This document discusses several standards related to controlled substances in pharmacy practice, including standards for mailing, destroying, faxing prescriptions for, and reporting loss of controlled substances. It provides details on the requirements for mailing controlled substances, destroying them according to state regulations, faxing prescriptions (which are allowed only in certain situations), standards for prescriptions by nurse practitioners, and requirements for reporting loss or theft of controlled substances to the DEA and state board of pharmacy. The document aims to review some common rules regarding controlled substances but does not present all state and federal regulations.
Controlled substances are drugs with high potential for abuse that are regulated by the Controlled Substances Act. This law established a closed system for proper handling of these drugs through licensing and established the DEA to enforce the law. Controlled substances are categorized into 5 schedules based on their abuse potential and legal restrictions. Strict record keeping and security measures are required for ordering, receiving, inventorying, and distributing controlled substances to ensure proper use and prevent diversion.
This document provides an overview of managing controlled substances in EMS. It discusses diversion control and why record keeping is necessary to prevent theft and protect public health. Key points include:
- Controlled substances must be securely stored and strict records kept of ordering, inventory, administration and disposal.
- Schedule II drugs like fentanyl require DEA Form 222 to order and have separate record keeping from other schedules.
- Inventories must be taken at least annually and any shortages or evidence of tampering reported immediately.
- Proper training, policies, separation of duties and periodic audits can help ensure compliance and prevent diversion within EMS agencies.
This document provides an overview of controlled drug (CD) legislation in the UK, including the role of accountable officers, requirements for destruction of stock and patient-returned CDs, and details required on CD instalment prescriptions. It discusses the Shipman inquiry which identified shortcomings in CD audit and management. It outlines the responsibilities of accountable officers and new regulations aimed at supporting healthcare professionals while encouraging good practice and identifying potential issues. Key points covered include prescription requirements, instalment scripts, frequently asked questions about prescribing and obtaining CDs, and restrictions around doctors prescribing for themselves or family.
Narcotic controlled drugs policy and procedurelastKnikkos
This document outlines policies and procedures for handling narcotic and controlled drugs in MOH hospitals. It defines key terms and assigns responsibilities to various departments and roles. The pharmacy department is responsible for receiving, storing, and dispensing these drugs, while maintaining proper documentation. Nurses are responsible for auditing drug counts. Strict protocols are established for prescribing, dispensing, administering, storing, recording use, and disposing of unused portions of narcotic and controlled drugs. Prescriptions must meet specific requirements and be properly documented.
The document discusses federal regulations regarding the disposal of medicines from the FDA, DEA, and USPS. The FDA recommends mixing most medicines with unpalatable substances and throwing them in the trash or using drug take-back programs. However, some controlled substances should not be thrown in the trash due to the risk of accidental ingestion; these may require approval from the DEA for disposal. The USPS allows returning prescription drugs by mail for recalls, withdrawals, or errors when sent to the manufacturer.
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
This document provides an overview of the key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
The document discusses the history and classification of controlled substances in the United States. It begins with a brief history of increasing drug regulation since the early 1900s, culminating in the 1970 Controlled Substances Act (CSA) which established five drug schedules based on a drug's medical use, abuse potential, and safety. The CSA contains laws governing the manufacture, distribution, and possession of controlled substances. The document then outlines the five drug schedules, providing examples of drugs in each schedule. It concludes by discussing prescribing, procurement, storage, dispensing, inventory control, and disposal of controlled substances in accordance with the CSA.
Controlled substances are drugs with high potential for abuse that are regulated by the Controlled Substances Act. This law established a closed system for proper handling of these drugs through licensing and established the DEA to enforce the law. Controlled substances are categorized into 5 schedules based on their abuse potential and legal restrictions. Strict record keeping and security measures are required for ordering, receiving, inventorying, and distributing controlled substances to ensure proper use and prevent diversion.
This document provides an overview of managing controlled substances in EMS. It discusses diversion control and why record keeping is necessary to prevent theft and protect public health. Key points include:
- Controlled substances must be securely stored and strict records kept of ordering, inventory, administration and disposal.
- Schedule II drugs like fentanyl require DEA Form 222 to order and have separate record keeping from other schedules.
- Inventories must be taken at least annually and any shortages or evidence of tampering reported immediately.
- Proper training, policies, separation of duties and periodic audits can help ensure compliance and prevent diversion within EMS agencies.
This document provides an overview of controlled drug (CD) legislation in the UK, including the role of accountable officers, requirements for destruction of stock and patient-returned CDs, and details required on CD instalment prescriptions. It discusses the Shipman inquiry which identified shortcomings in CD audit and management. It outlines the responsibilities of accountable officers and new regulations aimed at supporting healthcare professionals while encouraging good practice and identifying potential issues. Key points covered include prescription requirements, instalment scripts, frequently asked questions about prescribing and obtaining CDs, and restrictions around doctors prescribing for themselves or family.
Narcotic controlled drugs policy and procedurelastKnikkos
This document outlines policies and procedures for handling narcotic and controlled drugs in MOH hospitals. It defines key terms and assigns responsibilities to various departments and roles. The pharmacy department is responsible for receiving, storing, and dispensing these drugs, while maintaining proper documentation. Nurses are responsible for auditing drug counts. Strict protocols are established for prescribing, dispensing, administering, storing, recording use, and disposing of unused portions of narcotic and controlled drugs. Prescriptions must meet specific requirements and be properly documented.
The document discusses federal regulations regarding the disposal of medicines from the FDA, DEA, and USPS. The FDA recommends mixing most medicines with unpalatable substances and throwing them in the trash or using drug take-back programs. However, some controlled substances should not be thrown in the trash due to the risk of accidental ingestion; these may require approval from the DEA for disposal. The USPS allows returning prescription drugs by mail for recalls, withdrawals, or errors when sent to the manufacturer.
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
This document provides an overview of the key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
The document discusses the history and classification of controlled substances in the United States. It begins with a brief history of increasing drug regulation since the early 1900s, culminating in the 1970 Controlled Substances Act (CSA) which established five drug schedules based on a drug's medical use, abuse potential, and safety. The CSA contains laws governing the manufacture, distribution, and possession of controlled substances. The document then outlines the five drug schedules, providing examples of drugs in each schedule. It concludes by discussing prescribing, procurement, storage, dispensing, inventory control, and disposal of controlled substances in accordance with the CSA.
This document discusses labels for pharmaceutical products. It defines a label and describes two main types - manufacturer labels and dispensing labels. Manufacturer labels contain drug information for medical professionals and must include the name, strength, dosage form, quantity, instructions, precautions, registration number, batch number, dates and manufacturer details. Dispensing labels are affixed by pharmacists and include the patient's name, prescription number, directions for use, pharmacy information and sometimes interactions. Labels provide important information to ensure drugs are used safely and effectively.
Objectives, scope, Organization and structure of retail and wholesale drug store, type and design, dispensing of proprietary products, legal requirements
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
The document discusses the administration of the Drugs and Cosmetics Act and Rules in India. It outlines the roles and qualifications of government analysts, drugs inspectors, and their powers and duties. Government analysts are appointed by state and central governments to analyze drug and cosmetic samples. They must have qualifications in medicine, science, pharmacy or pharmaceutical chemistry. Drugs inspectors inspect premises where drugs are manufactured and sold. They collect samples, examine records, and seize stocks if needed. Inspectors investigate complaints and work to detect illegal drug sales.
The document summarizes the discussions and updates from the monthly meeting of the Board of Pharmacy. Key topics included: the Prescription Drug Monitoring Program monthly report; compounding regulations under Sections 503A and 503B; applications for a change of ownership, reinstatement, and reciprocal licensure; a standing order to dispense naloxone; technician training requirements; and the roles and terms of Board members.
(I) In India previously, there were no restrictions on practicing pharmacy and people without proper education in pharmacy were practicing it. This was harming public health.
(II) To regulate the profession, the Pharmacy Bill was introduced in 1947 and passed in 1948 as the Pharmacy Act. This act established the Central Council of Pharmacy to set education standards and approve courses for pharmacists.
(III) The Act requires a minimum level of professional education to practice pharmacy, protects the title of pharmacist, and establishes state pharmacy councils to maintain registers of qualified pharmacists.
Definitions according to Drug Regulatory Authority of Pakistan (DRAP medical ...Arooj Abid
This document defines key terms related to medical devices and their regulation in Pakistan. It provides definitions for different types of medical devices including active devices, implants, and in vitro diagnostics. It also defines terms related to the regulation of medical devices such as clinical evaluation, clinical investigation, misbranded devices, notified bodies, and essential principles. The definitions cover a wide range of topics from different types of medical devices to regulatory concepts, organizations, and processes.
This document discusses controlled substances and their regulations. It defines controlled substances as drugs with potential for abuse or dependence. It categorizes controlled substances into 5 schedules based on their abuse potential and accepted medical use. It outlines the roles and responsibilities of various parties like administration, pharmacists, and nurses in properly ordering, storing, dispensing and recording controlled substances in hospitals. It discusses policies around prescribing, administering, and charging patients for controlled substances.
Drugs Technical Advisory Board (DTAB) Minutes of meetingsRakeshDahiya16
This division deals with organizing and convening meetings of ‘Drugs Technical Advisory Board (DTAB)’.
The recommendations of DTAB on the matters rose out of administration of the Drugs and Cosmetics Act and Rules thereunder shall be done by amending the relevant particulars of the Drugs and Cosmetics Act and Rules thereunder.
This chapter discusses various drug information resources available to pharmacy technicians. It covers primary, secondary, and tertiary literature references as well as common references like Drug Facts and Comparisons, USP DI, Martindale, and AHFS. Other reference types discussed include textbooks, newsletters, indexes, the FDA Orange Book, and Material Safety Data Sheets. The chapter also reviews resources available through the internet, personal digital assistants, and pharmacy technician organizations.
This document outlines procedures for controlling regulated substances like narcotics in a hospital setting. It discusses identifying and resolving discrepancies in controlled substance counts, defines who can prescribe and handle these drugs, and lists some commonly used narcotics. It provides details on ordering, prescribing, dispensing, and tracking controlled substances within the hospital. The document also describes protocols for reporting diversion or abuse of drugs, including which outside agencies to notify. It discusses types of diversion cases and notes that physician and pharmacy diversion is most common. It outlines investigating incidents internally and procedures for reporting to outside agencies, as well as potential penalties for employees.
Prescribed medication order & Communication Skills for PharmacistDr Manish Pal Singh
The document discusses prescribed medication orders and communication skills for pharmacists. It covers what a prescription is, the parts of a prescription, abbreviations used in prescriptions, legal requirements, and communication skills when interacting with prescribers and patients. Good communication is important for pharmacists to properly handle, interpret, authenticate and record prescriptions and counsel patients.
Drugs and magic remedies act 1954 and rules Rupali Bhoje
This document outlines the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954 in India. The key points are:
- It prohibits advertising of drugs for certain purposes like abortion, contraception, and treatment of diseases listed in a schedule like cancer, tuberculosis, etc.
- Advertising is also banned for "magic remedies" that claim to treat diseases through charms or rituals.
- Exemptions are provided for certain advertisements directed at medical professionals with prior government approval.
- Penalties are defined for violations which include fines and imprisonment on conviction.
This document summarizes rules and regulations for physicians regarding controlled substances and prescription practices in Florida. It outlines 8 common mistakes physicians could make, such as failing to follow proper prescription pad rules, failing to register as a controlled substance prescribing practitioner, and failing to satisfy documentation requirements. It then provides more details on the 9 main rules physicians must follow, including DEA requirements, registration deadlines for prescribing controlled substances for chronic pain, and definitions of key terms.
This document outlines the requirements and guidelines for permission to import and/or manufacture new drugs for sale or to undertake clinical trials in India. It discusses the relevant acts and rules that regulate drug importation, manufacture, and clinical trials. It provides information on the application process and required data for new drugs, including chemical, pharmaceutical, pre-clinical, and clinical information. It also describes the responsibilities of clinical trial sponsors, investigators, and ethics committees and the processes for informed consent and approval of clinical trial protocols.
Pharmaceutical jurisprudence(pharm d 3rd yr)AnushkaDubey9
The document outlines the qualifications, powers, duties, and procedures of drug inspectors in India. Drug inspectors must have a degree in pharmacy or medicine and experience in drug manufacturing or testing. Their powers include inspecting premises where drugs are made, sold, or distributed; collecting samples; and examining records. Their duties are to inspect licensed drug establishments twice a year, investigate complaints, maintain records, detect illegal drug sales, and send samples for testing. They are to follow procedures for collecting samples, sending them to a government analyst, and reporting results to court for drugs found to be substandard or of standard quality.
The document defines key terms related to pharmacy practice in Illinois, including pharmacy, practice of pharmacy, prescription, pharmacist in charge, dispense, compounding, patient counseling, automated pharmacy system, drug regimen review, electronic transmission prescription, medication therapy management services, pharmacist care, pharmacy technician registration, and certified pharmacy technician. It also outlines the composition and duties of the Illinois State Board of Pharmacy.
The document discusses Indian regulatory requirements for drugs, including the Central Drugs Standard Control Organization (CDSCO) which regulates drugs, cosmetics, diagnostics and devices in India. CDSCO is headed by the Drug Controller General of India and oversees functions like new drug approval, clinical trials, good manufacturing practices, and state licensing. It provides an overview of the application and approval process for new drugs in India.
Objectives
By completing the lesson, the pharmacist will be able to:
• Discuss the history of the REMS program
• Describe the elements of the REMS program
• Identify when a REMS might be used for a particular drug
• Identify REMS elements employed with medications dispensed in community pharmacy
• Discuss selection provision in Ohio law related to REMS requirements
Holiday Gift Program Mc Gladrey Wmb 91212billybooe
The document provides options and pricing for McGladrey's holiday gift program. It includes gifts ranging in price from $25-$60+, such as cookie tins, popcorn tins, coffee gift sets, and towers of treats. For each gift, it provides details on contents, packaging, pricing at different quantities, setup and shipping fees. The gifts can be customized with the McGladrey logo or other imprints for an additional fee.
This document discusses labels for pharmaceutical products. It defines a label and describes two main types - manufacturer labels and dispensing labels. Manufacturer labels contain drug information for medical professionals and must include the name, strength, dosage form, quantity, instructions, precautions, registration number, batch number, dates and manufacturer details. Dispensing labels are affixed by pharmacists and include the patient's name, prescription number, directions for use, pharmacy information and sometimes interactions. Labels provide important information to ensure drugs are used safely and effectively.
Objectives, scope, Organization and structure of retail and wholesale drug store, type and design, dispensing of proprietary products, legal requirements
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
The document discusses the administration of the Drugs and Cosmetics Act and Rules in India. It outlines the roles and qualifications of government analysts, drugs inspectors, and their powers and duties. Government analysts are appointed by state and central governments to analyze drug and cosmetic samples. They must have qualifications in medicine, science, pharmacy or pharmaceutical chemistry. Drugs inspectors inspect premises where drugs are manufactured and sold. They collect samples, examine records, and seize stocks if needed. Inspectors investigate complaints and work to detect illegal drug sales.
The document summarizes the discussions and updates from the monthly meeting of the Board of Pharmacy. Key topics included: the Prescription Drug Monitoring Program monthly report; compounding regulations under Sections 503A and 503B; applications for a change of ownership, reinstatement, and reciprocal licensure; a standing order to dispense naloxone; technician training requirements; and the roles and terms of Board members.
(I) In India previously, there were no restrictions on practicing pharmacy and people without proper education in pharmacy were practicing it. This was harming public health.
(II) To regulate the profession, the Pharmacy Bill was introduced in 1947 and passed in 1948 as the Pharmacy Act. This act established the Central Council of Pharmacy to set education standards and approve courses for pharmacists.
(III) The Act requires a minimum level of professional education to practice pharmacy, protects the title of pharmacist, and establishes state pharmacy councils to maintain registers of qualified pharmacists.
Definitions according to Drug Regulatory Authority of Pakistan (DRAP medical ...Arooj Abid
This document defines key terms related to medical devices and their regulation in Pakistan. It provides definitions for different types of medical devices including active devices, implants, and in vitro diagnostics. It also defines terms related to the regulation of medical devices such as clinical evaluation, clinical investigation, misbranded devices, notified bodies, and essential principles. The definitions cover a wide range of topics from different types of medical devices to regulatory concepts, organizations, and processes.
This document discusses controlled substances and their regulations. It defines controlled substances as drugs with potential for abuse or dependence. It categorizes controlled substances into 5 schedules based on their abuse potential and accepted medical use. It outlines the roles and responsibilities of various parties like administration, pharmacists, and nurses in properly ordering, storing, dispensing and recording controlled substances in hospitals. It discusses policies around prescribing, administering, and charging patients for controlled substances.
Drugs Technical Advisory Board (DTAB) Minutes of meetingsRakeshDahiya16
This division deals with organizing and convening meetings of ‘Drugs Technical Advisory Board (DTAB)’.
The recommendations of DTAB on the matters rose out of administration of the Drugs and Cosmetics Act and Rules thereunder shall be done by amending the relevant particulars of the Drugs and Cosmetics Act and Rules thereunder.
This chapter discusses various drug information resources available to pharmacy technicians. It covers primary, secondary, and tertiary literature references as well as common references like Drug Facts and Comparisons, USP DI, Martindale, and AHFS. Other reference types discussed include textbooks, newsletters, indexes, the FDA Orange Book, and Material Safety Data Sheets. The chapter also reviews resources available through the internet, personal digital assistants, and pharmacy technician organizations.
This document outlines procedures for controlling regulated substances like narcotics in a hospital setting. It discusses identifying and resolving discrepancies in controlled substance counts, defines who can prescribe and handle these drugs, and lists some commonly used narcotics. It provides details on ordering, prescribing, dispensing, and tracking controlled substances within the hospital. The document also describes protocols for reporting diversion or abuse of drugs, including which outside agencies to notify. It discusses types of diversion cases and notes that physician and pharmacy diversion is most common. It outlines investigating incidents internally and procedures for reporting to outside agencies, as well as potential penalties for employees.
Prescribed medication order & Communication Skills for PharmacistDr Manish Pal Singh
The document discusses prescribed medication orders and communication skills for pharmacists. It covers what a prescription is, the parts of a prescription, abbreviations used in prescriptions, legal requirements, and communication skills when interacting with prescribers and patients. Good communication is important for pharmacists to properly handle, interpret, authenticate and record prescriptions and counsel patients.
Drugs and magic remedies act 1954 and rules Rupali Bhoje
This document outlines the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954 in India. The key points are:
- It prohibits advertising of drugs for certain purposes like abortion, contraception, and treatment of diseases listed in a schedule like cancer, tuberculosis, etc.
- Advertising is also banned for "magic remedies" that claim to treat diseases through charms or rituals.
- Exemptions are provided for certain advertisements directed at medical professionals with prior government approval.
- Penalties are defined for violations which include fines and imprisonment on conviction.
This document summarizes rules and regulations for physicians regarding controlled substances and prescription practices in Florida. It outlines 8 common mistakes physicians could make, such as failing to follow proper prescription pad rules, failing to register as a controlled substance prescribing practitioner, and failing to satisfy documentation requirements. It then provides more details on the 9 main rules physicians must follow, including DEA requirements, registration deadlines for prescribing controlled substances for chronic pain, and definitions of key terms.
This document outlines the requirements and guidelines for permission to import and/or manufacture new drugs for sale or to undertake clinical trials in India. It discusses the relevant acts and rules that regulate drug importation, manufacture, and clinical trials. It provides information on the application process and required data for new drugs, including chemical, pharmaceutical, pre-clinical, and clinical information. It also describes the responsibilities of clinical trial sponsors, investigators, and ethics committees and the processes for informed consent and approval of clinical trial protocols.
Pharmaceutical jurisprudence(pharm d 3rd yr)AnushkaDubey9
The document outlines the qualifications, powers, duties, and procedures of drug inspectors in India. Drug inspectors must have a degree in pharmacy or medicine and experience in drug manufacturing or testing. Their powers include inspecting premises where drugs are made, sold, or distributed; collecting samples; and examining records. Their duties are to inspect licensed drug establishments twice a year, investigate complaints, maintain records, detect illegal drug sales, and send samples for testing. They are to follow procedures for collecting samples, sending them to a government analyst, and reporting results to court for drugs found to be substandard or of standard quality.
The document defines key terms related to pharmacy practice in Illinois, including pharmacy, practice of pharmacy, prescription, pharmacist in charge, dispense, compounding, patient counseling, automated pharmacy system, drug regimen review, electronic transmission prescription, medication therapy management services, pharmacist care, pharmacy technician registration, and certified pharmacy technician. It also outlines the composition and duties of the Illinois State Board of Pharmacy.
The document discusses Indian regulatory requirements for drugs, including the Central Drugs Standard Control Organization (CDSCO) which regulates drugs, cosmetics, diagnostics and devices in India. CDSCO is headed by the Drug Controller General of India and oversees functions like new drug approval, clinical trials, good manufacturing practices, and state licensing. It provides an overview of the application and approval process for new drugs in India.
Objectives
By completing the lesson, the pharmacist will be able to:
• Discuss the history of the REMS program
• Describe the elements of the REMS program
• Identify when a REMS might be used for a particular drug
• Identify REMS elements employed with medications dispensed in community pharmacy
• Discuss selection provision in Ohio law related to REMS requirements
Holiday Gift Program Mc Gladrey Wmb 91212billybooe
The document provides options and pricing for McGladrey's holiday gift program. It includes gifts ranging in price from $25-$60+, such as cookie tins, popcorn tins, coffee gift sets, and towers of treats. For each gift, it provides details on contents, packaging, pricing at different quantities, setup and shipping fees. The gifts can be customized with the McGladrey logo or other imprints for an additional fee.
Robert J. Garrity's pharmacist license was summarily suspended on February 8, 2001. He was found to have stolen controlled substances from CVS pharmacy on multiple occasions between December 2000 and January 2001 for his personal abuse and use. He admitted to being addicted to controlled substances. The Ohio State Board of Pharmacy revoked Garrity's pharmacist license based on findings that he committed felonies, gross immorality, dishonesty, was addicted to or abused drugs, and willfully violated drug laws.
1) Physician assistants in Ohio can now prescribe under certain conditions, including completing education requirements and practicing under the supervision of a physician.
2) Physician assistants must complete a minimum of 65 hours of education in pharmacology, clinical training, and legal implications of prescribing. They must also complete a provisional period of prescribing under physician supervision.
3) Physician assistant prescriptions are limited to drugs in an approved formulary and standards of the supervising physician. Controlled substances are further restricted.
This document provides product specifications for several corporate polo shirt and sport shirt options. It describes the materials, features, sizing, imprint details, pricing, and production time for each item. The options include classic poly-cotton polos, moisture wicking pima and baby pique sport shirts, textured polyester sport shirts, Dri-Fit micro pique shirts, and luxury cotton Callaway polos. Pricing ranges from $17.50 to $55 per unit depending on the style and size.
The document summarizes the client work and partnerships over the past year in 3 sentences. It looks forward to continued growth together in 2013 and thanks clients for their support. The recap highlights key accomplishments and programs from 2012 that strengthened brands, grew market share, and helped clients' businesses.
This document provides an overview of Ohio laws regarding pharmacy compounding. It defines different types of compounding and outlines legal requirements. Compounded drugs for administration by prescribers have specific limits, including only 5% of total sales, a 72-hour supply limit for prescribers, and labeling and record keeping rules. Compounding in a pharmacy for patient prescriptions requires following prescription and labeling rules, with limited batch preparation allowed based on routine orders.
Activate! is a full-service promotional marketing company founded in 1995. They have expertise in branded merchandise, marketing, and technology. Activate! utilizes value alliances for fulfillment, distribution, sourcing, and other services to reduce costs for customers. They provide various promotional products and services, as well as creative online stores and marketing programs. Activate! aims to drive business and create value through their unique business model and customer service.
Bluegrass Social Media Preso For 2010 Nsmbillybooe
This presentation discusses how social media can impact businesses. It provides an overview of LinkedIn, including its growth and demographics. It notes how LinkedIn can be used to increase visibility, connections, search engine results and more. The presentation also outlines dos and don'ts for social media use, such as avoiding oversharing personal details or political views. It closes by emphasizing responding to feedback, connecting with audiences, and asking for help in developing a social media strategy.
The document provides information about begonias, including that they are an annual plant, usually grow 6 to 24 inches tall and 8 to 12 inches wide, prefer shade to partial shade, and come in pink, red, and white colors blooming from late spring to early fall. It also notes that begonias are a common landscaping plant due to their low maintenance requirements.
The document discusses techniques for optimizing web application performance, including:
- Minifying CSS and JavaScript files using the Juicer gem to reduce file sizes and number of HTTP requests
- Serving static assets like images, CSS, and JavaScript files from multiple subdomains to allow the browser to make more parallel requests
- Enabling gzip compression and setting long cache expiration headers for static assets with Apache modules
- Adding cache busting query strings to asset files to ensure browsers fetch fresh versions when assets change
Findings of Fact
The DRE Protocol fails to produce an accurate and reliable determination of whether a suspect is impaired by drugs and by what specific drug he is impaired. The DRE training police officers receive does not enable DREs to accurately observe the signs and symptoms of drug impairment, therefore, police officers are not able to reach accurate and reliable conclusions regarding what drug may be causing impairment.
Conclusions of Law
The State failed to prove by a preponderance of the evidence that the drug evaluation and. Classification program is not new or novel and is generally accepted within the scientific community and, therefore, it is subject to analysis under Frye v. United States and Reed v. State. The drug evaluation and classification program does not survive a Frye/Reed challenge because it is not generally accepted as valid and reliable in the relevant scientific community which includes pharmacologists, neurologists, ophthalmologists, toxicologists, behavioral research psychologists, forensic specialists and medical doctors.
This document provides an overview of Ohio laws regarding pharmacy compounding. It defines different types of compounding and outlines legal requirements. Compounded drugs for administration by prescribers have specific limits, including only 5% of total sales, a 72-hour supply limit for prescribers, and labeling and record keeping rules. Compounding in a pharmacy for patient prescriptions requires following prescription and labeling rules, with limited batch preparation allowed based on routine orders.
• Discuss Ohio’s new laws concerning use of opioids in minors
• Describe the documents and record keeping for opioid prescriptions
• Discuss Ohio’s donated drug repository program
• Describe record keeping for drug repository program
THE MEDICINE SHOPPE V. LORETTA LYNCH, ETAL. PHARMACISTS A.docxoreo10
THE MEDICINE SHOPPE V. LORETTA LYNCH, ET
AL.: PHARMACISTS AND PRESCRIBING
PHYSICIANS ARE EQUALLY LIABLE
Grass, Jeffrey C, JD, MS, ACLM . The Health Lawyer ; Chicago Vol. 28, Iss. 3, (Feb 2016): 28-37.
ProQuest document link
ABSTRACT
[...]Petitioners challenged the DEA's interpretation of "legitimate medical purpose" under the Controlled Substances
Act ("CSA") and the "corresponding responsibility" standard under DEA Regulation 21 C.F.R. § 1306.04(a) (2014) on
the grounds that these standards exceed the United States Attorney General's and the DEA's statutory authority
under the CSA.7 On December 16, 2015, the Court denied The Medicine Shoppe's petition for review without
comment, thereby leaving open the question of whether or not the United States Attorney General may expand the
professional duty of pharmacists to require they either endorse or overrule the medical judgment of the prescribing
physician.
FULL TEXT
On November 3, 2011, the Dmg Enforcement Administration ("DEA") conducted an inspection of The Medicine
Shoppe, a small family-owned pharmacy in San Antonio, Texas. DEA Diversion Investigators ("Dis") seized
prescriptions filled by patients of a local physician who was under investigation for possible dmg diversion. On
October 7, 2013, the DEA Deputy Administrator issued an Order to Show Cause ("OTSC") to revoke The Medicine
Shoppe's controlled substances Certificate of Registration ("COR") on the grounds that the pharmacy had filled
prescriptions written by the target physician that were not for a "legitimate medical purpose."1 The DEA alleged
that The Medicine Shoppe's pharmacists failed to exercise their "corresponding responsibility," along with the
physician, "to assure that its prescription for controlled substances was issued for a legitimate medical purpose"
and "in the practitioner's usual course of professional practice" under DEA regulation.
The Medicine Shoppe responded that the pharmacists had known the patients and the prescribing physician for
many years and had contacted the prescribing physician's office to verify the prescriptions before filling them.2
The Medicine Shoppe argued that therefore it had complied with the requirements of their pharmacists'
professional licenses and absent clear evidence of diversion, the pharmacists were obliged to fill the
prescriptions.3
On October 2nd, 2014 the DEA revoked The Medicine Shoppe's COR.4 The Medicine Shoppe then filed a Petition for
Review with the United States Court of Appeals for the District of Columbia Circuit, which has original jurisdiction
for appeals of DEA Orders under the Administrative Procedure Act ("APA").5 The Medicine Shoppe appealed on the
grounds that imposing a "corresponding responsibility" on pharmacists to ensure that controlled substances are
prescribed for a "legitimate medical purpose'" requires them to make medical judgments beyond their education
and training.6 Moreover, should the DEA ...
This document discusses key aspects of prescriptions, including their components, types, and interpretation. A prescription contains information about the patient, medication, and directions. It is issued by a medical practitioner and provides instructions for a pharmacist to prepare and dispense a medication to a specific patient. Prescriptions can be written or electronic. They must be accurately interpreted and filled to ensure patients receive the correct medication as prescribed.
This document outlines provisions for drug registration in China, including:
- The State Food and Drug Administration is responsible for drug registration nationwide and oversees clinical trials, production, and importation of drugs.
- The registration process involves application and review of drugs for safety, efficacy, and quality. It includes clinical trials and inspections of manufacturing facilities.
- Applications are reviewed following principles of openness, fairness and protecting confidential information submitted by applicants.
The document provides guidelines for inspecting wards regarding drug storage and administration. It outlines that wards should have standard operating procedures covering medicine use to ensure safety. Responsibilities include a senior pharmacist establishing security systems and an appointed nurse maintaining them. Medicines must be securely stored and records kept of all transactions, administration, and disposal. Regular inspections by pharmacy staff should check security and reconciliation of ward stocks.
1. The document discusses protocols for handling narcotic drugs and psychotropic substances including tightly controlling their use and distribution due to abuse potential.
2. It defines narcotic drugs as including opioids like morphine and fentanyl that require a separate license, while psychotropic drugs like benzodiazepines and tramadol do not require an additional license.
3. Standard protocols include dispensing drugs only with a physician's order, keeping records of use for two years, and disciplinary action for policy violations. Procurement of narcotics involves approval quotas, applications, and ordering through vendors.
This document discusses the legal standard of "corresponding responsibility" that pharmacists have when dispensing prescriptions. A pharmacist must ensure each prescription is issued for a legitimate medical purpose by an authorized prescriber. While prescribers are responsible for proper prescribing, pharmacists have a duty to determine if a prescription is valid. The document outlines factors a pharmacist should consider to determine if a prescription has a legitimate medical purpose, such as prescription details, patient behavior, and prescriber characteristics. It also discusses legal cases and DEA guidance on prescribing and dispensing controlled substances. Overall, the document provides an overview of a pharmacist's legal responsibilities to validate prescriptions and factors that could indicate a prescription is not for a legitimate medical
This document provides an overview of various roles and organizations related to pharmacy practice. It describes pharmacy assistant and technician roles, different pharmacy settings like hospital and nuclear pharmacies. It also outlines the responsibilities of regulatory bodies like the FDA, DEA, USP, and state boards of pharmacy in enforcing drug laws, approving drugs, and regulating pharmacy practice. The document defines the broad scope of pharmacy practice under state laws and provides context on insurance programs and requirements for pharmacists and technicians.
The document defines a prescription as a written order from a medical practitioner to a pharmacist for medications to treat a patient's condition. A prescription contains information like the prescriber's details, patient details, medication, dosage, and instructions. It discusses the parts of a prescription like date, patient information, medication prescribed, directions to the pharmacist and patient. The document also outlines how pharmacists should handle prescriptions by checking validity, collecting ingredients, compounding accurately, and labeling properly. It notes legal requirements for a valid prescription and how pharmacists identify potential drug interactions using screening tools, records, resources and clinical judgment.
The document discusses various aspects of community pharmacy including definition, scope, management, legal requirements, staffing, drug coding and stocking, and maintenance of records. It notes that a community pharmacy dispenses medicines under the supervision of a registered pharmacist. It outlines the types of records that must be maintained related to drug purchases, sales, and patient information. Key activities of a community pharmacist include processing prescriptions, providing patient care, monitoring drug use, health promotion, and responding to minor ailments. A code of ethics for pharmacists is also presented.
The Circular 21/2018/TT-BYT elaborates:
- Criteria for determining a traditional drug that is fully exempt from clinical trial, exempt from certain phases of clinical trial or required to undergo phase 4 of clinical trial or all phases of clinical trial and requirements for clinical data about drug safety and efficacy as the basis for issuance of the certificate of traditional drug marketing authorization.
- Applications and procedures for issuance, extension, adjustment and revocation of certificates of traditional drug/herbal material marketing authorization.
The document discusses legal requirements and interpretation of prescriptions. It notes that recent legislation has legalized electronic prescriptions, but new technologies have also made prescriptions easier to alter or forge. As such, pharmacists must take care to properly handle, interpret, authenticate and record prescriptions. The document outlines the parts of a prescription, doctors' and patients' rights and responsibilities regarding prescriptions, and pharmacists' obligations to verify prescriptions and retain records. It also discusses common causes of dispensing errors like illegible writing or misinterpreted instructions and the importance of pharmacists ensuring the right patient receives the right drug and dose.
The document provides guidelines for inspecting hospital wards with regards to drug storage and administration. It outlines responsibilities for securing medicine stocks, ordering and record keeping, receipt of medicines, storage on wards, authorization for administration, administering to patients, and disposal of medicines. Proper procedures and record keeping are important to ensure safety, security and accountability of medicine handling in hospital wards.
This document provides an overview of pharmacy law and regulatory affairs in the United Arab Emirates (UAE). It includes the table of contents for an orientation course on pharmacy law, which covers topics like the UAE Federal Law on pharmaceutical professions and institutions, guidelines for good pharmacy practice, codes of conduct, and policies from the Health Authority of Abu Dhabi. The document provides details on licensing requirements for pharmacists, assistants, pharmacies, drug stores, medicine factories and scientific offices. It also outlines regulations regarding prescriptions, controlled substances, and the duties and prohibited acts of pharmacists.
The document is a certificate stating that a student named Mr/Miss [name] with registration number [number] of the second year Diploma in Pharmacy program at Shri Sangameshwar College of Pharmacy has satisfactorily completed the required term work in Community Pharmacy & Management for the academic years [year] to [year] as prescribed in the curriculum. It is signed by the subject teacher and principal.
This document discusses the definition, parts, handling, and care required for prescriptions. It defines a prescription as an order from a medical practitioner to a pharmacist for a specific medication for a patient. Prescriptions contain key information like the patient's name, drug names, quantities, and instructions. They are divided into sections like the superscription, inscription, subscription, and signatura. When filling a prescription, pharmacists must carefully receive, read, collect ingredients, compound, label, and package the medication. Careful checking of ingredients, clean working conditions, and double checking the finished product helps ensure prescriptions are accurately and safely dispensed.
Professional standards and guidance for the sale and supply of medicinesVerna Eunice Chan
This document provides standards and guidance for pharmacists and pharmacy technicians regarding the sale and supply of medicines. It expands on principles from the Code of Ethics, setting out professional responsibilities in areas like pharmaceutical stock, over-the-counter medicine supply, and prescribed medicine dispensing. Pharmacists and technicians must comply with mandatory standards around proper storage, quality control, patient counseling, and record keeping. The document is intended to ensure high quality care for patients and meet legal and regulatory obligations.
This document outlines steps for analyzing and dispensing prescriptions properly according to good practice principles. It discusses accepting prescriptions, ensuring clinical evaluation, calculating quantities, assembling items, labeling, entering data, finalizing, and documenting prescriptions. Key steps include interpreting prescriptions for legality, completeness, correctness of dose/duration, checking for interactions or allergies, taking a medication history, and verifying any unclear information with the prescriber. The goal is to deliver the right medication to the right patient in the proper dosage and package with clear instructions.
Are You Following the Script? Consequences for Medical Professionals Who Fail to Check Pharmacy Registries
As the problem of prescription drug addiction has grown, states have responded with the creation of prescription registries controlled by pharmacy boards. Anyone prescribing medications (specifically doctors, physician assistants and nurse practitioners) is required to check these registries before prescribing certain drugs, but this step is often missed. If discovered, failure to closely monitor your patient could result in discipline up to the loss of your license to practice medicine.
The document discusses various types and settings of pharmacy practice. It mentions that about 2/3 of pharmacy technicians work in retail settings, while others may work in hospitals, manufacturing, nuclear pharmacies, disease management, mail order pharmacies, or for insurance companies. It also lists some common pharmacy certifications and degrees.
This slide show give you basic conclusion for online ePharmacy and Pharmacy act 1940 and 1945. Here is points for what is favorable to ePharmacy and what to not? After doing discovery of act I found some conclusion for online ePharmacy in India.
Similar to Controlled Substances Laws (expired) (20)
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
1. Selected Controlled Substances Laws
Objectives
After reading this lesson, the pharmacist will be able to:
Describe standards for the mailing of controlled substances
Describe standards for the destruction of controlled substances
Describe standards for fax prescriptions for controlled substances
Describe standards for Nurse Practitioners and controlled substances
Describe rules for loss and reporting of controlled substances
Introduction
Most pharmacists deal with controlled substances every day. This lesson will review
some rules that come up in day to day pharmacy practice. This lesson will not attempt to
present all state and federal rules directed to handling controlled substances.
Mailing Controlled Substances
The ability to mail controlled substances can be very helpful in a number of scenarios. A
patient may be homebound and unable to physically come to the pharmacy to pick up the
medication. Where an agent for the patient cannot be reliably identified by the
pharmacist, mailing medication to the patient may be helpful.
The first Postal Service restriction to notice is that it is unlawful to mail a controlled
substance that can not otherwise be lawfully distributed. In other words, mailing the
controlled substance does not provide an exemption to the general prohibition against
distributing controlled substances. This is just common sense. However, if distribution
of the controlled substance is otherwise lawful, it may be mailed if:
a. The inner container of any package containing controlled substances is marked
and sealed under the applicable provisions of the Controlled Substances Act (21
USC 801, et seq., and any implementing regulation in 21 CFR 1300, et seq.) and
placed in a plain outer mailing container or securely overwrapped in plain paper;
b. If the mailing includes prescription drugs containing controlled substances, the
inner container is also labeled to show the prescription number and the name and
address of the pharmacy, practitioner, or other person dispensing the prescription;
and
c. The outer mailing wrapper or container is free of markings that indicate the
nature of the contents.
Destruction of Controlled Substances
Undesirable controlled substances must be handled with care. Broken tablets, expired
dosage forms, and the like must be disposed of properly. OAC 4729-9-06 provides that
any person legally authorized under Chapters 3719 and 4729 of the Revised Code to
possess dangerous drugs which are controlled substances may dispose of such drugs by
the following procedure. If the person is a registrant or prescriber required to keep
records pursuant to Chapters 3719 and 4729 of the Revised Code, the responsible
pharmacist or prescriber must send the state board of pharmacy a list of the dangerous
Page 1 of 8 Controlled Substances Lindon & Lindon, LLC
2. drugs which are controlled substances containing the name and quantity to be disposed
of.
If the person is not a registrant or prescriber, the person must submit to the state board of
pharmacy a letter stating:
The name and address of the person possessing the dangerous drugs which are
controlled substances to be disposed of;
The name and quantity of each controlled substance;
How the applicant obtained the controlled substances; and
The name, address, and registration number of the person who possessed the
controlled substances prior to the applicant, if known.
When the Board receives the list and/or letter, the Board’executive director must
s
authorize and instruct the applicant to dispose of the dangerous drugs which are
controlled substances in one of the following manners:
By transfer to persons registered under Chapters 3719 and 4729 of the Revised
Code, and authorized to possess the controlled substances;
By destruction in the presence of a state board of pharmacy officer, agent, or
inspector or other authorized person; or
By such other means as the state board of pharmacy may determine to assure that
the controlled substances do not become available to unauthorized persons.
In the event that a registrant is required regularly to dispose of controlled substances, the
executive director may authorize the registrant to dispose of such controlled substances
without prior approval of the state board of pharmacy in each instance. The executive
director can only do so on the condition that the registrant keep records of such disposals
and file periodic reports with the state board of pharmacy summarizing the disposals
made by the registrant. In granting such authority, the executive director may place
conditions on the disposal of dangerous drugs which are controlled substances. For
example, the executive director may specific the method of disposal and the frequency
and detail of required reports.
When the pharmacist or pharmacy has controlled substances that need to be disposed of,
the controlled substances must be stored in a separate and secure area apart from the
storage of drugs used for dispensing and administration. Methods of disposal shall
prevent the possession of the drugs by unauthorized persons pursuant to 4729-9-17 (D).
Facsimile Prescriptions for Controlled Substances
Fax machines have become standard equipment in most pharmacies. Fax machines can
be time savers when they allow for the exchange of information when the sender and
receiver have a difficult time making conduct – such as in a busy pharmacy or when a
prescriber may want to give information to a pharmacy before the pharmacy is open.
One thing that is helpful to keep in mind is that prescriptions for controlled substances
must also comply with the requirements for non controlled substances – a.k.a. dangerous
drugs.
Page 2 of 8 Controlled Substances Lindon & Lindon, LLC
3. When the fax machine is used to send a prescription, including a prescription for a
controlled substance, the facsimile will only be valid as a prescription if a system is in
place that will allow the pharmacist to maintain the facsimile as a part of the prescription
record. The facsimile must include the full name of the prescriber and, if transmitted by
the prescriber's agent, the full name of the agent as well as identification of the origin of
the facsimile. The pharmacist must record the prescription in writing or store the
facsimile copy in such a manner that will allow retention of the prescription record for
three years from the date of the last transaction.
The original prescription signed by the prescriber from which the facsimile is produced
must not be issued to the patient. Giving the patient the original and faxing the
prescription to the pharmacy would, or at least could, result in duplication. This is a
particular problem when the medication prescribed and dispensed is a controlled
substance. The original prescription signed by the prescriber must remain with the
patient’records at the prescriber’office or the institutional facility where it was issued.
s s
The facsimile of the prescription must include header information identifying the origin
of the facsimile.
A little used time-saving provision of the rules provides that a prescription copy,
including a copy for a controlled substance, may be transferred between two pharmacists
by the use of a facsimile machine. The facsimile may be considered to be a copy of a
prescription if all information requirements of 4729-5-24 (A), including invalidation of
the original prescription or computer records, are met. A system must be in place that
will show on the facsimile positive identification of the transferring and receiving
pharmacists which must become a part of the prescription record. Facsimile copies must
be recorded in writing or stored in such a manner that will allow retention of the
prescription record for three years from the date of the last transaction.
Prescriptions for schedule II controlled substances may not be transmitted by facsimile
except for:
(a) A resident of a long term care facility pursuant to rule 4729-17-09 of the
Administrative Code. An original signed prescription for a schedule II controlled
substance prepared in accordance with federal and state requirements and issued for a
resident in a long term care facility may be transmitted by the prescriber or the
prescriber's agent to the dispensing pharmacy by facsimile. The facsimile serves as the
original written prescription and shall be received and maintained pursuant to rules 4729-
5-21 and 4729-5-30 of the Administrative Code. The original signed prescription must
remain with the patient's records at either the prescriber's office or the long term care
facility
(b) A narcotic substance issued for a patient enrolled in a hospice. The original
prescription must indicate that the patient is a hospice patient. The facsimile transmission
must also meet the other requirements of this rule. When the original prescription is a
preprinted prescription forms, the original prescription may contain multiple orders on
one form and the prescriber may select as many drug orders as necessary. Additional
prescriptions may be manually added to this sheet. However preprinted forms may not
Page 3 of 8 Controlled Substances Lindon & Lindon, LLC
4. contain prescription orders for schedule II drugs. Schedule II drugs may be manually
added to the preprinted forms and signed by the prescriber. See rule 4729-5-14 of the
Administrative Code.
(c) A compounded sterile product prescription for a narcotic substance pursuant to
rule 4729-19-02 of the Administrative Code. Sterile product prescriptions must meet the
requirements of rule 4729-5-30 of the Administrative Code, except that a sterile product
prescription prepared in accordance with federal and state requirements that is for a
schedule II narcotic substance to be compounded for the direct administration to a patient
by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be
transmitted by the prescriber or the prescriber's agent to the dispensing pharmacy by
facsimile. The facsimile will serve as the original written prescription and shall be
received and maintained pursuant to rules 4729-5-21 and 4729-5-30 of the
Administrative Code. The original signed prescription must remain with the patient's
records at the prescriber's office or the institutional facility where it was issued.
A facsimile of a prescription received by a pharmacy in any manner other than
transmission directly from the prescriber or the prescriber’agent is not be considered a
s
valid prescription. The facsimile of the prescription must include header information
identifying the origin of the facsimile.
Nurse Practitioners
In order to prescribe drugs, including controlled substances, a clinical nurse specialist,
certified nurse-midwife, or certified nurse practitioner [collectively “
nurse practitioner” ]
seeking authority to prescribe drugs and therapeutic devices shall file with the board of
nursing a written application for a certificate to prescribe. The board of nursing will issue
a certificate to prescribe to each applicant who meets the legal requirements.
The nurse practitioner can only prescribe any drug or therapeutic device that is included
in the types of drugs and devices listed on the established formulary. The established
formulary can be found on line at the State of Ohio Board of Nursing at:
http://www.nursing.ohio.gov/PDFS/AdvPractice/CTPFormularyOct06.pdf. The
established formulary includes medications that the clinical nurse specialist, certified
nurse-midwife, or certified nurse practitioner may initiate as well as those medications
that must be initiated by a physician. The nurse practitioner may not prescribe
Amphetamines, such as Methylphenidate. The nurse practitioner may prescribe
controlled substances, however, the nurse's prescriptive authority shall not exceed the
prescriptive authority of the collaborating physician or podiatrist. The nurse practitioner
may personally furnish only antibiotics, antifungals, scabicides, contraceptives, and
prenatal vitamins – not controlled substances.
and
The nurse practitioner may prescribe a schedule II controlled substance but may not
prescribe a schedule II controlled substance in collaboration with a podiatrist. The nurse
practitioner may prescribe a schedule II controlled substance only in situations where all
of the following apply:
(1) A patient has a terminal condition;
Page 4 of 8 Controlled Substances Lindon & Lindon, LLC
5. (2) The nurse's collaborating physician initially prescribed the substance for the patient;
and
(3) The prescription is for a quantity that does not exceed the amount necessary for the
patient's use in a single, twenty-four hour period.
Report of theft or loss of dangerous drugs, controlled substances, and drug documents
Rule 4729-9-15
Unfortunately, dangerous drugs, including controlled substances do come up missing
from time to time. Each prescriber, terminal distributor of dangerous drugs, or wholesale
distributor of dangerous drugs must notify the following upon discovery of the theft or
significant loss of any dangerous drug or controlled substance. This includes dangerous
drugs in transit that were either shipped from or to the prescriber, terminal distributor of
dangerous drugs, or wholesale distributor of dangerous drugs.
The Board must be notified by telephone immediately upon discovery of the theft or
significant loss. The term “ significant loss” not clearly defined by the Board. The
is
following may be helpful in clarifying “ significant loss:”
(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those
controlled substances by specific individuals, or whether the loss can be attributed to
unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be
random, and the results of efforts taken to resolve the losses;
(5) Whether the specific controlled substances are likely candidates for diversion; and
(6) Local trends and other indicators of the diversion potential of the missing controlled
substance.
If a controlled substance is stolen or lost, the drug enforcement administration (DEA)
must also be notified. See 21 CFR Part 1301. The DEA registrant shall also complete
DEA Form 106 regarding such theft or loss. Thefts must be reported whether or not the
controlled substances are subsequently recovered and/or the responsible parties are
identified and action taken against them. A copy of the federal form regarding such theft
or loss shall be filed with the state board of pharmacy within thirty days following the
discovery of such theft or loss. A request for a waiver of the thirty-day limit must be
requested in writing.
When details concerning the specific circumstances surrounding the theft or loss are
unknown at the time of discovery, DEA recommends initial notice be provided by faxing
a short statement to DEA advising of the theft or significant loss. While such initial
notice may alternatively be mailed, delays occurring due to the mailing process may
hinder investigative efforts by DEA. The DEA Form 106 must document the
circumstances of the theft or significant loss and the quantities of controlled substances
involved. DEA recognizes that some time may elapse between the time initial notice of a
theft or loss is provided and the conclusion of the investigation. DEA suggests that if an
Page 5 of 8 Controlled Substances Lindon & Lindon, LLC
6. investigation takes more than two months to complete, registrants provide updates
regarding the investigation to DEA.
The Controlled Substances Act (CSA) requires “ every registrant under this title
manufacturing, distributing, or dispensing a controlled substance or substances shall
maintain, on a current basis, a complete and accurate record of each such substance
manufactured, received, sold, delivered, or otherwise disposed of …” U.S.C.
(21
827(a)(3)). No registrant should disregard any unexplained shortage of controlled
substances. Registrants should treat an individual theft or significant loss seriously and
should monitor occurrences so that patterns do not remain undetected. Record keeping
must be accurate and complete so as to serve as a reliable reporting and recording device.
DEA has become aware of instances in which registrants have used a DEA Form 106 to
document minor inventory discrepancies, thereby “ balancing the books.”DEA stresses
that the DEA Form 106 should be used only to document thefts or significant losses of
controlled substances. Minor inventory discrepancies, not attributable to theft, should not
be reported to DEA or recorded on a DEA Form 106. Rather, registrants should make
appropriate notations of minor inventory discrepancies in their records, indicating the
amount of variance between the physical count and the amount accounted for through
records. Such discrepancies need not be reported to DEA if they are not significant or
actual losses. If a registrant is unsure of the significance of a loss after considering the
factors described below, the registrant should file the report.
Law enforcement authorities must also be notified pursuant to section 2921.22 of the
Revised Code. Revised Code section 2921.22 provides that, among other things, no
person, knowing that a felony has been or is being committed, shall knowingly fail to
report such information to law enforcement authorities.
Conclusion
The distribution of controlled substances is highly regulated. This lesson has not
presented all the controlled substances regulations implicated in daily pharmacy practice.
Instead, the standards for mailing, destruction, faxing, loss reporting, and nurse
practitioners have been presented.
Page 6 of 8 Controlled Substances Lindon & Lindon, LLC
7. Questions
1. Mailing controlled substances is only legal if it is the only way to get a
medication to the patient.
a. True b. false
2. The outer mailing wrapper or container for the controlled substances must clearly
indicate the nature of the contents.
a. True b. false
3. When the pharmacist or pharmacy has controlled substances that need to be
disposed of, the controlled substances must be stored in a separate and secure area
apart from the storage of drugs used for dispensing and administration.
a. True b. false
4. Methods of disposal of controlled substances may allow for destruction in the
presence of a state board of pharmacy officer.
a. True b. false
5. A facsimile for a prescription drug must include the full name of the prescriber
and, if transmitted by the prescriber's agent, the full name of the agent as well as
identification of the origin of the facsimile.
a. True b. false
6. The pharmacist must record the prescription in writing or store the facsimile copy
in such a manner that will allow retention of the prescription record for four years
from the date of the last transaction.
a. True b. false
7. A prescription copy, including a copy for a controlled substance, may be
transferred between two pharmacists by the use of a facsimile machine.
a. True b. false
8. A nurse practitioner may prescribe a schedule II controlled substance in
collaboration with a podiatrist.
a. True b. false
9. Thefts of controlled substances must be reported whether or not the controlled
substances are subsequently recovered and/or the responsible parties are identified
and action taken against them.
a. True b. false
10. DEA Form 106 should be used only to document thefts or significant losses of
controlled substances.
a. True b. false
Page 7 of 8 Controlled Substances Lindon & Lindon, LLC
8.
Lesson number 036-368-06-003-H03 Answer Sheet: Expires December 31, 2009
Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of
Pharmacy
Selected Controlled Substances Laws
Answer Sheet – circle the one correct best answer
Question Answer Question Answer
1 True False 6 True False
2 True False 7 True False
3 True False 8 True False
4 True False 9 True False
5 True False 10 True False
Please return by mail with check for $15 payable to James Lindon at:
Lindon & Lindon, LLC
35104 Saddle Creek
Cleveland, Ohio 44011-4907
Phone 440-333-0011 Fax 419-710-4925
Please fax, e-mail, or mail [specify one, please] my continuing education certificate to:
Pharmacist Name ___________________________________
Street Address _____________________________
City ________________________ State _________ Zip _______
E-Mail ___________________________________
Phone ___________________________________
Ohio Pharmacist License Number _____________________
Yes, Please e-mail me your free pharmacy law newsletter
No, Do not e-mail me your free pharmacy law newsletter
Views expressed in this lesson are not necessarily those of the author or the law firm of
Lindon & Lindon. Copyright 2006 James Lindon, Lindon & Lindon LLC. This lesson
may be copied and distributed freely – the answer sheet is attached.
if
Suggestions for Future Topics: ________________________________________
Approximately How many minutes were required to complete this lesson? _____
What could be done to make presentation of this material clearer?
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
Page 8 of 8 Controlled Substances Lindon & Lindon, LLC