Aligning quality of life and guidelines for off-label psychotropic drugs in adults with intellectual disabilities and challenging behaviour

Figures & data

Figure 1. Delphi procedure.

Table 1. Statements where no consensus was reached in a Delphi procedure aimed to achieve consensus about statements on the responsible prescribing of psychotropic drugs in adults with intellectual disabilities and challenging behaviours (n respondents).

Principle	% ≥ 4 or 5^a	Median	IQR^b
Off-label use of psychotropic drugs or use outside professional guidelines’ advices is regarded from the perspective of ‘Quality of Life’ as a freedom-restricting measure*. *Freedom restricting measures are all measures that entail a restriction of the patient’s freedom of choice and/or freedom of movement and/or contact with the outside world. When applying freedom restricting measures, the criteria of proportionality, subsidiarity and effectiveness must be taken into account.	23.81	2	2.25
When commencing any psychotropic drugs for challenging behavior, an effort should be made to draw up a written multidisciplinary treatment plan, involving the patient’s and his/her family views*. The treatment plan includes at least information about the mechanism of action, the expected effectiveness of the medication, and potential side-effects. It also includes the plan for evaluation in terms of maintenance, reduction or cessation. * Efforts should be made to involve the family. If the family is unwilling or unable to participate, this should be reported in the medical file.	60.87	4	2
Recommendation
The prescriber and/or team should check and review the pharmacotherapeutic plan regularly. This should at least be taken into account the medical product’s criteria as listed in the BCFI* or GGZ-standaarden (Quality standards for mental health care in the Netherlands)** ; and preferably more frequently, adapted to the population and especially in the initial phase, depending on the indication, the drug, the context and the patient characteristics. *https://www.bcfi.be/nl/start **https://www.ggzstandaarden.nl/	73.91	4	1.5
The individual, a family member and/or their legal representative* should be informed and must give their consent (‘informed consent’) before medicinal treatment is commenced. The professional support worker should be informed about the medical treatment and is responsible for requesting the informed consent and should register the consent in the medical file. Preferably, information and/or consent should be sought again with each major change of dose and/or drug, except when changes are already included in the treatment plan**. *If there is no legal representative or family member, the personal caregiver should be informed and must give his/her consent. **If there is no time to inform or request the consent due to acute danger, this should be done retroactively.	60.87	4	2

^aAt least 70% of the participants agreed (score equal to or higher than 4).

^bInterquartile range.

Figure 2. Flow chart based on Embregts (2019). Multidisciplinaire Richtlijn Probleemgedrag bij volwassenen met een verstandelijke beperking. NVAVG, 2019.

Table

I. Principles	Reformulation (if required)	Consensus
1. Definition of challenging behavior: ‘internalizing and/or externalizing behavior that is seen as socio-culturally undesirable by the person him/herself and/or those around them in a specific context, and which is of such intensity, frequency or duration that it is harmful, stressful or damaging to the person him/herself and/or those around them’ (Embregts, 2019).		Round 1
2. More specifically, it is mainly about behavioral symptoms such as verbal and physical aggression, destruction of objects and sexual inappropriate behavior, that are severe and persistent, which do not respond sufficiently to non-medicinal treatments (NVAVG, 2016).	More specifically, it is mainly about behavioral signs and symptoms such as verbal and physical aggression, self-destructive behavior, internalizing harmful behavior and sexual inappropriate behavior, which cannot be explained from a physical condition, and which do not respond sufficiently to non-medicinal or other (i.e.. aimed at changes in environment) treatments.	Round 2
3. Psychotropic drugs* for challenging behavior can only be prescribed off-label in the interests of the client, when the challenging behavior is severe and persistent, when the other options have been exhausted, and under strict agreements regarding the indication, duration, evaluation and side-effects of the treatment. *Psychotropic drugs are drugs used to treat individuals with psychiatric disorders. These drugs act through the central nervous system and exert their effect by influencing affective and cognitive functions, thus also affecting behavior.	Psychotropic drugs* for challenging behavior should only be prescribed off-label or prescribed outside professional guidelines’ advices as an adjunctive therapy :1) in the interests of the patient;2) the diagnostics and the extent of non-pharmacological treatment are continuously cycled and reconsidered by a multidisciplinary team;3) there are strict agreements on following up on expected effectiveness, duration and side-effects of the treatment;4) with an informed consent of the patient and/or the legal representative;5) after a psychiatric assessment. *Psychotropic drugs are central to the treatment of a wide range of mental disorders. These drugs act through the central nervous system and exert their affect by influencing affective and cognitive functions, thus also affecting behavior	Round 4
4. Off-label prescription is defined as the prescription of a drug beyond the indications for which the medicine is registered, i.e. for an indication that is not mentioned in the official product information. (Embregts, 2019, p. 63)		Round 1
5. Treatment and evaluation of the treatment of challenging behavior should always be preceded by an interdisciplinary analysis of medical, psychological, personal and environmental factors (bio-psycho-social development model). After all, these factors – and the interaction between them – determine various domains and indicators of quality of life. Well-being, social participation and independence are central to this*. *Defining indicators to measure clinical changes and/or changes in functioning associated with improvements in quality of life is a strong driver for examining links and potential correlations between personal functioning and quality of life.		Round 1
6. Off-label use of psychotropic drugs is seen from the perspective of ‘Human Rights’ and ‘Quality of Life’ as a freedom-restricting measure and should therefore be regarded as such.		Removed
7. Consequently, psychotropic drugs are never the first choice for challenging behavior, with the exception of situations involving acute danger to the client or those around them.	Psychotropic drugs are not the first choice for challenging behavior, except for situations involving acute danger* to the client or those around them. *In case of acute danger, the person and/or his environment is in immediate danger and intervention is necessary.	Round 2
8. Situations in which the client him/herself is requesting the use of psychotropic drugs to improve his or her ‘quality of life’ are also exceptions.	In situations in which the patient him/herself is requesting the prescription of psychotropic drugs off-label and outside guidelines advice to improve his or her ‘quality of life’, prescribing should depend on the rationale of the request and on the estimation of the prescriber. The patient should be well informed about the risk benefit profile. Before starting medication, it is important that the patient or the legal representative should give their (oral or written) consent. The consent should be reported in the medical files.	Round 4
9. The ‘as-needed’ use of psychotropic drugs is not permitted, unless previously discussed and indicated or in acute situations. The agreements (conditions, duration and evaluation) about this should clearly be stated in the records and on the prescription.		Round 1
10. When commencing any psychotropic drugs for challenging behavior, a treatment plan is always drawn up. The treatment plan includes information about the mechanism of action, the anticipated effect and potential side-effects of the medication, among other things. It also includes the plan for reduction and cessation.		None
11. If possible, the treatment plan will always be drawn up in consultation with the client, his/her family or legal representative, and consent must be obtained before starting any drug treatment (except in the event of acute danger). In the event of acute danger, the client, his/her family or legal representative are informed afterwards and an ‘informed consent’ is added to the records.		Round 1
12. Professionals work according to evidence-based principles on the judicious off-label prescription of psychotropic drugs. It is a matter of searching for a ‘best practice’ together.		Round 1
13. Prescribing off-label medication is medico-legally the responsibility of the prescriber; however, in spirit, it is a shared responsibility of the patient’s entire team or network.	Prescribing off-label medication is medico-legally the responsibility of the prescriber; however, in spirit, prescribing, effect monitoring and evaluating is a shared responsibility of the patient and the patient’s entire team and network.	Round 2
II. Recommendations
Why do I prescribe?
1. Prepare a comprehensive, integrative and multidimensional picture and have consideration for the causes, dynamics and perpetuating factors of challenging behavior in people with intellectual disabilities (consideration for somatic conditions, context and system, and emotional developmental level). These findings are recorded in a basic document and are placed on the client’s integrated records.		Round 1
2. Make modifications to the environment to meet the client’s unique developmental needs. Compensate for adjustment difficulties by increasing the client’s skills.		Round 1
When do I prescribe?
3. When prescribing psychotropic drugs for challenging behavior, the prescriber and/or the team are responsible for providing as much information as possible about the indication and the duration of the use of medication.		Round 1
4. The prescriber and/or team should check and review this information every three months.		None
5. Identifying challenging behavior is a multidisciplinary process. The prescriber should ensure that an appropriate formulation of the target behavior is expressed and included in the treatment plan.		Round 1
6. The effect should preferably be monitored using standardized and validated scales or tools.	The clinical effectiveness should, in addition to the clinical evaluation by the prescriber, preferably be monitored using standardized, validated and user-friendly scales or tools.	Round 3
How (long) do I prescribe?
7. The prescribing doctor should ask the client and his/her supervisors about the potential presence of side-effects at every check-up. In addition, the doctor will have to systematically examine the client themselves. The frequency depends upon the indication and the drug that is prescribed. A plan for monitoring side effects will be drawn up.		Round 1
8. When examining potential side effects, the doctor may use several assessment measures, whereby validated scales should be used as far as possible.	When examining potential side effects, the doctor should use monitoring schedules (i.e. metabolic syndrome) and several assessment measures, whereby validated scales are strongly recommended, next to side-effect follow-up schemes.	Round 3
9. Off-label medication for challenging behavior should be seen as a supplement to non-medicinal treatment. This non-medicinal treatment should therefore be clearly described, monitored and evaluated.		Round 1
10. Consideration for withdrawal of medication and exploration of non-medicinal treatment should be ongoing and described in the treatment plan.		Round 1
11. The prescriber is responsible for assessing the individual’s ability to consent to treatment.		Round 1
12. The individual, their legal representative and/or personal supervisor must give their consent before medicinal treatment is commenced (‘informed consent’). Preferably, consent should be sought again (e.g. through the personal supervisor) with each change of dose and/or drug.		None
13. In the event that psychotropic drugs are administered in cases of acute danger, a debriefing will take place afterwards and the client, legal representative and/or personal supervisor will be informed post hoc. A note of this must be made in the treatment plan.		Round 1
14. The responsibility for prescription is clearly known and described and lies with a doctor.		Round 1
15. Medication safety (administering medication in the right way, storing medication, etc.) is a shared responsibility (doctor, pharmacist, nurse, supervisor) that must be defined beforehand.		Round 1
16. Also for this (medication safety), a responsible person is appointed.	Handling medication is a shared responsibility with a clear procedure. For medication safety, a person overseeing medication safety protocols should be appointed in the treatment facility.	Round 2
17. Medication should be used at the lowest possible dose for the minimum time required.		Round 1
18. The simultaneous use of different drugs from one group of psychotropic drugs with the same treatment objective should be avoided as much as possible.		Round 1
19. For the use of specific psychotropic drugs in psychopathology as part of specific syndromes (i.e. Down’s syndrome), reference is made to syndrome-specific guidelines. If there is a strong suspicion of a specific psychiatric disorder, disorder-specific guidelines should be followed for the choice of medication, dosage and duration of treatment		Round 1
20. Discontinue medication if there is no response to treatment with respect to the intended effect after 6 weeks, or sooner if an effect is achieved more quickly than expected and reduction or discontinuation of the medication is possible. A meticulous follow-up of the client is necessary to see the positive and negative effects. Review this evaluation with the client and those around them. Reassess the challenging behavior and consider further psychological or environmental interventions.		Round 1

Table

Principles
1.Challenging behavior is defined as ‘internalizing and/or externalizing behavior which is perceived as socioculturally undesirable by the person himself and/or his environment in a specific context, and which is of such intensity, frequency or duration that it is detrimental, stressful or harmful’ (Embregts, 2019). More specifically, it involves behavioral signs and symptoms such as verbal and physical aggression, self-destructive behavior, internalizing harmful behavior and sexually transgressive behavior, which cannot be explained from a physical condition and which do not respond adequately to non-medicated or other treatments (i.e. focused on environmental changes).
2. Psychotropic drugs^1 for challenging behavior should only be prescribed outside the indications or recommendations of professional guidelines, as adjunctive therapy: - in the best interest of the patient; - if the diagnosis and extent of non-pharmacological treatment are continuously evaluated and reconsidered; - if there are strict agreements on monitoring the efficacy, duration and expected side effects of the treatment; - with the informed consent of the patient and/or his legal representative; - after psychiatric examination. ^1 Psychotropic drugs are central to the treatment of a wide range of mental disorders. These drugs act through the central nervous system and exert their effects by influencing affective and cognitive functions and thus also affect behavior.
3. Off-label prescribing means prescribing a medicine outside the indications for which the drug is registered or, in other words, for an indication that is not listed in the official product information (Embregts, 2019, p. 63).
4. Treatment and evaluation of challenging behavior should always be preceded by an interdisciplinary analysis of medical psychological, personal and environmental factors (bio-psychosocial developmental model). After all, these factors - and the interaction between them – determine different domains and indicators of Quality of Life. Well-being, social participation and independence are central here^2. ^2 Defining indicators to measure clinical changes and/or changes in functioning measure related to improvements in Quality of Life is a strong motivation to establish links and possible correlations between personal functioning and Quality of Life.
5. Psychotropics are not the first choice for challenging behavior, except in situations where there is acute danger^3 to the patient or his/her environment. In situations where the patient himself/herself is asking for the off-label use of psychotropic drugs to improve his/her Quality of Life, the prescribing should depend on the rationale of the request and the estimation of the prescriber. The patient should be properly educated about the risk-benefit profile. Before starting medication, it is important that the patient or his legal representative gives consent (verbal or written). The consent should be recorded in the medical records. ^3 In acute danger, the person and/or his/her environment is in immediate danger and intervention is necessary.
6. 'If necessary’ use of psychotropics is, unless previously discussed and indicated or in acute situations, not permitted. The agreements (conditions, duration and evaluation) on this should be clearly stated in the medical file and on the prescription.
7. If possible, the treatment plan is always drawn up in consultation with the patient, his/her family or legal representative. Consent should be given before any medicinal treatment is initiated (except in the case of acute danger). In case of acute danger, the patient, his/her family or legal representative is informed afterwards and can still receive an informed (and discussed) consent statement ('informed consent’). This should be added afterwards in the file, stating the date.
8. Professionals work according to evidence-based principles regarding the judicious off-label prescribing of psychotropic drugs. They have to search together for the best way of working. Prescribing off-label medication is medically-legally the responsibility of the prescriber; in spirit, the prescribing, effect monitoring and evaluation, however, is a shared responsibility of the patient and the patient’s entire team and network.
Guidelines
Why do I prescribe?
1. Prepare a comprehensive, integrative and multidimensional picture and address the causes, dynamics and sustaining factors of challenging behavior in persons with intellectual disability (attention to somatic disorders, context and system and emotional developmental level). These findings are recorded in a baseline document and enter the patient’s integrated file.
2. Implement environmental modifications to meet the unique developmental needs of the patient. Compensate adjustment difficulties by increasing the patient’s skills.
When do I prescribe?
3. When prescribing psychotropics for challenging behavior, the prescriber and/or his team is responsible for providing as much information as possible about the indication and duration of medication use.
4. Mapping challenging behavior is a multidisciplinary process. The prescriber should ensure that an adequate formulation of the target behavior is pronounced and stated in the treatment plan. The clinical effectiveness, in addition to clinical evaluation by the prescriber, should preferably be monitored using standardized, validated and user-friendly scales or instruments.
How (long) do I prescribe?
5. The prescriber should ask the patient and his/her attendants at every check-up about the possible presence of side effects. In addition, the doctor should systematically examine the patient himself/herself. The frequency depends on the indication and the drug prescribed. A schedule around monitoring of side effects is established. When investigating possible side effects, the doctor should use monitoring schedules (i.e. metabolic syndrome) and various assessment measures, where validated scales are strongly recommended, in addition to schedules for the follow-up of adverse events.
6. Off-label medication in challenging behavior should be seen as complementary to the non-pharmacological treatment. That non-pharmacological treatment should therefore be clearly described, monitored and evaluated. Withdrawing of medication and exploring non-medical treatment should be continuously considered and described in the treatment plan.
7. The prescriber is responsible for assessing whether the individual is able to consent to treatment. When psychotropic drugs are administered at acute risk, a debriefing takes place afterwards and the patient, his/her legal representative and/or personal attendant will be informed post hoc. A note of this should be made in the treatment plan.
8.The responsibility for prescribing is clearly known and described. The prescriber is responsible. Medication safety (administering medication correctly, stocking medication, etc.) is a shared responsibility (doctor, pharmacist, nurse, supervisor) that needs to be defined in advance. Handling with medication is a shared responsibility with a clear procedure. For medication safety, one person should be designated in the treatment facility to oversee the medication safety protocols.
9. Medication should be used at the lowest possible dose for the minimum time required. The simultaneous use of different drugs from one group of psychotropics for the same treatment purpose should be avoided as much as possible.
10. For the use of specific psychotropic drugs in psychopathology as part of specific syndromes (i.e. Down syndrome), reference is made to syndrome-specific guidelines. If there is a strong suspicion of a specific psychiatric disorder, disorder-specific guidelines should be followed for the choice of medication, dosage and treatment duration.
11. Stop medication if there is no response to treatment after 6 weeks or sooner if an effect is achieved sooner than expected and reduction or discontinuation of the medication is possible. Close follow-up of the patient is necessary to see the positive and negative effects. Review this evaluation with the patient and his/her environment. Review the challenging behavior again and consider further psychological or environmental interventions.

Table

Tools for the recommendations and principles - Comprehensive, integrative and multidimensional imaging
Etiological diagnosis of intellectual disability
Medical history
Medication history
Somatic examination (focusing on a possible somatic cause for the behavioural problems)
Psychiatric examination
Intelligence test
Developmental anamnesis
Adaptive skills examination
Social-emotional development
Targeted autism measurement instruments
Depression
Personality problems
Behavioural problems
Context and subjective patient wishes
Current physical condition
Current social and system functioning.
Comprehensive overview per drug: https://www.farmacotherapeutischkompas.nl/
Tools for the recommendations and principles - Environmental conditions
Check, among other things, the following environmental conditions:
Appropriate daily structure and routines
Exercise
Stress regulation
Calming or distracting strategies
Relaxation
Competence-oriented work
Increasing client capacities/resilience training
(Functional) communication training
Team training
Training those involved
Adapting/optimising the environment in terms of lighting/noise and temperature
Reinforcement of positive behaviour and environmental enrichment
Tools for the recommendations and principles- Pharmacological part of the treatment plan
When medication is used as part of the treatment, this is described in the pharmacotherapy part of the treatment plan. By definition, the pharmacotherapy part of the treatment plan is drawn up by the prescribing doctor. The treatment plan includes:
1) The complains (both of the client and the environment and/or counselling) and request for help
2) Concrete treatment goals (both from the client and the environment and/or counselling)
3) Possible additional research
4) (Sequence of) interventions
5) Monitoring and evaluations
6) Policy for crisis situations
7) Duration of the treatment
8) Responsibilities of those involved
9) Information
10) 'Informed consent’ paragraph

Embregts. 2019. Multidisciplinaire Richtlijn Probleemgedrag bij volwassenen met een verstandelijke beperking. NVAVG, 2019.

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