SOAD Guidance - SOAD Handbook

This handbook is intended provide generic guidance. 

It should be read alongside the other MHA and HIW guidance. HIW has a legal duty to appoint and maintain a list of appropriately qualified medical practitioners to provide independent opinions under the Mental Health Act. This is crucial for safeguarding patients’ rights and ensuring that patients receive appropriate psychiatric treatment under the relevant legislation. 

The second opinion appointed doctors (SOADs) are appointed by HIW but not employed by HIW. Their role is to provide an independent opinion on treatment and therefore fulfils an important safeguarding function. 

Important points to note

1. If you are issuing a CO3 without being able to meet the patient face to face, by phone, or video conference (for example, If they refuse to see you or speak with you) please describe what attempts have been made to contact the patient. It may not be appropriate to issue a CO3 without a time limited, especially if authorising medication above British National Formulary (BNF) doses or complex medication regimes. If in doubt, please discuss with the Lead SOAD.
2. While your medical opinion is always an independent one, it may be appropriate to seek advice from HIW about completing a form or about a situation you encounter during an assessment, particularly if you are new to the role. 
3. Feedback from Second Opinion Appointed Doctors is important for updating this guide, keeping it relevant, and identifying topics and case presentations for the SOAD annual seminar. Suggestions are always welcome. 
4. SOADs may take a break from this work for personal or professional reasons. There is no need to be removed from the SOAD list if there is a period when you cannot undertake SOAD work. Please let the HIW administrative team know if this applies to you, or if you have any planned leave, so they know not to contact you during that time.
5. If there is a period that you would like more SOAD work, please get in touch.
6. We often struggle to find SOADs available for some geographical areas (for example, North Wales). Any offers will be greatly appreciated. 
7.  HIW may remove a doctor from the SOAD list if we are not satisfied that they continue to meet the criteria for inclusion on the list, or if we are not satisfied with the quality of their work despite suggestions for improvement.
8. HIW may remove a doctor from the SOAD list if we are not satisfied that they continue to meet the criteria for inclusion on the list, or if we are not satisfied with the quality of their work despite suggestions for improvement.
9. There is currently no limit on how many SOAD assessments you do per day. You decide what is suitable and appropriate. SOAD work is very flexible. You can do as many or as few assessments each month as you wish, but we hope you will offer to undertake at least 20 assessments a year. 
10. An early response to assessment requests is much appreciated so that our administrative staff can allocate SOADs for assessments efficiently. Please note that if you are explicit about offering a virtual assessment, the expectation is that assessment will take place face to face. You need to be clear about this when you offer to take any work.

SOAD purpose

• A voice for patients, listening to patients
• Safeguarding those who might have treatment forced upon them.
• Making sure that the patient, or those with authority to make decisions about their mental health treatment, are heard (such as court deputies and holders of powers of attorney). Best wishes and best interests influence substituted decision making.
• Safeguarding those who lack capacity, or those who are capaciously refusing treatment for which the SOAD certifies treatment.

• safeguard the rights of patients detained under the Act who either refuse the treatment prescribed by the Approved Clinician or are deemed incapable of consenting. 
• SOAD acts as individual and must reach their own professional judgement 
• The role of the SOAD is not to give a second clinical opinion but to decide whether 
  • the treatment recommended is appropriate, and 
  • due consideration has been given to the views and rights of the patient, and
  • the treatment is a medical necessity and in the best interest of the patient

1. Health Board (HB) sends SOAD1 or SOAD2 referral via secure email or portal to HIW.
2. HIW administrative staff check the request is complete and allocate a case number for each referral.
3. SOADs receive email communication with case numbers (usually twice a week), This includes information such as SOAD1 or SOAD2, medication and/or ECT, whether the patients is refusing or incapable of consenting, health board and hospital details, and any identified conflicts.
4. SOADs should respond promptly if they are able to take any referrals. They should clearly indicate if they want to carry out virtual assessments, as otherwise the expectation is that they will  see the patient face to face.
5. SOADs should read the uploaded information on to Objective Connect portal, contact the hospital, and arrange a visit. 
6. SOAD will want to interview the patient in private if possible. Others may attend if both the patient and the SOAD agree, or if it is thought that the SOAD or others would be at significant risk of physical harm from the patient.
7. SOAD should consult with the person in charge of the treatment,  and must consult two statutory consultees. The SOAD should also be prepared to consult a wider range of people professionally involved in the patient’s care. 

8. (A) Where sections 57, 58 or 58A apply: One statutory consultee must be a nurse; the other must not be a nurse or a medical doctor.

   (B) Where section 4A applies: at least one statutory consultee must not be a medical doctor and does not need to be a nurse. Neither consultee may be the clinician in charge of the of the proposed treatment or the responsible clinician.

   (C) Both consultees must have been professionally concerned with the patient's medical treatment.

       (D) Statutory consultees may include: a nurse, pharmacist, social worker, occupational therapist, psychologist, art therapist or psychotherapist, or other professionally registered individuals involved in the patient’s care.

    9. Once the review and consultations are completed, the SOAD should complete the relevant certificate, sign and date it,  and upload to Objective Connect

   10. The SOAD should complete SOAD3 form and the fees and terms and conditions form, then upload them to Objective Connect so administrative staff can remove the request from the SOAD’s page and submit the invoice to the finance team.

   11. The SOAD is expected to keep any relevant notes for four weeks and then shred them securely. 

CoP for medication after first 3 months

• Must clearly set out the specific forms of treatment to which they apply.
• All relevant drugs should be listed, including “as required” medication and drugs for side effects, either by name or by the classes described in the British National Formulary (BNF) or electronic British National Formulary (eBNF).
• If drugs are specified by class, the certificate should state clearly the number of drugs authorised in each class and whether any drugs within the class are excluded.
• The maximum dosage and route of administration should be clearly indicated for each drug or category of drugs proposed.
• A copy of the current certificate should be kept in the patient’s notes and with the patient’s medication administration record.

   1. What information do you need from the case material, the RC/AC in charge of treatment, and the consultees?

• What is the formulation of the patient’s problems, and is it correct?
• What treatment is the patient currently receiving?
• What is the treatment plan being requested, and what is the rationale for the plan?
• What (non-pharmacological) treatment alternatives have been explored?
• What are the risks and benefits of the treatment proposed, including the burden of any side effects?
• Is the treatment medically necessary? 
• What are the views of the patient about treatment, and have these views been taken into account?
• What are the team’s views about capacity? (Usually, the SOAD request follows a capacity assessment, but different team members have different perspectives.)
• How will the RC know if the treatment has worked?

   2. Call the hospital before your visit to ensure the patient is NOT on leave or has not moved wards or hospital (This happens frequently.)

   3. What if the patient refuses to talk to you?

• It is good practice to at least see the patient or confirm refusal directly with the patient This is not always possible when working remotely, so you need a clear description of patient’s response)
• You may continue the assessment even if the patient refuses to participate
• It is acceptable not to see a CTO patient, although an assessment should still be offered.
• Patient assessments should normally take place in private, though exceptions apply, for example:

      - e.g. the patient is vulnerable and wants a familiar face around.    

      - there are risk issues

• Difficult assessments

  - Patient in seclusion

  - Patient in long-term segregation

   4. What will you be looking for when you interview the patient? 

We all work differently, but key areas to explore include:

• Encouraging engagement in the interview and explaining the purpose of your interaction. *   
• Understanding their story of contact with services
• Identifying What symptoms, they are presenting with now
• Exploring What side effects from they are experiencing from their treatment
• Assessing their understanding of their mental disorder and its treatment.
• Establishing What, if any, understanding they have of the RC’s future treatment plan?
• Exploring their view of perceived risk.

You also need to decide on the medical necessity of the proposed plan, and the patient’s capacity.

You should thank the patient for their time at the end of the interview. You do not tell the patient what you have concluded.

   5. Writing up Treatment Plans

  (A) A SOAD’s treatment plan sets out the parameters for treatment – itis not an instruction to the RC/AC in charge of treatment. It must be readily comprehensible by RCs and dispensing nurses

• It is acceptable to use paper BNF or eBNF as reference when completing treatment plans. (It may be helpful to quote the edition if using a paper BNF).
• Be aware that the BNF changes over time, as does clinical practice. For example, note the increased concerns about valproate and updated safety guidance.
• If drugs are specified by class, the certificate should clearly state the number of drugs authorised in each class, and whether any drugs within that class are excluded. The maximum dose and route of administration should be clearly indicated for each drug or category of drugs proposed. 

  (B) Treatment plan can be completely explicit, specifying certified medications and dosages

• Zuclopentixol decanoate up to 400 mg weekly
• Mianserin up to 30 mg daily

Generic, allowing flexibility within the BNF:

• One depot antipsychotic within BNF limits (or up to 67% BNF limits if preferred)
• One oral antidepressant within BNF limits  (or up to 67% BNF limits if preferred)

A mixture of explicit and generic:

• One depot antipsychotic within BNF limits
• One oral antidepressant within BNF limits
• As required for agitation 
• Promethazine orally or intramuscularly (regular and/or as required): 25 mg – 50 mg, with a maximum of 100 mg in 24 hours

   (C) Treatment plans – specifying BNF limits

The major concern is antipsychotic polypharmacy and high dosage antipsychotic treatment. Remember the Royal College of Psychiatrists Consensus Statement or any available local guidelines.

Dosage levels are calculated using “the percentage method”

• For each antipsychotic requested, what percentage of the BNF maximum is being used?
• Regular and as-required medication both count to the 100% limit. For example,
• Zuclopentixol decanoate 600 mg weekly = 100% 

• Olanzapine (oral or IM) for tranquillisation 10 mg in 24 hours = 50%   

  Total = 150% of BNF limits, therefore high dosage

• Consider being specific when authorizing prn medication. A possible form of words is:
• One depot/ LAI (Long-Acting Injectable) antipsychotic within BNF limits
• As required for severe agitation: olanzapine orally or intramuscularly up to 10 mg in 24 hours

(likely alongside other medication requested)       

   (D) Ensuring what you think and write is what happens

• Remember that a CO3 can last a long time, and RCs may change – from someone you know well to someone entirely new. Treatment plans must therefore be clear and explicit.
• Use the BNF textual descriptors, for example: “One oral antidepressant within BNF limits.”
• You can be more specific if you wish, for example: “One oral selective serotonin reuptake inhibitor for treatment of obsessional symptoms.”
• You will often wish to be specific in certifying adjunctive treatments, for example use of augmenting aripiprazole in low dose to address hyperprolactinemia.
• you can time-limit parts of the treatment.
• Off license medications should be specified.
• You advise monitoring or note that treatment will be in accordance with HDAT policy.

   (E) when the BNF isn’t useful

Some common treatments are not covered within the BNF, for example:

• Clonazepam for mania and management of acute behavioural disturbance
• Lorazepam and promethazine for sedation

The recommendation here is to specify the indication, the route of administration, the drug, and certified dosage range. You should consider doing this for any “off license” treatment

Certification of antipsychotics for management of behavioural problems associated with dementia, learning disability/autism, or personality disorder

The recommendation here is to think carefully about whether the treatment is “medically necessary”. If you conclude that it is, it seems appropriate to refer to recognized BNF limits for antipsychotics.

Dose limitation and specifying the antipsychotic used (for example, risperidone for multiple indications and clozapine for Emotionally Unstable Personality Disorder (EUPD) may be appropriate and aligns to the evidence base.

General principles

Reasons must address the “medical necessity” of the treatment certified and, for a CO3 and CO6, the capacity assessment of the patient

• For CO3s, if you assess the person as having capacity but authorise treatment, you will need to provide compelling reasons for doing this (see Jones 24th edition 1- 770 p. 370)
• Make clear what evidence you took into account.
• Consider including direct quotes from the patient.
• Incorporate the patient’s views and explain if, and why you differed.
• If there were professional differences of view, explain why you took the approach you did.
• It is helpful to have a structure for your reasons …
• … but it is important that reasons are not entirely formulaic or generic, and that they relate to the specific details of the case.
• It is up to you to develop your own way of working.
• We are planning to draft guidance for reasoning that sets out how SOAD work is assessed and will act as a useful prompt 
• Reasons need to weigh the risks and benefits of the proposed treatment.
• Do not forget to consider relevant physical health issues.

Specific aspects to cover in reasons writing

 1. Evidence of mental disorder and its severity

1. The SOAD should record RC’s diagnosis, including sufficient details of past history and admissions, as well as the current admission, to characterise patient’s disorder in the Reasons section.
2. The SOAD should record key features of the patient’s mental state and behaviour (from the interview) or relevant abnormalities from the clinical record in the Reasons section.
3. The SOAD should record the impact of the patient’s mental disorder on their presentation, behaviour and social functioning in the Reasons section.        
4. The SOAD should record key risk history, including recent or past harm to others, self-harm, or harm to the patient’s own health, or note if any risk history is absent in the Reasons section. 

 2. RC’s Treatment Plan and Discussion with consultees

1. The SOAD should document the discussion with consultees in the Reasons section.
2. The SOAD should record the outline treatment plan at the time of the assessment, as requested by the RC/AC in charge of treatment, in the Reasons section.

 3. Patient’s views about the treatment plan

1. The SOAD should record whether the interview was carried out in person or remotely.
2. The SOAD should record the patient’s views about current or proposed treatment, including possible benefits and possible or actual side effects, using direct quotes where possible.    
3. If the patient is mute or unwilling to cooperate, a clear explanation should be documented, along with details of attempts made. 

4. Approval of the treatment plan

1. Does the treatment plan, as certified, include a clear rationale in the Reasons section, including, where necessary, whether alternatives have been explored?  
2. The SOAD must give explicit reasons for supporting above BNF limits for antipsychotics – whether as a single drug or cumulative (including PRN & depot medication).
3. The SOAD must indicate whether the treatment authorised is “appropriate treatment”.   

Under the revised Act, SOADs approving treatment must certify that “it is appropriate for the treatment to be given”.  This means that treatment must be:

• “…appropriate in [the patient's] case, taking into account the nature and degree of the mental disorder from which he is suffering and all other circumstances of his case; and
• “treatment the purpose of which is to alleviate, or prevent a worsening of, the disorder or one or more of its symptoms or manifestations.”  

Factors to consider include:

• The patient’s views and wishes regarding treatment 
• The applicable advanced decisions
• Physical health and how this influences treatment
• Disabilities (physical, sensory, mental or communication related)
• Culture, ethnicity, age, gender, sexual orientation, religion and beliefs
• Location of available treatment
• Implications for family and social relationships 
• Education, work and employment considerations
• Consequences of the patient not receiving treatment
• Willingness to accept treatment 
• At what point in the course of treatment it is appropriate to administer the intervention

   d. The SOAD should indicate -when considering the authorisation of treatment without consent - whether such treatment is medically and therapeutically necessary?

   e.  When considering the authorisation of treatment without consent, the SOAD should also indicate whether such treatment is in the patient's best interests. 

 5. Capacity Assessment

1. The SOAD should clearly document the patient’s capacity. The SOAD should explain the basis for their conclusion on capacity, providing clear reasoning.  

They should also consider explicitly documenting the specific points on which the patient fails capacity assessment.

Inability to make decisions

For the purposes of section 2, a person is unable to make a decision for himself if he is unable - 

1. to understand the information relevant to the decision,
2. to retain that information,
3. to use or weigh that information as part of the process of making the decision, or
4. to communicate his decision (whether by talking, using sign language or any other means).

SOADs will need to avoid errors in completing Certificates, as thesemay invalidate them. For example:

• No second consultee entered where one is necessary
• Certificate unsigned
• Certificate undated or dated incorrectly
• Use of wrong Certificate for ECT or medication
• Failure to delete non-applicable capacity clauses
• Use of non-professional consultee
• Transposition of names or designations into wrong boxes

To avoid conflicts of interest:

• Do not complete a SOAD opinion for a patient where you have sat on a Tribunal, and vice-versa. The rule is two years. 
• Avoid undertaking SOAD work within your own health board - and for one year after you have left it. 
• Always avoid past patients of yours. 
• It is impossible to avoid RCs you know. 
• You may wish to avoid your partner’s patients.

1.  Medications authorisation - Class, route, dose 

• Must clearly set out the specific forms of treatment to which the authorisation applies.
• All relevant drugs should be listed, including “as required” medication and any prescribed for side effects, either by name or by the classes described in the BNF or eBNF.
• If drugs are specified by class, the Certificate should state clearly the number of drugs authorised in each class, and whether any drugs within  that class are excluded.
• The maximum dosage and route of administration should be clearly indicated for each drug or category of drugs proposed.
• A copy of current Certificate should be kept in the patient’s notes and with the patient’s medication administration record.

   2.  Regarding Clozapine - Does SOAD need to request authorisation in the first three months?

• No authorisation is needed in the first three months. Clozapine follows the same requirements as other medical treatment.
• After three months, Clozapine administered intramuscularly is not licenced in the UK, and its use should follow a local provider protocol. It may be used as an option during the early titration of patients onto clozapine and is strictly a short-term measure.
• It is for providers to develop a protocol for the use of this unlicensed (and relatively expensive) medication. This work is generally led by the Head Pharmacist and Medical Director. 
• English providers would not normally consider using intramuscular clozapine under Section 62; however, it would not be unlawful provided that the criteria for necessity under Section 62 could be demonstrated.

   3. We have had a patient change their name by Deed Poll who is on a CO3. Do we need to do a Report 1 or any review forms because of this?

• An address change after a CO3 does not invalidate the form. Using the same principle, a name change does not invalidate it either.
• Staff involved should document the name change by Deed Poll in the patient’s case notes.
• There is no need to change the name on CO3 unless the section is due for renewal and detaining authority uses the new name on the section papers. At that point, it would make sense to request a SOAD.

Ultimately, the health board may need to take legal advice on all such forms.

   4. Query from MHA administrator - The ECT suite does not think the SOAD has included enough information on Form C06 to explain the treatments. From what I understand,  they believe ‘maintenance ECT’ should have been mentioned.

• There is no legal requirement to mention maintenance ECT, although it may be useful.

It is more important that the number of ECT treatments is recorded. From a practical perspective, noting ECT treatments given, and those to be given before using the new CO6 form is, helpful. This aligns with common practice under section 62, where the phrase “including previous treatments under section 62” is often used.

   5. Valproate request for under 55 years old

MHRA Valproate requirements - Please read the MHRA information regarding Valproate. 

• If a Responsible Clinician (RC) plans to use Valproate for a patient under 55 years old, must request a local second opinion. 
• SOADs must not be used as the second “independent specialist”. If the local second opinion doctor agrees with the RC’s decision, the RC may then request a SOAD assessment (where applicable, as with any other medication). 
• When the SOAD discusses the treatment plan with the RC, the SOAD should ask whether the MHRA requirements have been met. 
• If the SOAD authorises Valproate, they should state on the CO3 or CO7, as a condition, that the MHRA requirements must be met.

   6. Anxiolytic drugs CO3

RC’s have sometimes asked whether an entry for a “regular anxiolytic” covers medications other than Benzodiazepines and Buspirone (which are included in full in the anxiety chapter of the BNF), for example antidepressants or Pregabalin. 

We have previously considered that this would not comfortably include other drugs such as antidepressants prescribed for anxiety or Pregabalin. 

However, we now take the view that it is reasonable for a SOAD to write an entry for a regular “anxiolytic” with the intention that this should cover any drug licensed for anxiety or anxiety disorder. 

If you wish to authorise particular drugs or types of medication, please specify this in your entries and make this as clear as possible to RCs. 

Please also phrase your entries clearly where there are medication you do not wish to authorise. 

examples of CO3 entries:

• Fluoxetine (oral, regular) off-licence for anxiety, up to a maximum daily dosage of X mg per day
• A regular oral SSRI for anxiety, as per BNF dosage and frequency guidelines where licensed for anxiety; or, if an SSRI is used off-license for anxiety (and the SOAD wishes to authorise this), as per BNF dosage and frequency guidelines for depression (or state the appropriate limits) 
• An antidepressant licensed for anxiety, as per BNF dosage and frequency guidelines for that indication
• If you wish to authorise Pregabalin, please state that the Pregabalin is for generalised anxiety disorder

   7. The patient is refusing to speak to the SOAD or is not available for interview. Can a CO3/CO7 form still be issued? 

The Mental Health Act states that the functions of the SOAD include interviewing the patient, carrying out a medical examination and inspecting medical records. Normally, the SOAD would be expected to interview the patient as part of their assessment. 

The SOAD is expected to consult with the patient except when it is impracticable to do so. in such circumstances, a certificate may be issued without an interview or consultation. It is good practice for the SOAD to make reasonable efforts to interview the patient. 

If an inpatient is not available, a second assessment should be arranged. If the patient is in the community, there should be a discussion with the RC or other staff about arranging a second assessment. This could coincide with a CPA meeting, or outpatient appointment, or a community visit with a CPN. 

The principle is that a patient should not be able to avoid treatment simply by repeatedly avoiding an interview or refusing to speak. In such case, the SOAD may have to judge whether to return for a second assessment or whether the clinical grounds are sufficient to issue the CO3. Factors may include urgency of treatment (for example, ECT) and the degree of disturbance, such as a severely psychotic presentation.

To  complete a CO3, the SOAD must be able to reach a judgement on: 

• The patient’s capacity
• The likelihood of the treatment benefiting the patient
• For ECT, whether the patient lacks capacity to consent

In practice, the SOAD may be able to reach  the necessary conclusions after reviewing the case notes, discussing the patient with the RC, the two statutory consultees, and other members of the care team who may know the patient’s views about treatment. 

If a certificate is issued without a patient interview, in addition to sending the CO3 form, we advise the SOAD to consider sending a letter or report to the RC recording the circumstances of the decision. It may also be appropriate to issue a CO3 with a time limit, such as advising review within one year, or in some cases within a few months (particularly where polypharmacy or HDAT is involved). 

   8. What would be considered a conflict of interest for a SOAD? 

It is not possible to predict every situation.

In general, SOADs should avoid any perceived conflict of interest. If this is a possibility, an alternative SOAD should be arranged. Please inform the administrative team if you think there may be a conflict of interest when you receive a request for assessment. 

We recently held a helpful discussion and considered the pros and cons of our previous guidance. 

We agreed that:

• If you have previously been the RC for the patient, you should not be the SOAD for at least two years. After that period, the patient must agree to you undertaking the assessment.
• If you have recently moved health boards, you cannot accept any referrals from your former health board for one year.
• If you were the medical member of a tribunal for the current CTO, you should not be the SOAD.
• If a SOAD subsequently becomes the RC (for example, due to service reorganisation, job changes, or the patient moving to another area), a new SOAD opinion should be arranged as soon as possible.
•  Psychiatrists working in the private sector must not assess patients in their own hospital or any related facility belonging to the same company.
•  Issues sometimes arise about subsequent SOAD assessments for an individual patient. While it may be appropriate for the same SOAD to carry out a further assessment when a new CO3 is required, this should be arranged by  HIW. An RC or health board may request  the same SOAD, but the final decision rests with HIW
• SOADs should decline assessments if there could be any other perceived conflict of interest (e.g. relatives or close personal friends). If in doubt, always discuss with Lead SOAD or Admin Team.

   9. What paperwork is required if the treatment plan is not approved? 

A few SOADs have been unsure about whether to issue a CO3 if they are not approving treatment. The CO3 is the certificate of the SOAD’s consent and must not be completed if you believe the treatment is inappropriate, or it is no longer being proposed for any reason. Instead, a short letter outlining your position should be sent to the RC. A copy should also be sent to HIW via OC.

It is always helpful to have a constructive discussion with the RC to see whether mutual agreement can be reached. It is also helpful to seek advice from the Lead SOAD where appropriate. A SOAD has the option of not issuing the CO3 and contacting HIW for further advice. It is also possible to recommend that another SOAD with specialist experience should see the patient. 

SOADS sometimes issues a time-limited CO3 (for example, six months) and/or specify an action e.g. obtaining a pharmacist’s opinion. Please remember if this is part of your authorisation, it must be included within the treatment description  on the CO3 form itself, and it is the RC’s responsibility to request the next SOAD visit.

   10. What is the status of a previous CO2 when a CO3 is issued? 

It is legal to have a CO2 and CO3 in place at the same time for different medications. In Wales, we do not particularly recommend this, but we accept it is legally permissible.

If a CO3 is issued, it revokes any previous CO2 for the same medications. We would also advise discussing with the RC whether any of the remaining medications should be included on the CO3, or whether the patient still has capacity to consent to some items. 

If medication previously listed on a CO2 is added to a CO3, the SOAD should advise the RC that the new CO2 is required (or the SOAD may issue one at the same time as the CO3). Alternatively, the SOAD may decide, following the discussion with the RC, that all medications should be included on the CO3. Ultimately, this is a matter of SOAD’s judgement. 

A CO2 or CO3 will cease to be valid when a patient is no longer subject to treatment under the Mental Health Act.

   11. Do SOADs need authorise medication as covert when it is used covertly?

• This is not a SOAD issue (Although it is an important issue for MHRT)
• Do not comment on “covert” medication within the certified treatment plan
• Instead, you may include wording in the Reasons section along the following lines:

“I note that it is proposed to give medication covertly, it will be necessary to follow appropriate policies and procedures” 

It is then for the RC to decide what to communicate to the patient. 

   Q1. How should a SOAD respond to a request to approve the unlicensed use of licensed medication (off-label prescribing)? 

This issue has been raised by several SOADs, and the following is intended as general guidance. 

Many treatments used routinely in psychiatric practice involve unlicensed uses of licensed medications. SOADs have also asked for guidance on how to consider requests to approve novel treatments or ‘unlicensed combinations’ that they may be unfamiliar with.

General principles:

• no SOAD should feel obliged to approve a treatment outside their expertise. If the treatment falls beyond your competence or experience, the referral should be returned to HIW so that it can be allocated to another SOAD.
• When considering an unlicensed indication, SOADs should refer to the Royal College of Psychiatrists’ publication CR210 - Use of Licensed Medicines for Unlicensed Applications in Psychiatric Practice (2nd edition, 2017). 
• If there is evidence supporting the effectiveness of the proposed treatment, and the SOAD agrees with the clinical rationale, a Form CO3 may be issued. For high-dose antipsychotic treatment, reference may be made to the Royal College of Psychiatrists’ Consensus Statement on High Dose Antipsychotic Medication (CR190, May 2014). 
• SOADs may also refer to other guidelines or local protocols in the treatment plan authorised on the CO3. 
• SOADs should consider carefully what is recorded in the CO3 treatment plan. Where a SOAD approves use of a medication for an indication for which it is not licenced, they should: 
• specify the precise indication and explicitly state that the use is unlicensed. 
• specify the dose authorised, including individual doses, dose intervals (where appropriate), and always the maximum daily dose.
• If approval is time-limited, specify this clearly, along with any required review before the treatment is continued.
•  or specify monitoring of physical health, such as blood tests. A review of medication options by a clinical pharmacist with experience of mental health could be recommended. If the medication involves combination therapy, there could, for example, be references to respected guidelines such as Maudsley Prescribing Guidelines for dose ranges. Alternatively, a specific reference in the literature could be included in the treatment plan on the Form CO3. Examples include augmentation of Clozapine with other antipsychotics.

It is the responsibility of the referring RC to ensure that a copy of any literature or references is available for the SOAD to refer to, and that a clear rationale for the use of the medication is recorded in the case notes. 

SOADs have been asked to consent to treatments which they regarded as unproven and considered it debatable if they should be included on a CO3. On the one hand, there is concern about a wide range of products being included inappropriately on a Form CO3 and being given a legitimacy as treatments, they may not have. On the other hand, Part of the Mental Health Act refers to any medicine being “given as treatment for Mental Disorder or in consequence of the patient having a mental disorder” and should therefore be included if the treatment is intended for this purpose. If there is any doubt, it is probably safer to add a medication to a treatment plan. As evidence develops, the advice for any one medication may therefore change over time. This is intended as general guidance and SOADs are welcome to contact HIW to discuss specific situations. Feedback is welcome so that this guidance can be further developed.

It may be helpful  to read:

• Royal College of Psychiatrists, Use of licensed medicines for unlicensed applications in psychiatric practice (2nd edition) (CR210, Dec 2017)
• GMC, Prescribing unlicensed medicines – ethical guidance
• Royal College of Psychiatrists, Consensus statement on high‑dose antipsychotic medication (CR190, May 2014)

   Q2. Should treatments for drug and/or alcohol dependence be included on a CO3? 

We are most commonly asked about treatments for drug dependency, such as Methadone, or for alcohol, such as Antabuse. The Mental Health Act (MHA) states that a person is not mentally disordered by reason only of “dependence on, or use of, alcohol or drugs.” 

Occasionally, it may be appropriate to include this on a CO3 certificate if it forms part of the overall treatment plan for a drug-induced psychosis. However, in general, as drug dependence is excluded as a mental disorder under the MHA, it would not be appropriate to include the treatment solely for drug dependency on a form CO3.

If there is any doubt, please consult with one of the senior SOAD doctors or Lead SOAD.

   Q3. Should medication for physical Health Issues and Side Effects be included on a CO3? 

Most medications for physical side effects of psychotropic medication (e.g. Procyclidine or Kwells) can be prescribed on CO3 forms. When a patient is developing side effects from a psychiatric medication and refuses the medication intended to lessen those side effects in order to prevent the administration of treatment for mental disorder, the medication to reduce the side effects becomes integral to the treatment of the mental disorder and therefore may be stated on the CO3.  

However, medications for physical health, such as routine diabetic medications and thyroid hormone would not normally be included on a CO3.  

There will always be some occasions where it is debatable whether to include a medication on the CO3, e.g. Propranolol, which may be used both for hypertension and anxiety. In such cases, decide which is the primary purpose. If in doubt, err on the side of including the medication on the CO3.

   Q4. Should fish oil (omega-3) be included on a T3B? 

If fish oil is being used as an adjunct treatment for schizophrenia by the RC, then it can be regarded as a treatment for mental disorder and can be included on a CO3. If it is being taken as a dietary supplement, then it does not need to be included. A CO2 would be completed if the patient is capable and consents. However, if the patient is consenting, we would not consider it a significant breach of the legislation if it is not included on a CO2 treatment plan, as it is only a dietary supplement.

   Q5. Should homoeopathic and herbal remedies be included on a CO3? 

SOADs have asked about this, and some RCs have felt pressurised by relatives to include these on the treatment plan for a CO3. In general, there is no evidence base for the use of this type of medication in mental disorder, and it is not appropriate for to include them on a CO3 for patients who cannot or do not consent. 

If a patient wishes to include such remedies on their CO2, we would not object, but do not regard it as necessary. It may be appropriate to include St John’s Wort, as there is some evidence from a Cochrane review. However, SOADs should be aware that the BNF advises that it should not be recommended or prescribed for depression, as it can induce drug metabolising enzymes, and several interactions have been identified. 

We think SOAD’s should be cautious about being asked to include items on CO2 or CO3 forms to give legitimacy to inappropriate, alternative or complementary treatments for which there is no evidence base (and/or for which they have no expertise), or as a mechanism to obtain hospital funding for over-the-counter remedies. 

If a patient is already receiving a homoeopathic remedy, it may be appropriate to include it on CO2 certificate if the patient has previously chosen to take this medication and is on established therapy. We would have concerns about it being commenced at the request of other parties, such as relatives. However, we do not think it can be regarded as a treatment for mental disorder and therefore should not be included on a CO3.

   Q6. Should medication for ADHD be included on a T3B?

ADHD is likely to be a co-morbid diagnosis, and, in this situation, all psychotropic medication should be included on form CO3 or CO2. Note that for some adults, certain medication for ADHD has unlicensed indications.

   Q7. Other medications 

Clonazepam: If used as an anxiolytic, this would be an unlicensed indication. 

Melatonin: The licence is for short-term use in adults over 55 for insomnia. 

The SOAD must make a clinical judgement about whether the medication is being used for the treatment of mental disorder. It should be clearly documented.

   Q8. Issues about mood stabilisers  

Sample wording for a general entry in a CO3 covering any one oral mood stabiliser can be taken to authorise any one of the following 4 medications:

“One oral mood stabilizer given regularly (which covers one of Lithium, sodium valproate, valproic acid (preparations such as Depakote), Lamotrigine or Carbamazepine) given within BNF dose and frequency guidelines.” 

If the patient is a woman of child-bearing age, then please include the sentence: 

“If sodium valproate or valproic acid is prescribed, this should be prescribed with the additional precautions of the Prevention of Pregnancy Programme.” 

It may be appropriate to specify individual mood stabilisers by name if you wish to do so. For example, to exclude valproate for a woman of child-bearing age. Please also ensure you are familiar with the recent guidance on valproate use in men. 

It is best practice to mention blood tests for lithium, although this is not essential. (Unlike Clozapine, blood tests must be specified on the CO3.)

   Q9. What does the Commission advise about Midazolam for emergency tranquilisation? 

This has been an issue for psychiatry because of intermittent manufacture and supply problems with IM Lorazepam since 2011. We advise SOADs to continue to discuss with the RC requirements for ‘if required’ medication in some detail. Consider whether oral Lorazepam alone would be sufficient for the patient. 

Midazolam is listed in the status epilepticus section of the BNF and is not licensed for the acute management of disturbed or violent behaviour. The CO3 treatment plan entry for IM Midazolam should record the indication (for rapid tranquillisation) and clearly state that this is an unlicensed use of Midazolam. This will usually be for use only when IM Lorazepam supplies are unavailable. If this is the case, this should also be stated in the entry. 

The SOAD should clearly state in the CO3 treatment plan entry the dose they are authorising (as there is no dosage range in the BNF for this indication). The medication prescription sheet/electronic prescribing should be written so that it is not possible for IM Lorazepam and IM Midazolam to be co- administered. In other words, it should be clearly recorded that IM Midazolam is for use only when IM Lorazepam is unavailable. 

Some SOADs have raised concerns about prescription sheets that might allow inexperienced nurses to give both medications. 

Sample wording for IM Midazolam on CO3: 

• “IM Midazolam can be used as an alternative to IM Lorazepam if IM Lorazepam is unavailable (unlicensed use of Midazolam).” 
• “IM Midazolam if required for severe agitation, max X mg per dose, minimum dosage interval Y hourly, up to a maximum of dose of Z mg per 24 hours.” 

It would be good practice to refer on the CO3 to any local protocols or guidelines for the use of Midazolam, however, the doses authorised should still be specifically entered on the CO3.

   Q10. How should CO3 entries for ‘if required’ Promethazine be worded? 

Promethazine hydrochloride is licensed for “sedation (short-term use)”. The doses listed in the BNF appear as single doses, without additional information on dosage intervals or maximum daily dose. Complete the CO3 entry specifying Promethazine hydrochloride (to distinguish from Promethazine teoclate). 

Example wording: 

• “Promethazine hydrochloride orally ‘if required’ for agitation, maximum single dose a XX mg, minimum frequency XX hourly, up to maximum XX mg per day (total dose combined with IM ‘if required’ Promethazine shall not exceed XX mg per day).” 
• “Promethazine hydrochloride IM ‘if required’ for severe agitation, maximum single dose a mg, minimum frequency b hourly, up to maximum c mg per day (total dose combined with oral ‘if required’ Promethazine shall not exceed x mg per day).” 

• Chapter 23 Appropriate Medical Treatment
• Chapter 24 Medical Treatment
• Chapter 25 Treatment subject to special rules and procedures
• Chapter 26 Safe and therapeutic responses to challenging behaviour