Controlled Substance Prescribing in the Geriatric Population

1. Controlled Substance Prescribing in the Geriatric Population Lisa Byrd PhD, FNP-BC, GNP-BC Gerontologist

2. Outline • Review classes of controlled substances • Guidelines for Prescribing • Discuss onset of action of short-acting, long-acting, & rapid onset opioids • Identify enduring & emerging opioid therapies • Describe elements of an overall treatment program that includes opioids • Outline the advantages and disadvantages of risk management tools & techniques to identify aberrant behavior, abuse, & addiction

3. DISCLOSURE • Medications to manage pain & other symptoms will be discussed • Controlled Substances will be discussed • Off-label use may be mentioned but this will be discussed • Generic & Trade names will be used • Material has been researched & presented by author of this presentation • Presenter is on Speaker’s Bureau for: • Novartis Pharmaceuticals • Avanir Pharmaceuticals

4. USE OF CONTROLLED SUBSTANCES • are essential to the treatment of a myriad of disorders and represent a wide spectrum of pharmaceutical agents • prescribing these substances involves considering a number of important medical, social, and cultural variables along with adherence to applicable federal and state regulations • prescribers often stand at the crossroads of these issues and serve as the ultimate gatekeepers of safe and effective treatment

5. PRESCRIBERS… • Must be well-versed in the legal requirements including knowledge of both federal & state law • Controlled Substances Act (CSA) is the federal law that regulates such substances • The Drug Enforcement Administration (DEA) publishes a guide for prescribers entitled: "Practitioner's Manual, an Informational Outline of the Controlled Substances Act"

6. TYPES OF PRESCRIBERS • Physicians, Doctor of osteopath, Dentists, Podiatrists, & Veterinarians to prescribe controlled substances • Other licensed healthcare professionals: • Nurse Practitioners • Physician Assistants • Naturopathic Physicians • Optometrists • Medscape's US Nurse Practitioner Prescribing Law: A State-by-State Summary • DEA's Midlevel Practitioners Authorized by State Website

7. Evaluation of a Patient • Medical history & physical examination • FOR PAIN MANAGEMENT: the medical record should document: • the nature & intensity of the pain • current & past treatments for pain • underlying or coexisting diseases or conditions • the effect of the pain on physical & psychological function • history of substance abuse • Medical indications for the use of a controlled substance

8. TREATMENT PLAN:PAIN MANAGEMENT • State objectives that will be used to determine treatment success • should indicate if any further diagnostic evaluations or other treatments are planned • Adjust drug therapy to the individual medical needs of each patient • Other treatment modalities or a rehabilitation program may be necessary

9. INFORMED CONSENT &AGREEMENT FOR TREATMENT • Discuss the risks & benefits of the use of controlled substances • One prescriber & One pharmacy • If at high risk for medication abuse or has a history of substance abuse • consider the use of a written agreement

10. Pain Management Contract • between prescriber and patient outlining patient responsibilities: • urine/serum medication levels screening when requested • number and frequency of all prescription refills • reasons for which drug therapy may be discontinued • e.g., violation of agreement

11. STATE PRESCRIPTION DRUG MONITORING PROGRAMS • support access to legitimate medical use of controlled substances • drug abuse & diversion • intervention with & treatment of persons addicted to prescription drugs • inform public health initiatives • educate individuals about PDMPs • The Alliance of States with Prescription Monitoring Programswww.pmpalliance.org

12. PERIDODIC REVIEW • The course of pain treatment & any new information about the etiology of the pain • Evaluate progress toward treatment objectives • Satisfactory response to treatment • Objective evidence of improved or diminished function • If the patient's progress is unsatisfactory, the prescriber should assess the appropriateness of continued use

13. CONSULTATION • Refer the patient as necessary • Special attention if potential misuse, abuse or diversion • History of substance abuse or with a co-morbid psychiatric disorder

14. MEDICAL RECORDS • The prescriber should keep accurate and complete records to include: 1. medical history & physical examination 2.diagnostic, therapeutic and laboratory results 3. evaluations & consultations 4. treatment objectives 5. discussion of risks & benefits 6. informed consent 7. treatments 8. medications including date, type, dosage & quantity prescribed 9. instructions and agreements 10. periodic reviews • Records should remain current and be maintained in an accessible manner and readily available for review

15. Compliance With Controlled Substances Laws and Regulations • Prescriber must be licensed in the state & comply with applicable federal and state regulations • Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations

16. DEFINITIONS COMMON TERMS IN USE OF CONTROLLED SUBSTANCES

17. PAIN • an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

18. ACUTE PAIN • is the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus & typically is associated with invasive procedures, trauma and disease • generally time-limited

19. CHRONIC PAIN • persists beyond the usual course of an acute disease • or persists after healing of an injury • or may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain

20. CHRONIC PAIN SYNDROME (CPS) • presents a major challenge to healthcare providers because of its complexity • ongoing pain lasting longer than 6 months as diagnostic, • minimum of 3 months as the minimum criterion • constellation of syndromes that usually do not respond to the medical model of care

21. CPS-Pathophysiology • Multifactorial & Complex • Some suggest-learned behavioral syndrome • External re-inforcers • Individuals prone: • major depression, somatization disorder, hypochondriasis, & conversion disorder

22. TOLERANCE • is a physiologic state resulting from regular use of a drug in which an increased dosage is needed • may or may not be evident during treatment • does not equate with addiction

23. SUBSTANCE ABUSE • is the use of any substance(s) for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed

24. PHYSICAL DEPENDENCE • is a state of adaptation that is manifested by drug class-specific signs & symptoms that can be produced by: • abrupt cessation • rapid dose reduction • decreasing blood level of the drug, and/or administration of an antagonist • it is, by itself, does not equate with addiction

25. PSUEDOADDICTION • the iatrogenic syndrome resulting from the misinterpretation of relief seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction • resolve upon institution of effective analgesic therapy

26. ADDICTION • is a primary, chronic, neurobiologic disease, with genetic, psychosocial, & environmental factors influencing its development and manifestations • it is characterized by behaviors: • impaired control over drug use, craving, compulsive use, & continued use despite harm • physical dependence & tolerance are normal physiological consequences of extended therapy and are not the same as addiction

27. A Treatment Improvement Protocol Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders http://store.samhsa.gov/shin/content//SMA12-4671/SMA12-4671.pdf

28. Pain Control… is every patient’s right

29. BASIC PRINCIPLES • Pain diagnosis based on • inferred pathophysiology • identification of contributing factors • identification of barriers

30. Principles of Pain Management • Anticipate, prevent, and treat pain • Anticipate, prevent, and treat adverse effects of pain management

31. Pain Assessment • Pain history • Location • Intensity • Quality • Pattern • Aggravating or alleviating factors • Medication history

32. Physical Examination • Observe for non-verbal cues • withdrawal, fatigue, grimaces, irritability • Examine sites of pain • skin breakdown, changes in bony structure • Palpate areas of tenderness • Assess the patient • Auscultate lungs, abdomen • Percuss for fluid accumulation or gas • Conduct neurological exam

34. 4 types of pain • Nociceptive • Mechanical • Inflammatory • Tissue destructive • Neuropathic • Muscular • Psychogenic

35. NOCICEPTIVE PAIN • Nociception implies active mechanical, thermal or chemical process

36. Neuropathic pain • Aberrant signaling in the pain transmission or pain modulation pathways • Diabetic patient with neuropathy can experience pain due to spontaneous firing of damaged nerves • Quality is typically burning & often there is a paroxysmal quality such as shooting, jabbing or shock-like pain

37. MUSCULAR PAIN • is pulling, tight or aching • certain movements or positions may accelerate or trigger muscular pain • the location or pattern coincides with the affected muscles

38. Psychogenic pain • is pain that originates through cognitive & emotional processing • examples are conversion disorder, factitious disorder, & somatization disorder

39. PAIN SCALES • In acute pain: assessment of pain intensity using formal rating scales • 0 – 10 • visual analog scale where intensity is marked on a 10 cm line from NO PAIN to WORST POSSIBLE PAIN • In chronic pain management, intensity is evaluated based on assessing impairment, function, impact of pain & relative improvement in pain

41. Types of pain management agents • Analgesic agents • Nonsteroidal anti-inflammatory agents • Non-opioids • Opioids • Antidepressants • Anticonvulsants • Anxiolytic agents

42. Routes of Administration • Oral-offers pain relief equivalent to other routes but due to first pass metabolism-dosing must be increased when compared to IM, IV, or SQ routes • i.e.10 morphine IV, IM, or SQ is equivalent to 30 mg orally • Immediate release-MS IR • Liquid • Long acting (sustained release)-MS Contin, Oxycontin, Oramorph, Kadian sprinkles • Longer acting allows dosing of 8, 12, 24 hour intervals

43. Routes of Administration • Rectal (also stomal/vaginal) • Thrombocytopenia or painful lesions preclude this routes • Long acting opioid tablets can be placed rectally when patients are no longer able to swallow • Pharmacokinetic studies demonstrate approximately 90% of concentrations in plasma levels achieved when compared to oral delivery • Transdermal • Only formulary is fentanyl-patch applied every 72 hours (25, 50, 100 mcg/hr) • Delayed peak of onset of 17 hours after applying 1st patch • Effects of cachexia and fever are believed to accelerate drug distribution

44. TRICYCLIC ANTIDEPRESSANTS • are effective adjuvant analgesics in a wide range of painful conditions • unless contraindicated, consider in most chronic pain patients, especially in cases of neuropathic pain with continuous dysesthesias • side effects of these drugs help us choose them for individual patients based on which side effects are minimized or advantageous

45. ANTICONVULSANTS • used in the management of • Neuropathic pain • Trigeminal neuralgia • Carbamazepine is usually the first choice anti-convulsant for pain • Phenytoin, clonazepam and valproic acid are also used in the same settings • Newer anti-convulsant gabapentin (NeurontinB) for managing neuropathic pain

46. PAIN MEDICATIONS • NON-OPIOIDS • Non-steroidal anti-inflammatory drugs Acetaminophen • WEAK OPlOlDS • Codeine, Propoxyphene, Hydrocodone, Tramadol • OPIOID AGONIST/ANTAGONISTS • Butorphanol, Nalbuphine, Pentazocine • STRONG OPlOlDS • Morphine, Hydromorphone, Oxycodone, Levorphanol, Methadone, Meperidine, Fentanyl

47. Pharmacological Therapies for Pain Management • Nonopioids • Acetaminophen (Tylenol) • Action-analgesia, antipyretic • DOSAGE: • Acetaminophen (Tylenol) 325–500mg every 4 h or 500–1,000mg • Maximum dose usually 4 g daily • Reduce maximum dose 50% to 75% in patients with hepaticinsufficiency or history of alcohol abuse

48. Pharmacological Therapies for Pain Management • Nonsteroidal anti-inflammatory drugs (NSAIDS) • Aspirin, Ibuprofen (Motrin), Naproxen (Naprosyn) • Action-Analgesia, antiinflammatory, antipyretic, and inhibits prostoglandins by blocking cyclooxygebase. Prostoglandins are rich in the periosteum of bones and in the uterus-thus NSAIDS are very useful in relieving bone pain and dysmenorrhea • Do have a ceiling effect-increasing doses above a certain point will not increase analgesia

49. Tramadol (UltramB) • is an analgesic drug that works through two different mechanisms: • a weak mu opioid receptor agonist • has properties of serotonin and norepinephrine reuptake inhibition • Requires a DEA number for prescriptions • Analgesic potency is similar to that of other weak opioids. • Doses are 50 - 100 mg every 4-6 hours up to 400 mg per day. • most common side effects are gastrointestinal symptoms, dizziness, dry mouth, drowsiness, constipation, & seizures

50. Pharmacological Therapies for Pain Management • Opiods-Agonists • Codiene • Morphine (MS Contin, Oramorph, Kadian, Roxanol) • Hydrocodone (Vicodin, Lortab) • Methadone (Dolophine) • Oxycodone (OxyContin, Roxicodone, Roxifast)