Minutes of the Assembly Committee on Commerce, 4-16-1975
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Drug Code List
HCPCS/Drug Code List Version 13.2 Revised 6/1/21 List will be updated routinely Disclaimer: For drug codes that require an NDC, coverage depends on the drug NDC status (rebate eligible, Non-DESI, non-termed, etc) on the date of service. Note: Physician/Facility-administered medications are reimbursed using the Centers for Medicare and Medicaid Services (CMS) Part B Drug pricing file found on the CMS website--www.cms.gov. In the absence of a fee, pricing may reflect the methodolgy used for retail pharmacies. Go to data.medicaid.gov for a complete list of drug NDCs participating in the Medicaid drug rebate program. Consult with each Managed Care Organization (MCO) about their coverage guidelines and prior authroization requirements, if applicable. Highlights represent updated material for each specific revision of the Drug Code List. Code Description Brand Name NDC NDC unit Category Service AC CAH P NP MW MH HS PO OPH HI ID DC Special Instructions req. of Limits OP OP TF for measure drug rebate ? 90281 human ig, im Gamastan Yes ML Antisera NONE X X X X Closed 3/31/13. 90283 human ig, iv Gamimune, Yes ML Antisera NONE X X X X Closed 3/31/13. Cost invoice required with claim. Restricted to ICD-9 diagnoses codes 204.10 - 204.12, Flebogamma, 279.02, 279.04, 279.06, 279.12, 287.31, and 446.1, and must be included on claim form, effective 10/1/09. Gammagard 90287 botulinum antitoxin N/A Antisera Not Covered 90288 botulism ig, iv No ML NONE X X X X Requires documentation and medical review 90291 cmv ig, iv Cytogam Yes ML Antisera NONE X X X X Closed 3/31/13. -
Pharmaceutical Patient Safety Policy (PM509)
Original Department: Pharmacy 09/12/2007 Approval: Policy #: PM509 Last Approval: 12/10/2020 Title: Pharmaceutical Patient Safety Approved By: Medical Management Leadership Team Dependencies: None Line(s) of Business WAH-IMC (HCA) BHSO Medicare Advantage (CMS) Medicare SNP (CMS) Cascade Select Purpose Community Health Plan of Washington (CHPW) is committed to ensuring pharmaceutical patient safety. For this reason, in conjunction with its pharmacy benefit manager (PBM), CHPW has established the following programs for all lines of business: • Concurrent Drug Utilization Review (DUR) • Retrospective Drug Utilization Review (DUR) • Drug Recall Safety Alerts Policy CHPW, in conjunction with its PBM, maintains a Concurrent Drug Utilization Review (DUR) at the point- of-dispensing. The goal of the Concurrent DUR is to serve as a secondary source of pharmaceutical information designed to enhance patient safety and to identify the most relevant drug interactions that could impact patient care and potentially result in an adverse drug reaction. In addition, CHPW alerts physicians and members about significant patient-safety related issues including, but not limited to, market withdrawals1, black box warnings2, and class I recalls3. CONCURRENT DUR The Concurrent DUR system is a clinically-based real-time process. The Concurrent DUR system that CHPW and its PBM use follows criteria standards found in 42 C.F.R 456.703(f)(1). It takes place during the claims adjudication process and is designed to identify important patient- specific pharmaceutical care concerns through the use of the following 13 modules: 1 Market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. -
Drug Recall: an Incubus for Pharmaceutical Companies and Most Serious Drug Recall of History
Review Article Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history Upendra Nagaich, Divya Sadhna1 Departments of Pharmaceutics and 1Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India Abstract There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company’s discovery, customer’s complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm’s recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall. Key words: Drug product recall, guidelines, process, recall information INTRODUCTION Regardless a company’s best exists that dangerously defective drug product may reach the customers. These products may cause A drug recall is an instance to return to the maker a batch or disasters, leading to adverse verdicts in drug product liability an entire production run of a drug product, usually due to the litigations. -
This Is Your Products Liability Restatement on Drugs Lars Noah
Brooklyn Law Review Volume 74 Issue 3 SYMPOSIUM: Article 9 The rP oducts Liability Restatement: Was it a Success? 2009 This Is Your Products Liability Restatement on Drugs Lars Noah Follow this and additional works at: https://brooklynworks.brooklaw.edu/blr Recommended Citation Lars Noah, This Is Your Products Liability Restatement on Drugs, 74 Brook. L. Rev. (2009). Available at: https://brooklynworks.brooklaw.edu/blr/vol74/iss3/9 This Article is brought to you for free and open access by the Law Journals at BrooklynWorks. It has been accepted for inclusion in Brooklyn Law Review by an authorized editor of BrooklynWorks. This Is Your Products Liability Restatement on Drugs Lars Noah† TABLE OF CONTENTS I. INTRODUCTION ................................................................................................ 840 II. FLAWS IN PRODUCTION .................................................................................... 841 A. Manufacturing Defects ........................................................................... 841 B. Design Defects ........................................................................................ 842 1. MUDs and Child’s Play .................................................................. 848 2. Snowflakes (and Cost-Consciousness) in Medical Practice ............ 855 3. Myths About Designer (and “Lifestyle”) Drugs ............................. 861 C. Case Studies ........................................................................................... 868 1. Ritodrine ........................................................................................ -
Code of Alabama 1975
CODE OF ALABAMA 1975 CUMULATIVE SUPPLEMENT INCLUDING ACT OF 2009 LEGISLATURE TITLE 34 CHAPTER 23 PRACTICE OF PHARMACY ACT 205 LEGISLATURE 1966 ALABAMA STATE BOARD OF PHARMACY December 7, 2009 1 PHARMACISTS AND PHARMACIES Article 1. Sec. General Provisions 34-23-1. Definitions. 34-23-2. Objects and purposes of chapter. 34-23-3. State drug inspectors. 34-23-4. Recognition of schools and colleges of pharmacy. 34-23-5. Pharmacists exempt from jury duty. 34-23-6. Bankruptcy sales, auction sales, etc., of drugs and medicines. 34-23-7. Illegal possession of prescription drugs. 34-23-8. Substitution of drugs or brands of drugs. 34-23-9. Purity of drugs dispensed. 34-23-10. Notification by pharmacists of change of employment. 34-23-11. Physicians, dentists, registered nurses, etc., exempt from chapter. 34-23-12. Injunctions against violations of chapter. 34-23-13. Penalty for practicing pharmacy without a license; compounding or dispensing prescriptions by unauthorized persons; violations of chapter or rules and regulations of board. Article 2. Licenses and Permits. Division 1. General Provisions. 34-23-30. Pharmacy permits generally. 34-23-31. Permits for mail-order houses. 34-23-32. Manufacturer, bottler, packer, repackager, or wholesale distributor of drugs. 34-23-32.1 FDA requirements to be adhered to by affected parties. 34-23-33. Revocation or suspension of licensed pharmacist, holder of pharmacy intern or extern certificate, permit to operate - Grounds. 34-23-34. Revocation or suspension of licenses to practice pharmacy and pharmacy permits – Statement of charges and notice of hearing. Division 2. Pharmacists' Licenses. -
Reproductive Health & Wellness Program RHWP Title X Clinical
Reproductive Health & Wellness Program RHWP Title X Clinical Services & Protocols 2021 Ohio Department of Health Reviewed by: Cynthia Shellhas MD, MPH March 2021 1 TABLE OF CONTENTS SECTION 1 – Providing Quality Family Planning Services Introduction Introduction……………………………………………………………………………………... 6 Service Plans and Protocols…………………………………………………………………….. 7 Procedural Outline……………………………………………………………………………… 8 Client Encounters……………………………………………………………………………….. 10 Checklist of FP and Related Preventative Health Services for Women………………………... 11 Checklist of FP and Related Preventative Health Services for Men…………………………… 12 Family Planning Services Contraceptive Services…………………………………………………………………………. 13 Broad Range of Contraceptives………………………………………………………………. 13 The Clinic Visit……………………………………………………………………………….. 14 Physical and Laboratory Assessment………………………………………………………… 15 Client Education and Counseling…………………………………………………………….. 16 Contraceptive Counseling to Adolescent Clients…………………………………………….. 17 Counseling Returning Clients………………………………………………………………… 18 Preventative Health Promotion and Referral…………………………………………………. 18 Preconception Health Services Medical History for Female Clients………………………………………………………….. 18 Medical History for Male Clients……………………………………………………………. 19 Physical Examination for all Clients…………………………………………………………. 19 Client Plan and Education……………………………………………………………………. 19 Referral……………………………………………………………………………………….. 20 Achieving Pregnancy Services Client Assessment…………………………………………………………………………….. 20 Client Education and Counseling……………………………………………………………. -
China Regulatory and Market Access Pharmaceutical Report 2014
CHINA REGULATORY AND MARKET ACCESS PHARMACEUTICAL REPORT 2014 Pacific Bridge Medical 7315 Wisconsin Avenue, Suite 609E Bethesda, MD 20814 Tel: (301) 469-3400 Fax: (301) 469-3409 Email: [email protected] Copyright © 2014 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be copied, reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances. CHINA REGULATORY AND MARKET ACCESS PHARMACEUTICAL REPORT (2013) TABLE OF CONTENTS I. China Pharmaceutical Industry Overview .......................................................5 A. Overview B. China Pharmaceutical Market Trends C. China’s Pharmaceutical Distribution System D. Brief Overview of China’s Pharmaceutical Regulations E. China Food and Drug Administration (CFDA) II. The China Healthcare System .........................................................................13 A. History of China’s Healthcare System B. Struggling Healthcare Services Sector C. 2009 Healthcare Reform D. Hospitals and Medical Resources 1. Hospitals in China 2. Current Problems in the Hospital Sector 3. Private Investment in the Hospital Sector 4. Hospital Reform E. Health Insurance in China III. Drug Registration Regulations ........................................................................21 A. Drug Registration Policy B. Classification of Drugs C. Drug Registration Applications D. Application Documents for New Drug Registration E. -
Download PDF File
INTERVENTIONAL CARDIOLOGY Cardiology Journal 20XX, Vol. XX, No. X, XXX–XXX DOI: 10.5603/CJ.a2020.0168 Copyright © 20XX Via Medica REVIEW ARTICLE ISSN 1897–5593 eISSN 1898–018X The plague of unexpected drug recalls and the pandemic of falsified medications in cardiovascular medicine as a threat to patient safety and global public health: A brief review Damian Świeczkowski1, Szymon Zdanowski2, Piotr Merks3, 4, Łukasz Szarpak5, 6, Régis Vaillancourt7, Miłosz J. Jaguszewski1 1First Department of Cardiology, Medical University of Gdansk, Poland 2Department of Anesthesiology and Intensive Therapy, Medical University of Gdansk, Poland 3Medical Department, Cardinal Stefan Wyszynski University in Warsaw, Poland 4Department of Pharmaceutical Technology, Faculty of Pharmacy, Collegium Medicum in Bydgoszcz, Poland 5Bialystok Oncology Center, Bialystok, Poland 6Maria Sklodowska-Curie Medical Academy, Warsaw, Poland 7Children’s Hospital of Eastern Ontario, Ottawa, Canada This paper was guest edited by Prof. Togay Evrin Abstract Valsartan, losartan, and irbesartan, are widely used in the treatment strategies of cardiovascular medi- cine diseases, including hypertension and heart failure. Recently, many formulations for the aforemen- tioned diseases contained active pharmaceutical ingredients and had been abruptly recalled from the market due to safety concerns mainly associated with unwanted impurities — nitrosamines, which are highly carcinogenic substances accidentally produced during manufacturing. Along with cardiovascular medications, formulations containing ranitidine were also recalled from the market. This poses a par- ticular threat to public health due to the non-prescription status of these drugs. Regulatory authorities, including the Food and Drug Administration and European Medicines Agency among others, have taken action to minimize patient risk and improve the manufacturing quality as well as re-checking current guidelines and recommendations. -
FDA Consumer., March 1974
MARCH 1974 NSUMER. "mbatting ug "use e Government's mandate under the mprehensive Drug Abuse Preven , and Control Act of 1970 is to re se the frightening and expanding LEAM/EMT- trend of recent years in the indiscrim inate, excessive, or illicit use of chem ical substances that alter the mind, behavior, or health of the abuser. It is a phenomenon that has touched all parts of our society. .. C Co28 8 Z Z & Co4-coo a |||||| FLDOO3OOO90 This Month an your kitchen pass the food storage test? We’ll ( bet most kitchens can’t. This month, FDA CON SUMER takes a tour through a kitchen to point out the main food storage problems. We hope you’ll use the information in the article to go over your own kitchen and correct the deficiencies you find. This month, FDA CONSUMER continues its effort to inform the public about vitamins. “Myths of Vitamins” describes some of the false or inaccurate qualities some people have claimed for vitamins, and what the scien tific evidence actually shows. In a few months, we’ll present “A Primer on Vitamins,” which will look at the same subject from another viewpoint. “Combatting Drug Abuse” describes FDA's con tribution to the Federal Government's fight against the abuse of legitimate and illicit drugs. FDA is not the en forcement arm of the Federal Government in this im portant area, but its recommendations to the Drug En forcement Administration and its other activities are important elements in the Government's program. The word “recall” has become familiar to every con sumer in the past decade.