City and County of San Francisco
Department of Public Health
POPULATION HEALTH AND PREVENTION
COMMUNITY BEHAVIORAL HEALTH SERVICES
1380 Howard Street, 5th Floor
San Francisco, CA 94103
POLICY/PROCEDURE REGARDING: General Procedure and Protocol For Clinical Pharmacists
Manual Number: 3.07-5.
To formally recognize the expanded role of clinical pharmacists to provide continuing care and optimal medication management for referred patients.
1. Provide a more cost-effective means of maintenance medication management
2. Increase patient adherence to medications
3. Maximize therapeutic benefits of medication and increase periods of clinical stability
4. Improve symptom and side effect management
5. Increase patient's self-medication and symptom management abilities
6. Improve patient satisfaction
7. Facilitate outpatient research opportunities
The text for the CBHS policy for granting pharmacists clinical privileges is taken from the applicable statutes.† A new law (AB 826) is intended "to remove unnecessary restrictions on a pharmacist's ability to provide their services in a broader range of clinical settingsĒ.† The law does not change what services the pharmacist may provide or how those services are provided. Rather, the law simply expands where these services can be provided so that patients can receive them in convenient settings.†† Studies show that the active participation of pharmacists in drug therapy improves patient outcomes and reduces the cost of health care.† AB 826 became law January 1, 2002. It incorporates changes in Sections 4050-2 of the Business and Professions Code.† It was sponsored by the California State Board of Pharmacy and it does the following:
∑ Eliminates restrictions on the locations outside of a pharmacy where a pharmacist may provide clinical advice, information or patient consultation
∑ Eliminates the provision that limits a pharmacist's authority to initiate a patient's drug regimen only for patients in a licensed health care facility, thereby permitting this service to be provided in a variety of outpatient settings.
∑ Permits a pharmacist to adjust a patient's drug regimen, including the substitution or selection of a different drug, as authorized by a protocol developed with the patient's physician.
∑ Requires the pharmacist within 24 hours of initiating a drug regimen for a patient to notify the patient's prescriber in writing, or enter the appropriate information in an electronic patient record system shared with the patient's prescriber.
∑ Revises the definition of the practice of pharmacy to include "communication for clinical and consultative purposes".
The pharmacist may perform the following procedures or functions in a clinic in accordance with policies, procedures, or protocols developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the clinic director:
∑ Ordering or performing routine drug therapy-related patient assessment procedures including temperature, pulse, and respiration.
∑ Ordering drug therapy-related laboratory tests.
∑ Administering drugs and "biologicals" by injection pursuant to a prescriber's order (the administration of immunizations under the supervision of a prescriber may also be performed).
∑ Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's prescriber and in accordance with the policies, procedures, or protocols of the clinic. Adjusting the drug regimen does not include substituting or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide written notification to the patient's prescriber of any drug regimen initiated pursuant to this clause within 24 hours.
∑ A patient's prescriber may prohibit, by written instruction, any adjustment or change in the patient's drug regimen by the pharmacist.
∑ Provide consultation to patients and provide professional information, including clinical or pharmacological information, advice, or consultation to other health care professionals.
The procedures or protocols shall be developed by health care professionals, including physicians, pharmacists, and registered nurses, and, at a minimum, meet all of the following requirements:
∑ Require that the pharmacist functions as part of a multidisciplinary group that includes physicians and direct-care registered nurses. The multidisciplinary group shall determine the appropriate participation of the pharmacist and the direct care registered nurse.
∑ Require that the medical records of the patient be available to both the patient's prescriber and the pharmacist.
∑ Require that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physician.
∑ Require the procedures to be performed in accordance with a written, patient-specific protocol approved by the treating or supervising physician. Any change, adjustment, or modification of an approved preexisting treatment or drug therapy shall be provided in writing to the treating or supervising physician within 24 hours.
Prior to performing any procedure authorized by this policy a pharmacist shall :
∑ have received appropriate training as prescribed in the policies and procedures of the clinic and
∑ successfully completed clinical residency training or
∑ demonstrated clinical experience in direct patient care delivery to the satisfaction of the clinic medical director.
PROTOCOL FOR PHARMACIST CLINICAL PRIVILEGES
1) Criteria for Patient Referral to Pharmacist
Patients referred to CBHS pharmacist medication assessment and monitoring will meet the following criteria:
∑ be registered with CBHS,
∑ have been previously evaluated by a licensed psychiatrist,
∑ not be having a psychiatric emergency,
∑ and referred by their physician for pharmacist, monitoring, and medication management.
Upon referral by written order by a CBHS psychiatrist, psychotropic medication will be co-managed by the clinical pharmacist under the supervision of a CBHS psychiatrist. The clinical pharmacist will function as part of a multidisciplinary, collaborative drug therapy management team in accordance with this protocol.
Patients can be seen by the CBHS clinical pharmacist in individual sessions, drop-in clinics, or in group settings across the CBHS system of care. Individual sessions will focus on collecting and interpreting pertinent clinical data, and implementing, monitoring, recommending, and modifying pharmacotherapeutic plans for the patient. Sessions may also include a focus on patient education related to medication issues.
Drop-in clinic will focus on assessing clients who require medication refills. Patients may be referred to drop in clinic by a CBHS psychiatrist for regular medication refills and/or injections. Referrals to the drop-in clinic may be made by the OD in the special case where a patient needs a medication supply until their next physician appointment because they missed their physician appointment or lost their medication.† Drop-in clinic may also be used as triage for questions from patients regarding potential adverse drug reactions, efficacy, or other medication-related questions.
Group sessions may focus on: collecting and interpreting pertinent clinical data, and monitoring and modifying pharmacotherapeutic plans for the patient; psychomed education; issues related to drug therapy; and supportive therapy. Medication groups meet once weekly, once every two weeks, or once a month. Patients will be assigned to groups based on the level of care that is needed.
2) Disease States Managed
∑ All previously diagnosed psychiatric conditions listed in the DMS-IV that need non-emergent medication assessment and/or medication adjustments prior to the next physician re-evaluation.
∑ Treatment of emergent EPS and acute EPS, with appropriate referral
∑ Other treatment emergent side effects including, but not limited to, constipation, xerostomia, incontinence, sexual dysfunction, etc.
3) History Obtained and Patient Assessment Performed
The CBHS clinical pharmacist will refer to patientís CBHS medical record, if available, and will seek other sources of information to obtain additional medical, psychiatric, and medication history, laboratory results, and relevant findings.
The clinical pharmacist will assess and monitor psychiatric medication effects, compliance, adverse drug reactions, and outcomes related to therapy.
The pharmacist will evaluate the development of new, unanticipated, or recurrent problems and will consult with the physician supervisor and/or refer the patient to the appropriate service or personnel.
The clinical pharmacist functions may include obtaining a medication history, and ordering laboratory tests as appropriate.
Medication management will include adjusting medication doses and dosage schedules to minimize adverse effects and optimize therapeutic response including managing medication titration and tapering schedules as previously agreed upon with the prescribing physician.
Clinical Intervention Algorithm:
1. If there is no significant change in the patientís symptoms or functional level based on the assessment data above, proceed with 1.a in the Treatment Plan (below).
2. If the patient is symptomatic needing a minor medication adjustment (e.g., adjusting medications for EPS, antipsychotic cross-tapering, benzodiazepine tapering, adding OTCís such as stool softeners, etc.) proceed with 1.b in the Treatment Plan (below).
3. If the patient shows signs and symptoms of significant decompensation, consult with the supervising psychiatrist or available physician and refer for re-evaluation and more intensive treatment and intervention.
1.a.††††† If there is no significant change in a patientís symptoms of functional level, authorize and/or provide medication refills, and order laboratory tests as needed.
1.b.††††† If the patient is symptomatic and needs a minor medication, adjust medication regimen and authorize or provide medication refills, and order laboratory tests as needed. In addition, notify the physician of symptoms and treatment changes within 24 hours.
2. Counsel patient on the therapeutic effects of medication, the use of the medication, and side effects.
3. Refer patients to appropriate clinician for additional services or consultation when needed.
4. Consult with supervising psychiatrist for any complications or areas of concern.
5. Schedule follow up appointments according to each patientís individual needs and treatment plan.
5) †Drugs and Drug Classes Managed
Medications covered: medications used in the treatment or management of mental illness and other related conditions. Medications covered are limited to the CBHS formulary, including drugs in restricted (PAR) status.
6) Laboratory Tests Ordered and Criteria for Ordering Such Tests
The clinical pharmacist may order routine renal function screening (creatinine, BUN, specific gravity, etc.), thyroid function tests (TSH, T-4, etc.), liver function tests, urine and blood drug screens, urinalysis, hemograms, CBC, WBC, chemistry panels, pregnancy tests, therapeutic drug levels, and other tests on the CBHS Laboratory Formulary, as appropriate.
7) Specific Criteria for Physician Referral and Consultation
The patientís regular physician or, if not available, another physician will be consulted† under the following circumstances:
∑ When any significant deterioration or significant change from a patientís previous clinical status occurs.
∑ When there is a need for addition of a new medication, not previously discussed, to a patientís regimen. The clinical pharmacist may recommend an alternative treatment care plan to the supervising physician.
∑ If a patient experiences a severe or unusual side effect or adverse drug reaction.
∑ If there is an unexpected finding by history, physical assessment, or laboratory result.
∑ When a physician evaluation or re-evaluation has not been done in the last 3 months.
8) Billing and Documentation in the Medical Record
Services will be billed as CBHS Medication Support (361) billings to third party payers.
All pharmacist medication assessments and interventions will be documented in the patientís medical record following standard CBHS policies and procedures. The minimal data recorded will include the following:
∑ Assessment of patient compliance
∑ Assessment of treatment side effects
∑ Assessment of therapeutic efficacy, including target symptoms
∑ Medication authorized and dosages, including dosage adjustments
Medication adjustments will be written as verbal orders in the patientís chart and require physician co-signing in a timely manner. A standardized form to notify the physician to review the chart and sign verbal orders will be developed at each site implementing this protocol.
9) Clinical Pharmacist Supervision and Evaluation
Each individual pharmacist practicing under this protocol will be under the clinical supervision of a licensed CBHS physician at each specific practice site. The supervising physician will meet as often as clinically indicated with the clinical pharmacist to review cases. Cases managed by clinical pharmacists will be included in those cases selected for CBHS medication monitoring and physician peer review process.
The Director of CBHS Pharmacy Services will report routinely to the CBHS Medical Director on the status of the program.
The CBHS Medical Director, Supervising Physicians, and Director of Pharmacy Services will review the protocol annually and report their findings to the Pharmacy & Therapeutics Committee.
CBHS clinical pharmacist competence requirements will be determined by the site medical director and will include:
∑ Conducting mental status exams
∑ Treating acute EPS
∑ Administering injections
∑ Medication treatment guidelines
∑ Other areas deemed pertinent and in accordance with this policy.
Any specific modifications to this protocol made by a specific site are to be placed here.
Principles of Clinical Practice for Medical, Nursing, and Pharmacy staff:
1.† All medications that are to be dispensed must coincide with the medication order in††††
†††† patientís chart.† The chart must be reviewed before dispensing.
2.† If a patient is not stable, a clinical assessment must be done before any medications
†††† are dispensed.† This clinical assessment should ideally be done with a clinician that is
†††† familiar with the patient, e.g., the care manager or the treating psychiatrist.
3. After an assessment, any change in medications should be reviewed with the†
††† psychiatrist.† Exceptions to this principle are any minor adjustments (as defined above)
††† and treatment plans previously determined in collaboration with the treating††††
4. Patients that are new to the clinic must be evaluated by both the O.D. and O.D.
††† psychiatrist before any medications are dispensed.
Situations that require careful attention
1.† CT/NB patient recently discharged after a psychiatric hospitalization presents seeking††
†††† If the patient is stable and a hospital discharge summary is available:
a. review discharge plan (psychiatric and medical issues, discharge medications,
b. make minor adjustments if clinically necessary (minor adjustments defined above)
c. continue the dose of prescribed discharge medications until there has been
consultation with the treating or O.D. psychiatrist.
d. provide enough of the discharged medications until the patientís appointment with
the treating psychiatrist.† No more than a 14-day supply will be dispensed.
††††† If† the patient is not stable (significant change is observed and/or reported by the
††††† patient), then the treating or O.D. psychiatrist will be notified to assess and treat the††
2. CT/NB patient presents requesting medication.† The patient may have missed a M.D.
appointment, had the medications stolen, lost the medications or misused the medications.
a. Assess the patientís history of the medication and treatment compliance through
consultation with the patientís care manager or treating psychiatrist.† If the patient is clinically stable, provide enough medications until the next appointment with the treating psychiatrist.
b. If there is evidence or suspicion of misuse, the patientís care manager and a†
psychiatrist (the O.D. or treating) must be involved in the treatment.† How many
refills a patient may receive may be an issue to be addressed.
††††† c.†† If the patient is unstable, a psychiatrist must be consulted.