DOCSLIB.ORG

A. DSM-IV to ICD-9 Cross Walk

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
A. DSM-IV to ICD-9 Cross Walk San Mateo County Mental Health Services DSM IV to ICD 9 Cross Walk for Diagnoses Requiring Clinician Decision Use this cross walk of DSM IV diagnosis to record the appropriate ICD 9 diagnosis. These diagnoses require the clinician to choose the appropriate ICD 9 diagnoses. All other cross walks of DSM IV to ICD 9 will be done automatically by MIS. Schizophrenia and Other Psychotic Disorders DSM IV Disorder ICD 9 Disorder 295.10 Schizophrenia Disorganized Type 295.1x Schizophrenic Disorders, Disorganized Type 295.20 Schizophrenia Catatonic Type 295.2x Schizophrenic Disorders, Catatonic Type 295.30 Schizophrenia Paranoid Type 295.3x Schizophrenic Disorders, Paranoid Type 295.40 Schizophreniform Disorder 295.4x Acute Schizophrenic Episode 295.60 Schizophrenia Residual Type 295.6x Schizophrenic Disorders, Residual Type 295.70 Schizoaffective Disorder 295.7x Schizo-Affective Type 295.90 Schizophrenia Undifferentiated Type 295.9x Schizophrenic Disorders, Undifferentiated Type The 5th digit for the ICD 9 Diagnosis for the above Schizophrenic disorders must be specified as follows: 0 Unspecified 3 Subchronic w/ Acute Exacerbation 1 Subchronic 4 Chronic w/ Acute Exacerbation 2 Chronic 5 in Remission Pervasive Developmental Disorders DSM IV Disorder ICD 9 Disorder 299.00 Autistic Disorder 299.0x Infantile Autism 299.10 Childhood Disintegrative Disorder 299.1x Childhood Disintegrative Disorder The 5th digit for the ICD 9 Diagnosis for the above Autistic disorders must be specified as follows: 0 Current or Active Status 1 Residual State Other Conditions That May Be A Focus of Clinical Attention V61.12 Physical Abuse of Adult (if by Partner) V61.11 Counseling for Victim of Spousal or Partner Abuse Sexual Abuse of Adult (if by Partner) V61.12 Counseling for Perpetrator of Spousal or Partner Abuse Inclusion of a diagnosis on this sheet does not imply the diagnosis is medically necessary for specialty mental health services. QI-Policies\06-01 Attach A DSM-ICD Crosswalk.doc Page 1 of 2 San Mateo County Mental Health Services DSM IV to ICD 9 Cross Walk for Diagnoses Requiring Clinician Decision Use this cross walk of DSM IV diagnosis to record the appropriate ICD 9 diagnosis. These diagnoses require the clinician to choose the appropriate ICD 9 diagnoses. All other cross walks of DSM IV to ICD 9 will be done automatically by MIS. Substance Abuse Disorders DSM IV Disorder ICD 9 Disorder 303.00 Alcohol Intoxication 303.0x Acute Alcohol Intoxication 305.00 Alcohol Abuse 305.0x Alcohol Abuse 304.40 Amphetamine Dependence 304.4x Amphetamine and Other Psychostimulant Dependence 305.70 Amphetamine Abuse 305.7x Amphetamine or Related Acting Sympathomimetic 305.90 Caffeine Intoxication 305.9x Other, Mixed, or Drug Abuse PCP Abuse, Inhanlant Abuse, or Other (Unknown) Substance Abuse 304.30 Cannabis Dependence 304.3x Cannabis Dependence 305.20 Cannabis Abuse 305.2x Cannabis Abuse 304.20 Cocaine Dependence 304.2x Cocaine Dependence 305.60 Cocaine Abuse 305.6x Cocaine Abuse 304.50 Hallucinogen Dependence 304.5x Hallucinogen Dependence 305.30 Hallucinogen Abuse 305.3x Hallucinogen Abuse 304.6 Inhalant Abuse 304.6x Other Specified Drug Dependence PCP Abuse 304.00 Opioid Dependence 304.0x Opioid Type Dependence 305.50 Opioid Abuse 305.5x Opioid Abuse 304.10 Sedative, Hypnotic, or Anxiolytic Dependence 304.1x Barbituate and Similarly Acting Sedative or Hypnotic Dependence 305.40 Sedative, Hypnotic, or Anxiolytic Abuse 305.4x Barbituate and Similarly Acting Sedative or Hypnotic Abuse 304.80 Polysubstance Dependence 304.7x Combinations of Opioid Type Drug with Any Other 304.8x Combinations of Drug Dependence Excluding Opioid Type Drugs 304.90 Other (or Unknown) Substance Dependence 304.9x Unspecified Drug Dependence The 5th digit for the ICD 9 Diagnosis for the above Substance Use disorders must be specified as follows: 0 Unspecified 2 Episodic 1 Continuous 3 in Remission Inclusion of a diagnosis on this sheet does not imply the diagnosis is medically necessary for specialty mental health services. QI-Policies\06-01 Attach A DSM-ICD Crosswalk.doc Page 2 of 2 .
Load more

Recommended publications
  • International Standards for the Treatment of Drug Use Disorders
    "*+,-.*--- -!"#$%&-'",()0"ÿ23 45 "6789!"7(@&A($!7,0B"67$!C#+D"%"*+,9779C&B"!7%EE F33"*+,-.*--- -!"#$%&-'",()0" International standards for the treatment of drug use disorders REVISED EDITION INCORPORATING RESULTS OF FIELD-TESTING International standards for the treatment of drug use disorders: revised edition incorporating results of field-testing ISBN 978-92-4-000219-7 (electronic version) ISBN 978-92-4-000220-3 (print version) © World Health Organization and United Nations Office on Drugs and Crime, 2020 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons. org/licenses/by-nc-sa/3.0/igo). Under the terms of this license, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO or UNODC endorses any specific organization, products or services. The unauthorized use of the WHO or UNODC names or logos is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons license. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO) or the United Nations Office on Drugs and Crime (UNODC). Neither WHO nor UNODC are responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the license shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization (http://www.
    [Show full text]
  • Running Head: PHARMACOLOGICAL TREATMENT for METHAMPHETAMINE
    Running head: PHARMACOLOGICAL TREATMENT FOR METHAMPHETAMINE PHARMACOLOGICAL TREATMENT FOR METHAMPHETAMINE DEPENDENCE By BRINN CULVER A project submitted in partial fulfillment of the requirements for the degree of MASTER OF NURSING WASHINGTON STATE UNIVERSITY Department of Nursing APRIL 2014 PHARMACOLOGICAL TREATMENT FOR METHAMPHETAMINE ii To the Faculty of Washington State University: The members of the Committee appointed to examine the dissertation/thesis of BRINN CULVER find it satisfactory and recommend that it be accepted. Julie DeWitt-Kamada, DNP, ARNP, PMHNP Chair Anne Mason, DNP, ARNP, PMHNP Dawn Rondeau, DNP, ACNP, FNP PHARMACOLOGICAL TREATMENT FOR METHAMPHETAMINE iii PHARMACOLOGICAL TREATMENT FOR METHAMPHETAMINE DEPENDENCE Abstract By Brinn Culver Washington State University April 2014 Chair: Julie DeWitt-Kamada Methamphetamine (MA) is a highly addictive drug whose abuse causes widespread global consequences. The negative impact of MA use on individuals and communities warrants its consideration as a public health concern. MA has a complicated pharmacological action, and chronic use results in neurological dysfunction, including deficits in dopamine. Changes in dopaminergic function make treatment of MA dependence especially challenging, and the mainstay treatment of psychotherapy is insufficient in addressing dopamine deficit. Pharmacological treatments are being explored, but no medication has attained Federal Drug Administration approval, as it requires proof of achieving abstinence. From a harm reduction standpoint, several
    [Show full text]
  • DEMAND REDUCTION a Glossary of Terms
    UNITED NATIONS PUBLICATION Sales No. E.00.XI.9 ISBN: 92-1-148129-5 ACKNOWLEDGEMENTS This document was prepared by the: United Nations International Drug Control Programme (UNDCP), Vienna, Austria, in consultation with the Commonwealth of Health and Aged Care, Australia, and the informal international reference group. ii Contents Page Foreword . xi Demand reduction: A glossary of terms . 1 Abstinence . 1 Abuse . 1 Abuse liability . 2 Action research . 2 Addiction, addict . 2 Administration (method of) . 3 Adverse drug reaction . 4 Advice services . 4 Advocacy . 4 Agonist . 4 AIDS . 5 Al-Anon . 5 Alcohol . 5 Alcoholics Anonymous (AA) . 6 Alternatives to drug use . 6 Amfetamine . 6 Amotivational syndrome . 6 Amphetamine . 6 Amyl nitrate . 8 Analgesic . 8 iii Page Antagonist . 8 Anti-anxiety drug . 8 Antidepressant . 8 Backloading . 9 Bad trip . 9 Barbiturate . 9 Benzodiazepine . 10 Blood-borne virus . 10 Brief intervention . 11 Buprenorphine . 11 Caffeine . 12 Cannabis . 12 Chasing . 13 Cocaine . 13 Coca leaves . 14 Coca paste . 14 Cold turkey . 14 Community empowerment . 15 Co-morbidity . 15 Comprehensive Multidisciplinary Outline of Future Activities in Drug Abuse Control (CMO) . 15 Controlled substance . 15 Counselling and psychotherapy . 16 Court diversion . 16 Crash . 16 Cross-dependence . 17 Cross-tolerance . 17 Custody diversion . 17 Dance drug . 18 Decriminalization or depenalization . 18 Demand . 18 iv Page Demand reduction . 19 Dependence, dependence syndrome . 19 Dependence liability . 20 Depressant . 20 Designer drug . 20 Detoxification . 20 Diacetylmorphine/Diamorphine . 21 Diuretic . 21 Drug . 21 Drug abuse . 22 Drug abuse-related harm . 22 Drug abuse-related problem . 22 Drug policy . 23 Drug seeking . 23 Drug substitution . 23 Drug testing . 24 Drug use .
    [Show full text]
  • Substance Abuse and Addictions Management
    SUBSTANCE ABUSE AND ADDICTIONS MANAGEMENT Substance abuse , also known as drug abuse , is a patterned use of a substance (drug) in which the user consumes the substance in amounts or with methods neither approved nor supervised by medical professionals. Substance abuse/drug abuse is not limited to mood-altering or psycho-active drugs. If an activity is performed using the objects against the rules and policies of the matter (as in steroids for performance enhancement in sports), it is also called substance abused. Therefore, mood-altering and psychoactive substances are not the only types of drug abuse. Using illicit drugs – narcotics, stimulants, depressants (sedatives), hallucinogens, cannabis, even glues and paints, are also considered to be classified as drug/substance abuse. [2] Substance abuse often includes problems with impulse control and impulsive behaviour. The term "drug abuse" does not exclude dependency, but is otherwise used in a similar manner in nonmedical contexts. The terms have a huge range of definitions related to taking a psychoactive drug or performance enhancing drug for a non- therapeutic or non-medical effect. All of these definitions imply a negative judgment of the drug use in question (compare with the term responsible drug use for alternative views). Some of the drugs most often associated with this term include alcohol, amphetamines, barbiturates, benzodiazepines (particularly temazepam, nimetazepam, and flunitrazepam), cocaine, methaqualone, and opioids. Use of these drugs may lead to criminal penalty in addition to possible physical, social, and psychological harm, both strongly depending on local jurisdiction. [3] There are many cases in which criminal or antisocial behavior occur when the person is under the influence of a drug.
    [Show full text]
  • Alcoholism and Chemical Substance Abuse Dependency 15 Unit Course
    !1 Alcoholism and Chemical Substance Abuse Dependency Continuing Education Course (15 Hours/units) © 2019 by Aspira Continuing Education. All rights reserved. No part of this material may be transmitted or reproduced in any form, or by any means, mechanical or electronic without written permission of Aspira Continuing Education. Course Objectives: In addition to the course objectives listed, this course addresses the following content areas related to alcoholism and chemical substance abuse dependency: ✓ Counseling theory and practice ✓ Social and Cultural Foundations ✓ Assessment ✓ Professional practice issues ✓ Wellness and prevention ✓ Human growth and development Table of Contents: 1. Substance Use and Mental Health Indicators in the United States……….. 2 2. DSM-5 Diagnostic Summary…………………………………………….. 7 3. Types of Substance Abuse……………………………………………….. 11 4. Substance Abuse Treatment and Outcomes……………………………… 23 5. Substance Abuse Treatment for Clinicians………………………………. 33 6. Engaging Adolescents in Treatment……………………………………… 37 7. Brief Strategic Family Therapy for Adolescent Drug Abuse…………….. 45 8. Making the Connection: Trauma and Substance Abuse………………….. 86 9. Strategies for Working with Clients with Co-Occurring Disorders……… 93 10. HIV and Substance Abuse………………………………………………. 133 11. Sexually Transmitted Diseases and Substance Abuse…………………… 138 12. Substance Abuse and Domestic Violence……………………………….. 146 13. Substance Use and Mental Health Among College Students…………… 172 14. References………………………………………………………………. 176 !1 !2 1. Substance Use and Mental Health Indicators in the United States Summary The information below summarizes key findings from the 2018 National Survey on Drug Use and Health (NSDUH) for national indicators of substance use and mental health among people aged 12 or older in the civilian, non-institutionalized population of the United States. Results are provided for the overall category of people aged 12 or older and by age subgroups.
    [Show full text]
  • Prevalence and Co-Occurrence of Substance Use Disorders and Independent Mood and Anxiety Disorders
    Prevalence and Co-Occurrence of Substance Use Disorders and Independent Mood and Anxiety Disorders Results From the National Epidemiologic Survey on Alcohol and Related Conditions Bridget F. Grant, Ph.D., Ph.D., Frederick S. Stinson, Ph.D., Deborah A. Dawson, Ph.D., S. Patricia Chou, Ph.D., Mary C. Dufour, M.D., M.P.H., Wilson Compton, M.D., Roger P. Pickering, M.S., and Kenneth Kaplan Background: Uncertainties exist about the prevalence and comorbidity of substance use disorders and independent mood and anxiety disorders. Objective: To present nationally representative data on the prevalence and comorbidity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM–IV) alcohol and drug use disorders and independent mood and anxiety disorders (including only those that are not substance induced and that are not due to a general medical condition). Design: Face- to-face survey. Setting: The United States. Participants: Household and group quarters residents. Main Outcome Measures: Prevalence and associations of substance use disorders and independent mood and anxiety disorders. Results: The prevalences of 12-month DSM–IV independent mood and anxiety disorders in the U.S. population were 9.21 percent (95 percent confidence interval [CI], 8.78 percent–9.64 percent) and 11.08 percent (95 percent CI, 10.43 percent–11.73 percent), respectively. The rate of substance use disorders was 9.35 percent (95 percent CI, 8.86 percent–9.84 percent). Only a few individuals with mood or anxiety disorders were classified as having only substance-induced disorders. Associations between most substance use disorders and independent mood and anxiety disorders were positive and significant (p < .05).
    [Show full text]
  • View the Scientific Program Abstracts of the ACAAM 2020 Annual Meeting
    Scientific Program Abstracts of the ACAAM 2020 Annual Meeting AMERICAN COLLEGE OF ACADEMIC ADDICTION OF ACADEMIC MEDICINE AMERICAN COLLEGE ADDICTION OF ACADEMIC MEDICINE AMERICAN COLLEGE ADDICTION OF ACADEMIC MEDICINE AMERICAN COLLEGE ADDICTION OF ACADEMIC MEDICINE AMERICAN COLLEGE AMERICAN COLLEGE OF ACADEMIC ADDICTION MEDICINE OF ACADEMIC AMERICAN COLLEGE March 24, 2020 On behalf of the Poster Sub-Committee for the Annual Meeting of The American College of Academic Addiction Medicine I am writing with several updates about the canceled 2020 Annual Meeting poster session to which you had been accepted. 2020 Meeting & Poster Session The 2020 meeting previously scheduled for April in Denver will not be rescheduled as an in- person meeting. We are currently re-imagining the meeting as a series of bi-monthly online gatherings to stay in touch and share important information. One possibility is to use the June gathering to showcase your posters and celebrate the graduates. Expect to receive more information after the current public health issues become clearer and we work out the logistics. 2020 Poster Session Winners Poster session winners were selected prior to cancellation of the meeting and we would like to recognize them here: Emily Buirkle, MD - Rutgers University Co-Author: Erin Zerbo, MD Buprenorphine induction with microdosing: A review of the literature Haileigh Ross, OD - Ohio Health Grant Medical Center Co-Author: Krisanna Deppen, MD A novel case of injectable buprenorphine for opioid use disorder in pregnancy Kumar Vasudevan, MD - NYU School of Medicine Co-Authors: Mia Malone; Ryan McDonald, MA; Anna Cheng; Michael Matteo, CASAC; Monica Katyal, JD MPH; Jasdeep Mangat, MD; Jonathan Giftos, MD; Ross MacDonald, MD; Joshua D.
    [Show full text]
  • 4-Fluoroamphetamine (4-FA) Critical Review Report Agenda Item 5.4
    4-Fluoroamphetamine (4-FA) Critical Review Report Agenda item 5.4 Expert Committee on Drug Dependence Thirty-seventh Meeting Geneva, 16-20 November 2015 37th ECDD (2015) Agenda item 5.4 4-Fluoroamphetamine Page 2 of 35 37th ECDD (2015) Agenda item 5.4 4-Fluoroamphetamine Page 3 of 35 37th ECDD (2015) Agenda item 5.4 4-Fluoroamphetamine Contents Acknowledgements .......................................................................................................................... 6 Summary .......................................................................................................................................... 7 1. Substance identification ................................................................................................................ 8 A. International Nonproprietary Name (INN) .................................................................................... 8 B. Chemical Abstract Service (CAS) Registry Number ...................................................................... 8 C. Other Names .................................................................................................................................. 8 D. Trade Names .................................................................................................................................. 8 E. Street Names .................................................................................................................................. 8 F. Physical properties .......................................................................................................................
    [Show full text]
  • Toxicology Chapters 18, 19, 20, 21, and 22
    Toxicology Chapters 18, 19, 20, 21, and 22 Done by: Mashael Hussein & Amal Aseeri Revised by: Sara Aljebrin Correction file Chapter 18 Principles of Toxicology Definitions ❖ Toxic: Some use the term toxic synonymously with ‘poisonous’, meaning to imply that ingestion of a particular substance will cause death or illness. ❖ Lethal dose: To understand the definition of ‘lethal dose you need to know that drug sensitivity and resistance vary from individual to individual. A ‘lethal dose’ is said to represent the dose of that drug at which all subjects given the drug will die, and that dosage will be expressed in g, mg, mcg/kg. ❖ LD50: The dose at which 50% of those who take a particular dose would die. This partly depends on mode of drug administration (bioavailability) ❖ Drug receptor physiology: How well a particular drug will bind to a receptor determines how effectively it will act (or how toxic it will be). It is also important to know that receptors are capable of mutating. ❖ Drug tolerance: An individual is said to be tolerant when increasingly large doses of the drug produce less effect. It usually occurs after chronic exposure to a specific drug. ❖ Drug dependence: When an individual cannot function normally in the absence of a specific drug. It relates to tolerance which are both partly controlled by receptor distribution, density, and genetics. DSM-IV recognizes the following substance dependencies -Alcohol -Nicotine -Sedative, hypnotic, or anxiolytic -Amphetamines -Hallucinogens -Polysubstance dependence -Cannabis -Opiods -Phencyclidine -Cocaine -Inhalant -Unknown substances ...continue Chapter 18 ...Continue Definitions ❖ Drug withdrawal: The development of symptoms when a drug is abruptly discontinued.
    [Show full text]
  • Concurrent Mental Health Disclosures Learning Objectives
    14/04/2016 Disclosures • Faculty: Dr. Stefan Brennan • Relationships with commercial interests Concurrent Mental Health o Grants/research support: none o Speakers bureau/honoraria: Pfizer, Janssen-Ortho, Astra Zeneca, BMS, Valeant, Lundbeck, Paladin, Shire, Otsuka o Consulting fees: none Dr. Stefan Brennan MD FRCPC o Other: none Clinical Assistant Professor Department of Psychiatry, University of Saskatchewan Epidemiology Learning Objectives • 1 in 7 North Americans meet criteria for a substance use disorder in their lifetime – Alcohol – 13% – • Learn the principles of good concurrent mental health Drugs – 3% • 20% of visits to primary care physicians are related to alcohol, and addiction care. tobacco, and other drug problems. • Apply them to the more common mood and anxiety • Psychiatric disorders and substance use disorders have disorders. overlapping etiologies resulting in reciprocal causality • Appreciate that Borderline Personality Disorder • Lifetime prevalence of substance use co-morbidity: management is not an oxymoron. – Major depressive & dysthymic disorders – 32% - 54% • Understand the challenges in prescribing – Anxiety disorders – 36% methylphenidate or benzodiazepines to this – Bipolar disorder – 56.1% population. – Adult ADHD – 15 - 45% • Annual Cost to Canadian Society Reiger DA, et al. JAMA 1990;264:2511-2518 • Explore case examples. – $40,000,000,000.00 Kessler RC, et al. Arch Gen Psychiatry 1994;51:8-19 Brook DW, et al. Arch Gen Psychiatry 2002;59:1039-1044 Kushner MG, et al. Am J Psychiatry 1999;156:723-732 Bradley KA. Alcohol Health Res World 1994;18:97-104 Hasin D, et al. Arch Gen Psychiatry 2002;59:375-380 Farone SV, et al. Am J Addict 2007;16:24-32 Davis LL, et al.
    [Show full text]
  • United States District Court 6 Eastern District of California 7
    Case 1:13-cv-01303-SMS Document 30 Filed 03/19/15 Page 1 of 19 1 2 3 4 5 UNITED STATES DISTRICT COURT 6 EASTERN DISTRICT OF CALIFORNIA 7 8 9 JASON TRAVIS UHL, Case No. 1:13-cv-01303-SMS 10 Plaintiff, 11 ORDER AFFIRMING AGENCY’S DENIAL v. OF BENEFITS AND ORDERING 12 JUDGMENT FOR COMMISSIONER CAROLYN W. COLVIN, Acting 13 Commissioner of Social Security, 14 Defendant. 15 16 Plaintiff Jason Travis Uhl, by his attorneys, Law Offices of Lawrence D. Rohlfing, seeks 17 judicial review of a final decision of the Commissioner of Social Security (“Commissioner”) 18 denying his application for disability insurance benefits pursuant to Title II and for supplemental 19 security income (“SSI”) pursuant to Title XVI of the Social Security Act (42 U.S.C. § 301 et seq.) 20 (the “Act”). The matter is before the Court on the parties' cross-briefs, which were submitted, 21 without oral argument, to the Honorable Sandra M. Snyder, U.S. Magistrate Judge. 22 The sole issue in this case is whether the Administrative Law Judge (ALJ) appropriately 23 applied the provisions of SSR 13-2p to determine that Plaintiff would not be disabled but for his 24 drug and alcohol abuse. Following a review of the complete record and applicable law, the Court 25 finds the decision of the Administrative Law Judge ("ALJ") to be supported by substantial evidence 26 in the record as a whole and based on proper legal standards. 27 /// 28 1 Case 1:13-cv-01303-SMS Document 30 Filed 03/19/15 Page 2 of 19 1 I.
    [Show full text]
  • Report on the Deliberation Results December 6, 2010 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau
    Report on the Deliberation Results December 6, 2010 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Stelara Subcutaneous Injection 45 mg Syringe [Non-proprietary name] Ustekinumab (Genetical Recombination) (JAN*) [Applicant] Janssen Pharmaceutical K.K. [Date of application] January 21, 2010 [Results of deliberation] In the meeting held on November 29, 2010, the Second Committee on New Drugs concluded that the product may be approved and that this result should be presented to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council. The product is classified as a biological product, the re-examination period is 8 years, and the drug substance and the drug product are both classified as powerful drugs. The conditions for approval should be modified as follows. After modification [Conditions for approval] The applicant is required to: 1. Conduct a post-marketing drug use-results survey, which covers all the patients treated with the product, until data from a certain number of patients will be accumulated, in order to collect data on the safety and efficacy of the product as soon as possible and to take necessary measures to ensure proper use of the product. 2. Conduct a large-scale post-marketing surveillance study to fully evaluate the safety of the product and to investigate the efficacy and long-term safety of the product, including the occurrence of infections, etc. Before modification [Conditions for approval] The applicant is required to: 1. Conduct a post-marketing drug use-results survey, which covers all the patients treated with the product, until data from a certain number of patients will be accumulated, in order to collect data on the safety and efficacy of the product as soon as possible and to take necessary measures to ensure proper use of the product.
    [Show full text]