REGULATION 20 – The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

Regulation 20 requires the healthcare provider (in this case LPFT) to notify patients and their families of any unintended consequences caused by a regulated activity such as rapid tranquilisation.

If QT prolongation or reduced oxygen saturation below 90% is discovered the healthcare provider must inform the patient and their relatives that this unintended consequence has occurred. This is known as “duty of candour”

Failure to comply with the HSCA 2008 is a fitness to practice/hold office issue.

Zuclopenthixol acetate should never be prescribed for the following Appendix 2: Physical Health Monitoring Record

Patients who accept oral medication to treat agitation or psychosis eg antipsychotics. Patients who are neuroleptic naive.

Zuclopenthixol Acetate Physical Health Monitoring Form:

Patients who are sensitive to extrapyramidal symptoms (EPS)

Patients who are pregnant

Patients who are unconscious

Patients who have advanced hepatic or renal impairment

Patients with cardiac disease eg QT prolongation, recent MI, heart failure, cardiac arrhythmia, bradycardia (see SPC for further information)

Patients with history of seizures or epilepsy.

Appropriate S62 MHA paperwork should be completed to enable legal administration of zuclopenthixol acetate and other prescribed medications eg procyclidine, benzodiazepines. Unfortunately I am cut out of everything and I do not think from what Elizabeth has said that she has been given informed consent.

Rapid Tranquilisations

How many other family members have not been informed of frequent rapid tranquilisations involving restraint likewise. At Cygnet this seemed to be quite a frequent occurrence too.  Therefore a record of all this surely needs to be given to the family as per the above legislation.

Legal Duties: All staff should be aware of the legal framework that authorises the use of these interventions.  The guidance of the Mental Health Act Code of Practice (chapter 19) and the· Mental Capacity Act Code of Practice chapter 13 should be followed.  Any departures from the guidance should be clearly recorded and justified as· being in the service user’s best interest.

The problem is how can they say a treatment at enormous dosage is “best interest” when it leads to frequent rapid tranquilisation and no attempt is really looked at to explore pathological causes.

6.3.8 (LPFT) Guidelines for Medication Administration for Out of Area Patients Occasionally LPFT patients who have moved out of area may need medication both supplying and administering. There may also be patients who are not known to LPFT services that require medication whilst they are residing within Lincolnshire. The pathways for dealing with both of these circumstances can be found in Appendix 7.   Please supply Appendix 7. This I have requested.

Only medicines that are licensed in the UK may be prescribed, and only at doses listed in the British National Formulary (BNF) Occasionally a consultant may wish to use a medicine at a dose not listed in the BNF, or for an indication not covered by the terms of its UK licence, or use a medicine with no UK licence. In such cases the consultant MUST first complete an unlicensed medicine request form (Appendix 9) by completing this form the consultant accepts responsibility for all outcomes resulting from this use of the medicine. Pharmacy will NOT supply an unlicensed medicine, or a medicine being used outside the terms of its UK licence, or a medicine outside of BNF dosing recommendations unless the unlicensed medicines request form has first been completed. Where prescribing occurs outside of a UK licence of BNF dose limits, this will be highlighted to the relevant consultant (Appendix 9). So in that case why was Elizabeth told about being sent to London to put on a drug totally ineffective and not even licensed in this country and why is that allowed to go on? ie Clozapine IM injections.

Prescribing should be informed by evidenced based practice, local and national guidelines and formularies. Prescribing decisions should be made in reference to local policy; PACEF guidance and the Lincolnshire joint formulary.

Unlicensed Medicines / off label prescribing – see Appendix 9 for guidelines • Unlicensed medicines refer to a product that does not hold a UK marketing authorisation (product licence). • Off label prescribing is where medicines are prescribed outside of their licensed indications. • Consideration should be given to any obvious licensed medicines available to meet the patient’s need, there should be sufficient evidence base to support the prescribing and the Prescriber takes responsibility for any prescription that is unlicensed or off license use. Documenting the rationale clearly for the medicinal product choice.

Adverse Reaction Reporting • If a patient becomes aware of a severe or unexpected reaction to a prescribed medication the Prescriber should complete the Adverse Drug Reaction (ADR) reporting form or ‘yellow card scheme’. • The ADR must also be documented on the patient’s electronic notes, any prescription charts, and the GP informed. Informing Patients • Professionals must ensure that patients are aware they are being treated by a Prescriber and the scope and limitations of their prescribing. • If the patient is being cared for under a clinical management plan then the patient should be involved in the review of the plan. Well perhaps they can look thoroughly into the facts below:

Elizabeth has a large sebaceous cyst on her head.  This is well associated with the long-term use of neuroleptic medications.

That also needs a medical appraisal done.  This is not simply a cosmetic ADR but indicates a potential endocrine disorder linked to her inability to metabolise drugs. Incidentally this has also been known about for years.  Sebaceous cysts are NOT benign.  For one thing they may mask subdural lesions and inflammation making them difficult to define

Elizabeth needs monitoring for QT prolongation & blood oxygen saturation levels.  If oxygen sats fall below 90%, remedial action should state, “seek urgent medical review”.

Rapid tranquillisation is a regulated activity under  The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.