Management of medication refusal by Indian caregivers: A revisit after 2 decades

INTRODUCTION

Schizophrenia and bipolar disorders (BD) are major mental disorders that affect 0.4% and 0.3% of the Indian population, respectively.[1] Medications are a crucial aspect of managing people with these conditions.[2]

A number of studies indicate that nearly half of the patients with major mental disorders do not take their medications regularly.[3,4] Approximately 36% of patients stop medications within a month of hospitalization and 61% stop the treatment by the end of 4 years.[5,6] Early discontinuation of psychotropic medications is associated with higher rates of relapse, a higher number of hospitalizations, higher caregiver burden, poor functioning, and greater occurrence of comorbidities.[4,6] Even from an economic perspective, medication adherence (and related complications) is an important factor that contributes to the higher direct and indirect cost of illness.[7]

The health and economic implications aside, medication non-adherence has a significant impact on families and caregivers of mentally ill people.[8] This is especially pertinent in the Indian society where most of the people with mental illnesses are cared for by their family members in the home setting. Resultantly, they bear the brunt of the caregiver burden. This is in stark contrast to Western countries like the United Kingdom, where the state plays a substantial role in caring for people with severe and enduring mental illnesses. In the Indian setting, when a person with mental illness refuses to take medications, the onus of ensuring medication intake often rests on their family members. There is limited data from India on caregivers’ perspectives of ensuring medication intake in patients who refuse to take medications. Srinivasan and Thara[8] (2002) explored the family members’ perspectives on managing medication non-adherence in patients with schizophrenia. They found that many caregivers resorted to covert administration of medications. They used the term “family management of noncompliance” for this.[8] Over the years, no further data has emerged on the family member’s perspective to address the medication nonadherence in patients with schizophrenia and BD. Over the years, there is increased emphasis on patients’ right to autonomy and self-determination in India too. The United Nation Convention on the Rights of Persons with Disabilities and, more recently, the Mental Health Care Act 2017 have been important drivers in this direction. Whether the changing trend in the direction of patient autonomy has changed how families and caregivers manage mentally ill relatives is not clear. In this background, this study evaluated the caregivers’ perspective to address the medication adherence in patients with schizophrenia and bipolar disorder.

Reviewing the international literature on covert medication in psychosis or schizophrenia, there seems to be a real dearth. Considering that the initial experience from India is reported more than 19 years back and more importantly, the changing mental health laws and increasing importance are given to United Nation. Convention on rights to autonomy, we thought we would revisit the practice at present of approaches in covert medication.

METHODOLOGY

Setting

The study was conducted at the Asha Hospital, Hyderabad, India. The Asha hospital is a privately run psychiatric unit that provides both inpatient and outpatient care for people with various mental illnesses. The study was approved by the ethics committee of the institute in which it was conducted.

Data

The sample size for the sake of the study was determined to be 60 would be adequate. Data was not triangulated.

Sample

The study sample comprised caregivers of patients with schizophrenia or BD. The patients were required to fulfill the diagnosis of schizophrenia or BD (DSM -IVTR), with a duration of illness of at least 6 months. Patients with comorbid alcohol or substance use disorders, intellectual disabilities, and debilitating physical illnesses were excluded. Subjects were also excluded if they were unable to give informed consent for any reason, or if a caregiver (key informant) was unavailable to provide reliable information about the subjects’ illness and its treatment.

Sixty-three (n = 63) consenting subjects (age range from 16 to 65) and their caregivers (key informants) were recruited by convenience sampling from the inpatient and outpatient services of the hospital over a period of 6 months (February–July 2018).

The caregivers (key informants) were interviewed by a research worker using a qualitative semistructured interview schedule. The interview elicited the subjects’ background social, demographic, and illness details, as well as included probes to elicit information about their insight, adherence with prescribed medications, and how non-adherence was managed. The latter was based upon the semistructured questionnaire used by Srinivasan and Thara (2002).[8] Information was transcribed on a proforma (verbatim). Qualitative responses were coded based upon content themes and reported as frequencies.

RESULTS

The mean age of the patients was 33.7 years (SD = 11.38). The majority of the patients were female (55.6%), from an urban locality (63.5%), and from middle socioeconomic status (76.2%). Nearly half (50.8%) of the patients were married and two-thirds of them were literate (68%). Out of the 63 participants, 39 were diagnosed with schizophrenia and the remaining 24 were diagnosed with BD. The mean duration of illness was 7 years (SD: 5.89 years) [Table 1].

Table 1.

Profile of the patients

Variable	Frequency (%)
Gender
Male	28 (44.4)
Female	35 (55.6)
Residence
Urban	40 (63.5)
Semiurban	22 (34.9)
Rural	1 (1.6)
Socioeconomic status
Upper	10 (15.9)
Middle	48 (76.2)
Lower	5 (7.9)
Religion
Hindu	55 (87.3)
Muslim	8 (12.7)
Type of Family
Nuclear	49 (77.8)
Extended	10 (15.9)
Joint	4 (6.3)
Marital status
Single	29 (46.0)
Married	32 (50.8)
Separated	2 (3.2)
Education
Illiterate	2 (3.2)
Primary	2 (3.2)
High school	16 (25.4)
Graduate	38 (60.3)
Postgraduate	5 (8.0)
Diagnosis
Schizophrenia	39 (61.9)
BPAD	24 (38.1)

BPAD, bipolar affective disorder

Most of the caregivers were parents (58.7%). Caregivers were asked if the patients accepted the diagnosis and were adherent to the medications. Although only 41.3% of the subjects accepted that they had a psychiatric illness, 61.9% were described to be adherent to prescribed medications [Table 2]. Among those who were adherent to medications, about one-third of the participants took the medications on their own initiative (n = 19) while more than half (n = 33) of the participants took medications only on being prompted by their carers or were administered the same by their caregivers.

Table 2.

Patient compliance and its management

	Variable	Frequency (%)
1	Caregiver relation to the patient
	Parent	37 (58.7)
	Sibling	8 (12.7)
	Children	4 (6.3)
	Spouse	14 (22.2)
2	Does the patient accept that he/she has a mental illness?
	Yes	26 (41.3)
	No	37 (58.7)
3	Is the patient compliant with the medications prescribed?
	Yes	39 (61.9)
	No	24 (38.1)
4	Has the patient ever refused recommended medications for his mental illness?
	Yes	44 (68.3)
	No	19 (30.2)
5	If yes, how was the patient’s refusal to take medications managed?*
	Left alone	20 (45.5)
	Given without knowledge	12 (27.3)
	Forcibly at home	20 (45.5)
	Forcibly at hospital	7 (15.9)

^* Total number does not add up to 100% as more than one strategy was used for some patients

Forty-four subjects (69.8%) were reported to have refused treatment at some point during the course of their illness. Caregivers managed patients’ treatment refusal in different ways. More than one strategy was used to ensure that the medication was administered to the patient. Some patients were given medicines forcibly, either at home or in a hospital. Most commonly, medications were given surreptitiously in the form of liquid preparations (n = 23), rather than tablets (n = 11). About 22.7% of patients received a combination of liquids and tablets. In some cases, the caregivers mixed the medicines in either beverage (n = 14) or food (n = 24). Six caregivers (n = 6) gave medications directly to the patient under the pretense of giving medication for general physical conditions or vitamin pills.

Covert medications resulted in improvement in 75% of the cases. Carers observed that patients slept well, were less aggressive, and were more easily manageable after receiving medications. In three cases, there was no reported improvement, whereas in eight instances caregiver gave an account of the emergence of side effects in the form of excessive salivation, extrapyramidal symptoms, and being too drowsy most of the time.

Caregivers were asked about what advice was given by their psychiatrist regarding medication administration. All the caregivers reported that doctors advised patients to take medications regularly and attend regular follow-ups to ensure patients well-being and early recovery. In about half (52.3%) of the cases, doctors suggested covert medications to manage nonadherence.

When the caregivers were asked about patients becoming aware of being given covert medications, and their reactions to the same, only 11 out of the 44 patients given covert medications eventually became aware of receiving covert medications. About one-fifth (n = 8) reacted with anger and suspicion toward the family members. Five subjects refused to eat food cooked at home and did not interact well with the caregiver. These caregivers reported developing a strained relationship with their patient. Interestingly, one female patient became more compassionate toward her parents and expressed gratitude for taking care of her during her “bad” phase. Eight of the 11 patients continued to have anger and trust issues with their caregivers while the remaining three have had no lasting change in the relationship with carers.

Finally, informants who had administered surreptitious medication were asked to give their opinion about the future use of covert medication to manage nonadherence in their patients. About two-fifths (42.5%) of the informants believed that it was OK to give covert medication as it helped manage the patient and they are able to function well. About 14.3% reported that “they had no choice, but to give medication without patients’ knowledge,” thus suggesting that they might have avoided it if there was an alternative. About 12.7% stated that they could no longer give any medication to patients either because they were scared or patients no longer trusted them. Only 3% of carers were unsure of their actions and whether it was acceptable to treat without the patient’s knowledge.

DISCUSSION

The practice of administering surreptitious medications to ill patients (albeit by caregiving family members) is common practice in the Indian scenario but is rarely, if ever, openly acknowledged in clinical or research circles.[9] In spite of the fact that surreptitious administration of psychiatric medications is common, there are no professional or other guidelines regarding its place within the psychiatric practice. An important reason is that surreptitious administration of medications is illegal and not entirely ethical—notwithstanding any arguments that can be made to support it. As such, it is likely to place prescribing psychiatrists in a very difficult position if it were to come up in a court (given that it is unlikely to be endorsed by a professional guideline or body of responsible professionals). The findings of this study are similar to those of the 2002 study by Srinivasan and Thara—suggesting that not much has changed in the past two decades. A large proportion of patients with schizophrenia and BD receive medications under the supervision of their caregivers and at times receive covert medications. Nearly two-thirds of patients refuse to take prescribed medications at some point in their illness. These instances are managed by their family caregivers in a number of ways ranging from forcible administration either at home or in hospital or through the administration of medications surreptitiously (covert medications). The latter is mainly through the use of liquid formulations, which are mixed with food or drink. This strategy appears to help with the patients’ symptoms in the majority of cases, though some do experience side effects.

Many patients who became aware of surreptitious administration of medications by family members reacted by becoming angry—thus affecting their relationship with their families. Although some studies suggest that some patients felt this to be in their best interest (retrospectively), this was not very evident from the interview transcripts of the present study.[10,11] It appears, therefore, that patients who were given medications without their knowledge did not appreciate their right to autonomy being undermined. Accordingly, in the absence of reliable community mental health services, the onus of managing medication refusal and consequent relapses falls upon the patient’s family members, who are then compelled to address the issue by resorting to surreptitious administration of medications.

Caregivers (family members) therefore, continue to play a crucial role in the clinical management of patients with schizophrenia and BD in India even today. Most of the caregiver’s feel that surreptitious administration of medications (when the patients were refusing the same) is an acceptable practice, especially because it is often the only option available. Although there has been an emphasis on promoting patient autonomy and self-determination in the Mental Health Care Act 2017, the lack of a robust and credible community mental health service and very limited inpatient psychiatric beds seriously limit the implementation of this Act in its true spirit. There are also very real concerns about the applicability of the construct of individualistic autonomy (as used in the West) to the Indian setting where autonomy seems to be embedded within a more relational social and family context.

Given the absence of alternate community resources to manage patients refusing medication, and the ubiquity of this practice, it is perhaps time for the Indian Psychiatric Society and other professional bodies to acknowledge this practice and to invest in researching it so as to develop some practice guidelines to regulate the same. This study is limited by small sample size, and limiting the study to a single centre. Future studies must attempt to overcome these limitations.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.