Controlled Drugs - MPharm PHA221 PDF

WEEK 11 MPharm Programme Controlled Drugs Part 1: Background and Schedules John Sherwood MRPharmS 11th October 2024 Slide 1 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11...

WEEK 11 MPharm Programme Controlled Drugs Part 1: Background and Schedules John Sherwood MRPharmS 11th October 2024 Slide 1 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Learning outcomes Understand why CD legislation is so strict and have knowledge of 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 and know how to find the schedule of any UK licensed CD 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 prescription requirements, safe custody, records, destruction and invoices Slide 2 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 BACKGROUND TO CD LEGISLATION Slide 3 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 needed to be ‘controlled’ Misuse is associated with a wider social impact, e.g., crime and anti-social behaviour But there are inconsistencies e.g., alcohol, tobacco vs cannabis CD legislation operates in parallel with wider medicines law e.g., Human Medicine Regulations 2012 Slide 4 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Medicines Legislation Human Medicine Regulations 2012 Regulates all medicines for human use Medicines Act 1968 Still applies to retail pharmacy businesses Both are administered by the Department of Health and Social Care Misuse of Drugs Act 1971 and associated Regulations Regulates narcotics and other controlled drugs Administered by the Home Office Slide 5 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Controlled Drugs Legislation 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 as allowed by a licence from the Secretary of State) for: Possession (compared to prescription only medicines) Supply (including prescribing) Manufacture Import or export Use of CDs in medicine is permitted by Misuse of Drugs Regulations 2001 (as amended) Slide 6 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 1971 so that CDs can be used in medicine Slide 7 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 What drugs are 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: Barbiturates Benzodiazepines Anabolic steroids More recently, gabapentin and pregabalin (2019) Slide 8 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 How did he do it? Used diamorphine to murder his patients Shipman prescribed diamorphine to his patients (who often did not clinically need it) He often collected these prescriptions on behalf of patients (and then used either some, or all of it, for his own purposes) The controls that applied at the time did not identify these practices Shipman was well regarded by his patients and by other healthcare professionals Why did he do it? Slide 10 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 What about the pharmacist who dispensed the prescriptions? Mrs Brant was the pharmacist who managed 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Were the requests unusual? Mrs Brant believed that Shipman was using 30 mg 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 pharmacy 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 But the pharmacy inspector also failed to notice this ‘unusual pattern of prescribing’ ‘Guilt by association is 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Changes made to CD legislation and CD requirements post-Shipman Duration of validity of Rx reduced to 28 days Private prescriptions to be written on a standardised form (FP10PCD) Private prescriptions to be sent to the NHSBSA Accountable Officers introduced for organisations Oversight of the management of CDs by the Care Quality Commission Maximum quantity of CD on a Rx introduced* Running balances recommended in CD registers* (* these are good practice requirements and not legal requirements) Slide 15 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 This is usually a senior manager in an organisation but they should not prescribe, supply, administer or dispose of CDs as part of their regular duties Have many roles (list not exhaustive): Audit 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 Networks 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 CLASSIFICATION OF CDS Slide 17 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Classification of CDs Act and Regulations attempt to address relative risk of 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Who decides the classification? The Advisory Council on the Misuse of Drugs advises the Government Includes people that have experience in: The practice of medicine The practice of dentistry The practice of veterinary medicine The practice of pharmacy The pharmaceutical industry Chemistry They also have other roles in relation to CDs such as education of the public, promoting research, promoting co-operation between professional groups Slide 19 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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), methylamphetamine, 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Class B Penalties not as severe as Class A Class B includes oral amphetamines (but, methylamphetamine 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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. Also, 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 1 [CD Lic] (1) Includes cannabis (non-medicinal), LSD, MDMA, khat This Schedule contains drugs subject to the strictest controls The drugs have little or no medical value, but cause social problems through misuse Production and possession 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 Possession by practitioners (Drs and pharmacists) is NOT allowed except under license Slide 23 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 1 [CD Lic] (2) A pharmacist cannot take possession of a Schedule 1 CD other than in two cases where exemptions are granted: 1. for the purpose of destruction 2. 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 was drug dealing? Slide 24 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 2 [CD POM] (1) This Schedule contains must of the opiates (such as diamorphine, morphine, and methadone) and stimulants (such as the amphetamines) 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 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 2 [CD POM] (2) May be administered only by, or on direction of, an authorised prescriber Safe custody requirements apply - they must all be kept in a CD cabinet except quinalbarbital Safe custody requirements also apply to Schedule 2 CDs returned by patients, until they can be destroyed (see CD lecture Part 2) Destruction of out-of-date CDs or patient returned CDs is subject to strict control All transactions MUST be recorded in the CD register Must ascertain the identity of the person collecting the CD How do you find the schedule for a CD? Slide 26 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Safe custody of CDs (1) The regulations relating to safe custody (keeping in a CD cabinet) applies to all CDs in Schedules 1 and 2 (except quinalbarbital) The regulations also state that all Schedule 3 CDs are subject to safe custody unless they are specifically exempt Must keep CDs that legally require safe custody in a ‘locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs’ Specifications for cabinets, rooms etc. is given in detail in the Regulations It is possible to apply for an exemption certificate from the police to store the CDs in a non-Regulation CD cabinet (such as a safe) This applies to community pharmacies, private hospitals and care homes but not NHS hospitals Pharmacies may decide to keep other CDs in the cabinet in response to any local issues with CDs for extra security Slide 27 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Safe custody of CDs (2) When CDs requiring safe custody are not kept in the CD cabinet, safe or room they must be under ‘the direct personal supervision’ of a pharmacist. This applies to when a CD is being dispensed. However, caution should be exercised if a dispensed CD is awaiting collection. Access to CD drugs (including handling of ‘CD keys’) should be documented within a policy which includes an audit trail of access to the keys (i.e., a CD key log) or electronic logs if there is an electronic access system. The policy should seek to prevent unauthorised access to CDs. Access to the CD cabinet keys should be restricted to those authorised to access the CD cabinet. A template CD key log is available on the RPS website. Careful thought is needed regarding overnight security of the keys and transfer to another pharmacist. Safe custody applies to patient returned CDs, out of date CDs and obsolete CDs until they can be destroyed but only if they are CDs which are normally required to be kept under safe custody Slide 28 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 3 [CD No Reg POM] Schedule 3 includes barbiturates (e.g., phenobarbital) and other drugs such as buprenorphine, temazepam, 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 Safe custody requirements apply, but all drugs are exempt except temazepam, diethylpropion, buprenorphine and flunitrazepam Any new drug added to schedule 3 will also require safe custody, unless specifically exempted Controls are the same as for schedule 2 except: Difference in who can possess and supply them Less strict destruction requirements No record is needed in the CD register Invoices need to be retained for two years Slide 29 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 4 CDs Schedule 4 is split into two parts: Part I [CD Benz POM] contains most benzodiazepines (such as diazepam and nitrazepam) and ‘z’ hypnotics Part II [CD Anab POM] contains most of the anabolic, androgenic steroids and growth hormones CD prescription and labelling requirements do not apply (except for validity of a prescription being limited to 28 days) – but HMR 2012 prescription requirements for POMs apply No safe custody requirements No requirement to keep records of supply No destruction requirements for pharmacies No restriction on possession of schedule 4 part II drugs when contained in a medicinal product Slide 30 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Schedule 5 [CD Inv POM / P] This Schedule contains dilute preparations of drugs in Schedule 2. i.e., preparations containing a low strength of CD 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 No authority needed for destruction Slide 31 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Dihydrocodeine Different formulations are available: Dihydrocodeine tartrate 50mg/mL injection [CD POM] Dihydrocodeine tartrate 30mg tablets [CD Inv POM] Dihydrocodeine tartrate 7.46mg tablets [CD Inv P] marketed as Paramol® tabs (DHC and paracetamol) 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 100 mg (base) it is classified as CD Inv POM (this is why dihydrocodeine tablets 30mg are CD Inv POM) Slide 32 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 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 33 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Common CDs (1) Schedule 2 Schedule 3 Diamorphine Buprenorphine Methadone Gabapentin Morphine Pentazocine Oxycodone Phenobarbital Pregabalin Pethidine Temazepam Tramadol Remember that there may be several brand names for a generic drug Slide 34 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Common CDs (2) Schedule 4 Part 1 Schedule 5 Diazepam Caution: Low strengths or Lorazepam certain forms only Nitrazepam Codeine (note that codeine linctus is a POM) Zopiclone Dihydrocodeine Zolpidem Morphine Pholcodine (no longer available - withdrawn) Remember that there may be several brand names for a generic drug Slide 35 of 36 MPharm PHA221 Controlled Drugs - Schedules WEEK 11 Further information Medicines, Ethics and Practice contains a table summarising various legal requirements for each schedule of controlled drug. In the online MEP this is table 12 which can be found in the section 3.6.2 on ‘classification’ (of controlled drugs) Slide 36 of 36 MPharm PHA221 Controlled Drugs - Schedules