Pharmacy Practice, Fourth Edition

Pharmacy Practice, Fourth Edition
Chapter 2 Pharmacy Law, Regulations, and Standards © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Presentation Topics The Need for Drug Control History of US Statutory Pharmacy Law Regulatory Law—Role of National Oversight Agencies Legal Duties of Pharmacy Personnel Violation of Laws and Regulations Drug and Professional Standards © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Learning Objectives Distinguish among laws, regulations, professional standards, and ethics. List and describe the major impacts on the profession of pharmacy by major pieces of statutory federal drug law in the twentieth century. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Learning Objectives Discuss the roles of the Food and Drug Administration Drug Enforcement Administration Occupational Safety and Health Administration National and state boards of pharmacy © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Learning Objectives Enumerate the duties that may legally be performed by pharmacy technicians in most states. Explain the potential for tort actions under the common law related to negligence and other forms of malpractice. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Learning Objectives Discuss the importance of drug and professional standards. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

The Need for Drug Control
Pharmacy Practice, Fourth Edition The Need for Drug Control Laws Regulations Standards © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

The Need for Drug Control
Pharmacy Practice, Fourth Edition The Need for Drug Control Laws in the US are generally stricter than in other countries. Many organizations exercise control: Courts Federal and state legislatures Federal and state agencies US Pharmacopeia Professional organizations Individual institutions (hospitals, pharmacies, etc.) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion What might happen without adequate drug control? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember law a rule that is designed to protect the public and usually enforced through local, state, or federal governments © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Laws Laws are rules passed and enforced by the legislative branch of government. Laws offer a minimum level of acceptable standards. Violations may result in various punishments. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember regulation a written rule and procedure that exists to carry out a law of the state or federal government © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Regulations A regulation is a written rule and procedure to carry out a law. Many regulations are published by federal agencies. When a law and regulation conflict, the more strict one applies. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember standard a set of criteria to measure product quality or professional performance against a norm © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Standards A standard is a set of criteria to measure product quality or professional performance against a norm. Organizations set standards that must be met before their approval can be earned. Ethics provide standards of personal conduct within a profession. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion What are the six general ways the practice of pharmacy is controlled in the US? Courts Federal, state, and local legislatures Federal and state regulatory agencies United States Pharmacopeia (USP) Professional organizations Individual institutions © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

History of US Statutory Pharmacy Law
Pharmacy Practice, Fourth Edition History of US Statutory Pharmacy Law During the 1800s, drugs in the US were unregulated. Opium was widely available without a prescription. Traveling medicine shows proclaimed the latest “miracle cure.” There were major concerns regarding the purity of imported drugs. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

History of US Statutory Pharmacy Law
Pharmacy Practice, Fourth Edition History of US Statutory Pharmacy Law © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion How were drugs in the US manufactured and marketed in the nineteenth century? Why did this climate lead to the passage of US statutory pharmacy laws? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pure Food and Drug Act of 1906
Pharmacy Practice, Fourth Edition Pure Food and Drug Act of 1906 Passed to fight abuses in drug formulation, labeling, and marketing Forbade drug labels from containing false information Proved to be unenforceable © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Food, Drug, and Cosmetic Act of 1938
Pharmacy Practice, Fourth Edition Food, Drug, and Cosmetic Act of 1938 Response to manufactured drugs that were more powerful and potentially dangerous Created the FDA Required drug makers to File new drug applications (NDAs) Prove that the product was safe for human use Conduct studies and submit results Required drugs to be safe, but not necessarily effective © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember new drug application (NDA) the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Food, Drug, and Cosmetic Act of 1938
Pharmacy Practice, Fourth Edition Food, Drug, and Cosmetic Act of 1938 The Act expanded the definitions of adulterated and misbranded drugs. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion Why was the Food, Drug, and Cosmetic (FDC) Act of 1938 one of the most important pieces of legislation in pharmaceutical history? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Durham-Humphrey Amendment of 1951
Pharmacy Practice, Fourth Edition Durham-Humphrey Amendment of 1951 Established distinction between prescription and non-prescription drugs Authorized verbal prescriptions Allowed prescription refills © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Kefauver-Harris Amendment of 1962
Pharmacy Practice, Fourth Edition Kefauver-Harris Amendment of 1962 Passed in response to thalidomide-caused birth defects Required drugs to be not only safe but also effective Required drug makers to file investigational new drug application (INDA) Lengthened time to market – balanced by patent protection for drug makers © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember Controlled Substances Act (CSA) laws created to combat and control drug abuse controlled substance a drug with potential for abuse; organized into five schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Comprehensive Drug Abuse Prevention and Control Act of 1970
Pharmacy Practice, Fourth Edition Comprehensive Drug Abuse Prevention and Control Act of 1970 Referred to as the Controlled Substances Act Created to combat drug abuse Classified drugs according to their potential for abuse Schedule I: not legally dispensed Schedule II: no refills Schedule III – V: limits on refills © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Comprehensive Drug Abuse Prevention and Control Act of 1970
Pharmacy Practice, Fourth Edition Comprehensive Drug Abuse Prevention and Control Act of 1970 CSA ranked drugs according to their potential for abuse and addiction. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion How did the Controlled Substances Act classify drugs? Why was it passed? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember child-resistant container a medication container with a special lid that cannot be opened by 80% of children but can be opened by 90% of adults; a container designed to prevent child access in order to reduce the number of accidental poisonings © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Poison Prevention Packaging Act of 1970
Pharmacy Practice, Fourth Edition Poison Prevention Packaging Act of 1970 Passed to prevent accidental childhood poisonings Applies to both prescription and OTC drugs Requires child-resistant containers that Cannot be opened by 80% of children Can be opened by 90% of adults © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Poison Prevention Packaging Act of 1970
Pharmacy Practice, Fourth Edition Poison Prevention Packaging Act of 1970 The Act allows some drugs to be dispensed in non-childproof packages. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Drug Listing Act of 1972 Gives FDA authority to compile a list of currently marketed drugs Each drug given unique National Drug Code (NDC) Allows FDA to maintain a database of drugs by Use Manufacturer Active ingredients © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember orphan drug a medication approved by the FDA to treat rare diseases © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Orphan Drug Act of 1983 Developing and marketing orphan drugs is prohibitively expensive. Orphan Drug Act encourages their development by Giving tax incentives Granting exclusive licenses Allowing expedited review and approval Over 250 orphan drugs have been approved by FDA. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember brand name the name under which the manufacturer markets a drug; also known as the trade name © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

© Paradigm Publishing, Inc.
Pharmacy Practice, Fourth Edition Terms to Remember generic name a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; for example, acetaminophen is the generic drug name for Tylenol © Paradigm Publishing, Inc. 38 © Paradigm Publishing, Inc. 38

Drug Price Competition and Patent-Term Restoration Act of 1984
Pharmacy Practice, Fourth Edition Drug Price Competition and Patent-Term Restoration Act of 1984 Was a response to pressure to reduce drug costs Encouraged the creation of generic drugs Extended patent licenses to allow manufactures to recoup research and development costs © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Drug Price Competition and Patent-Term Restoration Act of 1984
Pharmacy Practice, Fourth Edition Drug Price Competition and Patent-Term Restoration Act of 1984 Generics are comparable to brand name drugs in Dosage form Safety Strength Quality Performance Generics must demonstrate bioequivalence to brand name product. Over 60% of prescriptions in community pharmacies are filled with generics. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion What was the purpose of the Drug Price Competition and Patent-Term Restoration Act of 1984? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Prescription Drug Marketing Act of 1987
Pharmacy Practice, Fourth Edition Prescription Drug Marketing Act of 1987 Prohibits re-importation of drugs into US by anyone but manufacturer Passed in response to concerns over safety and competition issues Has become a major issue as seniors travel to Canada for prescriptions or order medications by mail © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Anabolic Steroid Act of 1990
Pharmacy Practice, Fourth Edition Anabolic Steroid Act of 1990 Anabolic steroids are a synthetic version of testosterone. Abuse by athletes has been widely reported. Adverse side effects are serious and permanent. Act identifies anabolic steroids as a Class III drug, allowing greater restrictions. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Omnibus Budget Reconciliation Act of 1990
Pharmacy Practice, Fourth Edition Omnibus Budget Reconciliation Act of 1990 Requires state standards of practice for drug utilization reviews Pharmacist must screen for Therapeutic duplication Drug-disease contraindication Drug-drug interactions Incorrect dosage or duration of treatment Drug-allergy interactions Clinical abuse/misuse Possibility of loss of Medicaid reimbursements used to enforce rules © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Omnibus Budget Reconciliation Act of 1990 Also requires pharmacist to offer to review and discuss with the patient name and description of medication dosage form dose route of administration duration of drug therapy action to take after a missed dose common severe side effects or adverse effects © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Omnibus Budget Reconciliation Act of 1990 Also requires pharmacist to offer to review and discuss with the patient —continued interactions and therapeutic contraindications, ways to prevent the same, and actions to be taken if they occur methods for self-monitoring of the drug therapy prescription refill information proper storage of the drug special directions and precautions for preparation, administration, and use by the patient © Paradigm Publishing, Inc. 46 © Paradigm Publishing, Inc. 46

Dietary Supplement Health and Education Act of 1994
Pharmacy Practice, Fourth Edition Dietary Supplement Health and Education Act of 1994 FDA has limited oversight in diet supplement market. Manufacturers are not required to prove Safety Effectiveness Standardization © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Dietary Supplement Health and Education Act of 1994 Act provided definitions and guidelines on diet supplements. FDA may only review “false claims” advertisements and monitor safety. FDA may remove unsafe supplements, but burden is on FDA to prove that the product is unsafe. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Dietary Supplement Health and Education Act of 1994 The FDA does not regulate diet supplements. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion How is the FDA’s regulation of diet supplements different from its regulation of prescription and nonprescription drugs? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Health Insurance Portability and Accountability Act of 1996
Pharmacy Practice, Fourth Edition Health Insurance Portability and Accountability Act of 1996 HIPAA has wide-ranging provisions. For pharmacies, impact is mostly on confidentiality of patient records: Must document and provide to patient information on how health information is safeguarded Must have an employee training program with yearly renewals © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Food and Drug Administration Modernization Act
Pharmacy Practice, Fourth Edition Food and Drug Administration Modernization Act Passed to update labeling on prescription medications Authorizes new drug application (NDA) fees which are used by FDA to accelerate review of new drugs © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Medicare Prescription Drug, Improvement, and Modernization Act of 2003
Pharmacy Practice, Fourth Edition Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Better known as Medicare Part D Provides prescription drug coverage to patients eligible for Medicare Voluntary program Patients pay an extra premium Usually have a deductible Also established health/savings accounts (HSAs) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Combat Methamphetamine Epidemic Act of 2005
Pharmacy Practice, Fourth Edition Combat Methamphetamine Epidemic Act of 2005 Methamphetamine Highly addictive stimulant Made from OTC products Restricts the availability of products used to make it: Pseudoephedrine Phenylpropanolamine Ephedrine Products must be stored “behind the counter” and purchases must be documented. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

National Oversight Agencies
Pharmacy Practice, Fourth Edition National Oversight Agencies Food and Drug Administration (FDA) Drug Enforcement Administration (DEA) Occupational Safety and Health Administration (OSHA) National Association of Boards of Pharmacy (NABP) State boards of pharmacy © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember regulatory law the system of rules and regulations established by governmental bodies © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember Food and Drug Administration (FDA) the agency of the federal government that is responsible for ensuring the safety and efficacy of food and drugs prepared for the market © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Food and Drug Administration (FDA)
Pharmacy Practice, Fourth Edition Food and Drug Administration (FDA) Under Department of Health and Human Services (HHS) FDA’s Center for Drug Evaluation and Research (CDER) impacts pharmacy: New drug development and review Generic drug review Over-the-counter drug review Post-drug approval activities © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Food and Drug Administration (FDA) Primary responsibility and authority to enforce the law No legal authority over the practice of pharmacy in each state FDA activities Requires manufactures to file applications for investigative studies and drug approvals Provides guidelines for packaging and advertisement Oversees the recall of dangerous products Produces annual Orange Book reference © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Food and Drug Administration (FDA) The FDA regulates OTC labeling so it is understandable to a layperson. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember Drug Enforcement Administration (DEA) the branch of the US Justice Department that is responsible for regulating the sale and use of drugs with abuse potential © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Drug Enforcement Administration (DEA)
Pharmacy Practice, Fourth Edition Drug Enforcement Administration (DEA) Most of its effort spent on illegal drug trafficking, but also supervises legal use of controlled substances Inspects medical facilities and pharmacies; usually just those where suspicious activity has been detected Maintains an audit trail of narcotics from manufacturer to warehouse to pharmacy to patient © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Drug Enforcement Administration (DEA) DEA registration is required for all individuals, institutions, and businesses involved in controlled substances, including Manufacturing Distributing Dispensing Researching Instructional activities Detoxification programs Importing / exporting Compounding © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Drug Enforcement Administration (DEA) CSA defines who may prescribe controlled substances. Prescriptions must be written for a legitimate reason related to the physician’s practice (e.g., dentist can prescribe narcotics for dental pain but not for back pain). Except for emergencies, prescription must be written rather than phoned or faxed. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion How does the Drug Enforcement Administration supervise the distribution of controlled substances? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Occupational Safety and Health Administration (OSHA)
Pharmacy Practice, Fourth Edition Occupational Safety and Health Administration (OSHA) Ensures the safety and health of US workers OSHA’s role in pharmacies, hospitals, and home health care is to Protect against inadvertent needle sticks Ensure safe disposal of syringes Oversee policies to protect employees from unnecessary drug exposures © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember National Association of Boards of Pharmacy (NABP) an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams reciprocation the administrative process for relicensure of pharmacists in another state © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

National Association of Boards of Pharmacy (NABP)
Pharmacy Practice, Fourth Edition National Association of Boards of Pharmacy (NABP) Has no regulatory authority Primary role is to develop national pharmacist license examination Coordinates reciprocation of pharmacists practicing in other states Provides guidance to state boards of pharmacy Developed Model State Pharmacy Practices Act for national continuity © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion How does the NABP assist state boards of pharmacy? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

State Boards of Pharmacy
Pharmacy Practice, Fourth Edition State Boards of Pharmacy Consist of leaders from the pharmacy community and also consumer members Review applications and administer examinations developed by NABP Maintain a database of active pharmacists Inspect all new pharmacies Provide regulations regarding refilling of prescriptions © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Legal Duties of Pharmacy Personnel
Pharmacy Practice, Fourth Edition Legal Duties of Pharmacy Personnel Role of the pharmacy tech Not defined by federal statute Not uniformly defined from state to state Constantly changing Some states limit the ratio of pharmacy techs to pharmacists. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Legal Duties of Pharmacy Personnel
Pharmacy Practice, Fourth Edition Legal Duties of Pharmacy Personnel Duties not required to be done by pharmacists may be carried out by the pharmacy technician. All technicians’ duties must be carried out under the direct supervision of the pharmacist. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Duties Typically Performed by Pharmacists
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Dispensing, recordkeeping, and pricing receiving a verbal, or oral, prescription in person or by telephone preparing the written form of the verbal prescription from a doctor’s office or another pharmacy interpreting and evaluating prescriptions reviewing patient profile (e.g., medication history, duplication of medications, allergies, drug interactions) verifying and certifying records transferring prescriptions to other pharmacies (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Preparing Doses of Precompounded Medications checking/verifying finished prescriptions Preparing Doses of Extemporaneously Compounded, Nonsterile Medications checking and verifying that drugs were selected properly calculating weights and measures verifying that weighing and measuring were done properly verifying finished product (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Preparing Doses of Extemporaneously Compounded, Sterile Medications verifying that drugs were selected properly calculating weights and measures verifying use of aseptic equipment and procedures verifying that weighing and measuring were done properly checking and verifying finished product (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Transporting Medications to and from floors/units in a hospital (especially controlled substances) checking and verifying delivery records examining returned medications for integrity and reusability emptying returned medications into stock containers (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Replenishing floor stocks (especially controlled substances) checking and verifying replenishing stocks certifying and checking drug stations disposing of unused items and discontinued medications Verifying finished product against original order or prescription (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion What are some duties carried out by the pharmacist that cannot be carried out by the pharmacy technician? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Dispensing, recordkeeping, and pricing receiving written prescriptions and conveying them to the pharmacist answering and properly directing telephone calls preparing records, including patient profiles and billing records (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Some states allow certified pharmacy technicians to accept prescriptions over the telephone.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Preparing Doses of Precompounded Medications retrieving medications from shelf or supply cabinet selecting containers preparing labels counting or pouring medications reconstituting prefabricated medications pricing prescriptions (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Preparing Doses of Extemporaneously Compounded, Nonsterile Medications retrieving medications from shelf or supply cabinet selecting equipment for the compounding operation weighing and measuring compounding preparing labels selecting containers packaging maintaining and filing records of extemporaneous compounding cleaning area and equipment (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Preparing Doses of Extemporaneously Compounded, Sterile Medications retrieving medications from shelf or supply cabinet selecting equipment for the compounding operation using aseptic equipment and procedures weighing and measuring admixing parenteral products preparing labels selecting containers packaging maintaining and filing records of extemporaneous compounding cleaning area and equipment (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Transporting Medications to and from floors/units preparing cart, tray, or other means of conveyance delivering controlled drugs maintaining delivery records distributing medications to wards organizing medications for administration to patients retrieving, reconciling, and recording credit for medications not administered returning unused medications to unit dose bins and injectables to stock (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Some states allow a “tech check tech” system in which one technician is allowed to check another technician’s work preparing unit dose carts. © Paradigm Publishing, Inc. 85 © Paradigm Publishing, Inc. 85

Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Replenishing Floor Stocks Checking for expiration dates Removing overstocks (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Violation of Laws and Regulations
Pharmacy Practice, Fourth Edition Violation of Laws and Regulations Civil laws Torts Law of agency and contracts © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember plaintiff one who files a lawsuit for the courts to decide defendant one who defends against accusations brought forward in a lawsuit © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Violation of Laws and Regulations
Pharmacy Practice, Fourth Edition Violation of Laws and Regulations Plaintiff must prove his or her case – burden of proof. Punishments may include Fines Probation Incarceration Licensed healthcare providers may have licenses revoked. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember civil law the areas of the law that concern US citizens and the crimes they commit against one another common law the system of precedents established by decisions in cases throughout legal history © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Civil Laws Concern wrongs against another citizen, but not necessarily against local, state, or federal law Derived from English common law Defendant may face both civil and criminal proceedings for the same act © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember tort the legal term in a lawsuit for personal injuries that one citizen commits against another © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Torts A tort refers to personal injuries. Governments (local, state, federal) do not take part in these lawsuits. Examples of torts include Broken contracts Negligence Malpractice Slander © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember negligence a tort for not providing the minimum standard of care © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember malpractice a form of negligence in which the standard of care was not met and was a direct cause of injury standard of care the usual and customary level of practice in the community © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Torts Negligence is the most common tort in medicine Malpractice – a form of negligence in which the standard of care is not met Two criteria pertaining to standard of care Level of training of healthcare provider Normal practices for the area © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Torts In negligence or malpractice cases, the burden of proof is on the plaintiff. The plaintiff must prove the “four Ds” of negligence: Duty (had a duty to provide care) Dereliction (was derelict in this duty) Damages (dereliction caused real harm) Direct cause (harm was directly caused) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Torts Burden of proof is lower for torts than for criminal cases (preponderance of the evidence). Pharmacies, pharmacists, and sometimes pharmacy techs carry liability insurance to protect assets in lawsuit. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion What is an example of a civil suit that might be brought against a pharmacist or a pharmacy? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember law of agency and contracts the general principle that allows an employee to enter into contracts on the employer’s behalf © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Law of Agency and Contracts
Pharmacy Practice, Fourth Edition Law of Agency and Contracts Based on the Latin term respondeat superior – “let the master answer” Employees act as “agents” of their employer. Employer (pharmacy or pharmacist) must answer for the actions of employees. Implied contract between patient and provider © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Drug and Professional Standards
Pharmacy Practice, Fourth Edition Drug and Professional Standards United States Pharmacopeia (USP) Professional organizations © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember professional standards guidelines of acceptable behavior and performance established by professional associations © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember United States Pharmacopeia (USP) the independent scientific organization responsible for setting official quality standards for all drugs sold in the United States as well as standards for practice © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Terms to Remember United States Pharmacopeia–National Formulary (USP–NF) a book that contains US standards for medicines, dosage forms, drug substances, excipients or inactive substances, medical devices, and dietary supplements © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

United States Pharmacopeia
Pharmacy Practice, Fourth Edition United States Pharmacopeia Independent scientific organization Sets quality standards in US for Prescription drugs OTC drug Dietary supplements Mission is to promote public health by developing and disseminating medical information © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

United States Pharmacopeia
Pharmacy Practice, Fourth Edition United States Pharmacopeia Publishes United States Pharmacopeia–National Formulary (USP–NF) Contains standards for Medicines Dosage forms Drug substances, excipients, inactive substances Medical devices Dietary substances Rose out of the FDC Act of 1938 Recognized by FDA and accrediting agencies © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Professional Organizations
Pharmacy Practice, Fourth Edition Professional Organizations Mission statements are to set high standards and advance practice of pharmacy Seek to provide a standard of care beyond the minimum required by law © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion How did the USP–NF become the official compendia for drugs marketed in the United States? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Professional Organizations Set standards for Postgraduate residency training American Pharmacists Association (APhA) American Society of Health-System Pharmacists (ASHP) American Society of Consulting Pharmacists (ASCP) Online electronic billing National Council for Prescription Drug Programs (NCPDP) Certification in specialty areas National Institute for Standards in Pharmacist Credentialing (NISPC) Internet pharmacies Verified Internet Pharmacy Practice Sites (VIPPS) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Pharmacy Practice, Fourth Edition Professional Organizations Professional organizations for pharmacy techs focus on certification and acquisition of advanced knowledge and skills: Pharmacy Technician Certification Board (PTCB) Institute for Certification of Pharmacy Technicians (ICPT) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Discussion Why are professional organizations important in the practice of pharmacy? © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

Assignments Complete Chapter Review activities Answer questions in Study Notes document Study Partner Quiz in Review mode Matching activities © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.

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