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