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      Current challenges in practice of psychiatry in India

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      Indian Journal of Psychiatry
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          Abstract

          Honorable immediate past President Dr. T.V. Asokan, members of the Executive Committee, all the zonal, state, regional and local branch office bearers of the IPS and above all most revered life fellows, fellows and members of the IPS. On the eve of my presidency, IPS is at its most glorious era. Two of alumni have held or are holding Presidentship of international organizations, an active member is the secretary general of the WPA, four of our members are holding high offices at the WPA and one IPS member has been bestowed with a prestigious international award. First of all I am assuming office when Dr. Asokan with his vision, modesty and skill has led the IPS to a position which makes my task easier for the coming year. I have chosen my topic as current challenges in practice of psychiatry in India because that defines my life of last 38 years as a psychiatrist and as an individual. What better way to describe my expertise and experience than this, which may guide younger colleagues in practice of psychiatry. MY EARLY DAYS I entered this magnificent branch of medicine as a postgraduate student in 1974 which was the era of Diagnostic and Statistical Manual of Mental Disorders, Second Edition (DSM II) and International Classification of Diseases 9 (ICD 9). Mental illness was understood and interpreted in terms of psychodynamics of the symptoms. My interest in psychodynamic theory did not help me to convert it into any therapeutic success. However, it helped me to nurture my interest in theatre. As a physician then attached to Film and Television Institute of India at Pune, I had an opportunity to associate and interact with many theater and film personalities such as Girish Karnad, Dr. Jabbar Patel, Naseeruddin Shah, Satish Alekar and Dr. Mohan Agashe. This association helped me immensely in my practice. I acquired better communication skills and learned to apply it effectively to psychoeducate patients and caregivers. The enhanced communication skills helped me not only in my doctor-patient relationship but also to communicate effectively with fellow professionals. However, that was not a substitute for a search for better understanding and improved treatment skills. My seniors and colleagues would often come up with innovative ideas, which contributed to improved patient care. NEW CHALLENGES The field of psychiatry has since witnessed major strides. We now have adequate data to claim that mental illness is a disease of the brain. Neuroimaging and success of pharmacology raised hopes of a significant breakthrough which is yet to become a reality. Today, we face multiple challenges and criticism from within (and outside the field of medicine in general and psychiatry, in particular) that threaten the practice of psychiatry. The new mental health legislation is awaiting Parliament's approval. My predecessors have made relentless efforts to get the voice of IPS reaches the lawmakers. Insurance companies do not acknowledge the needs of the mentally ill. The trend is changing but yet a lot more needs to be done. Closer to our clinical needs, DSM V is published. It was launched by our own alumni Dr. Dilip Jeste. Mastering the new classification will require much learning and re-orientation. ICD 11 is likely to be published in 2017. That will need some more new learning for all of us. Criticism against professionalism and alleged moral corruption by doctors is now being published in the world media and scientific literature. At a global level, the graph curves for cure, life expectancy and quality of life for patients of many serious and potentially life-threatening illnesses have shown major trend for the better. However the prevalence, morbidity and quality of life curves for mental illness have not shown any such bend for the better. Suicide rates, disability rates and eventual improvement rates of mental illness have not shown any significant improvement in the past three decades. Dr. Thomas Insel mentioned at his presentation at the APA last year (and I quote) “that the diagnosis of mental illness is by symptom cluster, etiology is presumptive and treatment is by trial and error and most of all there is no accountability.” Doctors blame the administrators, administrators blame the governing policies and government blames the medical practitioners, thus completing the circle with advantage to none. Humans now live longer. The current social structure (with disintegrating joint families) is not geared to deal with the rise in the ageing population. Human genome project failed to contribute to the improved understanding of mental illness. Psycho-pharmacology has a useful yet controversial role. Because of treatment emergent adverse effects there are certain reservations regarding prescribing psychotropic drugs as a first line of treatment. All this adds to the ambivalence against psychiatry. There appears to be a paradigm shift from the focus on morbidities of mental health to propagating positive mental health. This innovative concept of positive psychiatry is now receiving global accolades. PRACTICE OF PSYCHIATRY Psychiatry clinic and hospital Twenty-first century has witnessed the emergence of corporate hospitals. I work in a multi-disciplinary trust hospital in Pune. From the beginning, I have been fortunate to work in a group practice with other mental health professionals such as other psychiatrist colleagues, psychologists, social workers, nurses and technicians. The advantage is that of more effective management of all types of psychiatric disorders with the team work approach. Currently Poona Hospital and Research Centre has cardiology, neurology and intensive care services available 24/7. This has helped me to manage complicated patients with medical co-morbidities. Furthermore, any anesthesia related complication during electroconvulsive therapy (ECT) can be tackled successfully. I wish to highlight the usefulness of ECT in our clinical practice. We have a special theatre to administer ECT which is adjacent to my chamber. In my opinion, ECT is extremely cost effective and beneficial treatment to a variety of psychiatric disorders. Along with standard indications such as severe or suicidal depression, psychotic depression, catatonic states in psychoses and mood disorders, I have found ECT effective in acute mania and schizophrenia. Phutane et al.[1] have reported that in a survey of the practice of ECT in teaching hospitals in India, schizophrenia is the most common diagnosis for which patients receive ECT. Further, they found that in schizophrenia the most common indication was augmentation of pharmacotherapy. Some of the other unusual conditions where I found ECT was useful are the following: Resistant conversion symptoms Disruptive behavior symptoms in mentally retarded individual Severe psychiatric co-morbidity in Parkinson's disease Severe behavioral and psychological symptoms in dementia. Even though these are isolated case reports, which I have not published, similar findings have been reported elsewhere. For example in a retrospective, systematic chart review in Maclean Hospital, USA the authors identified 16 patients who had received ECT for agitation and aggression in dementia. The mean age was 67 years, and they had received a mean of 9 bilateral ECT. All (except one) showed significant improvement and post ECT confusion was severe in only two patients.[2] In the opinion of many psychiatrists in India and abroad, ECT is being underused in practice. Is there a need to promote more invasive procedures like deep brain stimulation and vagus nerve stimulation while keeping ECT in a cupboard? ECT is completely safe even in elderly and those with medical co-morbidity, provided the infrastructure is well-equipped. The complications with ECT are few and relatively uncommon. We have reported a case of “lorazepam-induced prolonged apnea after ECT-induced prolonged seizure” in Indian Journal of Psychiatry.[3] Ms. R, a 20-year-old 45 kg woman with a DSM IV diagnosis of schizophreniform psychosis received ECT thrice weekly. During the 6th ECT, she had prolonged seizure, and the anesthetist injected intravenous lorazepam 4 mg, which was repeated again after 1 min to terminate the seizure. The seizure disappeared, but spontaneous respiration did not resume. She was shifted to Intensive Care Unit (ICU) and put on a ventilator. She was successfully weaned off the ventilator next day, and she improved progressively. The only explanation for prolonged apnea was benzodiazepine-induced respiratory depression. Emergency room physicians have standard operating procedures (SOPs) for patients who are brought in an unconscious state. These are a set of practices that are required to be initiated and followed when specific circumstances arise. Similarly, SOPs in psychiatry are required for special settings such as in the ECT unit. Here, SOPs are required not only for routines related to consenting and investigating fitness for ECT but also for emergency situations that may arise, as in the case discussed earlier.[4] Pharmacotherapy The advances in psychiatry were propelled by the discovery of new atypical antipsychotic drugs as well as newer antidepressants, beginning with selective serotonin reuptake inhibitors. However, except for the difference in adverse effect profile the current research has not established any significant superiority in their efficacy over previously used drugs such as typical antipsychotics and tricyclic or heterocyclic antidepressants. Choice of drug is essentially the treating clinician's prerogative. Though clozapine was described as a dirty drug for its extensive neuroreceptor affinity, the drug has proved to be a class apart. I use it extensively. Furthermore, I use clozapine if a course of ECT and other antipsychotics have not produced a satisfactory response. In a recent study on the attitude of practicing psychiatrists toward clozapine, the authors reported surprising results with 64% psychiatrists opting to combine two antipsychotics rather than go for clozapine, in spite of treatment guidelines recommending otherwise. Clozapine's use mandates blood monitoring which may perhaps be seen as a barrier against its more frequent use, even though the incidence of agranulocytosis is now reported to be as low as 0.38%.[5] Nevertheless, statistics does not count when the adverse event actually occurs in an individual. I cite a case to emphasize the importance of caution. A 45-year-old female patient of chronic schizophrenia was started on clozapine and showed excellent response on a daily dose of 300 mg built over time. The blood count during first 3 months was normal. One day she complained of fever, tachycardia and mild confusion. Her blood count was repeated which showed total white blood cell (WBC) count of 2000. Clozapine was stopped. She was admitted and referred to a hematologist for treatment. However, on 4th day the total WBC count dropped down further to 100. Even though I was feeling anxious, the hematologist assured me that she will recover. Similarly, I counselled the patient's family by my twice daily hospital visits. She was discharged after 10 days and was completely well. There are few studies on clozapine in the Indian subcontinent, and most of these are case reports. Among them was a case of a young patient who developed total absence of granulocytes during the 4th month of treatment with clozapine and who was successfully treated with granulocyte colony-stimulating factor.[6] Personally, this was a lesson in crisis management and the role of consultation-liaison psychiatrist. It reinforced the relevance of continuous interaction with other specialists and the patient's family during periods of spontaneous and iatrogenic crisis. It also brought home the point that professionalism mandates leadership attributes, initiative and acceptance of responsibilities without preoccupation with fears of legal implication and adverse publicity. Consultation-liaison psychiatry as a superspecialty is the area of clinical psychiatry that encompasses clinical, teaching and research activities of psychiatrists and allied mental health professionals of a general hospital.[7] Consultation refers to the provision of expert opinion and liaison refers to linking up of groups for the purpose of effective collaboration. Hence for consultation to be most effective, the consultant psychiatrist needs to have personal contact with both the patient (including his family) and the specialists. Where pharmacotherapy is concerned what is the current prescription pattern of psychiatrist in our country? Grover et al.[8] conducted the Indian Psychiatric Society multicentric study which aimed to assess the first prescription handed over to psychiatrically ill patients whenever they contact a psychiatrist. Escitalopram and sertraline are the most commonly prescribed anti-depressants, olanzapine and risperidone are the most commonly prescribed antipsychotics and clonazepam are the most commonly prescribed benzodiazepine. There are very few variations in prescription patterns across various centers in the country. It is important to emphasize the efficacy of older antipsychotics as well as antidepressants in treatment resistant states. For example, short-term use of haloperidol and imipramine in appropriate conditions can be useful though currently there are not many systematic studies to support it. Similarly, use of lithium needs to be put in a proper perspective. I have used lithium extensively in bipolar disorders (both mania and depression) and in schizoaffective disorder. Much like clozapine, lithium monitoring should be routinely followed but many patients, as well as doctors, fail to comply. Even though a patient may be on low or normal doses of lithium, it is important to do periodic lithium and renal function assessments. In practice, therefore, we are likely to come across unexpected and unusual side effects or adverse drug reactions (ADRs) of psychotropic drugs. These must be reported. It is important for psychiatrists to be aware of the process involved in identifying and reporting ADRs, especially those that are new or unrecognized. These processes form the basis for the medical discipline of pharmacovigilance.[9] Any psychiatrist can report adverse effects. A standard form is available which can be downloaded from CDSCO website. The positive effects of pharmacovigilance in psychiatry are the obvious benefits both to the patient and to the clinician. Legal and media perspectives An emerging challenge to every clinician and psychiatrist is the risk of being subjected to legal action. This risk is now a reality. At this time and juncture, surgical branches and gynecologists are at a higher risk than the psychiatrist. In my practice of over three decades, I was fortunate not to face any medico-legal action. However, I had to face one enquiry by MMC. This was initiated by my female patient who was a diagnosed case of delusional disorder. She alleged that I had issued a false certificate to prove her being mentally ill. Actually, an admission note was given as she was nonadherent to treatment. Naturally, this enquiry was suspended. Unexpected complications, even death, can occur in patients under our treatment. A 60-year-old male patient with alcohol-induced psychotic disorder was brought to Poona hospital for treatment after a gap of 10 years. He was found to have breathlessness and hence referred to a cardiologist. I did not see the patient till the next day morning when he was brought dead to the hospital. On enquiry, I found that his computed tomography thorax done on the previous day had showed presence of pulmonary embolism, but the patient did not collect the report and went home without informing anyone. I did not involve anyone in blame game and talked to the family and signed the death certificate. It is not unusual for a family or friends to become disturbed or even violent under such circumstances, and the doctor may even be assaulted. In Maharashtra, there is a new act which has been in force now to prevent such occurrences by a penalty of up to Rs. 50,000 and/or imprisonment. This offence of assaulting a medical or nursing staff is a non-bailable offence. I have been called as a witness in over 50 plus occasions, most often to depose in cases of marital discord over past mental illness in one of the spouses. I have never avoided attending court even though it is time-consuming and fruitless. I have found that if you carry patient's record and give your deposition sincerely, most of the judges respect you and follow your advice. I would recommend you all to keep proper documentation and do not try to avoid a court appearance or even avoid treatment of cases where this is likely. Needless to remind you all that photocopy of the case records and/or a certificate should not be given to anyone except the patient or the courts. The way we practice has already been affected since the introduction of Consumer Protection Act. Going further, our practice is likely to be dictated by number of new acts or laws pertaining to doctors. E.g., introduction of mental health care bill in the present format is likely to make treatment of uncooperative patients and their admission procedure more difficult. There is an apprehension (probably justified) that the stigma of visiting a psychiatric clinic or hospital will increase. The Clinical Establishment Act 2010 has been passed by the cabinet. This lays down basic criteria for operationalizing clinics, hospitals, laboratories, etc., What would this mean? Among other objections by the medical fraternity, this would increase the cost of running a clinic or hospital and in turn, make healthcare more expensive. The only silver lining is that each state is free to modify it. In this age of media hype and trial by media, doctors need to be media savvy. This involves giving quick interviews on the telephone to reporters about any incident which has occurred, writing informative articles in newspaper and magazine and promoting mental health by participating in public talks and debates on TV or stage. Recently, in the press, we are constantly getting negative publicity about so-called unethical and corrupt practices. How do we set these things right? This is another challenge which we need to take up. PSYCHIATRIC ASSOCIATIONS My maximum participation has been with the city level Poona Psychiatrists’ Association, which is one of the oldest psychiatric associations in the country. We have our regular monthly meetings with different case conferences, symposia as well as new drug launches. The Poona Psychiatrists’ Association trained me to deliver talks, to assume leadership roles and to sharpen presentation skills. It is my earnest request to young psychiatrists to participate in all local and zonal activities which will also help in your continued professional development. I believe this helps in bonding with your colleagues and reduces professional jealousy and unethical competition. Most importantly, it will go a long way toward making Indian Psychiatric Society a strong force and a united professional body which can determine the mental health policies in this country. MARKET FORCES It is an undeniable fact that doctors in practice are being lured by variable market forces under the guise of sponsorship to various meetings in India and abroad as well as offering expensive gifts and entertainment. According to current Medical Council of India recommendations, this is unethical. Such favors adversely affect prescription patterns and ultimately patient care. In the West, already guidelines are in place regarding pharma-doctor relationship and strict punishment can be given to doctors who violate these guidelines. Even in India, there are instances where registration of doctors has been suspended for periods varying from 6 months to 3 years. A copy-cat acceptance of unethical enticement could endanger individual career, social repute and personal credibility. It is time now for us to accept financial responsibility for our professional development and refuse the temptations which are on offer. PEEP INTO FUTURE OF PSYCHIATRY The field of psychiatry is still growing. One of them is the increase in postgraduate seats in DPM, M.D. and D.N.B. Two super specialty courses in psychiatry were started, e.g. DM in geriatric mental health and DM in child and adolescent psychiatry. Among other courses awaiting approval is DM in addiction medicine.[10] Perhaps some of the younger psychiatrists will choose their way ahead in terms of further specialization. This will offer additional expertise to our patients. We the IPS members are all busy practitioners. Most of our professional time is spent in examination, diagnosis and treatment of patients. Few among us are able to spend time in meticulous record keeping, studying the data or carrying out original research. It is indeed unfortunate that the wealth of clinical data have remained underutilized. It is ironical that some of the significant contributors of original research are of Indian origin but have blossomed overseas. MY MISSION AND VISION FOR THE ENSUING YEAR During my tenure, I propose to give impetus to an initiative of the IPS. I propose to explore the hidden talents of Indian Psychiatry and harness their energy through various IPS committees especially those that involve research, planning and coordination. I am also exploring the possibility of encouraging IPS members’ data bank of unusual clinical cases in practice. This might be a rich source of research, similar to APA's data bank. Now an important step has been taken by the IPS that a state of the art clinic-based software program has been offered to every member of the IPS entirely free of cost. At the IPS council, we visualize and trust that this activity will encourage and establish Indian norms even as it would provide an opportunity to generate “make in India” original research. The obvious advantage would be to share clinical experience between members in practice and facilitate learning. Ladies and gentlemen, I have sat through long winded Presidential address in India and abroad. I am aware of their sequel. Can anyone list the notable achievements of the Indian Psychiatric Society in the past 50 years? This question was raised in the e-ips and has generated much debate. I am sure each of you have different opinions. In response, I have to add that if we believe we are what make the IPS, then your achievements are those of the IPS! As was famously said “do not expect what the IPS can do for you, rather what you can do for IPS.” Ambitions know no bounds, aspirations are many. May the God support us and promote our growth. The collective strength of the IPS is indeed a force to be that can rub shoulders with the best in the world. Ladies and gentlemen, let us stand united in the singular task of setting up a platform that will be the envy of all. God bless the IPS and guide us to great heights of achievements! Long live IPS!

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          Indian Psychiatric Society multicentric study: Prescription patterns of psychotropics in India

          Background: There is a lack of national level data from India on prescription of psychotropics by psychiatrists. Aim and Objective: This study aimed to assess the first prescription handed over to the psychiatrically ill patients whenever they contact a psychiatrist. Materials and Methods: Data were collected across 11 centers. Psychiatric diagnosis was made as per the International Classification of Diseases Classification of Mental and Behavioural Disorders 10th edition criteria based on Mini International Neuropsychiatric Interview, and the data of psychotropic prescriptions was collected. Results: Study included 4480 patients, slightly more than half of the subjects were of male (54.8%) and most of the participants were married (71.8%). Half of the participants were from the urban background, and about half (46.9%) were educated up to or beyond high school. The most common diagnostic category was that of affective disorders (54.3%), followed by Neurotic, stress-related and somatoform disorders (22.2%) and psychotic disorders (19.1%). Other diagnostic categories formed a very small proportion of the study participants. Among the antidepressants, most commonly prescribed antidepressant included escitalopram followed by sertraline. Escitalopram was the most common antidepressant across 7 out of 11 centers and second most common in three centers. Among the antipsychotics, the most commonly prescribed antipsychotic was olanzapine followed by risperidone. Olanzapine was the most commonly prescribed antipsychotic across 6 out of 11 centers and second most common antipsychotic across rest of the centers. Among the mood stabilizers valproate was prescribed more often, and it was the most commonly prescribed mood stabilizer in 8 out of 11 centers. Clonazepam was prescribed as anxiolytic about 5 times more commonly than lorazepam. Clonazepam was the most common benzodiazepine prescribed in 6 out of the 11 centers. Rate of polypharmacy was low. Conclusion: Escitalopram is the most commonly prescribed antidepressant, olanzapine is the most commonly prescribed antipsychotic and clonazepam is most commonly prescribed benzodiazepine. There are very few variations in prescription patterns across various centers.
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            Standard operating procedures for clinical practice

            What are standard operating procedures (SOPs)? These are a specific set of practices that are required to be initiated and followed when specific circumstances arise. For example, emergency room physicians have SOPs for patients who are brought in an unconscious state; nurses in an operating theater have SOPs for the forceps and swabs that they hand over to the operating surgeons; and laboratory technicians have SOPs for handling, testing, and subsequently discarding body fluids obtained from patients. The origins of the term SOP are obscure. The Encyclopedia Britannica indicates that the abbreviation came into use around the mid-1900s[1] and was already in use during World War II. Today, SOPs exist in contexts ranging from military operations to business routines, and from manufacturing processes to medical activities. In military circles, the term standard operating procedure or standing operating procedure is used to describe a procedure or set of procedures for the performance of a given action or for a reaction to a given event. There is a popular misconception that SOPs are standardized across the universe of practice. However, the very nature of an SOP is that it is not universally applied, such as across a large military element (e.g. a corps or division), but rather describes the unique operating procedure of a smaller unit (e.g. a battalion or company) within that larger element. That the operating procedure in question is said to be standing indicates that it is in effect until further notice, and that it may later be amended or dissolved. In the context of clinical trials, the International Conference on Harmonisation (ICH), born in 1990 out of an effort to harmonize regulatory requirements for medicinal products, defines SOPs as detailed, written instructions to achieve uniformity of the performance of a specific function. This is also in keeping with the goal of Good Clinical Practice.[2] In present day medicine, clinicians are familiar with SOPs in restricted contexts, such as those described at the beginning of this article. Clinicians are also aware of the use of SOPs in the context of clinical trials, either with regard to the functioning of ethics committees or with regard to screening, consenting, assessing, and treating patients across the course of the clinical trial. An idea whose time has now come is the introduction of SOPs into routine clinical practice; that is, not for special patients (e.g. those who are unconscious) or for special circumstances (e.g. clinical trials), but for every patient in everyday clinical care. To understand why such SOPs are necessary, let us first pose a question to the reader: How often in routine practice do we ask female patients of reproductive age about the date of their last menstrual period, or about contraceptive precautions that they may have adopted? Do we record these details? Chances are that such information is not regularly obtained; yet, it should be obvious that this information should be sought and recorded at every consultation (whether initial or follow-up) with every female patient in whom pregnancy is even a remote possibility. If SOPs are set in place, it is unlikely that such information would be neglected. Digressing briefly, how are SOPs different from practice guidelines? The terms SOPs, guidelines and pathways are defined by different medical bodies.[3–8]Furthermore, whereas clinical practice guidelines are systematically developed statements that assist decisions about appropriate health care for specific circumstances,[9 10]SOPs are more specific than guidelines and are defined in greater detail. They provide a comprehensive set of rigid criteria outlining the management steps for a single clinical condition or aspects of organization.[11] Guidelines are rigorously developed using evidence-based medicine criteria and consist of two distinct components: the evidence summary and the detailed instructions for the application of that evidence to patient care.[8] For the common health care provider, guidelines require local adaptation to suit local circumstances and to achieve a feeling of ownership, both of which are important factors in guideline uptake and use.[12] SOPs, therefore, help bridge the gap between evidence-based medicine, clinical practice guidelines, and the local realities at the point-of-care. It is fairly obvious that SOPs ensure a higher standard of medical attention in serious situations, examples of which include lithium toxicity and the neuroleptic malignant syndrome. In a study of the treatment of sepsis, Kortgen et al. (2006) found that the use of SOPs facilitated the implementation of new therapeutic strategies, particularly as bundles or packages, thereby improving the standard of care. SOPs also reduce the time lag between the publication of randomized controlled trials and the incorporation of the findings of these trials into clinical practice. Also, irrespective of their content, SOPs hasten the initiation of therapy for individual patients by increasing the awareness of the need to vigorously and rapidly treat such patients.[13] We now return to our contention that SOPs need to be introduced into the clinical routine and not be reserved for special patients or special circumstances. To start with the general consultation, SOPs regarding the structure of outpatient consultations are necessary for every patient to ensure that the patient and/or his family are aware of the nature of the diagnosis, the prognosis, the nature and duration of treatment, the time course of treatment response, possible adverse effects of treatment, and related issues; some of such education will need to be repeated at follow-up visits because no client will remember all that has been conveyed at the first meeting. Such SOPs can be constructed by structuring the duration and component parts of the consultation. Research shows that in longer consultations doctors prescribe less,[14 15] listen better to their patients, identify more problems, explore more psychosocial problems, and provide more health promotion.[16 17]If these measures are viewed as a proxy for quality, longer consultations appear better.[18 19] In longer consultations, the patient gives more information, especially about lifestyle and social behaviors.[20] The consultation can be structured as an SOP with component parts that include the duration of consultation, social behavior, agreement, rapport building, partnership building, giving directions, giving information, asking questions and counseling.[20] SOPs for initial assessment and work-up are necessary to identify factors such as danger to life (e.g. high suicidal risk in a patient with mood disorder), risk of adverse effects with medication (e.g. a family history of diabetes mellitus in a patient advised olanzapine), comorbid medical disorders (e.g. acid-peptic disease in a patient advised fluoxetine), and drug interactions (e.g. thiazide diuretic use in a patient advised lithium). SOPs remind clinicians that there may be interactions between medical illnesses or the treatment thereof with psychiatric illnesses or the treatment thereof. The use of a treatment algorithm for patients at suicide risk, based on a failure modes and effects analysis (FMEA) model, can reduce in-patient suicide risk.[21] Similarly, application of SOPs can reduce treatment-related adverse event rates.[22] SOPs are necessary to remind clinicians of the need for medical evaluations such as ultrasonography of the ovaries in young women advised valproate, physical and metabolic monitoring in patients advised olanzapine, and thyroid assessments in patients with mood disorders. Incorporating reminders in the form of SOPs can improve the rate of compliance with the relevant guidelines.[23] SOPS are necessary to incorporate aspects of treatment which are not highlighted in guidelines[13] or which are parts of different guidelines. This will ensure that attention is paid to areas as diverse as problem-solving, communication, social support, family burden, and caregiver stress. SOPs are necessary to ensure that easily implemented strategies that benefit mental health are not neglected; examples of behavioral targets are diet, exercise, sleep, stress management, and the pursuit of leisure and pleasure activities. SOPs are necessary to monitor medication compliance, a variable that can make or break the success of a psychopharmacological treatment plan. SOPs are necessary for special settings such as the electroconvulsive therapy (ECT) unit. Here, SOPs are required not only for routines related to consenting and investigating fitness for ECT but also for emergency situations that may arise, such as ECT-induced cardiac arrhythmias, prolonged seizures, or prolonged apnea. All SOPs should be prominently available in the clinician's consulting chamber, in the outpatient department, in the hospital wards, in the ECT suite, and in any zone related to patient care. Taking the subject to the final frontier, client-individualized SOPs can also be developed. Just as there could be specific SOPs for women, for elderly patients, for patients with a particular diagnosis, for patients advised a particular drug, for patients with a particular medical comorbidity, and for patients in different stages of therapy, there could be customized SOPs which would address combinations of such patient characteristics. Thus, for example, there could be a special SOP for elderly women with depression and diabetes, who may be prescribed mirtazapine during maintenance therapy. Is this a ridiculous and impossible suggestion? Not at all. If SOPs are available in spreadsheet format for each subcategory of gender, age, diagnosis, comorbidity, drug, and so on, then a few mouse clicks can easily customize a pooled SOP for the combination of subcategories in a specific patient. Printouts of such tailor-made SOPs can be inserted into patient files. We remind readers who consider our suggestions impractical that SOPs of a sort are already in place in everyday clinical practice; as an obvious example, undergraduate and postgraduate students have a clear framework for obtaining a clinical history and for conducting a general examination, systemic examination, and mental status examination. To a certain extent, SOPs also exist for aspects of record-keeping and hospital administration. An extension of such structure into routine clinical care is what we are now suggesting. The use of SOPs will have the added advantages of utilizing an optimized process for care, implementation of best evidence-based medicine, cost-effectiveness, improved continuing medical education, improved induction of new hospital staff, integrated quality control, transparency and enhanced protection from malpractice.[24] When all these SOPs are in place, the quality of patient care will substantially improve. The Indian Psychiatric Society has constituted task forces for various activities and has issued treatment guidelines for different psychiatric disorders and contexts. The formulation of SOPs for routine clinical practice at all levels of care is a potential activity that the Society should address in the future. Such SOPs will of necessity be templates that can be customized to individual contexts, depending on what happens to be practical and expedient in the environment in which they are applied.
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              Pharmacovigilance for psychiatrists: An introduction

              Patients with psychiatric disorders are often managed with pharmacotherapy. Because of the chronic and relapsing nature of some of these disorders, most practice guidelines recommend that medications should be continued for several months or years.[1 2 3] As a result, patients are at risk of experiencing a variety of adverse drug reactions (ADRs). At times, these ADRs can be life-threatening (such as neuroleptic malignant syndrome)[4] or disabling (such as drug-induced tardive dyskinesia).[5] It is important for psychiatrists to be aware of the processes involved in identifying and reporting ADRs, especially those that are new or unrecognized. These processes form the basis for the medical discipline of pharmacovigilance. Pharmacovigilance has been defined by the World Health Organization (WHO) as the science and activities related to the detection, assessment, understanding, and prevention of adverse drug effects.[6] As such, pharmacovigilance is not a “specialist” activity: It is one that must be carried out by all those involved in caring for patients on medication, including doctors, nurses, and pharmacists.[7 8] The birth of pharmacovigilance has a close relationship to psychiatry. In the 1960s, thalidomide was widely used in several countries to treat insomnia during pregnancy – a common problem affecting many women. It was soon noticed by physicians that babies exposed to the drug in utero developed congenital malformations, and it was this tragedy – related to a drug that was marketed as a “safe sedative” – that was the beginning of the field of pharmacovigilance.[9] This relationship has continued to the present day. In a recent review of nine major ADRs reported in Europe from 1995 to 2008, two of them involved psychotropics – seizures with bupropion, and suicidality in children taking SSRI antidepressants.[10] While the latter was identified by a re-analysis of data from the pharmaceutical industry, the former was identified through physician reports. In an analysis of ADRs reported to the FDA between 1998 and 2005, many of the frequently implicated drugs were psychotropics[11] – antipsychotics (clozapine, olanzapine, risperidone), antidepressants (duloxetine, sertraline, paroxetine, bupropion), mood stabilizers (carbamazepine, valproate, lamotrigine), and even anti-ADHD medication (atomoxetine). Now, as then, clinicians have a key role in identifying and reporting new or serious adverse drug effects. WHY IS PHARMACOVIGILANCE IMPORTANT IN PSYCHIATRY? Pharmacovigilance activities are an important part of medical practice in general. A meta-analysis found that around 5% of hospitalizations in a general medical setting are due to adverse drug effects.[12] A study in a general hospital in France found that 3% of new admissions were due to ADRs, and 6.6% of patients developed a significant ADR during their hospital stay.[13] However, there are four reasons why this field is of special importance to psychiatrists. First, pharmacotherapy is the principal modality of management in several psychiatric disorders. Most drugs used in psychiatry are frequently associated with ADRs. Often, patients do not respond to initial drug therapy, and may require several trials of different medications.[14 15] Some patients may require a combination of various drugs – polypharmacy – which can increase the risk of adverse effects or drug interactions.[16] Second, most clinical trials of psychotropics are conducted in “ideal” conditions – patients are selected according to stringent criteria, and comorbid medical conditions are usually excluded. These trials also tend to be short-term, lasting for a few weeks or months. By contrast, the patients we encounter in practice often have more complex presentations and comorbid medical illnesses, and they remain under our care for longer periods of time.[17] In this context, ADRs that were not noticed in the context of a trial become more apparent, and the burden of managing them falls on the psychiatrist. Third, there is a publication bias in clinical trials, particularly those in psychiatry.[18] Even in published trials, ADRs are not always reliably reported, and there is a concern that relevant data may be misrepresented in some cases.[19] Hence, the onus is on treating psychiatrists to identify such reactions and report them, particularly those related to newer drugs. Fourth, psychotropics directly affect brain functioning, and can produce undesirable changes in behavior. Sometimes, these changes can be life-threatening, as in the case of suicidal behavior induced by antidepressants in children.[20] In other cases, long-term changes in behavior can be seen, including the re-appearance of symptoms – a phenomenon that has recently been documented with antidepressants, and has been termed “tardive dysphoria.”[21] For all these reasons, it is important that psychiatrists acquaint themselves with the concepts and methods of pharmacovigilance. The first step in this process is the identification of potential ADRs. ADVERSE DRUG REACTIONS: CLASSIFICATION AND IDENTIFICATION An adverse drug reaction (ADR) can be defined as any adverse patient outcome that occurs at therapeutic doses of a drug, and which can be causally linked to use of the given drug.[22] The terms used in describing ADRs differ somewhat from the similar-sounding terms used in drug trials. To avoid confusion, the definitions used in the field of pharmacovigilance are listed in [Table 1]. Table 1 Common terms used in describing drug-related events[22] The severity of ADRs can be categorized as mild, moderate, or severe based on the modified Hartweig and Seigel scale.[23] Table 2 gives examples of ADRs based on severity. Table 2 Examples of ADR severity in psychiatry When an ADR results in a serious outcome, such as death, disability, threats to life, hospitalization, or birth defects, then it is known as a serious ADR.[24] Examples of serious ADRs [Table 3]. Table 3 Examples of serious adverse drug reactions in psychiatry ADRs are commonly divided into two broad categories: Type A and type B.[25] Type A reactions are those that are predictable on the basis of the drug's mechanism of action, such as extrapyramidal side effects with antipsychotics. They tend to be common and are easier to recognize. Type B reactions, on the other hand, are unpredictable and rare, can be fatal, and are related to idiosyncratic mechanisms such as immune reactions. Examples of type B reactions are clozapine-induced myocarditis and Stevens-Johnson syndrome with carbamazepine. A higher index of suspicion is needed to identify such reactions. Recently, a third category – type C adverse reactions – has been added.[26] This term refers to an increased frequency of “spontaneous” disease that may be statistically related to the drug, but in which causality is difficult to prove. An example is the increased risk of gastrointestinal bleeding in patients taking SSRIs.[27] Every adverse event that occurs during drug treatment need not necessarily be an ADR, as is discussed in Table 1. In order to establish causality, various methods of causality assessment have been developed, the most common being Naranjo's algorithm[28] and the WHO causality assessment scale.[29] These scales use different parameters for assessment, which include: Temporal relationship: Did the suspected ADR occur after starting the drug? Did it occur within a reasonable time frame (days or weeks for an acute event; can be longer for a chronic event) Abnormal laboratory tests: Is there documented evidence of organ dysfunction, as indicated by investigations (such as ECG changes or abnormal liver enzymes)? Absence of other causes: Is there no other cause, or no other concurrent drug, that can explain the ADR? (for example, if a patient taking both valproate and isoniazid develops hepatitis, either drug could be responsible). Response to de-challenge: Does the ADR, including the abnormal lab values, resolve after discontinuation of the drug? Response to re-challenge: Does the ADR, including the abnormal lab values, re-appear when the drug is started again? (Note that this may not be ethically possible in some cases, particularly in a life-threatening event). The following [Table 4], based on the World Health Organization criteria, can help a practicing psychiatrist in identifying the likelihood that a specific adverse event is due to a particular drug. Table 4 Estimating the likelihood that an event or laboratory abnormality is due to a drug In cases where re-challenge is not feasible, only a “likely” or “possible” level of certainty can be achieved. But even in such cases, reporting an ADR can have positive long-term benefits. WHAT IS THE PSYCHIATRIC CLINICIAN'S ROLE IN PHARMACOVIGILANCE? There are various methods by which ADRs can be identified on a large scale. All of these depend on “signal generation” – a credible report (the “signal”) of a specific, new adverse effect associated with a given drug.[26] Not all “signals” will be confirmed on further evaluation, as some of them may represent “false positives” due to confounding factors. The process by which further reports confirm the original signal is known as “signal strengthening.”[30] As a signal grows stronger – that is, as more and more reports of the same ADR accumulate – then it can be systematically assessed, described in the literature, and guide clinical practice. Some “signals” come from pharmaceutical company data, or from the pooled analysis of data from hospitals or academic centers. However, the most cost-effective form of signal generation is through a “spontaneous reporting database,” through which clinicians can submit reports of suspected ADRs to a central authority. Though this method has its limitations – particularly reporting biases – it is used throughout the world, and was recently implemented in India. As the number of reports of a particular ADR increase, the “signal” in this database grows stronger, and can then be analyzed statistically. This process of analysis is known as data mining.[7 30] The question always arises as to whether clinicians should publish new ADRs as case reports, or report it to a “spontaneous ADR database.” The answer to this question depends on the nature of the reaction being reported. Most journals have a publication bias toward rare, life-threatening or disabling adverse events. Hence, reports of a less “dramatic” ADR – such as sexual dysfunction with a new antidepressant – may go unpublished. On the other hand, reporting to a spontaneous database will allow a “signal” to be generated over time, even for relatively minor adverse effects. Hence, it is always better to report ADRs to local or national databases. Publication of case reports is an academic activity that can supplement pharmacovigilance, but cannot replace it. PHARMACOVIGILANCE STUDIES OF PSYCHOTROPICS In the past decade, there have been several published studies that examine different aspects of pharmacovigilance related to psychotropics. These include: General drug-based studies: Some studies have focused exclusively on all ADRs reported with the use of a particular drug. Examples include UK-based studies of mirtazapine[31] and olanzapine.[32] The latter led to the identification of drug-induced diabetes mellitus as a significant ADR. Serious ADR drug-based studies: Other researchers have mainly focused on serious ADRs occurring with a particular drug, or group of drugs, that is widely used. Such studies are helpful in informing clinical practice. Examples include a French-based study of bupropion, which found that allergic reactions and seizures were both common serious ADRs.[33] Specific ADR drug-based studies: Some studies have “followed a signal” by studying the association between a particular drug group and a rare ADR. Examples include studies of pituitary tumors with antipsychotics (which found a positive association),[34] ischemic colitis with antipsychotics (a rare but positive association was found)[35] and gastrointestinal bleeding with SSRIs (where a risk of up to 1% was found).[27] Specific adverse event studies: A French study studied the relationship between falls and the use of any psychotropic medication, and found a specific association not only with benzodiazepines, but with antidepressants.[36] Studies in special populations: A study from England examined the profile of ADRs seen in children and adolescents taking antipsychotics, and found it to be similar to that of adults – weight gain, extrapyramidal symptoms, and raised prolactin were all common.[37] Recently, pharmacovigilance studies of psychotropics in India have also been published. A study of out-patients in Kolkata found that 17% of patients studied had “possible” ADRs.[38] Antipsychotics were the most commonly implicated drugs, and common ADRs included tremors, weight gain, and constipation. A study of olanzapine in Pondicherry[39] found that weight gain, tremors, elevated plasma glucose, and somnolence were all probable adverse effects. There is a definite need for more research to examine the burden of adverse reactions to psychotropics in the Indian setting. THE PHARMACOVIGILANCE PROGRAMME IN INDIA In India, attempts were made to initiate pharmacovigilance activities in 1986, 1997, and 2005. These efforts were short-lived. However, in 2010, the Pharmacovigilance Program (PvPI) of India was started by an initiative of the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, Government of India.[40] The Indian Pharmacopoeia Commission, Ghaziabad is presently entrusted with the responsibility of spearheading the program as the National Coordinating Centre (NCC). The PvPI is based on the WHO recommendations. Its aim is to foster the reporting of ADRs by health workers in India, and thereby generate data on ADRs in the Indian context and share it with the WHO's Uppasala Monitoring Centre (UMC) in Sweden. The PvPI is in the process of establishing ADR monitoring centers (AMC) in medical colleges. At present there are 22 AMCs as per the CDSCO website. The PvPI's vision is to have an AMC in every medical college, and thereby make our country a center of excellence in the field of pharmacovigilance in the Asia Pacific region by 2015. The reports which are collected at the AMC are sent to the NCC, Ghaziabad with the help of a special software package named Vigiflow, which is a web-based report management tool. Through this software, data may also be sent to the WHO ADR monitoring center in Uppsala, Sweden. On receiving reports, the NCC performs causality analyses and checks for signal generation. The NCC then sends the information to the CDSCO, which takes regulatory actions as recommended by the expert panel of the NCC. Under the PvPI, any health worker can report a suspected ADR to the ADR monitoring center of their hospital. HOW SHOULD AN ADR BE REPORTED? As mentioned above, any psychiatrist – whether in Government or private practice – can report adverse effects. A standard form is available for reporting ADRs, which can be downloaded from the CDSCO website. All information collected will be kept strictly confidential, including the reporter's identity. There is no medico-legal liability associated with making an ADR report. This form can be accessed at: http://cdsco.nic.in/pharmacovigilance.htm Information should be as complete as possible so as to gather adequate data for causality analysis, and should include patient details, details of diagnosis and treatment, comorbid medical conditions or substance use, and other drugs that the patient was taking at the time. This is important in psychiatry because patients often receive multiple medications. However, even an incomplete report is better than none at all. It is not necessary to perform a “re-challenge” or to be “certain” [Table 3] about the cause of an ADR when reporting. Even if a clinician finds that the event is only “probable” or “possible,” the event should be reported, as this can help in signal generation. There is a tendency to report only serious ADRs. But in psychiatry, where the long-term consequences of drug treatment are still being unraveled, any unusual events – including behavioral changes – should be reported. Similarly, if a patient with comorbid medical and psychiatric illness experiences a worsening of medical illness during psychotropic treatment, this could represent an ADR. THE BENEFITS OF PHARMACOVIGILANCE IN A PSYCHIATRIC SETTING The positive effects of pharmacovigilance in psychiatry can be broadly divided into four categories: Benefits to the patient, benefits to clinicians, benefits to the pharmaceutical industry, and benefits to regulatory authorities. Benefits to the patient: Most adverse drug events, even if not life-threatening, can be distressing and troublesome to patients. Reporting these events could help in building trust between patients and physicians. The practice of regular reporting can also lead to earlier identification of problems, which can improve patient compliance and quality of life. Benefits to the physician: The practice of pharmacovigilance can help psychiatrists to identify and manage potential ADRs. In several cases, physicians may be responsible for bringing a particular ADR to light, and can gain credit for this. This is particularly the case for events such as behavioral toxicity (drug-induced mania, drug-induced suicidality) that are best recognized by practitioners who are in close contact with their patients. Benefits to the pharmaceutical industry: The role of the pharmaceutical industry in psychiatry has come under fire recently, with reports of serious ADRs being under-reported and suppressed during trials.[41] If the principal investigators in such trials develop a “culture of pharmacovigilance,” then such ADRs can be identified at the earliest possible stage, and necessary action taken before the drug is marketed. The CDSCO has made the reporting of adverse reactions by the pharmaceutical industry mandatory.[40] This is known as “periodic safety update reporting” (PSUR). Benefits to regulatory authorities: As mentioned above, most published trials of psychotropic medication are short-term trials. Regulatory authorities may grant approval on the basis of this data, but long-term adverse effects may emerge much later. Early “signal detection” of such events could help authorities in withdrawing the drug responsible, or limiting its use. CONCLUSION Pharmacovigilance is an essential activity for all practicing physicians. In the field of psychiatry, where long-term drug therapy is the norm, clinicians are ideally placed to identify and report ADRs to regulatory authorities. With the setting up of the Pharmacovigilance Program in India, it is important for all psychiatrists to familiarize themselves with the key principles of this science, and to apply them for the welfare of our patients and the healthcare community.
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                Author and article information

                Journal
                Indian J Psychiatry
                Indian J Psychiatry
                IJPsy
                Indian Journal of Psychiatry
                Medknow Publications & Media Pvt Ltd (India )
                0019-5545
                1998-3794
                Apr-Jun 2015
                : 57
                : 2
                : 125-130
                Affiliations
                [1]Consultant Psychiatrist, Poona Hospital & Research Centre, Pune, Maharashtra, India
                Author notes
                Address for correspondence: Dr. Vidyadhar Watve, President Indian Psychiatric Society, Poona Hospital and Research Centre, 27 Sadashiv Peth, Pune - 411 030, Maharashtra, India. E-mail: vidyadharw@ 123456gmail.com

                Presidential address delivered at ANCIPS 2015 at Hyderabad

                Article
                IJPsy-57-125
                10.4103/0019-5545.158132
                4462780
                152c6dfa-d1e4-4fb6-b00f-7b1804a0ad95
                Copyright: © Indian Journal of Psychiatry

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