1(c). Orapred ODT (Prednisolone sodium phosphate disintegrating tablets) is a sodium salt of the phosphoester of the glucocorticoid prednisolone. It is indicated in the treatment of the atopic dermatitis, Crohn's disease, ulcerative colitis and acute exacerbations of chronic obstructive pulmonary disease (COPD).
Dosage of Orapred ODT should be individualized according to the severity of the disease and the response of the patient.
The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated.
Fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain are commonly reported side effects of Orapred.
2(c). The active ingredient of Abelcet is Amphotericin B. It is also available under the following trade names: Amphotec (a powder for injection), and Ambisome (a liposomal form). It should be given parenterally via an I.V. infusion. It is an antifungal agent. It is indicated for the treatment of invasive fungal infections caused by invasive aspergillosis.
The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. Abelcet should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.
Patients should be pretreated with antipyretics, antihistamines, antiemetics and with Meperidine to reduce the signs and symptoms of shaking chills and fever.
Abdominal pain, anorexia, anxiety, hypokalemia, anemia, nephrotoxicity and diarrhea are reported side effects of the drug.
3(a). Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:
1. Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18.
2. Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
It is also indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.
4(e). Zelapar orally disintegrating tablets contain Selegiline hydrochloride as an active ingredient. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO). It is available for oral administration (not to be swallowed) in a strength of 1.25 mg.
It is indicated as an adjunct in the management of patients with Parkinson's disease (not the hypertension) being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to the therapy.
Treatment should be initiated with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating Zelapar. It should be taken in the morning before breakfast and without liquid.
A severe hypertensive crisis, orthostatic/postural hypotension, dizziness, somnolence, ECG abnormality, nausea, dyspepsia, abnormal dreams, and infection are reported side effects of Zelapar.
5(c). Xolegel contains the antifungal agent Ketoconazole 2% in a topical anhydrous gel vehicle for topical administration. It is indicated for the topical treatment of seborrheic dermatitis in immuno competent adults and children 12 years of age and older.
The gel should be applied once daily to the affected area for 2 weeks. Xolegel is for topical use only, and not for oral, ophthalmic, or intra vaginal use.
6(d). Abilify (Aripiprazole) is classified as an antipsychotic agent. It is indicated for the treatment of schizophrenia. The recommended therapeutic dose of the drug is 10 to 30 mg once a day without regard to meals.
NMS, tardive dyskinesia, extrapyramidal symptoms and agitation are reported side effects of Abilify. It is available as a tablet for an oral administration.
7(e). Humira (Adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). It is supplied as a sterile, preservative-free solution of Adalimumab for subcutaneous administration.
It is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and Crohn's disease.
The recommended dose of Humira for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 40 mg administered every other week.
The recommended dose of Humira for patients 4 to 17 years of age with polyarticular juvenile idiopathic arthritis is based on weight of patients.
The recommended dose of Humira for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Patients treated with Humira are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Humira should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
1. Active tuberculosis, including reactivation of latent tuberculosis.
2. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.
3. Bacterial, viral and other infections due to opportunistic pathogens.
8(d). Noxafil (Posaconazole) is a triazole antifungal agent available in a suspension for an oral administration. It is a white, cherry flavored immediate-release suspension containing 40 mg of Posaconazole per ml.
It is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT)recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
It is also indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.
Each dose of Noxafil should be administered during or immediately (i.e. within 20 minutes) following a full meal. In patients who cannot eat a full meal, each dose of Noxafil should be administered with a liquid nutritional supplement or an acidic carbonated beverage.
For patients who cannot eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage, alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections.
A pharmacist should instruct a patient to shake Noxafil oral suspension well before use.
Arrhythmias, QT prolongation and liver toxicity are reported side effects of the drug.
9(d). Travatan Z (Travoprost) is a new formulation of Travatan solution in which benzalkonium chloride is replaced with SofZia, a robust ionic buffered preservative system that is gentle to the ocular surface.
Travoprost is a synthetic prostaglandin F analogue. It is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications.
The recommended dosage is one drop in the affected eye(s) once daily in the evening. It should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
10(e). Ativan (Lorazepam) is classified as the benzodiazepine class of drugs. It is indicated for the treatment of anxiety and insomnia. The parenteral form of Lorazepam reduces the severity and duration of nausea and vomiting associated with emetogenic cancer therapy.
It is available in tablet, concentrated oral solution and injection form.
Sedation, depression, constipation, lethargy, fatigue, diplopia and nystagmus are reported side effects of the drug.
Librium (Chlordiazepoxide), Tranxene (Clorazepate), Valium (Diazepam) and Serax (Oxazepam) are indicated for the relief of acute alcohol withdrawal symptoms like agitation, tremor, impending and acute delirium.
11(c). Fentora (Fentanyl buccal tablet) is a potent opioid analgesic, intended for buccal mucosal administration. Fentora is formulated as a flat-faced, round, beveled-edge white tablet. Fentora is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of Fentanyl across the oral mucosa.
Fentora employs the OraVescent drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of Fentanyl through the buccal mucosa.
Each tablet contains Fentanyl citrate equivalent to Fentanyl base: 100, 200, 300, 400, 600 and 800 micrograms. It is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer.
This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, Fentora is contraindicated in the management of acute or postoperative pain.
Physicians should individualize treatment using a progressive plan of pain management. For opioid-tolerant patients not being converted from Actiq, the initial dose of Fentora is always 100 mcg.
12(b). Pylera capsules are a combination antimicrobial product containing Bismuth subcitrate potassium, Metronidazole, and Tetracycline hydrochloride for oral administration. Each hard gelatin capsule contains:
1. Bismuth subcitrate potassium, 140 mg
2. Metronidazole, 125 mg
3. Tetracycline hydrochloride, 125 mg
Pylera capsules, in combination with Omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Each dose of Pylera includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days.
Patients should be instructed to swallow the Pylera capsules whole with a full glass of water (8 ounces). One Omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days.
13(c). Risperdal (Risperidone) is classified as an antipsychotic agent. It is available in tablet, oral solution and orally disintegrating tablet form.
Each tablet for an oral administration contains 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, or 4 mg Risperidone. It is also available as a 1 mg/mL oral solution. Risperdal M-Tab (orally disintegrating tablets) are available in 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. It is indicated for the acute and maintenance treatment of schizophrenia.
On October 6, 2006 - The U.S. Food and Drug Administration (FDA) approved Risperdal (Risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums.
The dosage of Risperdal should be individualized according to the response and tolerability of the patient. The total daily dose of Risperdal can be administered once daily or half the total daily dose can be administered twice daily.
Caution should be exercised with dosage for smaller children who weigh less than 15 kg. NMS, tardive dyskinesia, extrapyramidal symptoms and agitation are reported side effects of the drug.
14(e). Brovana (Arformoterol tartrate) is a selective beta2-adrenergic bronchodilator.
It is indicated for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
It is for use by nebulization only. The recommended dose of Brovana (Arformoterol tartrate) inhalation solution for COPD patients is 15 mcg administered twice a day (morning and evening) by nebulization. A total daily dose greater than 30 mcg (15 mcg twice daily) is not recommended.
Brovana should be stored refrigerated in foil pouches. Asthenia, fever, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor are reported side effects of Brovana.
15(e). Elixir contains 5 to 40% alcohol. All of the mentioned drugs have been found to interact with alcohol and may produce disulfiram-like reactions.
Ethanol is generally converted to acetaldehyde by an alcohol dehydrogenase enzyme, which is then subsequently converted to acetic acid by action of aldehyde dehydrogenase enzyme.
Accumulation of acetaldehyde may be responsible for producing hot flashing, throbbing headaches and disulfiram-like reactions. All of the above drugs inhibit the aldehyde dehydrogenase enzyme and produce disulfiram-like reactions. Therefore, the final dosage form of these all mentioned drugs could not be an elixir.
16(e). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of Tyzeka (Telbivudine) alone or in combination with antiretrovirals.
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Tyzeka.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue antihepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
17(c). Since both the 250 mg and 500 mg tablets of amoxicillin/clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin/clavulanate potassium 250 mg tablets are not equivalentto one 500 mg amoxicillin/clavulanate potassium tablet.
Therefore two 250 mg amoxicillin/clavulanate potassium tablets should not be substituted for one 500 mg amoxicillin/clavulanate potassium tablet.
18(d). If more than one non-oral live vaccine (e.g., live attenuated influenza vaccine [LAIV], varicella, mumps) needs to be administered, it is recommended that thevaccines be given on the same day.
However, if this is not possible, doses of the live vaccines should be separated by at least four weeks. The four-week interval reduces the interference of immune response to the firstvaccine by the second vaccine.
This rule for separation does not apply to the administration of oral live vaccines not given on the same day: typhoid and rotavirus. These vaccines can be given less than four weeks apart. However, this scenario isn’t likely to occur because the age groups for which these vaccines are recommended do not overlap.
In addition, parenteral or intranasal administration of a live vaccine is not thought to affect the immune response of a subsequently administered oral live vaccine.
A live vaccine and an inactivated vaccine can be administered without regard to the timing of the other. Antipyretics/analgesics such as acetaminophen or ibuprofen should not routinely be given prior to immunization.
They might reduce a patient’s immune response. However, if needed, these meds can be used for treatment of fever and pain as needed following vaccination.
19(c). PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine.
PNEUMOVAX 23 is NOT approved for use in children younger than 2 years of age because children in this age group do not develop an effective immune response to capsular types contained in the polysaccharide vaccine.
The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with PNEUMOVAX 23.
Routine revaccination of immunocompetent persons previously vaccinated with a23-valent vaccine, is not recommended. All persons in this category should receive the pneumococcal vaccine, including previously unvaccinated persons and persons who have not received vaccine within 5 years (and were <65 years of age at the time of vaccination).
For any person who has received a dose of pneumococcal vaccine at age greater than 65 years, revaccination is not indicated.
Pneumococcal vaccine is administered intramuscularly or subcutaneously as one 0.5-mL dose. Pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine. Pneumococcal vaccine also may be administered concurrently with other vaccines.
The administration of pneumococcal vaccine with combined diphtheria, tetanus, and pertussis (DTP); poliovirus; or other vaccines does not increase the severity of reactions or diminish antibody responses.
Canadian and U.S. product labeling do say to consider separating administration of Zostavax and Pneumovax 23 by at least four weeks, since concurrent administration of these vaccines can reduce patients’ immune responses to Zostavax.
20(b). On January 13, 2011, the U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per dosage unit.
The FDA hasstated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing. The FDA requested this change be effected by January 2014.
Abbott, the manufacturer of Vicodin, has complied with this directive ahead of the FDA’s requested date and has introduced new formulations of Vicodin (Hydrocodone bitartrate and Acetaminophen tablets, USP) with reduced acetaminophen content in the third quarter of2012.Vicodin is available in the following new formulations:
1. VICODIN® (hydrocodone bitartrate and acetaminophen tablets, USP) 5 mg/300 mg
2. VICODIN ES® (hydrocodone bitartrate and acetaminophen tablets, USP) 7.5 mg/300 mg
3. VICODIN HP® (hydrocodone bitartrate and acetaminophen tablets, USP) 10 mg/300 mg.
21.(d) Acarbose (Precose) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. It delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, Precose reduces levels of glycosylated hemoglobin in patients with type 2 diabetes mellitus. In contrast to sulfonylureas, Precose does not enhance insulin secretion. The antihyperglycemics action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. The recommended starting dosage of Acarbose (Precose) is 25 mg given orally three times daily at the start (with the first bite) of each main meal . However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d. Hypoglycemia, gas, bloating and diarrhea are commonly reported side effects of Acarbose (Precose).
22. Answer: (b). 1. "Prescription" means:
(a). An order given individually for the person for whom prescribed, directly from the practitioner, or the practitioner's agent, to a pharmacist or indirectly by means of an order signed by the practitioner or an electronic transmission from the practitioner to a pharmacist.
(b). A chart order written for an inpatient specifying drugs which he or she is to take home upon discharge.
2. "Prescription" does not include a chart order written for an inpatient for use while he or she is an inpatient.
Answer:(c). A pharmacist, dispensing prescriber, or veterinarian who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 shall transmit the data by electronic media or other means as approved by the State Pharmacy Board. The requested data shall be transmitted in the format established by the American Society for Automation in Pharmacy (ASAP) telecommunications format for controlled substances.
24. Answer: (d) All. The illegal production and distribution of methamphetamine is an increasing problem nationwide. The methamphetamine is a highly addictive drug that can be manufactured in small and portable laboratories. These laboratories are operated by individuals who manufacture the drug in a clandestine and unsafe manner, often resulting in explosions and fires that can injure not only the individuals involved, but their families, neighbors, law-enforcement officers and firemen. The use of methamphetamine can result in fatal kidney and lung disorders, brain damage, liver damage, blood clots, chronic depression, hallucinations, violent and aggressive behavior, malnutrition, disturbed personality development, deficient immune system and psychosis. Children born to mothers who are abusers of methamphetamine can be born addicted and suffer birth defects, low birth weight, tremors, excessive crying, attention deficit disorder and behavior disorders. In addition to the physical consequences to an individual who uses methamphetamine, usage of the drug also produces an increase in automobile accidents, explosions and fires, increased criminal activity, increased medical costs due to emergency room visits, increases in domestic violence, increased spread of infectious diseases and a loss in worker productivity. That environmental damage is another consequence of the methamphetamine epidemic. Each pound of methamphetamine produced leaves behind five to six pounds of toxic waste. Chemicals and byproducts that result from the manufacture of methamphetamine are often poured into plumbing systems, storm drains or directly onto the ground. Clean up of methamphetamine laboratories is extremely resource-intensive, with an average remediation cost of five thousand dollars.
25. Answer: Schedule III controlled drug, [Section 811(g)(3)(A) Controlled Substances Act]. To be exempt from controlled substance requirement, the ratio of Acetaminophen to Butalbital is set to 70:15. In other words, for every 15mg Butalbital, there shall be at least 70 mg or more Acetaminophen required to exempt the formulation from controlled substance requirement.
In above prescription, the quantity of Butalbital is 50 mg; to exempt it from controlled substance requirement, we need to mix it with at least 233 mg or more Acetaminophen. The prescriber has requested Acetaminophen quantity to be set to 200mg; therefore the final formulation shall be classified as Schedule III controlled substance.
**Please note: Butalbital is classified as Schedule III controlled drug under the DEA. **
Currently, Fioricet (Acetaminophen 325mg, Butalbital 50mg and Caffeine 40mg) is classified as a Schedule III controlled drug under the Georgia State Pharmacy Law. **
26. Answer: (b), Bupropion. Bupropion hydrochloride (Wellbutrin) is an antidepressant of the aminoketone class. It is supplied for oral administration as 75-mg (yellow-gold) and 100-mg (red) film-coated tablets. It is indicated for the treatment of major depressive disorder (MDD). The recommended starting dose is 200 mg per day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg per day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. Dosing above 300 mg per day may be accomplished using the 75-or 100-mg tablets. A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day. Administer the 100-mg tablet 4 times daily to not exceed the limit of 150 mg in a single dose. To minimize the risk of seizure, increase the dose gradually. Increases in dose should not exceed 100 mg per day in a 3-day period. Due to its CNS stimulation property, it shall be avoided in patients suffering from severe anxiety. In such patients, instead Bupropion, one can use Mirtazapine or Paroxetine for its sedative effects. Below is the list of antidepressants and their special effects:
27. Answer: (e), Afrezza. The U.S. Food and Drug Administration has recently approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal. Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
28. Answer:(d). CDC Vaccine Storage Recommendations List: Vaccines Require To Be Stored In Referigerator (2 to 8 degrees C):
29. Answer: (c) Naloxone. The active ingredients found in Targiniq ER are Oxycodone and Naloxone. It is an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, anxiety, and sweating are commonly reported side effects of (Oxycodone + Naloxone) Targiniq ER.
30. Answer: (d), Flonase. The U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray)as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies. Flonase Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms3,4 including runny nose, sneezing, itchy nose, nasal congestion and itchy and watery eyes.Flonase Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief.
31. Answer: (d), All. The Ebola virus currently raging in West Africa has a well-earned reputation as one of the world's most deadly illnesses. But experts stress that early and intense medical care can greatly improve a person's chances of survival. There's no cure or vaccine for Ebola, which wreaks life-threatening havoc within the body by attacking multiple organ systems at the same time. Instead, doctors must fall back on the basics of "good meticulous intensive care," supporting the patient and targeting treatment toward the organs that are under attack by the virus. The virus is particularly tough to combat because once it gets into the human body, it attacks so many different tissues. In contrast, most viruses tend to target one specific organ. For example, influenza goes after the respiratory system. Ebola attacks every organ system, including the heart, lungs, brain, liver and kidneys. It even attacks a person's blood, thinning it and causing Ebola's trademark bleeding from multiple orifices.
32. (a) I only, Cardioviva is a natural, over-the-counter probiotic supplement. The probiotic strain in Cardioviva is Lactobacillus reuteri. It is clinically proven to support healthy Cholesterol levels in adults. The suggested dose is one 100 mg capsule twice daily with meals. Gas and bloating are commonly reported side effects of Cardioviva.
33. Answer:(d), All. Ebola hemorrhagic fever (Ebola HF) is one of numerous Viral Hemorrhagic Fevers. It is a severe, often fatal disease in humans and nonhuman primates (such as monkeys, gorillas, and chimpanzees).
Ebola HF is caused by infection with a virus of the family Filoviridae, genus Ebolavirus. When infection occurs, symptoms usually begin abruptly. The first Ebolavirus species was discovered in 1976 in what is now the Democratic Republic of the Congo near the Ebola River. Since then, outbreaks have appeared sporadically.
There are five identified subspecies of Ebolavirus. Four of the five have caused disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); Taï Forest virus (Taï Forest ebolavirus, formerly Côte d'Ivoire ebolavirus); and Bundibugyo virus (Bundibugyo ebolavirus). The fifth, Reston virus (Reston ebolavirus), has caused disease in nonhuman primates, but not in humans.
34. Answer:II and III only.
1. S.T.E.P.S. stands for System for Thalidomide Education and Prescribing Safety, a proprietary education and restrictive distribution program for Thalomid (Thalidomide).
The S.T.E.P.S. program was developed because of the toxicity associated with fetal exposure to Thalomid (Thalidomide) and to minimize the chance of fetal exposure to Thalomid (Thalidomide).
2. Thalidomide in combination with Dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma and Erythema Nodosum Leprosum.
3. All prescribers must register in the S.T.E.P.S. Prescriber Registry via the Prescriber Registration Card that is located in every S.T.E.P.S. folder.
4. Only licensed prescribers may register. They should complete, sign, and return the Prescriber Registration Card. Prescriptions cannot be issued by telephone under this program.
5. Prescribers shall not prescribe more than 4 weeks (28 days) of therapy with no automatic refills. A patient shall be informed that all prescriptions must be filled within 7 days (NOT 3 days).
35. Answer: Management of chronic weight reduction. The U.S. Food and Drug Administration today approved Contrave (Naltrexone hydrochloride and Bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
36. Vitamin D3. Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Fosamax Plus D contains Alendronate sodium, a bisphosphonate, and Cholecalciferol (vitamin D3). Cholecalciferol (vitamin D3) is a secosterol that is the natural precursor of the calcium-regulating hormone calcitriol (1,25 dihydroxyvitamin D3).
It is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
The recommended dosage is one 70 mg Alendronate/2800 international units vitamin D3 or one 70 mg Alendronate/5600 international units vitamin D3 tablet once weekly.
37. (b) 500 mg. Risedronate (Actonel) With Calcium is a co-package product containing Risedronate sodium tablets, 35 mg for once weekly dosing and calcium carbonate tablets, USP (1250 mg, equivalent to 500 mg elemental calcium) for daily dosing for the remaining 6 days of the week. Each package contains a 28-day course of therapy.
Risedronate (Actonel) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. It is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Risedronate (Actonel) should be taken at least 30 minutes before the first food or drink of the day other than water. Risedronate (Actonel) should not be taken at the same time as other medications, including calcium.
To facilitate delivery to the stomach, Risedronate (Actonel) should be swallowed while the patient is in an upright position and with a full glass of plain water (6 to 8 oz). Patients should not lie down for 30 minutes after taking the medication.
Risedronate (Actonel) is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min). No dosage adjustment is necessary in patients with a creatinine clearance ≥ 30 mL/min or in the elderly.
One 1250 mg calcium carbonate tablet (500 mg elemental calcium) orally, taken with food daily on each of the remaining six days (Days 2 through 7 of the 7-day treatment cycle).
Arthralgia, myalgia and nausea are commonly reported side effects of Risedronate (Actonel).
38. All. Ezetimibe (Zetia), administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and nonhigh- density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia.
The combination of Ezetimibe (Zetia) and Atorvastatin or Simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).
It is also indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
The recommended dose of Ezetimibe (Zetia) is 10 mg once daily with or without food. Liver enzyme abnormalities, rhabdomyolysis and myopathy are commonly reported side effects of Zetia.
39. Answer: Serum potassium level. Eplerenone (Inspra) is a blocker of aldosterone binding at the mineralocorticoid receptor. It is available for oral administration contains 25 mg or 50 mg of Eplerenone (Inspra). It is indicated for the treatment of Congestive Heart Failure Post-Myocardial Infarction and Hypertension.
Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone (Inspra) may be administered with or without food.
Serum potassium should be measured before initiating Eplerenone (Inspra) therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter.
For hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of Eplerenone (Inspra) should be reduced to 25 mg once daily. In all patients taking Eplerenone (Inspra) who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3-7 days.
Hyperkalemia, dizziness, diarrhea and abdominal pain are reported side effects of Eplerenone (Inspra).
40. Answer: d. Amiodarone (Cordarone) is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects, available for oral administration as pink, scored tablets containing 200 mg of Amiodarone hydrochloride.
Amiodarone (Cordarone) contains 37.3% iodine by weight. Therefore, it shall be carefully prescribed to patients suffering from hypo-hyper-thyroidism.
Because of its life-threatening side effects and the substantial management difficulties associated with its use, Amiodarone (Cordarone) is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.
1. Recurrent ventricular fibrillation.
2. Recurrent hemodynamically unstable ventricular tachycardia.
Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. Administration of Amiodarone (Cordarone) in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs. If side effects become excessive, the dose should be reduced.
When adequate arrhythmia control is achieved, or if side effects become prominent, Amiodarone (Cordarone) dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.
Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of Amiodarone, grapefruit juice should not be taken during treatment with oral Amiodarone.
Since amiodarone is a substrate for CYP3A4 and CYP2C8, drugs/substances that inhibit CYP3A4 may decrease the metabolism and increase serum concentrations of Amiodarone.
Hepatic injury, hypothyroidism, hyperthyroidism, tremor, poor coordination and pulmonary fibrosis are commonly reported side effects of Amiodarone (Cordarone).
41. Answer: (b). Oxybutynin (Ditropan XL) is an antispasmodic, anticholinergic agent. Each Oxybutynin (Ditropan XL) Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of Oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin (Ditropan XL) uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours.
Oxybutynin (Ditropan XL) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It is also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Oxybutynin (Ditropan XL) must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. It may be administered with or without food. The recommended starting dose of Oxybutynin (Ditropan XL) in adult is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day).
For pediatric patients aged 6 years of age and older, the recommended starting dose of Oxybutynin (Ditropan XL) is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).
Dry mouth, constipation, blurred vision and vasodilation are commonly reported side effects of Oxybutynin (Ditropan XL).
42. Answer: (d). Ledipasvir and Sofosbuvir (Harvoni) . Ledipasvir and Sofosbuvir (Harvoni)
is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Ledipasvir and Sofosbuvir (Harvoni) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C genotype 1 infection. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
Ledipasvir and Sofosbuvir (Harvoni) is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Simeprevir (Olysio) in November 2013 and Sofosbuvir (Sovaldi) in December 2013.
The most common side effects reported in clinical trial participants were fatigue and headache.
43. Answer:(b), Loratadine. Normally, the active ingredient found in Tavist is Clemastine. It is indicated for the treatment of seasonal and perennial allergic rhinitis; and chronic idiopathic urticaria. The recommended dose is 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.
Sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, thickening of bronchial secretions are commonly reported side effects of Clemastine (Tavist).
The active ingredient found in Tavist ND is 10 mg Loratadine.
44. Answer:(d). The active ingredient found in Bydureon is Exenatide indicated for the treatment of type II diabetes mellitus. It is an incretin mimetic agent. Incretins, such as glucagon-like peptide-1 (GLP-1), enhance glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following their release into the circulation from the gut. Bydureon is a GLP-1 receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.
Bydureon is an extended-release formulation of Exenatide, administered as an injection once every 7 days (weekly). It is also available under the trade name Byetta. Byetta is an immediate release solution of Exenatide administered by SC route. Byetta should be initiated at 5 mcg administered twice daily at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart).
Nausea, vomiting, diarrhea, dyspepsia, injection site reactions, constipation and hypoglycemia are commonly reported side effects of Bydureon.
45. Answer: (c) is NOT TRUE. Folic acid is a water-soluble vitamin that has antidepressant, antiproliferative, anti-teratogenic, gingival and anti-inflammatory effects. It is indicated for prevention of neural tube defects in pregnancy. It is also indicated for the treatment of megaloblastic anemia.
It shall not be used in presence of pernicious and megaloblastic anemia due to Vit B12 deficiency.
The recommended daily allowance is 400 mcg (NOT mg) per day. Erythema, pruritus, urticaria, irritability, nausea, bloating and flatulence are reported side effects of the drug.
46. Answer: (c) Beta-Sitosterol. Beta-sitosterol is a substance found in plants. Chemists call it a “plant sterol ester.” It is found in fruits, vegetables, nuts, and seeds. It is used to make medicine.
Beta-sitosterol is used for heart disease and high cholesterol. It is also used for boosting the immune system and for preventing colon cancer, as well as for gallstones, the common cold and flu (influenza), HIV/AIDS, rheumatoid arthritis, tuberculosis, psoriasis, allergies, cervical cancer, fibromyalgia, systemic lupus erythematosus (SLE), asthma, hair loss, bronchitis, migraine headache, and chronic fatigue syndrome.
Men use beta-sitosterol for enlarged prostate (benign prostatic hyperplasia or BPH). Beta-sitosterol supports the good prostate health primarily by maintaining healthy male hormone balance. Some women use it for symptoms of menopause. It is also used for enhancing sexual activity.
Marathon runners sometimes use beta-sitosterol to reduce pain and swelling after a run.
Some people apply beta-sitosterol to the skin for treating wounds and burns.
47. Answer: (d) II and III only. All Coricidin HBP (High Blood Pressure) products are free of decongestants and therefore they can safely be used in patients suffering from high blood pressure. The active ingredients found in Coricidin HBP Night are 500mg Acetaminophen, 10mg Dextromethorphan Hydrobromide and 2mg Chlorpheniramine. The active ingredients found in Coricidin HBP Day are 10mg Dextromethorphan Hydrobromide and 200mg Guaifenesin.
It is indicated for the symptomatic relief of cold and cough, runny nose and sneezing, and bronchial irritation. Since Coricidin HBP Night contains anti-histamine (Chlorpheniramine), it shall be carefully prescribed to patients suffering from glaucoma or BPH.
The recommended dose is 1 tablet every 6 hours, not more than 4 tablets in 24 hours.
Nausea, vomiting, sedation, drowsiness, dizziness and blurred vision are commonly reported side effects of the drug.
48. Answer: (c) 1:750. Benzalkonium chloride is indicated for prophylaxis and treatment of skin infections. It is antimicrobial against a wide variety of bacteria, fungi and protozoa. A 1:750 concentration of benzalkonium chloride is used for preoperative skin preparation, treatment of minor wounds, and lacerations, as a surgical scrub, and for sterilizing metallic instruments. The antimicrobial action of benzalkonium chloride is attributed to its ability to inactivate bacterial enzyme.
49. Answer: (e) Esomeprazole (Nexium). Esomeprazole (Nexium) is the S-Isomer of Omeprazole (Prilosec). It is classified as a Proton Pump Inhibitor (PPI). It is indicated for the treatment of duodenal ulcer, gastric ulcer, Zollinger Ellison Syndrome and GERD. The OTC version of Esomeprazole (Nexium) 24 HR is also commonly known as “Purple Pill”.
It is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of Esomeprazole (Nexium).
Each packet of Esomeprazole (Nexium) for delayed-release oral suspension contains 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg of Esomeprazole (Nexium), in the form of the same enteric-coated granules used in Esomeprazole (Nexium) delayed-release capsules.
The recommended dose is 20 to 40 mg once daily for 4 to 8 weeks.
Diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth are commonly reported side effects of Esomeprazole (Nexium).
50. Answer: (c) The Z-drugs, which include Eszopiclone (Lunesta), Zolpidem (Ambien), and Zaleplon (Sonata), are benzodiazepine receptor agonists. That means they work in a similar way to the benzodiazepine drugs inside the brain. They are GABA agonists meaning they somewhat mimic the action of gamma-Aminobutyric acid, the inhibitory neurotransmitter and thereby induce sleepiness.
These drugs are sometimes referred to as non-benzodiazepine hypnotics or just non-benzodiazepines. That’s a dumb name, if you ask us. Too unspecific and vague, especially if you are not in the context of sleep medicine. Further, even within sleep medicine, there are compounds that are non-benzodiazepine hypnotics that would not be considered part of this class: antihistamines and Ramelteon, for instance.
One problem is that the chemists don’t have a category that these drugs all fall into which is narrow enough to signify what medical practitioners are talking about. These drugs are in the categories pyrazolopyrimidines, imidazopyridines or cyclopyrrones, but they are not all in the same category.
Therefore, we prefer the term Z-drugs. The generic names for these drugs all contain the letter Z, and it is as good a name as any.
51. Answer: (c) Interferons are proteins produced by tumor cells or host cells that are infected with viruses, bacteria and other unknown nucleic acids. Interferons also activate other cells that serve as part of the immune system and destroy invading pathogens.
Interferons are classed as: alpha (from white cells), beta (from fibroblasts) and gamma (from lymphocytes). Interferons enhance the immune system in many ways so can be used to treat different conditions involving the immune system.
Interferons used therapeutically are manufactured using recombinant DNA technology.
Interferon alphas are used to treat viral infections (chronic hepatitis, human papillomavirus) and treating cancer (hairy cell leukemia, AIDS related - Kaposi sarcoma, malignant melanoma).
Interferon betas are used to treat or slow down the progression of multiple sclerosis.
Interferon gamma is used to treat chronic granulomatous disease.
52. Answer: 96.7%. Ultraviolet light can cause oxidation, hydrolysis and loss of potency to sensitive meds in solution. This loss can be greatly minimised by protecting from light. Amber glass protection is expensive, foil wrapping is cumbersome and time consuming. Amber Bags offer a fast, cost effective solution. They effectively filter out 96.7% of the rays in the ultraviolet spectrum, providing the required safety.
53. Answer: (c) 240 mg/dl. Below is the chart that describes the correlation between A1C% and blood glucose concentration in mg/dl.
54. Answer: (C) All. Diabetes Risk Factors:
1. Physical inactivity.
2. First-degree relative with diabetes.
3. Women who delivered a baby >9 lb or were diagnosed with GDM.
4. High-risk race/ethnicity.
5. A1C ≥5.7%, Impaired Glucose Tolerance (IGT), or Impaired Fasting Glucose (IFG) on previous testing.
6. Hypertension (≥140/90 mm Hg or on therapy).
7. HDL-C <35 mg/dL ± TG >250 mg/dL.
55. Answer: True. The terms "prescription" and "drug order" do not include an order for medication requiring a prescription to be dispensed, which is provided for the immediate administration to the ultimate user or recipient.
Answer 56: I and II are true. Mifepristone (Mifeprex) is a synthetic steroid with antiprogestational effects.
Mifepristone (Mifeprex) is indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 day cycle with ovulation occurring at mid-cycle.
The duration of pregnancy may be determined from menstrual history and by clinical examination. Ultrasonographic scan should be used if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected.
Any intrauterine device (“IUD”) should be removed before treatment with Mifepristone (Mifeprex) begins.
Patients taking Mifepristone (Mifeprex) must take 400 μg of Misoprostol two days after taking Mifepristone (Mifeprex) unless a complete abortion has already been confirmed before that time.
Day One: Mifeprex Administration
Patients must read the MEDICATION GUIDE and read and sign the PATIENT AGREEMENT before Mifeprex is administered.
Three 200 mg tablets (600 mg) of Mifeprex are taken in a single oral dose.
Day Three: Misoprostol Administration
The patient returns to the health care provider two days after ingesting Mifeprex. Unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two 200 μg tablets (400 μg) of misoprostol orally.
During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms.
The patient should be given instructions on what to do if significant discomfort, excessive vaginal bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of the Misoprostol.
In addition, the name and phone number of the physician who will be handling emergencies should be provided to the patient.
Day 14: Post-Treatment Examination
Patients will return for a follow-up visit approximately 14 days after the administration of Mifeprex. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.
Pregnancy termination by surgery is recommended in cases when Mifepristone (Mifeprex) and misoprostol fail to cause termination of intrauterine pregnancy Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristone (Mifeprex) use.
Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking Misoprostol.
57. Answer: Green. As used in this section, "cryogenic vessel" means an insulated metal container in the form of a cylinder or other design used to hold gases that have been liquefied by extreme reductions in temperature.
(C). Each cryogenic vessel subject to this section shall meet the following requirements:
(1). The vessel shall be properly labeled according to the medical gas contained in the vessel.
(2). The vessel shall be color coded as follows:
(a). Air - yellow;
(b). Carbon dioxide - gray;
(c). Cyclopropane - orange;
(d). Helium - brown;
(e). Nitrogen - black;
(f). Nitrous oxide - blue;
(g). Oxygen - green. The colors specified in this division shall not be used for any medical gas other than those specified in this division.
58. Answer: High risk for misuse, [https://www.nabp.net].
NARXCHECK is an automatic prescription drug abuse assessment and management tool for health care providers. Once integrated into the facility's system, NARxCHECK automatically queries the state PMP database to generate a report that includes a score for three different drug classes: narcotics, sedatives, and stimulants.
These three-digit scores (000-999) help practitioners to decide whether or not they need to review a patient history before prescribing additional medications.
The score is easy to read using the following guidelines:
1. Less than 200 = Be confident - low risk for misuse.
2. 200 - 500 = Be curious - moderate risk for misuse.
3. Greater than 500 = Be cautious - higher risk for misuse.
59(b): I and II only. Levetiracetam (Spritam) is indicated for the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.
Spritam utilizes Aprecia's proprietary ZipDose® Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.1 While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.
ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. As a result, Spritam enhances the patient experience - administration of even the largest strengths of Levetiracetam (Spritam) with just a sip of liquid. In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go.
The recommended daily dose is 1000 to 3000 mg per day.
Sleepiness, weakness, dizziness, infection, tiredness, acting aggressive, nasal congestion, decreased appetite, and irritability are commonly reported side effects of Levetiracetam (Spritam).
Levetiracetam is also available under the trade names Keppra and Elepsia.
60. Answer: HSDD. The U.S. Food and Drug Administration has recently approved Addyi (Flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.
Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies.
Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi.
Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol.
The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi.
Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.
61.Answer: (c). The active ingredient found in Onfi is Clobazam. It is classified as schedule IV controlled substance. Each Onfi (Clobazam) tablet contains 10 mg or 20 mg of clobazam. It is also available for oral administration as an off-white suspension containing clobazam at a concentration of 2.5 mg/mL.
Onfi (Clobazam) is classified as benzodiazepine. Clobazam potentiates the GABAergic neurotransmission by binding at the benzodiazepine site of the GABAa receptor.
Onfi (Clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
A daily dose of Onfi (Clobazam) greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose.
As with all antiepileptic drugs and benzodiazepines, withdraw Onfi (Clobazam) gradually. The patient should taper by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued.
Somnolence, depression, sedation, withdrawal symptoms, serious dermatological reactions and suicidal behavior and ideation are commonly reported side effects of Onfi (Clobazam).
62. Answer: I and II only. Homocysteine is an amino acid. Amino acids are the building blocks of proteins. It is not possible to get homocysteine from the diet. It must be made from methionine, another amino acid that is found in meat, fish, and dairy products. Vitamins B6 (pyridoxine), B12 and folic acid are needed to make this reaction occur.
Foods containing methionine are transformed into homocysteine in the bloodstream. Homocysteine is converted in the body to cysteine, with vitamin B6 facilitating this reaction. Homocysteine can also be recycled back into methionine using vitamin B12-related enzymes.
Cysteine is an important protein in the body that has many roles. It is involved in the way proteins within cells are folded, maintain their shape, and link to each other. Cysteine is a source of sulfide and is part of the metabolism of different metals in the body including iron, zinc and copper. Cysteine also acts as an anti-oxidant.
If homocysteine cannot be converted into cysteine or returned to the methionine form, levels of homocysteine in the body increase. Elevated homocysteine levels have been associated with heart attack, stroke, blood clot formation, and perhaps the development of Alzheimer's disease.
63. Answer: (c). The U.S. Food and Drug Administration approved Rolapitant (Varubi) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Rolapitant (Varubi) is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.
Rolapitant (Varubi) is a substance P/neurokinin-1 (NK-1) receptor antagonist. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase. It is available in tablet form.
Rolapitant (Varubi) inhibits the CYP2D6 enzyme, which is responsible for metabolizing certain drugs. Varubi is contraindicated with the use of thioridazine, a drug metabolized by the CYP2D6 enzyme, because use of the two drugs together may increase the amount of thioridazine in the blood and cause an abnormal heart rhythm that can be serious.
The most common side effects in patients treated with Rolapitant (Varubi) include a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness.
64. Answer: (d) II and III are true. Durlaza is an aspirin formulation for secondary prevention in high-risk CVD patients. The aspirin delivery technology in Durlaza extends the release of aspirin in a manner designed to provide a stable antiplatelet effect over the course of the day.
Low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular disease. This is primarily due to aspirin’s ability to inhibit platelet aggregation (blood clotting).
While the body is making platelets 24-hours a day, current immediate-release traditional aspirin only stays in the blood for about a mean duration of four to six hours, with peak plasma concentrations peaking after just 30 minutes.
Durlaza utilizes extended-release, microcapsule technology to prolong aspirin release. Durlaza offers the only once-daily, 24-hour antiplatelet therapy through the extended release of its 162.5mg dose, resulting in prolonged absorption, and sustained platelet exposure to aspirin. Durlaza, like immediate-release aspirin, increases the risk of bleeding and gastric ulceration, and may cause fetal harm when administered to a pregnant woman.
65. Answer: Herpes zoster.
The following vaccines are required to be stored in refrigerator (2 to 8 degree C):
1. HepA (Hepatitis A)
2. HepB (Hepatitis B)
3. Hib (Haemophilus influenzae type b)
4. HPV (Human papilloma virus)
9. Any diphtheria/tetanus toxoid, pertussis combination
The following vaccines are required to be stored in freezer (-50 to -15 degrees C):
1. VAR (Varicella)
2. HZV (Herpes Zoster Vaccine)
3. MMRV = Measles, mumps, rubella, varicella
The following vaccines can be stored in refrigerator (2 to 8 degree C) or freezer (-50 to -15 degrees C):
1. MMR (Measles, mumps, rubella)
66. Answer: 7 alphanumeric characters. The U.S. Department of Health and Human Services (HHS) announced a final rule that will facilitate the United States’ ongoing transition to an electronic health care environment through adoption of new healthcare code sets for use in electronic health care transactions. This rule adopts updated versions of the code sets, under the authority of HIPAA (ICD-10 final rule). The ICD-10 code sets replace the current ICD-9-CM code set.
The industry currently uses about 4,000 unique ICD-9-CM volume 3 codes to describe inpatient procedures. ICD-9 procedure codes are 3-4 digits in length (e.g., 47.01 – Laparoscopic appendectomy). With the ICD-10-PCS mandate, the length of inpatient procedure codes will increase to 7 alphanumeric characters (e.g., ODTJ4ZZ – Laparoscopic appendectomy).
67. Answer: (a,b). Dose adjustments may be necessary in patients with concomitant use of:
Strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, or enoxacin);
Moderate or weak CYP1A2 inhibitors (e.g., oral contraceptives, or caffeine);
CYP2D6 or CYP3A4 inhibitors (e.g., cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline);
CYP3A4 inducers (e.g., phenytoin, carbamazepine, St. John’s wort, and rifampin); or
CYP1A2 inducers (e.g., tobacco smoking).
68. Answer: (a,b,c,d). TPN solutions are made according to a variety of formulations and compounding protocols. Thus, there are possibilities of calcium phosphate precipitates and many other chemical incompatibilities. Precipitates could develop because of a number of factors such as: the concentration, pH, and phosphate content of the amino acid solutions; the calcium and phosphorous additives; the order of mixing; the mixing process; or the compounder. The presence of a lipid emulsion in the TPN admixture would obscure the presence of any precipitate.
Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition admixtures.
1. The amounts of phosphorous and of calcium added to the admixture are critical. The solubility of the added calcium should be calculated from the volume at the time the calcium is added. It should not be based upon the final volume.
Some amino acid injections for TPN admixtures contain phosphate ions (as a phosphoric acid buffer). These phosphate ions and the volume at the time the phosphate is added should be considered when calculating the concentration of phosphate additives. Also, when adding calcium and phosphate to an admixture, the phosphate should be added first.
2. The line should be flushed between the addition of any potentially incompatible components.
3. A lipid emulsion in a three-in-one admixture obscures the presence of a precipitate. Therefore, if a lipid emulsion is needed, either:
(1). use a two-in-one admixture with the lipid infused separately, or
(2). if a three-in-one admixture is medically necessary, then add the calcium before the lipid emulsion and according to the recommendations in number 1 above.
If the amount of calcium or phosphate which must be added is likely to cause a precipitate, some or all of the calcium should be administered separately. Such separate infusions must be properly diluted and slowly infused to avoid serious adverse events related to the calcium.
4. A filter should be used when infusing either central or peripheral parenteral nutrition admixtures. Standards of practice vary, but the following is suggested: a 1.2 micron air eliminating filter for lipid containing admixtures, and a 0.22 micron air eliminating filter for nonlipid containing admixtures.
69. Answer: (a,b,d,e).
|Pitavastatin||Any time of the day||With or without food|
|Atorvastatin||Any time of the day||With or without food|
|Fluvastatin||Evening||With or without food|
|Pravastatin||Any time of the day||With or without food|
|Rosuvastatin||Any time of the day||With or without food|
Answer: (b,c,e). Zurampic (Lesinurad) is a URAT1 inhibitor. It is available as blue film-coated tablets for oral administration containing 200 mg Lesinurad. It should be used in combination with a xanthine oxidase inhibitor. Lesinurad reduces serum uric acid levels by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney. It is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.
Zurampic (Lesinurad) is not recommended for the treatment of asymptomatic hyperuricemia. Zurampic (Lesinurad) should not be used as monotherapy.
Zurampic (Lesinurad) tablets are for oral use and should be co-administered with a xanthine oxidase inhibitor, including allopurinol or febuxostat. Zurampic (Lesinurad) is recommended at 200 mg once daily. This is also the maximum daily dose. Zurampic (Lesinurad) should be taken by mouth, in the morning with food and water.
Zurampic (Lesinurad) causes an increase in renal uric acid excretion, which may lead to renal events including transient increases in serum creatinine, renal-related adverse reactions, and kidney stones. These renal events occurred more frequently in patients receiving Zurampic (Lesinurad) 400 mg, when used as monotherapy or in combination with a xanthine oxidase inhibitor. Kidney function is required to monitor.
71. Answer: (d), Type 4 hypersensitivity is often called delayed type. Delayed hypersensitivity does not start to be noticeable until several hours to a full day after exposure to the antigen. It may last for over a week.
Poison ivy rash is caused by an allergic reaction to an oily resin called urushiol (u-ROO-she-ol). This oil is in the leaves, stems and roots of poison ivy, poison oak and poison sumac. Urushiol, which is a hapten, when absorbed through the skin from a poison ivy plant, it (urushiol) undergoes oxidation in the skin cells to generate the actual hapten, a reactive molecule called a quinone, which then reacts with skin proteins to form hapten adducts.
T lymphocytes recognize the foreign substances, usually after the antigen is eaten, degraded, and presented (in pieces) by so-called antigen-presenting cells such as Langerhans cells in the skin, or macrophages. Urushiol metabolites (metabolite of Poison Ivy) are presented by this and other mechanisms. The T lymphocytes pour out inflammatory signal substances called cytokines. These call in armies of white blood cells called monocytes, which become macrophages. The macrophages become activated by the cytokines and attack everything in the vicinity, and can cause severe tissue damage.
Usually, the first exposure causes only sensitization, in which there is a proliferation of effector T-cells. After a subsequent, second exposure, the proliferated T-cells can become activated, generating an immune reaction that produces typical blisters of a poison ivy exposure.
In addition to poison ivy, a good example is the skin reaction to injected tuberculosis antigen. In fact, when tuberculosis bacteria infect the lung, it is the delayed hypersensitivity against them which destroys the lung. Unlike the other types, it is not antibody mediated but rather is a type of cell-mediated response.
72. Answer: (a,b,c,d). Extrapyramidal symptoms (EPS) are drug-induced movement disorders that include acute and tardive symptoms. These symptoms include dystonia (continuous spasms and muscle contractions), akathisia (motor restlessness), Parkinsonism (characteristic symptoms such as rigidity, bradykinesia, and tremor), and tardive dyskinesia (irregular, jerky movements).
Since it is difficult to measure extrapyramidal symptoms, rating scales are commonly used to assess the severity of movement disorders. The Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS), and Extrapyramidal Symptom Rating Scale (ESRS) are rating scales frequently used for such assessment and are not weighted for diagnostic purposes.
73. Home ovulation tests usually detect a preovulatory surge in which of the following in the urine?
e. Luteinizing hormone
Answer: (e). An ovulation home test is used by women to help determine the time in the menstrual cycle when getting pregnant is most likely. The test detects a rise in luteinizing hormone (LH) in the urine. A rise in this hormone signals the ovary to release the egg.
74. Slow channel blocking drugs will reduce the movement of which substance into smooth muscle cells? (Select All that apply)
Answer: (c). Slow channel blockers inhibit the slow inward calcium current, which may prolong conduction and refractoriness in the AV node.
75. Which of the following inhibits CYP 3A4? (Select All that apply)
Answer: (a) Below is the list of drugs that inhibit specifically CYP 3A4:
16. Entacapone (high dose)
18. Ethinyl estradiol
23. Grapefruit juice
37. Paroxetine (weak)
41. Quinupristin and Dalfopristin
49. Valproic acid
76. Which of the following information is TRUE ABOUT anaerobic respiration? (Select All that apply)
a. Waste products are carbon dioxide and water.
b. It may produce between 36 and 38 ATP molecules.
c. In animals, including humans, the anaerobic cycle produces lactic acid, which causes muscle cramps.
d. The fermentation process in anaerobic respiration is roughly 5 percent as effective as what cells can do when they have access to oxygen.
e. In bacteria, it may produce nitrite, nitrogen gas, hydrogen sulfide, methane and acetic acid.
Answer (c, d and e). "Anaerobic" means without oxygen, and respiration refers to the processes in a cell that convert biochemical energy, such as that found in glucose, into usable energy in the form of ATP. Waste products like carbon dioxide are also produced during this process.
The fermentation process in anaerobic respiration is roughly 5 percent as effective as what cells can do when they have access to oxygen. An aerobic cycle may produce between 36 and 38 ATP molecules, while anaerobic respiration only creates 2 ATP molecules.
Since muscles often run out of oxygen during extreme exertion, anaerobic respiration keeps them running. In animals, including humans, the anaerobic cycle produces lactic acid, which causes muscle cramps. In order for these cramps to stop, oxygen must find its way back into the muscle again so these cells can switch back to aerobic respiration and stop building up lactic acid.
Anaerobic respiration is also common in bacteria that live in environments without oxygen; depending on the bacteria, the products of their respiration include nitrite, nitrogen gas, hydrogen sulfide, methane and acetic acid.
77. Which of the following best describes the Capitation System?
a. Risk free income for healthcare service providers.
b. Healthcare provider may get more incentive to provide an extended treatment to a patient.
c. A fixed amount of money per patient per unit of time paid in advance to the physician for the delivery of health care services.
d. A patient gets more benefit if he/she gets services from Healthcare provider receiving reimbursement through capitation.
e. Free prescription benefits to patients.
Answer: Capitation payments are used by managed care organizations to control health care costs. Capitation payments control use of health care resources by putting the physician at financial risk for services provided to patients. At the same time, in order to ensure that patients do not receive suboptimal care through under-utilization of health care services, managed care organizations measure rates of resource utilization in physician practices. These reports are made available to the public as a measure of health care quality, and can be linked to financial rewards, such as bonuses.
Capitation is a fixed amount of money per patient per unit of time paid in advance to the physician for the delivery of health care services. The actual amount of money paid is determined by the ranges of services that are provided, the number of patients involved, and the period of time during which the services are provided. Capitation rates are developed using local costs and average utilization of services and therefore can vary from one region of the country to another. In many plans, a risk pool is established as a percentage of the capitation payment. Money in this risk pool is withheld from the physician until the end of the fiscal year. If the health plan does well financially, the money is paid to the physician; if the health plan does poorly, the money is kept to pay the deficit expenses.
When the primary care provider signs a capitation agreement, a list of specific services that must be provided to patients is included in the contract. The amount of the capitation will be determined in part by the number of services provided and will vary from health plan to health plan, but most capitation payment plans for primary care services include the following:
· Preventive, diagnostic, and treatment services
· Injections, immunizations, and medications administered in the office
· Outpatient laboratory tests done either in the office or at a designated laboratory
· Health education and counseling services performed in the office
· Routine vision and hearing screening
78. Thiazide diuretics should NOT be used as a first line treatment for hypertension in patient suffering from:
b. Heart failure
e. Peripheral artery disease
Answer :(d). Thiazide diuretics may increase the reabsorption of uric acid from renal tubules and may cause hyperuricemia. It should NOT be used as a first line treatment for hypertension in patient suffering from gout.
79. Which of the following is/are false positive tuberculin skin test reactions? (Select All that apply)
a. Infection with non-tuberculosis mycobacteria
b. Cutaneous anergy
c. Previous BCG vaccination
d. Very old TB infection
e. Recent live-virus vaccination
Answer: (a,c). The Mantoux tuberculin skin test (TST) is the standard method of determining whether a person is infected with Mycobacterium tuberculosis. Reliable administration and reading of the TST requires standardization of procedures, training, supervision, and practice.
The TST is performed by injecting 0.1 ml of tuberculin purified protein derivative (PPD) into the inner surface of the forearm. The injection should be made with a tuberculin syringe, with the needle bevel facing upward. The TST is an intradermal injection. When placed correctly, the injection should produce a pale elevation of the skin (a wheal) 6 to 10 mm in diameter.
The skin test reaction should be read between 48 and 72 hours after administration. A patient who does not return within 72 hours will need to be rescheduled for another skin test.
The reaction should be measured in millimeters of the induration (palpable, raised, hardened area or swelling). The reader should not measure erythema (redness). The diameter of the indurated area should be measured across the forearm (perpendicular to the long axis).
Skin test interpretation depends on two factors:
1. Measurement in millimeters of the induration
2. Person’s risk of being infected with TB and of progression to disease if infected
What Are False-Positive Reactions?
Some persons may react to the TST even though they are not infected with M. tuberculosis. The causes of these false-positive reactions may include, but are not limited to, the following:
1. Infection with non-tuberculosis mycobacteria
2. Previous BCG vaccination
3. Incorrect method of TST administration
4. Incorrect interpretation of reaction
5. Incorrect bottle of antigen used
What Are False-Negative Reactions?
Some persons may not react to the TST even though they are infected with M. tuberculosis. The reasons for these false-negative reactions may include, but are not limited to, the following:
1. Cutaneous anergy (anergy is the inability to react to skin tests because of a weakened immune system)
2. Recent TB infection (within 8-10 weeks of exposure)
3. Very old TB infection (many years)
4. Very young age (less than 6 months old)
5. Recent live-virus vaccination (e.g., measles and smallpox)
6. Overwhelming TB disease
7. Some viral illnesses (e.g., measles and chicken pox)
8. Incorrect method of TST administration
9. Incorrect interpretation of reaction
80. After completing the therapy, H. pylori follow-up status testing shall be done within what time frame to ensure H. Pylori has been completely eradicated?
a. 7 days
b. 72 hours
c. 4 weeks
d. 6 months
e. a month
Answer: (c) Before the seriousness of H. pylori infections was fully appreciated and when it was still believed that H. pylori eradication therapy could routinely cure more than 90% of patients, confirmation of cure testing was not routinely recommended. Although confirmation for cure testing is currently considered the standard of care, preferably with noninvasive tests such as the stool antigen or a urea breath test, it is often not done. Post eradication testing is not only useful to confirm H. pylori eradication but also serves to alert the clinician when resistance begins to undermine their locally effective current regimens. In this issue of Clinical Gastroenterology and Hepatology, Gatta et al report a pilot study suggesting that it may be possible to accurately assess cure using changes in serum pepsinogen II levels.
A positive urea breath test (UBT), histology, culture, or rapid urease test (RUT) any time after therapy is considered as evidence of treatment failure. However, it has been recommended that posttreatment testing be delayed for at least 4 weeks after the end of therapy. This recommendation is based on the fact that it takes time for any remaining bacteria to recover and repopulate the stomach in sufficient numbers to be detected reliably. By 4 weeks, the accuracy of a negative test is in the range of 98% to 100%. There is little or no gain by repeating negative tests to ensure success (eg, 2 negative urea breath tests) as a second urea breath test has not shown an increase in accuracy and adds an incremental cost with little clinical benefit. One caveat among available noninvasive tests is that when using the stool antigen to assess outcome, it may be best to increase the interval from 4 to 6 or 8 weeks to ensure that a positive result is not false positive. The available data show that the stool antigen tests that use monoclonal anti-H. pylori antibodies are more reliable than polyclonal stool antigen tests and monoclonal antibody-based stool antigen tests are recommended.
81. Which of the following information is TRUE about Invokana (Canagliflozin)? (Select All that apply)
a. The 300-mg dose of Invokana is proven to show greater A1C reductions than Januvia.
b. It is a once-daily pill that works around the clock.
c. It is not for weight loss, but may help a patient to lose weight—on average 3%.
d. In most clinical trials, the majority of people taking Invokana reached an A1C goal of less than 7%.
e. The most common side effect associated with the use of Invokana is hypoglycemia.
Answer: (a,b,c, and d). Invokana (Canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The recommended starting dose is 100 mg once daily, taken before the first meal of the day. Dose can be increased to 300 mg once daily in patients tolerating Invokana (Canagliflozin) 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control. Invokana (Canagliflozin) is limited to 100 mg once daily in patients who have an eGFR of 45 to less than 60 mL/min/1.73 m2. Assess renal function before initiating Invokana (Canagliflozin). Do not initiate Invokana (Canagliflozin) if eGFR is below 45 mL/min/1.73 m2. Discontinue Invokana (Canagliflozin) if eGFR falls persistently below 45 mL/min/1.73 m2.
It can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Invokana (Canagliflozin).
It causes intravascular volume contraction. Symptomatic hypotension can occur after initiating Invokana (Canagliflozin)®, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone system, or patients with low systolic blood pressure. Before initiating in patients with ≥1 of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating.
The most common side effects of Invokana (Canagliflozin) include genital yeast infections, urinary tract infection, and changes in urination.
82. Which of the following drugs interacts with Invokana (Canagliflozin)? (Select All that apply)
Answer: (a and b). Co-administration of Canagliflozin with rifampin, a nonselective inducer of several UGT enzymes, including UGT1A9, UGT2B4, decreased Canagliflozin area under the curve (AUC) by 51%. This decrease in exposure to Canagliflozin may decrease efficacy. If an inducer of these UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) must be co-administered with Invokana (Canagliflozin) (Canagliflozin), consider increasing the dose to 300 mg once daily if patients are currently tolerating Invokana (Canagliflozin) 100 mg once daily, have an eGFR greater than 60 mL/min/1.73 m2, and require additional glycemic control.
Consider other antihyperglycemic therapy in patients with an eGFR of 45 to less than 60 mL/min/1.73 m2 receiving concurrent therapy with a UGT inducer and require additional glycemic control.
There was an increase in the AUC and mean peak drug concentration (Cmax) of digoxin (20% and 36%, respectively) when co-administered with Invokana (Canagliflozin) 300 mg. Patients taking Invokana (Canagliflozin) with concomitant digoxin should be monitored appropriately.
83. Which of the following statements correctly describes the mechanism of action of Invokana (Canagliflozin)?
a. Increase insulin sensitivity towards blood glucose.
b. Stimulates insulin release from functioning beta cells of pancreas.
c. Delayed the absorption of glucose from gut to blood.
d. Increase gluconeogenesis in the liver.
e. Increase excretion of glucose through kidney.
Answer: (e). Sodium-glucose co-transporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Canagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, Canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), and thereby increases urinary glucose excretion (UGE).
84. Which of the following information is TRUE ABOUT Tall Man Letters? (Select All that apply).
a. Several studies have shown that highlighting sections of words using tall man lettering can make similar drug names easier to distinguish.
b. The Institute for Safe Medication Practices (ISMP), the FDA, The Joint Commission, and other safety-conscious organizations such as the National Association of Boards of Pharmacy (NABP) have promoted the use of tall man letters as one means of reducing confusion between similar drug names.
c. Nearly all of surveyed (87%) conducted by ISMP for Tall Man Letters felt that the use of tall man letters by the medical product industry helped to reduce errors in drug selection.
d. Approximately 50% of all survey respondents reported using tall man letters in conjunction with pharmacy-generated product and shelf labels, computer screens, and medication administration records.
e. Use of the tall man letters on computer-generated pharmacy labels was the most prevalent and was considered to be most effective, whereas use of the letters on preprinted order forms was among the least prevalent and was considered to be least effective.
Answer: (a,b,c,d and e). Tall man (uppercase) letters are used within a drug name to highlight its primary dissimilarities and help to differentiate look-alike names. Several studies have shown that highlighting sections of words using tall man lettering can make similar drug names easier to distinguish, and fewer errors are made when tall man letters are used to differentiate products with look-alike names.
The Institute for Safe Medication Practices (ISMP), the FDA, The Joint Commission, and other safety-conscious organizations such as the National Association of Boards of Pharmacy (NABP) have promoted the use of tall man letters as one means of reducing confusion between similar drug names.
From a survey conducted by the ISMP in 2008, most respondents appeared to agree. Nearly all of those surveyed (87%) felt that the use of tall man letters by the medical product industry helped to reduce errors in drug selection, and two-thirds (64%) reported that tall man lettering actually prevented them from dispensing or administering the wrong medication.
A fully alphabetized list of drug names with tall man lettering can be found at www.ismp.org/Tools/tallmanletters.pdf.
Approximately 50% of all survey respondents reported using tall man letters in conjunction with pharmacy-generated product and shelf labels, computer screens, and medication administration records. Half to three-quarters of respondents who used tall man letters with look-alike drug name pairs felt that this strategy was effective in reducing the risk of errors, depending on where it was used.
Use of the tall man letters on computer-generated pharmacy labels was the most prevalent and was considered to be most effective, whereas use of the letters on preprinted order forms was among the least prevalent and was considered to be least effective. In general, between one-quarter and one-third of respondents were undecided about the effectiveness of tall man letters, but very few reported that the letters were wholly ineffective in reducing the risk of errors. The use of tall man letters was less widely reported for drugs listed on prescriber order entry screens and smart pump libraries.
85. Which of the following information is/are TRUE about PMP InterConnect?
I. InterConnect is comprehensive and thorough tool for prescribers and dispensers to use in identifying potential opioid abuse.
II. InterConnect is a highly secure communications exchange platform that facilitates the transmission of PMP data across state lines to authorized requestors, while ensuring that each state’s data-access rules are enforced.
III. It is mandatory for all states to participate in PMP Interconnect.
a. I only
b. III only
c. I and II only
d. II and III only
Answer: (I and II only). PMP InterConnect is a highly secure communications exchange platform that facilitates the transmission of PMP data across state lines to authorized requestors, while ensuring that each state’s data-access rules are enforced. It is comprehensive and thorough tool for prescribers and dispensers to use in identifying potential opioid abuse. Additional information about PMP InterConnect, including a map of participants, is available in the Programs section of the NABP website. It is NOT MANDATORY for states to participate in PMP InterConnect.
Alabama, the District of Columbia, Massachusetts, and Pennsylvania have joined 38 other states by executing a memorandum of understanding with NABP to participate in NABP PMP InterConnect®. These states/jurisdictions will be working toward a live connection with other states in the coming months.
“A key enhancement of the Massachusetts Prescription Awareness Tool (MassPAT) is the sharing of interstate prescription data with nearly every state in the country,” said Eric J. Sheehan, JD, Acting Bureau Director, Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality. “Through its collaboration with NABP, the connection between MassPAT and NABP’s PMP InterConnect will result in a more comprehensive and thorough tool for Massachusetts prescribers and dispensers to use in identifying potential opioid abuse.”
In addition, the New York Prescription Monitoring Program Registry and Vermont Prescription Monitoring System joined 31 state prescription monitoring programs (PMPs) that have already implemented use of PMP InterConnect, giving authorized PMP users the ability to request and share program data across state lines: Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Nevada, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, West Virginia, and Wisconsin.
In an effort to combat prescription drug abuse and diversion with neighboring states, New York announced in a press release that the state began sharing PMP data with New Jersey on April 14, 2016. Governor Andrew Cuomo said, “Sharing controlled substance data with neighboring states allows us to more effectively combat prescription drug abuse and fraud . . . Prescription drug abuse impacts families nationwide, and I am proud of the crucial step we are taking to stem this epidemic.” According to the press release, New York plans to extend its PMP data sharing efforts to other PMP InterConnect participants.
NABP also continues to work with other states to facilitate their participation. Three more states are currently reviewing the memorandum of understanding. NABP staff highlighted the importance of state PMPs in the fight against prescription drug abuse in a recent interview with NPR.
86. NABP reports a recent rise in forged prescriptions for Promethazine with Codeine. Promethazine with codeine, a Schedule V CS, has been used for years as a cough medication. Abusers commonly refer to it as:
a. Elixir of Heaven
b. Purple Drank
c. Orange Cocktail
d. Levoni’s Drink
Answer: Purple Drank. NABP reports a recent rise in forged prescriptions for promethazine with codeine. Promethazine with codeine, a Schedule V CS, has been used for years as a cough medication. Abusers commonly refer to it as “purple drank.” “Purple drank” is a combination of promethazine with codeine mixed with a carbonated soda, such as Sprite or Mountain Dew, and candy, such as crushed Jolly Ranchers, mixed in for additional flavor.
The NABP has seen an increase in forged prescriptions for promethazine with codeine, and pharmacists have unknowingly filled them across United States in recent months. Pharmacists should be on the alert for promethazine with codeine prescriptions and perform due diligence in confirming that the prescription is legitimate.
Look for common red flags such as a prescription being presented right before closing, an out-of-the-area prescriber you do not recognize, a patient you do not recognize, a large quantity or exact quantity for “473 mL,” or a cash-paying patient you do not know.
87. According to Washington State Pharmacy Law, which of the following information about Electronic Prescriptions for Controlled Substances (EPCS) is/are TRUE?
I. Electronic signatures are required on all electronically communicated prescriptions.
II. The prescription that is generated electronically and transmitted via fax shall follow the ECPS rules.
III. An ECPS cannot be used to prescribe Schedule II controlled substance.
a. I only
b. I and II only
c. II and III only
Answer: I only is true, [Washington State Pharmacy Law July 2016 News Letter].
All 50 states, including Washington State, have rules in place allowing electronic prescriptions for controlled substances (EPCS), including Schedule II medications.
Pharmacies and practitioners wishing to use EPCS must first select software that meets the requirements of Title 21 Code of Federal Regulations (CFR) §1311. The software application provider must be approved by the federal Drug Enforcement Administration (DEA), and in Washington State it must also be approved by the Commission. Practitioners may not transmit, and pharmacies may not receive, EPCS until their software provider obtains a third-party audit or certification review that determines that their software application complies with DEA’s requirements and provides the audit/certification report to the practitioner/pharmacy.
Under Title 21 CFR §1300.03, electronic prescription is defined as a prescription that is generated on an electronic application and transmitted as an electronic data file. Therefore, an electronic prescription does not include prescriptions transmitted by facsimile, even if generated electronically and transmitted via fax, or printed on a computer printer.
An electronic signature is defined as a method of signing an electronic message that identifies a particular person as the source of the message and indicates the person’s approval of the information contained in the message.
According to DEA, electronic signatures are required on all electronically communicated prescriptions and are not allowed on CS prescriptions delivered by fax or hard copy to the pharmacy. CS prescriptions sent from fax to fax, computer to fax, printed on a computer printer, or manually written must all contain a manual signature. A manual, or wet, signature means the practitioner directly signs the prescription by hand using ink or indelible pencil.
Signing a signature pad on a computer so the prescription is printed or faxed with the signature image, or stamping the prescription with a signature stamp, does not meet DEA requirements for manual signatures. This also applies to EPCS where the electronic transmission fails and the prescription is returned to the practitioner by the intermediary.
These prescriptions must be manually signed by the prescriber before being faxed to the pharmacy, even if they include an electronic signature. Pharmacists should recognize they are responsible for ensuring CS prescriptions meet DEA signature requirements and contacting the prescriber whenever necessary.
88. The laboratory finding reveals that 57 year-old patient is suffering from metabolic acidosis. What kind of metabolic acidosis is he suffering from?
100% O2 Sat on Room Air
Electrolytes: Na 145 mEq/L, K 4.5 mEq/L, Cl 105 mEq/L, HCO3 25 mEq/L
a. Anion-gap metabolic acidosis
b. Non-Anion-gap metabolic acidosis
c. Cation gap metabolic acidosis
d. Non-Cation-gap metabolic acidosis
Answer(a): If the patient is suffering from metabolic acidosis (low pH with low HCO3), the next step is to calculate the anion gap because the anion gap helps determining the etiology of the metabolic acidosis.
The anion gap is the difference between the measured serum cations (positively charged particles) and the measured serum anions (negatively charged particles). The commonly measured cation is sodium and the measured anions include chloride and bicarbonate.
Anion gap = [Na+] - ([Cl-] + [HCO3-])
The normal anion gap value is between 8 and 12. An anion gap of greater than 12 is "increased".
The differential diagnosis for an elevated anion gap metabolic acidosis (simply called "anion gap acidosis") differs from the differential diagnosis for an non-elevated anion gap metabolic acidosis (simply called "non-anion gap acidosis").
So, in the above example:
Anion gap = [Na+] - ([Cl-] + [HCO3-])
Anion gap = 145 - (105 + 25)
Anion gap = 15
The calculated anion gap = 15(above the normal gap of 8-12), therefore there is an anion gap acidosis.
90. Which of the following information is/are TRUE ABOUT Essential Fatty Acids? [Select ALL That Apply]
a. Linoleic and alpha-linolenic are essential fatty acids.
b. Arachidonic acid is classified as ‘conditionally essential’ fatty acid.
c. Ideally, in the diet, the ratio of omega-6 to omega-3 fatty acids should be between 1:1 and 4:1.
d. Excessive intake of omega-6 fatty acids can cause the deficiency of omega-3 fatty acids.
Answer (a, b, c and d). Essential fatty acids, or EFAs, are fatty acids that humans and other animals must ingest because the body requires them for good health but cannot synthesize them.
Only two fatty acids are known to be essential for humans: alpha-linolenic acid (an omega-3 fatty acid) and linoleic acid (an omega-6 fatty acid). Some other fatty acids are sometimes classified as "conditionally essential," meaning that they can become essential under some developmental or disease conditions; examples include docosahexaenoic acid and gamma-linolenic acid.
It is not only important to incorporate good sources of omega-3 and omega-6s in a diet, but also consume these fatty acids in the proper ratio. Omega-6 fatty acids compete with omega-3 fatty acids for use in the body, and therefore excessive intake of omega-6 fatty acids can inhibit the use of omega-3 fatty acids by the body.
Ideally, the ratio of omega-6 to omega-3 fatty acids should be between 1:1 and 4:1. Instead, most Americans consume these fatty acids at a ratio of omega-6: omega-3 between 10:1 and 25:1, and are consequently unable to reap the benefits of omega-3s.
This imbalance is due to a reliance on processed foods and oils, which are now common in the Western diet. To combat this issue it is necessary to eat a low-fat diet with minimal processed foods and with naturally occurring omega-3 fatty acids. A lower omega-6: omega-3 ratio is desirable for reducing the risk of many chronic diseases.
Arachidonic acid is not one of the essential fatty acids. However, it does become essential if there is a deficiency in linoleic acid or if there is an inability to convert linoleic acid to arachidonic acid.
91. Which of the following are administered by Centers for Medicare & Medicaid Services (CMS)? [Select ALL That Apply]
c. Clinical Laboratory Improvement Amendments (CLIA)
d. Children's Health Insurance Program (CHIP)
Answer (a, b, c and d). The Centers for Medicare & Medicaid Services (CMS), a component of the Department of Health and Human Services (HHS), administers Medicare, Medicaid, the Children's Health Insurance Program (CHIP), the Clinical Laboratory Improvement Amendments (CLIA) and parts of the Affordable Care Act (ACA.
Along with the Departments of Labor and Treasury, CMS also implements the insurance reform provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and most aspects of the Patient Protection and Affordable Care Act (PPACA) of 2010 as amended.
The Social Security Administration is responsible for determining Medicare eligibility, eligibility for and payment of Extra Help/Low Income Subsidy payments related to Part D Medicare, and collecting some premium payments for the Medicare program.
93. Which of the following information is/are TRUE ABOUT Naloxone? [Select All That Apply].
a. Naloxone hydrochloride is a pure opioid antagonist that competitively binds to μ-opioid receptors only when opioids are present.
b. No tolerance or dependence is associated with naloxone use
c. When comparing the μ-opioid receptor affinity of naloxone with that of most opioids, including heroin, naloxone has a greater affinity to bind to the receptor site.
d. Naloxone has a short duration of activity about 30 to 90 minutes.
Answer: (a, b, c and d). Naloxone was patented in 1961, was first approved by the Food and Drug Administration (FDA) in 1971, and is currently on the World Health Organization’s List of Essential Medicines.
Naloxone hydrochloride is a pure opioid antagonist that competitively binds to μ-opioid receptors only when opioids are present and bound at the receptor site. Naloxone demonstrates no effect on mu, kappa, or delta receptors in a person who has not taken opioids. No tolerance or dependence is associated with naloxone use.
The reversal of opioid toxicity with naloxone is dose dependent. Individuals who have used a particularly potent opioid (e.g., fentanyl), have high concentration of opioids in their system, or have used a long-acting opioid may require more frequent and/or larger doses of naloxone to reverse symptoms.
When comparing the μ-opioid receptor affinity of naloxone with that of most opioids, including heroin, naloxone has a greater affinity to bind to the receptor site. This mechanism allows naloxone to remove the opioid from the receptor site and then bind it more securely. When this occurs, respiratory depression resolves partially or fully (depending on the amount, form, and route of opioids taken), hypotension resolves, and CNS depression abates.
Depending on the type of opioid used, the individual may be at risk for experiencing rebound opioid toxicity and/or acute respiratory depression because of the short duration of activity of naloxone (i.e., 30–90 minutes).
This effect most often occurs when an individual has taken a long-acting opioid such as methadone or extended-release oxycodone. Naloxone’s short duration of action is an important reason to convey to patients that receiving emergency medical care for an opioid overdose is important, even if the person has responded to the naloxone.
Naloxone is not effective in treating overdoses of non-opioid prescription medicines like benzodiazepines or barbiturates. It also is not effective in overdoses with stimulants, such as cocaine and amphetamines, or other non-opioid illicit drugs such as MDMA (Ecstasy, Molly), GHB (G), or ketamine (Special K). However, a polysubstance overdose that includes opioids warrants the use of naloxone.
93. The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of “individual benefit and risk” when increasing daily dose to above ____ morphine milligrams equivalent per day.
Answer(b): The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of “individual benefit and risk” when increasing daily dose to above 50 morphine milligrams equivalent per day, and avoidance of doses greater than 90 MME per day.
94. A 35-year-old man who is a regular patient of yours comes to your pharmacy counter with a new prescription. His shoulders appear tense and his eyebrows are knit tightly.
He says to you, “I can’t believe I have to fill another prescription today. I was just in three weeks ago and spent $75 dollars on some fancy new medication that didn’t do a darn thing!” What might be an appropriate active listening response to this patient?
a. It must be very frustrating to have to try something new.
b. It’s too bad we can’t take a prescription back for a refund.
c. I can provide you with a smaller quantity this time.
d. Your doctor is trying to find the best medication for you.
Answer (a). It must be very frustrating to have to try something new. Answer “b” does not acknowledge the patient’s feelings; answer “c” moves to finding a solution without acknowledging the patient’s feelings and “d” is placating.