1. Pharmacology Overview by Drug Class Jeff Fortner, Pharm.D. Pacific University School of Pharmacy

2. Learning Objectives Recognize frequently prescribed drugs Recognize frequently prescribed drugs Identify brand/generic names, drug families, common indications, and common side effects Identify brand/generic names, drug families, common indications, and common side effects Describe some legal issues with OTCs and prescription drugs (federal and state) Describe some legal issues with OTCs and prescription drugs (federal and state)

3. How a drug goes to market FDA estimates average time for drug approval is 8.5 years Patents last 20 years Exclusivity, lasts 3-7 years, designed by FDA to promote balance between new drug innovation and generic competition. Certain drugs can be fast-tracked if there is a great need http://www.fda.gov/cder/handbook/develop.htm

4. Gastrointestinal: Acid Reducers “Acid Reducers all OTC?” Switched to OTC when “safe without MD advice” Switched to OTC when “safe without MD advice” Long term or short term use Long term or short term use Know when to seek medical attention Know when to seek medical attention

5. Gastrointestinal: Acid Reducers Proton Pump Inhibitors Proton Pump Inhibitors Omeprazole = Prilosec OTC Omeprazole = Prilosec OTC Lansoprazole = Prevacid Lansoprazole = Prevacid Pantoprazole = Protonix Pantoprazole = Protonix Esomeprazole = Nexium Esomeprazole = Nexium Rabeprazole = AcipHex Rabeprazole = AcipHex H 2 Receptor antagonists H 2 Receptor antagonists Ranitidine = Zantac OTC Ranitidine = Zantac OTC Famotidine = Pepcid OTC Famotidine = Pepcid OTC Side Effects Side Effects rare rare

6. Cardiovascular: Statins “What statin are you taking?” Highest use drugs Highest use drugs Diet control should accompany drug therapy Diet control should accompany drug therapy Debatable difference between drugs BUT switch if not effective Debatable difference between drugs BUT switch if not effective Expect long term use Expect long term use

7. Cardiovascular: “statins” Cholesterol Lowering Cholesterol Lowering Atorvastatin = Lipitor Atorvastatin = Lipitor Fluvastatin = Lescol Fluvastatin = Lescol Lovastatin = Mevacor Lovastatin = Mevacor Simvastatin = Zocor Simvastatin = Zocor Pravastatin = Pravachol Pravastatin = Pravachol Rosuvastatin = Crestor Rosuvastatin = Crestor Side Effects: Side Effects: few overall, muscle aches, weakness few overall, muscle aches, weakness

8. Cardiovascular: Beta blockers “Look, one more use for beta- blockers” Don’t stop taking abruptly Don’t stop taking abruptly Watch for low blood pressure symptoms (dizziness) Watch for low blood pressure symptoms (dizziness) Can decrease sexual ability Can decrease sexual ability Other uses: performance anxiety, essential tremor, Raynaud’s syndrome, migraine prophylaxis, esophagus bleeding in ESLD Other uses: performance anxiety, essential tremor, Raynaud’s syndrome, migraine prophylaxis, esophagus bleeding in ESLD

9. Cardiovascular: Beta Blockers, “olols” Hypertension (high blood pressure), Arrhythmias, Heart Failure, MI (Myocardial Infarction), etc. Hypertension (high blood pressure), Arrhythmias, Heart Failure, MI (Myocardial Infarction), etc. Metoprolol = Toprol XL, Lopressor Metoprolol = Toprol XL, Lopressor Atenolol = Tenormin Atenolol = Tenormin Propranolol = Inderal Propranolol = Inderal Carvedilol = Coreg Carvedilol = Coreg

10. Cardiovascular: “Heart-ache” drugs Digitalis: Heart Failure, A-fib Digitalis: Heart Failure, A-fib Digoxin = Lanoxin Digoxin = Lanoxin Side effects: Dose dependent, nausea Side effects: Dose dependent, nausea Nitrates: Angina Nitrates: Angina Isosorbide Mononitrate = Imdur Isosorbide Mononitrate = Imdur Nitroglycerin sublingual tablets Nitroglycerin sublingual tablets Side effects: headache but can adapt Side effects: headache but can adapt Refill every 6 months - 1 year Refill every 6 months - 1 year

11. Cardiovascular: Anticoagulants “When to clot and when to not…” Hold prior to surgery then bridge therapy with low-molecular weight heparin Hold prior to surgery then bridge therapy with low-molecular weight heparin Too much warfarin = Vitamin K Too much warfarin = Vitamin K Monitoring is vital to safety Monitoring is vital to safety Avoid the term “blood thinner” Avoid the term “blood thinner”

12. Cardiovascular: Anticoagulants Use: blood clot prevention or decrease further development Use: blood clot prevention or decrease further development Warfarin = Coumadin Warfarin = Coumadin Clopidogrel = Plavix Clopidogrel = Plavix Side effects: Side effects: signs of bleeding/bruising signs of bleeding/bruising Diet should be consistent regarding vitamin K content Diet should be consistent regarding vitamin K content

13. Cardiovascular: Diuretics “Latest study says add diuretics…” Dramatic increase in use of inexpensive drugs Dramatic increase in use of inexpensive drugs Effective to decrease blood volume and hence the pressure Effective to decrease blood volume and hence the pressure

14. Cardiovascular: Diuretics Decrease excess inside water Decrease excess inside water Hydrochlorothiazide = HCTZ, Hydrodiurel Hydrochlorothiazide = HCTZ, Hydrodiurel Furosemide = Lasix Furosemide = Lasix Triamterene/HCTZ= Maxzide, Dyazide Triamterene/HCTZ= Maxzide, Dyazide Side effects: Side effects: Nausea, photosensitivity, dizziness Nausea, photosensitivity, dizziness Low blood pressure Low blood pressure

15. Cardiovascular: ACE-I and ARBs Angiotensin constricts blood vessels Angiotensin constricts blood vessels ACE-Inhibitors = “-prils” ACE-Inhibitors = “-prils” Captopril = Capoten Enalapril = Vasotec Captopril = Capoten Enalapril = Vasotec Lisinopril = Zestril/Prinivil Ramipril = Altace Lisinopril = Zestril/Prinivil Ramipril = Altace Quinapril = Accupril Benazepril = Lotensin Quinapril = Accupril Benazepril = Lotensin Fosinopril = Monopril Trandolapil = Mavik Fosinopril = Monopril Trandolapil = Mavik Perindopril = Aceon Moexipril = Univasc Perindopril = Aceon Moexipril = Univasc Side effects Side effects Cough, swollen tongue/lips, increased K+ Cough, swollen tongue/lips, increased K+

16. Cardiovascular: ACE-I and ARBs Angiotensin Receptor Blockers (ARBs) Angiotensin Receptor Blockers (ARBs) Losartan = Cozaar Losartan = Cozaar Valsartan = Diovan Valsartan = Diovan Candesartan = Atacand Candesartan = Atacand Irbesartan = Avapro Irbesartan = Avapro Olmesartan = Benicar Olmesartan = Benicar Telmisartan = Micardis Telmisartan = Micardis Eprosartan = Teveten Eprosartan = Teveten Side effects Side effects Increased K+, little/no cough or angioedema Increased K+, little/no cough or angioedema

17. Cardiovascular: ACE-I and ARBs Uses Uses Diabetes - prevent progression to chronic kidney disease Diabetes - prevent progression to chronic kidney disease Heart failure - decreased stiffening of heart muscle Heart failure - decreased stiffening of heart muscle Hypertension Hypertension

18. Cardiovascular: Hypertension “I feel fine, why treat high blood pressure?” Cardiovascular: Hypertension “I feel fine, why treat high blood pressure?” Check blood pressure frequently Check blood pressure frequently Device accuracy: Arm cuff vs. finger device Device accuracy: Arm cuff vs. finger device When to contact the physician When to contact the physician

19. Cardiovascular: Hypertension High Blood Pressure: High Blood Pressure: Clonidine = Catapres Clonidine = Catapres Doxazosin = Cardura Doxazosin = Cardura Amlodipine/Benazepril = Lotrel Amlodipine/Benazepril = Lotrel Side effects: Side effects: dizziness, headache dizziness, headache

20. Respiratory: Allergies Antihistamines Antihistamines Cetirizine = Zyrtec OTC Cetirizine = Zyrtec OTC Fexofenadine = Allegra Fexofenadine = Allegra Loratadine = Claritin OTC Loratadine = Claritin OTC Side Effects Side Effects Drowsiness or stimulant Drowsiness or stimulant

21. Respiratory: “Allergies/Cold Sxs: What works?” Combinations with pseudoephedrine? Combinations with pseudoephedrine? Combinations with phenylephrine? Combinations with phenylephrine? Combinations with dextromethorphan effective? Combinations with dextromethorphan effective? Chicken soup, water and rest? Chicken soup, water and rest? Hot Toddy? Hot Toddy?

22. Pseudoephedrine scoop Effective decongestant Effective decongestant Schedule III in Oregon Schedule III in Oregon All “EPP” products restricted by federal law Why? Precursor to methamphetamine All “EPP” products restricted by federal law Why? Precursor to methamphetamine Ephedrine Ephedrine No longer marketed No longer marketed Phenylpropanolamine (PPA) Phenylpropanolamine (PPA) No longer marketed No longer marketed FDA proposed final rule to place PPA in Category III (not approved for use) regarding OTC products FDA proposed final rule to place PPA in Category III (not approved for use) regarding OTC products Pseudoephedrine Pseudoephedrine Limited access by federal law Limited access by federal law

23. Respiratory: Allergies Nasal Corticosteroids Nasal Corticosteroids Fluticasone = Flonase Fluticasone = Flonase Mometasone = Nasonex Mometasone = Nasonex Side Effects Side Effects Headache, bloody nose Headache, bloody nose Concern regarding long term use? Concern regarding long term use?

24. Respiratory: Asthma Inhalers “Rescue” “Rescue” Albuterol = Proair, Proventil Albuterol = Proair, Proventil Side effects: Side effects: Increased heart rate, “jittery” Increased heart rate, “jittery” “Controllers” “Controllers” Fluticasone/Salmeterol = Advair Diskus Fluticasone/Salmeterol = Advair Diskus Side effects: Side effects: Headache Headache Thrush, voice changes Thrush, voice changes Aero Chamber device for accurate administration Aero Chamber device for accurate administration

25. Respiratory: Asthma Oral Medications Corticosteroids Corticosteroids Prednisone Prednisone Methylprednisolone Methylprednisolone Side effects: Side effects: Insomnia, nervousness Insomnia, nervousness Nausea: Take With Food Nausea: Take With Food Long term use concern Long term use concern Montelukast = Singulair Montelukast = Singulair Side effects: rare Side effects: rare

26. Antibiotics: “The latest is the b est! I want that one!” Side effects: Side effects: Diarrhea Diarrhea Nausea Nausea Yeast infections Yeast infections Tips: Tips: New drug isn’t always best New drug isn’t always best Resistance is inevitable--- but we can delay it Resistance is inevitable--- but we can delay it Take until gone Take until gone With or w/o food variable With or w/o food variable

27. Antibiotics: Penicillins & their relatives Penicillin VK Penicillin VK Amoxicillin = Trimox Amoxicillin = Trimox Amoxicillin/Clavulanate = Augmentin Amoxicillin/Clavulanate = Augmentin Cephalexin = Keflex Cephalexin = Keflex Cautions: Cross-sensitivities and allergies Cautions: Cross-sensitivities and allergies Can still be very effective even though “old drugs” Can still be very effective even though “old drugs”

28. Antibiotics: Azithromycin = Zithromax Azithromycin = Zithromax Doxycycline Doxycycline Cautions: Cautions: Do not take with milk, antacids Do not take with milk, antacids Sun sensitivity Sun sensitivity Trimethoprim/sulfamethoxazole = Cotrim, Septra, Bactrim Trimethoprim/sulfamethoxazole = Cotrim, Septra, Bactrim Cautions: Sun sensitivity, Increase fluid intake, allergies Cautions: Sun sensitivity, Increase fluid intake, allergies

29. Antibiotics: Quinolones Ciprofloxacin = Cipro Ciprofloxacin = Cipro Levofloxacin = Levaquin Levofloxacin = Levaquin Cautions: Cautions: Do not take with milk, antacids Do not take with milk, antacids Sun sensitivity Sun sensitivity Moxifloxacin = Avelox Moxifloxacin = Avelox Cautions: Cautions: Do not take with milk, antacids Do not take with milk, antacids Sun sensitivity Sun sensitivity

30. CNS: Antidepressants “Let’s add them to the water” Frequently prescribed Frequently prescribed Long term or short term use Long term or short term use Time to effect Time to effect Switch to another if not effective Switch to another if not effective Often taper off drug Often taper off drug Okay for adolescents? Okay for adolescents? Suicidal ideology? Suicidal ideology?

31. “Antidepressants a Suicide Risk for Young Adults Study Says Cases Double for Those 18 to 25 Using Medicine to Control Depression” Black box warning 2004 Black box warning 2004 Washington Post 2006 Washington Post 2006 FDA investigations 2007 FDA investigations 2007 Pediatric studies lacking Pediatric studies lacking

32. CNS: Antidepressants SSRIs SSRIs Fluoxetine = Prozac Fluoxetine = Prozac Sertraline = Zoloft Sertraline = Zoloft Paroxetine = Paxil, Paxil CR Paroxetine = Paxil, Paxil CR Citalopram = Celexa Citalopram = Celexa Escitalopram = Lexapro Escitalopram = Lexapro Side effects: Side effects: headache, nausea, insomnia or somnolence headache, nausea, insomnia or somnolence

33. CNS: Antidepressants TCAs TCAs Amitriptyline = Elavil Amitriptyline = Elavil Side effects: sedation, dry mouth Side effects: sedation, dry mouth “Other” types “Other” types Bupropion = Wellbutrin, Wellbutrin XL Bupropion = Wellbutrin, Wellbutrin XL Venlafaxine = Effexor, Effexor XR Venlafaxine = Effexor, Effexor XR Trazodone = Deseryl Trazodone = Deseryl Side effects: dizziness, drowsiness Side effects: dizziness, drowsiness

34. CNS: Antianxiety and/or Insomnia “Popular” drugs “Popular” drugs Half-life varies Half-life varies Long - Diazepam Long - Diazepam Short - Triazolam Short - Triazolam Infrequent use extends effectiveness Infrequent use extends effectiveness Caution in elderly Caution in elderly

35. CNS: Antianxiety and/or Insomnia Benzodiazepines Benzodiazepines Lorazepam = Ativan Lorazepam = Ativan Clonazepam = Klonipin Clonazepam = Klonipin Diazepam = Valium Diazepam = Valium Temazepam = Restoril Temazepam = Restoril Alprazolam = Xanax Alprazolam = Xanax Side effects: drowsiness Side effects: drowsiness Insomnia Insomnia Zolpidem = Ambien Zolpidem = Ambien Side effects: headache Side effects: headache

36. CNS: Insomnia Ambien and it’s interesting side effects Sleepwalking Sleepwalking Binge eating at night Binge eating at night Nightmares Nightmares How to interpret and advise patients: Take pill as you get into bed. How to interpret and advise patients: Take pill as you get into bed.

37. Questions?

38. Endocrine: Osteoporosis Alendronate = Fosamax Alendronate = Fosamax Risedronate = Actonel Risedronate = Actonel Side Effects: Side Effects: Esophagitis, Nausea Esophagitis, Nausea Once weekly dosing possible Once weekly dosing possible Raloxifene = Evista Raloxifene = Evista Side Effects: Side Effects: Hot flashes, Nausea Hot flashes, Nausea

39. CNS Antipsychotics Antipsychotics Risperidone = Risperdal Risperidone = Risperdal Side effects: agitation, insomnia Side effects: agitation, insomnia Don’t stop abruptly Don’t stop abruptly Aripiprazole = Abilify Aripiprazole = Abilify Side effects: akathisia, HA, weakness Side effects: akathisia, HA, weakness Don’t confuse with PPI’s which also end in “- prazole” Don’t confuse with PPI’s which also end in “- prazole”

40. CNS Anticonvulsant Anticonvulsant Gabapentin = Neurontin Gabapentin = Neurontin Side effects: dizziness, fatigue, nausea Side effects: dizziness, fatigue, nausea Used for nerve pain, etc Used for nerve pain, etc Pregabalin = Lyrica Pregabalin = Lyrica Approved for fibromyalgia! Approved for fibromyalgia! Phenytoin = Dilantin Phenytoin = Dilantin Side effects: gingival hyperplasia Side effects: gingival hyperplasia Important to monitor drug levels Important to monitor drug levels

41. Analgesic: Anti-inflammatory Ibuprofen = Motrin, Advil OTC Ibuprofen = Motrin, Advil OTC Naproxen = Naprosyn, Anaprox OTC Naproxen = Naprosyn, Anaprox OTC Side Effects: Side Effects: GI = take with food GI = take with food Dizziness? Dizziness? Caution with warfarin, history of ulcer/GERD Caution with warfarin, history of ulcer/GERD

42. Analgesic: Anti-inflammatory “The next generation or off the market?” Celecoxib = Celebrex Celecoxib = Celebrex Side Effects: Side Effects: GI (less)= take with food GI (less)= take with food Vioxx = Rofecoxib (09/04 off market) Vioxx = Rofecoxib (09/04 off market) Bextra = Valdecoxib (04/05 off market) Bextra = Valdecoxib (04/05 off market)

43. Analgesic: Muscle Relaxants Cyclobenzaprine = Flexeril Cyclobenzaprine = Flexeril Effectiveness vs. gorkiness Effectiveness vs. gorkiness Carisoprodol = Soma Carisoprodol = Soma Schedule IV in Oregon Schedule IV in Oregon Side Effects: Side Effects: Dizziness, Drowsiness Dizziness, Drowsiness Dependence? Should it be a Scheduled drug? Dependence? Should it be a Scheduled drug? Do not take with alcohol Do not take with alcohol

44. Controlled Substances Schedules I - High potential for abuse and/or no medical use I - High potential for abuse and/or no medical use Heroin, LSD, mescaline Heroin, LSD, mescaline II - Highest potential for abuse with medical use II - Highest potential for abuse with medical use Opiate (eg, meperidine, codeine, morphine, oxycodone, methadone, cocaine) Opiate (eg, meperidine, codeine, morphine, oxycodone, methadone, cocaine) Non-opiate stimulants (eg, methylphenidate, amphetamine, phenmetrazine, methamphetamine) Non-opiate stimulants (eg, methylphenidate, amphetamine, phenmetrazine, methamphetamine) Non-opiate depressants (eg, barbiturates, methaqualone) Non-opiate depressants (eg, barbiturates, methaqualone)

45. CS Schedules - continued III - Narcotic combinations and others III - Narcotic combinations and others Up to 90 mg codeine per dose plus other active ingredients Up to 90 mg codeine per dose plus other active ingredients Hydrocodone plus APAP Hydrocodone plus APAP Doriden (glutethimide) Doriden (glutethimide) Anabolic steroids (eg, methyltestosterone) Anabolic steroids (eg, methyltestosterone) Benzphetamine and phendimetrazine (Didex) Benzphetamine and phendimetrazine (Didex) Barbiturate suppositories Barbiturate suppositories Barbiturate combos (eg, Fiorinal, Fioricet with Codeine) Barbiturate combos (eg, Fiorinal, Fioricet with Codeine) Marinol Marinol Ephedrine, Pseudoephedrine, Phenylpropanolamine in Oregon Ephedrine, Pseudoephedrine, Phenylpropanolamine in Oregon

46. CSA Schedules - continued IV - Primarily non-narcotics IV - Primarily non-narcotics Benzodiazepines (eg, Valium, Halcion) Benzodiazepines (eg, Valium, Halcion) Meprobamate Meprobamate Phenobarbital Phenobarbital Chloral hydrate Chloral hydrate Phentermine, mazindol, diethylpropion Phentermine, mazindol, diethylpropion Propoxyphene dosage forms (powder = CII) Propoxyphene dosage forms (powder = CII) Dichloralphenazone (component of Midrin®) 9/01 Dichloralphenazone (component of Midrin®) 9/01 Carisoprodol in OR Carisoprodol in OR

47. CSA Schedules - continued V - “Exempt narcotics” V - “Exempt narcotics” Low dose combinations of codeine with other ingredients for diarrhea, pain, or cough -- some may be sold OTC in other states Low dose combinations of codeine with other ingredients for diarrhea, pain, or cough -- some may be sold OTC in other states Diphenoxylate with atropine Diphenoxylate with atropine Generally no more than 10 mg codeine per 5 mL (Tylenol w/ Codeine 12 mg/5mL) Generally no more than 10 mg codeine per 5 mL (Tylenol w/ Codeine 12 mg/5mL) No OTC Schedule V in Oregon currently No OTC Schedule V in Oregon currently

48. Analgesic: Narcotic Combinations Hydrocodone/APAP = Vicodin, Lortab Hydrocodone/APAP = Vicodin, Lortab Codeine/APAP = Tylenol #3 Codeine/APAP = Tylenol #3 Propoxyphene/APAP = Darvocet Propoxyphene/APAP = Darvocet Oxycodone/APAP = Percocet Oxycodone/APAP = Percocet Side Effects: Side Effects: Dizziness, Drowsiness Dizziness, Drowsiness Constipation Constipation Dependence? Abuse? Dependence? Abuse? Do not take with alcohol Do not take with alcohol

49. Analgesic: Opioids “Abuse potential high yet effective” Oxycodone = Oxycontin Oxycodone = Oxycontin Side effects: see previous slide Side effects: see previous slide High abuse potential due to extended release formulation High abuse potential due to extended release formulation Tramadol = Ultram Tramadol = Ultram Side Effects: Side Effects: Dizziness, Drowsiness Dizziness, Drowsiness Dependence? Abuse? Dependence? Abuse? Do not take with alcohol Do not take with alcohol

50. Analgesics: “Abuse vs. Legitimate Use?” Sickle cell anemia Sickle cell anemia Fibromyalgia Fibromyalgia Terminal cancer Terminal cancer Chronic back pain Chronic back pain Muscular dystrophy Muscular dystrophy Neuropathic pain Neuropathic pain ADD, ADHD ADD, ADHD How do you evaluate and help? How do you evaluate and help?

51. Medical Marijuana Act Oregon Medical Marijuana Act ORS 475.300 - 475.346This Act allows use of marijuana by Oregonians with debilitating medical conditions for medical purposes determined by their physician. Oregon Medical Marijuana Act ORS 475.300 - 475.346This Act allows use of marijuana by Oregonians with debilitating medical conditions for medical purposes determined by their physician. “Debilitating medical condition” includes glaucoma, cancer, HIV or AIDS, or a condition which produces cachexia, severe pain, severe nausea, seizures, persistent muscle spasms or condition approved by the department “Debilitating medical condition” includes glaucoma, cancer, HIV or AIDS, or a condition which produces cachexia, severe pain, severe nausea, seizures, persistent muscle spasms or condition approved by the department A medical registry identification card is required for the patient and caregiver A medical registry identification card is required for the patient and caregiver A registrant may possess 6 mature plants and 24 ounces of usable marijuana at a time A registrant may possess 6 mature plants and 24 ounces of usable marijuana at a time

52. Death With Dignity Act Death With Dignity Act http://www.oregon.gov/DHS/ph/pas/index.shtmlOAR 333-009-0000 – 333-009-0030 ORS 127.800 – 127.897An adult, who is a resident of Oregon, has been determined by the attending physician and consulting physician to be suffering from a terminal disease. The adult must make an oral and written request to end their life. Death With Dignity Act http://www.oregon.gov/DHS/ph/pas/index.shtmlOAR 333-009-0000 – 333-009-0030 ORS 127.800 – 127.897An adult, who is a resident of Oregon, has been determined by the attending physician and consulting physician to be suffering from a terminal disease. The adult must make an oral and written request to end their life. http://www.oregon.gov/DHS/ph/pas/index.shtml 15 days between oral request and written request 15 days between oral request and written request Authorized prescribers include MD or DO Authorized prescribers include MD or DO Health care providers may choose not to participate Health care providers may choose not to participate See link for necessary reporting See link for necessary reporting

53. Endocrine: Estrogens “Estrogen replacement unnecessary?” How safe? How safe? How necessary? How necessary? Risk vs. benefit Risk vs. benefit 1970’s data and marketing campaign 1970’s data and marketing campaign Women’s Health Initiative study Women’s Health Initiative study

54. Endocrine: Female Hormones Menopausal women Menopausal women Conjugated Estrogens = Premarin Conjugated Estrogens = Premarin Conjugated Estrogens/ Medroxyprogesterone = Prempro Conjugated Estrogens/ Medroxyprogesterone = Prempro Estradiol Estradiol Medroxyprogesterone Medroxyprogesterone Oral contraceptives Oral contraceptives Ortho-Tricyclen Ortho-Tricyclen Ortho-Novum Ortho-Novum Ortho-Evra (transdermal) Ortho-Evra (transdermal) Side effects: Side effects: Breast tenderness, spotting Breast tenderness, spotting Bloating, Nausea Bloating, Nausea

55. Plan B OTC August 2006 Without a prescription if >18yo Without a prescription if >18yo Behind the counter at licensed pharmacies or healthcare facilities Behind the counter at licensed pharmacies or healthcare facilities Pharmacist must be on duty but not necessary to make the transaction Pharmacist must be on duty but not necessary to make the transaction No gender distinction, no log required No gender distinction, no log required Patient must receive information, pharmacist must be available for questions http://www.fda.gov/cder/foi/label/2006/021045s011lbl.pdf

56. Endocrine: Injectable Diabetic agents Insulin Insulin Rapid acting Rapid acting Novolog, Humalog Novolog, Humalog Short-acting Short-acting Regular Regular Intermediate acting Intermediate acting NPH NPH Combination products Combination products Mixed insulin (70/30) Mixed insulin (70/30) Synthetic vs. animal source Synthetic vs. animal source

57. Endocrine: Diabetes Side Effects: Side Effects: Dose dependent Dose dependent Okay at room temperature once opened x 30days Okay at room temperature once opened x 30days Roll before withdrawing dose, rotate sites, change syringes Roll before withdrawing dose, rotate sites, change syringes Scheduled pump option Scheduled pump option

58. Endocrine: Oral Diabetic agents Rosiglitazone = Avandia Rosiglitazone = Avandia Pioglitazone = Actos Pioglitazone = Actos Side Effects: dose dependent Side Effects: dose dependent Metformin = Glucophage Metformin = Glucophage Side Effects: dose dependent Side Effects: dose dependent Glipizide ER Glipizide ER Glyburide Glyburide

59. Endocrine: Diabetes “Avandia May Cause Risk of Heart Attack and Death” How relevant? How relevant? Open display of results? Open display of results? Remove from market? Remove from market? Class effect? Do all glitazones cause this Class effect? Do all glitazones cause this Would this happen anyway? Would this happen anyway?

60. Endocrine: Diabetes Start with oral therapy, progress to insulin if cannot control Start with oral therapy, progress to insulin if cannot control Diet control in tandem with drug therapy Diet control in tandem with drug therapy Diligent foot care, eye care, wound care Diligent foot care, eye care, wound care Consistency Consistency http://www.diabetes.org/home.jsp http://www.diabetes.org/home.jsp

61. Endocrine: Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Sildenafil = Viagra Sildenafil = Viagra Side Effects: Nausea, Headache, Visual Side Effects: Nausea, Headache, Visual Tadalafil = Cialis Tadalafil = Cialis Another indication: pulmonary hypertension Another indication: pulmonary hypertension Compounded preparations Compounded preparations

62. Endocrine: Erectile Dysfunction “Fastest growing drug class” Little blue pill Little blue pill DTC advertising DTC advertising Paradigm shift Paradigm shift Dietary supplement availability Dietary supplement availability Drug content found Drug content found

63. Supplements/Vitamins Supplements/Vitamins Potassium supplements for low potassium Potassium supplements for low potassium Potassium chloride = K-Dur, Klor Con, Micro-K” Potassium chloride = K-Dur, Klor Con, Micro-K” Side effects: nausea, diarrhea Side effects: nausea, diarrhea Folic Acid deficiency for neonatal development Folic Acid deficiency for neonatal development Folic Acid = Folate Folic Acid = Folate Side effects: nausea Side effects: nausea

64. Prescription vs. Dietary Supplement “Long Weekend Dietary Supplement” FDA Recall 2007 FDA Recall 2007 Contained undeclared tadalafil (Cialis) Contained undeclared tadalafil (Cialis) “Zencore” recalled 9/2007 “Zencore” recalled 9/2007 Keeping prescription drugs behind the counter Keeping prescription drugs behind the counter What is really in a dietary supplement? What is really in a dietary supplement?

65. Dietary Supplement Health and Education Act (DSHEA) Federal Trade Commission regulates advertising Federal Trade Commission regulates advertising FDA through the DSHEA FDA through the DSHEA DSHEA 1994: power by FDA to ensure safe, properly labeled and claims made are substantiated Pharmacists must use care in making claims not otherwise allowed under this law DSHEA 1994: power by FDA to ensure safe, properly labeled and claims made are substantiated Pharmacists must use care in making claims not otherwise allowed under this law http://www.fda.gov/opacom/laws/dshea.html http://www.fda.gov/opacom/laws/dshea.html http://www.fda.gov/opacom/laws/dshea.html Great Natural Products and Complementary Care website:http://nccam.nih.gov/ Great Natural Products and Complementary Care website:http://nccam.nih.gov/

66. What is really in that pill? Manufacturer Standards? Manufacturer Standards? USP USP http://www.usp.org/USPVerified/dietarySupplemen ts/ http://www.usp.org/USPVerified/dietarySupplemen ts/ http://www.usp.org/USPVerified/dietarySupplemen ts/ http://www.usp.org/USPVerified/dietarySupplemen ts/ Consumer Lab Consumer Lab http://www.consumerlab.com/aboutcl.asp#testpro g http://www.consumerlab.com/aboutcl.asp#testpro g http://www.consumerlab.com/aboutcl.asp#testpro g http://www.consumerlab.com/aboutcl.asp#testpro g NSF International NSF International http://www.nsf.org/ http://www.nsf.org/ http://www.nsf.org/

67. Cool Resources For You Pharmacists Manual DEA Pharmacists Manual DEA Pharmacists Manual DEA Pharmacists Manual DEA http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.htm http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.htm APhA Links APhA Links APhA Links APhA Links http://www.pharmacist.com/AM/Template.cfm?section=Links2 http://www.pharmacist.com/AM/Template.cfm?section=Links2 http://www.pharmacist.com/AM/Template.cfm?section=Links2 ASHP Drug Information ASHP Drug Information ASHP Drug Information ASHP Drug Information http://www.ashp.org/ahfs/index.cfm http://www.ashp.org/ahfs/index.cfm Clinical Trials Repository Clinical Trials Repository Clinical Trials Repository Clinical Trials Repository http://www.clinicaltrials.gov/ http://www.clinicaltrials.gov/ Dietary Supplements Dietary Supplements Dietary Supplements Dietary Supplements http://www.cfsan.fda.gov/~dms/supplmnt.html http://www.cfsan.fda.gov/~dms/supplmnt.html Pharmacy Compounding Pharmacy Compounding Pharmacy Compounding Pharmacy Compounding http://www.fda.gov/cder/pharmcomp/default.htm http://www.fda.gov/cder/pharmcomp/default.htm http://www.fda.gov/cder/pharmcomp/default.htm Medication Information Medication Information Medication Information Medication Information http://medlineplus.gov/ http://medlineplus.gov/ http://medlineplus.gov/