Pharmacology Chapter 1-11

biotechnology

the use of microorganisms such as bacteria or yeasts, or biological substances such as enzymes, to produce drugs, synthetic hormones, and other medical products

dosage form

The makeup of a particular type of drug; the form in which it is given.

formulary

a document that specifies particular drug forms and compositions

genetic engineering

the scientific alteration of the structure of genetic material in a living organism that involves the production and use of recombinant DNA

immunity

protection from a disease

pharmaceutical care

The care provided to a patient by the pharmacy, which encompasses all aspects of drug therapy from dispensing to drug monitoring.

pharmacopoeias

Books containing official lists of medicinal drugs and information about their preparation and use.

pharmacy shop

term used to describe the first stand-alone pharmacies

prescriptions

written instruction from licensed physicians or other individuals indicating drugs, their forms, strengths, and other information that are to be dispensed to specific patients.

vaccination

a small amount of toxin administered to increase one's resistance and prevent illness from higher exposure to same toxin.

assay and control unit

A group with the responsibility for auditing the control system and evaluating product quality; similar to a quality control unit.

certified

For a pharmacy technician, this means being granted recognition by a nongovernmental agency or association because of meeting predetermined qualifications they have specified as necessary. A certified pharmacy technician is credentialed as a "CPhT."

competencies

unique skill sets and abilities in a particular field

confidentiality

the nondisclosure of a customer's privileged information unless the customer has given his or her consent.

Continuing Education

additional topics of study that must be earned in order to maintain certifications, including certified pharmacy technician status.

drug control

a method used to eliminate or reduce the potential harm of the drug distributed

ethics

a set of standards of behavior; in a profession, a guide to correct actions that should be followed

inpatient

pharmacy is located inside a hospital or institution in which patients stay overnight or for long periods of time.

licensed

Being granted permission by a government agency to engage in an occupation. Most states do not require pharmacy technicians to be licensed.

nondiscretionary

Not subject or left to an individual's own discretion. For pharmacy technicians, nondiscretionary duties include typing, computer usage, reports and other documentation, and ordering of supplies.

outpatient

In relation to pharmacy, this means community pharmacy settings.

pharmacy

The art and science of dispensing and preparing medication and providing drug-related information to the public.

profession

An occupation or career that requires specialized education, ongoing training, and knowledge.

quality control

in the pharmaceutical field, an organized effort for all individuals directly or indirectly involved in the production, packaging, and distribution of quality medications, which are safe, effective, and acceptable

quality control unit

A group with the responsibility for auditing the control system and evaluating product quality; sometimes called an assay and control unit.

registered

Being placed on a list of similar practicing individuals by the state board of pharmacy.

United States Pharmacopeia (USP)

a nonprofit organization that sets standards for the identity, strength, quality, purity, packaging, and labeling of drug products

Pharmacist

professionals who have advanced training in the pharmaceutical science; a PharmD degree is required; licensure is also required.

What are the degree options for individuals interested in becoming pharmacy technicians?

Certificate programs, diploma programs, and associates degree programs

Pharmacy technicians

Pharmacy technicians assist licensed pharmacists by completing tasks that do not require the professional judgement of a pharmacist to ensure accuracy

American Association of Colleges of Pharmacy (AACP)

represents all 129 pharmacy colleges and schools in the United States; national organization representing the interests of pharmaceutical education and educators

American Association of Pharmaceutical Scientists(AAPSs)

represents pharmaceutical scientists employed in academia, industry, government, and other research institutions

American Association of Pharmacy Technicians(AAPTs)

A national organization which has chapters in many states. Represents pharmacy technicians and promotes certification of technicians.

American College of Clinical Pharmacy(ACCP)

Professional and scientific society that provides leadership, education, advocacy, and resources for clinical pharmacists.

American Council for Pharmacy Education(ACPE)

National accrediting agency for pharmacy education programs recognized by the US Secretary of Education

American Pharmacists Association (APhA)

advocates the interests of pharmacists

American Society of Health-System Pharmacists(ASHPs)

A national accrediting organization for pharmacy residency and pharmacy technicians training programs

National Pharmacy Technician Association (NPTA)

a national organization promoting pharmacy technicians

Pharmacy Technician Certification Board (PTCB)

a national organization that develops pharmacy technician standards and serves as a credentialing agency for pharmacy technicians

Pharmacy Technician Educators Council(PTEC)

An association of educators who prepare people for careers as pharmacy technicians.

accessory

any individual who helps a person to violate the law either directly or indirectly

administrative law

regulations set forth by governmental agencies, such as the International Revenue Service(IRS) and the Social Security Administration(SSA); also called regulatory law

adulterated

Tampering with or contaminating a product or substance.

barbiturates

Drugs derived from barbituric acid, which act as central nervous system depressants.

Bioethics

A discipline dealing with the ethical and moral implications of biological research and applications.

Civil Law

Rules and regulations that govern the relationship between individuals within a society

crime

a violation of the law

criminal

An individual who violates the law.

Criminal Law

A law that defines crimes against the public order.

Felony

A serious crime that carries a penalty of at least one year of imprisonment

Food and Drug Administration (FDA)

The agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and radioactive products

law

A rule or regulation established by a governing body

malpractice

professional misconduct or demonstration of an unreasonable lack of skill with the result of injury, loss, or damage to the patient

medical ethics

The discipline in which merits, risks, and social concerns are evaluated concerning the practice of medicine.

misbranding

Fraudulent labeling or marking.

misdemeanor

A crime less serious than a felony

National Drug Code (NDC)

A unique and permanent product code assigned to each new drug as it becomes available in the marketplace; it identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.

National Formulary (NF)

a database of officially recognized drug names

negligence

failure to take proper care in doing something

orphan drug

A drug that is developed for small populations of people in need of the drug.

Regulatory Law

Regulations set forth by governmental agencies. It is also called administrative law.

Standard Code Sets

Under HIPAA, "codes used to encode data elements, tables of terms, medical concepts, diagnostic codes, or medical procedure." A code set includes the codes and descriptors of the codes.

standards

Established by authority, custom, or general consent as a model or example; something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality.

statutes

Rules and regulations resulting from decisions by legislatures

tort

A civil wrong committed against a person or property

Beneficence

actions designed to benefit patients and pharmacy customers

Fidelity

Promises are kept so that patients needs are fulfilled correctly and on time.

Veracity

truthfulness

Justice

fairness

Autonomy

self-reliance

Assumption of Risk

This refers to a patient who does not follow medical advice, and, therefore, becomes responsible for any problems that occur as a result of his or her decision.

Defendant

The person or group against whom charges are brought in a court action.

Deposition

An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony

Interrogatory

A written set of questions that must be answered under oath as if in a court, within a specific period

Jurisdiction

The power, right, and authority given to a court to hear a case and to make a judgment.

Litigant

A party to a lawsuit.

Litigation

A lawsuit or a contest in court.

Plaintiff

The person who files a lawsuit initiating a civil legal action. In criminal actions, the prosecution (government) is the plaintiff acting on behalf of the people

Statute of limitations

The law that limits the period during which a person can sue. The period varies from one to three years.

Subpoena

A court order that requires an individual to appear as a witness in court or to make himself or herself available to be deposed.

Contract law

Law that refers to agreements between individuals and entities that are binding

Pure Food and Drug Act of 1906

This law forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines and gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. It paved the way for the eventual creation of the Food and Drug Administration (FDA) still in existence as the FDA.

The Harrison Narcotics Act of 1914

Intended to stop the recreational use of opium.

Food, Drug, and Cosmetic Act of 1938

Requires new drugs must be proven safe before marketing

The Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs".

• The emphasis on this act was to insure safety thru qualified medical supervision.

Kefauver-Harris Amendment of 1962

requires all medications in US to be pure safe and effective

Comprehensive Drug Abuse Prevention and Control Act of 1970

Directs the manufacture, distribution, and dispensing of controlled substances that have potential for addiction and abuse.

Schedule I

high potential for abuse, no accepted medical use

Schedule II

high potential for abuse, but are currently accepted for medical use. Abuse of drugs may result in psychological or physical dependence.

Schedule III

moderate to low potential for abuse and are accepted for medical use. Contain limited quantities of certain narcotic and non-narcotic drugs

Schedule IV

low potential abuse, long-acting barbiturates

Schedule V

lowest abuse potential, generally used for antitussive and antidiarrheal purposes

Poison Prevention Packaging Act of 1970

Requires use of child-resistant containers for prescription and nonprescription drugs

Occupational Safety and Health Administration (OSHA)

Ensure workplace safety and a healthy environment within the workplace

Drug Listing Act of 1972

each new drug is assigned a unique and permanent product code, known as a National Drug Code (NDC)

Medical Device Amendments of 1976

Required manufacturers to register and list their products, follow good manufacturing practices, and report device failures

Orphan Drug Act of 1983

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases.

Drug Price Competition and Patent Term Restoration Act of 1984

Largely consumer-oriented and designed to lower drug prices by providing a mechanism to increase competition in the drug industry

Prescription Drug Marketing Act of 1987

Deals with safety and competition issues raised by secondary markets for drugs

Anabolic Steroids Control Act of 1990

placed anabolic steroids under the regulatory provisions of the CSA