OSPAP: Controlled Drugs & Instalment Prescriptions

• OSPAP Programme - Controlled Drugs Part 3: CD Instalment Prescriptions, presented by John Sherwood MRPharmS on 6th November 2024.

Learning Outcomes

• Define addiction and the three components of being addicted to an opioid.
• Understand 'harm reduction' and the three principles.
• Describe legal requirements for a FP10MDA prescription and the records to make.
• Explain Home Office approved wording and scenarios it covers.
• Describe action to take when a patient's representative wishes to collect their dose.
• Be aware of clinical concerns and legal issues when a patient misses doses of their opioid.

Addiction

• A person is considered addicted to a drug if, as a result of repeated administration, they become so dependent that they have an overpowering desire for its continued administration.
• Addiction has three components: physical dependence, psychological dependence, and tolerance.

Harm Reduction

• Intended to reduce adverse effects of drug misuse until the misuser stops misusing the drug.
• The three principles are: accepting drug misuse without approval, treating the user as a normal human being, and ensuring harm reduction not necessarily leading to a long-term goal of ending drug misuse.
• Methadone or buprenorphine are used, though diamorphine may be an alternative.
• Best used with psychosocial support and includes detoxification or maintenance programs.
• A complete history and toxicology screening are needed to assess current drug use, and prescribing is tailored to individual requirements.

Prescriptions for Addiction

• In England, instalment prescribing uses FP10MDA form, used by both drug treatment centers and GPs.
• A maximum 14-day supply of Schedule 2 CD, buprenorphine, and diazepam can be prescribed for addiction treatment with the FP10MDA form.
• Doctors with a Home Office license can prescribe cocaine, diamorphine, or dipipanone for addiction treatment.

FP10MDA Prescription Requirements

• It has the same legal requirements as any CD prescription.
• Must include an 'instalment direction', consisting of the amount of medicine per instalment and the interval between each instalment.
• The instalment amount and the dose must be specified separately.
• Prescriptions may contain Home Office approved wording (not legally required).
• The prescription must be marked with each date of dispensing.
• The prescription doesn't need a start date, but first dispensing must be within 28 days of the appropriate date.
• A specified start date must be complied with.

Methadone

• Metabolized slowly compared to other morphine-based drugs because it is lipophilic, with a variable half-life of around 22 hours.
• Given once a day.
• Available in liquid form, tablets, and injection.
• There are varying strengths of liquid form: 1mg/mL, 1mg/mL sugar-free, 2mg/5mL linctus, 10mg/mL concentrate, and 20mg/mL concentrate.

Buprenorphine (Subutex®)

• It is an opioid partial agonist.
• It is less sedating than methadone.
• It can be used to treat patients with moderate opioid dependence.
• Care is needed when dispensing.

Supervision of Patients in the Pharmacy

• Pharmacists supervise methadone and Subutex administration to prevent patient selling/misuse and ensure adherence.
• Subutex tablets take up to 10 minutes to dissolve, impacting patient and pharmacist.
• Crushing buprenorphine sublingual tabs is outside the manufacturer's marketing authorisation, so it renders the product unlicensed.
• The pharmacist may assume liability for supplying a product outside its licensed indication(s).
• The prescriber and patient should agree to tablet crushing before administration and be informed on the risks and benefits of crushing and should be for the patient's benefit, not the pharmacist's convenience.

Collection by a Patient’s Representative (Unsupervised Doses)

• It is good practice (but not legally required) to obtain a letter of authorisation from the patient each time a third party collects a CD for a patient undergoing treatment for drug addiction.
• Keep the letter in the pharmacy.
• The prescription doesn't need to specify that a third party can collect the medication.
• The pharmacist needs to be satisfied that the letter is genuine.
• It is good practice to insist on seeing the patient at least once a week, unless impractical.
• This also applies to patients detained in police custody.

Collection by a Patient’s Representative (Supervised Doses)

• 'Supervision' is not a legal requirement/statement on a FP10MDA.
• The pharmacist can contact the prescriber to see if they are agreeable to have the supply given to a representative rather than it being supervised.
• Verbal confirmation by the prescriber is acceptable if documented.
• Confirmation from the prescriber isn't needed if the patient is in police custody, where schedule 2 and 3 CDs will be administered by a healthcare professional.
• Annotate the prescription and PMR to show dose has not been supervised.

Home Office Approved Wording

• Wording approved by the Home Office allows pharmacists flexibility when making supplies due to various scenarios.
• Approved wording is not in legislation, but it provides pharmacists degree of protection from consequences of supplying against and unlawful prescription.
• The wording consists of five statements used individually or combined.
• An instalment prescription that contains wording different from that approved by the Home Office does not provide the dispensing pharmacist the security conferred by a prescription containing approved Home Office wording.
• The five statements are: dispense instalments due on pharmacy closed days on a prior suitable day, if an instalment collection day has been missed, dispense the amount due for remaining days of that instalment, consult the prescriber if three or more consecutive prescription days have been missed, supervise consumption on collection days, and dispense daily doses in separate containers.
• Wording may not always be necessary; the prescriber decides whether to include it on the prescription.

Missed Dose

• Prescriber should be made aware if patient misses a daily dose.
• Prescription will be stopped if patient misses three consecutive days, and the patient will be reassessed.
• Approved wording covers this, but local Drug Treatment Centre usually has a policy.
• If a patient misses three or more consecutive doses, be titrated back to their 'optimum' dose, and the current dose should not be dispensed pending advice from the prescriber.

Dispensing in Daily Dose Bottles

• Some patients collect more than one day's doses at a time.
• Methadone may be supplied in individual bottles for each day's dose or one bottle with all doses.
• There are overdosing /underdosing concerns if patients measure their own dose from a multiple dose bottle.
• Daily dose dispensing bottles are safer/good practice regardless of any Home Office approved wording on the prescription.
• As little as 5ml of methadone can kill a baby if a residual amount is left in the bottle.

Disposing of Methadone Bottles

• Methadone bottles (stock or patient dispensed) should be rinsed, and the liquid added to a CD denaturing kit (kit added to pharmaceutical waste when full).
• You can find CD disposal instructions in CD Lecture Part 2.
• Liquid waste medicines must not be poured down the sink or toilet.
• It is not necessary to record disposal of these rinsings.
• Remove/obliterate dispensing labels before disposing of container in ordinary waste.

Preparing and Dispensing Extemporaneous Methadone Mixture

• Refer to the 'Licensing' lecture.
• See MEP (online – search 'methadone' and select 'Extemporaneous methadone').