; Co-dydramol; and Codeine phosphate. Guidance has been issued by the Royal College of Podiatry on the supply of codeine Changes to legislation on Codeine (rcpod.org.uk) This applies to appropriately qualified persons register with the Health and Care Professions Council and who hold the annotation POM-S which indicates they have received the required training and have the skill required in the standards of proficiency for supply of prescription only medicines. Podiatrists who are POM(S) annotated through the HCPC may: • Supply no more than is required for a 3-day course, vis a vis the smallest pack size supplied by the manufacturer / pharmacy, i.e., a pack size of 28. • Provide clear instruction to the patient that it is a 3-day course, and that there will be some tabs left over (as they are not packed by the manufacturer as a 3-day course). • Recommend the patient return the remaining tabs (i.e. the 'spares' remaining after the 3-day course is completed) back to the pharmacy for safe disposal. (extract from the guidance Changes to legislation on Codeine (rcpod.org.uk)) 43 Controlled Drugs Original pack dispensing - England As reported in July 2023 that the Human Medicines Regulations 2012 (HMR) would be amended to allow original pack dispensing. This amendment was made on 11 October 2023 with the insertion of regulation 217B into the HMR. However, the new provision did not take effect in England and Wales pending amendments to the NHS terms of service there. The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No.2) Regulations 2024 have just been laid before Parliament. They provide that the NHS terms of service in England will be amended with effect from 1 January 2025. Except for controlled drugs in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001, and except for specials, the NHS terms of service will allow a different quantity to be provided to that ordered on the prescription form to allow a drug to supplied in its manufacturer’s original outer packaging. This is subject to: • the quantity supplied in a manufacturer’s original pack must be no more than 10% greater or no more than 10% less than the quantity prescribed • the pharmacist supplying or directly supervising the supply does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity may mean that the patient does not, or is not able to follow the medication regimen as intended by the prescriber. • the pharmacist must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to supply a different quantity, having regard to the benefits to patients when the drugs are provided in their manufacturer’s original outer packaging. This means that the changes to original pack dispensing in England will only apply to Schedule 5 medicines in CD (inv) P and CD(INV) POM. Schedule 1 medicines are NOT currently prescribed. 44