The Isle of Wight Primary Care Trust, under the Pharmaceutical Services (Advanced and Enhanced Services)(England) Directions 2005 as amended, authorises the following pharmaceutical service from pharmacists included in its Pharmaceutical List for the pharmacist to supervise the administration of prescribed medicines in the pharmacy to persons within its area, as per paragraph (4)(1)(r) of those Directions.

  1. Service description
  2. This service should require the pharmacist to supervise the consumption of prescribedliquids or solid dosage forms intended for sub-lingual administration at the point of dispensing in the pharmacy for substance misuse clients, ensuring that the dose has been administered.
  3. The pharmacyshould offer a user-friendly, non-judgmental, client-centred and confidential service.
  4. The pharmacy should provide support and advice to the patient, including referral to primary care or specialist centres where appropriate.
  1. Aims and intended service outcomes
  2. To ensure compliance with the agreed treatment plan by:
  3. dispensing in specified instalments (doses may be dispensed for the patient to take away to cover days when the pharmacy is closed); and
  4. ensuring each supervised dose is correctly consumed bythe patient for whom it was intended.
  5. To reduce the risk to local communities of:
  6. over usage or under usage of medicines;
  7. diversion of prescribed medicines onto the illicit drugs market; and
  8. accidental exposure to the supervised medicines.
  9. To provide clients with regular contact with health care professionals and to help them access further advice or assistance. The clientshould be referred to specialist treatment centres or other health and social careprofessionals where appropriate.
  1. Training and Staffing Requirements
  2. The pharmacy contractor should ensure that pharmacists and staff meet the requirements of the Competency and Training Framework for Supervised Consumption of Prescribed Medicines provided by the Harmonisation of Accreditation Group of the North West Pharmacy Workgroup. A copy of this document is provided as Appendix 1 of this document.
  3. The pharmacy contractor has a duty to ensure that pharmacists and staff involved in the provision of the service have relevant knowledge and are appropriately trained in the operation of the service.
  4. The pharmacy contractor has a duty to ensure that pharmacists and staff involved in the provision of the service are aware of and operate within local protocols.
  5. The rehabilitation of Offenders Act does not apply and therefore the pharmacy shall ensure that all staff working in the service declare any previous convictions. If a member of staff declares or is found to have previous convictions, the pharmacy’sparticipation must be agreed with the PCT.
  1. Service outline
  2. The part of the pharmacy used for provision of the service provides a sufficient level of privacy and safety and meets other locally agreed criteria.
  3. The pharmacy contractor should be informed of any past behaviour of the client which might influence the decision to accept the client into the service at the pharmacy.
  4. The clientshould have entered into an agreement between the prescriber, pharmacist and themselves to agree how the service should operate, what constitutes acceptable behaviour by the client, and what action should be taken by the prescriber and pharmacist if the user does not comply with the agreement. A copy of this agreement is provided as Appendix 2 of this document.
  5. The pharmacy should receive a copy of the signature sheet of the agreement for each client for whom they provide the service.
  6. At the first meeting between the pharmacist and the client, they should go through the signed agreement and highlight:
  7. the most appropriate time for collection and arrangements for weekend and bank holiday doses;
  8. that medication not be suppliedif the pharmacist believes the patient is intoxicated;
  9. that missed doses will not be supplied on a later date; and
  10. what to do if the client cannot attend.
  11. The pharmacist may wish to take the opportunity to exchange phone contact details with the client to facilitate contact in the event of difficulties with a prescription.
  12. The pharmacy should check prescriptions upon their receipt and report any perceived difficulties to the prescriber at the earliest opportunity. A checklist of good practice guidelines is provided at Appendix 3.
  13. In the event that there is no indication on the prescription of a requirement for supervised consumption, either by omission by the prescriber or by decision during a prescription’s duration, the pharmacist may annotate the prescription with the requirement together with the name of the person requesting the supervision, the date of notification, the pharmacist’s signature and RPSGB registration number.
  14. The pharmacy should dispense the dose according to the legal requirements including appropriate labelling and, where possible, prior to the client attending.
  15. When the client attends:
  16. For liquid dosage forms:
  17. the dose should be poured into a,disposable cup and the bottle available for the client to check.
  18. The pharmacist should be satisfied that the dose has been swallowed either by water being swallowed after the dose, conversing with the patient or other means to ensure that the medicine is not retained in the mouth.
  19. For sub-lingual dosage forms:
  20. the dose should begiven in the dispensing container and the client instructed to place the medication under the tongue;
  21. the client should demonstrate the dose is in place;
  22. a period of at least three minutes should then elapse before the client demonstrates once more that either the dose has dissolved completely or to such an extent that the pharmacist is satisfied that transmission of the dose is unlikely.
  23. Doses that are intended to be taken on Sundays or Public Holidays should be dispensed and appropriately labelled. The pharmacist shall take every opportunity to emphasise the need for safe storage of all medicines in the home, especially controlled drugs.
  24. The pharmacy will report to the prescriber if:
  25. regularly missed doses or whole doses are not consumed under supervision;
  26. client is attempting to or wishes to avoid supervised consumption;
  27. three or more consecutive doses are missed and tolerance may have fallen and should not dispense any further from the prescription until notified by the prescriber;
  28. the client displays inappropriate behaviour. In the event that this behaviour is unacceptable, the pharmacy can request that they withdraw the service from the patient and an alternative pharmacy should be found by the prescriber. A reporting proforma is provided at Appendix 4.
  29. the client requeststo crush sub-lingual tablets. Subutex is not currently licensed to be administered in this way and there may be problems with product liability as the manufacturer is no longer liable for any adverse effects caused. This service therefore does not support crushing of Subutex in community pharmacies.
  30. the client is intoxicated, either by drugs or alcohol;
  31. there is deterioration in health and other health concerns;
  32. there are problems concerning the prescription; and
  33. a client requests supervision.
  34. In the event of cancellation of a whole prescription, either by non-attendance or decision of the prescriber, the prescription should be clearly voided across the body and returned to the prescriber in due course.
  35. The pharmacy should maintain appropriate records to ensure effective ongoing service delivery and audit.
  36. The pharmacyshould share relevant information with other health care professionals and agencies, where confidentiality arrangements have been agreed.
  37. The PCT should arrange at least one contractor meeting per year to promote service development and update the knowledge of pharmacy staff.
  38. The PCTshould provide details of relevant referral points which pharmacy staff can use to signpost clients who require further assistance.
  1. Quality Indicators
  2. The PCT shouldprovide health promotion material available for the user group and the pharmacy should promote this information to the clients.
  3. The pharmacy should review its standard operating procedures and the referral pathways for the service on an annual basis.
  4. The pharmacy should be able to demonstrate that pharmacists and staff involved in the provision of the service have undertaken CPD relevant to this service.
  5. The pharmacy should co-operate with any locally agreed assessment of client experience.
  1. Remuneration
  2. The PCT will pay a sum as agreed between itself, the Local Representative Committee and other commissioning partners to the pharmacy contractor on submission of a monthly claim. Payment will be within 30 days from the end of the calendar month in which the claim is received.
  3. Claims should be made on the form provided (see Appendix 5) and accompanied by photocopies of the prescription to facilitate audit of the service.
  4. Claims should be made within six months of the service provision. Claims made after this time will not be eligible for payment.

Appendix 1: HAG Accreditation Framework

Community Pharmacy Enhanced Services
Competencies and Training Framework
Enhanced Service: / Supervised Consumption of Prescribed Medicines for Substance Misusers
Version: / 1
Issue Date: / February 2007
Review Date: / February 2009
No. of pages: / 6
Authorised by: / North West Pharmacy Workforce Development Group
1. / Introduction
Community Pharmacists wishing to provide Supervised Consumption of Prescribed Medicines for Substance Misusers as an enhanced service must be accredited (see Section 3.1) and have their names on an enhanced service provider list kept by the PCT on whose behalf they are providing the service. Throughout this document the abbreviation PCT is used in place of “Primary Care Trusts or other Commissioning Bodies”.
The information in this document outlines the purpose and design of suitable local training which will allow accredited Community Pharmacists to be recognised by all PCTs in the NHS Northwest. The following process has been approved by the NW Harmonisation of Accreditation Group which is a subgroup of the North West Pharmacy Workforce Development Group. This training and competency framework supports the competencies required to achieve the Drug and Alcohol National Occupational Standards (DANOS).
2. / Core Competencies
These core competencies have been linked, where appropriate, to the general pharmacist competences of the Royal Pharmaceutical Society of Great Britain which are shown in [ ].
a)Understands the terminology and definitions of substance misuse, the theories of drug dependence, concept and practice of harm reduction [G1].
b)Is aware of commonly misused substances [G1].
c)Understands the treatment of substance misuse, including multidisciplinary team working, assessment and care planning, pharmacotherapeutic and non-pharmacotherapeutic options [G1, G5].
d)Communicates with substance misusers appropriately and sensitively. [G2, G3]
e)Is able to counsel and advise individuals about their substance misuse and enable them to take their medication as prescribed whilst respecting their privacy and treating them with dignity [G2].
f)Knows how and when to refer / signpost clients and when to ask for support and advice [G7].
g)Understands the legislation, ethics, duty of care and professional judgement for this client group [G1, G10].
h)Is aware of the management, planning, and delivery of pharmacy services for substance misusers including conflict resolution. [G4, G5].
3. / Framework of Training
3.1Underpinning Knowledge
A Centre for Pharmacy Postgraduate Education (CPPE) open learning programme provides pharmacists with the necessary knowledge to underpin the provision of this enhanced service:
  • CPPE Substance Use and Misuse
This should be completed within six months of starting to provide a Supervised Consumption Service and a record of completion of this programme must be kept and a copy sent to the accrediting PCT for full accreditation.
CPPE also has a Pharmacy Technician Substance Use and Misuse open learning programme available. This will support the development of such services.
3.2Local PCT / Drug and Alcohol Action Team Commissioned (DAAT) Workshop
Attendance at a workshop is not considered a prerequisite in order for Pharmacists to provide a Supervised Consumptionservice. Knowledge of local services should be provided by reference to the PCT / DAAT’s service specification.
[The National Treatment Agency recommends that the PCT should arrange at least one contractor meeting per year to promote service development and update the knowledge of pharmacy staff.]
4. / Summary of Assessment & Accreditation
Each pharmacist must be undertaking or have successfully completed the required assessment for:
  • CPPE Substance Use and Misuse open learning programme
Temporary accreditation for the first six months may be achieved by written self declaration to the PCT stating that the CPPE training pack has been commenced and will be completed within six months. Full accreditation is proved by possession of an expiry dated certificate provided by the accrediting PCT which bears the standard mark of the NW Harmonisation of Accreditation Group. PCTs are recommended to maintain records of pharmacists accredited or re-accredited for a minimum of three years.
5. / Re-accreditation
Updates are recommended every two years which may be in the form of a self declaration of competency or other method of assessment as considered appropriate by the accrediting PCT. Where there are concerns regarding poor performance, this should be addressed separately as a clinical governance matter.

The complete document may be downloaded from:

Appendix 2: Three way agreement

Any client wishing to receive substitute medication for the treatment of drug or alcohol dependency must agree to and sign the following “contract.”

The contract below functions is a shared-care arrangement and is officially called a “Four-Way Agreement. The contract is agreed to and signed by you, IDAS, the prescribing doctor and your GP as well as your designated pharmacist.

This contract is initiated at the onset of treatment and needs to be mutually agreed. It outlines the expectations of the services involved and what you may expect from each. All parties shall be provided a copy of the agreement.

Open communication between these services is likely during the treatment period. Therefore, your signature on this contract gives IDAS your consent to liase with the other treatment providers listed.

Client Name / DOB / / /

Address

/

Phone

Prescribing
Doctor / Phone
Key Worker / Phone / 526654
GP/Doctor / Phone
Pharmacy / Phone
Drugs Prescribed / Daily Dose / Regime Details / S/V Consumption
Stabilising Dose or Reduction Plan
Daily / Weekly / Other
Pick Up - WHEN?
1.
2.
3.
Other Prescribed Medications / 1.
2.
3.

Client Signature: ______Date: _____ / _____ / _____

PRESCRIBING CONTRACT CONDITIONS
Client Name: / DOB
The following contains a list of conditions that must be agreed to prior to the initiation of a substitute prescription at IDAS. In order to obtain a prescription, you must sign that the following has been explained to you and that you understand and agree to the conditions that are listed. Your signature below signifies that you agree to the listed conditions for obtaining a substitute prescription.
Client Signature: / Date

You are expected to attend all appointments as necessary and to try and ensure that you are prompt. This also includes attending the pharmacy at an arranged time daily. If you are unable to attend an appointment with either your key worker or the doctor, you must telephone to cancel it and reschedule as soon as possible.

You must not make out of hours or emergency GP appointments with regard to the prescribing of your medication. If you are being prescribed by a GP, you should try to see the same doctor who has agreed to prescribe to you on each occasion. This is essential for the continuity of your treatment. If you are regularly late or if you miss your appointments repeatedly without contacting IDAS or your prescriber, your prescription may be temporarily withheld at IDAS until we are able to re-establish contact with you.

Threatening, abusive or offending behaviour such as stealing, either towards staff members or IDAS property will not be tolerated by IDAS, the GP surgery or your pharmacist. Such behaviour is likely to result in your prescription being stopped and treatment services being withdrawn. Police may also be contacted depending upon the severity of the incident.

You need to attend a nominated chemist at an agreed time. You must also inform IDAS of any changes with regard to this arrangement. The pharmacist requests that you attend their premises unaccompanied and that you do not loiter before or after picking up your prescription. They also request that you do not attend while under the influence of alcohol or other drugs Smoking and alcohol consumption is forbidden on the premises of both IDAS and the pharmacy.

You are required to attend your pharmacist daily to have your medication dispensed. A double dose will be given on Saturday. Initially, dispensing of your prescription is likely to be on a supervised consumptionbasis. This requirement normally lasts for at least 3 months or until you have attained stability. You may be required to wash you medication down with water or to talk to the pharmacist to ensure that it has been swallowed.

According to law, your medication must be dispensed directly to you as designated on your prescription. The pharmacist cannot give you anything other than what is stated on your prescription and only the designated dose on the date indicated. If you repeatedly miss collecting your medication or if you do not collect it for 3 days or more, then, for safety reasons, your prescription will be stopped and your treatment will be formally reviewed. Any dose that is not consumed or is missed cannot be collected at a later date and will be deleted from your prescription. Please note your medication will not be dispensed to anyone other than YOU!

It is your responsibility to ensure that you have a valid prescription at the chemists. Once the prescription has been issued or the medication has been dispensed it is your responsibility to look after it.Lost, stolen or damaged prescriptions and medication will not be replaced.

Your medication is for your use only!– Since it is prescribed to you, you are legally entitled to be in possession of it. However, supplying your medication to any other person, for whatever reason, is a criminal offence.