COALINGA STATE HOSPITAL NURSING POLICY AND PROCEDURE MANUAL SECTION - Medications POLICY NUMBER: 510

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COALINGA STATE HOSPITAL NURSING POLICY AND PROCEDURE MANUAL SECTION - Medications POLICY NUMBER: 510 Effective Date: August 31, 2006 SUBJECT: CARE OF THE INDIVIDUAL RECEIVING CLOZAPINE 1. GENERAL: Clozapine is indicated for the severely ill schizophrenic Individual who has not responded to other neuroleptic medication or who is experiencing intolerable side effects from current medication. During the stabilization, period Individuals will be titrated up from an initial low dose. Because of potentially severe blood dyscrasias, Pharmacy will only distribute unit dose supplies based on mandatory weekly or biweekly white blood counts (WBCs). Due to the effect of clozapine on the GI tract, special consideration must be given when assessing the Individual for potential or actual constipation. A Individual may be constipated or have a partial impaction with no symptoms, or subtle symptoms. Nursing is required to assess any change in Individual status that may indicate constipation or formation of an impaction. The following changes in a Individual s status can indicate the beginning of an impaction: changes in mental status (e.g. confusion, delirium); an increase in the Individual s presenting psychiatric or psychotic symptoms; physical changes such as bloating, discomfort or pain in the abdomen or rectum. If changes are found upon assessment, the change in status must be referred to the physician immediately. Though some Individuals on clozapine have had no difficulty with constipation, each Individual will be monitored by eliminative subsystem each shift. 2. PURPOSE: To assure that clozapine is administered safely and in a manner that minimizes risk from potential untoward reactions. 3. PROCEDURE: A. Pre-Treatment Baseline: NURSING ACTION A. All Individuals on clozapine will have a Wellness and Recovery Plan as long as they are on the medication and must -1- RATIONALE-PRECAUTIONS A. Individual will be evaluated and educated regarding diet, fluid intake, exercise and other related factors

agree to follow the plan. B. Obtain a physician's order for baseline lab work. C. The physician will receive a start-up packet from pharmacy containing all the necessary paperwork. The following baseline data is completed or current by: -Lab Within 30 days: WBC Within previous year: - Serum creatinine - Electrolytes - Liver function panel - Total protein - Albumin - Urinalysis -30 days prior to starting, a complete physical assessment including: - abdominal and rectal exam - KUB -EKG - Within previous year D. Complete set of Vital signs twice daily for 3 days. E. Observation and documentation of bowel habits two weeks prior to initiation of clozapine. F. Prior to initiating clozapine, a referral will be sent to Nutrition Services associated with clozapine with special emphasis on constipation. B. Ongoing monitoring of the Individual for potential adverse reactions requires adequate baseline information to interpret changes. C. Pharmacy will not dispense the medication until it has received verification that baseline work-up is complete. E. If constipation is present or part of the Individual's history, the problem must be resolved/treated before clozapine therapy is instituted. F. Nutrition Services has a vital role in nutritional intake and prevention of constipation B. Obtaining the Medication: A. The initial dose of medication will not be distributed until the pretreatment procedures and forms are completed and the clozapine registry has been contacted and an authorization number has been received. Physician s orders must -2-

also be sent to the pharmacy. B. To obtain subsequent doses of the medication, bring a copy of the physician's orders. C. Return to the Pharmacy any pills left over after the dosing period. D. If new orders are written and/or the current, on-hand supply is insufficient, bring the remaining doses back to Pharmacy with the most current orders and new medication will be dispensed. E. If the Individual refuses a dose and/or a dose needs to be wasted, notify Pharmacy so that additional doses can be dispensed. F. If Pharmacy is closed and it is necessary to obtain doses of the medication, call NOD. C. All doses must be accounted for. F. To assure there is no interruption of the Individual s treatment. C. Monitoring White Blood Counts: A. Obtain a physician's order for weekly WBC s with differential for the first 6 months or weekly or bi-weekly WBC's with differential after the first 6 months (weekly or bi-weekly will be determined by the physician after the first 6 months of treatment). Monthly KUB times three months and then quarterly thereafter. B. Write "WCB with DIFF. for Clozapine" in the box labeled "test requested" on the lab slip any time a CBC is ordered on a clozapine Individual.Individual C. Schedule the Individual to have a CBC drawn weekly. D. If the routine lab day falls on a holiday; an extra lab draw must be scheduled. E. If the WBC falls below 3500, labs will be drawn twice weekly. Vital signs will be A. Agranulocytosis may occur and is a potential severe adverse reaction. B. Laboratory personnel must be notified on the lab slip that the Individual is being monitored for clozapine in order to process the results. C. To avoid duplicate or unnecessary needle punctures. The lab can obtain all the needed samples with a single puncture. D. The lab is closed on all state holidays and the interval between CBCs must never be more than seven (7) days. E. If the WBC reveals a significant drop in cell count, even if WBC count is still in -3-

taken daily. F. If the WBC drops below 3000, Clozapine will be stopped. If WBC drops below 2000, the Individual will be admitted to the Infirmary Unit for reverse isolation normal range, or WBC tests reveal three or more consecutive drops in WBC cell counts the Individual needs closer monitoring for potential infection. F. To reduce and prevent infection in a Individual whose WBC may be low. D. Ongoing Nursing Care of the Individual on Clozapine: 1. Vital Signs: A. One hour after the first dose then twice daily for 21 days after the first dose. B. Report fever or sore throat to attending physician immediately. A. Monitoring vital signs when initiating clozapine is important since side effect such as hypotension, tachycardia, and fever may occur. Special consideration needs to be given to Individuals who may also be on a benzodiazepine due to possible respiratory collapse or hypotension. B. These are frequently the first signs of dropping WBC. 3. Lab work: A. Monitor weekly or bi-weekly WBC with differential. Assist the Individual to keep weekly or bi-weekly appointments. Liver function panels are required every six (6) months. Serum creatinine levels are done at the 3rd and 6th months, then every 6 months thereafter. B. Reinforce with the Individual the importance of general infection control measures (hand hygiene, not sharing cups, etc.). C. Educate Individual regarding fluid intake (if medical condition permits) to a minimum of 2000 cc per 24 hours (four ounces of prune juice may be ordered to be given with medications up to three times a day) along with adequate fiber, exercise, and use of stool softener (if ordered). Encourage Individual to -4- A. Agranulocytosis may occur in Individuals receiving clozapine. Liver and kidney function must also be monitored. B. To prevent infection in a Individual whose WBC may be low. C. To prevent constipation, a frequent and possible life threatening side effect. Some Individuals who may not be able to monitor hydration effectively themselves may need further assistance such as an extra cup of water or juice at meal and medication times.

increase fluid intake further during warm weather. D. Monitor oral intake. Baseline data will include intake at meals and medication times or any other time decided by staff/individual (e.g. snack time). E. Encourage 15-30 minutes of exercise (e.g. walking) at least three times a week. If the Individual is not capable, refer to rehabilitation therapist for alternative activities. F. If the Individual becomes constipated during clozapine treatment, observe stool and immediately report results to the physician. If the Individual does not have a bowel movement within 48 hours, refer Individual to the physician. G. Continue to encourage fluid intake and supplemental liquid dietary fiber, e.g., prune juice and/or a fiber enhanced supplement. The Registered Dietician and physician treat additional modifications in fiber on an individual basis. H. If the Individual has a fecal impaction unit staff will notify a physician immediately for evaluation and intervention(s). I. Educate the Individual for possible side effects of sedation and/or dizziness. Benign hyperthermia (5% of Individuals) usually occurs early in the treatment and may be as high as 104 degrees. As with any other fever, an infectious process should be ruled out. Tachycardia has been observed in about 25% of Individuals who experience an average increase of 10-15 beats per minute. It is dose dependent. D. To provide consistency in accomplishing adequate fluid intake. To assure that the Individual is drinking fluids. E. To prevent constipation. F. It is estimated that up to 60% of Individuals receiving clozapine will become constipated. H. If the Individual has a fecal impaction this may be a medical emergency. J. A towel may be placed on the Individual's pillow at night for increased J. Hypersalivation is a known side effect and is typically worse during sleep. -5-

salivation. K. The Individual may cough at night due to hypersalivation. If excessive coughing occurs this should be brought to the attention of the physician and documented by the staff in the Individual s chart. (affecting approximately 31% of Individuals). K. If the Individual coughs often at night he may develop respiratory problems due to aspirating small amounts of saliva. E. Managing Identified Adverse Reactions: 1. Seizures: A. Maintain the Individual's safety.observe the course of the seizure and record. Hold the medication and report to the psychiatrist. A. Seizures increase in likelihood as the dose increases. 2. Hypotension: A. Teach the Individual to sit on the edge of the bed several minutes before rising, then to rise slowly to a standing position. B. Have the Individual report any symptoms of dizziness, lightheadedness, or difficulty breathing. A. Orthostatic hypotension can be a side effect and can be particularly severe during initial dose adjustment. B. Individuals with pre-existing cardiac conditions are at highest risk. Individuals receiving benzodiazepines are also at risk. F. Continuity of Care when Individuals are transferred from One Unit to Another: A. The transferring unit will notify the receiving unit of impending transfer in sufficient time to allow the receiving unit to coordinate lab draw times. B. The transferring unit will return any remaining doses to Pharmacy. C. The receiving unit will obtain medication as described in above Section II B. A. Weekly or bi-weekly blood-draw schedules must not be interrupted as Pharmacy will not dispense medication without a current WBC (no older than seven (7) days). G. Continuity of Care after Discharge from the Hospital: A. If the Individual is going to court or is being discharged, complete the Nursing A. The Nursing Discharge Summary is an essential tool to assure that the continuity -6-

Discharge Summary and include pertinent aftercare information (e.g. last 3 WBC dates and results). B. If Individual was recently taken off clozapine (within the last two weeks), record this information on the Nursing Discharge Summary. WBC s need to continue to be drawn for three weeks after Clozapine is discontinued of Clozapine treatment and supportive care is not interrupted. B. To prevent an atropine overload, at the receiving facility, the dose and discontinued date of Clozapine is required. To continue to monitor the Individual for side effects till the medication is no longer in his system. -7-