Chapter 4 Regulations

The Pure Food and Drug Act of 1906

A bill that required the accurate labeling of drugs to prevent substitution or mislabeled ingredients.

How controlled substance counting works.

Sign your name to the log after verifying the drugs counted match the ones at hand. This may be done once per day, once per shift, or once per week. Two professionals count the controlled substances on hand, one counts the actual medications, the other compares the count it's the narcotics logs to verify that the numbers match.

When the FDA can expedite the review and approval process of a drug.

Since 1997, this organization can accelerate their review and approval process (to as quickly as 6 months) for drugs needed by patients who are in a critical or life-threatening stage of illness

Brand or trade name.

Sometimes called a proprietary name, to which the company owns the rights. Name of a drug once it clears phases I to III of clinical trials, ready to be put on the market. Company selects a name that is easy to remember and may indicate the drug's purposes (e.g. Aleve). The initial letters of this name are capitalized followed by R or TM with circles. No one else can use the name during the patent period.

Withdrawal

Symptoms that appear when a patient stops taking a medication such as tremors, emotional distress, hallucinations.

compassionate use

The FDA allows some physicians to prescribe the use of an investigational new drug (IND) before approval in patients who are suffering greatly and may die without the drug. Most HMOs, private, or public insurers do not cover experimental drugs, costs of obtaining drug is expensive if you are not participating in the research.

Center for Drug Evaluation and Research (CDER)

The FDA evaluates premarket drugs through this to ensure that beneficial drug products are safe, available, and labeled with information on risks and benefits.

What happens once a drug's patent period ends.

The drug's trademark status is not protected, so other companies may produce the drug under its common or generic name, however no one except the manufacturer holding the trademark status can use the brand name.

Schedule IV drugs

lower abuse potential but are still controlled health-care professionals may write the prescription (e.g., name, route, dosage), but the prescriber must sign it. Refills of drugs in this category are allowed up to five times in 6 months. A health-care professional can fax or phone in these orders to the pharmacy or facility. Examples include lorazepam (Ativan), diazepam (Valium), and alprazolam (Xanax).

Schedule V drugs

lowest potential for abuse Examples include OTC cough suppressants to which a small amount of codeine has been added, as well as preparations for diarrhea, such as paregoric and opium tincture. Because the cough syrup is thick, overdose is difficult. Examples are diphenoxylate hydrochloride and atropine sulfate preparations (Lomotil), Robitussin A-C, and Children's Tylenol 3.

double-blind

neither the patient nor the researcher in the clinical trail knows who has the placebo and who has the drug being tested

generic name

official name of the drug; nonproprietary. Unlike the brand name, the first letter of the name is capitalized only if it begins a sentence. Can also provide a clue to a drug's class (type). May have a different shape and/or color from the trade drug.

-done

opioid analgesics

-ide

oral hypoglycemics

False

A witness is not required for any controlled substances wasted (e.g. full dose not administered, break a vial, drop a pill) (True/False)

True

An Inventory log is required to document when receiving certain controlled medications and to who you dispense them (True/False)

-pril

ACE inhibitors

The major reason healthcare professionals should be vigilant in maintaining the security of controlled substances.

Addicted staff members under the influence will steal drugs, cause harm to patients, etc.

When drug development begins.

After researchers discover, identify, or create agents that show promising effects against a disease or disorder. These agents must pass through many stages of development and exploration and meet strict regulatory requirements before they can be tested on humans. After testing in laboratories and/or on animals, a drug must be carefully tested in humans.

-statin

Antilipidemic

-vir

Antivirals

True

Any drug can be abused if it is used improperly. (True/False)

What you should do if a colleague or patient is doing substance abuse.

Be familiar with local resources, community resources. Do not cover things up.

True

Because the generic drug is less expensive, HMOs often require that patients and prescribers use it or forfeit reimbursement. (True/False)

-olol

Beta blockers (cardiovascular)

False

DEA does not decide which drugs are controlled and assigns the drugs to a schedule, or category, based on their abuse potential, the FDA does. (True/False)

Physical signs of substance abuse

Changes in sleep habits Excessive weight change Excessive sweating Excessive tremors Confusion Poor coordination or slow reflexes Jaundice Dilated of constricted pupils Needle marks

addiction

Compulsively driven to take a drug, often to the exclusion of all other activities; craving it psychologically or physically.

What happens once a drug is on the market and available for use.

Continually monitored and evaluated for its benefits and risks, not only by the FDA, but also by health-care providers and patients taking the drugs.

Durham-Humphrey Amendment of 1951

Defined prescription drugs as drugs that must be administered under the supervision of a physician.

-mide -zide

Diuretics

Best way to mitigate behavior that may lead to tolerance or habituation.

Educating the patient the purpose of the purpose of the medication, reason for adhering to ordered dose, side effects and cautionary situations.

How substance abuse is treated in employees of a hospital.

Employee assistance programs or support groups organized through Human Resources department

True

Follow agency policy in regard to signing off regarding which patient received what dosage along with your signature. (True/False)

What should be done when you need to dispose of a controlled medication.

Have someone witness the disposal, and the medication must be destroyed beyond any possible reuse. Many states require that you return unused medications to a pharmacy or state police facility for incineration, to ensure complete disposal.

The FDA holds annual public meetings for this.

Hear comments from patients, pharmaceutical manufacturers, and health-care professionals about the safety and effectiveness of drugs.

Schedule II drugs

High potential for physical/psychological addiction. Dispensed through written prescription only, no refills permitted. In an emergency, the prescriber may phone in an order to a nurse (e.g., if the patient is in the hospital), but a handwritten copy of the prescription must be submitted within 72 hours. includes drugs that suppress the central nervous system such as morphine, as well as amphetamines, which stimulate it. Examples include cocaine, PCP, methylphenidate (Ritalin), hydrocodone (Hydrocet), and oxycodone (OxyContin).

Food, Drugs, and Cosmetics Act of 1938

Holds drug developer responsible for drug safety, oversees the safe development of new drugs.

How clinical trials are used.

Human subjects are used to test the effects of a drug with the goal of determining effectiveness, side effects, toxicity, and interactions. During which the effect of the active drug is compared with a placebo. May also be compared with another drug on the market.

Number of Clinical Trial Phases

I, II, III, IV

What happens when an impaired colleague is reported.

If they have a license, the supervisor reports the behavior to the state board of medicine, board of nursing, or another board depending on the license. Most licensing boards will not take away a person's license to practice permanently unless the person caused some serious harm while impaired. Their practice will be limited for a period of time or indefinitely.

True

In some patients, the drug is more effective in the brand name form than in the generic form, but most adapt well to a generic brand. (True/False)

How controlled substances should be labeled.

Label on the medication bottle shows a "C" for controlled substances. Do not put controlled substances in unmarked containers.

True

Legal and illegal drugs often have street or slang names. (True/false)

-caine

Local anesthetics

substance abuse

Maladaptive pattern of behavior marked by the use of chemical agent. The patient does not adapt well under the influence of a substance.

What prescribers do when patients engage in drug seeking behavior.

May reduce the amount of medication allowed and refer the patient to psychological counseling.

Program that FDA surveillances problems with drugs through.

MedWatch program.

Schedule III drugs

Moderately addictive and may lead to limited dependence. Health-care professionals may write the prescription for the drug, but the prescriber must sign it Refills are allowed up to five times in 6 months. category includes combination drugs that contain a small amount of a narcotic with a less-addictive medication, such as acetaminophen or aspirin. The patient absorbs less of the narcotic dose in each tablet, but the drug is still powerful. Examples are anabolic steroids, ketamine, testosterone, and Tylenol with codeine.

Schedule I drugs

Most highly controlled drugs, considered to be highly addictive, both physically and psychologically, and they have no medical use. Considered so dangerous that they are illegal to process, distribute, and use. (e.g. Heroin, ecstasy, marijuana, LSD, methaqualone). They are not prescribed except in carefully controlled research facilities in which patients are closely monitored.

Chemical name

Name of a drug when it is first developed. Known by its mix of chemicals and structure which is meaningful to researchers, companies who want to copy a successful drug, but means little to others. eg. 2-acetyloxybenzoic acid

-nium

Neuromuscular blocking agents

What you should do if controlled drug count is not as recorded.

Notify the physician or supervisor immediately. These records must be kept for 2 years.

Who takes out the controlled substances and how they are stored.

Nurses usually count and take out the controlled substances. These drugs are kept double-locked in a safe place whenever they are not in your sight.

True

OTC drugs do not require a prescription, but the purchaser must present a valid ID at the pharmacy and sign for the drug. This protocol may vary from state to state. Some discussion has suggested adding these drugs to the controlled substances list, which would make them at least schedule V drugs. (True/False)

How study participants are assigned.

Randomly placed (via computers generating random numbers) in one of at least two groups (study drug and placebo look alike now) One group is the placebo or control group; the other group receives the active study drug or drugs.

How assigning study participants into a placebo and control group is helpful, and the clinician conducting the study not knowing which patients were taking the active drug.

Participants are prevented from invalidating the study by reporting effects they were not truly experiencing. The scientist not knowing either prevents change of the results, consciously or subconsciously; double-blind.

What prescribers do when patients have chronic pain especially when they are terminally ill (dying).

Patients experience increasing, not decreasing pain as the disease worsens so more painkillers are prescribed over time, but must be careful not to suppress respiration.

Phase I of a Clinical Trial

Patients: 20-100 Time: Several months Purpose: Safety; does the drug do harm? Healthy participants, usually men (over pregnancy concerns), are used to measure any harmful effects, if significant harmful effects are demonstrated, the trial stops.

Phase II of a Clinical Trial

Patients: Several hundred Time: Several months-2 years Purpose: Efficacy; does this drug help the patient? And safety. Involves hundreds of patients (all who have disease targeted by drug) for longer periods of time. Main goal is to see whether a drug works as desired (efficacy).

Phase III of a Clinical Trial

Patients: Several hundred to thousands Time: 1-4 years Purpose: Efficacy and safety. For drugs that have been proven to be safe and effective. Conducted in several facilities, enrolling hundreds of patients. Manufacturer tests for safety, effectiveness, and dosage. Therapeutic (best) dose is evaluated during this phase; least amount of drug possible to gain necessary effect.

Phase IV (postmarketing trials) Clinical Trial

Patients: Thousands Time: Ongoing Purpose: Continuing evaluation through MedWatch. Once approved by the FDA, a drug can be marketed and distributed outside clinical trial groups. Additional research may also be conducted.

Behavioral signs of substance abuse

Poor work performance Sloppy work and frequent mistakes Moodiness, including restlessness, irritability, withdrawal, defensiveness, and violent temper outbursts Forgetfulness Change in personal hygiene

Habituated

Psychologically dependent on the drug, believing they cannot live without it.

drug enforcement administration (DEA)

Purpose is to enforce the controlled substances laws and regulations for the United States. This includes the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. Controlled substances are those that must be tracked or tightly controlled (narcotics, stimulants, depressants, hallucinogens, and anabolic steroids).

Combat Methamphetamine Epidemic Act of 2005

Regulate over-the-counter drugs that contain ephedrine, pseudoephedrine, or phenylpropanolamine, which are ingredients used in the production of crystal meth, an illegal street drug.

What a health-care provider should do when they observe an adverser reaction to a medication.

Report it to MedWatch.

What you should do if one of your colleagues are impaired.

Report the behavior to a supervisor or office manager immediately.

A major part of drug development.

Requires that developers conduct clinical trials or studies.

When the FDA decides to approve a drug.

Requires that drugs be scientifically researched; so it may take 8 years or longer for a company to gain approval of a drug, even if that drug is approved and sold in another country. Each drug must go through extensive development and clinical trials. All drugs must be proven safe and effective before they can be approved and marketed. This means that the drugs must perform the indicated action without causing unacceptable harm. Deems that the benefits of the drug outweigh the risks for the intended population and use.

Specific requirements for manufacturers of generic drugs.

The drug must have the active ingredient the generic name specifies, but different fillers can be used.

What should be done when controlled substances or stolen or lost.

The prescriber who has a DEA number must file DEA Form 106, Theft or Loss of Controlled Substances, theft of a significant amount should be reported to the local police department.

False

There are policies and procedures for handling and storing controlled substances, if you have access to them, you're not always responsible for them. (True/False)

How volunteers are encouraged to participate in a drug study.

Treatment is usually free, they are paid for participating or may receive funds to cover transportation costs to and from trial facilities, they must also sign a detailed consent form.

Tolerance

When more of the drug is needed to produce the same effect.

United States Pharmacopoeia/National Formulary, or USP/NF

Where a drug approved by the FDA is added, contains a comprehensive listing of all approved drugs in the US.

True

You can be held responsible if you fail to report a colleague and he or she harms a patient, coworker, or himself or herself while impaired. (True/False)

investigational new drug (IND)

a drug under development and in the first three phases of clinical trials use is limited to persons who meet specific criteria for inclusion in the trial. If the drug is being developed to help critically ill patients, special exceptions can be made.

Controlled substances are assigned one of five schedules designated by the Roman numerals I to V

according to their potential for addiction and abuse.

-iam -pam

antianxiety agents

-cillin -micin -mycin -oxacin

antibiotics

-dine

antiulcer agents

chemical name

drug name that reflects the chemical makeup of the drug

food and drug administration (FDA)

created to maintain public safety by establishing guidelines and regulations for food and quality and drug development and distribution. goals are to ensure that beneficial drug products are safe, available, and labeled with information on risks and benefits. approves a drug when it deems that the benefits of the drug outweigh the risks for the intended population and use.

Kefauver-Harris Amendment of 1962

enacted in response to thalidomide use during pregnancy and the drug's direct link to birth defects. This act requires drug manufacturers to show product effectiveness and safety, to report adverse events to the FDA, and to ensure that any advertisements to physicians disclose a product's risks and benefits.

Orphan Drug Act of 1983

established to facilitate the development of drugs for rare diseases (i.e., diseases that affect fewer than 1 in 200,000 people). Encouraged the development of these drugs by guaranteeing marketing exclusivity, tax credits, and waiver of other fees.

control group

group of people in clinical trials who receive the placebo or usual treatment, in contrast to the group given the treatment or medication being studied

new drug application (NDA)

if a clinical trial shows that the drug is dafe and effective, and a therapeutic dose is established, the manufacturer next applies to the FDA for approval and submits application. depending on the drug, the approval process can take 6 months to several years, and up to 12 years may pass from preclinical trials to approval. only about 1 drug is marketed for every 5,000 to 10,000 compounds tested. Once approved, The manufacturer usually receives a 17- to 20-year patent to recover the cost and make a profit.

placebo

inactive substance or treatment used as a nonspecific or inactive control in a test of a therapy that is suspected of being useful for a particular disease or condition; also, given to satisfy a patient's demand for medicine

patent medicine

remedy of questionable value that may harm the patient

clinical trials

scientific tests that research the efficacy and safety of a medication

-sone

sterioid

Controlled Substances Act of 1970

substances monitored under the comprehensive drug abuse prevention and control act, a law enacted in 1971 to control the distribution and use of all depressant and stimulant drugs and other drugs of abuse or potential abuse as may be designated by the drug enforcement administration of the U.S. Department of Justice

What happens when a drug has multiple reports of adverse reactions or a serious event such as death.

the manufacturer may voluntarily recall a drug, or the FDA may order a recall.

What happens in a recall.

the manufacturer of the drug must stop distributing it and must contact customers to inform them of the product name, size, lot number, code or serial number, reason for recall, and instructions on how to proceed.

Where recalled drugs are listed.

weekly FDA Enforcement Report