Updates in Pharmacy: What’s New, What’s Gone, What’s Off-Label that’s Useful

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Updates in Pharmacy: What’s New, What’s Gone, What’s Off-Label that’s Useful

Learning Objectives:


  • To review those new pharmaceuticals that are available on the market and their usefulness to prescribing NDs

  • To understand why certain drugs have been removed from the prescribing arsenal and how to handle patients’ concerns

  • To consider off-label and alternative routes of administration of current medications that may be of benefit to the naturopathic profession

  • As a side note to the above listed objective, a cursory introduction to the types of pharmacies filling our prescriptions is in order, as well as the accreditation of compounding pharmacies

Outline (this is a work in progress)

Introduction


  1. Show of hands as to who writes prescriptions; who has a trusted relationship with a particular pharmacy/pharmacist; who knows if the compounding pharmacy s/he uses is accredited

  2. Show of hands as to who likes to be the first to use a new drug on the market; who knows what a Black Box Warning is, where it’s located

  3. Ask participants to write down how/why prescriptive authority relates to naturopathic doctors who are supposedly known for using nature to cure—is writing a prescription something NDs should be habitually doing; are we losing ourselves and becoming green allopaths—to be dropped into a box at the end of the presentation

What’s New



  1. Cardiology

    1. Vascepa (icosapent ethyl) by Amarin Pharmaceuticals—for the treatment of hypertriglyceridemia; approved July 2012

  2. Dermatology

    1. Eviredge (vismodegib) by Genentech—for the treatment of basal cell carcinoma; approved January 2012
    2. Horizant (gabapentin enacarbil) by GlaxoSmithKline--for the treatment of postherpetic neuralgia; approved June 2012


    3. Picato (ingenol mebutate) gel by LEO Pharma—for the treatment of actinic keratosis; approved January 2012

    4. Sklice (ivermectin) lotion by Sanofi Pasteur—for the treatment of head lice; approved February 2012

  3. Endocrinology

    1. Belviq (loraserin hydrochloride) by Arena Pharmaceuticals—for the chronic management of weight loss; approved June 2012

    2. Bio-T-Gel (testosterone gel) by Teva Pharmaceuticals—for the treatment of hypogonadism; approved February 2012

    3. Elelyso (taliglucerase alfa) by Pfizer Inc—for the treatment of Gaucher disease; approved May 2012

    4. Jentadueto (linagliptin + metformin hydrochloride) by Eli Lilly—for the treatment of type II diabetes; approved February 2012

    5. Korlym (mifepristone) by Corcept Therapeutics—for the control of hyperglycemia in adults with endogenous Cushing’s syndrome; approved February 2012

    6. Lucentis (ranibizumab ) injection by Genentech—for the treatment of diabetic macular edema; approved August 2012

    7. Qsymia (phentermine + topiramate) extended release by Vivus—for the treatment of chronic weight management; approved July 2012

    8. Ultresa (pancrelipase) delayed release capsules by Aptalis Pharma—for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions; approved March 2012
    9. Viokace (pancrelipase) tablets by Aptalis Pharma—for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy; approved March 2012


  4. Gastroenterology

    1. Elelyso (taliglucerase alfa) by Pfizer Inc—for the treatment of Gaucher disease; approved May 2012

    2. Linzess (linaclotide) by Forest Labs and Ironwood Pharmaceuticals—for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation; approved August 2012

    3. Stivarga (regorafenib) by Bayer HealthCare Pharmaceuticals—for the treatment of previously treated patients with metastatic colorectal cancer; approved September 2012

    4. Ultresa (pancrelipase) delayed release capsules Aptalis Pharma—for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions; approved March 2012

    5. Viokace (pancrelipase) tablets by Aptalis Pharma—for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy; approved March 2012

    6. Xandi (enzalutamide) by Medivation—for the treatment of metastatic castration-resistant prostate cancer; approved August 2012

    7. Zaltrap (ziv-aflibercept) by Sanofi Aventis US—for the treatment of metastatic colorectal cancer; approved August 2012

  5. Hematology

    1. Bosulif (bosutinib) by Pfizer—for the treatment of Ph+ chronic myelogenous leukemia; approved September 2012

    2. Elelyso (taliglucerase alfa) by Pfizer Inc—for the treatment of Gaucher disease; approved May 2012

    3. Kyprolis (carfilzomib) by Onyx Pharmaceuticals—for the treatment of multiple myeloma; approved July 2012

    4. Marqibo (vincristine sulfate liposome) injection by Talon Therapeutics—for the treatment of Ph- acute lymphoblastic leukemia; approved August 2012


    5. Neutroval (tbo-filgrastim) by Teva Pharmaceuticals—for the reduction in the duration of severe chemotherapy-induced neutropenia; approved August 2012

    6. Omontys (peginesatide) by Affymax—for the treatment of anemia due to chronic kidney disease; approved March 2012

    7. Synribo (omacetaxine mepesuccinate) by Teva Pharmaceuticals—for the treatment of chronic or accelerated phase chronic myeloid leukemia; approved October 2012

  6. Immunology

    1. Horizant (gabapentin enacarbil) by GlaxoSmithKline—for the treatment of postherpetic neuralgia; approved June 2012

    2. Qnasl (beclomethasone dipropionate) nasal aerosol by Teva Pharmaceuticals—for the treatment of seasonal and perennial allergic rhinitis; approved March 2012

    3. Rayos (prednisone) delayed release tablets by Horizon Pharma—for the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions; approved July of 2012

    4. Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) by Gilead Sciences—for the treatment of HIV-1 infection; approved August 2012

    5. Tudorza Pressair (aclidinium bromide) inhalation powder by Forest Labs—for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease; approved July 2012

  7. Musculoskeletal
    1. Aubagio (teriflunomide) by Sanofi Aventis-for the treatment of multiple sclerosis; approved September 2012


    2. Elelyso (taliglucerase alfa) by Pfizer Inc—for the treatment of Gaucher disease; approved May 2012

    3. Lyrica (pregabalin) by Pfizer—for the treatment of neuropathic pain associated with spinal cord injury; approved June 2012

    4. Myrbetriq (mirabegron) by Astellas Pharma US, Inc.—for the treatment of overactive bladder; approved June 2012

    5. Nuepro (rotigotine) transdermal system by UCB—for the treatment of Restless Legs Syndrome; approved April 2012

    6. Rayos (prednisone) delayed release tablets by Horizon Pharma—for the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions; approved July of 2012

    7. Stendra (avanafil) by Vivus—for the treatment of erectile dysfunction; approved April 2012

    8. Votrient (pazopanib) by GlaxoSmithKline—for the treatment of soft tissue sarcoma; approved April 2012

  8. Nephrology

    1. Afinitor (everolimus) by Novartis Pharmaceuticals Corporation—for the treatment of renal angiomyolipoma associated with tuberous sclerosis complex; approved April 2012

    2. Inlyta (axitinib) by Pfizer—for the treatment of advanced renal cell carcinoma; approved January 2012

    3. Myrbetriq (mirabegron) by Astellas Pharma US, Inc.—for the treatment of overactive bladder; approved June 2012
    4. Omontys (peginasatide) by Affymax; For the treatment of anemia due to chronic kidney disease; approved March 2012


    5. Stendra (avanafil) by Vivus—for the treatment of erectile dysfunction; approved April 2012

    6. Stivarga (regorafenib) by Bayer HealthCare Pharmaceuticals—for the treatment of previously treated patients with metastatic colorectal cancer; approved September 2012

    7. Voraxaze (glucarpidase) by BTG International—for the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function; approved January 2012

  9. Neurology

    1. Fycompa (perampanel) by Eisai—for the treatment of partial-onset seizures with or without secondarily generalized seizures; approved October 2012

    2. Horizant (gabapentin enacarbil) by GlaxoSmithKline—for the treatment of postherpetic neuralgia; approved June 2012

    3. Lyrica (pregabalin) by Pfizer-for the treatment of neuropathic pain associated with spinal cord injury; approved June 2012

    4. Neupro (rotigotine) transdermal system by UCB—for the treatment of Restless Legs Syndrome; approved April 2012

    5. Oxtellar XR (oxcarbazepine) extended release by Supernus Pharmaceuticals—for the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age; approved October 2012

    6. Quillivant XR (methylphenidate hydrochloride) by NextWave Pharmaceuticals—for the treatment of Attention Deficit Hyperactivity Disorder; approved September 2012

    7. Subsys (fentanyl) sublingual spray by Insys Therapeutics—for the treatment of breakthrough cancer pain; approved January of 2012

  10. Obstetrics/Gynecology


    1. Afinitor (everolimus) by Novartis—for the treatment of hormone receptor-positive, HER2-negative breast cancer; approved July 2012

    2. Natazia (estradiol valerate and estradiol valerate + dienogest) by Bayer HealthCare—for the treatment of heavy menstrual bleeding; approved March 2012

    3. Perjeta (pertuzumab) by Genentech—for the first-line treatment of HER2+ metastatic breast cancer; approved June 2012

  11. Oncology

    1. Abraxane (paclitaxel) protein-bound particles for injectable suspension by Celgene—for the treatment of non-small cell lung cancer; approved October 2012

    2. Afinitor (everolimus) by Novartis—for the treatment of hormone receptor-positive, HER2-negative breast cancer; approved July 2012—for the treatment of renal angiomyolipoma associated with tuberous sclerosis complex; approved April 2012

    3. Bosulif (bosutinib) by Pfizer---for the treatment of Ph+ chronic myelogenous leukemia; approved September 2012

    4. Botrient (pazopanib) by GlaxoSmithKline—for the treatment of soft tissue sarcoma; approved April 2012

    5. Erivedge (vismodegib) by Genentech—for the treatment of basal cell carcinoma; approved January 2012

    6. Inlyta (axitinib) by Pfizer—for the treatment of advanced renal cell carcinoma; approved January 2012

    7. Kyprolis (carfilzomib) by Onyx Pharmaceuticals—for the treatment of multiple myeloma; approved July 2012
    8. Marqibo (vincristine sulfate liposome) injection by Talon Therapeutics—for the treatment of Ph- acute lymphoblastic leukemia; approved August 2012


    9. Neutroval (tbo-filgrastim) by Teva Pharmaceuticals—for the reduction in the duration of severe chemotherapy-induced neutropenia; approved August 2012

    10. Perjeta (pertuzumab) by Genentech—for the first-line treatment of HER2+ metastatic breast cancer; approved June 2012

    11. Picato (ingenol mebutate) gel by LEO Pharma—for the treatment of actinic keratosis; approved January 2012

    12. Stivarga (regorafenib) by Bayer HealthCare Pharmaceuticals—for the treatment of previously treated patients with metastatic colorectal cancer; approved September 2012

    13. Subsys (fentanyl) sublingual spray by Insys Therapeutics—for the treatment of breakthrough cancer pain; approved January of 2012

    14. Synribo (omacetaxine mepesuccinate) by Teva Pharmaceuticals—for the treatment of chronic or accelerated phase chronic myeloid leukemia; approved October 2012

    15. Xtandi (enazlutamide) by Medivation—for the treatment of metastatic castration-resistant prostate cancer; approved August 2012

    16. Zaltrap (ziv-aflibercept) by Sanofi Aventis US—for the treatment of metastatic colorectal cancer; approved August 2012

  12. Ophthalmology

    1. Cystaran (cysteamine hydrochloride) by Sigma Tau Pharmaceuticals—for the treatment of corneal cystine crystal accumulation due to cystinosis; approved October 2012

    2. Jetrea (ocriplasmin) by Thrombogenics—for the treatment of symptomatic vitreomacular adhesion; approved October 2012
    3. Lucentis (ranibizumab) injection by Genentech—for the treatment of diabetic macular edema; approved August 2012


    4. Zioptan (tafluprost) ophthalmic solution by Merck—for the treatment of elevated intraocular pressure; approved February 2012

  13. Otolaryngology

    1. Dymista (azelastine hydrochloride + fluticasone propionate) by Meda Pharmaceuticals Inc.—for the relief of symptoms of seasonal allergic rhinitis; approved May 2012

    2. Qnasl (beclomethasone dipropionate) nasal aerosol by Teva Pharmaceuticals—for the treatment of seasonal and perennial allergic rhinitis; approved March 2012

  14. Pediatrics/Neonatology

    1. Fycompa (perampanel) by Eisai—for the treatment of partial-onset seizures with or without secondarily generalized seizures; approved October 2012

    2. Oxtellar XR (oxcarbazepine) extended release by Supernus Pharmaceuticals—for the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age; approved October 2012

    3. Qnasl (beclomethasone dipropionate) nasal aerosol by Teva Pharmaceuticals—for the treatment of seasonal and perennial allergic rhinitis; approved March 2012

    4. Quillivant XR (methylphenidate hydrochloride) by NextWave Pharmaceuticals—for the treatment of Attention Deficit Hyperactivity Disorder; approved September 2012

    5. Sklice (ivermectin) lotion by Sanofi Pasteur—for the treatment of head lice; approved February 2012

    6. Surfaxin (lucinactant) by Discovery Laboratories—for the treatment of respiratory distress syndrome in premature infants; approved March 2012

  15. Pharmacology/Toxicology
    1. Voraxaze (glucarpidase) by BTG International—for the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function; approved January 2012


  16. Psychiatry/Psychology

    1. Qsymia (phentermine + topiramate) extended release by Vivus—for the treatment of chronic weight management; approved July 2012

    2. Quillivant XR (methylphenidate hydrochloride) by NextWave Pharmaceuticals—for the treatment of Attention Deficit Hyperactivity Disorder; approved September 2012

  17. Pulmonary/Respiratory

    1. Abraxane (paclitaxel) protein-bound particles for injectable suspension by Celgene—for the treatment of non-small cell lung cancer; approved October 2012

    2. Dymista (azelastine hydrochloride + fluticasone propionate) by Meda Pharmaceuticals Inc.—for the relief of symptoms of seasonal allergic rhinitis; approved May 2012

    3. Kalydeco (ivacaftor) by Vertex Pharmaceuticals—for the treatment of cystic fibrosis with the G551D mutation in the CFTR gene; approved January of 2012

    4. Qnasl (beclomethasone dipropionate) nasal aerosol by Teva Pharmaceuticals—for the treatment of seasonal and perennial allergic rhinitis; approved March 2012

    5. Rayos (prednisone) delayed release tablets by Horizon Pharma—for the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions; approved July of 2012

    6. Surfaxin (lucinactant) by Discovery Laboratories—for the treatment of respiratory distress syndrome in premature infants; approved March 2012

    7. Tudorza pressair (aclidinium bromide) inhalation powder by Forest Labs—for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease; approved July 2012

  18. Rheumatology


    1. Rayos (prednisone) delayed release tablets by Horizon Pharma—for the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions; approved July of 2012

  19. Trauma

    1. Lyrica (pregabalin) by Pfizer—for the treatment of neuropathic pain associated with spinal cord injury; approved June 2012

Discontinued Drugs



  1. Chloramphenicol, July 2012 on the market since 1949, antibacterial—bone marrow toxicity (aplastic anemia)

  2. Darvon/Darvocet (propoxyphene/+ acetaminophen) 2010 after being on market since 1957—increased risk of heart attack/stroke

  3. Avandia (rosiglitazone) 2010 in Europe—increased risk of heart attack/death—still available in US!

Off-Label & Alternative Uses



  1. ibuprofen with itraconazole or terbinafine in DMSO topically for nail fungus

  2. cimetidine topically for warts

  3. low dose naltrexone (1.5-4.5mg) orally for neuropathy, autoimmune diseases, fibromyalgia, autism, PTSD, PCOS

  4. ketamine, gabapentin, clonidine or amitriptyline with NSAID and guaifenesin topically for neuropathic pain (guaifenesin is muscle relaxant when used topically)

  5. atropine, ketoconazole, biotin in vaginal suppository form for vulvodynia

  6. dextromethorphan mixed with opioid orally to reduce tolerance

  7. phenytoin topically to enhance wound healing

  8. carbidopa/chromium/5-HTP in a lollipop for weight loss
  9. betahistine 8mg bid for tinnitus & vertigo


  10. metformin for use in gestational diabetes, PCOS, HIV lipodystrophy

  11. Keppra XR (levetiracetam) for migraines, neuropathic pain, bipolar disorder, anxiety disorders, and substance abuse/addictions, seizures associated with traumatic brain injury and/or tumor

  12. Lamictal (lamotrigine) as monotherapy, or for bipolar II, treatment-resistant bipolar disorder, treatment-resistant depression

  13. any SSRI or SNRI (other than Prozac or Lexapro) to adolescents

  14. Topamax (topiramate) or Trileptal (oxcarbazepine) for bipolar disorder

  15. clonidine for use in hot flashes, migraine headaches, restless legs syndrome (RLS), attention-deficit/hyperactivity disorder (ADHD), sleep apnea, smoking cessation, Tourette's syndrome, withdrawal from alcohol and narcotics

  16. SSRIs for generalized anxiety disorder, premature ejaculation, migraine headaches, diabetic neuropathy, fibromyalgia, neurocardiogenic syncope

  17. Neurontin (gabapentin) for bipolar disorder, peripheral neuropathy, diabetic neuropathy, complex regional pain syndrome, ADD, RLS, trigeminal neuralgia, periodic limb movement disorder of sleep (PLMD), migraine headaches, alcohol withdrawal

  18. Adderall (dextroamphetamine + amphetamine) for use in depression, “study drug”, appetite suppressant

  19. Wellbutrin (bupropion) for weight loss, adult ADD/ADHD, RLS/PLMD, sexual dysfunction, bipolar depression, depression of Parkinson’s; Zyban (bupropion) for depression!

Pharmacy Accreditations and Why that’s Important



  • Pharmacy Compounding Accreditation Board (PCAB)

  • Accredited Continuing Pharmacy Education (ACPE)

References: http://www.centerwatch.com/drug-information/fda-approvals/


www.Rxlist.com

http://en.wikipedia.org/wiki/List_of_withdrawn_drugs

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm319905.htm

http://en.wikipedia.org/wiki/Chloramphenicol

http://www.medicinenet.com/propoxyphene/article.htm

http://www.gibbonslaw.com/UserFiles/Image/1193175381.pdf

http://www.latimes.com/news/nationworld/nation/la-122001fda,0,4840718,full.story

http://www.citizen.org/Page.aspx?pid=2366#rr6

http://articles.mercola.com/sites/articles/archive/2012/02/11/leading-causes-of-death-cost-for-us-economy.aspx

Introduction to Compounded Medication Alternatives, Natalie Gustafson, PharmD; presentation to OANP, June 15, 2010



http://diabetes.emedtv.com/metformin/metformin-uses.html

http://www.crazymeds.us/pmwiki/pmwiki.php/Meds/Keppra-XR

http://www.crazymeds.us/pmwiki/pmwiki.php/Meds/LamictalApprovedAndOffLabelUses

http://consumerreports.org/cro/2012/05/off-label-use-of-clonidine/index.htm

http://www.aafp.org/afp/2003/0801/p498.html

http://www.amcp.org/data/jmcp/contemporary%20subject-559-568.pdf

http://adderall.legalview.com/articles/off-label-use-of-adderall-poses-increasing-threat/173925/

http://www.crazymeds.us/pmwiki/pmwiki.php/Meds/WellbutrinApprovedAndOffLabelUses
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