PTCB - Chapter 3 - Drug Regulation and Control - Key Concepts

Drug Regulation

• In the US, the leading federal enforcement agency for regulations concerning drug products is the Food and Drug Administration
• The distribution of drugs that may be easily abused is controlled by the Drug Enforcement Administration (DEA) within the Justice Department
• Manufacturers' containers for prescription drugs must have this legend on the label: "Rx only"

New Drug Approval

• Before it is approved for marketing, a new drug must be shown to be both safe and effective and that its benefits substantially outweigh its risks
• Placebos are inactive substances used to test the effectiveness of drugs

Marketed Drugs

• Once a patient fir a brand drug expires, other manufacturers may copy the drug and release it under its generic name

Behind the Counter OTC Medications

• Some OTC medications are kept behind the counter even if they do not require a prescription; these include OTC medications containing ephedrine and pseudoephedrine, exempt narcotics, and emergency contraceptives

Sample Labels

• The minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements

Controlled Substances

• Manufacturers must clearly label controlled drugs with their control classification
• All prescribers of controlled substances must be registered with the DEA and are assigned a DEA number that must be used on all controlled drug prescriptions

Additional DEA Forms

• Although DEA Form 222 is the most frequently used DEA form, manufacturers, distributors, and dispensers of controlled substances are also required to use other specific DEA forms to register with the DEA and otherwise monitor inventory

Public Safety

• Recalls are, with a few exceptions, voluntary on the part of the manufacturer

Law and the Technician

• Federal laws provide a foundation for the state laws that govern pharmacy practice
• State boards of pharmacy are responsible for licensing all prescribers and dispensers and administering regulations for the practice of pharmacy in the state
• Legal liability means you can be prosecuted for misconduct, including negligence

Ethics and Compliance

• Taking on ethical perspective means examining a situation with moral standards
• Institutions form committees such as institutional review boards to provide guidance on ethical issues and ensure compliance

PTCB - Chapter 3 - Drug Regulation and Control - Extras

1914 Harrison Tax Act
In response to growing addiction to opiates and cocaine containing medicines, the Harrison Tax Act establishes the manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax

1938 Food, Drug and Cosmetic (FDC) Act
In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing

1951 Durham Humphrey Amendment
Defines which drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: "Caution: Federal law prohibits dispensing without a prescription" or "Rx only"

1962 Kefauver Harris Amendment
Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug

1970 Poison Prevention Packaging Act (PPPA)
Requires childhood packaging on all controlled and most prescription drugs dispensed by pharmacies. Non-childproof containers may only be used if the prescriber or patient request one

1970 Controlled Substances Act (CSA)
Classifies five levels of controlled substances that have potential for abuse and therefore restricts their distribution; establishes the Drug Enforcement Administration (DEA) as a division of the Justice Department

1990 Omnibus Budget Reconciliation Act (OBRA)
Among other things, this act requires pharmacists to offer counseling to Medicaid patients regarding medications

1996 Health Insurance Portability and Accountability Act (HIPAA)
Among other things, this act defined the scope of health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy. These regulations govern the transfer of patient health information whether it is communicated electronically, on paper, or orally

2005 Combat Methamphetamine Epidemic Act
Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine

Testing Phases in Humans

• Phase 1: 20 - 100 patients, several months
• Purpose: safety
• Phase 2: up to several hundred patients, several months to 2 years
• Purpose: short term safety but mainly effectiveness
• Phase 3: several hundred to several thousand patients, one to 4 years
• Purpose: safety, dosage, and effectiveness
• Phase 4: for when a drug found another use

Controlled Substances Schedules

• Schedule 1: Drugs with a high potential for abuse and no accepted medical use in the U.S. They may not be prescribed. Heroin, various opium derivates, and hallucinogenic substances are included on this schedule
• Schedule II: Drugs that have a high potential for abuse which may lead to physical or psychological dependence but that also have currently accepted medical uses in the U.S. Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule
• Schedule III: Drugs with a potential  for abuse less than those in Schedules I and II. These drugs have currently accepted medical uses in the U.S., but their abuse may lead to moderate or low physical dependence. Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on this schedule
• Schedule IV: Drugs with low potential for abuse relative to Schedule III drugs. These drugs have currently accepted medical uses in the U.S. but their abuse may lead to limited physical dependence or psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group
• Schedule V: Drugs with a low potential for abuse relative to Schedule IV drugs. These drugs have currently accepted medical uses in the U.S. but their abuse may lead to limited physical dependence or psychological dependence. Compounds containing limited amounts of a narcotic such as codeine are included in this group

Recall classification

• Class 1: Where there is a strong likelihood that the product will cause serious adverse effects or death
• Class 2: Where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects
• Class 3: Where a product is not likely to cause adverse effects

Recall Process

1. Reports of adverse effects
2. Manufacturer agrees to recall
3. Customers contacted
4. Recalls listed publicly

Basic values in ethical considerations

1. Autonomy: patients have the right to choose their treatment
2. Beneficence: the actions of the health care provider should be in the best interest of the patient
3. Dignity: the health care provider should treat the patient with dignity and respect
4. Non-maleficence: the health care provider should do no harm in providing care to the patient
5. Justice: fairness and equally should be applied when providing care to all patients
6. Truthfulness and honesty: health care providers should be truthful and honest when providing care to patients

PTCB - Chapter 3 - Drug Regulation and Control - Definitions

Legend drug

- any drug that requires a prescription and either of these legends on the label: "Caution: Federal law prohibits dispensing without a prescription" or "Rx only"

Pediatric

- having to do with the treatment of children

Placebo

- an inactive substance given in place of a medication

Pharmaceutical equivalent

- drug products that contain identical amounts of the same active ingredients in the dosage form

Product labeling

- important associated information that is not on the label of a drug product itself, but is provided with the product in the form of an insert, brochure, or other document

Therapeutic equivalent

- pharmaceutical equivalents that produce the same effects in patients

Combat Methamphetamine Epidemic Act (CMEA)

- federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine

Dual marketing

- status of medications like Plan B that are classified as both prescription drugs and OTC drugs

Exempt narcotics

- medications with habit forming ingredients that could be dispensed by a pharmacist without a prescription to persons at least 18 years of age

CMEA

 - sets daily and monthly restrictions on the amount of ephedrine or pseudoephedrine that can be sold to an individual (3.6 grams per day and 9 grams per month, of which not more than 7.5 grams may be imported by means of a common or contract  carrier or U.S. Postal Service). The law requires purchasers to present  photo identification and retailers to keep personal information about the purchasers for at least 2 years after each purchase

Controlled substance mark

- the mark (CII - CV) that indicates the control category of a drug with a potential for abuse

NDC (National Drug Code) Numbers

 - an NDC number is an identification number assigned by the manufacturer to a drug product. Each NDC number has 3 sets of numbers: the first set indicates the manufacturer; the second set indicates the medication, its strength, and dosage form; and third set indicates the package size. Last set of numbers has 2 digits

Controlled substances

- five groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by five control schedules set forth in the CSA

DEA Form 222

- used to order CI and CII substances. Copy 1 is retained by the supplier, Copy 2 is forwarded to the DEA, and Copy 3 is retained by the purchaser. All forms must be kept on hand for 2 years, even if they are filled out incorrectly. CIII to CV don't require federal order forms because of their lower potential for abuse

CSA

- requires manufacturers, distributors, or dispensers of controlled substances to register with the Drug Enforcement Administration (DEA) of the Justice Department

Adverse effect
- an unintended side effect of a medication that is negative or in some way injurious to a patient's health

Injunction
- a court order preventing a specific action, such as the distribution of a potentially dangerous drug

Recall
- the action taken to remove a drug from the market and have it returned to the manufacturer

Voluntary Med Watch
- reports for adverse reactions to drugs may be submitted online

Vaccine Adverse Event Reporting System (VAERS)
- adverse reactions to vaccines are reported through the VAERS maintained by the Centers for Disease Control (CDC) and the FDA

Compliance
- doing what is required

Protocol
- specific guideline for practice

Liability
- legal responsibility for costs or damages arising from misconduct or negligence

Negligence
- failing to do something that should or must be done

American Society of Health System Pharmacists
- The ASHP is a 30,000 member association for pharmacists practicing in hospitals, HMOs, long term care facilities, home care agencies, and other health care systems. It is an accrediting organizations for pharmacy residency and pharmacy technician training programs

United States Pharmacopeia Convention
- the USP is a voluntary not for profit organization that sets standards for the manufacture and distribution of drugs and related products in the U.S. These standards are directly referred to by federal and state laws and are published in the United States Pharmacopeia and the National Formulary

The Joint Commission
- TJC is an independent nonprofit organization that establishes standards and monitors compliance for nearly 20,000 health care programs in the U.S. TJC-accredited programs include hospitals, health care networks, HMOs, and nursing homes, among others

The American Society for Consultant Pharmacists
- the ASCP sets standards for practice for pharmacists who provide medication distribution and consultant services to nursing homes

Ethics
- a branch of philosophy that helps determine what should be done in a principled sense

PTCB - Chapter 2 - The Pharmacy Technician - Key Concepts

The Pharmacy Technician

• Pharmacy technicians perform essential tasks that do not require the pharmacist's expertise
• Pharmacy technicians work under the direct supervision of a licensed pharmacist who is legally responsible for their performance
• Specific responsibilities and tasks for pharmacy technicians differ by setting and are described by each employer through job descriptions, policy and procedure manuals, and other documents
• Having technicians perform these tasks gives the pharmacist more time for activities that require a greater level of expertise, such as consulting with patients
• What individuals may or may not do in their jobs is often referred to as their scope of practice
• Most pharmacy technicians are employed in community pharmacies and hospitals but they are also employed in clinics, home care, long term care, mail order prescription pharmacies, and various other settings
• Hospitals and other environments have specialized technician jobs that require more advanced training and skills

Personal Standards

• Pharmacy technicians are entrusted with confidential patient information, dangerous substances, and perishable products
• Drugs, whether prescription or over the counter, can be dangerous if misused, and mistakes by pharmacy technicians can be life threatening
• Pharmacy technicians routinely perform mathematical calculations in filling prescriptions and other activities
• Pharmacy technicians must learn the specific pharmaceutical terminology that will be used on the job
• Pharmacy technicians most be able to communicate, cooperate, and work effectively with others

Training and Competency

• Standards for pharmacy technician training and/or competency are established by the state boards of pharmacy; regulations vary considerably but most states require some form of technician training

Certification

• Although certification is mainly voluntary, many states recognize national certification and some require pharmacy technicians to take the PTCE, ExCPT, or other exam approved by their state board
• The CPhT designation, Certified Pharmacy Technician, is good for two years. It verifies an individual's competence as a technician, and indicates a high level of knowledge and skill

PTCB - Chapter 2 - The Pharmacy Technician - Definitions

Professional
- individuals who receive extensive and advanced levels of education before being allowed to practice, such as physicians and pharmacists

Scope of practice
- what individuals may and may not do in their jobs

Technician
- individuals who are given a basic level of training designed to help them perform specific tasks

Confidentiality
- the requirement of health care providers to keep all patient information private among the patient, the patient's insurer, and the providers directly involved in the patient's care

Personal inventory
- an assessment of one's characteristic, skills, qualities, etc

Competent
- being qualified and capable

Certification
- a legal document certifying that an individual meets certain objective standards, usually provided by a neutral professional organization

PTCB - Chapter 1 - Pharmacy and Health Care - Key Concepts

From Medicine's Origins

• People have used drugs derived from plants to treat illnesses and other physical conditions for thousand of years
• The ancient Greeks used the bark of a white willow tree to relive pain. The bark contained salicylic acid, the natural forerunner of the active ingredient in aspirin
• Cocaine was the first effective local anesthetic

To Modern Medicine

• The average life span in the United States increased by over 30 years since 1900
• In World War I, more soldiers died from infections than the wounds themselves; in World War II, the mass production of the antibiotic penicillin saved thousands of lives and was seen as a critical factor in the success of the Allied Forces

Medicine Through the Ages

• The foxglove plant contains digitalis, which has been widely used in treating heart disease
• Louis Pasteur's experiments showed that microorganisms cause food spoilage, and that heat can be used to kill them and preserve the food
• Frederick Banting and Charles Best showed that an extract of the hormone insulin lowered blood sugar in dogs and might be useful in the treatment of diabetes
• Alexander Fleming discovered the antibiotic chemical, penicillin
• The Human Genome Project is an attempt to map the entire DNA sequence in the human genome. This information will provide a better understanding of hereditary diseases and how to treat them

Pharmacy Today

• To become a pharmacist in the U.S., an individual must graduate from an accredited college of pharmacy, pass a state licensing exam, and perform an internship working under a licensed pharmacist
• Once licensed, pharmacist must receive continuing education to maintain their license
• The cost of health care in the U.S. from 1970 to 2000 rose by over 1500 percent
• Medication Therapy Management services provide patients with a comprehensive look at all of the medications they are taking rather than consultation on only the prescriptions dispensed on a given day

Computers in Pharmacy

• Computerized pharmacy management systems put customer profiles, product, inventory, pricing, and other essential information within easy access. One result has been that pharmacies and pharmacists dispense more prescriptions and information than ever before

PTCB - Chapter 1 - Pharmacy and Health Care - Definitions

Panacea

- a cure for all

Pharmacology

- the study of drugs: their properties, uses, application, and effects

Synthetic

- combining simpler chemicals into more complex compounds, creating a new chemical not found in nature

Antibiotic

- a substance that harms or kills microorganisms like bacteria and fungi

Materia medica

- generally pharmacology, but also refers to the drugs in use

Pharmaceutics

- of or about drugs; also, a drug product

Antitoxin

- a substance that acts against a toxin in the body; also, a vaccine containing antitoxins, used to fight disease

Hormones

- chemicals produced by the body that regulate body functions and processes

Human genome

- the complete set of genetic material contained in a human cell

Data

- information that is entered into and stored in a computer system

Sample Computer System

- patient profile, prescriber profile, education, product selection, inventory, labeling, security, pricing, management reporting, billing

Pharmacognosi

- the study of physical, chemical, biochemical, and biological properties of drugs as well as the search for new drugs from natural sources

Pharmaceutical

- of or about drugs; also, a drug product