Spring 2004
O'Shaughnessy's
Journal of the California Cannabis Research Medical
Group
|
Implementation of the Compassionate
Use Act
In a Family Medical Practice:
Seven Years' Clinical Experience
By Frank H. Lucido, MD, with
Mariavittoria Mangini, PhD, FNP
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 situation1. (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).
A Medico-Legal Consultation
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 of evaluations
on 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 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.
So, for more than seven years, 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
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.
"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).
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 (restating a 1997 edict), "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.
Lucido at his desk. |
General requirements
1. The patient should have a current source of primary care -a Primary Care
Provider (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 important 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.
Our staff is available to help patients complete requests for medical records,
and to assist patients in collecting and collating their medical documentation.
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 reproducibiliab 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."
Limitations
Significant limitations on my discussions with medical cannabis patients are
imposed by federal government requirements or threats.
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.
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, as defined by Health & Safety
Code section 11362.5 (Prop 215).
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 naive 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 naive 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 patients learn to use?
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 California law
. (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 to 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.
Office Setting
My office is close to the University of California campus in a lovely 60-year-old
brick medical-dental building in Berkeley that reminds me of the medical
buildings I went to when I was a kid in Michigan in the '50's. There is a
small garden behind the office and a generally welcoming and calm atmosphere,
surrounded by the bustling activity of a busy academic community. We share
the office building with a dental practice, and there are persons of all
ages, backgrounds and walks of life in our waiting room. We have a multi-cultural
staff, and several languages are spoken in the office.
Dr. Lucido can be contacted at drfrank<AT>drlucido<DOT>com
or 510-848-0958.
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: Research 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.
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 investgations have not come from patients
or caregivers, but from officials in various branches of law enforcement.
The few exceptions include a complaint from a spouse in the midst of a
bitter divorce, and a complaint from a high school principal. |