Controlled Drugs Part 2: Supply PDF

WEEK 13 14 Controlled Drugs Part 2: Supply John Sherwood MRPharmS 23rd October / 30th October 2024 Slide 1 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Learning outcomes...

WEEK 13 14 Controlled Drugs Part 2: Supply John Sherwood MRPharmS 23rd October / 30th October 2024 Slide 1 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Learning outcomes Describe the lawful supply of CDs in Schedules 2-5 relating to possession, prescriptions (NHS and private) and requisitions Describe the legal and good practice requirements that apply to record keeping, storage and destruction of CDs Know what amendments a pharmacist can make to a CD prescription and how this should be done Describe regulations relating to the supply of CDs to midwives Describe regulations relating to CDs and driving List which CDs may be supplied on a PGD Describe regulations relating to psychoactive substances Describe how witness protection can affect CD prescriptions Be able to provide information to patients about travelling with CDs Describe the amendments to the supply of CDs that could occur during a pandemic Slide 2 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Possession and supply of CDs (1) It is unlawful for any person to be in possession of a controlled drug unless the Regulations allow it, or the person has a licence from the Home Office Possession of Schedule 4 Part 2 or Schedule 5 drugs are not controlled Possession by patients is allowed if the CD has been prescribed by a doctor, supplementary prescriber, nurse IP, pharmacist IP, physiotherapist IP, chiropodist/podiatrist IP or dentist Healthcare professions and other people are listed separately in the Regulations together with the drugs/schedules that they can supply (NB but only whilst they are acting in that capacity) Slide 3 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Possession and supply of CDs (2) Pharmacists may possess, manufacture, compound and supply any schedule 2,3,4 or 5 drug (NB but only whilst they are acting in their professional capacity) A person authorised to supply may only supply a person authorised to possess Any person who is lawfully in possession of a CD may supply that drug to the person from whom he lawfully obtained it Any person who is lawfully in possession of a CD schedule 2,3,4 or 5 may supply that drug to any doctor, dentist or pharmacist for the purpose of destruction Slide 4 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Possession and supply of CDs (3) - Examples Class of person Possession Supply Practitioner S2 S3 S4 S5 S2 S3 S4 S5 Pharmacist S2 S3 S4 S5 S2 S3 S4 S5 Nurse IP or pharmacist IP S2 S3 S4 S5 S2 S3 S4 S5 Constable S1 S2 S3 S4 S5 S1 S2 S3 S4 S5 A person authorised by S2 S3 S4 S5 S2 S3 S4 S5 the GPhC Officer of HM Customs S1 S2 S3 S4 S5 S1 S2 S3 S4 S5 and Excise A person with an Any as specified in Any as specified in appropriate licence from the licence the licence the Home Office Master of a foreign ship S2 S3 S4 S5 None which is in a GB port Slide 5 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 PRESCRIBING AND DISPENSING CDs Slide 6 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Who can prescribe CDs? (1) Dr and dentists – any Schedule 2-5 (Drs – also cocaine, dipipanone or diamorphine for treating addiction if a licence has been obtained from the Home office) Nurse independent prescribers and pharmacist independent prescribers – any Schedule 2-5 (but not cocaine, dipipanone or diamorphine for treating addiction) Supplementary prescribers are permitted, when acting under and in accordance with the terms of a clinical management plan (CMP), to administer and/or supply Controlled Drugs in Schedules 2-5 Slide 7 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Who can prescribe CDs? (2) Physiotherapist independent prescribers - diazepam (o), dihydrocodeine (o), fentanyl (transdermal), lorazepam (o), morphine (o, inj), oxycodone (o), temazepam (o) Chiropodist/podiatrist independent prescribers - diazepam (o), dihydrocodeine (o), lorazepam (o), temazepam (o) Therapeutic Radiographer independent prescribers - codeine (o), diazepam (o), lorazepam (o), morphine (o, inj), oxycodone (o), tramadol (o) Paramedic independent prescribers – codeine (o), diazepam (o, inj), lorazepam (inj), midazolam (oromucosal, inj), morphine (o, inj) Approved country health professionals – schedules 4 and 5 o = oral route, inj = injection Slide 8 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Secretary of State prohibitions Home Secretary has power, under MDA 1971, to make a direction against an individual practitioner prohibiting: Possession Prescribing Administering Manufacturing Compounding Supplying Authorising the administration or supply Confirmation of prohibitions relating to practitioners is available from Home Office (telephone number in MEP) Slide 9 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Prescription requirements (1) A prescription for a Schedule 2 or 3 CD for human use must not be dispensed unless it complies with the following: 1) Be written so as to be indelible 2) Signed by person issuing it with their usual signature or, if on an electronic prescription, an ‘advanced electronic signature’ 3) Except in the case of a health prescription, specify the prescriber’s address 4) If issued by a dentist, must state the words ‘For dental treatment only’ 5) Specify the name and address of patient for whose treatment it is issued Slide 10 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Prescription requirements (2) 6) Specify the dose to be taken 7) If the CD is a preparation, specify the form of the medicine 8) Specify the strength of the medicine if more than one strength is available 9) Specify the total quantity or number of dosage units, in both words and figures to be supplied 10) Must include a date The name of the medicine is (still) not a legal requirement! Note that prescriptions for CDs must also comply with the legal requirements for prescriptions for POMs Slide 11 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Validity of prescriptions for Schedule 2, 3 and 4 controlled drugs Prescriptions are valid for 28 days from the appropriate date Clarification by the Home Office has confirmed that this is 28 days after the appropriate date Example: If the date on the prescription is 1st November, the 28-day validity runs until the 29th November. Supply on the 30th November would be illegal as the period of validity has expired. Slide 12 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Supply of CDs on a prescription It is illegal to supply a Schedule 2 or 3 CD on a prescription: Unless the prescription complies with the provisions set out above Unless the prescriber’s address is within the UK Unless the supplier is either acquainted with the prescriber's signature and has no reason to believe that it is not genuine or has taken reasonably sufficient steps to satisfy him/herself that it is genuine (Advanced electronic signatures can be accepted where the Electronic Prescribing Service (EPS) is used.) Before the date specified on the prescription Later than 28 days after the date specified on the prescription (unless it is an instalment prescription – Part 3) Although not a legal requirement, it is considered good practice (by the DoHSC) that the quantity of Schedule 2, 3 and 4 CD should not exceed 30 days supply Slide 13 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Expiry of a CD prescription Prescriptions for CDs in Schedule 2, 3 and 4 cannot be dispensed 28 days after the appropriate date When a prescriber wishes the 28-day period to start on a date other than the date of signing, s/he may specify a start date from which the period will begin The date of dispensing must be marked on the prescription at the time of supply. This also applies to split supplies (e.g., ‘owings’), so that it is clear when and what was supplied to the patient The full quantity on the prescription must be supplied within the period of validity of the prescription (unless it is an instalment prescription – see Part 3) Slide 14 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Private prescriptions for CDs For schedule 2 and 3 CDs, in addition to the above requirements: Must be on a special form (FP10PCD in England) – illegal to dispense it if this form is not used Must contain the prescriber’s private CD identification number Original form sent to NHSBSA Keep a copy of the prescription in the pharmacy for 2 years NHSBSA will monitor the private prescribing of CDs as for NHS prescribing Other drugs which are not CDs Schedule 2 or 3 should not be prescribed on this form Use of FP10PCD and submission to NHSBSA does not apply to hospital private prescription (if dispensed in the same hospital), veterinary prescription, or to some prison pharmacy services Slide 15 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Repeat prescriptions Repeat prescriptions for Schedule 2 and 3 CDs are not allowed Repeats for schedule 4 CDs are allowed This applies to private repeat prescriptions and NHS repeat dispensing prescriptions For repeat prescriptions, the first dispensing for a Schedule 4 CD must be within 28 days of the appropriate date (and for schedule 5, 6 months) There is no time limit to subsequent dispensing of the repeats on a private prescription This does not apply to FP10MDAs which are instalment prescriptions and are not considered to be repeat prescriptions Slide 16 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Errors on Schedule 2 and 3 CD prescriptions (1) The only errors that pharmacist may amend are: Minor typographical errors Minor spelling mistakes If the quantity is missing in words or figures (but not both) Dispensing may only take place if: Pharmacist has exercised all due diligence and believes on reasonable grounds that the prescription is genuine Pharmacist has exercised all due diligence and believes on reasonable grounds that they are supplying the drug in accordance with the intention of the prescriber Slide 17 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Errors on Schedule 2 and 3 CD prescriptions (2) Dispensing may only take place if (continued from previous slide): Pharmacist amends the prescription in ink or otherwise indelibly to correct the mistakes or add either the total quantity in words or figures as necessary Pharmacist marks the prescription to show s/he has made the amendment (e.g., name, date, signature, GPhC number) If two pharmacists are involved in supplying the prescription (e.g., via an owing) then both should mark the prescription Any other details missing or incorrect on the prescription cannot be amended or added by the pharmacist – only the original prescriber can do this Slide 18 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 SAFE CUSTODY Slide 19 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Safe custody of CDs (1) Misuse of Drugs (Safe Custody) Regulations 1973 This applies to all CDs in Schedules 1 and 2 (except quinalbarbital) and some Schedule 3 CDs Note that the ‘default’ for Schedule 3 CDs is that they should all be kept in a CD cabinet unless they are exempted in the legislation 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 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 20 of 68 OSPAP MPHM15 CDs: Background and Classification WEEK 13 14 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 21 of 68 OSPAP MPHM15 CDs: Background and Classification WEEK 13 14 Slide 22 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 CD REGISTERs Slide 23 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Controlled drug registers (1) Those authorised to possess CDs in schedule 2 must keep records of all receipts and supplies The CD register may be on paper or in an electronic form A separate register or separate part of the register must be used for each drug, strength and form The following are minimum requirements that must be recorded, additional relevant information can be added CDs Received: Date on which received Name and address of person or firm from whom received Quantity received Slide 24 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Controlled drug registers (2) CDs Supplied Date on which supply was made Name and address of person or firm supplied Details of authority to possess – prescriber or licence holder’s details (NB person who signed the prescription not the name of prescriber on the prescription if this is different to the person who signed the prescription) Quantity supplied Person collecting the drug (patient, patient’s representative or healthcare professional) and if a healthcare professional, their name and address must be recorded Was proof of identity of patient or patient’s representative requested? (yes/no) Was proof of identity of person collecting provided? (yes/no) Slide 25 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Controlled drug registers (3) CD register must be a bound book (unless kept electronically) Entries must be in chronological sequence Entries must be on day of transaction or, if that is not reasonably practicable, the next following day No cancellation, obliteration or alteration of any entry may be made. Correction should be by a footnote or margin note and must be dated. The identity of the person making any amendments must be stated (name, signature, GPhC number, date) Entries (and any corrections) must be in ink or otherwise indelible Register must be kept at premises to which it relates Register must be kept for 2 years after the date of the last entry unless it included records of destruction in which case it should be kept for 7 years Slide 26 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Controlled drug registers (4) Morphine MST 10 mg Tabs Patient’s name Yes Prescriber’s Patient Yes Date of And address (Driving 56 name Supply License) Slide 27 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Controlled drug registers (5) – Electronic registers Electronic registers can be used providing: The author of the entry is identifiable Entries cannot be altered on a later date A log of all data is kept and can be recalled for audit purposes Adequate backups are made Access is controlled to prevent unauthorised or unnecessary access to the data Must be able to be viewed without disrupting the dispensing process Should be able to be printed out if needed Slide 28 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Controlled drug registers (6) – Running balances Aim is to identify irregularities or discrepancies as quickly as possible It is not a legal requirement to keep a CD running balance, but it is good practice to do so Balances should be checked regularly. Frequency of checking will depend on many factors RPS recommend weekly checking (not necessarily on the same day of the week) An SOP should be written on how to check running balances and how to deal with discrepancies If a discrepancy can be resolved following a check, a margin note or footnote should be made in the register and the discrepancy corrected. This should be signed and dated by the person making the amendment. Running balances for liquid CDs can be affected by overage, residue and spillage Running balance checks should be recorded, signed and dated by the person carrying out the check and, if possible, two people should carry out the checks Once electronic registers are commonly used this is likely to become a legal requirement Slide 29 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Collection of Schedule 2 CDs It is a legal requirement to ascertain whether the person collecting is the patient, patient’s representative or healthcare professional If it is the patient or their representative collecting the CD, then evidence of identity should be requested unless already known If it is a healthcare professional collecting the CD, then evidence of identity should be requested unless already known and the professional’s name and address must be obtained If evidence of identity is unavailable, the pharmacist has discretion about whether to supply or not, based on professional judgement This collection information needs to be recorded in the CD register FP10s have a place for the collector to sign their name (for schedule 3 as well) – this is good practice and is an important part of the audit trail of the dispensing of a CD Note that if a CD is to be delivered by the pharmacy, the delivery driver is the collector (as above) and can sign on behalf of the patient but there should be another process to confirm that the patient has received the CD Slide 30 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Slide 31 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 CD REQUISITIONS Slide 32 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Requisitions for CDs Schedules 2 and 3 – (1) Also known as ‘signed orders’ Remember that this transaction falls under the definition of wholesale dealing (see separate lecture) Supplier must obtain written requisition before delivering to: A practitioner Person in charge of hospital, organisation providing ambulance services or care home Senior nurse in charge of any department of a hospital or nursing home from person responsible for supplying medicines there Person in charge of a laboratory Owner or master of ship with no doctor on board Master of a foreign ship in a GB port Installation manager of an offshore installation A supplementary prescriber Nurse or pharmacist independent prescriber Operating department practitioner Slide 33 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Requisitions for CDs Schedules 2 and 3 – (2) It is a legal requirement that a special requisition form (FP10CDF in England) must be used (except hospices and prisons). Hospitals are exempt if the supply is within the same organisation. The use of this requisition form applies to CDs for human and veterinary use. These forms can be downloaded from NHSBSA website. Requisitions must: Be signed by recipient State name, address, profession/occupation of recipient Specify total quantity of drug State purpose for which the CD is required Slide 34 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Requisitions for CDs Schedules 2 and 3 – (3) The supplier must be reasonably satisfied that details supplied, including signature, are genuine The requisition must be marked indelibly by pharmacy (name and address) and sent to NHSBSA (not if a veterinary requisition). A copy should be kept in the pharmacy for 2 years (good practice) Note that veterinary requisitions should NOT be sent to the NHSBSA. The original veterinary requisition should be retained at the pharmacy for 5 years (legal requirement) Supplies against a faxed or photocopied CD requisition are not allowed A wholesaler does not require a requisition for supplying a CD to a pharmacy Slide 35 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Requisitions for CDs Schedules 2 and 3 – (4) If there is urgency to the supply, and the practitioner is unable to provide a written requisition because of some emergency, the supplier may supply a CD without a requisition on the undertaking that the practitioner will supply a requisition within 24 hours. A requisition given by the master of a foreign ship must contain a statement that the quantity to be supplied is necessary for the equipment of the ship and be signed by the proper officer of the port health authority A requisition given by the person in charge of a hospital or care home must also be signed by a doctor or dentist employed or engaged there There is no legal requirement for a requisition to be used between pharmacies but the Home Office advice is to use the standard form For Schedule 2 CDs it is good practice to make a record in POM register, for schedule 3 CDs this is a legal requirement Slide 36 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Slide 37 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Slide 38 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Requisitions for CDs Schedules 2 and 3 - (5) The purchaser (i.e., the person who has signed the requisition) may send another person (sometimes called a messenger) to collect the CD on their behalf A messenger may only be supplied with the CD if s/he produces to the pharmacy a statement in writing given by the purchaser to the effect that the messenger is empowered to receive the drugs on his behalf. (i.e., has been given a letter of authority by the purchaser to receive the CD on their behalf) There are no legal requirements for what details should appear on the letter but, at the very least, it should be signed and dated by the purchaser and include details of the messenger and a statement that they authorise them to collect the CD The pharmacy must be reasonably satisfied that the letter is genuine and must retain it for two years Slide 39 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Hospital requisitions for Schedules 2 and 3 CDs Hospital requisitions that are presented to a hospital pharmacy that is a separate legal entity must meet the legal requirements above including the use of FP10CDF. This would also apply to a hospital requesting CDs from a community pharmacy. A yearly ‘bulk’ or ‘global’ requisition on the approved form can be used to order CDs from a pharmacy which is a separate legal entity Stock can then be sent from the pharmacy ‘as needed’ throughout the year in response to completed forms from CD requisition books with duplicate pages Supply of CDs from hospital pharmacies which are the same legal entity are not required to use the FP10CDF although it would be good practice to have a clear audit trail for stock requested and issued Slide 40 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Midwives and CDs (1) A registered midwife may administer and possess diamorphine, morphine and pethidine in her own right so far as necessary for the practice of her profession Supplies of diamorphine, morphine and pethidine may only be made to her on the authority of a midwife’s supply order signed by the ‘appropriate medical officer’ The order must be in writing and must contain the following particulars: Name of the midwife, occupation of the midwife, name of the person to whom the CD is to be administered or supplied, the purpose for which the CD is required, the total quantity to be obtained, the signature of an ‘appropriate medical officer’ Slide 41 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Midwives and CDs (2) ‘Appropriate medical officer’ is a doctor who is authorised to exercise supervision over midwives within the area A midwife is required to keep a record of supplies of diamorphine, morphine and pethidine received and administered in a book solely for that purpose She must not destroy surplus stock but may surrender it to the ‘appropriate medical officer’ or to the person from whom she obtained the CD The pharmacist should retain the midwives supply order for two years. There is no need to send this to the NHSBSA. What about pharmacy records in the CD register? Legal and good practice considerations should be made as described for other requisitions Slide 42 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 DESTRUCTION OF CDs Slide 43 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Destruction of CDs Pharmacies are required to denature CDs prior to disposal The processing of denaturing renders the CD irretrievable without the use of specialist equipment Denaturing is important because: Prevents the drug being retrieved and misused Prevents harm to the environment Ensure the waste may be transported safely with less risk Usually, denaturing CDs requires an appropriate licence. In England and Wales, an exemption is issued by the Environment Agency and is known as the ‘T28 exemption’. This allows pharmacies to denature CDs prior to disposal without a licence The Home Office advises that all CDs in schedules 2, 3 and 4 (part 1) should be denatured prior to disposal There are two different CD destruction scenarios Out of date stock CDs returned by a patient or their representative Slide 44 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 1) Out of date stock Until they can be destroyed, out of date CD stock that requires safe custody must be kept segregated from other CDs in the CD cabinet The destruction of Schedule 2 stock that goes out of date must be witnessed by an ‘authorised person’ (this is a person authorised by the Secretary of State or authorised by a CD Accountable Officer) An Accountable Officer cannot be an ‘authorised person’ An authorised person is usually a senior member of staff in an organisation who is not involved in the day-to-day management or use of CDs The authorised person will record the destroyed quantities in the CD register and sign the register entry There is no legal requirement for the authorised person to be present for the destruction of other schedules or for records to be kept of destruction of other schedules For schedule 3 CDs, it is good practice to have another member of staff (preferably a registered healthcare professional) witness the denaturing Slide 45 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 2) Patient returns (1) A pharmacist may destroy CDs returned by a patient or a patient’s representative CDs should be destroyed as soon as possible and not allowed to accumulate CDs should be segregated, stored appropriately (in the CD cabinet if legally required) and clearly marked for destruction Schedule 2 CDs must not be entered in the CD register It is good practice to maintain a record of Schedule 2 CDs that have been returned by patients (but this must not be in the CD register) This record must be kept for 7 years It is good practice for another member of staff (preferably a registered healthcare professional) to witness the destruction Pharmacies are not able to accept any waste medicines (including CDs) from care homes that provide nursing care or CDs returned by a healthcare professional Slide 46 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 2) Patient returns (2) Records for Schedule 2 CDs Date received Received by (name and signature) Patient’s name (if known) Patient’s address (if known) Name of CD Form and strength of CD Quantity of CD Role of person returning the CD (if known) Date destroyed By pharmacist (name and signature) Witnessed by (name and signature) Ideally the first 8 columns are completed on receipt of the CD and the last 3 columns completed when the CD is destroyed Slide 47 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 How are CDs destroyed? Pharmaceutical waste should not be disposed of into the sewage system (i.e., down the toilet or down the sink) CDs in Schedule 2, 3 and 4 (part I) must be denatured before disposal Pharmacists are advised to use CD denaturing kits to denature CDs. Other methods can be used (see MEP for more details on other methods) but the use of CD denaturing kits is preferable Need to ensure appropriate Health and Safety measures are taken (e.g., PPE, well-ventilated area etc.) when denaturing Denaturing kits containing denatured CDs can then be added to the general pharmaceutical waste bin (containing other pharmaceutical waste) which is sent away to be incinerated MEP (3.6.10 online) provides further information on disposal Slide 48 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Slide 49 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Denaturing controlled drugs (1) Solid dose formulations Best practice would be to grind or crush the tablets or capsules with a pestle and mortar before adding to the CD denaturing kit to ensure that whole tablets or capsules are not readily recoverable Using a small amount of water during grinding may minimise the risk of particles being released into the air Place ground/crushed powder into CD denaturing kit and add water to the ‘fill’ line, screw on lid and shake vigorously If no denaturing kit, can grind or crush tabs/caps and place in warm soapy water and stir to ensure the drug has been dissolved or dispersed. The resulting mixture may then be poured on to an appropriate product (cat litter?) and then added to the general pharmaceutical waste bin Slide 50 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Denaturing controlled drugs (2) Liquid dose formulations A CD liquid can be poured from its container into the CD denaturing kit where it will mix with other waste materials and kit contents, thus rendering it irretrievable. Do not add liquid above the ‘fill’ line on the kit. Add water to the ‘fill’ line (if necessary), screw on lid and shake vigorously If no CD denaturing kit, use an appropriate product (cat litter?) and then add this to the general pharmaceutical waste bin The empty bottle that contained the CD will need to be rinsed and the rinsings poured into the kit. The empty bottle can then be disposed of as general waste or recycled (any labels containing patient identifiable details should be removed or the details obliterated) Slide 51 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Denaturing controlled drugs (3) Parenteral formulations Ampoules containing liquid should be opened and as much of the content as possible emptied into the CD denaturing kit. Then continue process as for liquids. The ampoule should be disposed of in a sharps bin. Ampoules containing the CD in powder form can be opened, water added to dissolve the powder and the resultant mixture poured into the CD denaturing kit. Then continue process as for liquids. The ampoule should be disposed of in a sharps bin. A less preferable method, involving crushing the whole ampoule and its contents, is described in the MEP Slide 52 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Denaturing controlled drugs (4) Patches Remove backing on the patch and fold the patch over on itself (sticky side inwards) and place in the CD denaturing kit The MEP says the folded patch may be disposed of in the pharmaceutical waste disposal bin Slide 53 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Denaturing controlled drugs (5) Aerosol formulations These should be expelled into water (to prevent droplets of drug from entering the air) The resulting solution can then be disposed of in accordance with the guidance on destruction of liquid formulations If this is not possible, expel the contents onto an absorbent material and add this to the general pharmaceutical waste Slide 54 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 OTHER ISSUES RELATING TO CDs Slide 55 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Patient Group Directions (PGD) Currently, the following controlled drugs can be included in PGDs: Schedule 2: Morphine and diamorphine (only by registered nurses and pharmacists for the immediate necessary treatment of a sick or injured person (except for treating addiction)). Ketamine. Schedule 3: Midazolam Schedule 4: All drugs except anabolic steroids and injections used for treating addiction Schedule 5: All drugs Note that the following professionals cannot administer or supply any CD (in any schedule) on a PGD: Dietitians Speech and language therapists Dental therapists and dental hygienists Pharmacy technicians Slide 56 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Drugs and driving (1) There is an offence of driving with certain specified controlled drugs in excess of specified levels in the body even if the driving is not impaired Two groups of drugs Commonly abused drugs (e.g., cannabis, cocaine, ecstasy, heroin, ketamine, MDMA) – low limit set Licensed medicines that can be abused – higher limit set. Drugs are flunitrazepam, clonazepam, oxazepam, diazepam, lorazepam, temazepam, methadone, morphine and any opiate. NB: The higher limit is generally set above the normal therapeutic range Roadside screening tests are used by the police to detect the presence of these drugs Slide 57 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Drugs and driving (2) If patients are taking these medicines legitimately then they can use a statutory ‘medical defence’ if The drug was lawfully prescribed, supplied or purchased OTC and The drug was taken in accordance with advice by the prescriber/supplier and in accordance with any accompanying written instruction Note than section 4 of the Road Traffic Act 1988 still can apply regarding driving whilst impaired because of drugs (legally prescribed or illegally taken) and there is no statutory medical defence for this Slide 58 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Drugs and driving (3) A warning label appears on the medicine packaging and in the PIL regarding driving Patient counselling is important Warn about driving, especially if the medicine is newly prescribed or the dose has increased Advise patients to carry evidence that they are prescribed the drugs (e.g., repeat prescription slip, labelled bottle) Remind patients to avoid alcohol, even in small amounts Pharmacists need to be alert for new drugs started which may interact with a listed substance and increase its serum levels Slide 59 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Standard operating procedures (SOPs) for CDs The Health Act 2006 states that SOPs must be in place which relate to the use and management of CDs Legislation does not list what specific activities these SOPs should cover RPS professional guidance suggests that the following topics, in relation to CDs in pharmacy, should be covered: Security, including access to CDs Ordering and receipt Record keeping (including audit requirements) Supply Transport, including records Denaturing and disposal Investigation and reporting of concerns Slide 60 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Witness protection and CD prescriptions The address of the patient is a legal requirement on a prescription for a CD However, ‘home address’ is not specified in the legislation An alternative address may be used in cases such as witness protection Some GP clinical systems default to ‘NFA’ (see below) or use the address of the GP surgery Home Office advice is that the dispensing pharmacist should verify that the address on the prescription is deliberate and is to be used as the address of the patient ‘No Fixed abode’ or ‘NFA’ may be used for patients who are homeless. This is not a valid address but the advice from the Home Office is that it may be used in justifiable circumstances Need to remember patient confidentiality and privacy of the patient when querying such details on a prescription Slide 61 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Travelling with CDs A personal licence is not required by the Home Office if a person is travelling with less than three month’s supply of a CD However, it is recommended that the person carries a covering letter, signed by the prescriber, confirming drug name, dose, quantity and travel plans Regulations for all countries the patient is travelling through and the destination country should be checked with foreign embassies or high commissions to ensure that regulations are complied with for the full duration of the trip Note that the travel operator/airline company may also have additional requirements Remember that classification and legislation of CDs can vary widely in different countries Penalties for illegal importation/exportation can be severe in some countries Slide 62 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Psychoactive substances Psychoactive Substances Act 2016 Bans production, distribution, sale and supply of psychoactive substances in the UK Previously these substances were known as ‘legal highs’ and were sold widely from some shops and on the internet ‘Psychoactive substance’ means any substance which is capable of producing a psychoactive effect in a person who consumes it, and is not an exempted substance Exempted substances include controlled drugs, medicinal products, alcohol or alcoholic products, nicotine, tobacco products, caffeine or caffeine products. Possession is not an offence except in a ‘custodial institution’. Possession with intent to supply, import or export is an offence Slide 63 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Emergency measures relating to CDs during a pandemic (1) In April 2020, in response to the Covid-19 pandemic, three temporary emergency measures were introduced by the UK Government into legislation These measures have been introduced but not activated – an announcement from the Secretary of State will specify which measure(s) is/are being activated, how long the measure(s) will apply (including a start date) and the geographical area to which the measure(s) applies They will only be activated if there are severe disruptions to the supply of repeat prescriptions for CDs for patients The emergency measures will only last for the duration of the emergency. The maximum period for which a measure will apply is 3 months (although it could be extended for another 3 months if the Secretary of State decides it is necessary) Slide 64 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Emergency measures relating to CDs during a pandemic (2) 1) Emergency supply of a CD at the request of a patient Allowing the supply of a schedule 2 or 3 CD 2) Supply of a CD under a Serious Shortage Protocol (SSP) Extends the use of a SSP to include a schedule 2, 3 or 4 (Part 1) CD This would be only used as a last resort and in exceptional circumstances The SSP will be highly specific and limited in scope to ensure patient safety 3) Enabling pharmacists to vary the frequency of dispensing an instalment prescription (i.e., FP10MDA) for CDs Pharmacists will be able to vary the frequency of instalments on instalment prescriptions But only if they have first consulted the prescriber (or an appointed representative of the prescriber) Note that these measures have NOT yet been activated – it is illegal to do any of the above until advised that the measure has been activated by the Secretary of State. Further guidance will be released if and when this happens. Slide 65 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 Supply of naloxone by drug treatment services Naloxone is an opioid/opiate antagonist which can completely or partially reverse the central nervous system depression, especially respiratory depression, caused by an overdose of an opiate Naloxone is a POM but, after a change in the law, staff who are engaged or employed in ‘lawful drug treatment services’ can obtain naloxone from a wholesaler and supply it to patients without a prescription or PGD Naloxone can be supplied in this way as an injection or nasal spray Commissioned service providers of drug treatment services (such as community pharmacies) are also included in this Anyone can administer naloxone for the purpose of saving a life in an emergency Note that it is lawful to also supply it to anyone who may witness an overdose such as family members and friends Any supply should be accompanied with information when it should be used and how to administer it Slide 66 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 And finally, something clinical! The Gosport Report is the finding of an investigation into opioid use at Gosport War Memorial Hospital between 1988 and 2000 At least 450 patients are thought to have died after the administration of very high dose opioids There was no evidence that pharmacists had queried or challenged the prescribing of these opioids The GPhC has produced a ‘Learnings from Gosport’ document (on Canvas) Opioid prescribing, misuse and abuse is a current focus in primary care Trying to ensure appropriate prescribing for an appropriate duration is important for all primary care clinicians, including pharmacists Resources to help facilitate and support this are available (from the Faculty of Pain Medicine, www.fpm.ac.uk) Pharmacists should also be vigilant when selling CD Sch 5 medicines or supplying any CDs in an emergency supply scenario Written private prescriptions on letter headed paper should also be scrutinised fully to ensure that the prescription is genuine Slide 67 of 68 OSPAP MPHM15 Controlled Drugs: Supply WEEK 13 14 CD Resources and further information See MEP online (section 3.6) for a list of other documents and sources of further information RPS Pharmacy Guides - see titles here Slide 68 of 68 OSPAP MPHM15 Controlled Drugs: Supply