Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures June 2021 Chair: Dr. Felicia Tornabene

TOPIC or Last Next review Document Owners Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Committee Date BOT approval AHS System Wide Policies & Procedures

VISITING 03/2020 05/2024 Janet McInnes, Chief  Revisions to Purpose  P&T: 5/24/21 HOURS/VISITORS Administrative and Policy paragraphs  CPC: 06/03/2021 Officer/Nurse Executive 06/15/21 eVote Approval after revisions made  MEC: Sedation/Analgesia for the 05/2024 Theresa Cooper - Patient  Protocol updated to  CPC 06/03/2021 Mechanically Ventilated Care Services – Highland address our TJC fallouts 06/15/21 eVote Approval surrounding the titration after revisions made Patient Violeta Luna-Jones of analgesic and  MEC: sedation drips on the ventilated patient in ICU.

System Medication 10/2019 07/2024 Priya Patel PharmD  Minor revision to include  System P&T approval language that samples 6/28/2021 Samples are only allowed if  CPC: 07/01/2021 approved by P&T  MEC:

Sedation Medications on NA 07/2024 Violeta Luna   System P&T approval 6/28/2021 the Vent Policy Jones/Theresa Cooper  CPC: 07/01/2021  MEC:

COVID-19 Vaccine Policy 05/2021 07/2024 Priya Patel PharmD  Minor revision to add  System P&T approval language on process for 6/28/2021 procuring federally  CPC: 07/01/2021 funded vaccine, HRSA  MEC:

2/62 Pharmaceutical Waste 12/2017 07/2024 Priya Patel PharmD  No changes. Triennial  System P&T approval review for JC 6/28/2021  CPC: 07/01/2021  MEC:

Medication Area 08/2020 07/2024 Jackie Ho PharmD  Revisions to Inspection  System P&T approval List for pharmacists 6/28/2021 Inspections Policy  CPC: 07/01/2021  MEC:

Discharge Medications 01/2020 07/2024 Priya Patel PharmD  Add language to align  System P&T approval with new State Board of 6/28/2021 Policy Pharmacy Requirements  CPC: 07/01/2021 for discharge medication  MEC: counseling

Highland Hospital Policies & Procedures

None  

San Leandro Hospital Policies & Procedures

None N/A N/A N/A N/A  N/A  N/A

John George Psychiatric Hospital Policies & Procedures

None N/A N/A N/A N/A  N/A  N/A

Alameda Hospital Policies & Procedures

None N/A N/A N/A N/A  N/A  N/A

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VISITING HOURS/VISITORS

Effective Date Not Set Date Revised 06/11/2021 Document Owner CHIEF ADMIN Next Scheduled Review 06/11/2024 OFCR/CHIEF NURSE EXEC Executive Responsible BOT, QPSC Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To provide support for patients during their stay by accommodating visitors and encouraging visitation. To ensure that all visitors enjoy full and equal visitation privileges that are consistent with patient preference and our ability to provide patient and family centered care.

POLICY

It is the policy of Alameda Health System (AHS) to uphold patients’ rights to designate visitors of his/her choosing and to allow patient visitation, as authorized and in accordance with the provisions set forth below.

DEFINITIONS:

A. “Patient and family-centered care” is based on the assumption that “family” is the primary source of strength and support. Family-centered providers recognize that family members hold essential information that enhances the patient’s care. B. Family – “Family” is defined by the patient as the group of significant people that normally provide physical, psychological, or emotional support. C. “Visitors” are defined as any individual who presents to the health care facility for the purpose of visiting a patient.

RESTRICTED VISITATION During flu season and public health situations/emergencies such as pandemic these practices may be amended to reflect infection control safety concerns. Patients who are symptomatic PUI or Covid19+ and continue to be on transmission-based precautions (on isolation) will not be allowed visitors. When time permits a consensus statement will be issued by the infectious disease department. Emergent situations will be handled by each site’s Infection Control department and administrative leaders.

PROCEDURE Visitor identification enforcement policy: All in-patient visitors that come into any of the AHS campuses are required to check-in and receive a visitor pass while at AHS. Badges are one day

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self-expiring badges that expire approximately 15 hours after activation. When red lines have appeared the visitor badge is not valid and must be replaced immediately. Badges will be color coded for Highland Hospital ONLY.

 Emergency Department Red Visitor Badge  ICU Yellow Visitor Badge  4th Floor Purple Visitor Badge  3rd Floor ISSU White Visitor Badge  5th Floor Yellow Visitor Badge  6th Floor Dark Blue Visitor Badge  7th Floor Green Visitor Badge  8th/9th Floor Blue Visitor Badge

Visiting hours are from 9 a.m. to 10 p.m. except in FBC and ICU. From 10 p.m. to 9 a.m. is designated hospital quiet time. A security officer is posted at the fourth-floor elevator area 24 hours a day to screen all persons entering the acute care hospital.

It is recommended that only two people should visit any patient at one time.

1. Children visiting must be supervised by responsible adults, other than the patient at all times. Children visiting must be supervised by responsible adults, other than the patient at all times. Children under 12 are not permitted in the ICU and NICU (see document)

Special arrangements may be made through the Nurse Manager or designee for visits for pre-op patients.

Limiting the number of family members and/or visitors in a room may be necessary due to space and patient access issues.

There may be special circumstances when staff may request families/visitors to leave the patient’s bedside for a limited time. Staff will explain to visitors the clinical rationale for the request, when visitors may return, and where they may wait. Examples of circumstances which may necessitate restrictions or limitations on visitors might include (but are not limited to), when:

• When there might be an infection control issue • Visitation might interfere with the care of other patients • The hospital is aware of an existing court order restricting contact • The patient is undergoing care interventions; however, if possible, the patient request that at least one visitor be allowed to remain in the room to provide support and comfort will be accommodated. • During a resuscitation process we will do everything possible to accommodate family request to be present if desired.

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Only 1 visitor may stay overnight in private rooms. Arrangements must be made with the charge nurse. Minors (under 12) are not permitted to stay overnight except for exclusive breastfeeding babies under the age of 6 months if accompanied by a caregiver other than the patient. (See infant border policy)

Individuals who are disruptive to patient care or operations of the facility will be asked to leave. Acts or threats of violence, intimidation, vandalism, or verbal abuse will not be permitted or tolerated under any circumstances. Anyone engaging in these behaviors will be asked to leave.

Visitors should refrain from sitting or lying on patient's bed.

1. POST ANESTHESIA CARE UNIT  Visiting patients in the PACU is not allowed unless permission is granted by the PACU nurse.

2. ICUs  Visitors for the CRITICAL CARE units may visit patients for 30 minutes in an hour. Visiting hours are not restricted.  No one under 12 years of age is allowed in the ICU's unless special arrangements are made through the Charge Nurse.

3. EMERGENCY DEPARTMENT  The Emergency Department allows for the presence of a support individual (visitor) of the patient’s choice unless the individuals presence infringes on safety or is medically or therapeutically contraindicated. If a visitor is already with a patient and the patient is agreeable the visitor may stay during rounds. Security will bring visitors back at the scheduled time after checking with the patient’s nurse. The Emergency Department Charge Nurse has the authority to suspend visiting anytime that there is a situation where visitors would be a safety issue, i.e., multiple GSW traumas. Visiting would resume as soon as the situation has resolved.

4. FAMILY BIRTH CENTER A. Family and friends should refrain from visiting if they are febrile, have diarrhea, or have symptoms of an upper respiratory infection. Cold sores should be covered with a mask until lesion is dry and scabbed. Anyone exposed to a known communicable disease (such as chickenpox or influenza) is not allowed in the birthing center. All visitors must clean their hands and forearms when entering the mother’s room, and before handling the infant. B. Each mother will be asked to designate her primary support person. This support person will have unlimited access to the mother and her infant(s). A mask will be provided to the support person if he/she has any signs of illness.

C. All visitors will sign in and obtain a designated visitor badge to wear at all times while in the birthing center. Visiting hours are as follows: L&D unrestricted; PP unrestricted for designated primary support person, 9 a.m. – 10 p.m. for all others; NICU 9 a.m. – 10 p.m.

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Visitors are allowed in the mother’s room or in the waiting room. They may not wait in the hallways or by the doors. D. A member of the health-care team may request that the number and timing of visitors be limited at certain times to facilitate adequate patient access for care. Requests by staff members to limit the number of visitors and/or length of visit should include information that helps the family and friends understand the patient’s needs. If a visitor refuses to comply with the request to move to the waiting area, or is disruptive or violent, security will be notified. E. Visitation during labor: i. No more than one visitor may accompany patients being evaluated in the OB Triage area for the initial 15 minutes. This is to protect the safety and privacy of other patients in the area. ii. After admission, the designated primary support person and a limited number of visitors may remain in the room throughout labor at the discretion of the birthing mother, the staff, and as dictated by patient safety. iii. Children of any age may be present during labor at the discretion of the birthing mother, the staff, and as dictated by patient safety. Another responsible adult must be present to care for the child. iv. During a non-emergent cesarean section, the designated primary support person may attend at the discretion of the patient. The support person is required to gown in appropriate attire, use head/hair cover, shoe cover, and mask. The support person is allowed to sit at the head of the OR table under the direction of Anesthesia Services. The surgeon, staff, or anesthesiologist may ask the support person to leave the room if complications arise, however, every effort will be made to permit the support person to remain at the bedside if desired. (add reference at end) v. During an emergency cesarean birth, only surgical personnel are allowed in the operating room until the mother and infant are stable. vi. No more than two visitors may accompany patients in the post-anesthesia recovery area (PACU). No food or drink can be brought into the PACU. No children are permitted in the PACU. F. Mother/baby visitation: vii. The decision to allow visitors during the postpartum period is made by the patient and supported by the nursing staff based on maternal and infant needs. viii. The designated primary support person may remain with the patient overnight and will be provided with a couch or recliner and bed linens. The support person will provide her or his own food and personal items and will maintain a clean and orderly space. ix. Children of any age are encouraged to visit but may not stay overnight if they are under the age of 12. A responsible adult (not the patient) must be present to care for the child. Children who become disruptive or who will not remain in the patient’s room must be taken by a responsible adult outside the unit until the behavior is resolved. G. NICU visitation:

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i. Only the mother and her designated, banded support person are allowed in the nursery. Either the mother or designated, banded support person may bring one other visitor to the bedside, not to exceed two at the bedside at any one time. IDENTIFICATION BANDS WILL BE VERIFIED FOR ALL VISITS ii. All visitors will be instructed on hand-washing and must clean hands and forearms with antiseptic soap or waterless cleanser when entering the NICU. i. The mother and her designated support person may visit at any time. ii. Each infant may have only 2 visitors at a time. Visitation may be limited at the discretion of the infant’s nurse or other staff. Because infant care is the first priority, any visitor may be asked to leave in the event of any treatments, procedures, or emergencies. iii. Children under the age of 14 are not allowed in the NICU unless they are siblings of the infant. Siblings are allowed brief visits in the NICU, with constant supervision by a responsible adult. During periods of communicable disease outbreaks, sibling visitation in the NICU may be suspended indefinitely at the discretion of the medical staff or infection-control nurse, or on community recommendations.

5. CRIMINAL JUSTICE  Visitors are not allowed unless authorized by the law enforcement agency responsible for the patient.

6. VISITING PERSONNEL  Alameda Health System personnel are required to observe regular visiting hours if they have friends who are patients.

SHERIFF/SECURITY CONTACT NUMBERS: Alameda County Sheriff Office: 44100 Highland Security 44900

APPROVALS

System Alameda

Department Date: N/A 03/2020 Pharmacy and Date: N/A N/A Therapeutics (P&T) Clinical Practice Date: 03/2020, 06/2021 N/A Council (CPC) Medical Executive Date: 03/2020, TBD N/A Committee Board of Trustees Date: 03/2020, TBD N/A

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Sedation/Analgesia for the Mechanically Ventilated Patient Protocol

Effective Date No Date Set Date Revised Not Approved Yet Document Owner VP, PATIENT Next Scheduled Review No Review Date CARE SERVICES Executive Responsible CNO/CAO Printed copies are for reference only. Please refer to electronic copy for the latest version.

Protocol

A. Obtain physician order to include level of sedation as outlined in RASS scale (Refer to Appendix B) and/or the presence of pain as identified by CPOT scale (Refer to Appendix C) and specific dosage parameters of sedatives and/or analgesics. (Refer to Appendix A).

B. RASS and CPOT cannot be used to assess mechanically ventilated patients receiving paralytics.

C. Establish a baseline physical assessment, LOC, respiratory and cardiac status; continuous EKG monitoring and documentation of vital signs every 5-15 minutes until patient is stable.

D. Provide continuous pulse oximetry. RASS assessment every 2 hours.

E. First treat pain. An analgesia-first sedation strategy decreases the length of mechanical ventilation. However, the analgesia-first sedation approach may not be appropriate for patients with GABA agonist/sedative needs: • Alcohol/Drug Withdrawal and drug intoxication • Neuromuscular blockade • Status Epilepticus • Elevated Intracranial pressure

F. Titrate the dosage of opioid analgesia to meet analgesic parameters set by the physician. Desired CPOT, generally < 2.

G. Titrate the dosage of sedative to meet sedation parameters set by the physician. Desired RASS generally -2.

Opioid analgesic infusion—Fentanyl or Hydromorphone is the recommended first-line agent for pain and sedation control. (Monitor for respiratory depression. Do NOT use Morphine in patients with hypotension and renal insufficiency.)

Consider adding enteral gabapentin, carbamazepine or pregabalin in patients with neuropathic pain. Non-opioid analgesic such as acetaminophen or ketamine may be considered to improve pain control, decrease the amount of opioid needed and the opioid-related side effects.

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Second-line agent(s) for pain- Ketamine infusion is an analgesic-sedative. Ketamine can also be used as an opioid-sparing agent for pain and sedation control. (Ketamine is contraindicated in patients with poorly controlled acute cardiovascular disease, pregnancy or poorly controlled active psychosis.)

H. Titrate and maintain the analgesic infusion to the maximum dose as tolerated first. If the CPOT goal has been met but the RASS goal has not been reached, then add a first line sedative infusion.

I. First-line sedatives :

• Dexmedetomidine infusion: (Monitor for side effects of hypotension, bradycardia. Do not use this alone when patient is on neuromuscular blocker infusion.) • Propofol infusion: (It is contraindicated in patients with allergies to soybeans or soy products, egg or egg products. Use caution for propofol if patients have poor left ventricular (LV) function or hyperlipidemia. Monitor for side effects of bradycardia, hypotension, depression of myocardial contractility, hypertriglyceridemia and rarely Propofol infusion syndrome.)

J. Second-line sedatives (If the patient cannot achieve the goal RASS score after reaching the maximum dose ordered or develops side effects while on first-line sedation agents) add:

• Lorazepam infusion: (Monitor for respiratory depression and increased risk of ICU delirium) • Midazolam infusion: (Monitor for respiratory depression and increased risk of ICU delirium)

K. If the patient is on multiple sedative or analgesic infusions being titrated to the same sedation RASS score, the physician needs to clarify in the medication orders and communicate with the nurse about the sequence of titration.

The suggested sequence of titration, as long as the patient tolerates it without developing side effects, is to optimize:  first, narcotic analgesic (Fentanyl, hydromorphone), or ketamine  then, dexmedetomidine or propofol  then, lorazepam or midazolam

L. If the patient is on a sedative infusion for another indication other than a RASS score such as epilepsy, control of ICP (intracranial pressure), the physician needs to clarify in the medication orders and communicate with the nurse about the specific goal of the other indications (e.g. negative EEG epileptiform activity, negative Ceribell™ epileptiform activity, specific signs of epilepsy without EEG or Ceribell™ monitoring (such as facial twitching, myoclonus, tonus, tonic-clonic seizure, epileptic spasm, specific goal ICP number.)

M. Document IV drip rates and pertinent observation in the patient medical record.

N. Continuously monitor vital signs and respiratory status. (HR, BP and O2 saturation).

O. Assess level of sedation every 2 hours and no longer than 15 minutes following each dosage adjustment of sedative infusion.

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P. Assess for the elimination of pain as outlined in CPOT scale (Refer to Appendix C) every 2 hours and following each dosage adjustment of analgesic infusion. Goal suggested is CPOT score less than 2.

Q. Avoid abrupt discontinuation of medication being used for continuous IV sedation and/or analgesia without a physician order.

R. Upon tapering down or titrating off sedation infusions, if the patient is on multiple sedative or analgesic infusions being titrated to the same sedation RASS score, the physician needs to clarify in the medication order and communicate with the nurse about the sequence of tapering down or off.

A suggested sequence of tapering down or titrating off infusions, as long as the patient tolerates it without developing side effects is:  First, lorazepam or midazolam,  then, dexmedetomidine or propofol,  then, narcotic analgesic (Fentanyl, hydromorphone), or ketamine

S. Coordinate daily spontaneous awakening trials (SAT), and spontaneous breathing trials (SBT) with Respiratory Therapy.

 Awaken patient daily to assess neurological status between 5 and 6 am, unless contraindications to SAT and SBT,  Follow the hospital SAT/SBT protocol that defines the process or steps for sedation weaning.  RASS Sedation level assessment every 2 hours and with each dose change until goal RASS is met. CAM-ICU assessment (Refer to Appendix D) is performed every shift, or more often as necessary (see attachments to this policy above). Respiratory Therapist is to assess for readiness to wean status using the ventilator protocol.

T. Communicate frequently with patient/family while providing care. Explanation of the procedures and regular re-orientation to time and place may reduce patient anxiety and discomfort during periods of sedation

U. Strategies to optimize early mobilization will be explored and implemented as soon as tolerated by the patient. Range of motion exercises and frequent repositioning, mobilizing to a chair, may prevent patient from developing muscle atrophy, and skin breakdown.

APPENDIX A

Medication Administration Guidelines – Opioid Analgesics

General Information: i Pharmacology: Opioid binds to opioid mu receptors in the CNS and: • inhibits the transmission of nociceptive input from the periphery to the spinal cord • activates descending inhibitory pathways that modulate transmission in the spinal cord, and • alters limbic system activity where opioid modifies the pain sensation 3

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ii Actions: • Opioid remains a mainstay therapy to treat non-neuropathic pain in critically ill patients. • Non-opioid analgesic such as acetaminophen or ketamine may be considered to improve pain control, decrease the amount of opioid needed and the opioid-related side effects. • Gabapentin, pregabalin or carbamazepine given enterally can be added to opioid to treat neuropathic pain

iii Side effects: • Sedation, mental clouding or confusion, respiratory depression, nausea, vomiting, constipation, pruritus (itching), and urinary retention • Fentanyl has lower risk of causing hypotension than morphine. • Hypotension, especially when administered in with other cardiopulmonary depressants.

iv Metabolism: • Morphine should be used with caution in patients with severe renal insufficiency because accumulation of an active metabolite, M6G may cause agitation, confusion, delirium and other adverse effects. • Fentanyl is largely metabolized by CYP3A4. Consequently, CYP 3A4 inhibitors such as the azole antifungals, macrolides, protease inhibitors, and non-dihydropyridine calcium channel blockers (e.g. diltiazem, verapamil) may potentiate fentanyl. On the other hand, CYP3A4 inducers such as barbiturates, rifampin, and carbamazepine may weaken fentanyl. In addition, fentanyl competes with midazolam for clearance by CYP3A4 and reduces its clearance. • The metabolism of hydromorphone is mainly hepatic, and it is represented by the generation of hydromorphone-3-glucuronide with neuroexcitatory potential.

Medication Onset of Concentratio Initial IV Infusion rate Black Box Warning (BBB) s action ns push Morphine 5-10 minutes 1 mg/ml 2 mg IV If more than 2 initial IV  Use with extreme caution in following IV (50 mg/50 push every pushes are given within patient with head injury, administratio ml) 15 minutes 1 hour, start infusion at intracranial lesion, or elevated n as needed 2 mg/ml 2 mg/hour, titrate by 1 ICP. for goal  May cause hypotension in (100 mg/50 mg/hour every 5 analgesia or patients with hypovolemia, ml) sedation minutes to cardiovascular disease, and 5 mg/mL score 1) goal 1: CPOT <2 circulatory shock. (250 mg/50 OR  Accumulation of ml) 2) goal 2: RASS of -2 neuroexcitatory metabolites, compounded OR M3G, M6G in patients with by pharmacy) 3) goal 3: CPOT or renal failure  Abrupt discontinuation (mixed in RASS goal following prolonged use may specified by D5W or NS) lead to withdrawal symptoms, physician if used > 7 days dose should (aim for a RASS= - be tapered. 4 to -5 if vent synchrony is the desired target)

Max dose 30 mg/hour. 4

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Notify MD if RR< 12 OR SBP< 90. Fentanyl 1-2 minutes 10 mcg/ml 50 mcg IV If more than 2 initial IV  Should only be prescribed for following IV (2500 mcg/250 push every pushes are given within Opioid-tolerant patients. May admin ml) 15 minutes 1 hour, start infusion at cause potentially life- as needed 20 mcg/mL 50 mcg/hour, titrate by threatening hypoventilation, (5000 mcg/250 for goal respiratory depression and/or 25 mcg/hour every 1 ml) analgesia or death. 50mcg/mL sedation minute to  Use with caution with patients (2500 mcg/50 score 1) goal 1: CPOT <2 with bradycardia, can produce ml) OR further bradycardia. compounded 2) goal 2: RASS of -2  Inject slowly over 3-5 by pharmacy) OR minutes; rapid I.V. (mixed in 3) goal 3: CPOT or infusion may result in D5W or NS or RASS goal skeletal muscle and chest undiluted) specified by wall rigidity.  Abrupt discontinuation physician following prolonged use may (aim for a RASS= - lead to withdrawal 4 to -5 if vent symptoms. If used > 7 days, synchrony is the dose should be tapered. desired target)  Less hypotensive effects than morphine. Max dose 300 mcg/hour

Notify MD if RR< 12 OR SBP< 90. Hydromorp 5-15 minutes 0.2 mg/ml 0.5 mg IV If more than 2 initial IV  Use with caution in hone following IV (10 mg/50 ml) push every pushes are given within patients with (Dilaudid) admin 0.4 mg/ml 15 minutes 1 hour, start infusion at hypovolemia, as needed (20 mg/50 ml) 0.5mg/hour, titrate by cardiovascular disease for goal (including acute MI) 1 mg/ml 0.5 mg/hour every 5 analgesia or or drugs which may (50 mg/50 ml) sedation minutes to exaggerate compounded score 1) goal 1: CPOT <2 hypotensive effects. by pharmacy) OR  Myoclonus and seizures have (mixed in 2) goal 2: RASS of -2 been reported with high doses. D5W or NS) OR  Abrupt discontinuation 4) goal 3: CPOT or following prolonged use may RASS goal also lead to withdrawal specified by symptoms. physician (aim for a RASS= - 4 to -5 if vent synchrony is the desired target)

Max dose 5 mg/hour

Notify MD if RR< 12 OR SBP< 90.

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Medication Onset of Concentration Initial Infusion rate Black Box Warning (BBB) s action bolus Ketamine 30 seconds 1 mg/ml One-time Start at 0.1 mg/kg/hour, Please refer to the AHS infusion for following IV initial bolus titrate by 0.1 mg/kg/hour “Ketamine Infusion for pain pain dose (500 mg/500 dose= 0.3 every 15 minutes to Clinical Practice Guideline ml) mg/kg in NS goal 1: CPOT <2 Hypersensitivity to ketamine or 3-4 minutes 50 ml, OR any component of the formulation following OR infused over goal 2: Decrease pain (benzethonium) IM dose 15 minutes scale by a minimum of 2 Poorly controlled acute 2 mg/ml cardiovascular disease (e.g. Max bolus Max dose 1 mg/kg/hour. uncontrolled/poorly controlled (500 dose= 50 mg hypertension, acute heart failure, mg/250ml) Call HO if HR>120 or unstable tachyarrhythmias, SBP>160 ACS/MI, acute stroke, unstable Mixed in D5W angina, severe aortic stenosis, or NS preeclampsia or eclampsia)* Pregnancy Compatibilitie Poorly controlled active psychosis s: DO NOT disease mix with Ketamine is contraindicated in barbiturates those for which a significant (e.g.. elevation in blood pressure or phenobarbital, hear rate would constitute a pentobarbital) serious hazard. or diazepam (precipitation may occur)

APPENDIX A

Medication Administration Guidelines-Sedatives Benzodiazepines (Midazolam [Versed], Lorazepam [Ativan])

General Information:

i Pharmacology: Benzodiazepines activate GABAA receptors in the brain.

ii Actions: • Anxiolytic, sedating, hypnotic, anticonvulsant, antiemetic and amnestic effects, but NO analgesic activity. • Midazolam is more lipophilic than lorazepam, crossing blood brain barrier (BBB) faster and resulting in faster onset of action and a larger volume of distribution than lorazepam. • Elderly patients are more sensitive to the sedative effects of benzodiazepine.

iii Side effects: • Respiratory depression • Hypotension, especially when administered in with other cardiopulmonary depressants, particularly opioids. • Benzodiazepine-induced cardiopulmonary instability is more likely to occur in critically ill patients with baseline respiratory insufficiency and/or cardiovascular instability. • Tolerance to benzodiazepines develop with long term administration. Withdrawal or Rebound symptoms may occur with abrupt discontinuation after prolonged use 6

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• Lorazepam IV contains propylene glycol as a diluent. Initially, propylene glycol toxicity is thought to happen only in patients receiving very high lorazepam doses via continuous infusion (i.e., 15–25 mg/hr), but current evidence suggests that it can happen in IV doses as low as 1 mg/kg/day. Serum osmolar gap >10-12 mOsm/L may help identify lorazepam- induced propylene glycol accumulation. • Due to possible precipitation, lorazepam continuous infusion should be infused via an in-line 0.22 micron filter.

iv Metabolism: • All benzodiazepines are metabolized in the liver. • The active metabolites of midazolam may accumulate with prolonged administration, especially in patients with renal failure. • The elimination half-life and duration of clinical effect of lorazepam are also increased in patients with renal failure • Studies show that prolonged use of midazolam results in greater variability and longer time to awakening than with that of lorazepam.

Medications Onset of Concentrations Initial Maintenance Infusion rate Information action infusion rate Midazolam 2-5 minutes 1 mg/mL Start at 1 Titrate by 0.5 mg/hour every 5  Rapid onset of action (Versed) following mg/hour minutes to  Hypotension seen more IV 1) goal 1: RASS of -2 frequently in patients administrati OR receiving opioid analgesia on 2) goal 2: RASS goal specified by  prolonged usage results physician in prolonged duration of (aim at RASS= -4 to -5 if vent (50 mg/50 ml or action due to synchrony is the desired target) 100 mg/100 ml accumulation of active metabolites. compounded by

pharmacy) Max dose 10 mg/hour. (mixed in D5W

or NS) Call HO if RR<12 or SBP<90

Lorazepam 15-20 1 mg/mL Infuse via Infuse via nitroglycerin tubing  Onset of action: (Ativan) minutes nitro- and 0.22 micron filter. Slower onset of action following (50 mg/50 ml or glycerin than Versed, making it IV loading 100 mg/100 ml tubing Titrate by 0.5 mg/hour every 5 less useful for dose compounded by and 0.22 minutes to treatment of acute pharmacy) micron 1) goal 1: RASS of -2 agitation in the ICU Patient. (mixed in D5W filter. OR NON-PVC bag 2) goal 2: RASS goal specified by  The polyethylene or glass bottle) Start at 0.5 physician glycol and propylene

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0.2 mg/mL mg/hour (aim at RASS= -4 to -5 if vent glycol solvents in synchrony is the desired target) lorazepam injection can (50 mg/250 ml accumulate and lead to reversible acute tubular compounded by necrosis, lactic pharmacy) Max dose 10 mg/hour. acidosis, and (mixed in D5W hyperosmolar states NON-PVC bag Call HO if RR<12 or SBP<90 with prolonged, high- or glass bottle) dose infusions.  Monitor for toxicity when administering continuous lorazepam infusion.  Continuous infusion solutions should have an in-line filter and solution should be checked frequently for possible precipitation.  Use cautiously in patients with hepatic impairment may worsen hepatic encephalopathy

APPENDIX A

Medication Administration Guidelines-Sedatives: Propofol (Diprivan)

General Information: i. Pharmacology: Propofol binds to GABAA, glycine, nicotinic, and M1 muscarinic receptors in the brain. ii. Actions: • Anxiolytic, sedating, hypnotic, anticonvulsant, antiemetic and amnestic effects, but NO analgesic activity. The amnestic effect of propofol is lighter than that of benzodiazepine. • Propofol is highly lipid soluble and quickly crosses the BBB, resulting in the rapid onset of sedation. • Due to its high lipid solubility, propofol rapidly redistributes into peripheral tissues. This rapid redistribution, combined with high hepatic and extrahepatic clearance, results in a rapid offset of effect following short-term propofol administration. • The lipophilic propofol is dissolved in a white oil-in-water emulsion. The emulsion contains 10% (10 gram/100 ml or 100 mg/ml) soybean oil which provides 1.1 kcal/ml. This intralipid content should be taken into account for patients receiving T P N . v Side effects: • Dose-dependent respiratory depression • Hypotension due to systemic vasodilation. • Propofol-induced cardiopulmonary instability is more likely to occur in critically ill patients with baseline respiratory insufficiency and/or cardiovascular instability. 8

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• The hypotension and/or cardiovascular depression caused by propofol may be significant. These effects are responsive to discontinuation of propofol, IV fluid administration, and/or vasopressor therapy. • Other side effects include hypertriglyceridemia, acute pancreatitis, and myoclonus. • Propofol Infusion Syndrome is a rare, but fatal adverse effect. It is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes (Coved ST segment elevation) and/or cardiac failure. The following appear to be major risk factors for the development of these events: • Decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; • High dosages of one or more of the following pharmacological agents: • vasoconstrictors, steroids, inotropes and/or • prolonged, high-dose infusions of propofol (greater than 83 mcg/kg/minute for greater than 48h). vi Other considerations: • Transient local pain on administration of propofol can be minimized if the larger veins of the forearm or antecubital fossa are used. Pain during intravenous injection may also be reduced by prior IV injection of 1% lidocaine, 1mL.

• Strict aseptic technique must always be maintained during handling as propofol is a single patient infusion vial. Although propofol vial contains the antiseptic inhibiting the growth of microorganisms for up to 12 hours, in the event of accidental extrinsic contamination, do not use if contamination is suspected. Discard unused drug product after 12 hours. The antiseptic in: • Diprivan® is disodium edetate (EDTA) 0.005% (or 0.05 mg/ml). • Generic propofol (by Sagent®) is sodium metabisulfite 0.25 mg/ml • Generic propofol (by Hospira, Inc) is benzyl alcohol 1.5 mg/mL and sodium benzoate 0.7 mg/mL • Generic propofol (by Actavis Pharm, Inc) is sodium benzoate 0.1% (or 1 mg/mL)

• Propofol Injectable Emulsion must be prepared for single-patient use only. Strict aseptic techniques must be followed. • The vial rubber stopper should be disinfected using 70% isopropyl alcohol. • A sterile vent spike and sterile tubing must be used for administration of Propofol Injectable Emulsion. • Administration should commence promptly and must be completed within 12 hours after the vial has been spiked. • The tubing and any unused Propofol Injectable Emulsion drug product must be discarded after 12 hours. • If Propofol Injectable Emulsion is transferred to a syringe prior to administration, it should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing Propofol Injectable Emulsion from a vial, a sterile vent spike should be used. The syringe should be labeled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened. • Propofol Injectable Emulsion should be discarded and administration lines changed after 12 hours

• Potential contraindications in patients with allergies to soybeans or soy products, egg or egg 9

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products: This is because propofol is dissolved in a white oil-in-water emulsion which contains 100 mg/ml soybean oil, 12 mg/ml egg lecithin and 22.5 mg/ml glycerol.

• Diprivan® contains 0.005% disodium edetate (EDTA) which chelates zinc. In patients who are predisposed to zinc deficiency, such as those with burns, diarrhea, and/or major sepsis, the need for supplemental zinc should be considered during prolonged therapy (>5 days) with Diprivan®.

• Generic propofol (by Sagent®) contain metabisulfite, which may cause sulfite allergic reactions, which is more commonly seemed in asthmatics.

vii Metabolism: • Propofol is mainly metabolized by hepatic conjugation to inactive metabolites which are then excreted by the kidney. • Long-term (10 days of use) propofol administration can lead to the saturation of peripheral tissues and prolonged time to awakening.

Medications Onset of Concentrations Initial Maintenance Infusion Information action infusion rate rate Propofol 1-2 minutes 10 mg/mL (1%) Infuse via Infuse via vented line General Information: (Diprivan) following (1000 mg/100 ml) vented line  Not used for patients IV doses. Titrate by 10 allergic to intralipids (soy (Premixed bottle) Start at 10 mcg/kg/min every 5 bean oil, egg, lecithin, Wait at mcg/kg/min min to glycerol) or hyperlipidemic. least 5 1) goal 1: RASS of -2  Intralipids content should minutes for OR be taken into account for onset of 2) goal 2: RASS goal patients receiving effects specified by parenteral nutritional physician supports. (aim for a RASS= -4  May be administered to -5 if vent through central line or peripheral line. synchrony is the

desired target) Dosage Guidelines:  Dosage and rate of Max Dose: 80 administration should be mcg/kg/min. individualized and titrated to the desired effect according Call HO if RR<12 or to clinically relevant factors SBP<90 such as age, concomitant medications, ASA physical

classification and level of (Flush line q12 hrs. debilitation Discard tubing and unused emulsion after Nursing Considerations for 12 hrs from vial Propofol infusion: spiking. Maintain strict  Increase subsequent aseptic technique increments by 5mcg/kg/min until desired level of during handling.) sedation is achieved unless otherwise ordered.  Because Propofol has no preservative, tubing and

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unused infusion shall be changed every 12 hours.  If glass ampules or any technique which requires transfer of the agent is used, tubing and container must be replaced every 12 hours.  Monitor patient for hypotension, cardiovascular depression.

APPENDIX A Medication Administration Guidelines-Sedatives: Dexmedetomidine (Precedex®) General Information: i. Pharmacology: a selective centrally acting α2-receptor agonist, binding to α2 receptors in the locus coeruleus, the predominant noradrenergic nucleus of the brain and spinal cord inhibits neuronal firing, causing hypotension, bradycardia, sedation, and analgesia. Studies have shown that dexmedetomidine is 8 times more specific for α2 adrenoceptors than clonidine (ratios of α2:α1 activity, 1620:1 for dexmedetomidine, 220:1 for clonidine). ii. Actions: • Anxiolytic, sedating, hypnotic, sympatholytic effects, opioid sparing activity.  Dexmedetomidine may increase the effects of concomitantly administered anesthetics, sedatives, hypnotics or Opioid analgesics. A decrease in the dosage of the concomitant agent or Dexmedetomidine may be required.  Dexmedetomidine is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an ICU setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures.  Patients receiving Dexmedetomidine should be continuously monitored.  Dexmedetomidine® has a different mechanism of action and sedative profile than other IV sedatives. Patients receiving Dexmedetomidine may be arousable and alert when stimulated— this does NOT mean that the patient is not adequately sedated. The decision to increase the dose or administer additional analgesics or sedatives should be based on overall clinical picture. Question the patient prior to administration of additional medication to accurately assess the patient’s status and medication requirements  Dexmedetomidine does not cause respiratory depression. Patients may be extubated prior to discontinuing the Dexmedetomidine infusion. However, dexmedetomidine can cause a loss of oropharyngeal muscle tone which can lead to airway obstruction in non-intubated patients, so continuous respiratory monitoring for hypoventilation and hypoxia is indicated. Dexmedetomidine should be titrated down as tolerated. Abrupt discontinuation should be avoided, as it may result in withdrawal symptoms such as nervousness, agitation, headaches, and rapid rises in blood pressure. Adult ICU patients receiving dexmedetomidine infusion for up to 7 days have developed withdrawal symptoms, nausea, vomiting, agitation, within 24-48 hours of discontinuing dexmedetomidine. i Side effects:  The most common adverse reactions include hypotension, bradycardia and dry mouth. These events may be more pronounced in elderly or hypovolemic patients and in patients with diabetes mellitus or chronic hypertension. Moderate heart rate and blood pressure reductions should be anticipated and do not always warrant therapy discontinuation. 11

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 If medical intervention is required for hypotension or bradycardia, treatment may include:  decreasing or stopping the infusion of Dexmedetomidine  Increasing the rate of IV fluid administration  Elevation of lower extremities  Use of agents, such as glycopyrrolate 0.1 mg IV q3 mins prn up to 6 doses, atropine 0.5 mg IV q3 mins prn up to 6 doses or ephedrine 25-50 mg IV/IM  Loading dose administration is associated with a higher risk of clinically significant episodes of bradycardia and sinus arrest. Omitting or reducing the dose of the loading dose may be necessary in some patients.  Due to the increased incidence of bradycardia and hypotension in the elderly, and the potential for reduced clearance in patients with impaired hepatic or renal function, dose reductions should be considered in these patient groups.  Caution in patients on vasopressors to maintain blood pressure

i Metabolism: • Dexmedetomidine is rapidly redistributed into peripheral tissues. • It is metabolized by the liver. In patients with normal liver function, the elimination half- life is approximately 3 hrs. Patients with severe hepatic dysfunction have impaired dexmedetomidine clearance, can experience prolonged emergence, and may require lower dexmedetomidine doses.

Dosing and Monitoring Dexmedetomidine:

Medications Onset of action Concentrations Initial Maintenance Infusion rate infusion rate Dex-medetomidine 5-10 minutes following IV 4 mcg/ml 0.4 Titrate by 0.2 mcg/kg/hour every (Precedex®) loading dose mcg/kg/hour 20 minute to (200 mcg/ 50 ml 1) goal 1: RASS of -2 15 minutes following IV OR infusion dose without OR 2) goal 2: RASS goal specified loading dose. by physician 400 mcg/100 ml (aim for a RASS= -4 to -5 if vent synchrony is the desired OR target)

1000 mcg/250 ml) Max dose 1.5 mcg/kg/hour. Mixed in NS or in Premixed bottle Call HO if HR<60 or SBP<90

APPENDIX A

Medication Administration Guidelines-Analgia-sedatives: Ketamine (Katalar®) (in NON- anesthetic setting) Overview1:  It is a phencyclidine structural analog producing dissociative anesthesia, characterized by catatonia, catalepsy and amnesia and is due to dissociation between the cortical and limbic system.

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 It is a noncompetitive NMDA (N-methyl-D-aspartate) receptor inhibitor, responsible for its analgesic, amnesic, antidepressant and psychosensory effects. Additionally, it binds to opioid receptors, stimulates the noradrenergic neurons and has central anticholinergic effect.  Ketamine administration generally results in increases in heart rate, systolic and diastolic blood pressure, salivary and tracheobronchial secretions, and bronchodilation due to its stimulatory effects on the sympathetic nervous system. On the other hand, ketamine has a myocardial depressant effect in catecholamine depleted individuals (e.g. acute heart failure, long-term trauma or intensive care patients).  Its onset of action is 30 seconds following IV dose, 3-4 minutes following IM dose.  The elimination half-life is approximately 2–3 hours.

Indication include, but are not limited to: i Sedation of intubated and mechanically ventilated patients ii Sedation prior to and/or during surgical and other procedures

iii Please refer to the AHS “Ketamine Infusion for Pain Clinical Practice Guidelines” if the indications are • Analgesia (subanesthetic dosing) for acute moderate to severe pain • Adjuvant analgesia during and following surgery • Analgesia in the opioid tolerant patient • Analgesia for individuals with refractory pain

Absolute Contraindications: ● Hypersensitivity to ketamine or any component of the formulation (e.g. benzethonium) ● Poorly controlled acute cardiovascular disease (e.g. uncontrolled/poorly controlled hypertension, acute heart failure, unstable tachyarrhythmias, ACS/MI, acute stroke, unstable angina, severe aortic stenosis, preeclampsia or eclampsia)* ● Pregnancy ● Poorly controlled active psychosis disease *Ketamine is contraindicated in those for which a significant elevation in blood pressure or heart rate would constitute a serious hazard.

Relative contraindications: ● Cardiac decompensation ● CNS depression ● Tachyarrhythmia ● Increased intraocular pressure ● Aneurysms ● Thyrotoxicosis

General considerations: 1. All patients must be educated on ketamine-induced hallucinations and other associated reactions prior to bolus and infusion initiation 2. The nurse must be available to be at bedside with the patient for the first 15 min after administration of the ketamine bolus. 13

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3. Ketamine IV bolus for sedation can be given over 3 minutes. Ketamine IV Infusions can be given via peripheral IV or central IV lines 4. Weight a. Use Actual Body Weight (ABW) in kg b. If patient’s BMI is more than 30, use ideal body weight (IBW) in kg 5. Ketamine infusions are compatible and can be used with other intravenous or oral opioids (e.g. fentanyl) 6. Ketamine must be administered in a clinical area where the following is available: a. Non-invasive BP, HR, RR b. Pulse oximetry c. Oxygen saturation d. Resuscitative equipment/cardiac arrest cart is available

Dosing Recommendations: 1. Ketamine Bolus dose for sedation: a. IV bolus of 0.3 mg/kg dose for sedation can be given over 3 minutes. 2. Ketamine Continuous Infusion: a. Initial infusion rate of 0.1 mg/kg/hour b. Titrate by 0.1 mg/kg/hour every 15 min (Maximum rate: 1 mg/kg/hour) 3. Dose adjustments based on suspected toxicity a. Stop infusion and alert primary/covering team and/or ordering team b. Ketamine infusion should be stopped until toxicity symptoms resolve c. Once toxic symptoms resolve, may resume ketamine infusion at a lower rate if ordered by medical provider. (e.g. decrease the rate of the continuous infusion by 0.5mg/kg/h from the previous rate) 4. Discontinuation of Infusion a. Weaning is suggested if infusion is > 0.5 mg/kg/hr for > 48 hours) i. At the end of the infusion, decrease rate by 50% for 4 hours before discontinuing the infusion to avoid potential withdrawal symptoms 5. As needed medications for side effects: a. Excessive lacrimation or salivation i. Glycopyrrolate 0.2 mg IV Q6H PRN excessive lacrimation or salivation b. Delirium i. Midazolam 1 mg IV Q2H PRN delirium (Max total 24-hour dose 5mg)  Notify MD if delirium persists after 5 mg  Midazolam IV is limited to the use of patients on mechanical ventilation ii. Lorazepam 1 mg IV Q2H PRN delirium  Notify MD if delirium persists after 4 mg

Personnel: 1. Supervising clinician: a supervising physician who is familiar with this System Ketamine Clinical Guidelines 2. Administering clinician: registered nurse who has completed training in safe administration of Ketamine for pain 14

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Monitoring 1. Setting: a. Outside OR, ICU, and ED units, does not need to be administered in a telemetry monitored bed b. If provider concerned for cardiac history or hemodynamic instability, can be administered in a telemetry monitored bed 2. Initial Baseline: a. Blood pressure (BP), Heart rate (HR), Respiratory rate (RR), transcutaneous O2 saturation, history and discussion of emergence reactions, pain score, location of pain 3. During infusion: a. BP, HR, RR, SpO2, pain score/location of pain, assessment of ketamine toxicity i. Every 15 minutes x 1 hr, 30 minutes x 1 hr, then every 4 hours until treatment completed ii. With every dose change, restart intensive monitoring (i.e. Every 15 minutes x 1 hr, 30 minutes x 1 hr, then every 4 hours until treatment completed) b. Once ketamine infusion discontinued, then monitor the BP, HR, RR, SpO2, and pain score 1-hour post ketamine infusion

Bolus and Infusion Preparation: 1. Preparation: a. To prepare ketamine for bolus administration, dilute ketamine (concentration of 50 mg/mL, 100 mg/mL) 50 mL of D5W or NS and mix well. b. To prepare ketamine for infusion, dilute to a 1 mg/mL concentration by combining 10 mL (50 mg/mL) or 5 mL (100 mg/mL) of product with 500 mL of D5W or NS. c. If fluid restriction is required, may dilute to a 2 mg/mL concentration by combining in 250 mL diluent

Nursing Responsibilities 1. IV Ketamine should be administered only through the Alaris Pump using the Guardrails Safety System 2. Ketamine IV Infusions can be given via peripheral IV or central IV lines 3. Notify ordering physician (but continue infusion) if: a. SBP > 160 mmHg b. HR > 120 bpm 4. Stop the infusion and call the ordering physician IF: a. Systemic blood pressure > 180 mmHg b. Blood pressure increases > 30 mmHg diastolic or systolic c. Heart rate > 140 bpm d. Respiratory rate < 8 bpm e. spO2% < 93 % f. Respiratory distress or respiratory depression g. Agitation unresponsive to midazolam 15

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5. Provide patient education on ketamine-induced vivid dreams prior to starting infusion 6. Ketamine toxicity signs and symptoms a. Respiratory depression b. Hypertension c. Pulmonary edema d. Hypertensive encephalopathy e. Cerebral hemorrhage f. Delirium

Sub-anesthetic Dosing and Non-anesthetic Monitoring Ketamine (Katalar®) :

Medications Onset of action Concentrations Initial Maintenance Infusion rate infusion rate Ketamine 30 seconds following 1 mg/ml 0.1 Titrate by 0.1 mg/kg/hour every IV dose mg/kg/hour 15 minute to (500 mg/500 ml) 1) goal 1: RASS of -2 3-4 minutes following OR IM dose OR 2) goal 2: RASS goal specified by physician 2 mg/ml (aim for a RASS= -4 to -5 if vent synchrony is the (500 mg/250ml) desired target)

Mixed in D5W Max dose 1 mg/kg/hour. or NS Call HO if HR>120 or SBP>160 Compatibilities: DO NOT mix with barbiturates (e.g. phenobarbital, pentobarbital) or diazepam (precipitation may occur)

APPENDIX A

Medication Administration Guidelines: Antipsychotics

Haloperidol (Haldol) - Black Box Warning (BBW)  The response to IV Haldol may be delayed by several minutes.  May alter cardiac conduction and prolong QT interval, life threatening arrhythmias have occurred with therapeutic doses of antipsychotic.  Use with caution or avoid use in patients with electrolyte abnormalities or underlying cardiac abnormalities which may potentiate risk.  Monitor ECG closely for dose-related QT effects such as QTc prolongation or Torsades de pointes.  May cause anticholinergic effects. 16

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 High risk for Extrapyramidal symptoms (EPS).  Use may be associated with Neuroleptic malignant syndrome (NMS) - monitor for mental status changes, fever, muscle rigidity, and /or autonomic instability.  May cause transitory orthostatic hypotension.  Use with caution in patients at risk of seizures.  Sedative effect may be potentiated when used with other sedative drugs.  Use cautiously in the elderly, increased risk of tardive dyskinesia, particularly in elderly women.

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APPENDIX B

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Appendix C

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APPENDIX D

Reference. Ely EW, et al. Crit Care Med 2001; 29:1370-1379

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APPENDIX D

To evaluate the Feature 2. Inattention of CAM-ICU

Reference. Ely EW, et al. Crit Care Med 2001; 29:1370-1379

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APPENDIX D

To evaluate the Feature 2. Inattention of CAM-ICU

Reference. Ely EW, etal. Crit Care Med 2001; 29:1370-1379

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APPENDIX D

Reference. Ely EW, et al. Crit Care Med 2001;29:1370-1379

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References

1. Aiken, L.M. Protocol –directed sedation to reduce duration of mechanical ventilation 2. Cochrane Database Systematic Review 2015:1.doi.1002/14651858.CD009771.pub2. 3. Pun, B. Caring for Critically Ill Patients with ABCDEF Bundle in over 15,000 Adults Critical Care Medicine Jan 2019:47:1 3-14. 4. Humphrey, M. An evaluation of patient specific characteristics on attainment of target sedation in an intensive care unit Heart and Lung May 2018: 47:387-391. 5. Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306 6. Subramaniam K, etal. Ketamine as Adjuvant Analgesic to Opioids: A Quantitative and Qualitative Systematic Review. Anesth Analg 2004;99:482-495 7. American Pharmacists Association. Drug Information Handbook. A Comprehensive Resource for all Clinicians and Healthcare Professionals. 16th ed. 2008-2009. Lexi-Comp. P.882-883 8. Ketamine Hydrochloride Injection, USP Drug Information-Medicine Online http://www.medicineonline.com/drugs/K/1939/Ketalar-Ketamine-Hydrochloride- InjectionUSP.html 9. Guillou N, et al. The Effects of Small-Dose Ketamine on Morphine Consumption in Surgical Intensive Care Unit Patients After Major Abdominal Surgery. Anesth Analg 2003;97:843-7 10. Adam F, etal. Small-Dose Ketamine Infusion Improves Postoperative analgesia and rehabilitation after total knee arthroplasty. Anes Analg 2005;100:475-80 11. Hurth KP, etal. The Reemergence of Ketamine for Treatment in Critically Ill Adults. Crit Care Med 2020; 48:899–911 12. Schwenk ES, et al. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med 2018;43: 456–466 13. Ely EW, et al. Evaluation of delirium in critically ill patients: Validation of the Confusion Assessment method for the Intensive Care Unit (CAM-ICU). Crit Care Med 2001;29:1370- 1379 14. Gertler, R, et al. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan; 14(1): 13–21

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SYSTEM MEDICATION SAMPLES

Department Pharmacy, Medical Effective Date 06/2019 Staff Campus AHS System Date Revised 01/2019 Category Clinical, Medical Next Scheduled 01/2021 Staff Review Document Owner Medication Safety Executive Chief Nurse Executive/Chief Officer Responsible Administrative Officer; Chief Medical Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To provide strict control and quality of all medications used in the hospital and clinics.

POLICY Drug samples for use is not allowed for either patients in the hospital or outpatient clinics at any AHS sites unless specific sample medications for use is reviewed and approved by P&T.

PROCEDURE 1. All departments and employees of AHS who are offered drug samples by the drug manufacturer sales representatives will not accept such offers unless approved by P&T. 2. Sales representatives will be instructed not to leave any samples at the facility. 3. Emergency Department will not use drug samples for starter doses for outpatient unless approved by P&T.

REFERENCES TJC Medication Management Standards

Page 1 of 1

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Sedation/Analgesia for the Mechanically Ventilated Patient

Effective Date No Date Set Date Revised Not Approved Yet Document Owner THERESA COOPER (VP, Next Scheduled Review No Review Date PATIENT CARE SERVICES) Executive Responsible CNO/CAO Printed copies are for reference only. Please refer to electronic copy for the latest version.

Purpose

To provide safe patient care guidelines for the administration of sedation and analgesia for the mechanically ventilated patient.

Policy

POLICY: THIS POLICY PERTAINS ONLY TO PATIENTS IN A CRITICAL CARE AND EMERGENCY DEPARTMENT SETTING AND ON A VENTILATOR REQUIRING CONTINUOUS IV SEDATION.

Physician order to include: drug, maximum dose sedation and pain level goals, and frequency of wake-up assessment if more often than daily.

The Richmond Agitation and Sedation Scale (RASS) scale is used to assess sedation.

The Critical –Care Pain Observation Tool (CPOT) scale is used to identify the presence of pain in intubated, non-verbal patients.

The Confusion Assessment Method in the ICU (CAM-ICU) is used to assess for delirium.

Please see Sedation/Analgesia for the Mechanically Ventilated Patient Procedure for details.

General Sedation & Analgesia Information

Personalized medication management for a mechanically ventilated patient produces a sense of well being, relaxed skeletal muscles, increased compliance with mechanical ventilation, and prevention of self extubation or IV removal without fear of unpleasant procedures or memory loss events. Patients with inadequately controlled pain, agitation, or delirium face a higher risk of mortality and morbidity.

 To outline the nursing management of the patient on continuous IV infusion of sedatives.  To provide for relief of anxiety and / or agitation that is compromising the safety or well being of the patient.  To promote comfort, mental / physical rest and facilitate mechanical ventilatory support.

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 Ensure mechanically ventilated patients are assessed accurately for pain, sedation and delirium.  Ensure mechanically ventilated patients are continuously monitored to maintain neurologic function and avoid over sedation or other complications

1. Medication used for continuous IV sedation, analgesia, delirium and anxiety management are High Alert Medications.

2. Reversal drugs and emergency ventilatory support will be immediately available.

3. All continuous IV sedation or analgesia medications shall be administered via a controlled IV Pump.

4. Pharmacy will provide standard concentration of IV solutions.

5. Consideration for reduction in initial dosing should be made for the elderly and patients with hepatic and renal impairment.

6. Except ketamine, sedatives referenced in this policy and procedure do not contain analgesic properties.

7. Assessment of pain and appropriate analgesia shall be performed for all patients. For sedated patients use the CPOT. (Critical –Care Pain Observation Tool).

8. Recommend daily wake-up to facilitate performance of neurological evaluation and to assess readiness to wean.

9. Achieving the balance of sedation and analgesia is challenging and requires the use of consistent assessment tools in addition to target levels of sedation.

10. Sedatives are common adjuncts for the treatment of anxiety and agitation.

11. The causes of anxiety in critically ill patients are multi-factorial and are likely to be s e c o n d a r y to an inability to communicate amid continuous noise, continuous ambient light, excessive stimulation, inadequate analgesia, vital signs, repositioning, lack of mobility and room temperature.

12. Sleep deprivation and the circumstances that lead to an ICU admission may increase patient anxiety, affecting up to 50% of ICU patients.

13. Frequent reorientation, maintenance of patient comfort, provision of adequate analgesia, optimization of the environment and supplementation are just some of the thing that can be done to reduce patient anxiety.

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14. The consequences of inadequate sedation and analgesia can be substantial, including: Self-extubation Removal of important intra-luminal tubes and vascular catheter Aggressive behavior by patients against care providers Poor patient-ventilator synchrony

15. Therapeutic sedation has inherent risks, however, particularly when excessive for prolonged periods.

16. The increasing recognition that the use of sedative medications can have substantial impact on duration of ICU length of stay and complications has raised the awareness of the value of structured sedation evaluation.

References

1. Aiken, L.M. Protocol –directed sedation to reduce duration of mechanical ventilation 2. Cochrane Database Systematic Review 2015:1.doi.1002/14651858.CD009771.pub2. 3. Pun, B. Caring for Critically Ill Patients with ABCDEF Bundle in over 15,000 Adults Critical Care Medicine Jan 2019:47:1 3-14. 4. Humphrey, M. An evaluation of patient specific characteristics on attainment of target sedation in an intensive care unit Heart and Lung May 2018: 47:387-391. 5. Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306 6. Subramaniam K, etal. Ketamine as Adjuvant Analgesic to Opioids: A Quantitiative and Qualitative Systematic Review. Anesth Analg 2004;99:482-495 7. American Pharmacists Association. Drug Information Handbook. A Comprehensive Resource for all Clinicans and Healthcare Professionals. 16th ed. 2008-2009. Lexi-Comp. P.882-883 8. Ketamine Hydrochloride Injection, USP Drug Information-Medicine Online http://www.medicineonline.com/drugs/K/1939/Ketalar-Ketamine-Hydrochloride-InjectionUSP.html 9. Guillou N, etal. The Effects of Small-Dose Ketamine on Morphine Consumption in Surgical Intensive Care Unit Patients After Major Abdominal Surgery. Anesth Analg 2003;97:843-7 10. Adam F, etal. Small-Dose Ketamine Infusion Improves Postoperative analgesia and rehabilitation after total knee arthroplasty. Anes Analg 2005;100:475-80 11. Hurth KP, etal. The Reemergence of Ketamine for Treatment in Critically Ill Adults. Crit Care Med 2020; 48:899–911 12. Schwenk ES, etal. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med 2018;43: 456–466 13. Ely EW, etal. Evaluation of delirium in critically ill patients: Validation of the Confusion Assessment method for the Intensive Care Unit (CAM-ICU). Crit Care Med 2001;29:1370-1379 14. Gertler, R, etal. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan; 14(1): 13–21

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Approvals

System Alameda AHS Core San Leandro Departmental Date: Patient Care Leadership Team Date: Clinical Practice Council Date: 7/2021 Medical Executive Committee Date: Board of Trustees Date:

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COVID-19 VACCINE POLICY (AHS)

Effective Date No Date Set Date Revised Not Approved Yet Document Owner MGR, SYS MED Next Scheduled Review No Review Date SAFETY/CLIN PHARM Executive Responsible DIRECTOR, PHARMACYBOT, QPSC Printed copies are for reference only. Please refer to electronic copy for the latest version.

POLICY Alameda Health System will adhere to the guidelines for the safe handling, storage and administration of COVID-19 Vaccine consistent with CDPH, CDC and drug manufacturer recommendations.

PURPOSE To provide guidelines for the safe handling, storage and administration of COVID-19 Vaccine consistent with CDPH, CDC and drug manufacturer recommendations.

GENERAL Staff must be trained to appropriately manage and administer COVID-19 vaccine. Additional vaccine-specific information can be found at the CDC COVID-19 Vaccination Program Interim Playbook.

KEY STAFF There will be a vaccine coordinator that is the Point of Contact for receiving vaccine shipments, monitoring storage unit temperatures, and managing vaccine inventory.

SHIPPING AND RECEIVING 1. Vaccine delivery via direct shipment must be coordinated for each site

2. Ancillary supply kits (needles, syringes, alcohol swabs, surgical masks, face shields, and vaccination record cards) will ship separately from the vaccine

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3. Packages will be inspected for any opened, broken, torn or tampered vaccine a. Call manufacturer for any packages that have been opened, broken, torn or tampered with

4. The shipper temperature logger will be reviewed for any temperature deviations a. Call manufacturer for any temperature excursions

STORAGE AND HANDLING 1. Dry Ice – See Dry Ice Policy for specifics a. Dry ice must be stored in well-ventilated locations and placed in insulated and ventilated storage areas, chests, insulated coolers or special coolers designed for dry ice storage. b. Employees handling dry ice must wear impermeable/loose fitting gloves and eye protection (safety glasses, face shield, or goggles)

2. Pfizer Vaccine a. Shipper Packaging Storage i. Pfizer vaccine will arrive in a dry-ice thermal shipper with an included temperature device ii. If vaccine is to continue to be stored in thermal shipper, keep the vials within their trays iii. Upon receipt, ensure precautions for handling dry ice (metal scoop, insulated gloves, eye protection and ventilated area). iv. Verify appropriate contents and condition of shipment. Quantities should match inventory expected. v. The thermal shipper itself can store vaccine for up to 15 days if dry ice is replenished appropriately by adding 22lb of dry per recharge. To utilize this method, dry ice must be replenished within 24 hours of receipt, then every 5 days, for up to an additional two times (3 total re-icings, including initial replenishment). The shipper should only be opened twice per day for no more than 3 minutes at a time. After storage for 15 days in the shipper, vaccine can be placed in a refrigerator for 5 days of additional storage at 2°C to 8°C (36°F to 46°F). a) It is key to ensure plans in place to utilize all doses within the storage timeframe. b) Beyond Use Date (BUD) labels should be available from CDC to assist in identifying timeframes by which you must use the vaccine (i.e. if refrigerated, must use within 5 days) c) Amount of dry ice for replenishment of shipper: 23 kg (51 lbs.) and the Dry ice must be in pellet form vi. A temperature device included with the shipper may be re-activated to monitor temperatures. vii. Thermal shipper itself and embedded temperature device must be returned to Pfizer within 20 days (instructions included in shipper)

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b. Sub-Zero Ultra Low Freezer (ULF) Storage i. General Requirements a) No food in freezer b) Keep vaccines in original boxes until ready to use or place in metal baskets/bins c) Temperature range will be kept between -600C to -800C d) Freezer will be plugged into an emergency power plug where available e) Pharmacy to ensure doors of the ULF are sealed and closed properly ii. Store at -60oC to -80oC for up to 6 months c. Refrigerator i. Store at 2oC to 8oC (36oF to 46oF) for up to 5 days. It is key to ensure plans are in place to utilize all doses within storage timeframe. ii. Thawed vaccine in the refrigerator cannot be returned to the Ultra cold storage or thermal shipper. d. Room Temperature i. If removed directly from ultra-cold temperatures, vaccine must be thawed ~30 minutes at room temperature before dilution. ii. Once vaccine is thawed, it must be diluted within 2 hours. If unable to dilute within 2 hours, store at 2oC to 8oC (36oF to 46oF) . iii. Must use diluted vaccine within 6 hours (discard any unused, diluted vaccine after 6 hours) It is key to ensure plans are in place to utilize all doses within storage timeframe

3. Moderna Vaccine a. Shipper Packaging Storage i. Moderna vaccine will arrive in a frozen thermal shipper with an included temperature device ii. Verify appropriate contents and condition of shipment. Quantities should match inventory expected. b. Freezer Storage i. Store at -50oC to -15oC for up to 6 months; NOTE: This is narrower in range than varicella-containing vaccine storage ranges. c. Refrigerator Storage i. May store at 2oC to 8oC for up to 30 days if the vial has not been punctured ii. Refrigeration results in thawing of the vaccine. iii. Thawed refrigerated vaccines cannot be returned to the freezer. d. Room Temperature i. Let vial stand at room temperature for 15 minutes before administering ii. The total time between removal from refrigeration and administration should be no more than 12 hours iii. Once the vial has been entered, it must be used within 12 hours (discard any unused vaccine after 12 hours).

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iv. Once thawed, swirl vaccine gently prior to withdrawing a dose. Do NOT shake.

4. Janssen Vaccine a. Shipper Packing Storage i. Initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F) ii. Each shipment contains two temperature monitors iii. The WarmMark monitor is located under the frozen gel packs at the top of the cooler iv. The FreezeMark indicator is located inside the inner box, next to the vaccine v. Remove the instruction card for each temperature monitor vi. If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F) vii. If needed immediately, thaw at 9°C to 25°C (47°F to 77°F) viii. A carton will take approximately 1 hour to thaw ix. Do not refreeze once thawed b. Refrigerator Storage i. Temperature range: Between 2°C to 8°C (36°F to 46°F) ii. Unpunctured vaccine may be stored in the refrigerator until the expiration date a) Expiration date is NOT printed on the vaccine vial or carton b) Scan the QR code on the outer carton c) Call 1-800-565-4008 d) Go to www.vaxcheck.j iii. Punctured vial may be stored in the refrigerator for up to 6 hours iv. Protect from light c. Room Temperature i. 9°C to 25°C (47°F to 77°F) ii. Unpunctured vials may be stored for up to 12 hours at room temp iii. Punctured via may be stored up to 2 hours at room temp 5. HRSA acquired COVID-19 Vaccine will follow all State and Federal requirements.

Daily Temperature Monitoring and Temperature Excursions 1. Temperature Monitoring a. Temperatures must be monitored at all times to ensure viability b. Utilize a digital data logger (DDL) for continuous monitoring (24/7) and recording of storage temperatures. If an ultra-cold freezer is in use, be sure your data logger is capable of registering such temperatures. c. Minimum/maximum: Min/max provides the highest and lowest temperature reached since min/max was last checked or since device was cleared. This is an

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important assessment as it allows you to identify an out-of-range temperature, even if “current” temperatures recovered. Some devices require that min/max is physically CLEARED after each assessment of min/max (ex: VFC5000). Others may clear automatically. Please ensure you understand these intricacies of your device features d. Temperature logs for ultra-cold temperature documentation is provided by the CDC. Temperature documentation must include temperatures, name or initials of person documenting temperatures, the exact time of temperatures taken, and any notes about excursions if noted e. Document temperatures at least twice daily (AM and PM) on temperature logs as follows: i. AM, before vaccination: Current temperature and minimum/maximum temperature ii. PM: Current temperature

2. Temperature Excursions3 a. Out-of-range temperatures (current, min, or max) are considered excursions. These must be documented on the temperature logs and require immediate action. b. Stop vaccination while investigating any excursions. Vaccines exposed to out- of-range temperatures must be labeled “do not use” and stored at the required temperature until further information on usability can be gathered. Do NOT use vaccine exposed to excursions until manufacturer stability information has been obtained and Local Health Department (LHD) guidance provided. c. Contact manufacturers for all products exposed to the excursion to obtain stability determinations on the vaccine. They will provide documentation as to whether use of the vaccine is supported or not. d. Notify the Local Health Department of all excursions and provide all documentation to the LHD. e. Maintain all documentation related to excursions – data logger downloads, temp logs, manufacturer stability reports, etc.

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TRANSPORT AND REDISTRIBUTION 1. CDC does not recommend transporting ultra-cold vaccine (Vaccine A/Pfizer vaccine).

2. If necessary, this vaccine may be transported in its original shipping container with dry ice or in a portable ultra-cold freezer that can maintain -80° C.

3. Alternatively, it may be transported at refrigerated temperatures using appropriate qualified transport containers that maintain at 2°C to 8°C (36° F to 46° F). a. A qualified transport container is A type of container and supplies specifically designed for use when packing vaccines for transport. They are passive containers that do not require a power source and are “qualified” through laboratory testing under controlled conditions to ensure they achieve and maintain desired temperatures for a set amount of time.

4. However, at refrigerated temperatures, Pfizer vaccine is only viable for up to 5 days/120 hours. Transport time counts towards this 120-hour limit.

5. When transporting vaccine a digital data logger will be used to monitor and record temperatures if an imbedded temperature logger is not available.

6. Both the redistributing site and the recipient site must ensure the COVID Vaccine inventory reflects movement of vaccine prior to administration of doses

7. When transporting and redistributing, the following must be documented. a. Name of transporter b. Sending Site, Contact name of Sending Site, Date/Time of Transfer, Temperature of ULF or refrigerator prior to transfer and temperature of cooler before departure c. Receiving site, contact name at receiving site, Lot#, BUD, # of doses, temperature of cooler upon arrival, Temperature of refrigerator, storage of vaccine

INVENTORY CONTROL 1. Security to Access a. Security to access to COVID Vaccine storage areas will only be accessible to authorized staff

2. Chain of Custody a. Two staff members will be involved in each chain of custody process for when the vaccine is being received, distributed or wasted. b. A log will be created to document chain of custody during each transfer process.

3. Waste a. As indicated by the Provider Agreement, providers must report COVID-19 vaccines and diluents that were used, spoiled, expired, or wasted as required by CDPH

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4. Reporting of Inventory a. On-hand inventory must be reported to CDC’s Vaccine Finder each day: www.vaccinefinder.org b. Providers enrolled in the COVID-19 vaccine program will receive an email from the “COVID Locating Health Provider Portal” with instructions for completing the enrollment process. This email will be sent to the provider organization’s email address submitted in the provider enrollment form

ADMINISTRATION 1. Pfizer Vaccine a. 2mL preservative-free multi-dose vial with 0.45mL frozen vaccine product (at least 5 doses per vial). b. Thaw vial prior to use: Up to 30 min at room temperature or 3 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F) c. Dilute the vaccine multi-dose vial with 1.8 mL of diluent (provided in the ancillary kits). When reconstituting, do not shake – Instead, invert gently 10 times. After reconstitution, the vial contains enough for at least 5 doses of vaccine. d. ONCE reconstituted, must use within 6 hours e. Mark the vial with the time to ensure utilization of all doses within 6 hours once reconstituted f. Cleanse the vial stopper with antiseptic before every withdrawal from the vial. This is a key step as the Pfizer vaccine is preservative-free. g. Dose, Schedule, and Route of Pfizer COVID Vaccine i. Dose: Each dose is 0.3mL (NOTE THIS DOSAGE. This is different from most standard vaccine doses). ii. Schedule: 2 doses, 21 days apart. iii. Route: Administer as an intramuscular (IM) injection h. There are at least 6 doses per vial.

2. Moderna Vaccine a. No reconstitution needed b. Swirl vial gently after thawed, do not shake c. Storage: i. Freezer between -250C to -150C (-130F to 50F) for up to 6 months ii. Refrigerator between 20C to 80C (360F to 460F) for up to 30 days prior to first use iii. Room Temperature un-punctured vials may be stored between 80C to 250C (460F to 770F) for up to 12 hours. After the first dose has been withdrawn, the vial should be used within 6 hours. iv. Do not refreeze any vials stored in the refrigerator or room temperature. d. Mark the vial with the time to ensure utilization of all doses within 6 hours once reconstituted

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e. Cleanse the vial stopper with antiseptic before every withdrawal from the vial. This is a key step as the Moderna vaccine is preservative-free. f. Dose, Schedule, and Route of Moderna COVID Vaccine i. Dose: Each dose is 0.5mL ii. Schedule: 2 doses, 28 days apart. iii. Route: Administer as an intramuscular (IM) injection g. There are at least 10 doses per vial.

3. Janssen Vaccine a. No reconstitution needed b. Swirl vial gently for 10 seconds between each dose withdrawal c. Do NOT shake d. cleanse the vial stopper with a new, sterile alcohol prep pad e. Storage i. After the first dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F) ii. Discard punctured vial after 2 hours at room temperature or 6 hours at refrigerated temperature f. Record the date and time for first use on the Janssen COVID-19 Vaccine vial label i. g. Dose, Schedule and Route i. Dose: Each dose is 0.5 mL of vaccine into the syringe ii. Schedule: 1 time dose only iii. Route: Administer as an intramuscular (IM) Injection h. DO NOT POOL excess vaccine from multiple vials i. There are 5 doses per vial

DOSE DOCUMENTATION AND ADMINISTRATION REPORTING 1. Vaccine administration must be documented in the CAIRs within 24 hours of vaccination.

2. Required data elements to report:

Required Data Element (CDC Playbook, Appendix D) Administered at location: facility name/ID Administered at location: type Administration address (including county) Administration date CVX (Product) Dose number Recipient race, if available Recipient ethnicity, if available IIS recipient ID* IIS vaccination event ID Lot number: unit of use and/or unit of sale

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MVX (manufacturer) Recipient address* Recipient date of birth* Recipient name* Recipient sex Sending organization Vaccine administering provider suffix, if available Vaccine administering site (on the body), if available Vaccine expiration date Vaccine route of administration, if available *Identifiable information

PATIENT EDUCATION AND REPORTING OF ADVERSE EVENTS3 1. EUA Fact Sheets a. As indicated in the Provider Agreement, providers must provide an Emergency Use Authorization (EUA) fact sheet or vaccine information statement (VIS), as applicable, to each vaccine recipient/parent/legal guardian prior to vaccination

Vaccination Record Cards and Second Dose Reminders

b. As indicated in the Provider Agreement, providers must provide a COVID-19 vaccination record card to each vaccine recipient/parent/legal guardian. c. These cards will be provided as part of vaccine ancillary kits. Vaccination providers must complete these cards with accurate vaccine information (i.e., manufacturer, lot number, date of first dose, and second dose due date), and give them to each patient who receives vaccine to ensure a basic vaccination record is provided. Vaccination providers should encourage vaccine recipients to keep the card in case the CAIR or other system is not available when they return for their second dose. The card provides room for a written reminder for a second-dose appointment. d. If vaccine recipients have a smartphone, they may consider documenting their vaccine administration with a photo of their vaccination record and entering the date the next vaccine dose is due on their electronic calendar. e. Redundant methods and systems should be used to remind vaccine recipients about their need for second doses.

2. Vaccine Adverse Event Reporting System (VAERS): a. All adverse events or adverse reactions should be reported to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html and as an AHS Safety Alert b. Anyone can submit a report to VAERS, including patients, family members, healthcare providers, vaccine manufacturers and the general public. c. CDC and FDA encourage anyone who experiences an adverse event after receiving a vaccine to report to VAERS.

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d. Employees will also be encouraged to download the V-SAFE app on their phone to allow the CDC to provide telephone follow up to anyone who reports medically significant adverse events. The surveys will be sent to anyone who provides contact information daily for the first week post-vaccination and then weekly for six weeks. e. VAERS is a national reporting system to detect possible safety problems with vaccines. Anyone can submit a report to VAERS. VAERS is not designed to detect whether a vaccine caused an adverse event (AE), but it can identify “signals” that might indicate possible safety problems requiring additional investigation. f. Per the CDC COVID-19 Vaccination Program Provider Agreement, COVID-19 vaccination providers are required to report the following to VAERS: i. Vaccine administration errors (whether associated with an Adverse Event or not) ii. Serious Adverse Events (even if they are not sure if the vaccination caused the event) iii. Multisystem inflammatory syndrome (MIS) in children or adults, and iv. Cases of COVID-19 that result in hospitalization or death

Vaccination providers should also report any additional clinically significant adverse events following COVID-19 vaccination to VAERS, even if they are not sure if the vaccination caused the event. More information on submitting a VAERS report electronically can be found at https://vaers.hhs.gov/reportevent.html.

3. V-SAFE a. All vaccine recipients will be encouraged to sign up for the CDC V-SAFE tool. b. CDC will implement v-safe, a new smartphone-based tool that uses text messaging and web surveys to check in with early vaccine recipients (HCP, essential workers) to monitor for adverse events after a COVID-19 vaccination. V-safe will also provide second-dose reminders (if needed) and live telephone follow up by CDC if vaccinated individuals report a medically significant event during a v-safe check-in. c. V-safe asks questions to monitor the safety of COVID-19 vaccines. The information will be used to analyze common side effects (soreness in the arm, muscle aches, etc.) and detect unexpected, serious health problems if they occur. d. CDC will create a v-safe information sheet that contains background on the program and instructions for enrolling. Healthcare professionals and healthcare facilities that are giving COVID-19 vaccines are asked to provide printed hard copies of the v-safe information sheet to each vaccinated individual and counsel them on enrolling in v-safe. The v-safe information sheet and counseling script are in development and will be made available when completed. It is critically important for vaccine safety monitoring and assessment that healthcare professionals give each patient a v-safe information sheet at the time of vaccination and encourage patients to enroll.

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STAFF EDUCATION 1. All staff working with Dry Ice will be required to review Dry Ice Policy

2. All staff in pharmacy and Employee Health will be required to take the CDPH required training listed below a. COVID-19 Vaccination Program Participation Requirements b. COVID-19 Vaccine Training: General Overview c. Immunization Information System (IIS) Participation d. Ordering Vaccines e. Storage and Handling f. Temperature Monitoring g. Vaccine Administration h. Vaccine Management i. Reporting Requirements

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REFERENCES 1. OSHA Safety Manual on Storage and Handling of Dry Ice https://www.safetymanualosha.com/safe-handling-and-storage-of-dry-ice/

2. CDC COVID-19 Vaccination Program Interim Playbook https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program- Interim_Playbook.pdf

3. CDPH COVID-19 Vaccine Required Trainings https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/COVID- 19VaccineTraining.aspx

4. Pfizer EUA Fact Sheet HealthCare Professional – update 2/25/2021 https://www.fda.gov/media/144414/download 5. Moderna EUA Fact Sheet HealthCare Professional – update 12/2020 https://www.fda.gov/media/144637/download

6. Janssen EUA Fact Sheet HealthCare Professional – update 2/27/2021 https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine- Recipient-fact-sheet.pdf

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 3/2021 3/3021 Pharmacy and Date: 3/2021 N/A N/A Therapeutics (P&T) Clinical Practice Date: 02/2021; N/A N/A Council (CPC) 07/2021 Medical Executive Date: N/A Committee Board of Trustees Date: N/A N/A

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PHARMACEUTICAL WASTE

Effective Date No Date Set Date Revised Not Approved Yet Document Owner MGR, SYS MED Next Scheduled Review No Review Date SAFETY/CLIN PHARM Executive Responsible Pharmacy and Therapeutics, DIRECTOR – PHARMACY, CAO, CNE, CMO Printed copies are for reference only. Please refer to electronic copy for the latest version.

Purpose

To ensure Pharmaceutical waste is segregated, contained, transported, treated and disposed of in accordance with federal, state, county and city regulations.

Policy

1. The Department of Pharmacy Services shall serve as a resource for up-to-date information on pharmaceutical waste management. 2. Each patient care unit and department is responsible for appropriate handling, storage and disposal of pharmaceutical waste products that is generated from the medication use process. 3. Pharmaceutical waste containers will be labeled with a start date and a 90 day beyond use date. 4. When the container is full or one week before it reaches 90 day limit, the container will be sealed with provided seals and EVS contacted to have the container moved to the secured storage area for removal and incineration by an outside vendor. 5. The pharmaceutical waste may be stored on site at the hospital for up to 1 year from start date before transporting to a site for incineration. The transportation of the waste must be recorded using a Department of Health Service (DHS) approved medical waste tracking document.

Definition

Pharmaceutical waste is any partially used medication (more than trace amounts) in IV infusion containers, tubing, syringes, ampules or vials. Pharmaceutical waste also includes tablets, capsules, oral solutions, suppositories, topical products, patches and inhalers.

Procedure

1. Acceptable for Sewering: IV solutions containing normal saline, lactate, nutrients such as dextrose, vitamins and electrolytes such as potassium. These IV solutions shall be drained down the sewer and the IV containers and tubing discarded in the regular trash after removal of patient identifiers on IV label.

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2. NOT Acceptable for Sewering: Hazardous waste and non-hazardous waste as regulated under the Resource Conservation and Recovery Act (RCRA). This includes both liquid and solid pharmaceuticals and all controlled substances.

3. Pharmaceutical waste containers will be provided to patient care areas for waste management. Containers will be placed in point of use areas and secured as in the management of any sharps container. Pharmaceutical waste is segregated from other types of medical wastes and contained in sturdy leak-proof containers labeled on the top and sides with the words, “INCINERATION ONLY”. Each container will be labeled with the type of waste to be placed inside (see below).

Segregation of pharmaceutical wastes shall follow the guidelines as outlined in Attachment 1. This guideline will be posted adjacent to the pharmaceutical waste bins a. Pharmaceutical waste in WHITE bins with BLUE/PURPLE tops: IV containers, tubing, syringes, vials and ampules containing medications (except RCRA waste), tablets, capsules, topical products and inhalers. b. RCRA waste in BLACK bins with WHITE tops: Hazardous waste. RCRA items will be labeled “RCRA” by pharmacy. c. Chemotherapy/Biotherapy Waste in YELLOW bins with WHITE tops: anything that has trace or is empty chemotherapy/biotherapy IV bags, vials and syringes. d. When pharmaceutical waste bins are full or reaching the 6 month limit, call EVS for pick up and replacement. e. EVS will obtain and store pharmaceutical waste bin supplies from Central Supply and replace the bins as needed.

4. Controlled substance waste must be a witnessed disposal and documented on the medication administration record by both individuals. a. Tablets/capsules/suppositories- dispose in the WHITE bins with BLUE/PURPLE tops. b. Injections- dispose syringe and contents or partially used vial or ampule in the WHITE bins with BLUE/Purple tops. c. Oral solutions- pour remaining contents in the WHITE bins with BLUE/PURPLE tops. and place empty medication cups or bottles in regular trash after removing patient identifiers d. IV bags- cut IV bag to drain out any remaining contents in the WHITE bins with BLUE/PURPLE top. Remove patient identifiers and dispose the IV bag and tubing in the regular trash

5. Transportation and Storage: a. Filled, labeled, and tightly covered pharmaceutical waste containers shall be transported to the designated area by EVS. b. EVS shall store and dispose the pharmaceutical waste according to guidelines defined by the EVS Department.

References

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www.epa.gov/epawaste/inforesources/online/index.htm www.epa.gov/osw/hazard/wastetypes/universal/pharm.htm

Approvals

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MEDICATIONS: MEDICATION AREA INSPECTIONS

Effective Date No Date Set Date Revised Not Approved Yet Document Owner MGR, SYS MED Next Scheduled Review No Review Date SAFETY/CLIN PHARM Executive Responsible PHARMACY DIRECTOR Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To ensure safety and proper potency of medications, all medication storage areas will be inspected and documented every month.

POLICY Medications maintained on the nursing unit or other areas of the hospital/clinic where medications are dispensed, administered or stored, are inspected at least monthly by the Director of Pharmaceutical Services or their registered pharmacist designee. Any irregularities are to be reported to the Nurse Manager of each patient care unit or their designee.

PROCEDURE 1. All medication unit inspections are completed by a licensed Pharmacist

2. Medications are reviewed and inspected in all designated areas of the hospital including but not limited to: a. Automatic Dispensing Machines b. Medication rooms c. Shelves d. Procedure carts e. Treatment carts f. Cabinets g. Drawers

3. All outdated medications will be removed and replaced if they are still necessary to be kept on floors.

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4. The inspection should reflect aspects of medication distribution and storage including: a. Appropriate medication has been returned to the pharmacy, including: i. Medications of discharged Patients Medications discontinued for patients currently in the hospital ii. Outdated medications b. Open single-dose (refer to multi-dose policy) vials are immediately discarded. c. Multi-dose vials (with preservatives) if open, are initialed and dated in accordance with manufacturer’s recommendations or 28-day beyond use date, whichever shorter. d. Labels are clean and legible, and only authorized labeling is present. e. Medication Carts are neat, orderly, stocked, locked, and controlled substances are properly stored and locked. f. Medication room is neat, clean and orderly, properly stocked, and locked. i. Medications stored at the temperature range specified by the manufacturer package insert. ii. External medications stored separately from internals and injectables. g. Medication refrigerator and freezer is clean, frost and odor free, and maintained at an appropriate temperature. i. Refrigerator temperatures range from of 36-46oF and Freezer temperature ranges from -58oF to +5 oF. ii. No food is stored in the medication refrigerator. iii. Temperature logs are kept current. iv. Vaccines stored according to CDC guidelines. h. Crash carts are sealed and medication trays are not outdated. i. Visible availability of: i. Poison control telephone number ii. Weight and volume conversion charts posted iii. Antidote chart posted iv. Campus formulary available v. Look Alike and Sounds Alike medication chart vi. High Risk and High Alert medication chart j. The pharmacist will complete the inspection form (see Medication Area Inspection Form below). k. Immediately after inspection findings will be e-mailed or discussed with the Nurse Manager or charge nurse. l. The original inspection form will remain in the pharmacy for at least 3 years. m. Notices of recurring issues for any area will be forwarded to the Director of Nursing.

REFERENCES 1. TJC MM 03.01.01 EP 18 2. Title 22 70263 (q10)

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APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 03/2020 03/2020 Pharmacy and Date: 03/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 04/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 04/2020 04/2020 Committee Board of Trustees Date: 08/2020 N/A N/A

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ALAMEDA HEALTH SYSTEM MEDICATION AREA INSPECTION FORM

Site: □ Alameda □ Fairmont □ Highland □ John George □ San Leandro □ Wellness Clinic ______

Location: ______DATE: ______

PASSED FAILED N/A AREA OF REVIEW MEDICATION ROOM Medication carts/units/room locked at all times Medication room is neat and clean. And Medication Storage door not left opened. No drugs are found outside of designated area. Expired medications not present.  All open MDV medications labeled with correct BUD (i.e. 28 days.)  Check 5 random medication per Pyxis for expired and that appropriate expiration date is noted Medication stored properly  internals separated from externals  items requiring refrigeration properly stored Only approved medication stored in automatic dispensing machine or floor stock area, at approved levels. Sound Alike Look Alike medications (SALAD) are stored separately from each other and clearly labeled according to hospital policy. Discontinued medication(s) returned to the Pharmacy. Open single‐dose vials not present. All medication labels are clean, complete and legible. No medication samples present MEDICATION CARTS/KITS Current medication list on cart/kit posted properly All medication in date (not expired) Medication cart/kit properly locked Crash cart nursing log completed daily with lock numbers recorded. REFRIGERATOR Temperature of refrigerator and Freezer recorded by working thermometer and monitored at a minimum daily within USP 797 standards. Manually checked medication Refrigerator temperature log is posted and up to date. Manually checked room temperature log is posted and up to date. Refrigerator properly locked or located in a secure medication room. Refrigerator contains no food or non‐pharmaceutical items. CONTROL SUBSTANCES Tamper resistant controlled substance pad(s) locked in automatic dispensing machines/secure cabinet area. For non ADM area’s, controlled substance cabinet properly locked. (FMT only) MISCELLANEOUS Poison control telephone number displayed. Sound Alike Look Alike List displayed if applicable High Alert List displayed if applicable Metric/Apothecary conversion table displayed.

Antidote chart, look alike sound alike and high risk/high alert medication posted or available for reference All problems detected in previous rounds are corrected.

Comments/Corrective Action: ______Nursing Representative______Date:______Page 4 of 5

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Pharmacy Representative: ______Date:______

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DISCHARGE MEDICATIONS POLICY

Effective Date No Date Set Date Revised 6/2021 Not Approved Yet Document Owner MGR, SYS MED Next Scheduled Review No Review Date SAFETY/CLIN PHARM Executive Responsible Chief Administrative Officer/ Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To provide guidelines and a process for which discharge medications will be provided to AHS patients.

POLICY AHS hospital pharmacies will provide medications to patients upon discharge for high risk and HPAC patients in compliance with federal and state laws relating to patient inducement and other laws and regulations as may be applicable. Accordingly, AHS shall not offer waivers of coinsurance or deductible amounts as part of any advertisement or solicitation. AHS as an organization and its employees shall not routinely waive coinsurance or deductible amounts, and shall only waive such amounts after determining in good faith that the patient is in financial need, and after making reasonable efforts to collect the cost-sharing amounts from the patient.

PROCEDURE a. Provider will e-prescribe discharge medication order in the electronic health record for high risk and/or HPAC patients b. Pharmacy will dispense the medication upon receiving the order and deliver to patient care area c. Nursing or provider will provide patient medication education when discharge medications are delivered to nursing unit or picked up by nursing staff member. i. Consultation to include: 1. Use and storage of each medication 2. Precautions and relevant warnings 3. Importance of compliance with medication directions d. Pharmacist to provide oral consultation, in accordance with B&P 4074, when medications are picked up by patient or patient’s agent from the discharge pharmacy.

1. Non-24 hour pharmacies

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a. In the event that patients are discharged after hours, providers can e-prescribe to an outside pharmacy if the patient has insurance b. Providers and nurses can contact the AHS pharmacist on-call for unique patient cases

2. Collection of patient financial obligation (e.g. co-pay, deductibles share of cost) a. Pharmacy will make available, an invoice at the time of dispensing for patient financial obligation based on patient insurance type and medication coverage b. Patient will have an option to pay via mail or in-person within 30 days c. Pharmacy will make a reasonable and genuine attempt to collect all co-pays

3. Financial Assistance a. If the patient is not able to afford the financial obligation, then the patient will be referred to Patient Financial Services to determine eligibility for coverage under Charity Care. b. AHS will absorb the cost of charity care for prescription medications and will not pass this financial cost to the payer.

REFERENCES 1. The Anti‐Kickback Statute: 42 U.S.C. 1320a‐7b , et seq. 2. The Civil Monetary Penalty Statute: 42 U.S.C. 1320a‐7a, et seq. 3. Business and Professions Code Board of Pharmacy Regulations Section 4074. California Code Regulation Title 16 § 1707.2

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