PHA 575 Practice of Pharmacy V: Final Exam (Cumulative)

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Whenever the pharmacist is absent from the pharmacy (for more than the allowed amount of time), a sign shall be prominently displayed on the entrance to the prescription department announcing...

"Prescription Department Closed" with clear and legible letters not less than three (3) inches in size.

When Transferring-OUT prescriptions, "___________" is written across the face of the hard copy of non-controlled prescriptions, while "___________" is written across the face of the hard copy of controlled prescriptions.

"Transfer"; "VOID"

GA General Assembly (2020): HB 991 creates an oversight committee comprised of...

1 Physician 1 Pharmacist 1 Consumer Member 6 GGA Members

Bisphosphonates: (3)

1. Alendronate (Fosamax, Binosto): Dosing Form & Range: Tablet: 5-70 mg FDA Indications: 1. Post-menopausal Osteoporosis; treatment & prophylaxis 2. Male Osteoporosis; treatment 3. Glucocorticoid-induced osteoporosis 4. Paget Disease Drug Interactions: Aluminum, Calcium, Magnesium, Iron Common SEs: Fever, Flu-like Syndrome, Gastric Ulcer Rare but Serious SEs: 1. Jaw Osteonecrosis 2. Esophageal Cancer 3. Immune Hypersensitivity 4. Arrhythmia 5. Fractures 2. Ibandronate (Boniva): Dosing Form & Strength: Tablet: 150 mg FDA Indication: Post-menopausal Osteoporosis; Treatment & Prophylaxis Drug Interactions: Aluminum, Calcium, H2RAs, PPIs Common SEs: Indigestion, Backache, and Respiratory Tract Infections Rare but Serious SEs: 1. Jaw Osteonecrosis 2. Esophageal Cancer 3. Immune Hypersensitivity 4. Arrhythmia 5. Fractures 6. Severe Muscle Pain Clinical Pearl: Medication Guide required. 3. Risedronate (Actonel, Atelvia): Dosing Form & Range: IR Oral Tablet: 5-150 mg; DR Oral Tablet: 35 mg FDA Indications: 1. Post-menopausal Osteoporosis; treatment & prophylaxis 2. Male Osteoporosis; treatment 3. Glucocorticoid-induced osteoporosis 4. Paget Disease Drug Interactions: Aluminum, Calcium, H2RA, PPIs Common SEs: Rash, UTI, Abdominal Pain, Constipation, Diarrhea, Nausea, Indigestion, Backache Rare but Serious SEs: 1. Jaw Osteonecrosis 2. Hypersensitivity Clinical Pearl: Medication Guide required. Same for all: MOA: Binds to bone hydroxyapatite, and at the cellular level, inhibits osteoclast activity, thereby inhibiting bone resorption and modulating bone metabolism. Dose Adjustments: Renal dose adjustment for Ibandronate and Risedronate is CrCl < 30 mL/min, but the renal dose adjustment for Alendronate is CrCl < 35 mL/min. Contraindications: 1. Esophageal abnormalities 2. Hypersensitivity 3. HYPOcalcemia 4. Inability to sit or stand upright for at least 30 min 5. Increased risk for adverse esophageal effects Absorption: Food impairs absorption, so take 30-60 min prior to meal Efficacy Monitoring Parameters: 1. Increased BMD (T-score) 2. Decreased incidence of bone fracture 3. Normalization of alkaline phosphatase (Paget's) Toxicity Monitoring Parameters: 1. Baseline SCr 2. Calcium 3. Phosphorous 4. Severe skin rash 5. Difficulty swallowing 6. Swelling 7. Tooth problems 8. Severe pain (w/ urination) Patient Counseling: Sit up right and wait for 30 min to eat or drink after taking Alendronate or Risedronate but wait 60 min for Ibandronate.

Prescription LABEL Requirements: What requirements are Georgia-Specific? (3)

1. Dispensing Pharmacy's Telephone Number 2. Dispensing Pharmacist's Credentials 3. Drug Expiration Date

List the Joint Commission's requirements for medication reconciliation: (6)

1. Ensure your team is capturing the complete list of what patients have been prescribed, as well as what they are actually taking. 2. Recognize that a good faith effort meets the intent of the Joint Commission requirement for medication reconciliation. 3. Compare and reconcile all the medications identified. 4. Update the patient's record with the reconciled, accurate list. 5. Give patients and families written information about the medications you prescribe as a result of the encounter. 6. Impress upon patients the importance of managing their medication information. References: https://blog.cureatr.com/medication-reconciliation-according-to-the-joint-commission https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2018.pdf

What is the 3 step approach for determining the appropriate Statistical Test?

1. Evaluate Dependent Variable 2. Determine if Normal Distribution is present 3. Count the amount of groups in the study

Which measure(s) of central tendancy can be used for Nominal Data?

1. Frequency Distribution 2. Mode

Which measure(s) of central tendancy can be used for Ordinal Data?

1. Frequency Distribution 2. Mode 3. Median (IQR)

Which measure(s) of central tendancy can be used for Interval/Ratio Data?

1. Frequency Distribution 2. Mode 3. Median (IQR) 4. Mean (SD)

Georgia Prescription LABEL Requirements? (14)

1. Patient Name 2. Prescriber Name 3. Pharmacy Name 4. Pharmacy Address 5. Pharmacy Telephone # 6. Drug Name 7. Drug Strength 8. Drug Quantity 9. Drug Sig/Directions 10. Drug Expiration Date 11. Prescription Serial # 12. Date Dispensed/Filled 13. Cautionary Statements 14. Dispensing Pharmacist's Credentials Bolded = Specific to Georgia

Federal Prescription LABEL Requirements: (11)

1. Patient's Name 2. Prescriber's Name 3. Dispensing Pharmacy's Name 4. Dispensing Pharmacy's Address 5. Drug Name 6. Drug Strength 7. Drug Quantity 8. Drug Directions/Sig 9. Date Filled 10. Prescription Serial/Barcode Number 11. Caution Statement: "Federal Law prohibits the transfer of this drug to any other person than the patient for whom it was prescribed."

Georgia Community/Retail Pharmacy: Oral Prescription Requirements: (15)

1. Patient's name 2. Patient's address 3. Prescriber's name 4. Prescriber's address 5. Prescriber's telephone # 6. Prescriber's NPI # 7. Prescriber's DEA # (Controlled) 8. Authorized Agent's Name 9. Date Transcribed 10. Drug Name 11. Drug Strength 12. Drug Form 13. Drug Quantity 14. Directions/Sig 15. Refills, if any (Bolded = Different than Written)

Georgia Community/Retail Pharmacy: Written Prescription Requirements: (15)

1. Patient's name 2. Patient's address 3. Prescriber's name 4. Prescriber's address 5. Prescriber's telephone # 6. Prescriber's NPI # 7. Prescriber's DEA # (Controlled) 8. Prescriber's signature 9. Date Written 10. Drug Name 11. Drug Strength 12. Drug Form 13. Drug Quantity 14. Directions/Sig 15. Refills, if any (Bolded = Different than Oral)

What are the 4 reference materials required in all Ga Pharmacies?

1. Poison Control Telephone #: (800) 222-1222 2. GA Rules & Regs: (Current; Digital/Hard-Copy) 3. GA Pharmacy Practice Act 4. Controlled Substance Act

Pharmacy Drive-Thru Requirements: If a pneumatic tube system is used, then: (3)

1. Secured carriers must be utilized within the tube system. 2. Tubes must be constructed in a manner to prevent access by unauthorized persons 3. The tubes must originate in the prescription department, be accessible only by pharmacy personnel AND must terminate in a secure terminal in the drive-thru

List the rights of a GDNA Agent: (9)

1. Visit and inspect all areas of a pharmacy 2. Enter and inspect any vehicle 3. Investigate alleged violations 4. Take samples 5. Seize and take posession of contraband 6. Compel witnesses to appear and produce evidence 7. Make arrests 8. Transfer arrested person to the county sheriff's custody. 9. Prepare the dangerous drugs list.

Omeprazole

10, 20, 40 mg Duodenal/Gastric Ulcer, H. Pylori, GERD DIs: Clopidogrel, Warfarin NO common SE RBS SEs: Toxic Epidermal necrolysis, C. Dif diarrhea, pancreatitis, heaptotoxicity, hip fracture, rhabdo, acute interstitial nephritis PC: 1 hr before meals CP: Med guide required at dispensing

What is the max number of drive thru lanes allowed for a pharmacy?

2 (two)

The drive-thru window must be made of transparent material no less than ___________ in size. and where must it be placed?

2' x 3' in size; a wall within the pharmacy dept.

Pharmacy Drive-Thru Requirements: The lane farthest from the Pharmacy Dept. must be no more than ____________ from the window.

24 feet

Hospitals are NOT reimbursed for specific disease states that are not identified within ____________ of admission.

30 days

Pharmacists may leave the pharmacy unattended for NMT ______ minutes; anytime greater, the pharmacy must close and the pharmacy staff must discontinue work-related tasks until a pharmacist is once again present.

5 (five)

If p-value > 0.05

Accept the Alternative Hypothesis due to the absence of significant differences

Rabeprazole

Aciphex PPI FDA Indications: • GASTRIC ulcer, NOT Duodenal ulcer. • H. Pylori • Gastric Hypersecretion • GERD Absorption: Delayed by food Beers: Avoid over 8 weeks DIs: Warfarin, Clopidogrel, CYP2C8, 2C19, 3A4/5 No Common SE RBS SEs: SJS, Bone fractures, Rhabdo, nephritis, infections Toxicity MP: if long term use, check Mg and SCr PC: may open capsule and sprinkle on applesauce, or administer 15 min before meal. If used for duodenal ulcer (off-label) administer with breakfast CP: nothing special

Ratio Data: Examples:

Adds equal intervals between the named ordered categories and has TRUE ZERO! Examples: • Temperatures in Kelvin • Weight • Height • Time

Interval Data: Examples:

Adds equal intervals between the named ordered categories but does NOT have a true zero! Examples: • Age • Temperatures in Celsius or Fahrenheit

Orlistat

Alli Class: Weight Loss Indications: Obesity Dosage: 60 mg po TID with or 1 hr before each main meal containing fat. MOA: reversibly binds pancreatic and gastric lipase in the GI tract; non-systemic inhibitor of GI lipase, which are necessary for the breakdown of fat; thus reducing fat absorption and causing weight reduction. Pregnancy Category X DIs: Cyclosporine, Levothyroxine, Warfarin, Fat-Soluble Vitamins Common SE: Headache, Oily fecal spotting, abdominal cramps, flatulence w/ discharge (i.e. sharting), upper respiratory infection, influenza RBS SEs: Anaphylaxis, Angioedema, Bronchospasms, Hepatic failure, Hepatitis, Pancreatitis PC: must be accompanied w/ lifestyle modifications. Must be taken with low fat diet to avoid GI adverse events. Patient should take a MTV high in fat soluble vitamins 2 hrs before or after dose of orlistat (at bedtime)

Lubiprostone (____________)

Amitiza Chloride Channel Blocker FDA Indications: Chronic Idiopathic Constipation, IBS-C, and Opioid Induced Constipation MOA: Bicyclic fatty acid that acts at the apical intestine as a chloride channel activator, which increases intestinal fluid secretion and improves fecal transit. Pregnancy: Avoid Drug Interactions: Methadone Common SE: Headache, Nausea, Diarrhea RBS SE: HYPOtension, syncope PC: Take w/ food and water to reduce nausea CP: Not approved for males with IBS

Meclizine (____________)

Antivert, Bonine, Dramamine Class: Antihistamine and Antiemetic Oral Tablet: 12.5-25 mg po 1 hr before departure FDA Indications: Motion sickness, vertigo MOA: Suppresses the vasodepressor response to histamine while only slightly inhibiting acetylcholine Beers: Highly anticholinergic DIs: CNS Depressants, Anticholinergic agents Common SEs: Sedation RBS SEs: Anaphylaxis PC: Take w/ food to decrease GI sx, use in caution for pts affected by glaucoma, bph, or asthma CP: Take 1 hr before travel.

How to calculate BMI?

BMI = (weight in kg)/((height in meters)^2)

Alpha-D-Galactosidase

Beano Antigas 150, 300 units Indication: Flatulence MOA: Natural Food Enzyme PC: Must be administered before or with the first bite of food to ensure the enzyme is present in the stomach before the food. Patients w/ diabetes should know about the increase in carbohydrate will increase BG. CP: Limit air consuming; use a food diary to pin point problems,

Wheat dextrin

Benefiber Fiber (Bulk) Laxative Indications: Fiber supplement, Laxative MOA: soluble fiber that absorbs water in the intestine to soften stool, lubricate the intestine, and add bulk to promote peristalsis and decrease transit time Common SEs: diarrhea, cramping, flatulence RBS SEs: Electrolyte/Fluid Imbalance TC: Suddem ∆ in BM for nmt 14 d, or nmt 7 d w/ laxative *refer to HCP PC: Lifestyle mods, dissolve product in 120-240 mL of hot or cold non-carbonated beverage, produces BM in 12-24 but may take 72 hrs. CP: May be used as dietary fiber, 3 g/3.8 WD, may contain sugar so be cautious for DM, Start slow and build over 1-2 weeks.

Dicyclomine (___________):

Bentyl Tab/Cap/Sol: 10-20 mg FDA-Indication: IBS MOA: Relieves smooth muscle spasms of GI tract; i.e. anti-muscarinic Contraindication: < 6 months old, glaucoma Beers: Highly anticholinergic DIs: Anticholinergic drugs CSEs: Decreased sweating dry mouth, GI Distress, Blurred vision, Dizziness, Constipation, Drowsiness RBS SEs: Psychosis, Euphoria, Anaphylaxis, Dependence PC: drowsiness, heat prostration CP: Serious respiratory s/sx in infants

Align

Bifidobacterium infantis Probiotic Common SE: Diarrhea, Constipation, Abdominal Discomfort No RBS SE PC: Gas and bloating are common and tend to diminish over several days of treatment. Product should be stored in original packaging at room temperature to maintain potency. CP: When using alongside antibiotics, separate the dose at least 2 hours after the antibiotic and for up to a week after the antibiotic course. Consider dietary changes, exercise, and stress reduction

Pioglitazone:

Brand: Actos Drug Classes: Thiazolidinedione Antidiabetic Dosage Forms and Strength Ranges: Oral Tablet: 15 mg-45 mg FDA Indications: T2DM Usual Regimen: 15-30 mg po daily; may titrate to max 45 mg po daily as monotherapy, or in combination with sulfonylurea or metformin MOA: Pioglitazone is a thiazolidinedione antihyperglycemic and a potent peroxisome proliferator-activated receptor-γ (PPAR-γ) agonist used to improve insulin sensitivity in patients with Type 2 diabetes. Insulin-dependent glucose disposal in skeletal muscle is improved and hepatic glucose production is decreased; both actions contribute to pioglitazone's glucose-lowering effects. Dose Adjustments: Hepatic: Avoid if LFTs are elevated. Pregnancy Category: C Contraindications: Hypersensitivity to pioglitazone, NYHA III/IV heart failure Absorption: Food delays but does not reduce absorption BBW: Heart Failure Beers Criteria: Avoid in certain circumstances Drug Interactions: Corticosteroids, NSAIDs, SSRIs, MAOIs, CYP2C8 Inducers/Inhibitors/Substrates Common SEs: Edema and Weight Gain Rare but Serious SEs: Heart failure, anemia, hepatotoxicity, diabetic macular edema, hypoglycemia when used in combination with insulin or sulfonylureas, bladder cancer Efficacy Monitoring Parameters: Preprandial blood glucose between 70 and 130 mg/dL, HbA1c <7% (goal HbA1c may be 6.5-8% based on patient-specific characteristics). Toxicity Monitoring Parameters: Weight for assessment of edema, Hgb, LFTs; symptoms of hypoglycemia include, nausea, sweating, and loss of consciousness; seek care for bone pain, yellowing of skin or eyes, eye pain, or shortness of breath; eye exams. Patient Counseling: Monitor blood glucose in frequent intervals (2-4 times per d). May take without regard to food. May require several weeks for max effect. Clinical Pearls: Pioglitazone causes edema, which may exacerbate underlying heart failure; contraindicated with NYHA III/IV heart failure. Stimulates ovulation. Premenopausal anovulatory individuals may resume ovulation. Increased risk of pregnancy in premenopausal female diabetics; use effective birth control. Not for use in children. Medication guide required at dispensing.

Exenatide:

Brand: Byetta, Bydureon Drug Classes: GLP-1 Agonist Dosage Forms and Strength Ranges: SubQ 5 mcg/0.02 mL, 10 mcg/0.04 mL FDA Indications: T2DM Usual Regimen: 5-10 mcg sq bid before meals; extended release, 2 mg sq weekly MOA: Exenatide is an agonist of human glucagon-like peptide-1 (GLP-1) receptor and augments glucose dependent insulin secretion and slows gastric emptying. Dose Adjustments: Renal: CrCl 30-50 mL/min, initial dose 5 mcg and increase with caution; avoid if CrCl <30 mL/min Pregnancy Category: C Contraindications: Hypersensitivity BBW: Thyroid C-Cell Tumors (Bydureon) Drug Interactions: Warfarin Common SEs: Hypoglycemia, diarrhea, nausea, injection site reactions Rare but Serious SEs: Pancreatitis, anaphylaxis, acute renal failure, worsening of preexisting renal disease Efficacy Monitoring Parameters: Preprandial blood glucose between 70 and 130 mg/dL; HbAlc <7%. Toxicity Monitoring Parameters: Symptoms of hypoglycemia include nausea, sweating, and loss of consciousness; seek medical attention if severe GI upset, changes in urination, shortness of breath, or severe skin rash. Patient Counseling: Immediate-release product is dispensed in a prefilled pen containing 60 doses. Use this medicine 1 h before eating. Store new, unused pens in the refrigerator in the original carton. After using the pen for the first time, store it in a closed container at room temperature. Remove the needle from the pen before storing the medicine. Throw the pen away after using it for 30 d, even if there is some medicine left in it. Monitor FPG in frequent intervals (2-4 times per day). Carry candy or some type of sugar with you at all times for episodes of hypoglycemia, especially if you are away from home. Extended-release product is dispensed as powder with diluent in prefilled syringe. Patient instructions on weekly dose preparation and administration must be provided. Clinical Pearls: Metformin is first-line therapy for Type 2 diabetes. Exenatide may be added if HbAlc goals are not achieved with metformin alone. Many clinicians may try an oral sulfonylurea prior to exenatide. Dose- and duration-dependent thyroid C-cell tumors have developed in animal studies with Bydureon therapy; relevance in humans unknown. May increase risk of pancreatic duct metaplasia. Medication guide required with dispensing.

Glipizide:

Brand: Glucotrol Drug Classes: 2nd-Gen Sulfonylurea, Anti-Diabetic Dosage Forms and Strength Ranges: Oral Tablet: 5 mg, 10 mg; Oral Tablet, Extended Release: 2.5 mg, 5 mg, 10 mg FDA Indications: Type 2 Diabetic Mellitus Usual Regimen: 5-10 mg po daily, may titrate to max 40 mg daily, divide bid if doses >15 mg; extended release, 5-10 mg po daily, may titrate to max 20 mg daily MOA: Sulfonylureas enhance insulin secretion from pancreatic β-cells and potentiate insulin action on several extrahepatic tissues. Long-term sulfonylureas increase peripheral utilization of glucose, suppress hepatic gluconeogenesis, and possibly increase the sensitivity and/or number of peripheral insulin receptors. Dose Adjustments: Hepatic: Start with 2.5 mg po daily Renal: Start with 2.5 mg po daily Pregnancy Category: C Contraindications: Hypersensitivity to sulfonylureas, diabetic ketoacidosis, Type 1 diabetes Absorption: Food delays absorption by 40 min Drug Interactions: Beta Blockers, Fluroquinolones, NSAIDs, Fenofibrate, SSRIs, Somatostatin Analogues, CYP2C9 Inducers & Inhibitors, MAOIs, Psyllium, Sulfonamides Common SEs: Asthenia (abnormal physical weakness or lack of energy) Rare but Serious SEs: Cutaneous hypersensitivity, hemolytic anemia, hepatotoxicity, disulfiram reaction Efficacy Monitoring Parameters: Preprandial blood glucose between 70 and 130 mg/dL, HbA1c <7%. Toxicity Monitoring Parameters: Symptoms of hypoglycemia include nausea, sweating, and loss of consciousness. Seek medical attention if yellowing of skin or eyes, severe skin rash, unusual bruising, or bleeding. Patient Counseling: Monitor blood glucose in frequent intervals (2-4 times per day); if <70 mg/dL, eat candy or sugar and contact prescriber. Use a sunscreen and avoid sunlamps and tanning beds. Do not drink alcohol; may cause a disulfiram reaction. Take 30 min before morning meal. Do not chew or crush extended-release formulation. Clinical Pearls: Metformin is first-line therapy for Type 2 diabetes. A sulfonylurea may be added if HbA1c goals are not achieved with metformin alone. Not for use in children. Hemolytic anemia is most likely to occur in patients with G6PD deficiency. Patients on insulin: when starting glipizide, reduce insulin dose by 50%, or discontinue if <20 units/d.

Lidocaine:

Brand: Lidoderm Drug Class: Local Anesthetic Dosing Form and Strength: Topical Patch 5% Typical Regimen: 1-3 patches topically simultaneously for up to 12 h within a 24-h period (12 h on, 12 h off) FDA Indications: Postherpetic Neuralgia and Localized Pain MOA: Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses. The penetration of lidocaine in patch form into intact skin is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. Dose Adjustments: Hepatic: Severe hepatic dysfunction, use fewer patches, for shorter periods of time, and/or with longer treatment-free intervals Contraindications: Hypersensitivity Absorption: Only 3% of administered dose is absorbed through the skin. Common SEs: Skin Irritation, Somnolence Rare but Serious SEs: Cardiac Arrest, Cardiac Dysrhythmia, Seizure, Methemoglobinemia Efficacy Monitoring: Pain Relief Toxicity Monitoring: Application of too many patches, for too long a period of time, and/or without adequate drug-free period may increase toxicity; application to broken skin or covering with occlusive dressing may lead to toxicity, particularly cardiac dysrhythmia. Patient Counseling: Instruct patients on the appropriate application process. Leave patches on skin for no > 12 h within a 24-h period. Caution patients to administer only as directed, to intact skin, without covering with occlusive dressing or tight clothes. Clinical Pearls: Patches may be cut into smaller sizes prior to removal of release liner to refine dose to meet patients' needs. Patients should be instructed to fold used patches after removal so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Accidental ingestion of used patches can lead to serious adverse effects. Lidocaine also available in a wide range of other dosage forms, including topical ointments, lotions, gels and creams, injectables, and oral sprays and gels.

Gabapentin:

Brand: Neurontin, Gralise Drug Classes: Gamma Aminobutyric Acid, Anticonvulsant Dosage Forms and Strength Ranges: Oral Capsule: 100 mg, 300 mg, 400 mg; Oral Tablet: 300 mg, 600 mg, 800 mg; Oral Solution: 250 mg/5 mL, 300 mg/5 mL; Oral Tablet, Extended Release: 300 mg, 600 mg FDA Indications: Partial Seizure and Postherpetic Neuralgia MOA: Gabapentin is a cyclohexane compound that is structurally related to GABA; its mechanism of action is not known. Gabapentin does not interact with GABA receptors or alter the formation, release, degradation, or reuptake of GABA. Dose Adjustments: Renal: CrCl ≥60 mL/min, 900-3600 mg/d in 3 divided doses; CrCl 30-59 mL/min, 400-1400 mg/d in 2 divided doses; CrCl 15-29 mL/min, 200-700 mg/d given once daily Pregnancy Category: C Contraindications: Hypersensitivity Absorption: Food increases Absorption Beers Criteria: Avoid in certain circumstances Drug Interactions: Antacids (Separate administration by 2 h) Common SEs: Dizziness, Somnolence Rare but Serious SEs: Stevens-Johnson syndrome, suicidal thoughts Efficacy Monitoring Parameters: Resolution of FDA indications Toxicity Monitoring Parameters: Emergence or worsening of depression, suicidality, and/or any unusual behavioral or mood changes (anxiety, agitation, hostility, mania, and hypomania). Patient Counseling: First dose on 1st d should be taken at bedtime. ER formulation should be taken with the evening meal. Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness and somnolence. Report worsening depression, suicidal ideation, or unusual changes in behavior. Avoid sudden discontinuation of drug, as this may precipitate status epilepticus. Wait 2 h after antacid before taking gabapentin. Clinical Pearls: Use in renally compromised patients <12 y of age has not been studied. Dosage interval should not exceed 12 h. Gabapentin dose reductions, discontinuation, or substitutions with alternative medications should be performed gradually over a min 1 wk. Medication guide required at dispensing. Has been scheduled (C-V) in Kentucky and Michigan due to increasing recreational use. Under consideration for scheduling federally as well.

Progesterone:

Brand: Prometrium Drug Class: Progestin Hormone Dosage Forms & Strengths: Oral Capsule: 100 mg, 200 mg; Vaginal Gel: 4%, 8%; Vaginal Insert: 100 mg FDA Indications: 1. Prevention of estrogen-induced endometrial hyperplasia 2. Secondary physiologic amenorrhea 3. Assisted reproduction for infertile women MOA: Progesterone transforms proliferative endometrium into secretory endometrium. Parenterally administered progesterone inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation. Hepatic Dose Adjustment: Mild, moderate, lower dose; severe, avoid Absorption: Food Increases AUC Black Box Warnings: 1. CVD 2. Breast Cancer 3. Dementia Drug Interactions: CYP2C19, CYP3A4/5, Warfarin Common SEs: Weight ∆, Headache, Amenorrhea, Breast tenderness, Abdominal Pain Rare but Serious SEs: DVT, PE, OP Patient Counseling: 1. Menstrual bleeding should occur 3-7 d after last dose. 2. Report if menstruation does not occur within 7 d after last dose. 3. For vaginal formulation, avoid using other vaginal drugs within 6 h before or 6 h after using progesterone.

Eletriptan:

Brand: Relpax Drug Classes: Antimigraine Serotonin Receptor Agonist Dosage Forms and Strength Ranges: Oral Tablet: 20 mg, 40 mg FDA Indications: Migraine Usual Regimen: 20-40 mg po at onset of migraine, may repeat after 2 h prn; max single dose 40 mg, max daily dose 80 mg/d MOA: Eletriptan binds with high affinity to serotonin (5-HT) subtypes 1B, 1D, and 1F receptors. It has no significant affinity or pharmacological activity at adrenergic α1, α2, or β; dopaminergic D1 or D2; muscarinic; or opioid receptors. Serotonin receptor agonists are believed to be effective in migraine, either through vasoconstriction (via activation of 5-HT1 receptors located on intracranial blood vessels) or through activation of 5-HT1 receptors on sensory nerve endings in the trigeminal system, resulting in the inhibition of pro-inflammatory neuropeptide release. Dose Adjustments: Hepatic: Avoid in severe hepatic dysfunction Pregnancy Category: C Contraindications: Hypersensitivity to eletriptan, cerebrovascular syndromes, hemiplegic or basilar migraine, ischemic bowel disease, ischemic heart disease, peripheral vascular disease, severe hepatic impairment, uncontrolled hypertension Absorption: high-fat food increases bioavailability Drug Interactions: SSRIs, CYP3A4/5 Inducers and Inhibitors, Duplicate Therapies Common SE: Weakness Rare but Serious SEs: Angina, cardiac dysrhythmia, coronary arteriosclerosis, heart block, hypertension, acute myocardial infarction, aphasia, cerebral ischemia, stroke, dystonia, hemiplegia, neuropathy, transient ischemic attack, oculogyric crisis Efficacy Monitoring Parameters: Resolution Toxicity Monitoring Parameters: Seek medical attention for signs of ischemic bowel disease (eg, sudden severe abdominal pain, bloody diarrhea) or peripheral vascular disease (eg, Raynaud syndrome), serotonin syndrome (eg, agitation, hallucinations, tachycardia, hyperreflexia, incoordination, diarrhea, nausea), ischemic cardiac syndrome, or hypertensive crisis. Patient Counseling: Should avoid activities requiring mental alertness or coordination until drug effects are realized, as this drug may cause dizziness or somnolence. Clinical Pearls: These agents are not for prophylaxis—these are used for the treatment of acute migraine headache. Several serotonin agonists ("triptans") exist for migraine, administered via a variety of routes (oral, inhaled, injected). Each differs in onset and duration of action. If an agent is ineffective at max dose, recommend changing agents or route. Instruct patient to take a 2nd dose ≥2 h after the 1st if needed, but no >80 mg/d. Overuse of acute migraine medications can lead to medication overuse headache which may present similarly to migraine; may require detoxification including management of withdrawal symptoms.

Tamsulosin:

Brand: Flomax Class: α1-Adrenergic Blocker Oral Capsule: 0.4 mg FDA Indication: Benign prostatic hyperplasia: 0.4 mg po daily, may titrate to 0.8 mg po daily MOA: Tamsulosin is closely related to quinazoline derivatives that selectively block postsynaptic α1-adrenergic receptors. Total peripheral resistance is reduced through arterial and venous dilations. Reflex tachycardia that occurs with other vasodilators is infrequent because there is no presynaptic α2-receptor blockade. The drugs also decrease total cholesterol, increase HDL-cholesterol, and may improve glucose tolerance and reduce left ventricular mass during long-term therapy. They increase urine flow in BPH by relaxing smooth muscle tone in the bladder neck and prostate. Contraindications: Hypersensitivity Drug Interactions: Alpha-1 blockers, BBs, CCBs, MAOIs, CYP3A4/5, CYP2D6 Common SEs: Dizziness, HA, Abnormal Ejaculation, Rhinitis Rare but Serious SEs: Retinal Detachment, Priapism Patient Counseling: Administer 30 min after same meal daily as fasting increases bioavailability by 30%. Patient should avoid activities requiring coordination until drug effects are realized, as drug may cause vertigo or dizziness. Tell patient to rise slowly from a sitting/lying position, as this drug may cause orthostatic hypotension. Caution patient that syncope or loss of consciousness is possible with 1st dose or dose increases, especially if patient is in an upright position. Clinical Pearls: Alpha-blockers commonly used for hypertension. Patients with both hypertension and BPH should avoid taking other α-adrenergic blocking agents while taking this drug. Tamsulosin is not indicated for hypertension.

Sildenafil:

Brand: Viagra, Revatio Drug Classes: Erectile Dysfunction Agent and Pulmonary Hypertension Agent Dosage Forms and Strength Ranges: Oral Tablet: 20-100 mg; Oral Suspension: 10 mg/mL FDA Indications: Erectile Dysfunction, Pulmonary HTN MOA: Inhibition of phosphodiesterase type 5 (PDE5) by sildenafil increases the amount of cyclic guanosine monophosphate (GMP) enhancing erectile function and pulmonary vasculature relaxation. Penile erection during sexual stimulation is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cyclic GMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum and vasodilation in the pulmonary bed. Dose Adjustments: Hepatic: Avoid use in severe liver disease; Renal: CrCl <30 mL/min: 25 mg po if used for ED. Not required for pulmonary artery hypertension (PAH) Contraindications: Hypersensitivity, Concurrent nitrates, Concurrent guanylate cyclase stimulators, Concurrent HIV protease inhibitors when used for treating pulmonary hypertension Drug Interactions: CYP3A4/5 inducers/inhibitors, α-Adrenergic agents, Nitrates, Protease Inhibitors Common SEs: Flushing, Nausea, Headache, Visual disturbances, Lack of blue/green color discrimination Rare but Serious SEs: MI, Seizures, Strokes, Sudden hearing loss, Priapism Toxicity Monitoring Parameters: Seek medical attention if severe skin rash, chest pain, erection lasting > 4 h, tinnitus, dizziness, or shortness of breath. Patient Counseling: Take 30 min-4 h prior to anticipated sexual activity, but do not take more frequently than once q24h.

Colchicine:

Brands: Colcrys, Gloperba, Mitigare Drug Class: Anti-Gout Dosing Form and Strength: Oral Tablet/Capsule/Solution: 0.6 mg FDA Indications: Gout (acute & prevention), Familial Mediterranean Fever MOA: Exact mechanism unknown. In patients with gout, may interrupt the cycle of monosodium urate crystal deposition in joint tissues and the resultant inflammatory response that initiates and sustains an acute attack. Colchicine also inhibits urate crystal deposition, which is enhanced by a low pH in the tissues, probably by inhibiting oxidation of glucose and subsequent lactic acid production in leukocytes. Dose Adjustments: Hepatic: Severe hepatic failure, for gout flare do not repeat courses > once every 2 wk Renal: CrCl <30 mL/min, for gout flare, do not repeat course > once every 2 wk Pregnancy Category: C Contraindications: Hypersensitivity to colchicine; concurrent use with strong CYP3A4/5 inhibitors in patients with renal or hepatic failure Absorption: Not affected by food. Drug Interactions: Fibrates, Statins, CYP3A4/5 & P-Glycoprotein Inducers/Inhibitors Common SEs: Diarrhea and Nausea Rare but Serious SEs: Agranulocytosis and Rhabdomyolysis Efficacy Monitoring: Resolution of Gout symptoms Toxicity Monitoring: CBC, alkaline phosphatase at baseline and periodically during treatment. Instruct patients to discontinue the medication immediately and seek medical attention if signs and symptoms of agranulocytosis (severe neutropenia), or myotoxicity (including rhabdomyolysis). Monitor renal and hepatic function. Patient Counseling: Instruct patient on appropriate dosing strategy for gout flares (dosing to symptom relief or onset of adverse effects, particularly diarrhea). Clinical Pearls: Colchicine is a natural alkaloid found in plants such as the autumn crocus (Colchicum autumnale) and glory lily (Gloriosa superba). Medication guide required with dispensing.

Buprenorphine/Naloxone:

Brands: Bunavail, Suboxone, Zubsolv Drug Classes: Opioid Partial Agonist (Buprenorphine) and Antagonist (Naloxone) Dosage Forms and Strength Ranges: Sublingual Film, SL Tablet, Buccal Film FDA Indication: Opioid dependence MOA: Buprenorphine is a µ-opioid receptor partial agonist and a κ-opioid receptor antagonist. Naloxone is a µ-opioid receptor antagonist that causes opioid withdrawal when injected parenterally and is included in the formulation to reduce the risk of abuse. Dose Adjustments: Hepatic: Use with Caution Contraindications: Hypersensitivity Drug Interactions: CNS Depressants, Duplicate therapies, CYP3A4/5 inducers/inhibitors Common SEs: Vasodilation, sweating, headaches, insomnia, constipation, GI distress, opioid withdrawal, dizziness Rare but Serious SEs: SJS, Dependence, Tolerance, Elevated LFTs, Seizures Patient Counseling: Use a stool softener and/or laxative for preventing constipation. May cause drowsiness; avoid driving or other tasks requiring motor coordination. Avoid alcohol and other CNS depressants. Do not crush or swallow the sublingual tablet. Place the tablet under the tongue until it is dissolved. If you take ≥2 tablets at a time, place all of the tablets under the tongue together. If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all tablets have been taken. If you are using the sublingual film, place the film under the tongue until it is dissolved. If you need to take an additional film, place the new film on the opposite side from the first film. Do not chew, swallow, or move the film after placing it under the tongue. If using the buccal film, press and hold film to moistened cheek for 5 s with finger. If you need an additional film, place on the inside of other cheek. Do not use >2 buccal films simultaneously. Clinical Pearls: Monitor for signs of diversion; case reports exist of users crushing or dissolving various formulations of buprenorphine/naloxone. Taking opioids will result in precipitation of withdrawal symptoms. The opioid agonist properties of buprenorphine are limited by a ceiling effect which occurs at higher doses. The strength of sublingual films and tablets are not interchangeable. For example, one 8 mg film is not equivalent to 4 films of 2 mg each. Do not substitute multiple smaller dose films to equal a larger dose. Recommended as a component of therapy including counseling and psychosocial support. Not recommended for treatment of dependence on long-acting opiates or methadone; useful for withdrawal of short-acting opiates and heroin. Both naloxone and buprenorphine are available as separate agents in a wide range of formulations. Under REMS program requirements.

Docusate

Colace Stool softener 50-250 mg Indications: Constipation MOA: Anionic surfactant that stimulates intestinal secretions Common SEs: Abdominal Cramps, Bitter taste RBS SEs: None TC: Refer to HCP if sudden change in BM lasting > 14 days or has needed the laxative for > 7 consecutive days PC: Lifestyle modifications first, then laxatives; may require several days (1-3 d) of treatment CP: Does not stimulate, just reduces strain. May be combined w/ laxatives. Docusate + a stimulant laxative (dulcolax or senna) is the treatment of choice for patients experiencing constipation from opioids. Docusate is the laxative of choice for patients after surgery.

Prochlorperazine

Compazine Phenothiazine 5-25 mg FDA Indications: N/V, Anxiety (Non-Psychotic) MOA: D2 Antagonism Pregnancy Category C BBW: Mortality in elderly dementia patients Beers: Highly anticholinergic DIs: QTC prolongation, CNS Depressants, Dopamine agonists, MAOIs Common SE: Somnolence RBS SEs: Respiratory depression, all sedating type stuff PC: sedating CP: FDA approved for schizophrenia, seldom used.

Interval/Ratio Data aka...

Continuous Data

When selecting the most appropriate statistical test, what variable is evaluated?

Dependent Variable

A study compared rates of clinical cure in patients receiving metronidazole versus vancomycin therapy for the treatment of C. diff diarrhea. What is the Dependent Variable? What level is this Dependent Variable?

Dependent Variable: Cure: (resolution of diarrhea and stool that is negative for toxin) What Level? Nominal

deslansoprazole (___________)

Dexilant; Indications: Erosive Espophagitis and GERD Beers: Avoid scheduled use for more than 8 weeks Rare but Serious SE: SJS, Rhabdo, SLE PC: May be taken w/o regards to meals; do NOT take with Antacids Clinical Pearls: Med guide required at dispensing. Unlike Lansoprazole, Deslansoprazole does NOT interact with Clopidogrel.

Dimenhydrinate

Dramamine Classes: Antihistamine and Antiemetic 50 mg Indications: Motion Sickness MOA: dual salt that inhibits vestibular system by competing w/ histamine for H1 receptor sites on effector cells in the GI tract to ultimately block CTZ Pregnancy Category B Warnings: Patients w/ Asthma, glaucoma, etc DIs: CNS Depressants, Anticholinergics Common SEs: Dizziness, Drowsiness, nervousness RBS SEs: Hypersensitivity, Rash, Dysuria PC: Sedating CP: Take 30-60 min before travel.

Senna

Ex-Lax, Senokot Stimulant Laxative 8.6-25 mg Indication: Constipation MOA: direct action on intestinal mucosa by increasing rate of colonic motility, enhancing transit, and inhibiting water and electrolyte secretion. May be stool softening Common SEs: Abdominal cramps, urine discoloration RBS SEs: Electrolyte/Fluid Imbalance, Metabolic Acidosis/alkalosis, HYPOcalcemia TC: Suddem ∆ in BM for nmt 14 d, or nmt 7 d w/ laxative *refer to HCP PC: Lifestyles mods first, then senna as 2nd line. Generally administered at bedtime for BM in the AM CP: Produces BM within 6-12 hrs; chocolate forms pose risk in children consumption.

Ibuprofen:

FDA Indications: Fever, Headache, OA, RA, Juvenile Osteoarthritis MOA: Nonselective inhibitor of cyclo-oxygenase-1 (COX-1) and cyclo-oxygenase-2 (COX-2), and reversibly alters platelet function and prolongs bleeding time. Dose Adjustments: RENAL: Avoid in patients w/ severe renal dysfunction Pregnancy Categories: C (1st and 2nd trimesters); D (3rd trimester) Contraindications: Hypersensitivity to ibuprofen; concurrent use with ketorolac or pentoxifylline; asthma, urticaria, or allergic-type reaction following aspirin or other NSAID administration; CABG surgery, treatment of perioperative pain BBW: Cardiovascular Events, GI Toxicity, CABG Beers Criteria: Avoid Chronic Use Drug Interactions: Aspirin, LMWH, SSRIs, ACE-I, ARBs, Diuretics, Cyclosporine, Tacrolimus, Lithium, Ketorolac, Pentoxifylline, WARFARIN, Sulfonylureas Common SEs: None Less Common SEs: Edema, itching, rash, GI distress, dizziness, tinnitus, ototoxicity Rare but Serious SEs: Stevens-Johnson syndrome, GI bleeding, thrombosis, elevated liver functions, acute renal failure, congestive heart failure, aplastic anemia Clinical Pearls: Elderly patients are at increased risk of GI ulceration. NSAIDs are associated with an increased risk of adverse cardiovascular thrombotic events, including fatal MI and stroke. Use the lowest effective dose for the shortest possible duration; after observing initial response, adjust dose and frequency to meet individual patient's needs. NSAIDs are also associated with renal adverse events, especially in patients with preexisting CKD, nephrotic syndrome, liver disease, and patients who are volume depleted. Various OTC ibuprofen products are available; caution patients not to duplicate dosing with multiple ibuprofen products. Medication guide required at dispensing.

Sodium Phosphate Enema

Fleet Enema Class: Laxative Indication: Constipation MOA: Sodium phosphate causes osmotic retention of fluid, distending the colon, and increases peristaltic activity Common SE: Bloating, cramping, nausea, vomiting, ab pain RBS SEs: Electrolyte/fluid imbalance TC: Suddem ∆ in BM for nmt 14 d, or nmt 7 d w/ laxative *refer to HCP PC: NMT 1 enema per day CP: Produces BM within 3-5 min; oral use is strongly discouraged.

Simethicone

Gas-X, Mylicon Class: Antigas 80-180 mg Indications: Gas Relief MOA: antifoaming activity that alters the surface tension of gas bubbles. No known drug interactions CSEs: Diarrhea, Heartburn, Flatulence PC: Take AFTER meals CP: Can be used safely in newborns and infants. Simethicone does NOT reduce or prevent the formation of gas in the GI tract, rather it hastens its exit.

Polyethylene Glycol

Golytely (RX) Miralax (OTC) HYPERosmotic laxative 100-420 g FDA Indications: Colonoscopy, barium enema prep, Constipation MOA: induces catharsis by unabsorbed sulfate salts and PEG Pregnancy Category C DIs: Potassium supplements, Potassium Sparing Diuretics, ACE-Inhibitors Common SEs: Anal irritation, bloating, epigastric fullness, nausea, stomach cramps, vomiting RBS SEs: Anaphylaxis, dehydration, seizures Efficacy MP: BM should begin within 60 min of administration and should continue until rectal effluent is clear PC: Shake container vigorously to dissolve completely; avoid solid foods 3-4 hours prior to treatment. CP: Drink each portion rapidly, don't sip nor add ice.

GA General Assembly (2020): Makes significant improvements to the Pharmacy Audit Bill of Rights of 2019:

HB 918

GA General Assembly (2020): Prohibits pharmacies affiliated with PBMs from filling and billing for prescriptions that are illegally referred:

HB 918

GA General Assembly (2020): Prohibits recoupment from a pharmacy except in cases of fraud, overpayment (limited to the amount overpaid), and misfill:

HB 918

GA General Assembly (2020): Provides that a PBM shall not audit a pharmacy more than once every 6 months and increased the period of time to correct a clerical error from 20 days to 60 days:

HB 918

GA General Assembly (2020): Provides that when a patient receives the correct drug in the correct dosage and quantity pursuant to a prescription drug order than no misfill shall be found to have occurred:

HB 918

GA General Assembly (2020): Removes certain exemptions and loopholes related to the steering of patients:

HB 918

GA General Assembly (2020): Strengthens the Pharmacy Anti-Steering and Transparency Act of 2019:

HB 918

GA General Assembly (2020): Prohibits PBMs from basing reimbursement of a drug on patient scores or outcomes:

HB 946 and SB 313

GA General Assembly (2020): Prohibits PBMs from imposing point of sale or retroactive fees:

HB 946 and SB 313

GA General Assembly (2020): Provides the Insurance Commissioner with the authority to suspend PBM licenses for violation of the law:

HB 946 and SB 313

GA General Assembly (2020): Represents a comprehensive re-write of Georgia's PBM Code Section:

HB 946 and SB 313

GA General Assembly (2020): Requires PBMs to make their records available to the Insurance Commissioner:

HB 946 and SB 313

GA General Assembly (2020): Strengthens the ability of retail pharmacies to provide delivery services to their patients:

HB 946 and SB 313

GA General Assembly (2020): Strengthens the prohibition of patient steering:

HB 946 and SB 313

GA General Assembly (2020): Requires the Georgia Department of Community Health (DCH) to engage a Medicaid actuary to conduct a study on the potential savings from carving out pharmacy prescription benefits from the Medicaid managed care program:

HB 947

GA General Assembly (2020): Ensures that an oversight committee has broad access to plan records: