LUNCH AND LEARN. Sterile Drug Products Used in the Pain Management Practice Setting. August 12, 2016

Transcription

1 LUNCH AND LEARN Sterile Drug Products Used in the Pain Management Practice Setting August 12, 2016 Featured Speaker: Stephen Jankovic, Pharm.D. Clinical Staff Pharmacist Presence Saint Joseph Medical Center 1 CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Jankovic has no relevant commercial and/or financial relationships to disclose

2 Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar Go to Print your CE Statement online Live CE Deadline: September 9, 2016 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor upon completion of the self assessment and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 2

3 Resources Visit to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 Sterile Drug Products Used in the Pain Management Practice Setting Stephen Jankovic, PharmD Clinical Staff Pharmacist Presence Saint Joseph Medical Center August 12th,

4 Disclosure I have no actual or potential conflicts of interest to disclose in relation to this presentation PharMEDium container product offerings by drug were listed on the company website and internal documents as of the date of this presentation; however, due to ongoing revisions of container offerings, some information in this presentation may not reflect the latest container options. 7 Pharmacist Learning Objectives Identify appropriate indications for use of sterile drug products for pain management Compare various sterile drug products used in the pain management setting Describe the different types of pain modalities available to patients for pain management Evaluate potential sources of error while preparing and compounding sterile drug products 8 4

5 Pharmacy Technician Learning Objectives Describe common indications for sterile drug products used in pain management Identify sterile drug products used in the pain management setting Review various routes of administration of sterile drug products used in pain management Recognize common sources of error during the preparation of sterile drug products 9 Why Manage Pain? 1 Proper pain management high priority in US Experienced by > 100 million Americans Cost to treat pain > half a trillion dollars Most common reason to consult a physician 1. Use of Opioids for the Treatment of Chronic Pain: A Statement from the American Academy of Pain Management. AAPM February

6 Definition of Pain 1 Defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage Subjective in nature Varies from patient to patient 1. Pain terms: a list with definitions and notes on usage. Recommended by the IASP subcommittee on taxonomy. Pain 1979; 6: Causes of Pain 1 Can be experienced at rest or related to: Surgery Procedures Trauma/Burns Underlying conditions Cancer Diabetes Sickle Cell 1. Pain terms: A list with definitions and notes on usage. recommended by the IASP subcommittee on taxonomy. Pain 1979; 6:

7 Challenges of Pain Management 1 Subjective nature of pain Varies based on individual tolerance and underlying conditions Emphasis on individualized treatment for pain specialist Requires a multimodal approach Medications used for chronic moderate-to-severe pain often have adverse effects Risk vs. benefits assessment when choosing treatment options 1. Use of Opioids for the Treatment of Chronic Pain: A Statement from the American Academy of Pain Management. AAPM February Local/Regional Anesthetics Buffered lidocaine Bupivacaine Ropivacaine (both alone and in combination with other narcotics) Source:

8 Opioid Analgesics Fentanyl Hydromorphone Morphine Meperidine Methadone Source: 15 Combined Agents Fentanyl-bupivacaine Fentanyl-ropivacaine Hydromorphone-bupivacaine Hydromorphone-ropivacaine Sufentanil-bupivacaine Sufentanil-ropivacaine Source:

9 Lidocaine HCl 1 Mechanism of action Blocks initiation and conduction of nerve impulse via decreased neuronal membrane permeability to sodium ions, resulting in inhibition of depolarization with resultant blockade of conduction Antiarrhythmic properties as well es/buffered-lidocaine-group.jpg/image-full 1. Xylocaine (lidocaine HCl injection USP) Package Insert. AAP Pharmaceuticals, LLC Schaumburg, IL. February Lidocaine HCl 1 Indications Local/regional anesthetic Induction in rapid sequence intubation Compatibility Lidocaine concentration 1mg/mL Compatible in: Sodium bicarbonate (2.4 meq/l) Dextrose 5% (2.4 meq/l) 2 mg/ml Sodium bicarbonate (40 meq/l) 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition

10 Buffered Lidocaine Containers BD syringe Source: 19 Buffered Lidocaine 1 Administration Intra-dermal IV Common adverse effects Edema Erythema Petechiae Pruritus 1. Product Information: Zingo(TM) intradermal injection powder, lidocaine HCl monohydrate intradermal injection powder. Medline Industries, Inc. (per DailyMed), Mundelein, IL,

11 Why Buffered Lidocaine? 1 Infiltration of local anesthetic can be painful Believed to be due to acidity of lidocaine HCl Cochrane study found adjusting ph of lidocaine with sodium bicarbonate reduced pain of injection Based on 23 studies Larger magnitude of pain decrease found in lidocaine solutions containing both sodium bicarbonate AND epinephrine vs just sodium bicarbonate 1. Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the ph of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010;(12): CD Bupivacaine HCl 1 Mechanism of action Blocks generation and conduction of nerve impulses: Increases electrical excitation threshold in the nerve Slows propagation of the nerve impulse Reducing the rate of rise of action potential Progression of anesthesia determined by nerve fiber: Diameter Myelination Conduction velocity 1. Product Information: Marcaine(TM) Spinal solution for spinal injection, bupivacaine hydrochloride solution for spinal injection. Hospira, Inc., Lake Forest, IL,

12 Bupivacaine HCl 1 Indications Local/regional anesthetic Compatibility Bupivacaine concentration Compatible in: mg/ml 0.6 mg/ml 0.85 mg/ml 1mg/mL 1.25 mg/ml Sodium chloride 0.9% 0.6 mg/ml Dextrose 5% 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition Bupivacaine HCl Containers BD syringe Baxter Intravia bags Hospira LifeCare bag Smiths Medication Cassette Reservoir IFLOW On-Q Pre-filled Pain Pump Source:

13 Bupivacaine HCl 1 Administration Intrapleural Epidural Adverse Effects Bacterial meningitis Cardiac arrest Respiratory arrest Seizure 1. Product Information: Marcaine(TM) Spinal solution for spinal injection, bupivacaine hydrochloride solution for spinal injection. Hospira, Inc., Lake Forest, IL, Morphine Sulfate 1 Mechanism of action Pure opioid agonist activates mu-opioid receptors in central nervous system to achieve analgesia Decreased brain-stem respiratory response, CO2 tension, and electrical stimulation promote respiratory depression and analgesia Induces peripheral vasodilation and opioid-induced hypotension via histamine release 1. Product Information: morphine sulfate intravenous solution, USP, morphine sulfate intravenous solution, USP. Faulding Pharmaceutical Co, Paramus, NJ,

14 Morphine Sulfate 1 Compatible with virtually any solution D5W D10W D5LR D5NS D5W-1/2 NS NS ½ NS D5 in Ringer s Lactated Ringer s injection Ringer s injection 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition Morphine Sulfate 1 Concentration of 60 mg/ml in NS found to be incompatible Precipitated in 4-8 days under refrigeration About 50% loss of drug Discoloration occurred after 5 days at room temperature Found no loss in concentration after 14 days Stored in Cormed II Kalex pump reservoirs 1. Altman L, Hopkins RJ, Ahmed S, et al: Stability of morphine sulfate in Cormed III (Kalex) intravenous bags. Am J Hosp Pharm: :

15 Morphine Sulfate, continued 1 Common Indications Intractable chronic pain Moderate to severe pain unresponsive to non-narcotic analgesics Chest pain related to myocardial infarction Administration IV push Epidural Intrathecal PCA 1. Product Information: morphine sulfate intravenous solution, USP, morphine sulfate intravenous solution, USP. Faulding Pharmaceutical Co, Paramus, NJ, Morphine Sulfate, continued Containers BD syringe Baxter Intravia bag Hospira LifeCare bag Smiths Medication Cassette Reservoir Covidien monoject barrel/syringe Source:

16 Morphine Sulfate, continued 1 Common Adverse Effects Pruritus (epidural/intrathecal up to 80%) Nausea (epidural/intrathecal 15-70%) Respiratory depression Constipation Urinary retention (epidural/intrathecal 15-70%) Hypotension 1. Product Information: DURAMORPH(TM) injection, morphine sulfate injection. Baxter Healthcare Corporation, Deerfield, IL, Fentanyl Citrate 1 Mechanism of action Pure opioid agonist activates mu-opioid receptors in central nervous system to achieve analgesia Other pharmacological effects Anxiolytic/relaxation Euphoria Respiratory depression Cough suppression Reduced peristalsis of the GI system 1. Product Information: Fentanyl Citrate IV, IM injection. Hospira, Inc, Lake Forest, IL,

17 Fentanyl Citrate, continued 1 Common Indications General anesthesia Post-operative pain Analgesia for mechanically ventilated patients Pre-medication for procedures Ex: rapid sequence intubation Equianalgesic dose 100 mcg = 10 mg of morphine 1. Physician s Desk Reference Online (PDR.net): Available at: Accessed August 10, Fentanyl Citrate, continued 1 Compatibility Fentanyl concentration 1 mcg/ml 5 mcg/ml 12.5 mcg/ml 20 mcg/ ml 30 mcg/ ml 35 mcg/ml 1 mcg/ml 5 mcg/ml 20 mcg/ml 40 mcg/ml Compatible in: Sodium chloride 0.9% Dextrose 5% 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition

18 Fentanyl Citrate, continued Containers BD syringe Baxter Intravia bags Hospira LifeCare bag Smiths Medication Cassette Reservoir IFLOW On-Q Pre-filled Pain pump Covidien monoject barrel/syringe Hospira PCA vial Source: 35 Fentanyl Citrate, continued 1 Administration IV push Continuous infusion PCA Epidural Intrathecal Common Adverse Effects Bradycardia Hypotension Respiratory depression Constipation 1. Product Information: Fentanyl Citrate IV, IM injection, Fentanyl Citrate IV, IM injection. Hospira, Inc, Lake Forest, IL,

19 Hydromorphone HCl 1 Mechanism of action Pure opioid agonist activates mu-opioid receptors in central nervous system to achieve analgesia Morphine derivative 7-8 times more potent 1.5 mg = 10 mg of morphine 1. Product Information: DILAUDID(R), DILAUDID-HP(R) injection, hydromorphone hydrochloride injection. Hospira, Inc, Lake Forest, IL, Hydromorphone HCl, continued 1 Common Indications Moderate to severe pain in opioid-tolerant patients Pain when opioid analgesics are appropriate Administration IV push IM PCA Epidural 1. Product Information: hydromorphone HCl intravenous injection, intramuscular injection, subcutaneous injection. Akorn, Inc. Lake Forest, IL,

20 Hydromorphone HCl, continued 1 Compatible with D5W D5LR D5NS D5W-1/2 NS NS ½ NS D5 in Ringer s Lactated Ringer s injection Ringer s injection 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition Hydromorphone HCl, continued Containers Baxter Intravia bag BD syringe Hospira LifeCare bag Smiths Medication Cassette Reservoir Covidien monoject barrel/syringe Hospira PCA vial Source:

21 Hydromorphone HCl, continued 1 Common Adverse Effects Hypotension Respiratory depression Constipation 1. Product Information: hydromorphone HCl intravenous injection, intramuscular injection, subcutaneous injection. Akorn, Inc. Lake Forest, IL, Meperidine HCl 1 Mechanism of action Binds to opioid receptors in the CNS to produce analgesia and sedative effects NOT recommended for use as analgesic agent If used, treatment should be limited < 48 hr and dose <600 mg/hr 1. Product Information: Meperidine HCl intramuscular subcutaneous intravenous injection. West-ward Pharmaceutical Corp. Eatontown, NJ,

22 Meperidine HCl, continued 1 Indications Anesthesia adjunct Obstetric pain Commonly used off-label for treatment of pre- and post-op shivering Administration IV push Risk of drug accumulation with prolonged use IM Approved for IM administration, but not routinely recommended Product Information: Meperidine HCl intramuscular subcutaneous intravenous injection. West-ward Pharmaceutical Corp. Eatontown, NJ, Meperidine HCl, continued 1 Compatible with virtually any solution D5W D10W D5LR D5NS D5W-1/2 NS NS ½ NS D5 in Ringer s Lactated Ringer s injection Ringer s injection 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition

23 Meperidine HCl, continued 1 Containers BD syringe Baxter Intravia bag Smiths Medication Cassette Reservoir Covidien monoject barrel/syringe Source: 45 Meperidine HCl, continued 1 Common Adverse Effects Diaphoresis Nausea/vomiting Hypotension Respiratory depression 1. Product Information: Meperidine HCl intramuscular subcutaneous intravenous injection. West-ward Pharmaceutical Corp. Eatontown, NJ,

24 Methadone HCl 1 Mechanism of action Synthetic opioid agonist that binds to opioid receptors in the CNS to produce analgesia and sedative effects similar to morphine May also act as a N-methyl-D-aspartate (NMDA) receptor antagonist 1. Product Information: methadone hydrochloride intramuscular, intravenous, subcutaneous solution. aaipharma, Wilmington, NC. 47 Methadone HCl, continued 1 Common Indications Treatment of opioid dependence Drug detoxification Maintenance therapy Moderate-to-severe pain refractory to non-narcotic analgesics Administration IV push IM/subQ Recommended short-term; transition to PO as soon as feasible 1. Product Information: methadone hydrochloride intramuscular, intravenous, subcutaneous solution. aaipharma, Wilmington, NC

25 Methadone HCl, continued 1 Compatibility Methadone concentration 1 mg/ml 2mg/mL 5 mg/ml Compatible in: Sodium chloride 0.9% 1. Trissel LA. Trissel s Stability of Compounded Formulations, 5 th Edition Methadone HCl, continued Containers BD syringe Baxter Intravia bag Source:

26 Methadone HCl, continued 1 Common Adverse Effects Hypotension Diaphoresis Nausea/vomiting Constipation Prolonged QT interval Respiratory depression 1. Product Information: methadone hydrochloride intramuscular, intravenous, subcutaneous solution. aaipharma, Wilmington, NC. 51 Combined Epidural Agents Fentanyl-bupivacaine Fentanyl-ropivacaine Hydromorphone-bupivacaine Hydromorphone-ropivacaine Sufentanil-bupivacaine Sufentanil-ropivacaine Source:

27 Benefits of Combined Agents 1-2 Adequate analgesic relief with minimal motor block During labor and delivery Adequate analgesic relief with reduced dosage need Reduced incidence of adverse effects 1. Groen RA, Bolt ML, van Kleef JW, et al. Comparison between continuous epidural infusion of bupivacaine % plus sufentanil and bupivacaine 0.125% during labor. Reg Anesth 1992; 17(1): Elliott RD. Continuous infusion epidural analgesia for obstetrics: bupivacaine versus bupivacaine-fentanyl mixture. Can J Anaesth 1991; 38: PCA Pumps 1 Administration of medication controlled by patient Reduces delay in patient access to pain medication Multiple routes of administration IV Epidural (PCEA) Intrathecal Transdermal 1. Hudcova J, McNicol E, Quah C, Lau J, Carr DB. Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain. Cochrane Database Syst Rev /PCA-01.JPG/800px-PCA-01.JPG 27

28 Fentanyl Iontophoretic Transdermal System (IONSYS ) 1 First transdermal PCA Approved April 2015 for postoperative acute pain management in the hospital 1. Source: Product Information: IONSYS fentanyl iotophoretic transdermal system. The Medicines Company, Parsippany, NJ April Fentanyl Iontophoretic Transdermal System (IONSYS ) Source:

29 ON-Q Pain Relief System Balloon type pain pump: Fixed flow rate Variable rate controller Bolus option 1. Source: Product Information: ON-Q Pain Relief System Product Information. Kimberly-Clark Health Care Company, Roswell, GA Advantages of PCA Pumps 1 Puts patients in driver s seat and so they can take a more active role in their pain management Decreased risk of drug overdose Programmable doses Dose titratability Fixed lockout interval reduces risk of too much and too fast 1. Hudcova J, McNicol E, Quah C, Lau J, Carr DB. Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain. Cochrane Database Syst Rev

30 Major Potential Sources of Error During the Compounding Process 1 Product labeling Sterile drug product preparation Gathering all required supplies Sterile drug product compounding Deviations in aseptic technique 1. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for Safe Preparation of Compounded Sterile Preparations. Institute for Safe Medication Practices Potential Labeling Errors During the Compounding Process 1 Wrong/missing information on label Drug name Strengths/concentrations Ex: mg instead of mcg Storage/stability 1. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for Safe Preparation of Compounded Sterile Preparations. Institute for Safe Medication Practices

31 Standardized Labels 1 Standardized label TALLman lettering Drug strength/concentration Additional safety warnings IV USE ONLY Reduces risk of mislabeling errors 61 Source: HCl_0.jpg/image-full;max$900,900.ImageHandler 1. Bauer DT, Guerlain S. Improving the usability of intravenous medication labels to support safe medication delivery. Int J Ind Ergon Jul 1; 41(4): Potential Preparation/Compounding Errors 1 Wrong drug Look-alike sound-alike Wrong diluent/concentration Compatibility issues Stability issues Dosing issues 1. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for Safe Preparation of Compounded Sterile Preparations. Institute for Safe Medication Practices

32 Errors in Aseptic Technique 1 Contaminated product Can cause severe infection IV/Epidural administration Fungal meningitis outbreaks in 2012 FDA confirmed fungal and bacterial contamination in multiple unopened vials of 3 different sterile drug products Resulted in call for tighter regulations and FDA oversight 1. Pettit AC, Kropski JA, Castilho JL, et al. The index case for the fungal meningitis outbreak in the United States. N Engl J Med 2012;367 : ISMP General Recommendations 1 Organizational practices comply with USP Chapter <797> standards (Level 2) Policies and procedures that guide compounding of sterile products be well-defined (Level 3) Organizations identify standardized workflow processes that include quality control, process change control and documentation practices (Level 3) 1. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for Safe Preparation of Compounded Sterile Preparations. Institute for Safe Medication Practices

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