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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 415.255-3400 FAX 415.255-3567 |
POLICY/PROCEDURE REGARDING: General Procedure and Protocol For Clinical Pharmacists |
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Issued By:
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Manual Number: 3.07-5.
Reference: |
New Policy
GOAL
To formally recognize the expanded role of clinical pharmacists to provide continuing care and optimal medication management for referred patients.
OBJECTIVES
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
INTRODUCTION
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 settings”. 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 patient’s 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.
4) Procedure and Criteria for Adjusting Drug Therapy
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 patient’s 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 OTC’s 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.
Treatment
Plan:
1.a. If there is no significant change in a patient’s 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 patient’s 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
patient’s regular physician or, if not available, another physician will be
consulted under the following
circumstances:
·
When
any significant deterioration or significant change from a patient’s previous
clinical status occurs.
·
When
there is a need for addition of a new medication, not previously discussed, to
a patient’s 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
patient’s 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 patient’s 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.
10) Training:
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.
APPROVED BY:
_______________________________MD _______________________________RPh
Clinic
Medical Director Clinical
Pharmacist
AMENDMENTS:
Any
specific modifications to this protocol made by a specific site are to be
placed here.
CHINATOWN-NORTHBEACH
CLINIC SAMPLE
ONLY
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
patient’s 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
psychiatrist.
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
medications.
Plan:
If the patient is stable and a hospital discharge summary is available:
a. review discharge plan (psychiatric and medical issues, discharge medications,
laboratory results)
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 patient’s 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
patient.
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.
Plan:
a. Assess the patient’s history of the medication and treatment compliance through
consultation with the patient’s 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 patient’s 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.
_______________________________MD _______________________________RPh