PPM Controlled Drugs

1. what is drug misuse: - the use of a substance for a purpose which is inconsistent with legal or medical guidelines 2. What was coca cola first marketed as?: headache remedy - until 1903 contained cocaine and alcohol 3. what was heroin originally used for: - an antitussive (drug that suppresses coughing) - was sold openly in big department stores 4. what is an opiate: any of the natural opioid analgesic alkaloids found in the opium poppy plant - example: morphine codeine 5. what is an opioid: any chemical that resembles opiates in its pharmacological effects - diamorphine 6. what is a psychotropic: a chemical substance that changes brain function and alters perception, mood or consciousness - LSD 7. what are the legal uses of controlled drugs: - extreme pain killers used for severe pain: morphine, fentanyl, dihydrocodeine, codeine 8. what is habituation: - when drugs are used repeatedly, there is a risk of tolerance developing - tolerance occurs when the body becomes habituated to the presence of the drug and as a result the user needs a higher dose to feel the same effect 9. explain what happens when a addict stops taking drugs: - when users stop taking an addictive drug they will suffer from withdrawal symptoms - symptoms: restlessness, muscle and bone pain, insomnia, diarrhoea, vomiting, cold flashes, goosebumps, leg movements - major symptoms peak between 24-48 hrs after last dose and subside after a week 10. what personal problems does addiction cause: - health, diet, exercise seem less important - increased risk of blood-borne diseases if taking drugs by injection - accidental overdose - increased risk of accidents whilst under the influence - harm caused by other substances - employment - financial - legal proceedings 11. what family and friend issues are caused by addiction problems: - damaged relationships 1 / 11 - child neglect - stealing from family and friends 12. what societal issues are caused by addiction problems: - increased level of crime to fund the drug habit - massive profits made by organised criminal gangs who smuggle and distribute drugs - cost of treatment (NHS) - loss of tax income - loss of civic responsibility 13. what is substitution therapy: - prescribing another medicine as a replacement for the drug - used for those addicted to heroin. diamorphine given - avoids them having withdrawal symptoms - the substitutes do not give patients the same high as injecting or inhaling the drug 14. what are the two most used drugs for substitution therapy: - buprenorphine and methadone - prescribed in installments 15. explain harm minimisation for heroin addicts: - giving pharmaceutical grade heroin in a safe supervised injecting room - patients inject pre-filled syringe in private booth were nurses can monitor them through mirrored wall - spend 20 mins in booth and 20 mins in waiting area being monitored for overdose - drug use will be stabilised as nurses will grow relationship with the patients and be able to introduce them to mental/physical support welfare checks, housing advice - allowing them to inject themselves will teach safer behaviour 16. where does the law on controlled drugs come from: - international treaties: all united nations member countries signed up to - the single convention on narcotic drugs 1961 - convention on psychotropic substances 1971 - united nations convention against illicit traffic in narcotic drugs and psychotropic substances 1988 - then each country passes their own legislation to bring the international restrictions into effect 17. what does the single convention on narcotic drugs say: "the possession, use, trade in, distribution, import, export, manufacture, production of certain drugs should be exclusively limited to medical and scientific purposes" 18. what does the convention on psychotropic substances 1971 say: - establishes international control system for psychotropic drugs - created due to the diversification and expansion of the spectrum of drugs of abuse 2 / 11 - introduced controls on a number of synthetic drugs according to their abuse potential 19. what does the united nations convention against illicit traffic in narcotic drugs and psychotropic substances 1988 say: - provides comprehensive measures against drug trafficking and the diversion of precursor chemicals - provides international cooperation through extradition of drug traffickers, controlled deliveries and transfer proceedings 20. what is the Gosport report: report which illustrated the importance of pharmacists as medicine safety advocates and the need to follow best practice guidelines and professional standards 21. what are the two main legislations on controlled drugs: - Misuse of Drugs Act 1971 - Misuse of Drugs Regulations 2001 22. what is the misuse of drugs act 1971: - act passed to fulfil the UKs obligations under the single convention on Narcotic drugs - aim: control dangerous or otherwise harmful drugs - established the advisory council on the misuse of drugs - introduced a classification system for CDs - placed restrictions on the import, export, production, prescribing and supply of CDs - created a series of offences and penalties in relation to CDs - gave powers to the secondary of state to make regulations for preventing the misuse of CDs 23. what offences are unlawful under the misuse of drugs act: - unlawful possession of a CD substance - possession of a CD with intent to supply it - supplying or offering to supply a CD - manufacturing a CD - import or export of a CD - allowing premises individuals occupy or manage to be used unlawfully for the purpose of producing or supplying controlled drugs 24. what is the advisory council on the misuse of drugs: roles is to - keep under review drugs which are being or are likely to be misused and the misuse of which is or is likely to have harmful effects which may constitute a social problem - advise ministers on the action to be taken 25. give examples of class A drugs and the consequences of possessing it and supplying and producing it: - examples: heroin, methadone, cocaine, ecstasy, magic mushrooms, crystal meth - possession:7 years in prison, unlimited fine or both - supply and production: life in prison, unlimited fine or both 3 / 11 26. give examples of class B drugs and the consequences of possessing it and supplying and producing it: - examples: amphetamines, cannabis, dihydrocodeine - possession: 5 years in prison, unlimited fine or both - supply and production: 14 years in prison, unlimited fine or both 27. give examples of class C drugs and the consequences of possessing it and supplying and producing it: - examples: anabolic steroids, GHB, some tranquilisers - possession: 2 years in prison, unlimited fine or both - supply and production: 14 years in prison, unlimited fine or both 28. explain the misuse of drugs regulations 2001: - they define the categories of persons who are authorised to prescribe, supply and possess CDs whilst acting in their professional capacities impose controls on: - import/export - production - possession - safe custody - supply - record keeping - destruction of drugs - inspection 29. explain schedule 1 (CD Lic POM) controlled drugs: - most tightly controlled - includes hallucinogenic drugs (LSD, ecstasy, opium) - have potential for abuse and no therapeutic use - production, possession, supply prohibited - but home office may grant licences for these drugs to be possessed and supplied in accordance with the terms of the license 30. explain schedule 2 (CD POM) controlled drugs: - includes opiates (diamorphine, major stimulates) - have potential for misuse and medical uses - subject to control on import, export, manufacture, compounding - subject to extra Rx requirements, safe custody, controls on destruction, record keeping 31. explain schedule 3 (CD No Reg POM) controlled drugs: - includes minor stimulants(buprenorphine and temazepam) - have potential for misuse but considered less harmful 4 / 11 - no requirement for recording, no destruction requirements - do not need to be kept under safe custody unless exempted 32. explain schedule 4 (CD Benz POM and CD Anab POM): - part 1: most benzodiazepines (diazepam), non-benzodiazepine hypnotics and Sativex - part 2: most anabolic and androgenic steroids, clenbuterol and growth hormones - not subject to safe custody or Rx requirements - sativex possession, supply and destruction should be recorded in the CD register 33. explain schedule 5 (CD Inv POM or CD Inv P) controlled drugs: - preparations that include small amounts of CDS - codeine linctus or co-codamol - due to their low strength they are exempt from most of the CD requirements - pharms must keep invoices for these drugs for minimum 2 years 34. can doctors and dentists prescribe schedule 2-5 CDs: - yes - a home office licence is needed to prescribe cocaine, diamorphine, dipipanone for addiction 35. can vet surgeons prescribe schedule 2-5 CDs: - yes - sch 2 and 3 don't need to be on standardised forms but must include the RCVS reg number of the prescriber 36. can nurse/midwife independent prescriber, pharmacist independent prescriber, supplementary prescriber prescribe schedule 2-5 CDs: - yes - not cocaine, diamorphine, dipipanone for addiction 37. can a community practitioner nurse prescriber prescribe schedule 2-5 CDs: no 38. what are the Rx requirements for sch 2 and 3 drugs: 1. signature os prescriber 2. date which it was signed 3. prescriber address 4. name of the CD 5. form 6. strength 7. dose 8. total quantity (must be written in words and figures) 9. quantity prescribed 10. name of patient 11. address of patient 12. where the prescription is written by a dentist the words 'for dental treatment only' must be present 13. when Rx is intended to be supplied in instalments a valid installment direction is required 5 / 11 39. what are some additional requirements for a schedule 2 and 3 controlled drugs Rx: - mark the Rx with the date of supply at the time the supply is made - Rx must be written in indelible ink and can be computer generated - only supply sugar free and or colour free products when specific by the prescriber as these have greater potential for abuse 40. explain what can be done when there are technical errors on a controlled drugs Rx: - pharmacists can amend a CD Rx where there is a minor typographical error, spelling mistake or where the total quantity or number of dosage units is specified in either words or figures but not both 41. what are the private Rx requirements for schedule 2 and 3 CDs: - must be written on standardised form - must include the prescribers unique identification number - original Rx must be submitted to the NHS business services authority done on a monthly basis - vet Rx do not need to be written on a standardised forms or submitted to the relevant NHS agency must they must be retained for 5 years 42. explain whether repeatable private Rx are allowed for schedules 2-5 CDs: sch 2: not permitted although Rx to be supplied by instalment are allowed - sch 3: not permitted although Rx to be supplied by instalment are allowed - sch 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 - sch 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 43. how many chemicals does cannabis contain: - more than 400 chemical constituents including cannabinoids, terpenoids and phenolic compounds, many of which have potential for medicinal use 44. what are the licensed cannabis-based products available: - THC combined with CBD (sativex sch 4) - Nabilone ( POM) - CBD (Epidiolex sch 5) 45. what conditions must a product comply with in order to satisfy the definition of CBPM cannabis-based products for medicinal: 1. contain cannabis, cannabis resin, cannabinol or a cannabinor derivative 2. be produced for medicinal use in humans 3. be a product that is regulated as a medicinal product or an ingredient of a medicinal product 46. explain how CBPMs are prescribed: - all CBPMs are unlicensed medicines so it is the responsibility of the prescriber to determine the safety and effectiveness of the medication and whether it is appropriate for their patient 6 / 11 - patient should be informed that the med is unlicensed - sch 2 legal and CD requirements must be adhered to 47. what is cannabidiol (CBD) oil: - CBD is a non-psychoactive compound - products containing CBD oil are marketed as food supplements and categorised as novel food which is regulated by the food standards agency - these products must not contain the psychoactive compound tetrahydrocannabinol (THC) 48. explain what controlled drug requisitions are: - not a Rx - no patient details are on requisition - allows a pharm to purchase CDs from another pharmacist or supply CDs to another healthcare professional - requisition must be obtained by the supplying pharmacist before any drugs are supplied 49. who can a pharmacist supply sch 2 and 3 CDs to against a requisition in writing: - a practitioner - a person in charge of a hospital, organisation providing an ambulance service or care home - a person in charge of a lab - owner/master of a ship which does not carry a doctor - installation manager of an off-shore installation - master of a foreign ship in a port in Great Britain - supplementary prescriber - nurse independent prescriber - pharm independent prescriber - person who holds a certificate of proficiency in ambulance paramedic skills or a reg paramedic 50. what are the 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 51. what are the requirements for processing a requisition form: - must be marked with supplier's name and address - orig requisition must be copied and sent to relevant NHS agency - good practice to retain copy in pharmacy for 2 years from date of supply - emergency: doctor, dentist, vet practitioner/surgeon can be supplied with a sch 2/3 CD on the assurance that a requisition will be supplied within the next 24 hrs 7 / 11 52. when do the requisition requirements of mark on receipt, copy and send to the relevant NHS agency not apply: - where the supply is made by a hospital, care home, prison or organisation providing ambulance services. they must mark and retain the orig form for 2 years - to supplies made by pharmaceutical manufacturers - to supplies made by wholesalers - to supplies made against vet requisitions. orig form must be kept for 5 years - to supplies made against a midwife supply order. these are not treated as requisitions 53. what drugs can a registered midwife obtain using a midwife supply order: diamorphine - morphine - pethidine 54. what are the legal requirements for a midwife supply order: - name of midwife - occupation of the midwife - name of the person to whom the CD is to be administered or supplied - purpose for which the CD is required - total quantity of drug to be obtained - signature of an appropriate medical officer - a doctor authorised by the local supervising authority or the person appointed by the supervising authority to exercise supervision over midwives within the area 55. are emergency supplies of CDs allowed: - not permitted at the request of a prescriber for any sch 2 or 3 CDs except: - meds containing phenobarbital or phenobarbital sodium for epilepsy - emergency supplies for sch 4 or 5 are allowed - a max of 5 days' supply can be dispensed 56. in what circumstances is a pharmacists permitted to take possession of sch 1 CDs: - pharm can take possession of sch 1 for the purpose of destruction or to handover to a police officer 57. what actions are required when a dispensed sch 2 CD is collected by a patient representative: - when a representative of a drug misuse patient is collecting the pharms must obtain a letter from the drug misuser that authorises and names the representative (letter each time) - representative has to bring id - details of the representative should be included on the CD register - pharmacist must be satisfied that the letter is genuine 58. what actions are required when a dispensed sch 2 drug is collected by a patient or a patient representative: - pharmacist my request evidence of that 8 / 11 person's identity, unless already known to the pharmacist - the decision whether to supply or not is at the discretion of the supplying pharmacist 59. what action are required when a dispensed sch 2 CD is collected by a healthcare professional on behalf of the patient: - unless already known to the pharmacist, obtain: 1. name of healthcare professional 2. address of healthcare professional 3. request evidence of id - where evidence is not available the pharmacist has decision over whether to supply ot not 60. what does safe custody mean: - ensure certain CDs are kept securely: 'locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs - do not apply to sch 4 or 5, any liquid preparations,any list of exempted drugs - when CDs requiring safe custody are not kept in the designated area, they must be under the direct personal supervision of a pharmacist 61. what drugs needs to be kept under safe custody: - schedule 1 - schedule 2 except some liquid preparations and quinalbarbitone - schedule 3 unless exempted ( gabapentin, midazolam, phenobarbital, pregabalin, tramadol 62. what does the record contain for the disposal of CDs: - date of receipt of the drug - date of destruction - signature of the person destroying the drug and any witness - name, strength, quantity 63. what does it mean to denature a CD: - when unwanted CDs are rendered irretrievable by denaturing before being disposed of - denaturing kits used or were not possible cat litter 64. explain the denature, witness and record keeping requirements for patient returned CDs: - denturing required for sch 2,3,4 (part1) - authorised witness not required but is preferable for denaturing to be witnessed by another member of staff - a record should not be made in the CD register but records of patient returned sch 2 CDs and their subsequent destruction should be recorded in a separate record 65. explain the denature, witness and record keeping requirements for expired/obsolete/unwanted stock CDs: - denaturing required for sch 2,3,4 (part1) - authorised witness is required for sch 2 - sch 3 is good practice - an entry should be made in the CD register for sch 2 CDs 9 / 11 66. what sch CDs should pharmacies keep a record of: - schedule 1 and 2 that they have obtained and supplied - and sativex 67. for CDs received by the pharmacy what must they record: - the date supply was received - name and address from whom they were obtained - the quantity obtained. where the drugs is not in discrete units the number of ml or grams should be recorded 68. for CDs supplied what must be recorded: - date supply was made - name and address of the person supplied - details of authority to possess - quantity supplied - whether the person collecting the sch 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 - if it was the patient or representative, whether ID was asked for and whether it was provided 69. entries in CD registers must comply with what: - be in chronological order - be recorded promptly - be in indelible ink or computerised - must not be cancelled, obliterated or altered ( corrections must be made by signed, dated marginal notes) - the register must be kept at the premises and must be kept for two years from the date of the last entry - is good practice to keep a running balance 70. explain what additional info is needed if the CD register is kept electronically: - 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 related to and capable of being printed - the register must be secure and minimise access or unauthorised access - adequate backups must be made 71. what is an accountable officer: - officer who is to ensure the safe, appropriate and effective management and use of CDs within their organisation ensure: - every aspect of CD journey is in SOP - adequate destruction and disposal arrangements are in place 10 / 11 - relevant individuals receive appropriate training - monitoring and auditing the management and use of CDs - effective systems for reporting concerns - adequate record maintained regarding concerns - concerns assessed and investigated 72. what happens if a patient misses days of their installment CD drugs: - is 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 73. what are the record keeping requirements for instalment dispensing: for each supply - an entry in the CD register - an entry on the right hand side of the Rx - if a supply is missed this should also be recorded on the right hand side of the Rx 74. explain what supervised consumption is: - pharmacist must supervise the patient taking their daily dose and ensure that it has been taken - patients in substitution therapy are required to have supervised consumption until the prescriber is confident that the patient is stable and liely to comply with their instructions - usually 3 month period - why done: ensure patients' safety and prevent the medicine being sold on the illegal drugs market 75. what is the new psychoactive substances act 2016: - legislation to tackle the growth in use of 'legal highs' - substances such as: amphetamines with a minor chemical modifications - 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 76. what does the drugs and driving legislation mean: - it is illegal in england, scotland, wales to drive with certain specified drugs in excess of specific levels in the blood unless the drugs have been prescribed and taken in accordance with advice from a healthcare professional - drugs under the legislation are split into two groups - grp 1: drugs which are commonly abused, rarely prescribed: Cannabis, MDMA, ketamine, methylamphetamine, cocaine, LSD - grp 2: licensed meds which have a signif potential for abuse and have higher limits: amphetamine, clonazepam, diazepam, lorazepam, oxazepam, temazepam, flunitrazepam, methadone 11 / 11