In one scene from One Flew Over The Cuckoo’s Nest, Randle McMurphy (Jack Nicholson), presumed to be suffering from a psychiatric disorder, has to be violently subdued in a straitjacket. The health workers are brutal, a group of them holding him down, immobilizing him. This is a powerful way to represent an agitation crisis.
Fortunately, the use of straitjackets to immobilize patients has been almost completely abandoned, but it exemplifies very well what we are talking about. A crisis of agitation is a limiting situation, a psychiatric emergency that can lead to violence and aggression, with a high risk of injury both to the patient and to the health professionals involved. It often needs to be controlled by coercive means.
Obviously this is an added stigma for the patient. Mental illness is already stigmatized in itself, but in this case the dangerous patient label is added.
Psychiatric patients can, with greater or lesser frequency, experience bouts of agitation throughout their life. Crises that are triggered by little known circumstances, often related to low therapeutic compliance. They can also often be caused by everyday events or situations that most people can deal with naturally without much problem, but that in some psychiatric patients can cause the onset of agitation.
These crises can come on suddenly or slowly over time (minutes, hours or days). They increase in intensity, potentially leading to situations of aggression or violence such as those we have discussed. They can start with a certain degree of nervousness, of motor restlessness, of not being able to keep still. And they escalate in severity, with verbal aggression, insults, even physical violence. Crises almost always escalate over time, going from less to more. Being able to interrupt that escalation, being able to deal with the situation as soon as possible, is crucial in avoiding the worst consequences.
Agitation in psychiatric patients has, historically, been handled with the use of coercive measures, by force. Involuntary immobilization of patients in straitjackets or other means such as solitary confinement have been common practice for many centuries.
Fortunately, with the emergence of modern pharmacology and psychoactive drugs, patients have been treated with intramuscular or intravenous administrations of medications. However, although they may halt the onset of agitation, they can leave the patient sedated for many hours. They also require a degree of aggressiveness on the part of the health professional in order to forcibly inject the drug intramuscularly or intravenously. In a significant percentage of cases these measures do not work and the use of coercive measures, forced detentions or cell isolation are common.
The psychological impact that this has on patients - in a situation that they cannot voluntarily control, that forces them to go to the ER, where they are administered a medication often intravenously, sometimes against their will and then immobilized on a stretcher where they might remain for hours - is devastating. The first time a patient is immobilized is always a watershed.
The administration of inhaled drugs to control agitation is an attempt to respond to this serious situation. Through a sophisticated, newly patented system, the patient can orally inhale the required drug dose, to control the agitation almost immediately (in a matter of seconds). The symptoms can be controlled very quickly, and the progression or escalation of the crisis can be halted. In most cases the patient calms down quickly, without being sedated, normally making the use of coercive measures unnecessary. In short, patients can be controlled quickly, efficiently and safely in routine clinical practice, in the hospital setting or in the emergency room.
To date this type of solution can only be administered in a hospital or emergency room under the supervision of a health professional. But what would happen if patients (or their caregivers) could self-administer the medication at their own discretion, at home, in the very moment when the first symptoms of a new crisis are detected? Most likely, we would be able to arrest the onset of the crisis at a very early stage, making it unnecessary for the patient to go to the ER for treatment. Because, in reality, when a patient goes to request assistance at a hospital, the agitation is already in a more advanced phase and, at this point, measures other than coercive ones become impossible.
What has just been described is precisely the Beyond the Hospital Project. Probably the project with the greatest scope to be launched by Ferrer’s Scientific Department in the field of psychiatry. It is a multinational clinical trial involving more than 30 psychiatrists from different European countries and designed to answer the question: can a patient who has already been previously treated with the inhalation system in a hospital setting continue to use the same system freely at home under the supervision of a caregiver, such as a relative?
The study, which has just begun, will open the door to the ambulatory use of the inhalation route. It will allow patients (and their caregivers) to use this medication freely when they detect that something is not going well. Above all, it will alleviate the stigma of being subdued against their will to measures which can often involve some violence. It also opens the way for the use of this technology for other types of drugs that will arrive in the near future.
The project Beyond The Hospital has just started in Spain and Germany and is expected to be incorporated in the next few weeks in Austria, Romania and Sweden. The study is a fundamental step towards the empowerment of patients and caregivers, the use of the product in the very early stages of their disorder, and thus the quick management of agitation crises.