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Implementation of the
Compassionate Use Act in a Family Medical Practice:
Seven Years Clinical Experience
By Frank H. Lucido, MD
[email protected]
Clinical medicine, as I have experienced it during a quarter century of
practice, is a constantly evolving system. Every practitioner has a different
approach to gathering clinical information, diagnostic reasoning and
therapeutic decision making.
There is rarely a single correct way to care for patients. Instead, there is
usually a wide variety of acceptable approaches, any of which may be
appropriate in a given situation (Goldberg, 2002b).
Particularly for the student, but also for the experienced clinician working
to incorporate a new technique or finding into his or her established
practice, the array of choices may be disconcerting and may provoke a feeling
of reluctance to enter into unfamiliar clinical territory. The use of medical
cannabis to provide symptom relief to seriously ill patients is a practice
that has been rediscovered and refined following the 1996 passage of the
California Compassionate Use Act ("Proposition 215,"
which became Section 11362.5 of the state Health and Safety Code).
My practice
After the passage of Proposition 215, I began performing cannabis evaluations
on a very limited number of my existing primary care patients, who requested
it and whom I knew had clear indications such as nausea of cancer
chemotherapy,
Severe migraine headache, and
Chronic pain
Soon I was receiving referrals for medical cannabis evaluations for patients I
had not seen before. These referrals came from both patients and other health
care providers. This is not surprising, since most doctors are reluctant to
approve medical cannabis. Most physicians don't know the law, and have never
studied the medicinal uses and history of cannabis. Medical schools do not
teach about cannabis' potential benefits, medicinal uses and history. When
this lack of information is added to concerns that many health care providers
have about the legal and professional implications of cannabis recommendation,
it is understandable that a minority of doctors are doing the majority
evaluations on many cannabis patients.
As I began seeing more patients who were benefiting in a wide variety of ways,
it became clear to me that I had to become better acquainted with the
professional literature on cannabis as a medicine.
To the extent that my general primary care practice is typical, I would guess
that most general primary care practices in the Bay Area have seriously ill
patients who would be likely to benefit from the use of medical cannabis.
Possible benefits might include improved symptom relief, fewer side effects,
and/or lower cost than many commonly prescribed pharmaceuticals.
What is not typical about my practice is that even among the limited number of
doctors who are performing medical cannabis evaluations, I am one of the few
who does them in the context of a full-scope general medical practice.
Since that time, I have been conducting medico-legal consultations for
patients who are weighing cannabis as a treatment option. I have worked to
develop my own standards by reading the scientific literature, learning from
the experience of other practitioners, and through application of my past
experience in making clinical decisions.
In describing my own approach, I in no way intend to define the standard
that is appropriate for all providers or all clinical situations. Rather,
this article represents the
accumulated insights from my experience with
medical cannabis as a treatment,
with patients who have benefited from its
use, and with the practice of family medicine in a patient population that
includes persons from a wide variety of backgrounds, age groups and states
of health.
My goals are to give patients some ideas about what might be expected from a
medical cannabis consultation as it would be conducted in my office, and to
give clinicians some information about which aspects of the patient's
history, diagnosis and physical condition I consider most relevant in
decision making about medical cannabis use.
Full Disclosure
I am one of approximately nine physicians who have been investigated by the
Medical Board of California in relation to recommending medical cannabis.
My strong belief that I was practicing the highest standards of medicine
provided a level of comfort and confidence that I would not have expected to
maintain during such a stressful, time-consuming ordeal.
I was also reassured by having good legal counsel and the support of many
fellow physicians, as well as my patients, family, and friends. In August,
2003, one year after I was served a subpoena to appear at a Medical Board
hearing, I was effectively exonerated.
Regrettably, my experience with the Board has been shared by a number of
other responsible physicians who were also inappropriately targeted for
investigation for having recommended medical cannabis.
The complaints triggering these investigations have not come from patients
or caregivers, but almost exclusively from officials in various branches of
law enforcement.
"Acceptable Standards"
Because medicine is a constantly evolving field, there is a wide range of
acceptable standards of care for treating many specific problems. This is
more noticeable in dealing with symptom management as opposed to
curative therapy; it is particularly relevant in a new field such as
Cannabis Therapeutics, in which research has historically been constrained
by legal considerations.
In my practice, cannabis is most frequently employed for symptom management
(Larson, 1992) as well as for the reduction of what has been termed "symptom
distress" -the physical or mental anguish or suffering that results from the
symptoms the patient is experiencing (Rhodes & Watson, 1987).
Sidebar:
USES/INDICATIONS
Diagnoses for which medical cannabis is used, from from 348 unduplicated
medical cannabis patients seen from 5/28/02 to 11/4/02
(261 w single diagnosis; 32 with 2 dx; 15 w more than 2 dx)
primary diagnoses:
chronic pain: 235
headache 24
gastrointestinal (nausea ,anorexia, abd pain, irritable bowel syndrome,
crohn's disease, ulcerative colitis, chemotherapy) 23
chronic anxiety 10
depression 7
insomnia 6
ptsd 6
seizure disorder 5
asthma 5
glaucoma 4
bipolar disorder 3
add 2
OTHER:
Multiple Sclerosis (dysesthesia, muscle spasm)
severe dysmenorrhea
meniere's (vertigo, tinnitus)
restless leg syndrome
phantom limb pain
ocd
parkinson's
With appropriate use of medical cannabis, many of these patients have been
able to reduce or eliminate the use of opiates and other pain pills, ritalin,
tranquilizers, sleeping pills, anti-depressants and other psychiatric
medicines, as well as to substitute the use of medical cannabis as a harm
reduction measure for specific problematic or abused substances with a much
more serious risk profile (including alcohol, heroin/opiates, and cocaine).
The diagnoses of my medical cannabis patients (see sidebar "USES/INDICATION")
are consistent with the bulk of my medical practice diagnoses.
Symptoms are subjective phenomena by definition, and as such are difficult
to evaluate. Symptoms include, but are not limited to: fatigue, insomnia,
depression, anxiety, nausea, vomiting, anorexia, elimination problems, and
breathing difficulty.
The control of symptoms and the alleviation of symptom distress are some of
the most important therapeutic uses of cannabis. Both the alleviation and
the control of symptoms remain areas in which further research is needed
(Grant, 1992).
The need for additional research
on symptom management is compounded by the
lack of research and standards
for the use of cannabis therapies. Legal
disapprobation, restrictions on the opportunities for clinical research
intrinsic to cannabis' status as a Federal Schedule I Controlled Substance,
and a long historic gap in the accumulation of clinical writing on cannabis
therapeutics since criminalization in the 1930s have resulted in there being
relatively little clinical literature from which we can seek guidance.
The Medical Board of California (MBC) and the California Medical Association
(CMA) have a "working group" drafting guidelines, but seven years after the
therapeutic use of cannabis was legalized, there are no practice standards
other than what is usually expected of any clinician in the course of his or
her practice.
"Any physician who recommends the use of marijuana by a patient," according
to the Medical Board's July 2003 Action Report, "should have arrived at
that decision in accordance with accepted standards of medical
responsibility, i.e., history and physical examination of the patient;
development of a treatment plan with objectives; provision of informed
consent, including discussion of side effects; periodic review of the
treatment's efficacy and, of critical importance, proper record keeping that
supports the decision to recommend the use of marijuana. However, the Board
recognizes that these principles may require further elaboration to take
into account the factors that may affect the physician-patient relationship
in this context."
My Practice and Standards
I have developed (and continue to refine) standards for the recommendation
of medical cannabis in my own practice, reflecting my quarter century as a
Board certified Family Physician providing primary health care. These are my
own standards and should not be construed as criteria for any other
physician practicing within the scope of his or her training and license.
General requirements
1. The patient should have a current source of primary care -a Primary Care
Provider or PCP- whom he or she sees regularly.
2. The patient should be seen regularly for the serious illness or symptoms
for which medical cannabis is used, by either the PCP or by a specialist,
chiropractor, or other health practitioner of the patient's choice.
These requirements accomplish two improtant objectives:
* Affirming that the patient has access to primary care.
* Clarifying my role as a consulting physician, and not the primary care
practitioner (a common misunderstanding).
Even if the serious illness or symptom is stable, I advise the patient to
see his or her physician yearly, to review and update the history and
physical.
I generally describe this requirement to the patient by saying: "I don't
want to be the only physician who is aware of your illness or symptom, since
I am NOT your primary care practitioner."
My medical cannabis evaluation is a medical-legal consultation, and is not
to be confused with the provision of primary care.
Phone screening
Patients calling for a medical cannabis evaluation are screened by phone to
make sure they understand my requirements prior to being given an initial
appointment, and to eliminate those who clearly do not qualify.
Pre-appointment
A 45-minute appointment is scheduled for new patients, or 30 minutes for
annual re-evaluations. The patient is mailed a detailed questionnaire, along
with release forms to obtain records that will be required for the visit.
The patient must fill out the questionnaire in advance of the visit, and
must request or bring medical records related to his or her serious illness.
Appointment
The medical cannabis evaluation is conducted in a face-to-face office visit,
which includes the collection of relevant history, problem-specific physical
exam, and review of the completed questionnaire and outside medical records.
A written summary of the patient's interview and history is completed for
the patient's chart.
All of these data are assessed for indications that cannabis may be of
benefit for the patient's symptoms or problems.
Pros and cons of medical cannabis use are discussed with the patient, and
informed consent documents are
reviewed and signed. Patients are advised that they should continue to assess
the benefits that they receive from medical cannabis, and should continue its
use only if it continues to benefit their symptoms.
Based on all of the above, a decision is reached on whether or not to
recommend cannabis to the patient.
Limited approval -for three months or less- may be given in cases where
there exists some documentation or physical evidence of a serious illness
for which cannabis might be beneficial, but more recent records are required
and/or expected to arrive.
Follow-up
Appropriate follow-up appointments are arranged for patients receiving
recommendations. Yearly re-evaluation is a minimum.
More frequent follow-up visits may be required in certain circumstances,
such as in some psychiatric diagnoses and some mood disorders, especially if
the patient is not receiving ongoing psychiatric care. In this instance, I
may require the patient to return with a family member or close friend to
corroborate that patient does better with cannabis than without it.
Patients are to continue regular follow-up with the PCP and/or specialist
for the serious illness or symptom for which the patient uses cannabis
medicinally. At yearly renewal re-evaluation visits, I expect the patient
to bring in documentation that his or her primary provider is aware of the
serious illness or symptom, and is seeing the patient for re-evaluation at
least yearly.
Forms
I have developed the following forms for use in conducting medical cannabis
evaluations:
* Consent to assume risk for medical marijuana.
* A questionnaire (adapted from the questionnaire developed by the
California Cannabis Research Medical Group)
* Recommendation/approval form
If a 12-month recommendation is provided, it is dated to expire on the last
day of the month, to allow the patient a one-month window to be re-evaluated
in their anniversary month. Lately I have embossed the original
recommendation with my seal, and added small lettering on certificate that
says "original is embossed." The embossing limits the reproducibility of
the original. I began doing this after finding that a patient had altered
his original certificate. (An extremely rare occurrence.)
Safety
Regarding safety, U.S. Administrative Law Judge Francis L. Young in
September, 1988, after reviewing all the evidence on rescheduling cannabis
from Schedule I to Schedule II, stated:
"In strict medical terms marijuana is far safer than many foods we commonly
consume. For example, eating ten raw potatoes can result in a toxic
response. By comparison, it is physically impossible to eat enough marijuana
to induce death. Marijuana, in its natural form, is one of the safest
therapeutically active substances known to man. By any measure of rational
analysis marijuana can be safely used within a supervised routine of medical
care." (http://www.fcda.org/judge.young.htm
Limitations
Significant limitations on my discussions with medical cannabis patients are
imposed by federal government requirements or threats.
Experienced medical users will know how to titrate their dosage to achieve
the desired effect
For example, I don't suggest an amount of cannabis to use unless it's to
suggest "less" or a safer method of ingestion for harm reduction/risk
minimization purposes.
Experienced medical users will know how to titrate their dosage to achieve
the desired effect. In my experience, medical cannabis users consume widely
varying amounts. (The handful of patients who remain in the Federal IND
program, which supplies cannabis
to patients, receive six pounds per year in
tinned, pre-rolled cigarette form.)
Nor do I discuss the locations of dispensaries or how to obtain cannabis. If
asked, I explain that federal law prohibits my doing so.
Because accurate information is vital to health and patients should always
have access to accurate information, I make available a list of resources
other than dispensaries through which they can learn more. These include:
* California NORML's website:
http://www.canorml.org/
* Americans for Safe Access
510-486-8083
* The Oakland Cannabis Buyer's Cooperative 510-832-5346 (which also
provides patients with a photo ID that is easier to carry in one's wallet
than my full-page recommendation form)).
I don't sign any forms from dispensaries, and I don't sign caregiver forms.
The designation of a caregiver is not a medical decision, but is determined
by agreement between the patient and the caregiver, in accordance with
California law.
Documentation -Pros and Cons
There is a wide range of acceptable standards in medicine. Some doctors have
been criticized for not requiring documentation of diagnosis when they
approve cannabis use. Others feel that the requirement creates unnecessary
barriers for patients. My arguments for requiring documentation include:
* It is common in other situations in health care.
* It enhances patient protection, both medical, legal and financial.
* It gives me more confidence that, if called upon to do so, I could
successfully defend a patient's appropriate medical use in a court of law.
If law enforcement calls me to verify compliance with Prop 215, I am able to
say: "Not only did I assess the patient, but I have independent
documentation of the diagnosis for which the patient uses cannabis."
In most cases, law enforcement officers have been polite and replied
something to the effect of: "Thank you, doctor, we just wanted to make sure
it was a valid recommendation."
The following arguments have been made against requiring documentation:
* It is not necessarily consistent with the long tradition in medicine of a
trusted doctor/patient relationship.
* It may imply that it is less than acceptable for a doctor to do his or her
own evaluation, and determine that cannabis will or won't benefit a
particular patient.
* Records may be unavailable or difficult to obtain. Consider the situation
of a patient who suffered a traumatic injury many years ago, and doesn't
have ongoing care for chronic pain. The patient has been self-treating
effectively, and now wants to comply with state law. In this situation, the
history and physical examination might be enough to make me feel comfortable
without further documentation of the diagnosis.
Notes on Confidentiality
Many patients seek out cannabis consultants because they don't feel
comfortable disclosing to their primary care providers doctors that they
have been self-medicating with cannabis.
Although I do require that the patient's primary provider or other
appropriate practitioner be aware of, and follow, the serious illness for
which cannabis is used, I do not require that the patient disclose his or
her medical cannabis use to these providers in all cases. The
wording I generally use in explaining this is: "In a perfect world, you
should be able to tell your physician everything. But unless, and until the
federal government, employers and insurance companies no longer discriminate
against medical cannabis users, there is valid reason not to have cannabis
mentioned in your medical records."
I ask the patient to assess whether he or she feels safe in telling their
doctor "off the record" that they're using cannabis medicinally. If the
answer is yes, I encourage them to do so. Your own doctor knows you best,
and in a perfect world, one should be able to tell his or her doctor
everything.
I don't accept insurance for medical cannabis consultations, nor do I
recommend that the patient bill the insurance company, unless the patient is
willing to have his/her insurance company see these records.
Special circumstances
Some patient-care situations
deserve special mention, as they present
unusual complexities or problems.
Should a patient's medical cannabis use be questioned, some presentations or
diagnoses are particularly likely to be challenged by school, probation or
law enforcement authorities.
Psychiatric Patients
Psychiatric diagnoses, particularly if unstable, are likely to raise this
kind of "red flag." In such cases, it is important to have a good history
of the efficacy of cannabis for the patient. Approval of the therapist is
desirable; next best is a
significant other who can attest to the patient's
condition being improved by medical cannabis use.
Minors
The recommendation of medical cannabis use to minors is an area of
controversy. As in all of medicine, one must make a risk/benefit assessment.
The developmental needs of adolescents and children suggest that cannabis
use should be discouraged, unless, as would be true in a person of any age,
the medical benefit obtained outweighs the risk. Recommendations for
medical cannabis for minors should be issued conservatively, and evidence of
effectiveness should be well-documented, as should be parental consent.
Elders and/or naÔve users
Many elders have never been exposed to a social environment in which
cannabis is used recreationally. For these patients, as well as for any
naÔve or first-time user, the psychological effects may be disturbing. The
extensive report on medical cannabis prepared by the National Academy of
Sciences Institute of Medicine in 1999 suggests that "for some
patients-particularly older patients with no previous marijuana
experience-the psychological effects are disturbing (p. 4)."
In the years following the legalization of cannabis for medical use, only a
small fraction of patients seeking physician approval have been
cannabis-naive. At least 90 percent of those seeking approval from
CCRMG-affiliated physicians already know that, for them, the benefits
outweigh any adverse effects. More naive patients can be expected to inquire
about cannabis as a treatment option as favorable research results from
Europe are reported in the literature.
How will the naive patient learn to use cannabis?
An additional question in relation to the inexperienced user is that of how
the patient will learn to use cannabis.
Who is available to teach the patient?
Will an informed, experienced user be available when the patient first tries
medical cannabis?
In what form will the patient ingest cannabis?
Does he or she understand the concept of titration of the dose?
Is there a protected environment available to the patient for his or her
initial and subsequent use?
How should the patient be counseled about the possibility of unwanted
effects?
What precautions or preparation should the patient be advised to use?
Conclusions
Physicians who are considering whether to approve cannabis use by their
patients must first educate themselves on the subject. Cannabis has a long,
impressive history as a safe and effective medicine. Although the United
States has limited studies on the benefits of cannabis, the National
Institute on Drug Abuse has funded significant research into its mechanism
of action. Universities and major pharmacuetical companies are conducting
groundbreaking studies. Much of this research is available in: Grotenhermen
and Russo: Cannabis and Cannabinoids: Pharmacology, Toxicology, and
Therapeutic Potential.
My advice to colleagues, in brief:
* Practice responsible medicine, including encouraging patients to obtain
appropriate follow-up of their illnesses from their primary care
practitioner.
* Maintain good documentation, both of previous history and outside records,
and of your own history, physical, assessment, and follow-up plan.
* Be able to explain your decision-making process in a court of law should
you be called upon to support a legitimate patient, or to discuss a
patient's cannabis use with an employee health clinician. On occasion, a
question may arise as to whether a patient can perform safety-sensitive
functions in the workplace. It may be important to document that the
patient does not use cannabis in
a specified time frame in relation to hours
of work.
* Do not assist anyone in breaking the law. The vast majority of medical
cannabis patients are honest and appropriate medical users under the
Compassionate Use Act. (Notwithstanding the situations in which doctors have
had visits from undercover agents posing as patients).
I find cannabis patients to be, on the whole, as honest and forthright as
patients or people in general.
It should go without saying, but I will say it: No matter how convinced you
may be of the relative
benign-ness of cannabis, do not agree to do anything
illegal. Undercover agents have been known say to a doctor: "I don't have
an illness, I just want to be able to smoke marijuana." It should be clear
that this is not a legitimate use of the Compassionate Use Act .
There are millions of real patients to help.
References
Goldberg, C. (2002a, 8/28/03). A few thoughts. University of California,
Davis School of Medicine. Retrieved November 26, 2003, from:
http://medicine.ucsd.edu/clinicalmed
Goldberg, C. (2002b, 8/28/03). A practical guide to clinical medicine:
Outpatient clinics [website]. University of San Diego School of Medicine.
Retrieved November 24, 2003, from:
http://medicine.ucsd.edu/clinicalmed/clinic.htm
Grant, M. (1992). Future directions in symptom management. In P. Larson
(Ed.), Symptom management proceedings. San Francisco: UCSF Nursing Press.
Grotenhermen, F. & and E. Russo (2002) Cannabis and cannabinoids,
Pharmacology, toxicology, and therapeutic potential. Binghanton, NY Haworth
Press www.haworthprsss.com
Institute of Medicine (1999) Marijuana and medicine: Assessing the science
base. Washington D. C., National Academy Press
Larson, P. (1992). Symptom management procedings. Paper presented at the
Symptom management: Resaerch trajectories and practice implications, San
Francisco.
Rhodes, V., & Watson, P. (1987). Symptom distress - the concept, past and
current. Seminars in Oncology Nursing, 3(4), 242-247.
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| Input to the Medical Board
of California by year: |
| 2005 |
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January 21, 2005 --
Statement |
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Special meeting of the MBC to discuss the
Enforcement Monitor's preliminary report on their 2 year investigation
of the MBC |
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| 2004 |
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May 7,
2004 -- Transcript |
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Various question raised to the MBC. Comments on MBC positions. |
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| 2003 |
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May 8, 2003 |
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Defining standards of care, complaint initiation and
responsibility |
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