SAN FRANCISCO EMS AGENCY
`PROTOCOL MANUAL
`
`TABLE OF CONTENTS
`
`January 30, 2017
`
`PROTOCOL
`NUMBER
`
`1.01
`1.02
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`2.01
`2.02
`2.03
`2.04
`2.05
`2.06
`2.07
`2.08
`2.09
`2.10
`2.11
`2.12
`2.13
`2.14
`2.15
`2.16
`
`3.01
`3.02
`3.03
`3.04
`3.05
`3.06
`
`4.01
`4.02
`4.03
`
`TITLE
`Section 1: Assessment
`Patient Assessment – Primary Survey
`Patient Assessment – Secondary Survey
`Section 2: Medical
`Abdominal Discomfort
`Allergic Reaction
`Altered Mental Status
`Cardiac Arrest
`Post Cardiac Arrest/ROSC
`Chest Pain/Acute Coronary Syndrome
`Dysrhythmias: Bradycardia
`Dysrhythmias: Tachycardia
`Pain Control
`Poisoning and Overdose
`Respiratory Distress: Bronchospasm
`Respiratory Distress: Acute Pulmonary Edema
`Seizures
`Stroke
`Suspected Sepsis
`Shock
`Section 3: Environmental
`Bites, Stings and Envenomation
`Decompression Illness
`(Near) Drowning
`Hazardous Materials Overview
`Hyperthermia
`Hypothermia
`Section 4: Trauma
`General Trauma: Evaluation and Overview
`Traumatic Cardiac Arrest
`Head, Neck, and Facial Trauma
`
`Page 1 of 3
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`EFFECTIVE DATE
`
`03/01/2015
`03/01/2015
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`03/01/2015
`01/30/2017
`01/30/2017
`01/30/2017
`01/30/2017
`01/30/2017
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
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`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
`03/01/2015
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`03/01/2015
`03/01/2015
`03/01/2015
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`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 1
`
`

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`4.04
`4.05
`4.06
`
`5.01
`
`6.01
`
`7.01
`7.02
`7.03
`7.04
`7.05
`7.06
`7.07
`7.08
`7.09
`7.10
`7.11
`7.12
`7.13
`
`7.14
`7.15
`
`8.01
`8.02
`8.03
`8.04
`8.05
`8.06
`8.07
`8.08
`8.09
`8.10
`8.11
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`9.01
`9.02
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`
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`Chest, Abdominal and Pelvic Trauma
`Extremity Trauma
`Burns
`Section 5: GYN & OB
`Gynecological and Obstetrical Emergencies
`Section 6: Behavioral
`Agitated / Violent Patient
`Section 7: Procedures
`Airway Management
`Oral Endotracheal Intubation
`Extraglottic Airway
`Nasotracheal Intubation
`Needle Cricothyroidotomy
`Needle Thoracostomy
`Continuous Positive Airway Pressure (CPAP)
`Pulse Oximetry
`Carboxyhemoglobin Monitoring
`12-Lead ECG
`Spinal Motion Restriction
`Vascular Access with Intraosseous Device
`Vascular Access with Pre-Existing Vascular Access
`Device
`Reporting Assault / Abuse
`Splinting
`Section 8: Pediatric Medical
`Pediatric Allergic Reaction
`Pediatric Altered Mental Status
`Pediatric Dysrhythmias: Bradycardia
`Pediatric Dysrhythmias: Tachycardia
`Pediatric Cardiac Arrest: Neonatal Resuscitation
`Pediatric Cardiac Arrest: Bradyasystole and PEA
`Pediatric Cardiac Arrest: VF/Pulseless VT
`Pediatric Poison and Overdose
`Pediatric Respiratory Distress
`Pediatric Seizures
`Pediatric Shock
`Section 9: Pediatric Trauma
`Pediatric Trauma
`Pediatric Burns
`
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`Page 2 of 3
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`03/01/2015
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`01/30/2017
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`03/01/2015
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`03/01/2015
`01/30/2017
`03/01/2015
`01/30/2017
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`03/01/2015
`03/01/2015
`03/01/2015
`01/30/2017
`03/01/2015
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`03/01/2015
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`03/01/2015
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`03/01/2015
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`03/01/2015
`03/01/2015
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 2
`
`

`

`
`
`
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`
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`10.01
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`11.01
`11.02
`11.03
`11.04
`11.05
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`12.01
`12.02
`12.03
`12.04
`12.05
`12.06
`12.07
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`12.08
`12.09
`12. 10
`
`12.11
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`12.12
`12.13
`
`I
`II
`III
`
`Section 10: Pediatric Behavioral
`Pediatric Agitated/Violent Patient
`Section 11: Special Circumstances
`Austere Care Protocol
`Crush Syndrome
`Chemicals & Radiation
`Field Amputation
`Blast Injury
`Section 12: Critical Care Transport Paramedic
`Intravenous Infusion of Nitroglycerin
`Intravenous Infusion of Heparin
`Intravenous Infusion of Potassium Chloride
`Intravenous Infusion of Amiodarone
`Monitoring of Thoracostomy Tube
`Stoma and Tracheostomy Care
`Chemical Sedation for Ventilator Dependent and
`Agitated Patients
`Automatic Transport Ventilators
`Intravenous Infusion of Blood/Blood Products
`Intravenous Infusion of Glycoprotein IIb/IIIa
`Receptor Inhibitors
`Intravenous Infusion of Total Parental Nutrition
`(TPN)
`Intravenous Infusion of Morphine Sulfate
`Intravenous Infusion of Midazolam
`Section 13: References
`Medication List
`Abbreviations
`Pediatric Dosage Chart
`
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`03/01/2015
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`03/01/2015
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`03/01/2015
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`03/01/2015
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`03/01/2015
`03/01/2015
`03/01/2015
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`Page 3 of 3
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 3
`
`

`

`
`
`
`
`Protocol
`Number
`2.02
`
`
`
`
`Title
`Allergic Reaction
`
`
`2.03
`
`Altered Mental
`Status
`
`Summary of Changes effective January 30, 2017
`
` Summary of Protocol Revisions
`Action
`
`Taken
`Details
`Revision BLS Treatment: Added administration of intramuscular epinephrine by auto-
`injector for suspected anaphylaxis and/or severe asthma by trained EMT (new in
`state scope of practice for EMTs).
`•
`Epi added to EMT scope of practice due to statewide push to expand
`availability of treatment for anaphylaxis and/or severe asthma.
`Change added to Policy 2000 Personnel Standards and Scope of Practice
`
`•
`
`Revision BLS Treatment: Added Naloxone IN by trained EMTs (new in state scope of
`practice for EMTs).
`•
`Narcan added to EMT scope of practice due to statewide push to expand
`availability of treatment for opiod overdoses.
`Change added to Policy 2000 Personnel Standards and Scope of Practice.
`
`•
`
`ALS Treatment: Added Double Simultaneous External Defibrillation (DSED) (also
`called “dual defibrillation”) for refractory pulseless V fib /V tach.
`•
`Recent change in medical literature suggests DSED may convert persistent
`VF / VT due to change in energy vector.
`
`
`LVAD:
`• Minor edits to #9 to clarify Base Hospital vs. LVAD center field contact.
`•
`Added LVAD patient destination considerations for LVAD center (where the
`patient had the device implanted) in #10.
`
`2.04
`
`Cardiac Arrest
`
`
`Revision
`
`2.05
`
`Post Arrest & ROSC
`
`Revision
`
`2.06
`
`Chest Pain
`
`Revision
`
`5.01
`
`GYN & OB
`
`Revision
`
`Oral Endotracheal
`Intubation
`
`Nasotracheal
`Intubation
`
`Revision
`
`Revision
`
`12-Lead EKG
`
`Revision
`
`7.02
`
`7.04
`
`7.10
`
`
`
`
`Revised to conform to AHA 2015 guidelines for targeted temperature management
`by checking and maintaining temperature between 32 and 36 degrees Celsius for
`adults and 36.5 – 37.5 degrees Celsius for newborns.
`
`ALS Treatment: Added if 12-lead EKG interpretation is compatible with “STEMI” per
`EKG protocol, initiate transport and notification of the appropriate STAR center.
`
`Added AHA guidelines on neonatal temperature management in the comments
`section:
`• Newborn hypothermia can occur within minutes. Keep the baby on the
`mother’s belly skin to skin until the cord is clamped. If continued access to the
`infant is necessary (e.g. for positive pressure ventilation) keep the baby warm
`including the use of warmed blankets or radiant warmer if available).
`
`
`• Added requirement for end tidal CO2 monitoring to confirm tube placement.
`• Added requirement for continuous end tidal CO2 monitoring post-intubation.
`
`• Added requirement for end tidal CO2 monitoring to confirm tube placement.
`• Added requirement for continuous end tidal CO2 monitoring post-intubation.
`
`•
`
`Revised case definition for STEMI adding ***acute STEMI*** to EKG
`criteria and minimum ST elevation criteria to correct oversight in current
`protocol.
`Training requirement moved to a separate training guidance that will
`accompany the protocol release.
`
`•
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 4
`
`

`

`CITY AND COUNTY OF SAN FRANCISCO
`
`PREHOSPITAL CARE VISION AND ETHICS STATEMENT
`
`2015
`
`Our EMS community consists of a team of health care professionals including EMT-1’s, Paramedics,
`Nurses, Physicians, Researchers, Dispatchers and system Educators and Administrators. This statement
`defines our goals and ethical responsibilities and is beneficial in guiding our practice.
`
`We believe that…
`
`• We exist to provide the best possible emergency care to the residents and visitors of the City
`and County of San Francisco at all times and in all places.
`• Competent medical care must be provided with compassion and regard for human dignity to all
`persons, regardless of ethnicity, race, creed, gender, economic status, sexual orientation,
`gender identity, age or response to our care.
`• Patients who are competent have the right to determine what shall be done with their body and
`to receive or refuse medical service and to know the consequences of their decision.
`• We are accountable for providing medical care to the best of our ability and for accurately
`documenting our care.
`• Patients and colleagues must be dealt with in an honest and truthful manner in all matters
`pertaining to our prehospital care.
`• The highest standard of professional conduct must be maintained with providing medical care,
`including respect, confidentiality and maintenance of personal competence and teaching other
`members of the prehospital community.
`• We are responsible for upholding the standards of the profession and for participating in
`activities that contribute to its growth and improve our community.
`• We must obey and respect the law and not participate in any professionally unethical activities.
`We refuse to let personal considerations such as economic gain or convenience influence our
`provision of patient care, and we refrain from activities which may impair our professional
`judgment and our ability to act competently.
`• Our EMS system, organization, supervisors, peers and subordinates deserve our utmost loyalty.
`• Where conflicts of interest arise, our professional judgments should always be guided by our
`ultimate obligation which is to our patients and the public that we serve.
`• We are committed to accomplishing our job; and that commitment stems from the desire to be
`the best we can possibly be and the affirmation of all the preceding elements of this code.
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 5
`
`

`

`
`
`
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`
`
`Section 1: Assessment
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 6
`
`

`

`1.01 PATIENT ASSESSMENT—PRIMARY SURVEY
`
`The purpose of the primary survey is to identify and immediately correct life-threatening
`problems.
`
`SCENE SIZE-UP / GLOBAL ASSESSMENT:
`• Recognize hazards, ensure safety of scene and secure a safe area for treatment.
`• Apply appropriate universal body/substance isolation precautions.
`•
`Identify number of patients and whether additional resources are needed
`• Observe position of patient and determine chief complaint or mechanism of injury.
`• Plan strategy to protect evidence at potential crime scene.
`
`GENERAL IMPRESSION:
`• Check for life threatening conditions.
`• AVPU (A=alert, V=responds to verbal stimuli, P=responds to painful stimuli,
`U=unresponsive).
`
`
`AIRWAY:
`• Ensure open airway.
`• Protect spine from unnecessary movement in patients at risk for spinal injury.
`• Look and listen for evidence of upper airway problems and potential obstructions:
`• Utilize any appropriate adjuncts as indicated to maintain airway.
`
`BREATHING:
`• Assess for breathing.
`•
`Intervention for inadequate ventilation and/or oxygenation using approved adjuncts as
`indicated.
`
`
`CIRCULATION:
`Check for pulse. If no pulse, begin CPR and/or defibrillate while following appropriate cardiac
`arrest protocols.
`• Control life-threatening hemorrhage.
`
`
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`Page 1 of 1
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`
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`SAN FRANCISCO EMS AGENCY
`Effective: 03/01/15
`Supersedes: 01/01/11
`
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 7
`
`

`

`1.02 PATIENT ASSESSMENT –SECONDARY SURVEY
`
`
`
`5 = Oriented
`4 = Confused
`3 = Inappropriate words
`2 = Incomprehensible words
`1 = No Response
`
`
`Motor Response
`6 = Obeys Commands
`5 = Purposeful / Localizes pain
`4 = Withdraws to pain
`3 = Flexion to pain
`2 = Extension to pain
`1 = No Response
`
`
`The secondary survey is the systematic assessment and complaint-focused relevant physical
`examination of the patient.
`
`• The Primary Survey and initial treatment and stabilization of life-threatening airway,
`breathing and circulation difficulties.
`• Need for Spinal Motion Restriction.
`• A rapid trauma assessment (if indicated by related trauma protocol).
`• Transport of the potentially unstable or critical patient.
`•
`Investigation of the chief complaint and associated complaints, signs or symptoms.
`• An initial set of vital signs:
`o Pulse.
`o Blood pressure.
`o Respiration.
`o Lung sounds.
`o Pupils.
`o Cardiac rhythm (if indicated by related protocol).
`o Pulse oximetry.
`o Blood Glucose (if indicated by related protocol).
`o Determine Glascow Coma Scale (GCS) Score:
`Eye Opening
`Verbal Response
`4 = Spontaneous
`3 = To verbal stimuli
`2 = To painful stimuli
`1 = No Response
`
`
`
`USING THE GCS TO ASSESS INFANTS AND YOUNG CHILDREN:
`Eye Opening
`Verbal Response
`4 = Spontaneous
`5 = Smiles, oriented to sounds, follows objects,
`interacts
`4 = Cries but is consolable; inappropriate
`interactions
`3 = Inconsistently consolable, moaning
`2 = Inconsolable, agitated
`1 = No vocal response
`
`
`Motor Response
`6 = Obeys Commands
`
`5 = Purposeful/Localizes pain
`
`4 = Withdrawal from pain
`3 = Flexion to pain
`2 = Extension to pain
`1 = No motor response
`
`3 = To verbal stimuli
`
`2 = To painful stimuli
`1 = No response
`
`
`
`
`HISTORY
`• Obtain Patient History from available sources.
`• Allergies.
`• Medications. Past medical history relevant to chief complaint
`• Assessment questions, if appropriate:
`
`
`
`
`
`
`
`Page 1 of 2
`
`
`
`SAN FRANCISCO EMS AGENCY
`Effective: 03/01/15
`Supersedes: 01/01/11
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 8
`
`

`

`1.02 PATIENT ASSESSMENT –SECONDARY SURVEY
`
`
`
`o OPQRST (location, factors that increase or decrease the pain severity and a pain
`scale.)
` O= Onset (Sudden or gradual)
` P= Provoke (What were you doing when the pain started? Does anything
`make it better or worse?)
` Q= Quality (What does the pain feel like?)
` R= Region/Radiate (Where is the pain? Does it go anywhere else?)
` S= Severity (On a scale of 1-10, 10 being the worst pain you have ever had,
`how would you rate that pain now? How would you rate that pain at its
`worst or during exertion/movement?)
` T= Time (When or what time did this start?)
`o PASTE (Used for Shortness of Breath Assessment)
` P= Progression (Sudden or gradual?)
` A= Assoc. Chest Pain (If yes, which came first?)
` S= Sputum (Are you coughing anything up? If yes, what color is it?)
` T= Time, Temp, Talkability (When or what time did this start? Have you had
`or do you have a fever? How many word sentences can the patient speak in?)
` E= Exercise tolerance (What is the patient’s tolerance for exertion? Can they
`get up and walk without getting SOB? What is their baseline tolerance level?)
`• Mechanism of injury (as indicated by relevant protocol).
`For focused history findings relevant to specific patient complaints, see protocols
`related to each chief complaint.
`EXPOSE, EXAMINE & EVALUATE:
`
`• Minimize on scene time for trauma patients
`
`• All physical assessments for trauma should determine the presence or absence of DCAP-
`BTLS:
`o Deformity
`o Contusion/Crepitus
`o Abrasion
`o Puncture
`o Bruising/Bleeding
`o Tenderness
`o Laceration
`o Swelling
`In situations with suspected life threatening trauma mechanism, a rapid trauma assessment
`should be performed:
`o Expose head, trunk, and extremities.
`o Rapid Trauma Assessment looking for and treating life threatening injuries.
`o See relevant protocols for Head, Neck, Facial, Chest, Abdominal, Pelvis, and Extremity.
`• Treat any newly discovered life-threatening wounds.
`
`
`•
`
`
`
`
`
`
`
`Page 2 of 2
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`
`
`SAN FRANCISCO EMS AGENCY
`Effective: 03/01/15
`Supersedes: 01/01/11
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 9
`
`

`

`
`
`
`
`
`Section 2: Medical
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 10
`
`

`

`2.01ABDOMINAL DISCOMFORT
`BLS Treatment
`
`
`
`• Position of comfort.
`• NPO.
`• Oxygen as indicated.
`
`ALS Treatment
`
`•
`IV / IO of Normal Saline TKO.
`•
`If SBP <90 or signs of poor perfusion, Normal Saline fluid bolus.
`• For pain, may administer Morphine Sulfate.
`• For nausea/vomiting, may administer Ondansetron.
`
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`Page 1 of 1
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`
`
`SAN FRANCISCO EMS AGENCY
`Effective: 03/01/15/
`Supersedes: 01/07/13
`
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 11
`
`

`

`
`
`
`
`• Position of comfort.
`• NPO.
`• Oxygen as indicated.
`• May help patient administer their personal EpiPen autoinjector or equivalent product.
`•
`If patient does not have a personal autoinjector, give IM EpiPen autoinjector or equivalent
`product for suspected anaphylaxis and/or severe asthma if EMT has been trained.
`
`2.02 ALLERGIC REACTION
`BLS Treatment – ALL Allergic Reactions
`
`ALS Treatment - SPECIFIC Allergic Reactions
`MILD ALLERGIC REACTION
`Hives, rash and/or itching
`
`• Diphenhydramine
`
`
`MODERATE ALLERGIC REACTION
`Hives, rash. Mild bronchospasm.
`• Establish IV/IO Normal Saline TKO.
`• Diphenhydramine
`• Albuterol
`
`
`SEVERE ALLERGIC REACTION (ANAPHYLAXIS)
`Altered mental status, hypotension (SBP < 90) and evidence of hypoperfusion. Bronchospasm
`and/or angioedema
`
` •
`
` Epinephrine
`• Establish IV/IO Normal Saline TKO.
`•
`If no response to IM Epinephrine or patient is in extremis, administer IV Epinephrine.
`• Diphenhydramine
`• Albuterol
`•
`If SBP < 90 or signs of poor perfusion, Normal Saline fluid bolus.
`
`
`
`
`Page 1 of 1
`
`SAN FRANCISCO EMS AGENCY
`Effective:01/30/2017
`Supersedes 03/01/15
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 12
`
`

`

`2.03 ALTERED MENTAL STATUS
`BLS Treatment
`
`
`
`•
`
`
`
`• Position of comfort.
`• NPO except as noted below.
`• Oxygen as indicated.
`• Administer Glucose Paste or Oral Glucose to known diabetic patients with symptoms of
`hypoglycemia. Patient must be conscious and have an intact gag reflex.
`If opiate overdose is suspected AND respiratory depression are not responsive to BLS airway
`management: administer Naloxone IN if EMT has been trained.
`
`ALS Treatment
`
`•
`IV / IO of Normal Saline TKO.
`• Check blood glucose:
`o
`If blood glucose is <60 mg/dl, unmeasurable, or patient is a known diabetic: administer
`Dextrose.
`o
`If blood glucose < 60 mg/dl and IV cannot be established: administer Glucagon.
`If opiate overdose is suspected AND respiratory depression are not responsive to BLS airway
`management: administer Naloxone IN, IV or IM.
`
`
`•
`
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`Page 1 of 1
`
`
`
`
`
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes 03/01/15
`
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 13
`
`

`

`2.04 CARDIAC ARREST
`
`BLS Treatment - ALL Cardiac Arrest
`
`• CPR / AED
`• Oxygen as indicated.
`
`ALS Treatment - ALL Cardiac Arrest
`Current American Heart Association Guidelines concerning Emergency Cardiac Care
`assessments and interventions shall always take precedence over local protocols when there
`is a conflict concerning techniques of resuscitation.
`
`• Defibrillation if indicated.
`• Advanced airway if indicated.
`•
`IV Normal Saline if indicated.
`• Provide grief support and referrals for on-site survivors as needed.
`
`
`
`ALS Treatment - SPECIFIC Causes of Cardiac Arrest
`
`VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA
`
`
`• Defibrillation
`• Epinephrine
`• Amiodarone
`
`
`REFRACTORY PULSELESS VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA
`• Persistent pulseless VF/VT without ANY prior different rhythm
`• Administer Double Simultaneous External Defibrillation (DSED) as follows:
`1. After two shocks have been administered, if a second defibrillator is available, apply
`a second set of defibrillator pads to the patient in a DIFFERENT vector than the first
`set, not touching the first set. (If the first set has been applied in the anterior-lateral
`configuration, apply the second set anterior-posterior, and vice versa).
`
`2. After at least 2 defibrillation attempts, epinephrine, and amiodarone have been
`administered, if a shockable rhythm is present on next rhythm check, administer a
`single defibrillation shock using ONLY the second set of pads (alternate vector). If
`unsuccessful, this should be repeated once per ACLS algorithm.
`
`3. After at least 4 shocks have been delivered using at least two vectors with single
`defibrillators, and epinephrine and amiodarone have been administered, if a
`shockable rhythm is present on rhythm check, continue CPR and prepare for double
`simultaneous external defibrillation. Set both defibrillators to maximum energy and
`
`_____________________________________________________________________________________________________________________
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`Page 1 of 4
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 14
`
`

`

`2.04 CARDIAC ARREST
`
`charge both defibrillators simultaneously. Once both defibrillators are charged and
`all persons are clear, the code leader or other paramedic will push both shock
`buttons as synchronously as possible.
`
`4. Resume resuscitation as per ACLS guidelines, with all subsequent shocks being DSED.
`
`
`
`
`ASYSTOLE/PULSELESS ELECTRICAL ACTIVITY
`
`
`• Epinephrine
`
`TREAT REVERSIBLE CAUSES
`
`• Sodium Bicarbonate for suspected hyperkalemia, DKA, tricyclic or phenobarbital overdose.
`• Calcium Chloride for suspected hyperkalemia or calcium channel blocker overdose.
`• Magnesium Sulfate for either Torsades de Pointes or VF/VT with suspected
`hypomagnesemia.
`• Normal Saline fluid bolus for an organized rhythm with SBP < 90.
`If hypotension persists, may administer Dopamine.
`•
`
`CARDIAC ARREST IN PREGNANCY
`
`• Anticipate difficult airway; experienced provider preferred.
`•
`If SBP < 90 or signs of poor perfusion, Normal Saline fluid bolus. Reassess and repeat as
`indicated.
`If possible, place patient in Left Lateral Decubitus Position or manually displace gravid uterus
`to patient’s left side.
` If patient is receiving IV/IO Magnesium pre-arrest, stop infusion and switch to Normal
`Saline. Flush line with Normal Saline prior to giving IV/IO Calcium Chloride.
`
`
`•
`
`•
`
`
`
`______________________________________________________________
`
`FIELD TREATMENT CONSIDERATIONS FOR PATIENTS
`WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD)
`
`
`1. Attempt to locate a POLST form. Many patients have made end-of-life care decisions.
`
`2. Provide pre-hospital care to the patient in a manner consistent with ALS and BLS treatment
`protocols for the patient’s condition with the following exceptions:
`
`
`• Do NOT perform chest compressions since it will dislodge the LVAD and cause internal
`bleeding.
`_____________________________________________________________________________________________________________________
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`Page 2 of 4
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 15
`
`

`

`2.04 CARDIAC ARREST
`
`• Arrhythmias: Do not disconnect power source, defibrillate per ACLS protocol.
`• DO follow the directions of the patient’s caregiver when moving and transporting the
`patient.
`
`
`
`3. The HeartMate (HM) II LVAD replaces the pumping action of the left ventricle via a
`continuous blood flow mechanism, where there is no filling or emptying phase.
`• As a result, patients commonly have NO PALPABLE PULSE, NO OBTAINABLE PULSE
`OXIMETRY OR BLOOD PRESSURE, and only a “mean” arterial pressure detectable using a
`Doppler.
`• An LVAD patient’s ECG heart rate will differ from the pulse rate since the LVAD is not
`synchronized with the native heart rate.
`
`
`4. Assess the patient’s airway and intervene per protocol. If you are unable to obtain pulse
`oximetry readings, you should assume the patient is hypoxic and place the patient on
`supplemental oxygen.
`
`5. If the patient has an altered level of consciousness, immediately check for end-tidal CO2
`using capnography.
`
`6. Auscultate heart sounds to determine if the device is functioning. You should expect to hear
`a continuous “whirling” sound for most devices.
`
`
`7. Assess the device for any alarms / malfunctions. Check with patient or caregivers for device
`reference materials or contact the VAD Center.
`
`8. Start at least 1 large bore IV, and give a 1L Normal Saline fluid bolus if you obtain a low
`blood pressure (systolic < 100) or are unable to obtain a blood pressure or the patient has
`an altered level on consciousness.
`
`9. Call the LVAD Center (open 24/7) per patient or patient’s caretaker’s contact to get advice
`on caring for the patient.
`• You are authorized to take orders from professionals at the LVAD Center, as long as they
`are within your scope of practice.
`• Contact the Base Hospital with questions or if directed by patient’s caregiver or LVAD
`Center personnel to do something outside of your protocol.
`
`
`10. Always transport the patient to the LVAD Center that implanted the device (UCSF or CPMC-
`Pac). You are authorized to BYPASS the closest San Francisco LVAD Center to get the
`patient to the LVAD Center that implanted their device no matter the patient’s condition. If
`the LVAD Center that implanted the device is not in San Francisco, take the patient to the
`closest San Francisco based LVAD Center.
`
`_____________________________________________________________________________________________________________________
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`Page 3 of 4
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 16
`
`

`

`2.04 CARDIAC ARREST
`
`• Bring ALL of the patient’s equipment. Bring the patient’s caregiver to act as the
`information resource on the device. You are authorized
`to use the caregiver as an information resource on the device.
`
`
`11. Upon arrival to Emergency Department, immediately plug in the device into an electrical
`socket.
`
`12. Call the Base Hospital for in-field termination of care in the event there are no signs of life
`and end-tidal capnography is not consistent with life (< 10).
`
`
`_____________________________________________________________________________________________________________________
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`Page 4 of 4
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 17
`
`

`

`2.05 ADULT POST-CARDIAC ARREST or
`RETURN OF SPONTANEOUS CIRCULATION (ROSC)
`
`• CPR/AED
`• Oxygen as indicated.
`
`BLS Treatment
`
`ALS Treatment
`Current American Heart Association Guidelines concerning Emergency Cardiac Care
`assessments and interventions shall always take precedence over local protocols when there
`is a conflict concerning techniques of resuscitation.
`
`IV/IO with Normal Saline TKO. Place second large bore IV with Normal Saline.
`•
`• Normal Saline fluid bolus if SBP < 90 or signs of hypoperfusion, and lungs are clear. Repeat
`PRN.
`If fluid bolus ineffective, May administer Dopamine. Titrate to maintain SBP > 90.
`If therapeutic hypothermia is indicated, administer chilled Normal Saline boluses (if available
`and if total volume does not exceed Therapeutic Hypothermia dose (see below).
`• Obtain 12 Lead ECG.
`
`•
`•
`
`Therapeutic Hypothermia
`• Stop all forms of active warming (maintain modesty) and turn off cabin heat.
`• Apply Ice Packs (Preferred method) OR
`•
`Infuse 30 mL/Kg of Normal Saline chilled to 3° C (66 Kg = 2 L) using 300 mm/Hg pressure
`infusion sleeve(s) or BP cuff.
`•
`If uncontrolled shivering and SBP >90, may administer Midazolam
`• Check and maintain temperature between 32 and 36 degrees Celsius for adults and 36.5 –
`37.5 degrees Celsius for newborns.
`
`
`Base Hospital Contact Criteria
`
`• Midazolam use if SBP < 90.
`
`
`
`Page 1 of 2
`
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 18
`
`

`

`2.05 ADULT POST-CARDIAC ARREST or
`RETURN OF SPONTANEOUS CIRCULATION (ROSC)
`
`Comments
`THERAPEUTIC HYPOTHERMIA INDICATIONS
`•
`Immediately after ROSC.
`• Age 18 and over
`• Patient does NOT follow commands (unresponsive and GCS < 8).
`• Systolic blood pressure ≥ 90 mm Hg.
`• SpO2 > 85%.
`• Blood glucose > 60 mg/dL.
`
`
`CONTRAINDICATIONS TO THERAPEUTIC HYPOTHERMIA
`• Hypothermic cardiac arrest patients with return of spontaneous circulation should not be
`actively cooled. Keep patient covered and transport to STAR center.
`• Responsive post arrest with GCS ≥ 8, and/or rapidly improving GCS.
`• Traumatic cardiac arrest.
`• Pregnancy.
`• Do Not Resuscitate (DNR) Status.
`• Patients with known bleeding diathesis or with active ongoing bleeding.
`• Patients with significant known liver disease.
`• Core temperature ≤ 32°C (90°F).
`
`
` ICE PACK LOCATIONS
`Apply 8 ice packs to the following areas:
`• 2 to sides of head
`• 1 at each carotid artery in neck.
`• 1 at each axilla.
`• 1 at each femoral artery in groin.
`
`
`
`Page 2 of 2
`
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`
`
`
`
`
`
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 19
`
`

`

`2.06 CHEST PAIN / ACUTE CORONARY SYNDROME
`
`
`
`BLS Treatment
`• Assess circulation, airway, breathing, and responsiveness.
`• Position of comfort. Position supine as tolerated if SBP < 90 or dizzy.
`• NPO. Unless otherwise noted
`• Oxygen as indicated; with appropriate adjuncts as indicated.
`ALS Treatment
`Current American Heart Association Guidelines concerning Emergency Cardiac Care
`assessments and interventions shall always take precedence over local protocols when
`there is a conflict concerning techniques of resuscitation.
`
`• Aspirin
`• 12-lead EKG must be done prior to administration of Nitroglycerin (NTG) or Morphine Sulfate
`• If 12-lead EKG interpretation is compatible with “STEMI” per EKG protocol, initiate transport
`and notification of the appropriate STAR center.
`• IV with Normal Saline TKO, large bore if possible.
`• Nitroglycerin (NTG)
`• Morphine Sulfate
`• Ondansetron
`• Normal Saline fluid bolus
`• Dopamine
`
`USE 12-LEAD EKG TO DETERMINE SAFETY OF NITROGLYCERIN ADMINISTRATION
`• Determine presence of ST elevation in leads II, III and AVF. If ST elevation is present, then
`apply V4R lead.
`If ST elevation in V4R, DO NOT give NTG (in order to maintain RV filling pressure).
`If no ST elevation in V4R and no clinical signs of shock, including SBP < 90 Hg, then it is
`safe to give NTG.
`
`•
`•
`
`
`
`
`
`
`_____________________________________________________________________________________________________________________
`SAN FRANCISCO EMS AGENCY
`Effective: 01/30/17
`Supersedes: 03/01/15
`
`
`
`Page 1 of 1
`
`Opiant Exhibit 2216
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 20
`
`

`

`2.07 DYSRHYTHMIA: SYMPTOMATIC BRADYCARDIA
`BLS Treatment
`
`• Position of comfort.
`• NPO.
`• Oxygen as indicated.
`
`ALS Treatment
`Current American Heart Association Guidelines concerning Emergency Cardiac Care
`as