Misuse of Drugs Act Schedules of CDs MPH 212.pdf

WEEK 12 Controlled Drugs (CDs) Part 1: Background and Schedules John Sherwood MRPharmS 16th October 2024 Slide 1 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Learning o...

WEEK 12 Controlled Drugs (CDs) Part 1: Background and Schedules John Sherwood MRPharmS 16th October 2024 Slide 1 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Learning outcomes Understand why some drugs are subject to special control Understand how CD legislation has changed following the Shipman murders Describe how and why controlled drugs in the UK are classified into schedules and classes Give two examples of a drug in each class and three examples of a drug in each schedule Explain, with an example, how a drug may belong to more than one schedule Describe how, as the level of control decreases, legal requirements change relating to safe custody, records, destruction and invoices Describe the legal situation relating to the medicinal use of cannabis and products containing CBD Slide 2 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 BACKGROUND TO CD LEGISLATION Slide 3 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Why ‘control’ drugs? Some drugs are dangerous and have the potential to cause harm Some drugs can be abused Drugs with established or emerging patterns of non- medical use need to be further ‘controlled’ Misuse with wider social impact, e.g., crime and anti-social behaviour But there are inconsistencies e.g., alcohol, tobacco vs cannabis (recreational use) CD legislation operates in parallel with wider medicines law e.g., Human Medicine Regulations 2012 Slide 4 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Controlled Drugs Misuse of Drugs Act 1971 controls ‘dangerous or otherwise harmful drugs’ which are designated as ‘controlled drugs’ (CDs) Act is essentially restrictive, i.e., it seeks to prevent misuse through total prohibition (except as regulations allow or by licence from the Secretary of State) for: Possession (compared to POMs) Supply (including prescribing) Manufacture Import or export Use of CDs in medicine is permitted by Misuse of Drugs Regulations 2001 (as amended) Other regulations exist on safe custody, notification of addicts and supply of drugs to addicts Slide 5 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Misuse of Drugs Act 1971 Misuse of Drugs Act Prohibits all activities of CDs 1971 Provides exceptions to the restrictions of the Misuse of Drugs Misuse of Drugs Regulations 2001 Act so that CDs can be used in medicine Slide 6 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Medicines Legislation Human Medicine Regulations 2012 regulates all medicines for human use within wider EU framework administered by Department of Health and Social Care generally permissive legislation Misuse of Drugs Act 1971 and associated regulations regulates narcotics and other controlled drugs covers both legitimate (medicinal) use and unlawful (‘street’) misuse administered by Home Office restrictive legislation, but the Misuse of Drugs Regulations 2001 allows certain activities by certain people when CDs are used as medicines Slide 7 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 What is controlled? Traditionally, narcotics (opiates and cannabis) and cocaine Misuse of Drugs Act 1971 extended controls to amphetamines and psychotropic drugs such as LSD Subsequent regulations have reflected changing patterns of misuse by including: Benzodiazepines Anabolic steroids Tramadol Gabapentin and pregabalin (2019) What drugs may become CDs in the future? Slide 8 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Why is the law about CDs so strict? He is the most prolific known serial killer in history with over 200 murders thought to be committed by him On 7 September 1998, he was arrested and charged with the murder of Kathleen Grundy As police investigated they uncovered evidence of further murders Dr Harold F Shipman Slide 9 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 How did he do it? He used diamorphine to murder his patients Shipman prescribed diamorphine to his patients who did not always clinically need it He often collected these prescriptions on behalf of patients (but then used either some, or all the CD, for his own purposes) The controls that applied at the time did not identify these practices Shipman was well regarded by his patients and also by other healthcare professionals Why did he do it? Slide 10 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 The Shipman Murders “None of your victims realised that yours was not a healing touch. None of them knew that in truth you had brought them death, death which was disguised as the caring attention of a good doctor” Hon. Mr Justice Forbes, sentencing Shipman in January 2000. Shipman was given 15 life sentences for murder Slide 11 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 What about the pharmacist who dispensed the prescriptions? Mrs Brant was the pharmacist who manged the pharmacy next door to Dr Shipman’s surgery Mrs Brant was responsible for dispensing the great majority of Shipman's prescriptions for diamorphine over a six-year period Mrs Brant was interviewed by the police as part of the investigation and when questioned about the supply of single ampoules of diamorphine 30mg she said: 'I can recall that when I asked Dr Shipman about these prescriptions, he stated that the drugs were being used for patients with suspected chest pain and heart attacks which he was going to visit.‘ Mrs Brant said that she was confident in Dr Shipman's competence; she thought he knew what he was doing She said that it had not occurred to her that Shipman's requests for single 30mg ampoules were strange Slide 12 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Were the requests unusual? Mrs Brant believed that Shipman was using 30mg of diamorphine to treat acute MI From the BNF: ‘myocardial infarction, by slow IV injection 5mg followed by a further 2.5 – 5mg if necessary’ What about wastage? 5mg ampoules are available In one page of the CD register, every line (apart from the first) recorded the dispensing of a single 30mg ampoule prescribed by Shipman in the name of a different patient Yet Mrs Brant did not notice anything unusual. Does this mean she was negligent? Slide 13 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 RPSGB Fitness to Practice Committee (RPSGB was the pharmacy regulator before the GPhC) The complaint against Mrs Brant is that she failed to notice an unusual pattern of prescribing of 30mg diamorphine Pharmacy inspector also failed to notice this ‘unusual pattern of prescribing’ ‘Guilt by association is a wholly unacceptable’ ‘She is more to be praised than pilloried. Had it not been for her meticulous record-keeping [of the CD register] retained long after the law required it of her, much of what the police uncovered about Dr Shipman would have been lost for ever’ The Committee ruled that Mrs Brant had ‘No case to answer’ “No case to answer” ruling for Shipman pharmacist. Pharm J. (2005): 274; 374 - 376 Slide 14 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Changes made to CD legislation and requirements post-Shipman Duration of validity of prescription reduced to 28 days Private prescriptions to be written on a standardised form (FP10PCD) Private prescriptions to be sent to the NHSBSA Controlled Drug Accountable Officers introduced for organisations Oversight of the management of CDs by the Care Quality Commission Maximum quantity of CD on a prescription introduced* Running balances recommended in CD registers* (* these are good practice requirements and not legal requirements) Slide 15 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Who is a Controlled Drug Accountable Officer (CDAO)? CDAO means a fit, proper and suitable experienced person appointed or nominated by a designated body to ensure the safe, appropriate and effective management and use of CDs within organisations Usually, a senior manager in an organisation and should not prescribe, supply, administer or dispose of CDs as part of their regular duties Have many roles (list not exhaustive): Oversight of the monitoring and auditing of the management, prescribing and use of CDs Maintain a record of concerns and incidents regarding individuals and convening incident panels as necessary Sharing of information regarding CDs (including concerns and incidents) Attendance at CD Local Intelligence Network meetings Appointment of authorised witnesses for the destruction of CDs Note that community pharmacies are not required to appoint a CDAO but there should be a ‘Controlled Drugs lead’ Slide 16 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 CLASSIFICATION OF CDs Slide 17 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Different ways to classify CDs Schedules 1 – 5 (deal with levels of control when CDs are used legally as medicines) Classes A, B, C (deal with levels of penalty for illegal use or possession) Slide 18 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Advisory Council on Misuse of Drugs Advises the Secretary of State for the Home Office and Ministers of Health on any matter relating to controlled drugs Reviews the situation in the UK with respect to drugs which are being, or likely to be, misused resulting in likely social problems Representatives from medicine, dentistry, pharmacy Roles include Educate the public (particularly the young) regarding dangers of drug misuse Promote research in preventing misuse or dealing with social problems connected to misuse Restricting the availability of drugs or to supervise their arrangements for their supply Promote cooperation between professional and community services which deal with social problems caused by the misuse of drugs Also acts as a source of advice for Government regarding matters relating to drug dependence or misuse of drugs Slide 19 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Class A Class A are the most harmful drugs and attract the severest penalties Include: cocaine, diamorphine, LSD, opium, MDMA, magic mushrooms (either fresh or dried), methylamfetamine, morphine, methadone Penalties for possession include up to 7 years in prison or an unlimited fine or both Penalties for dealing include up to life in prison or an unlimited fine or both Slide 20 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Class B Penalties not as severe as Class A Class B includes oral amfetamines (but note that methylamfetamine is Class A), barbiturates, codeine, dihydrocodeine, methylphenidate, ketamine and cannabis Penalties for possession include up to 5 years in prison, or an unlimited fine, or both Penalties for dealing include up to 14 years in prison or an unlimited fine or both Slide 21 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Class C Penalties are not as severe as Class B Class C includes, benzodiazepines (such as diazepam, midazolam, temazepam), GHB, tramadol, zopiclone, khat, buprenorphine, anabolic steroids. Nitrous Oxide (2023) Penalties for possession include up to 2 years in prison, or an unlimited fine, or both. Penalties for dealing include up to 14 years in prison or an unlimited fine or both Slide 22 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 1 [CD Lic] (1) Includes, cannabis (non-medicinal use), LSD and MDMA (‘ecstasy’) This Schedule contains drugs subject to the strictest controls The drugs have little or no medical value, but cause social problems through misuse Production, possession and supply is limited to purposes of research or other special purposes A license from the Home Secretary is necessary to possess, produce, supply, offer to supply, administer, or cause these drugs to be administered Slide 23 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 1 [CD Lic] (2) A pharmacist cannot take possession of a Schedule 1 CD except in two cases where exemptions are granted: 1. Taking possession for the purpose of destruction, 2. Taking possession for the purpose of handing over to a police officer. The patient's confidentiality should be normally be maintained, and the police should be called in on the understanding that there will be no identification of the source What if the quantity were so large you suspected the patient were drug dealing? Slide 24 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 2 [CD POM] (1) This Schedule contains most of the opiates (such as diamorphine, morphine, and methadone) and stimulants (such as the amfetamines) A license is needed to import or export these drugs A pharmacist may supply them to a patient ONLY on the authority of a prescription in the required form, issued by an appropriate practitioner May be manufactured or compounded, when acting in a professional capacity, by: Licence holder Practitioner Pharmacist Person lawfully conducting a retail pharmacy business Nurse independent prescriber Supplementary prescriber Slide 25 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 2 [CD POM] (2) May be administered only by, or on direction of, an authorised prescriber Safe custody requirements apply to all drugs in this schedule except quinalbarbital Safe custody also applies to Schedule 2 CDs returned by patients, until they can be destroyed, and stock which has expired (see later) All transactions (stock coming in/out) MUST be recorded in the CD register Must ascertain the identity of the person collecting the CD Prescription valid for 28 days Invoices do not legally need to be retained for 2 years (although NICE advise that ALL CD invoices should be retained for 6 years for the purpose of HM Revenue and Customs) How do you find the schedule for a CD? Slide 26 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Examples of Sch 2 CDs Alfentanil Morphine Cannabis products for Nabilone medicinal use Oxycodone Diamorphine Pethidine Dipipanone Quinalbarbital Dronabinol (secobarbital) Fentanyl Remifentanil Hydromorphone Tapentadol Ketamine Lisdexamfetamine Remember that there may Methadone be several brand names for Methylphenidate a generic drug This list is not exhaustive Slide 27 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 3 [CD No Reg POM] Schedule 3 includes barbiturates (e.g., phenobarbital) and other drugs such as buprenorphine, temazepam, pregabalin and gabapentin Schedule 3 drugs are less likely to be misused than Schedule 2 and if they are misused they are less likely to be harmful Although safe custody applies, all drugs are exempted except temazepam, diethylpropion, buprenorphine and flunitrazepam Any new drug added to schedule 3 must be kept under safe custody unless specifically exempted (safe custody is covered in the next lecture) Prescription valid for 28 days Other controls are as for schedule 2 except: Difference in who can possess and supply No destruction requirements for out-of-date stock No record needed in CD register Invoices need to be retained for two years Slide 28 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Examples of Sch 3 CDs Buprenorphine Phenobarbital Diethylpropion Pregabalin Flunitrazepam Temazepam Gabapentin Tramadol Midazolam Pentazocine Remember that there may be several brand names for a generic drug This list is not exhaustive Slide 29 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 4 CDs Schedule 4 is split into two parts: Part I [CD Benz POM] contains most of the benzodiazepines and ‘z’ hypnotics Part II [CD Anab POM] contains most of the anabolic and androgenic steroids and growth hormones Restrictions are as for schedule 3 except: No restriction on imports or exports for Schedule 4 part II provided they are imported or exported by a person for self-administration No restriction on possession of Schedule 4 part II drugs when contained in a medicinal product CD prescription and labelling requirements do not apply – but Human Medicine Regulations 2012 requirements still apply No record needed in CD register No safe custody requirements No need to keep invoices for 2 years Prescription valid for 28 days Slide 30 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Examples of Sch 4 CDs Part 1 Alprozolam Oxazepam Chlordiazepoxide Sativex Clobazam Zopiclone Clonazepam Zolpidem Diazepam Flurazepam Remember that there may be several brand names for a generic drug Loprazolam Lorazepam This list is not exhaustive Lormetazepam Nitrazepam Slide 31 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Examples of Sch 4 CDs Part 2 Danazol Chorionic gonadotrophin Nandrolone (HCG) Stanozolol Clenbuterol Testosterone Non-human chorionic gonadotrophin Remember that there may be several Somatotropin brand names for a generic drug This list is not exhaustive Slide 32 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Schedule 5 [CD Inv POM / P] Contains preparations of some CDs exempt from full control due to presence in medicinal products at a low strength No restriction on import, export, possession or administration No safe custody required No entry in CD register required Invoice must be kept for two years May be manufactured and compounded by practitioner, pharmacist acting as such, or licence holder Prescription valid for 6 months Slide 33 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Examples of Sch 5 CDs Strength exemptions Codeine (note that codeine linctus is POM) Dextropropoxyphene Dihydrocodeine Morphine Remember that there may be several brand names for a generic Pholcodine (no longer drug available) This list is not exhaustive Slide 34 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Dihydrocodeine Different formulations are available: Dihydrocodeine tartrate 50mg/mL injection [CD POM] Dihydrocodeine tartrate 30mg tablets [CD Inv POM] Dihydrocodeine tartrate 7.4mg tablets [CD Inv P] marketed as Paramol If dihydrocodeine is for parenteral use it is classified as a CD POM [this is why dihydrocodeine injections are CD POM] If dihydrocodeine is for non-parenteral use and has a maximum strength of 100mg (base) it is classified as CD Inv POM (this is why dihydrocodeine tablets are CD Inv POM) Slide 35 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Relationship between Schedule and Class Drug Schedule Class Cannabis and 1 B Cannabis resin Diamorphine 2 A Temazepam 3 C Phenobarbital 3 B Raw Opium 1 A Flunitrazepam 3 C Nitrazepam 4 (part 1) C Slide 36 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 CANNABIS CONTAINING MEDICINAL PRODUCTS Slide 37 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Cannabis There are more than 100 different chemical compounds (cannabinoids) identified in the cannabis plant Cannabis and most cannabinoids (but not all) are controlled under the Misuse of Drugs Act 1971 (as Schedule 1 CDs) These include tetrahydrocannabinol (THC), the cannabinoid that gives cannabis its psychoactive effect, and cannabinol (CBN) Cannabidiol (CBD) is a non-psychoactive cannabinoid that is not controlled under the Misuse of Drugs Act Cannabis-based products which are for medicinal use are classified as schedule 2 CDs (this does not include synthetic cannabinoids) It is likely that in the future medicinal products will be classified by product name (rather than constituents being classified) There is a NICE guideline on ‘Cannabis-based products for medicinal use’ Note that ‘raw’ cannabis remains a schedule 1 CD and it is still illegal to grow and cultivate the cannabis plant (unless there is a licence in place from the Home Office Slide 38 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Cannabidiol (CBD) and ‘novel foods’ The CBD market has grown rapidly in recent years and products are available as oils and tinctures The MHRA advises that products containing CBD which are sold for medical purposes should be regulated as medicines (e.g., Epidyolex) Epidyolex (which contains CBD) is a Sch 5 because the levels of THC are low (< 0.1% w/w), meaning it has a low risk of abuse, dependency and diversion Many CBD products are sold by health food shops and on the internet as food supplements and are classed as ‘novel foods’. These are regulated by the Food Standards Agency (FSA). These products must not contain THC which is a controlled substance. The Home Office has warned that pure CBD is ‘very difficult’ to isolate and that if a product contains THC it is ‘highly likely’ to be a CD ‘Novel food’ legislation requires that products have a pre-market authorisation, including a risk assessment, to ensure consumer protection The FSA website can be used to check if a CBD product has been authorised Note that FSA authorisation is not an endorsement of the use of the product The GPhC advises that only CBD products which are authorised should be sold from a pharmacy Slide 39 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Prescribing cannabis-based products for medicinal use All these products (apart from Sativex, Epidyolex and nabilone capsules) are unlicensed medicines NICE guidance says the initial prescribing of unlicensed cannabis medicines should be done by a doctor who is listed on the Specialist Register of the General Medical Council and who has a specialist interest in the condition being treated The GMC online register includes an annotation next to the doctor’s name if they are on the Specialist Register (see MEP for details how to check the GMC register) These products should only be prescribed where there is clear published evidence of benefit or UK Guidelines recommend them Note that NICE guidance does NOT recommend the use of these products to treat chronic pain Slide 40 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Sativex Sativex is a cannabis based oromucosal mouth spray containing CBD and dronabinol Indicated as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis Classified as Schedule 4 part 1 Prescription should be written as for a Schedule 4 CD (i.e., no CD prescription requirements) No legal need for a CD register entry BUT pharmacists are required to keep records of Sativex. The Home Office strongly recommends using the CD register for this Needs to be stored in a fridge, no need for it to be locked Destruction – as per other Schedule 4 CDs Slide 41 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Nabilone and dronabinol Nabilone is a synthetic cannabinoid medicine Classified as schedule 2 Used for nausea and vomiting caused by chemotherapy which is unresponsive to conventional anti-emetics (preferably in a hospital setting) Dronabinol is a synthetic cannabinoid medicine which is a version of THC Classified as schedule 2 CD There are no single ingredient licensed products available in the UK Slide 42 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 Further information Medicines, Ethics and Practice (online) contains a table summarising legal requirements for different schedules of controlled drugs (table 12 in section 3.6.2) The RPS has various resources on its website relating to cannabis-based medicines and CBD oils Slide 43 of 44 OSPAP MPHM15 CDs: Background and Classification WEEK 12 CD Schedules: True/False? 1) MST (morphine) tablets 10 mg are classed as a Schedule 2 CD 2) All Schedule 2 CDs should be kept in the CD cupboard 3) Schedule 3 CDs should be written up in the CD register 4) Schedule 4 part I include most benzodiazepines, such as nitrazepam 5) Class A CDs are also classified as Schedule 2 CDs 6) Codeine phosphate tablets 30mg are classified as CD Inv POM 7) Co-codamol tablets 30/500 are classified as CD Inv POM 8) Co-codamol tablets 8/500 can be classified as CD Inv P 9) Temazepam elixir 10mg/5ml which has been returned by a patient should be stored in the CD cabinet 10) MST tablets which have been dispensed but are waiting for collection by the patient should be stored in the CD cabinet Slide 44 of 44 OSPAP MPHM15 CDs: Background and Classification