MPharm Controlled Drugs Supply PDF 2024

WEEK 12 13 MPharm Programme Controlled Drugs Part 2: Supply John Sherwood MRPharmS 18/25th October 2024 Slide 1 of 39 MPharm PHA221 Supply of Controlled Dru...

WEEK 12 13 MPharm Programme Controlled Drugs Part 2: Supply John Sherwood MRPharmS 18/25th October 2024 Slide 1 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Learning outcomes Describe the legal requirements relating to CDs in Schedules 2-5 regarding possession, prescriptions (NHS and private) and requisitions Describe the legal and good practice requirements that apply to record keeping and destruction of CDs Describe what corrections a pharmacist can make to a CD prescription and how this should be done Describe regulations relating to the supply of CDs to midwives Slide 2 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Possession and supply of CDs It is unlawful for any person to be in possession of a CD in Schedules 2, 3 or 4 (part 1) 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 Pharmacists are allowed to be in possession of CDs in schedules 2 to 4 (part 1) when acting in their capacity as a pharmacist Possession by patients is allowed if the CD has been prescribed by an appropriate practitioner A person who is allowed to supply a CD may only supply it to a person who is allowed to possess it A patient may supply a CD to a pharmacist for the purpose of destruction Slide 3 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Prescription requirements for CDs (1) It is unlawful for a practitioner to issue a prescription for a Schedule 2 or 3 CD unless it complies with the following requirements: 1) Be written in indelible ink (if not an electronic prescription) 2) Signed by person issuing it with their usual signature or their ‘advanced electronic signature’ 3) If issued by a dentist, must state the words ‘For dental treatment only’ 4) Specify the name and address of patient for whose treatment it is issued Slide 4 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Prescription requirements for CDs (2) 5) Specify the dose to be taken 6) If the CD is a preparation, specify the form of the medicine 7) Specify the strength of the medicine if more than one strength is available 8) Specify the total quantity of the medicine (in both words and figures) of the preparation or the number (in both words and figures) of dosage units to be supplied 9) Must be dated Note that prescriptions for CDs must also comply with the legal requirements for prescriptions for POMs Slide 5 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 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 6 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 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, 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 Slide 7 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Supply of CDs on a prescription A Schedule 2 or 3 CD must not be supplied 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 himself 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 appropriate date 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 8 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Private prescriptions for CDs In addition to the above requirements (for Schedule 2 and 3 CDs): These must be on a special form (FP10PCD in England) – illegal to dispense if this form is not used Must contain the prescriber’s private CD identification number Original form is sent to NHSBSA Keep a copy of the prescription in the pharmacy for 2 years NHSBSA will monitor 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 prescriptions (if dispensed in the same hospital), veterinary prescriptions, or to some prison pharmacy services. Slide 9 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Repeat prescriptions Repeat prescriptions for Schedule 2 and 3 CDs are not allowed Repeats for schedule 4 and 5 CDs are allowed For repeat prescriptions, the first dispensing for a Schedule 4 CD must be within 28 days of the appropriate date and for Schedule 5 CD within 6 months of the appropriate date There is no time limit to subsequent dispensing of the remaining repeats on a private prescription after the first dispensing has taken place Note that all the above does not apply to FP10MDAs (see next lecture) which are instalment prescriptions and are not considered to be repeat prescriptions Slide 10 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 Errors on CD Schedule 2 13 and schedule 3 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 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 11 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Errors on CD Schedule 2 and schedule 3 Prescriptions (2) Dispensing may only take place if (cont.): Pharmacist amends the prescription in ink or otherwise indelibly to correct the mistakes and adds 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 on the prescription or any other incorrect details cannot be added or amended by the pharmacist Slide 12 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 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 NHS prescription/FP10PCD have a place for the collector to sign their name (for schedule 3 as well) – this is good practice for schedule 3 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 13 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Slide 14 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 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 15 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 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 prescription if this is different to the signator) Quantity supplied Person collecting the drug (patient, patient’s representative or healthcare professional) and if a healthcare professional, their name and address Was proof of identity of patient or patient’s representative requested? (yes/no) Was proof of identity of person collecting provided? (yes/no) What about running balances? Slide 16 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 CD registers (3) – What to record? Morphine MST 10 mg Tabs Patient’s name Yes Date of Prescriber’s Patient Yes And address (Driving 56 name Supply License) Slide 17 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Controlled Drug Registers (4) 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 18 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Controlled Drug Registers (5) 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 19 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Controlled Drug Registers (6) Electronic Registers Can be used providing: The author of the entry is identifiable Entries cannot be altered later A log of all data is kept and can be recalled for audit purposes Adequate backups must be made Access should be 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 20 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Requisitions for CDs (1) Also known as ‘signed orders’ A requisition in writing must be obtained before a supplier supplies any Schedule 2 or 3 CD. This is ‘wholesaling’ (see later lecture) It is a legal requirement to use the Home Office requisition form (FP10CDF in England) in the community (available to download from the NHSBSA website) Supplier must be reasonably satisfied that details supplied, including signature, are genuine This applies to requisitions for human and veterinary use The requisition must: Be signed by the recipient (purchaser) State the recipient’s name and address, profession or occupation Specify the total quantity of required Specify the purpose for which the CD is required Slide 21 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Requisitions for CDs (2) The pharmacy should mark the requisition indelibly with the pharmacy’s name and address –if using a pharmacy stamp this must be clear and legible The original requisition is sent to the NHSBSA at the end of the month (but not veterinary requisitions) A copy of the requisition is kept in the pharmacy for 2 years (good practice) In an emergency, a doctor or dentist can be supplied with a schedule 2 or 3 CD without a requisition being present if a requisition is supplied within the next 24 hours. Failure to do so would be an offence on the part of the doctor or dentist There is no legal requirement for a requisition to be used between pharmacies but Home Office advice is to use the standard form Slide 22 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Slide 23 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Slide 24 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Requisitions for CDs (3) 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 25 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 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 (providing the pharmacy has registered their exemption with the Environment Agency) 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 26 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Destruction of CDs – 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’ 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 27 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Destruction of CDs – 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 Returned 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 28 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Destruction of CDs – Patient returns (2) - Records Date received Received by (name and signature) Patients name (if known) Patients 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 29 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 How are CDs destroyed? (1) 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 The online MEP provides further information on disposal (section 3.6.10) Slide 30 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Slide 31 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 How are CDs destroyed? (2) 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 32 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 How are CDs destroyed? (3) 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 33 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 How are CDs destroyed? (4) 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 34 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 How are CDs destroyed? (5) 13 Fentanyl / Buprenorphine patches Easy to dispose of Just remove backing on the patch and fold the patch over on itself (sticky side inwards) and place in the CD denaturing kit Slide 35 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 How are CDs destroyed? (6) 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 36 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Disposing of methadone bottles Methadone bottles (stock bottles or patient dispensed bottles) should be rinsed and the liquid added to a CD denaturing kit (and the kit added to the pharmaceutical waste when full) Liquid waste medicines must not be poured down the sink or toilet as a method of disposal It is not necessary to record the disposal of these rinsings Dispensing labels must be removed or obliterated before the clean, empty container is disposed of in the ‘ordinary’ waste for confidentiality reasons Slide 37 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Midwives and CDs (1) A registered midwife may administer and possess diamorphine, morphine and pethidine in his/her own right so far as necessary for the practice of her profession Supplies of diamorphine, morphine and pethidine may only be made to him/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 the ‘appropriate medical officer’ Slide 38 of 39 MPharm PHA221 Supply of Controlled Drugs WEEK 12 13 Midwives and CDs (2) ‘Appropriate medical officer’ is a doctor or a person 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 S/he must not destroy surplus stock but may surrender it to the ‘appropriate medical officer’ or to the person from whom s/he 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 records in the CD register? Legal and good practice records must be made as for requisitions Slide 39 of 39 MPharm PHA221 Supply of Controlled Drugs