THE PSYCHIATRIC PATIENT INFORMED CONSENT BILL PROPOSAL
SECTION 1 - INTRODUCTION:
This bill, should it be passed, would make it mandatory for psychiatrists or any treating healthcare provider (HCP) prescribing psychiatric/psychotropic/psychoactive medications to have "informed consent" or “information” sessions in which they would sit down with their patients or substitute decision makers in a session separate from any treatment, counselling, or psychiatric assessment. During these “informed consent” or “Information” sessions the psychiatrist or HCP would go through the “WARNINGS AND PRECAUTIONS” segment in the product monograph of each drug they are prescribing to their patient in order to give them full and accurate details of the risks, and side-effects of the drugs they are prescribing. These monographs would be the documentation supplied by the drug manufacturers for each individual drug. It is proposed that both the warnings and precautions in the Health Professional Information and the Consumer Information of the product monograph be disclosed. In this way, both doctor and patient would be made fully aware of possible side-effects, and it will be no one's "surprise" if the patient starts suffering from a particular side-effect. This will also give patients deemed “capable” before the law the opportunity to fully exercise their right to consent to or refuse the proposed drugs based on the information presented to them from the “warnings and precautions” segment in the drug monographs.
SECTION 2 - WHY THIS BILL IS NECESSARY:
In response to an Access to Information request, Health Canada's post-market surveillance program Canada Vigilance revealed that between 2015 and 2020 there had been 2,815 deaths in Canada in which antipsychotic medication was listed as the primary suspect in causing these deaths.
Of these deaths, 256 were due to sudden cardiac death, palpitations, arrhythmia, cardiac arrest and myocardial infarctions. 87 deaths were due to completed suicides (suicidal ideation and behaviors are also listed as possible risks with most antipsychotics).
In 2021 Health Canada had received 887 fatal adverse drug reaction reports in which psychoactive medications were listed as the suspected cause. Antipsychotics were the suspected cause for 670 of these deaths; Antidepressants were listed as the suspected cause for 87 deaths; benzodiazepines the suspected cause for 62 deaths; Mood stabilizers for 35 deaths; and ADHD stimulant medication the suspected cause for 32 deaths.
According to the Institute of Safe Medication Practices Canada[1], -- an independent national non-profit organization specialized in medication safety in healthcare settings -- an analysis team reviewing 523 death cases from 2007 to 2012 in which a medication incident was associated with the death, identified antipsychotics as the second most common medication involved in deaths resulting from medication incidents. The first being opioid medication.
The safety concerns of psychoactive drugs such as antipsychotics or neuroleptic medications have long been noted, as the American Psychiatric Association had done a task force report in 1987 after sudden, unexpected deaths in otherwise physically healthy psychiatric patients “raised the concern that the use of psychotropics, especially antipsychotics, may be associated with an increased risk for sudden death.”[2] General warnings have been placed on antipsychotics showing the risk of developing serious cardiac disorders[3]. Prominent medical journals such as the British Medical Journal have published multiple studies showing the link between antipsychotic use and fatal outcomes such as sudden cardiac death[4].
A study published in the British Journal of Psychiatry[5] in 2006, Schizophrenia, Neuroleptic Medication and Mortality, reported that cardiovascular complications derived from antipsychotics can also significantly shorten lifespan. The study found that even when making adjustments for age, gender, somatic diseases and other potential factors for premature death, there was a significant risk of mortality with the use of neuroleptic medications.
Health Canada and the U. S. Food and Drug Administration have issued advisories to patients, families and health professional to closely monitor for warning signs of suicidal behaviour in children and adults younger than 25 who take antidepressants[6].
Health Canada has also required the addition of a series of black box warnings about the suicidal potential of attention-deficit hyperactive disorder medications[7].
Aside from potentially life-threatening risks associated with psychoactive drugs, their side-effects can also cause severe physical and psychological distress. Several psychoactive medications contain warnings of the potential to develop Tardive Dyskinesia, an involuntary neurological movement disorder[8]. A 2008-2009 report[9] by the Joint Committee on Human Rights of the United Nations Convention on Persons with Disabilities stated, “the administration in detention in psychiatric institutions of drugs including neuroleptics, that cause trembling, shivering and contractions and make the subject apathetic and dull his or her intelligence has been recognized as a form of torture.”
A 2017 report[10] of the United Nations High Commissioner for Human Rights sited that “overmedication, including medications administered under false pretenses and without disclosure of risks not only violate the right to free and informed consent, but constitute ill-treatment and may amount to torture.”
“Informed Consent” sessions are crucial for the health and safety of patients and also for fully preserving their right to free and informed consent. Health Canada recognizes the product monograph as “a factual scientific document on a drug product that … describes the properties, claims, indications and conditions of use of the drug… that may be required for optimal, safe and effective use of the drug.”[11] Product monographs contain information on potentially lethal side-effects and also explicitly state that they should be read before a patient takes the specified medication and that the patient should discuss with their healthcare provider whether they fall into certain risk categories. For example, many psychiatric drugs have warnings that the drugs have potentially lethal consequences for persons who are obese, living with hypertension, high cholesterol levels, pulmonary artery disease or poor cardiac health. When the patient is made aware of these risks, they can then be given the opportunity to disclose to their psychiatrist if they suffer with these conditions or if these conditions run in their family. Some antipsychotic drugs such as paliperidone, for example, can cause infertility. And for a patient that has hopes to start a family or have another child, this would be very crucial for them to know and make an informed decision on whether or not they would like to proceed with the prescribed drug.
Many HCPs are only partially aware of some of the side effects of the drugs they are prescribing. Some doctors are even known to purposefully understate some of the risks associated with the drugs for fear that should the patient know certain side-effects associated with the drugs they are prescribed, they may refuse to take them. But for patients deemed to have the capacity to consent to or refuse treatment, this is their right. Canada has signed the United Nations Convention on the Rights of Persons with Disabilities which requires “health professionals to provide care of the same quality to persons with disabilities as to others, including on the basis of free and informed consent by, inter alia, raising awareness of the human rights, dignity, autonomy and needs of persons with disabilities through training and the promulgation of ethical standards for public and private health care”[12]
According to Ontario’s Health Care Consent Act[13] a health practitioner who proposes a treatment for a person shall not administer the treatment unless the person or substitute decision maker has given consent and “the consent must be informed.” The HCCA further goes on to define informed consent stating that “a consent to treatment is informed if, before giving it, the person received the information a reasonable person in the same circumstances would require in order to make a decision about the treatment; This includes:
The nature of the treatment
The expected benefits of the treatment
The material risks of the treatment
The material side effects of the treatment
Alternative courses of action
The likely consequences of not having the treatment
Consent to treatment is also informed if the person received responses to his or her requests for additional information about those matters.”[14]
According to the Institute of Safe Medication Practices Canada[15] communication gaps between patients and health care providers are negatively impacting patient safety. A total of 134 medication incidents associated with moderate to severe harm between 2009 to 2017 were extracted from ISMP Canada Community Pharmacy Incident Reporting program, of which 58 per cent involved communication gaps.
It has also been stated in several anecdotal experiences between patients and treating psychiatrists, that when a patient may later complain of certain side-effects they are experiencing, the doctor or HCP, because of their own limited knowledge of the “warnings and precautions” of the drug and who did not know this side-effect was a possibility, may even accuse the patient of "making things up" or "being dramatic." If an “informed consent” session were had, there would be full disclosure or risks and side-effects, and it is hoped that the treating HCP should take the patient’s complaints more seriously and be able to make changes for the benefit of their health and safety.
It should not be left up to the responsibility of patients, their caregivers or substitute decision makers to research the risks and side-effects for themselves. With few exceptions these are not medically trained individuals. Misapplication of these medications can have grave consequences for the patient, and so the “warnings and precautions” in the documentation for these drugs need to be discussed with their healthcare provider before consenting to treatment. Leaving these discussions to be had with a pharmacist upon dispensing the medications is also not sufficient since this does not allow for disclosed risks to be discussed with the HCP before agreeing to take the medications. Leaving these discussions to be had with a pharmacist also creates gaps in communication between the patient and their healthcare provider. The patient may also not remember all the details discussed by their pharmacist in order to properly raise concerns at a later period with their treating HCP.
SECTION 3 - PERSONS UNDER INVOLUNTARY TREATMENT:
The United Nations CRPD provision on free and informed consent is intended to be read in conjunction with Article 12 which prohibits the concept of “incapacity” and any form of involuntary treatment. It is recognized that Canada signed the Convention in 2010 with a conditional reservation on Article 12, preserving the right to use involuntary treatment “in appropriate circumstances and subject to appropriate and effective safeguards.”[16] Notwithstanding, persons who are deemed “unfit” to make decisions in regard to their psychiatric treatment still have the right to know what is being put in their own bodies. Persons being held involuntarily or placed under mandatory community treatment orders are no less entitled to the “warnings and precautions” of the drugs they are taking than persons who are deemed to have capacity. Full disclosure of risks, and side effects to both patient and doctor are necessary in ensuring patient safety. Safety precautions are no less necessary for patients under involuntary holds or treatment.
The Health Care Consent Act also states that a person is legally capable of giving their informed consent “if the person is able to understand the information that is relevant to making a decision about the treatment, admission or personal assistance service, as the case may be, and able to appreciate the reasonably foreseeable consequences of a decision or lack of decision.”[17] That being the case, most psychiatric patients who are not in acute mental distress or crisis, meet these conditions.
If a patient is in a psychologically compromised state in which they are incoherent or incapable of communication or comprehension, once the patient has recovered their ability to communicate and have coherent thought they should also be given the right to an “information” session. These “information” sessions should give full disclosure of the “warnings and precautions” in the monographs of each drug they are being administered, even if they do not have the legal right to consent to their treatment.
It is hoped that these information sessions would also empower patients to be able to contest or challenge an order for involuntary treatment on the basis of disclosure of an intolerable side-effect. For example, patients under community treatment orders still have the right to get married or have families. If a medication they are being administered has the side-effect of causing infertility and the patient is suffering from this side effect, knowledge of this would enable the patient to contest their community treatment order on the basis of its infringement of their reproductive rights.
SECTION 4 - EXECUTION:
The pharmaceutical companies have gone through the trouble of creating monographs or "pamphlets" that contain the “warnings and precautions” of the drugs they manufacture. These are also freely available on their websites.
During “informed consent” or “information” sessions, the information within the “warnings and precautions” of the monograph (in both the Health Professional and Consumer Information sections) for each drug should be printed out in font sizable enough to comfortably read and should be disclosed and explained in language understood by the patient. The HCP should also disclose whether Health Canada has issued any advisories or safety alerts with regards to the drug they are prescribing. The patient should be allowed to ask questions, raise concerns, and if there is medical terminology the patient does not understand, they are entitled to full and proper explanations of these terminologies. If the patient feels that they need a caregiver, family member, substitute decision maker or any other individual present to support them during their “informed consent” session, this should be allowed. Patients should be informed of their right to include a caregiver, family member or other support in their “informed consent” or “information” session.
During these sessions the patient should also be asked or given the opportunity to disclose whether they have any underlying or familial health issues that would make them particularly at risk to any particular side-effects. For example, if they suffer from obesity, hypertension, diabetes or any other conditions that could create a safety concern.
For example, the monograph[18] of the drug Abilify cautions against its use if patients “suffer from heart disease or have a family history of heart disease, stroke… high blood pressure” or “have risk factors for developing blood clots.” It would be crucial for patients who fall into this risk category to disclose this information to the prescribing health care provider.
“Informed consent” or “information” sessions could be conducted before discharge for individuals who have received in-patient treatment, during which the patient would also receive their discharge summary. In the case of out-patient treatment, “informed consent” or “information” sessions should be scheduled as a separate appointment.
An option should be available to the patient to forego these “informed consent” or “information” sessions, but they should be informed that they are entitled to these sessions. Unless the patient explicitly states they would like to forego their entitled “informed consent” or “information” session, the session should be conducted.
If patients have chosen to forego their “informed consent” or “information” sessions, however, later change their minds and would like to attend a session, then one should be provided.
Due to the increased risk of severe adverse reactions associated with psychotropic or psycho-active medications, “informed consent” sessions should be conducted by all health care providers across Ontario when prescribing psychiatric/psychotropic or psycho-active drugs or drugs for the management of their side-effects, such as anticholinergics, whether these HCPs are hospital-based, attached to Community Health Clinics, or those who have private practices.
The cost of these “informed consent” or “information” sessions should be covered by the Ontario Health Insurance Plan or the Interim Federal Health Program. However for patients who are not eligible for OHIP or IFHP coverage, these sessions should still be publicly funded by some means because of their necessity.
SECTION 5 - EXPEDIENCE AND EMERGENCIES:
It is understandable that a health care provider may need to act expediently for patients in acute distress or in emergency situations and may have to administer medication before the patient may have the chance or ability to be informed of the drug’s warnings and precautions. However, once the patient has stabilized and has the ability of communication and comprehension, the patient should then be entitled to an “informed consent” session or “information” session, which discloses the drugs they have been administered and goes through the “warnings and precautions” in each drug’s monograph.
SECTION 6.1 - DOCUMENTATION OF INFORMED CONSENT:
For legal purposes, patients and health care providers should also be made to sign a document stating that the patient has been informed of the “warnings and precautions” contained in the drug monographs by the HCP and has a full understanding of the risks and side-effects of all the drugs they have consented to taking, and that they are willing to take these drugs with the full knowledge of their effects.
According to the College of Physicians and Surgeons of Ontario, physicians must document in the patient’s record information regarding consent to treatment where treatment is likely to be more than mildly painful, carries appreciable risk, will result in ablation of a bodily function, is a surgical procedure, ow will lead to significant changes in consciousness[19].
If the patient, after the “informed consent” session has been conducted is not comfortable with the possible risks or side-effects associated with the drugs being prescribed, it is their right to refuse the proposed drug treatment. The patient and health care provider should also sign a document stating that the patient has refused to consent to the proposed drug/s on the basis of the information disclosed from the “warnings and precautions” in the monograph during the “informed consent” session.
For patients under community treatment orders, psychiatric holds or any other form of involuntary treatment, any concerns they raise regarding risks or side effects disclosed during their “information” session should also be documented.
SECTION 6.2 - LEGAL BENEFITS:
This practice would be legally beneficial to both patient and the treating HCP, because should the patient suffer severe or even lethal adverse effects from the drugs being prescribed which they have consented to, the document showing that the patient was fully informed and consented to the proposed treatment would protect the treating HCP from liability.
If the patient refuses the proposed treatment and experiences significant decline in their health, the documentation stating that the patient was fully informed and refused certain proposed drugs on the basis of the disclosed risks would also protect HCPs from liability.
For patients under community treatment orders or any form of involuntary treatment, who have conveyed concerns regarding risks disclosed in the “warnings and precautions” during their “information” session, and who later suffer lethal adverse reactions, it is proposed that the treating HCP or institution be held liable.
SECTION 7 - REVIEWED AND UPDATED INFORMED CONSENT SESSIONS:
“Informed consent” sessions or “Information” sessions should be held each time a medication is added or switched as a proposed treatment for a patient.
SECTION 8 - MINORS/CHILDREN, PERSONS WITH INTELLECTUAL DISABILITIES OR ANY OTHER COGNITIVE IMPAIRMENTS:
For patients who are minors, cognitively impaired or for any other reason are incapable of benefiting from “informed consent” sessions, then a parent, guardian or substitute decision maker should then attend the informed consent session on behalf of the patient so that they are made fully aware of the “warnings and precautions” in the monographs of the proposed drugs.
These substitute decision makers should also state whether, on behalf of the patient, they consent to or refuse the proposed treatment and sign documentation stating such. The treating HCP should also sign documentation stating they have fully disclosed the information in the monographs of the proposed medications to the substitute decision maker of the patient.
Persons under the age of 18 but who have the ability to comprehend and benefit from the disclosures made during “informed consent” sessions should be given the option of attending these sessions.
Patients should be given the right to attend “informed consent” sessions with their substitute decision makers even if they do not have the ability to comprehend or fully benefit from these sessions.
SECTION 9 - THE CURRENT REALITY:
While pharmaceutical companies have made information regarding risks and benefits of their drugs freely available, and Health Canada has also made the product monographs of these drugs freely accessible in their Drug Product Database[20], many psychiatric patients have never been presented with the monograph for any of the drugs they are being prescribed by their HCP. There is no excuse for this, especially considering that many product monographs explicitly state they should be carefully read before consumption of the drug. In lieu of this fact, Ontario's Health Care Consent Act is not being observed or made accessible to psychiatric patients when the “warnings and precautions” in drug monographs are not being disclosed or even being so much as made an after-thought for patients and health care providers to look at.
With the current practice of non or only partial disclosure of drug risks and side-effects, the health and safety of patients is severely compromised, especially for those who fall into certain risk categories due to social determinants of health.
For example, the Canadian Journal of Cardiology[21] reported in a 2015 study that there is a greater prevalence of cardiovascular diseases such as hypertension in black individuals when compared to their white counterparts. This is very salient information considering that most psychiatric drugs come with the risk of causing several metabolic dysfunctions such as obesity and cardiac disorders.
Statistics also show there is an over-representation of indigenous and black populations in the criminal justice system who are being filtered into the mental health court system according to a 2019 report by the Canadian Mental Health Association[22].
SECTION 10 - CONCLUSION:
Patients both voluntarily and involuntarily treated, as well as their caregivers or substitute decision makers, have the right to full disclosure of all possible risks, and side-effects of their psychiatric medication while medical decisions regarding their treatment are being made by their doctors or HCPs. Failure to do this violates patient rights to free and informed consent for those deemed to have capacity under the law, thus violating principles within the Convention of the Rights of Persons with Disabilities and the Health Care Consent Act, and places the safety of both voluntary and involuntary patients in jeopardy.
[1] Institute for Safe Medication Practices Canada “Deaths Associated with Medication Incidents: Learning from Collaborative Work with Provincial Offices of the Chief Coroner and Chief Medical Examiner” https://www.ismp-canada.org/download/safetyBulletins/2013/ISMPCSB2013-08_DeathsAssociatedWithMedicationIncidents.pdf
[2] “Sudden Death in psychiatric patients: The role of neuroleptic drugs” An American Psychiatric Association Task force report (1987) https://drive.google.com/file/d/1qb65BUM0QUyNQ9b0qrF29rF4as-2SsCA/view?usp=sharing
[3] Abilify Monograph Page 40 of 82 “Cardiac Disorders” https://otsukacanada.com/wp-content/uploads/2018/09/Abilify-Product-Monograph-EN.pdf
[4] British Medical Journal “Arrythmias and sudden death in patients taking antipsychotic drugs” https://drive.google.com/file/d/1wHil0ECzRV4s1nxpSqX4Wn2e7XBpZGLb/view?usp=sharing Journal of the American Heart Association “Antipsychotic drugs and the risk of Ventricular Arrhythmia and/or Sudden Cardiac Death: A Nations-wide Case-Crossover Study” https://drive.google.com/file/d/17EcmEvh88x0q6ZDTGVz7KjFgeYrv9fMP/view?usp=sharing
[5] Joukamaa, M. (2006). Schizophrenia, neuroleptic medication and mortality. British Journal of Psychiatry, 188, 122-127.
[6] HealthLinkBC – Health Canada and FDA Advisories for Antidepressants https://www.healthlinkbc.ca/health-topics/zu1129
[7] Canadian ADHD Black-Box Warnings https://www.thelancet.com/pdfs/journals/lanpsy/PIIS2215-0366(15)00428-9.pdf
[8] Tardive Dyskinesia https://rarediseases.org/rare-diseases/tardive-dyskinesia/#:~:text=Tardive%20dyskinesia%20(TD)%20is%20an,certain%20psychiatric%20or%20gastrointestinal%20conditions.
[9] House of Lords, House of Commons, Joint Committee on Human Rights (2009): The UN
Convention of Persons with Disabilities: First Report of Session 2008-09. London, United Kingdom: The Stationary Office.
[10] “Mental Health and Human Rights” Report of the United Nations High Commissioner for Human Rights, 2017 https://undocs.org/A/HRC/34/32
[11] “Product Monographs: Frequently Asked Questions: 2.0 General Information” Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/frequently-asked-questions-product-monographs-posted-health-canada-website.html
[12] United Nations Convention on the Rights of Persons with Disabilities article25: Health https://www.un.org/disabilities/documents/convention/convention_accessible_pdf.pdf
[13] Health Care Consent Act 10(1), 11(1) https://www.ontario.ca/laws/statute/96h02
[14] Health Car Consent Act: Consent to Treatment 11(2), 11(3) https://www.ontario.ca/laws/statute/96h02
[15] Communication gaps and patient safety, Samantha Li and Certina Ho, https://www.ismp-canada.org/download/hnews/201805-HospitalNews-CommunicationGaps.pdf
[16] “Position Statement: The United Nations Convention on the Rights of Persons with Disabilities”, Canadian Psychiatric Association https://www.cpa-apc.org/wp-content/uploads/CRPD-Position-Statement-EN-web-Final.pdf
[17] Health Care Consent Act 4(2) https://www.ontario.ca/laws/statute/96h02
[18] Abilify Mongraph, page 79 https://otsukacanada.com/wp-content/uploads/2018/09/Abilify-Product-Monograph-EN.pdf
[19] College of Physicians and Surgeons of Ontario, Consent to Treatment: Documenting Consent https://www.cpso.on.ca/Physicians/Policies-Guidance/Policies/Consent-to-Treatment
[20] Health Canada Drug Product Database: Access the database https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
[21] Canadian Journal of Cardiology, D Gasevic, E. Ross, S. Lear, June 24, 25 “Ethinc Differences in Cardiovascular Disease Risk Factors: A Systematic Review of North American Evidence” https://www.onlinecjc.ca/article/S0828-282X(15)00473-0/pdf
[22] Racialized Populations and Mental Health Court Diversion, May 2019 https://ontario.cmha.ca/wp-content/uploads/2019/05/Racialized-Populations-and-MH-Court-Diversion-May-2019.pdf