NURS 5602: Foundational Concepts for the Family Nurse Practitioner with complete solutions

Why is there a black box for medications?

What is the black box warning?

What do they indicate?

A black box warning is the strictest and most serious type of warning that the FDA gives a medication.

A black box warning is meant to draw attention to a medication's serious or life-threatening side effects or risks.

Black box warnings, also called boxed warnings, are required by the FDA for certain medications that carry serious safety risks.

Define scheduled medications

The Controlled Substances Act (CSA) places all substances that are regulated under existing federal law into one of five schedules, ranging from Schedule I drugs with a high potential for abuse and the potential to create severe psychological and/or physical dependence, to Schedule V drugs with the least potential for abuse.

Why are the symbols used on scheduled medications?

The symbol C (in a diamond shape) must appear on the labels of controlled products, and the letter N is printed on the label of all the opioid agents.

Schedules I through VIII are defined in the following list.

Benzodiazepines are classified as Targeted Substances, and the symbol T/C (in a box) must appear on all the labels for these drugs.

List the eight scheduled medications

Schedule I: Opium poppy & it derivatives (morphine, heroin), methadone, coca and its derivatives (cocaine)

Schedule II: Cannabis and its derivatives (marijuana, hashish)

Schedule III; Amphetamines, methylphenidate, lysergic acid diethylamide (LSD), methaqualone, psilocybin, mescaline

Schedule IV: Sedative-hypnotic agents (barbiturates, benzodiazepines); anabolic steroids

Schedule V: Propylhexedrine and any salt thereof

Schedule VI: Compounds that can serve as precursors for manufacturing controlled substances (Part 1, Part 2, Part 3)

Schedule VII: Cannabis resin 3 kg, Cannabis 3 kg

Schedule VIII: Cannabis resin 1 g, Cannabis 30 g

Who is NAPRA?

National Association of Pharmacy Regulatory Authorities - endorses a proposal for a national drug scheduling model

What schedule do Opioids, controlled substances, and prescription medications fall under?

Schedule I

Non-prescription are assigned to one of three categories

What are some other medications for opioids?

Heroin, Hydromorphone, Meperidine, Morphine, Oxycodone

Do schedule I drugs require a prescription?

Yes, requires a prescription for sale and provided to the public by the pharmacist following the diagnosis and professional intervention of a practitioner. Sale is controlled in a regulated environment as defined by provincial pharmacy regulation

Do schedule II drugs require a prescription?

Yes, though less strictly regulated, do require professional intervention from the pharmacist at the point of sale and possibly a referral to a practitioner. Whereas a prescription is not required, the drugs are available only from the pharmacist and must be retained within an area of the pharmacy where there is no public access and no opportunity for patient self-selection

Do schedule III drugs require a prescription?

No, but may present risks to certain populations in self-selection. Although available w/o a prescription, these drugs are to be sold from the self-selection area of the pharmacy, operated under the direct supervision of the pharmacist and subject to any local professional discretionary requirements that may increase the degree of control. The pharmacist is available, accessible, and approachable to assist the patient in making an appropriate self-medication selection.

Do unscheduled drugs require a prescription?

No, can be sold w/o professional supervision. Adequate information is available for the patient to make a safe and effective choice and labeling is deemed sufficient to ensure the appropriate use of the drug. These drugs are not include in the Schedules I, II, or III and may be sold from an retail outlet.

What are the FDA pregnancy categories?

A: Remote risk for fetal harm - controlled studies of women/1st trimester and no evidence of risk in later trimesters

B: Slightly more risk than A - animal studies show no fetal risk, controlled studies failed to demonstrate risk during 1st and no evidence in later trimesters

C: Greater risk than B - animal studies show risk for fetal harm, no controlled studies have been done in women

D: Proven risk for fetal harm - A statement on risk will appear in the WARNINGS section of drug labeling

X: Proven risk for fetal harm - Adverse reaction indicate evidence of fetal risk. Risks clearly outweigh any possible benefit. A statement on risk will appear in the CONTRAINDICATIONS section of drug labeling.

What type of warning has the FDA issued for pregnancy and lactation labeling ruling?

Also known as the PLLR

Addresses pregnancy, lactation, and female/males of reproductive potential

What type of medications can be or can't be given during pregnancy?

Heparin - causes osteoporosis, compression FXs of the spine

Heroin, cocaine, opioids, barbiturates, alcohol - drug-dependent infant (can go through withdrawal symptoms - shrill crying, vomiting, and extreme irritability - infant will be weaned)

Pain relievers - during delivery can depress respiration in the neonate

Benzodiazepines - taken late in pregnancy may cause hypoglycemia and respiratory complications along with a hypotonic state (commonly called floppy infant syndrome)

Aminoglycoside streptomycin - congenital deafness

Anticoagulant warfarin - fetal hemorrhage

Misoprostol - spontaneous abortion

Aspirin (if full dose taken in 3rd trimester)

Other Category D Drugs:

Gentamicin, Neomycin, Amikacin, Streptomycin, Kanamycin.

Trimethoprim-sulfamethoxazole.

Doxycycline, Minocycline, Tetracycline, Tigecycline.

Fluconazole, Voriconazole.

Primaquine, Hydroxychloroquine.

What is parvovirus B19?

How many phases?

How does it affect adults/children/fetus?

What is the host/carrier?

What are some tests that can be done?

Erythema infectiosum ("fifth disease")

3 Phases: 1st - "slapped-cheek" rash, 2nd - maculopapular rash, 3rd - returns w/ stress, exercise or overheating

Adults: Chronic arthropathy

Children: Bright-red rash on cheeks, confuse w/rubella | Maculopapular rash on trunk and extremities, may be pruritic | Circumoral pallor

Malaise | HA | Sore throat/pharyngitis | Conjunctivitis | Diarrhea

Fetus: Nonimmune hydrops fetalis | Stillbirth | Anemia

Host: Humans, Exposure to school-age to junior high, day-care centers, Teachers, Day-care center workers, Healthcare workers, Close contact or crowded situations

CBC w/Diff, IgG and IgM antibodies

What is rheumatic fever?

Autoimmune disease caused by streptococcal pharyngitis - High risk for recurrences

Can develop into rheumatic heart disease

GAS URIs - most common in children, age 5 to 15 years. Rare in infants and uncommon in pre-school

Pharyngitis HX, only 35 to 60% may have had URIs within the preceding 3 MOS

GAS and Streptococcus pyogenes

What is Rocky Mountain Spotted Fever?

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A systemic febrile illness accompanied by a characteristic rash from the bite of an infected tick. Most severe rickettsial illness

Involve the skin, CNS, cardiac and pulmonary, GI and muscles

Vector - Bite of an infected tick; needs 6 to 10 HRS of feeding

Early discovery and removal of tick is a preventive measure

Severe/long-term: Paraparesis, Hearing loss, Peripheral neuropathy, Seizures, Bowel incontinence, Cerebellar and vestibular dysfunction, Blindness

What is West Nile Virus?

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Mosquito (mostly culex) arbovirus infection

1st isolated in West Nile of Uganda

Two types: Non-neuroinvasive disease - less severe, often a febrile illness

Neuroinvasive disease leads to encephalitis, meningitis, and flaccid paralysis (requires intensive TX)

CDC maintains significant data and statistics

Vector - Mosquitos which feed off of infected animal hosts (wild birds - most common, other animals include horses, chickens)

What is the Zika virus?

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An arthropod-borne virus transmitted by the Aedes species of mosquito (same family as the Dengue virus, Yellow fever virus, West Nile virus)

Congenital microcephaly is a known pregnancy complication of the Zika viral infection

Vertical transmission can occur to fetus from primary infected mother or can occur from an infected male to non-infected female

What is Dengue virus?

A mosquito-borne viral disease occurring in tropical and subtropical areas.

Define Pneumonia

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Viral PNA is inflammation and consolidation of lung tissue d/t viral pathogen

Common in pediatric and elderly populations; children younger than five and elderly persons have higher rate of influenza-associated hospitalizations

Leading cause of death in children worldwide

Define TB in pediatrics - what do you see?

How do you test?

Vaccination of children?

TX for children?

[Page 245 - Cash / 6th Edition]

Exposed by someone with active disease

High risk groups: Minorities, young children (before age 5), elderly, foreign-born, prisoners, nursing home residents, teachers, indigents, migrant workers, and healthcare providers

Pediatric S/S: Non-productive cough, Failure to thrive (FTT), Difficulty gaining weight, Fever, Night sweats, Anorexia

Gastric aspirate specimens for children younger than 6 YRS (do not have a cough deep enough for a sputum specimen)

TX options:

Isoniazid (Laniazid, Nydrazid) 10-20 mg/kg PO Q day, not to exceed 300 mg/d

Rifampin (Rifadin) 10-20 mg/kg PO Q day, not to exceed 600 mg/d

Pyrazinamide (Tebrazid) Not recommended

Ethambutol (Myambutol) Children older than 13 YRS of age, not recommended for children under 13

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See Page 248 for further considerations of children/pediatrics

What is the meaning of sustainable goals?

The Sustainable Development Goals (SDGs) aim to transform our world. They are a call to action to end poverty and inequality, protect the planet, and ensure that all people enjoy health, justice and prosperity. It is critical that no one is left behind.

What is unsustainable goals?

The new UN Sustainable Development Goals (SDGs) offer firms the opportunity to improve both their performance and the societies in which they operate. But in order to achieve these goals, it's essential that companies have a sustainable supply chain strategy in place.

What are some Current Barriers to Culturally Competent Care

Lack of diversity in healthcare leadership and care teams.

Poorly-designed or poorly-functioning systems unable to meet the needs of diverse patient populations.

Cultural insensitivity or misconceptions.

Poor communication with patients of different cultural backgrounds.

Lack of access to interpreter services

Lack of education around healthcare disparities in diverse populations

What is prejudice?

Prejudice is both an attitude and a cognitive process, the identifiable and measurable outcome of which is the practice of discrimination.

What is another term for prejudice in healthcare?

Discrimination, Bias