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Questions and Answers
The Misuse of Drugs Act 1971 primarily aims to facilitate the medicinal use of dangerous drugs through regulated distribution channels.
The Misuse of Drugs Act 1971 primarily aims to facilitate the medicinal use of dangerous drugs through regulated distribution channels.
False (B)
The Human Medicine Regulations 2012, mirroring the Misuse of Drugs Act 1971, are principally designed to restrict the availability and use of all medicines within the EU framework.
The Human Medicine Regulations 2012, mirroring the Misuse of Drugs Act 1971, are principally designed to restrict the availability and use of all medicines within the EU framework.
False (B)
The Misuse of Drugs Act 1971 specifically targets narcotics, such as opiates and cannabis, alongside psychotropic substances excluding amphetamines.
The Misuse of Drugs Act 1971 specifically targets narcotics, such as opiates and cannabis, alongside psychotropic substances excluding amphetamines.
False (B)
Following the Shipman murders, the duration of validity for private prescriptions of Controlled Drugs (CDs) was extended to 90 days to improve patient access.
Following the Shipman murders, the duration of validity for private prescriptions of Controlled Drugs (CDs) was extended to 90 days to improve patient access.
A Controlled Drug Accountable Officer (CDAO) must be a junior staff member in an organisation so that they can have direct knowledge of any wrong-doing.
A Controlled Drug Accountable Officer (CDAO) must be a junior staff member in an organisation so that they can have direct knowledge of any wrong-doing.
Schedule 4 Controlled Drugs (CDs) are subject to the strictest controls due to their high potential for misuse and lack of therapeutic value.
Schedule 4 Controlled Drugs (CDs) are subject to the strictest controls due to their high potential for misuse and lack of therapeutic value.
The Advisory Council on Misuse of Drugs (ACMD) has the authority to enact primary legislation concerning drug classification and control.
The Advisory Council on Misuse of Drugs (ACMD) has the authority to enact primary legislation concerning drug classification and control.
Class A drugs, according to UK law, carry lesser penalties for possession compared to Class B drugs, reflecting their lower potential for harm.
Class A drugs, according to UK law, carry lesser penalties for possession compared to Class B drugs, reflecting their lower potential for harm.
Pharmacists are generally permitted to take possession of Schedule 1 Controlled Drugs (CDs) for routine dispensing purposes without specific exemptions.
Pharmacists are generally permitted to take possession of Schedule 1 Controlled Drugs (CDs) for routine dispensing purposes without specific exemptions.
Import or export of Schedule 2 Controlled Drugs (CDs) requires a license.
Import or export of Schedule 2 Controlled Drugs (CDs) requires a license.
Schedule 3 Controlled Drugs (CDs) necessitate meticulous record-keeping in a designated CD register for all transactions, similar to Schedule 2 CDs.
Schedule 3 Controlled Drugs (CDs) necessitate meticulous record-keeping in a designated CD register for all transactions, similar to Schedule 2 CDs.
All Schedule 4 Controlled Drugs (CDs), without exception, are subject to safe custody requirements, necessitating storage in a locked cabinet.
All Schedule 4 Controlled Drugs (CDs), without exception, are subject to safe custody requirements, necessitating storage in a locked cabinet.
Schedule 5 Controlled Drugs (CDs) are subject to import restrictions.
Schedule 5 Controlled Drugs (CDs) are subject to import restrictions.
In the UK, it is legal to grow cannabis provided it is for medicinal use and properly registered without requiring a Home Office license.
In the UK, it is legal to grow cannabis provided it is for medicinal use and properly registered without requiring a Home Office license.
Novel food legislation mandates that products containing pure CBD, irrespective of THC presence, require pre-market authorization and risk assessment.
Novel food legislation mandates that products containing pure CBD, irrespective of THC presence, require pre-market authorization and risk assessment.
NICE guidelines expressly endorse the use of cannabis-based medicinal products for the treatment of chronic pain, given sufficient clinical evidence.
NICE guidelines expressly endorse the use of cannabis-based medicinal products for the treatment of chronic pain, given sufficient clinical evidence.
Sativex prescriptions should be written with specific CD prescription requirements, similar to Schedule 2 drugs, to ensure strict regulatory compliance.
Sativex prescriptions should be written with specific CD prescription requirements, similar to Schedule 2 drugs, to ensure strict regulatory compliance.
Nabilone, classified as a Schedule 2 controlled drug, is primarily indicated for treating chemotherapy-induced nausea and vomiting irrespective of other anti-emetic treatments.
Nabilone, classified as a Schedule 2 controlled drug, is primarily indicated for treating chemotherapy-induced nausea and vomiting irrespective of other anti-emetic treatments.
The administration of diamorphine by Dr. Shipman was considered standard practice for treating acute MI patients according to guidelines at the time.
The administration of diamorphine by Dr. Shipman was considered standard practice for treating acute MI patients according to guidelines at the time.
Schedule 4 part II CD’s have no restriction on imports or exports.
Schedule 4 part II CD’s have no restriction on imports or exports.
MST (morphine) tablets 10 mg are correctly classified as a Schedule 2 CD.
MST (morphine) tablets 10 mg are correctly classified as a Schedule 2 CD.
As a matter of law, all Schedule 2 CDs must invariably be stored exclusively in a designated CD cupboard.
As a matter of law, all Schedule 2 CDs must invariably be stored exclusively in a designated CD cupboard.
There is now a legal requirement to record Schedule 3 CDs in the CD register.
There is now a legal requirement to record Schedule 3 CDs in the CD register.
Schedule 4 part I includes practically all of the benzodiazepines, including nitrazepam.
Schedule 4 part I includes practically all of the benzodiazepines, including nitrazepam.
All Class A CDs are also automatically classified as Schedule 2 CDs.
All Class A CDs are also automatically classified as Schedule 2 CDs.
Codeine phosphate 30mg tablets may legally be classified as CD Inv POM
Codeine phosphate 30mg tablets may legally be classified as CD Inv POM
Co-codamol tablets, formulated as 30/500, strictly necessitate classification as CD Inv POM under existing UK regulations.
Co-codamol tablets, formulated as 30/500, strictly necessitate classification as CD Inv POM under existing UK regulations.
Co-codamol tablets 8mg/500mg can be classified as CD Inv P.
Co-codamol tablets 8mg/500mg can be classified as CD Inv P.
Temazepam elixir 10mg/5ml, if returned by a patient, is exempt from the standard storage requirements applicable to other Schedule 3 CDs and does not need to be stored in the CD cabinet.
Temazepam elixir 10mg/5ml, if returned by a patient, is exempt from the standard storage requirements applicable to other Schedule 3 CDs and does not need to be stored in the CD cabinet.
MST tablets, once dispensed but awaiting patient collection, require storage within the controlled drug (CD) cabinet to adhere to stringent security protocols.
MST tablets, once dispensed but awaiting patient collection, require storage within the controlled drug (CD) cabinet to adhere to stringent security protocols.
The Shipman murders resulted in more relaxed guidelines regarding Controlled Drugs as authorities did not want to stigmatise seriously ill patients.
The Shipman murders resulted in more relaxed guidelines regarding Controlled Drugs as authorities did not want to stigmatise seriously ill patients.
Given the high risk of abuse, buprenorphine prescriptions require destruction of out-of-date stock.
Given the high risk of abuse, buprenorphine prescriptions require destruction of out-of-date stock.
It is permissible for an ordinary person with no prior authorizations to import Schedule 4 medications across the border for commercial purposes.
It is permissible for an ordinary person with no prior authorizations to import Schedule 4 medications across the border for commercial purposes.
Diamorphine is more dangerous than LSD.
Diamorphine is more dangerous than LSD.
NICE gives pharmacists the authority to prescribe medicinal cannabis.
NICE gives pharmacists the authority to prescribe medicinal cannabis.
Possession of Diazepam carries a maximum prison sentence of 14 years.
Possession of Diazepam carries a maximum prison sentence of 14 years.
Class C drugs attract more severe penalties for dealing than Class B drugs.
Class C drugs attract more severe penalties for dealing than Class B drugs.
A pharmacist is legally required to use the CD register for keeping records of Sativex.
A pharmacist is legally required to use the CD register for keeping records of Sativex.
Cannabidiol is a non-psychoactive cannabinoid. Therefore, it is still classified under the Misuse of Drugs Act.
Cannabidiol is a non-psychoactive cannabinoid. Therefore, it is still classified under the Misuse of Drugs Act.
A new drug being added to schedule 3 does not have to be kept under safe custody unless specifically exempted.
A new drug being added to schedule 3 does not have to be kept under safe custody unless specifically exempted.
MST (morphine) tablets 10 mg are correctly classified as a Schedule 2 Controlled Drug.
MST (morphine) tablets 10 mg are correctly classified as a Schedule 2 Controlled Drug.
All Schedule 2 Controlled Drugs, without exception, are mandated to be stored exclusively within a designated Controlled Drug cupboard to comply with storage regulations.
All Schedule 2 Controlled Drugs, without exception, are mandated to be stored exclusively within a designated Controlled Drug cupboard to comply with storage regulations.
Schedule 3 Controlled Drugs necessitate meticulous record-keeping, mandating their entry into the Controlled Drug register to ensure comprehensive tracking and accountability.
Schedule 3 Controlled Drugs necessitate meticulous record-keeping, mandating their entry into the Controlled Drug register to ensure comprehensive tracking and accountability.
Schedule 4 Part I classifications definitively encompass the majority of benzodiazepines, exemplified by nitrazepam, thereby simplifying regulatory oversight.
Schedule 4 Part I classifications definitively encompass the majority of benzodiazepines, exemplified by nitrazepam, thereby simplifying regulatory oversight.
Class A Controlled Drugs invariably receive simultaneous classification under Schedule 2 of the Misuse of Drugs Regulations 2001 due to their inherent risk profile.
Class A Controlled Drugs invariably receive simultaneous classification under Schedule 2 of the Misuse of Drugs Regulations 2001 due to their inherent risk profile.
Codeine phosphate tablets 30mg are classified as CD Inv POM
Codeine phosphate tablets 30mg are classified as CD Inv POM
Co-codamol tablets 30/500 are classified as CD No Reg POM
Co-codamol tablets 30/500 are classified as CD No Reg POM
Temazepam elixir 10mg/5ml which has been returned by a patient should be stored in the CD cabinet.
Temazepam elixir 10mg/5ml which has been returned by a patient should be stored in the CD cabinet.
MST tablets which have been dispensed but are awaiting collection by the patient must be stashed in the CD cabinet.
MST tablets which have been dispensed but are awaiting collection by the patient must be stashed in the CD cabinet.
Flashcards
Misuse of Drugs Act 1971
Misuse of Drugs Act 1971
Controls 'dangerous or otherwise harmful drugs'.
Misuse of Drugs Regulations 2001
Misuse of Drugs Regulations 2001
Permits the use of CDs in medicine.
Class A Drugs
Class A Drugs
Most harmful drugs with severest penalties. E.g. Cocaine, Diamorphine
Class B Drugs
Class B Drugs
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Class C Drugs
Class C Drugs
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Schedule 1 CDs
Schedule 1 CDs
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Schedule 2 CDs
Schedule 2 CDs
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Schedule 3 CDs
Schedule 3 CDs
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Schedule 4 CDs
Schedule 4 CDs
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Schedule 5 CDs
Schedule 5 CDs
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Controlled Drug Accountable Officer (CDAO)
Controlled Drug Accountable Officer (CDAO)
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Cannabidiol (CBD)
Cannabidiol (CBD)
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Tetrahydrocannabinol (THC)
Tetrahydrocannabinol (THC)
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Study Notes
Controlled Drugs (CDs) Background
- Some drugs are controlled because they are dangerous and can cause harm
- Drugs with established or emerging patterns of non-medical use are further controlled
- Certain drugs controlled to prevent misuse leading to wider social issues, such as antisocial behavior and crime
- Inconsistencies exist in drug control, such as alcohol and tobacco not being controlled like cannabis
- CD legislation runs in parallel with wider medicines law, like Human Medicine Regulations 2012
- The Misuse of Drugs Act 1971 controls drugs that are 'dangerous or otherwise harmful'
- The Misuse of Drugs Act 1971 seeks to prevent misuse through total prohibition, except as allowed by regulations or license from the Secretary of State, for possession, supply, manufacture, import or export
Relevant Legislation
- The Misuse of Drugs Regulations 2001 (as amended) allows CDs to be used in medicine
- Other regulations relate to safe custody, notification of addicts, and supply of drugs to addicts
- Human Medicine Regulations 2012 regulate all medicines for human use within the EU framework, administered by the Department of Health and Social Care and is generally permissive
- The Misuse of Drugs Act 1971 regulates narcotics and other controlled drugs, administered by the Home Office and covers both legitimate and unlawful use
- The Misuse of Drugs Act 1971 is restrictive, but the Misuse of Drugs Regulations 2001 allows certain activities by certain people when CDs are used as medicines
Controlled Substances
- Traditionally, controls focused on narcotics such as opiates, cannabis and cocaine
- The Misuse of Drugs Act 1971 extended controls to amphetamines and psychotropic drugs like LSD
- Subsequent regulations have included benzodiazepines, anabolic steroids, tramadol, gabapentin and pregabalin (2019) due to changing patterns of misuse
Dr. Harold Shipman
- Dr. Harold Shipman was a prolific serial killer who murdered over 200 people
- On September 7, 1998, he was arrested and charged with the murder of Kathleen Grundy
- Police uncovered further evidence of murders during the investigation
- He used diamorphine to murder his patients, prescribing it even when not clinically necessary
- He often collected prescriptions on behalf of patients and misused the drugs
- Controls at the time did not identify these practices
Mrs. Brant
- Mrs. Brant was the pharmacist who managed the pharmacy next to Dr. Shipman's surgery
- She dispensed the majority of Shipman's diamorphine prescriptions over six years
- Mrs. Brant stated that Shipman told her the drugs were for patients with suspected chest pain and heart attacks
- She was confident in Shipman's competence and thought he knew what he was doing
- Requests for single 30mg ampoules were strange but she did not make note
Post-Shipman Changes to CD Legislation
- Duration of prescription validity was reduced to 28 days
- Private prescriptions must be written on a standardized form (FP10PCD)
- Private prescriptions are sent to the NHSBSA
- Controlled Drug Accountable Officers were introduced for organizations
- The Care Quality Commission oversees the management of CDs
- Guidelines introduced maximum quantity of CD on a prescription and recommended running balances in CD registers, both of which are good practice but not legal requirements
Controlled Drug Accountable Officer (CDAO)
- CDAO is an experienced person appointed to ensure the safe and effective management of CDs
- CDAOs are senior managers who should not prescribe, supply, administer, or dispose of CDs as part of their regular duties
- Roles include monitoring, auditing, maintaining records of concerns, sharing information, attending local intelligence network meetings, and appointing authorised witnesses for CD destruction
- Community pharmacies are not required to appoint a CDAO, but should have a 'Controlled Drugs lead'
Classification of Controlled Drugs
- CDs are classified by Schedules 1-5 that determine level of control for legal medical use
- CDs are classified by Classes A, B, C that determine level of penalty for illegal use/possession
- The Advisory Council on Misuse of Drugs advises the Home Office and Health Ministers on controlled drugs
- Class A drugs are the most harmful and attract the severest penalties. Includes: cocaine, diamorphine, LSD, opium, MDMA, magic mushrooms, methylamfetamine, morphine, methadone with potential penalties of up to 7 years for possession and unlimited fine , up to life for dealing with unlimited fine.
- Class B includes oral amfetamines, barbiturates, codeine, dihydrocodeine, methylphenidate, ketamine and cannabis. Penalties include up to 5 years for possession with unlimited fine and up to 14 years for dealing with unlimited fine.
Drug Classification
- Class C includes benzodiazepines, GHB, tramadol, zopiclone, khat, buprenorphine, anabolic steroids, and nitrous oxide (2023)
- Penalties include up to 2 years for possession with unlimited fine and up to 14 years for dealing with unlimited fine
- Schedule 1 includes cannabis (non-medicinal use), LSD, and MDMA ('ecstasy')
- Schedule 1 drugs are subject to the strictest controls, have little to no medical value, cause social problems
- Production, possession, and supply are limited to research purposes, and require a license from the Home Secretary
- A pharmacist cannot take possession of a Schedule 1 CD except for destruction or handing over to police
Schedule 2 Controlled Drugs
- Schedule 2 includes most of the opiates e.g. diamorphine, morphine, and methadone and stimulants e.g. amfetamines
- A license is needed to import or export these drugs
- A pharmacist can only supply Schedule 2 drugs with an appropriate prescription from a practitioner. Schedule 2 drugs can be manufactured or compounded in a professional setting
- May be produced by license holder, practitioner, pharmacist, person lawfully conducting a retail pharmacy business, nurse independent prescriber and supplementary prescriber
- Schedule 2 drugs may only be administered by an authorised prescriber
- Safe custody requirements apply to all drugs in this schedule other than quinalbarbital
- Safe custody applies to returned Schedule 2 CDs from patients until destruction, stock which has expired
- All transactions must be recorded in the CD register; the identity of the person collecting the CD must be confirmed and the prescription is valid for 28 days
- Invoices do not legally need to be retained for 2 years, NICE recommend retaining all CD invoices for 6 years for HM Revenue and Customs purposes
- Examples include Alfentanil, cannabis products for medicinal use, diamorphine, dipipanone, dronabinol, fentanyl, hydromorphone, ketamine, lisdexamfetamine, methadone, methylphenidate, morphine, nabilone, oxycodone, pethidine, quinalbarbital (secobarbital), remifentanil and tapentadol
Schedule 3 Controlled Drugs
- Schedule 3 includes barbiturates (e.g., phenobarbital) and other drugs (buprenorphine, temazepam, pregabalin, gabapentin)
- Schedule 3 drugs are less likely to be misused than Schedule 2; and less harmful
- Although safe custody applies, all Schedule 3 drugs are exempted except temazepam, diethylpropion, buprenorphine and flunitrazepam
- Any new Schedule 3 drug must be kept under safe custody unless specifically exempted
- Prescription is valid for 28 days; other controls are as for Schedule 2 except in who can possess it, no destruction requirements for out of date stock, no record is needed in CD register and invoices need to be retained for two years
- Examples: Buprenorphine, Diethylpropion, Flunitrazepam, Gabapentin, Midazolam, Pentazocine, Phenobarbital, Pregabalin, Temazepam, Tramadol
Schedule 4 Controlled Drugs
- Schedule 4 is split into two parts; Part I [CD Benz POM] contains most benzodiazepines and 'z' hypnotics and Part II [CD Anab POM] contains most anabolic and androgenic steroids and growth hormones
- Restrictions are as for Schedule 3 except there are no restrictions on imports or exports for Schedule 4 part II provided it is for self-administration, no restrictions for possession when in a medicinal product, CD prescription and labelling requirements do not apply
- No record needed in CD register, no safe custody requirements, invoice keeping is not necessary beyond 2 years and prescriptions are valid for 28 days
- Part 1 examples include Alprozolam, Chlordiazepoxide, Clobazam, Clonazepam, Diazepam, Flurazepam, Loprazolam, Lorazepam, Lormetazepam, Nitrazepam, Oxazepam, Sativex, Zopiclone, Zolpidem
- Part 2 examples include Danazol, Nandrolone, Stanozolol, Testosterone, Chorionic gonadotrophin (HCG), Clenbuterol, Non-human chorionic gonadotrophin and Somatotropin
Schedule 5 Controlled Drugs
- Schedule 5 contains preparations of some CDs exempt from full control due to their low strength medicinal properties
- There is no restriction on import, export, possession or administration and no safe custody or entry in CD register is required
- Invoice must be kept for two years
- May be manufactured and compounded by practitioner, pharmacist or licence holder
- Prescription valid for 6 months; examples include codeine, dextropropoxyphene, dihydrocodeine, morphine and pholcodine
Cannabis Regulations
- Cannabis regulations note there are more than 100 different chemical compounds (cannabinoids) identified from cannabis plant
- Cannabis and most cannabinoids (but not all) are controlled under the Misuse of Drugs Act 1971 as Schedule 1 CDs; including tetrahydrocannabinol (THC) and cannabinol (CBN)
Cannabidiol
- Cannabidiol (CBD) is a non-psychoactive cannabinoid not controlled under the Misuse of Drugs Act
- Cannabis-based products for medicinal use are classified as schedule 2 CDs but this does not include synthetic cannabinoids
- NICE guidelines exist on 'Cannabis-based products for medicinal use'
- 'Raw' cannabis remains a Schedule 1 CD, growing and cultivating the cannabis plant is illegal without a Home Office license
Cannabidiol (CBD) and Novel Foods
- The MHRA advises that products containing CBD which are for medical purposes should be regulated as medicines e.g. Epidyolex
- Epidyolex (which contains CBD) is Sch 5 because the levels of THC are low; indicating a low risk of abuse, dependency and diversion
- Many CBD products are sold by health food shops as food supplements and are classed as 'novel foods', they are regulated by the Food Standards Agency (FSA) and these products must not contain THC
- The Home Office warned pure CBD is difficult to isolate, presence of THC is highly likely leading to CD
- 'Novel food' legislation requires pre-market authorisation to ensure consumer protection
- Check an FSA website to see if a product is authorised; only sell authorized product in the pharmacy
Prescribing Cannabis Based Products
- Prescribing cannabis based products apart from Sativex, Epidyolex and nabilone capsules are unlicensed medicines
- Initial prescription of unlicensed cannabis medicines should be done by a doctor who is listed on the Specialist Register of the General Medical Council and has a specialist interest
- The GMC online register includes an annotation if they are on the Specialist Register
- Products should only be prescribed where there is clear published evidence of benefit or UK Guidelines recommendation; NICE guidance does not recommend products to treat chronic pain
- Sativex is a cannabis based oromucosal mouth spray containing CBD and dronabinol; a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis
- It is classified as Schedule 4 part 1 and should be written as for Schedule 4 CD
- There is no legal need for a CD register entry but you must keep records of Sativex; store in a fridge, not locked and destroy as per schedule 4 CDS
- Nabilone is a synthetic cannabinoid medicine classified as schedule 2 CD for nausea and vomiting caused by chemotherapy
- Dronabinol is a synthetic cannabinoid version of THC and is a schedule 2 CD; there are no single ingredient licensed products available in the UK
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