PROTOCOL FOR THE SUPERVISION OF CONSUMPTION OF BUPRENORPHINE (SUBUTEX) ON COMMUNITY PHARMACY PREMISES.

  1. The prescriber will agree with each new patient the pharmacist by whom his/her Subutex will be dispensed and will ask the pharmacist if they can accept another patient.
  1. All patients who are to receive supervised Subutex should agree and sign a patient contract. An example of a suitable contract provided by the Primary Care Trust is contained in the appendix. If the patient is new, the pharmacist on duty should explain the contract and their own procedure and countersign it. A copy of the contract should be given to the patient.
  1. The pharmacist should introduce the patient to the counter staff so that the patient can be dealt with promptly each day

A copy of this protocol should be included with any briefing given to locum pharmacists brought in to cover holidays or other absences.

The pharmacist and patient should sign the contract and agree:

  • the most appropriate time for collection of medication
  • the arrangement for weekend and Bank Holiday doses
  • thatthe patient must place the dose under the tongue (it will not work if swallowed)
  • that unsuitable or offensive behaviour towards the pharmacist or their staff will result in the termination of the agreement
  • that the buprenorphine (Subutex) will not be supplied or supervised if the patient is intoxicated by drugs or alcohol
  • that the GP/Substance Misuse Service (SMS) will be told of missed doses
  • that if more than two doses are missed, the pharmacist will contact the prescriber before supply is continued
  • that missed doses will not be supplied at a later date and what to do if the patient cannot attend.

Dispensing

Unit dose packaging allows safer and more convenient handling, but risks confusion of strengths and difficulties in popping the tablet out of the blister if individual daily doses are ‘snipped’, dispensed and labelled. For this reason, some pharmacists currently dispensing buprenorphine (Subutex) have been dispensing the total amount of the prescription all at once. Daily doses for supervision are taken from these packets without individual Patient Medication Records (PMR) being made on the computerised records. However, the RPSGB legal department has insisted that pharmacists MUST fully dispense and label individual instalments.

Buprenorphine (Subutex) is a Schedule 3 controlled drug and does NOT require entry into the CD Register. It is subject to prescription writing and safe custody requirements for controlled drugs.

When a prescription is presented the pharmacist should check that the prescription is legally correct and that the patient has an existing contract with the pharmacy.

In order to comply with full legal requirements, the following procedure is suggested:

  1. Buprenorphine (Subutex) should be prescribed in instalments for supervised consumption using the blue form FPlO(MDA).
  1. The daily dose should be dispensed and labelled appropriately before the patient arrives (whena prescription is current). Sometimes this may involve a mixture of strengths which must be separately labelled in accordance with standard ‘best practice’ procedures.
  1. The patient should not witness removal of the dispensed container(s) from (or replacement in) the CD cupboard.
  1. The original prescription should be kept until the prescription expires.
  1. The patient’s identity should be checked before the dose is administered.
  1. Check for signs of intoxication in the patient (general appearance/demeanour etc).
  1. Check patient has been given and read the Subutex patient information leaflet.
  1. The supervision procedure should be discreet and efficient to be mindful of the patient’s dignity and the pharmacist’s time.
  1. Supervision should take place in a quiet, private area; it should not take place in the dispensary.
  1. A drink should be available for clients who may require it before dosing to moisten the mouth or after the tablet has completely gone to refresh the mouth. A drink should never be offered during dosing. In such cases, provision must be made for safe disposal of drinking cups to ensure no cross infection is possible. Patients should not be allowed to bring opened containers of drinks into the pharmacy. NB All cups should be rinsed and disposed of.
  1. The patient should check the name, quantity and dose on the label(s) before taking.
  1. The pharmacist should pop the tablets out of the blister pack into the tablet crusher. All buprenorphine should be crushed prior to administration, in accordance with the signed protocols from the treatment services and GPs.
  1. The crushed tablet(s) should be placed under the tongue and left to dissolve. The active ingredient passes through the buccal mucosa and produces its effect.
  1. The tablet should not be swallowed, as it is ineffective if taken this way.
  1. The summary of product characteristics states that the tablet will dissolve in five to ten minutes. In practice it has been found that this takes two to four minutes.
  1. The patient should not leave until the pharmacist is sure that the tablet is dissolved.
  1. Once dissolved, what remains is a chalky residue that can be swallowed.
  1. It is not necessary for the pharmacist to watch the client continuously.The pharmacist is only responsible for ensuring the does goes into the mouth, under the tongue and then confirming with the patient that the dose has been absorbed.
  1. The pharmacist must be satisfied (either by conversing with the patient, water being swallowed or other means) that the medication has not been concealed in the mouth.
  1. Do not give Subutex to a patient following more than two missed doses without first contacting the prescriber.
  1. If necessary at weekends and bank holidays a dose should be consumed on the day of collection of the take-home dose. Ensure a patient information leaflet is given with the supply.

Notes

1.The daily dispensing and supervision of Subutex is only one aspect of a broader harm minimisation strategy. Patients may be undergoing stabilisation and will be calling in at the pharmacy regularly — this service should therefore be as discreet as possible and the patient treated with respect and courtesy.

2.All occasions on which a patient fails to attend should be recorded on the prescription.

3.The key-worker or prescribing agency should be contacted in any of the following circumstances:

  • Following more than two missed doses or regularly missed single doses
  • Breach of patient contract
  • Unacceptable behaviour when visiting the pharmacy
  • Evidence of increasing health, emotional or other problems
  • Requests for help that the pharmacist is unwilling or unable to meet

A copy of this protocol should be included with any briefing given to locum pharmacists brought in to cover holidays or other absences.

Side effects

Buprenorphine (Subutex) is a partial agonist, therefore patients should be warned that they should not have taken an opiate in the last four to six hours or, in the case of methadone, in the last 24 hours, or they risk precipitating acute withdrawal.

Patients should be warned that it may cause a drop in blood pressure, causing them to feel dizzy if they get up too quickly from sitting or lying down.

Nausea and vomiting are common side-effects on first dose. Re-dosing should not be required as the drug is absorbed through the buccal mucosa. If the patient feels nauseous before dispensing, dispensing could be delayed. Alternatively, an anti-emetic may need to be prescribed.

APPENDIX

AGREEMENT BETWEEN PATIENT AND PHARMACY FOR THE SUPERVISION OF CONSUMPTION OF METHADONE/BUPRENORPHINE ON PHARMACY PREMISES.

PATIENT (please print)………………………………………….…

PHARMACY…………………………………………….

The patient is to be prescribed methadone/ buprenorphine as part of the course of treatment. For part of that course the patient has agreed to consume the prescribed medication on the pharmacy premises under the supervision of the dispensing pharmacist. The conditions attending this procedure are as follows:

The patient will attend personally on the correct day and during the stated time.

The time the patient will attend will be...... (Delete if inappropriate)

1)Medication to be consumed on Sundays and Bank holidays will be supplied in single dose containers. It is the patients' responsibility to keep this medication safely. It cannot and will not be replaced under any circumstances.

2)At all times the patient will be treated with courtesy and respect. It is expected that the patient will treat pharmacy staff and customers with the same courtesy and respect.

3)Should the patient’s behaviour be unacceptable, or the patient is grossly intoxicated, the pharmacy is under no obligation to continue to supply medication. The prescriber will be contacted and it will be at his/her discretion whether or not a new prescription will be issued.

4)The prescriber will be contacted if more than two doses are missed.

5)Should the patient feel aggrieved by the actions of any of the pharmacy staff, he/she should in the first instance bring this to the attention of the pharmacist. Should the patient still feel aggrieved the matter should be raised with the member of the addiction team responsible for his/her treatment.

6)The pharmacy will dispense the prescription in accordance with its written contents. There is no possibility of any alteration without a new prescription being first obtained from the prescribing doctor. It is the prescriber’s responsibility to supply a new prescription promptly should there be any problems. Should a dose be missed, it cannot be dispensed on a subsequent day. It isnot owed to the patient.

7)The patient must arrive and leave the pharmacy alone. Friends or relatives must wait outside. Should the pharmacy be busy, the patient must wait until he/she can be seen.

8)The dose of methadone/ buprenorphine must be taken under the supervision of the pharmacist. It will be followed by a drink of water. The patient will leave when it is agreed with the pharmacist.

9)The pharmacist is obliged to report certain information deemed to be in the patient’s interest, back to the addiction team. Examples of such information will include requests for injecting equipment, general health and demeanour of the patient, evidence of concurrent drug use, intoxication etc. Such information willnot be conveyed to any other party eg employers, family etc.

Additional rules may be added by the participating pharmacy, should the pharmacist deem it necessary. Any breach of the conditions of this agreement may result in the patient being banned from the pharmacy. A report on behaviour will be sent to the prescriber and medication may be stopped all together.

I have read the above terms and conditions. I understand and agree to be bound by them.

Signatures:

Patient / Date
Pharmacist / Date