Targiniq ER 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. Which of the following drugs provides abuse-deterrent property to Targiniq ER?
 
a. Oxycodone
b. Naltrexone
c. Naloxone
d. Methadone
e. Atropine

Targiniq ER 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. Which of the following drugs provides abuse-deterrent property to Targiniq ER?
 
a. Oxycodone
b. Naltrexone
c. Naloxone
d. Methadone
e. Atropine
 
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.

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The U.S. Food and Drug Administration has approved Insulin Human Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. It is available under the trade name:
 
a. Vazculep
b. Sivextro
c. Bunavail
d. Beleodaq
e. Afrezza

The U.S. Food and Drug Administration has approved Insulin Human Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. It is available under the trade name:
 
a. Vazculep
b. Sivextro
c. Bunavail
d. Beleodaq
e. Afrezza
 
Answer: (e), Afrezza. The U.S. Food and Drug Administration has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is available as single-use cartridges of (4 units, 8 units and 12 units).  
 
Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal.Afrezza should only be administered via oral inhalation using  the AFREZZA Inhaler. Afrezza is administered using a single inhalation per cartridge.
 
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.
 
Step 1: Starting Mealtime Dose:

1. Insulin Naïve Individuals: Start on 4 units of Afrezza at each meal.

2.  Individuals Using Subcutaneous Mealtime (Prandial) Insulin:  Determine the appropriate Afrezza dose for each meal by  converting from the injected dose using Figure 1.

3. Individuals Using Subcutaneous Pre-mixed Insulin: Estimate  the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1. Administer half of the total daily injected pre-mixed dose as an injected basal  insulin dose.


 
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.

Which of the following information about Naloxone Auto-Injector (Evzio) is/are TRUE?
 
I. It is indicated for treating a suspected opioid overdose.
 
II. The principal advantage of Naloxone is that it doesn't cause withdrawal symptoms such as sweating, increased heart rate or agitation even in an opioid dependent patient.
 
III. A person should use great caution to administer Naloxone to someone who is not using opioids.
 
a. I only
b. I and II only
c. All
d. None of the above

Which of the following information about Naloxone Auto-Injector (Evzio) is/are TRUE?
 
I. It is indicated for treating a suspected opioid overdose.
 
II. The principal advantage of Naloxone is that it doesn't cause withdrawal symptoms such as sweating, increased heart rate or agitation even in an opioid dependent patient.
 
III. A person should use great caution to administer Naloxone to someone who is not using opioids.
 
a. I only
b. I and II only
c. All
d. None of the above

Answer: (a) I is True only. Naloxone HCL (Evzio) is a pre-filled, single-use auto-injector. Naloxone HCL (Evzio) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
 
Naloxone HCL (Evzio) is intended for immediate administration as emergency therapy in settings where opioids may be present. It is for intramuscular and subcutaneous use only. Administer the initial dose of Naloxone HCL (Evzio) to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. There's no harm in giving Naloxone HCL (Evzio) to someone who is not using opioids.
 
Naloxone HCL (Evzio) can trigger withdrawal symptoms such as sweating, increased heart rate, or agitation in the opioid dependent patient. Hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest are commonly reported side effects of Naloxone HCl (Evzio).

A pharmacist receives a new prescription to compound each capsule such a way so that it contains 200mg Acetaminophen, 50mg Butalbital and 40mg Caffeine. The final formulation of this compounded prescription shall be classified as:
 
a. Schedule III controlled drug
b. Schedule IV controlled drug
c. Schedule V controlled drug
d. Non-controlled substance

A pharmacist receives a new prescription to compound each capsule such a way so that it contains 200mg Acetaminophen, 50mg Butalbital and 40mg Caffeine. The final formulation of this compounded prescription shall be classified as:
 
a. Schedule III controlled drug
b. Schedule IV controlled drug
c. Schedule V controlled drug
d. Non-controlled substance

Answer (a): 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. **
 
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Which of the following statements about methamphetamine is/are TRUE?
 
I. Methamphetamine is a highly addictive drug that can be manufactured in small and portable laboratories.

II. The use of methamphetamine can result in fatal kidney and lung disorders, brain damage, liver damage and blood clots.

III. Each pound of methamphetamine produced leaves behind five to six pounds of toxic waste.

IV. 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.
 
a. I only
b. I and IV only
c. II only
d. All

Which of the following statements about methamphetamine is/are TRUE?
 
I. Methamphetamine is a highly addictive drug that can be manufactured in small and portable laboratories.

II. The use of methamphetamine can result in fatal kidney and lung disorders, brain damage, liver damage and blood clots.

III. Each pound of methamphetamine produced leaves behind five to six pounds of toxic waste.

IV. 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.
 
a. I only
b. I and IV only
c. II only
d. All
 
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.

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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:
 
a. AHSP
b. PDRQ
c. ASAP
d. CRDD

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:
 
a. AHSP
b. PDRQ
c. ASAP
d. CRDD

Answer: (c), American Society for Automation in Pharmacy (ASAP).
 
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.

A pharmacist is reviewing a new prescription prepared by a pharmacy technician. The prescription label reads: Precose 25mg PO TID x 30 days; Qty: 90 5 Refills. Which of the following acts done by the pharmacist is the most appropriate?
 
a. Fill as it is.
b. Call the prescriber to verify the Precose dose.
c. Call the prescriber to verify the number of refills.
d. Ask the technician to add an auxiliary label: "Take With Meals".
e. Counsel the patient that this drug may cause "Severe Constipation".

A pharmacist is reviewing a new prescription prepared by a pharmacy technician. The prescription label reads: Precose 25mg PO TID x 30 days; Qty: 90 5 Refills. Which of the following acts done by the pharmacist is the most appropriate?
 
a. Fill as it is.
b. Call the prescriber to verify the Precose dose.
c. Call the prescriber to verify the number of refills.
d. Ask the technician to add an auxiliary label: "Take With Meals".
e. Counsel the patient that this drug may cause "Severe Constipation".
 
Answer: 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).

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For compounding purposes, if neither USP/NF grade substances nor FDA-approved substances are available, or when food, cosmetics, or other substances are, or must be used, the substance shall be of a chemical grade from:
 
I. Chemically Pure
II. Analytical Reagent
III. American Chemical Society
 
a. I only
b. I and II only
c. II and III only
d. All

For compounding purposes, if neither USP/NF grade substances nor FDA-approved substances are available, or when food, cosmetics, or other substances are, or must be used, the substance shall be of a chemical grade from:
 
I. Chemically Pure
II. Analytical Reagent
III. American Chemical Society
 
a. I only
b. I and II only
c. II and III only
d. All

Answer: (d) All. Ingredients used in a compounded preparation shall either originate from FDA-approved sources, if available, or be USP/NF grade substances. If neither USP/NF grade substances nor FDA-approved substances are available, or when food, cosmetics, or other substances are, or must be used, the substance shall be of a chemical grade in one of the following categories:
 
(1). Chemically Pure (CP); 
(2). Analytical Reagent (AR); or 
(3). American Chemical Society (ACS); or 
(4). Food Chemical Codex.
 

Who may fall to a major statin benefit groups?
 
I. Patients with LDL 190 mg/dL or higher.
II. Patients age 40 to 75 years of age with diabetes and LDL 70 to 189 mg/dL.
III. Patients without clinical atherosclerotic cardiovascular disease or diabetes with LDL 70 to 189 mg/dL.

a. I only
b. I and II only
c. II and III only
d. All

Who may fall to a major statin benefit groups?
 
I. Patients with LDL 190 mg/dL or higher.
II. Patients age 40 to 75 years of age with diabetes and LDL 70 to 189 mg/dL.
III. Patients without clinical atherosclerotic cardiovascular disease or diabetes with LDL 70 to 189 mg/dL.
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: d, All. There are four major statin benefit groups:

a. Patients with clinical atherosclerotic cardiovascular disease.

b. Patients with LDL 190 mg/dL (5 mmol/L) or higher.

c. Patients age 40 to 75 years of age with diabetes (but without clinical atherosclerotic cardiovascular disease) and LDL 70 to 189 mg/dL (1.8 to 4.9 mmol/L).

d. Patients without clinical atherosclerotic cardiovascular disease or diabetes with LDL 70 to 189 mg/dL (1.8 to 4.9 mmol/L), with an estimated 10-year risk of atherosclerotic cardiovascular disease of 7.5% or higher.

If a patient does not fit into one of the four statin benefit groups (e.g., LDL 70 to 189 mg/dL [1.8 to 4.9 mmol/L] with 10-year risk 5% to 7.5%), but there is clinical suspicion that they may benefit from a statin, additional factors can be taken into consideration:

a. LDL 160 mg/dL or higher or other evidence of genetic hyperlipidemia.

b. Cardiovascular disease onset in a first degree male relative before age 55, or in a first degree female relative before age 65.

c. High-sensitivity C-reactive protein 2 mg/dL or higher.

d. Elevated lifetime risk of atherosclerotic cardiovascular disease.

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Which of the following statements is/are NOT TRUE about hypertension therapy according to NEW JNC8 guidelines? [Select ALL THAT APPLY].
 
a. African Americans respond to ACE Inhibitors/Angiotensin Receptor blocker quite well.
b. Beta or alpha blockers are recommended initial therapy for nonblack patients.
c. Thiazides produce better cardiovascular outcomes than ACE inhibitors in African Americans.
d. Most African Americans will need at least three antihypertensives to control blood pressure.
e. In nonblack patients with diabetes, ACE Inhibitors/Angiotensin Receptor blockers are considered to be initial therapy.
 

Which of the following statements is/are NOT TRUE about hypertension therapy according to NEW JNC8 guidelines? [Select ALL THAT APPLY].
 
a. African Americans respond to ACE Inhibitors/Angiotensin Receptor blocker quite well.
b. Beta or alpha blockers are recommended initial therapy for nonblack patients.
c. Thiazides produce better cardiovascular outcomes than ACE inhibitors in African Americans.
d. Most African Americans will need at least three antihypertensives to control blood pressure.
e. In nonblack patients with diabetes, ACE Inhibitors/Angiotensin Receptor blockers are considered to be initial therapy.
 
Answer: a,b,d. NEW JNC8 guidelines for treating hypertension patients:
 
1. Thiazides no longer given preference as initial therapy.
 
2. Because patients with diabetes are at increased risk of nephropathy, coronary artery disease, and heart failure, conditions known to benefit from ACE Inhibitors and Angiotensin II Receptor Blockers, it makes sense to choose one of them first-line for hypertension in patients with diabetes.
 
3. For HTN, beta- and alpha-blockers have worse cardio vascular outcomes data than the recommended agents.
 
4. African Americans have high stroke risk. Calcium channel blockers provide better stroke prevention and blood pressure reduction in African Americans vs ACE Inhbitors.1
 
5.Thiazides produce better cardio vascular outcomes (including reduced stroke risk) than ACE inhibitors in African Americans.
 
6. African Americans tend to be “salt-sensitive.” This may explain their relatively poor response to ACE inhibitors. Encourage sodium restriction.
 
7. Most African Americans will need at least two antihypertensives to control blood pressure. African Americans and nonblacks have similar responses to combination therapy (i.e., thiazide plus ACE Inhibitor; Calcium channel blocker plus ACE Inhibitor).
 
8. Do not use an ACE Inhibitor plus an Angiotensin II Receptor Blocker; no added benefit, more side effects (e.g., hyperkalemia).
 
9. Thiazides and Calcium channel blockers reduce systolic BP more than diastolic BP.

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