Got Pain? 11/19/2013. Pain Kill Beyond The Pill. Yet it is often inadequately treated.

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1 Pain Kill Beyond The Pill An Innovative & Personalized Approach to Pain Treatment MAZEN BAISA, PharmD, RPh., MBA, ABAAHP, FAARM, CPE Director of Clinical Services BioMed Specialty Pharmacy Pain Kill Beyond the Pill An Innovative & Personalized Approach to Pain Treatment Disclosure: Dr. Baisa is on the speakers Bureau for PCCA, Freedom pharmaceutical, and NCPA Mazen Baisa, PharmD, MBA, ABAAHP, FAARM, CPE Pain Kill Beyond The Pill An Innovative & Personalized Approach to Pain Treatment Disclosures This continuing education activity is managed and accredited by Professional Education Services Group. Neither PESG, nor any accrediting organization support or endorse any product or service mentioned in this activity. PESG staff has no financial interest to disclose. Commercial Support was not received for this activity. Learning Objectives: At the end of this activity, participant will be able to: 1. Describe the issues and challenges with pain management and the socioeconomic consequences 2. Discuss the goals of pain management and how to integrate the topical compounds in treatment 1. Explain the benefits of topical pain compounds and the mechanism of action of the drugs used Got Pain? Pain is the most common symptom for which individuals seek medical help... Yet it is often inadequately treated. 1

2 Cost of Chronic Pain Pain: The Real Silent Enemy Quality of Life Psychological Morbidity According to the Institute of Medicine Social Consequences Socioeconomic Consequences Cancer 12mill Heart Disease 16 mill Diabetes 26 mill Pain 116 mill Your Patients Are in Pain! Fifty million Americans are partially or totally disabled due to chronic pain. The annual value of loss of productivity in 2010 ranged between $297.4 and $335.5 billion Causes of Poor Pain Management After Surgery The assumption that minor surgery is associated with little or no pain Nearly two in five (36%) Americans would refuse prescribed or physicianrecommended pain medication for fear of getting addicted One in three (34%) Americans believe pain medications that come with side effects are worse than the pain itself Of those being treated for their acute or recurrent pain, only 22% are satisfied with their current treatment Americans spend about $3 billion per year on over the counter (OTC) analgesics The emphasis on rapid recovery, return to street fitness and early discharge The fear of respiratory depressant and sedative effects of opioid drugs outside of immediate supervised medical care The presumption that patients or guardians may be ignorant of the risks of medications and may abuse them Restrictive policies in some pharmacies that make it difficult to have access to potent analgesics Concerns with Oral Pain Medications Many of the oral pain relievers are on the American Geriatrics Society (Beers Criteria) for Potentially Inappropriate Medication Use in Older Adults According to the Journal of Managed Care Pharmacy Its estimated that there are more than 2.4 millions falls per year due to medication related adverse effects The American Board of Internal Medicine in partnership with the American Society of Nephrology; advise avoiding NSAIDs in patients with hypertension, heart failure, diabetes, and chronic kidney disease From 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States, with 48% of acetaminophen related cases associated with accidental overdose 2.5 million individuals in the United States experience acute kidney injury from NSAID use annually Out of those hospitalized, 15 35% of all ulcer complications are due to oral NSAID use 2

3 The Opioids Dilemma The US has 5% of the world s population, yet consumes 85% of the world s prescription opioids Accidental opioid overdoses are now the leading cause of death in adults (above cancer, suicide, car accidents, heart attacks, smoking) The DEA and FDA are launching many restrictions & regulations for prescribing opioids Source The CDC Source The CDC Source The CDC Potential Rescheduling of Hydrocodone The Safe Prescribing Act of 2013 will reclassify hydrocodone products from Schedule III to Schedule II Reformulation of Vicodin Imagine the added workload will that create! 3

4 Barriers to Pain Treatment The Pain Challenge Common Under assessed and under treated Complex pathophysiology Multiple mechanisms Emotional element of pain Clinicians may doubt pain is real Patients respond differently to treatments Goals of Pain Management Treat/prevent recurrence of pain causing condition Reduce pain Improve physical / psychological function Biochemical Individuality A cookie cutter approach would be fine If we were treating cookies! Improve quality of life Is This Painful? Risk Continuum Most Invasive Oral medications Interventional techniques Topical medications Injections Least Invasive 4

5 This image cannot currently be displayed. 11/19/2013 Targeting The Pain Mediators at the Peripheral Level Targeting Points of Interception for Maximizing Pain Control Multimodal Analgesia Attacks Different Points Along the Pain Pathways The multimodal approach to pain management, traditionally accomplished using combination analgesics, has successfully been used in various applications to more efficiently provide analgesia. Dosage Considerations Most of the current pain medications on the market target the μ opioid, COX, serotonin, or norepinephrine receptors on the ascending and/or descending pathways. When these pathways are utilized at the same time, the analgesic effect can often be reached at a lower dose, partially allowing the side effect profile of multimodal therapies to be lower than that of an individual medications therapy. Because opioid related side effects are undesirable, it is likely that a preference of newer multimodal medications that are opioid sparing is warranted. Though the currently available multimodal therapies have made great strides on helping to manage pain, continued research is needed to develop new pain medications that provide at least the same or more effective analgesia with fewer side effects. Perry Fine MD, Professor of Anesthesiology, University of Utah School of Medicine Advantages of Topical Pain Compounds Lowers systemic absorption Avoid first pass effect Reduces organ toxicity Produces fewer side effects Various medications and concentrations Direct delivery to pain receptors Advantages of Topical Pain Compounds Lowers adverse drug interactions Minimizes abuse and addiction Reduces opioids tolerance Greater effectiveness and results Improved patient compliance Covered by many insurances 5

6 Treatment Options Transdermal AMPA Antagonism AMPA Na+ channel blockers Anticonvulsants (Gabapentin, Carbamazpine) Reduce excessive discharge Reduce spread Membrane stabilization Reference; International Journal of Pharmaceutical Compounding Transdermal AMPA Antagonism AMPA Na+ channel blockers Local Anesthetics (lidocaine, prilocaine) Membrane stabilization Reduce discharge from damaged and dysfunctional nerve Transdermal Norepinephrine (NE) Reuptake Inhibitors Medications include: Amitriptlyine, Desipramine, Cyclobenzaprine Tricyclic antidepressants act as five different drugs in one block the reuptake of biogenic amines, serotonin and norepinephrine, in the descending inhibitory pathway They possess anticholinergic antimuscarinic activity, α adrenergic antagonist activity, and also act as an antihistamine Through these mechanisms, along with blocking sodium and voltagegated potassium and calcium channels, down regulation of incoming pain signals improves the patient s ability to function Transdermal NMDA Antagonism NMDA Ca++ channel blockers (Ketamine, orphenadrine, amantadine, Dextromethorphan, Magnesium ) Glutamate antagonist (Gabapentin) This class alters the binding of glutamate on the NMDA receptor, which inhibits the receptor from opening and communicating signaling along the nerve, therefore, decreasing pain sensation Transdermal Pain Modulators Non NMDA Ca++ channel blocker: Nifedipine, Verapamil, pentoxifylline vasodilatation decreases total peripheral resistance Anti inflammatory NSAIDS (Ketoprofen, Diclofenac) Cox inhibition and conversion of arachidonic acid to prostaglandins which inhibits the inflammatory response mechanism 6

7 The Shot Gun Approach Block the physiologic nerve pathways with various mechanism NMDA Antagonist MU receptor agonist Calcium channel blockers Magnesium channel blocker AMPA antagonist GABA agonist Musculoskeletal Neuropathic Pain with Spasm General Pain Formula Examples Diclofenac 3%/ DMSO 10%/ Gabapentin 6%/ Amitriptylline 2% Cyclobenzaprine 2%/ Baclofen 2%/ Tetracaine 2% Ketamine 10%/ Gabapentin 6%/Amitriptyline 2%/ baclofen 2%/cyclobenzaprine 2%/ Diclofenac 3% Lidocaine 2% Diclofenac 3%/ Gabapentin 6%/Lidocaine 2%/ Prilocaine2% Case Study Diabetic Peripheral Neuropathy The patient is a 41 year old female with a history of diabetes who complains of severe foot pain that has been going on for many years. The patient reports that the pain is burning type, throbbing, tingling, and hotness like. The patient reports that the pain is a 9/10 on a VAS scale. She is reported to have low level of relief by pain medications and aggravated by standing and walking. She reports that her feet swell and become hot to the touch when the pain flairs. Her medications include Amitriptyline 50 mg p.o. q.h.s., Gabapentin 600 p.o. bid, Aspirin 81 mg q. day, Losartan 50 mg half a tablet two times a day, Metformin 1000 mg one tablet two times a day, Simvastatin 40 mg half a tablet q.h.s., and Vicodin ES 7.5/750 mg p.o. 1 2 tablets every 4 to 6 hours p.r.n. The patient was not finding adequate pain relief from the Vicodine ES as prescribed and she reportedly began taking two four pills every 2 3 hours. The patient was brought into see me by her sister and referred by one of the DPMs in our area. With the agreement of the DPM the patient was put on a topical pain compound containing: Ketamine% 10%, Gabapentin 6%, Amitriptyline 2%, Baclofen 2%, Cyclobenzaprine 2%, Diclofenac 3%, Lidocaine 5% QID. Her oral gabapentin and amitriptyline were tapered down and d/cd after 30 days, and she is down to taking one Vicodine ES for breakthrough and not exceeding 2 tabs a day. Choosing the Compounding Specialist What's their expertise? Do they comply with the regulations? What type of equipment do they use? What are the sources of their chemicals? Do they conduct testing and quality control? What type of bases do they utilize? What kind of support do they provide? Biochemical Individuality Your patients are unique! I invite You! 7

8 Contact information Mazen Baisa Direct Phone: (248) Direct Fax: (248) To receive CME/CE Credit If you would like to receive continuing education credit for this activity, please visit: 8