This document discusses the ethics of advising medical marijuana practitioners. It begins with legal basics on federal and state laws regarding medical marijuana. Under federal law, marijuana remains a Schedule I drug, though the DOJ has said prosecuting state-compliant medical marijuana cases is not a priority. It then details Pennsylvania's medical marijuana program requirements, including for physicians, dispensaries, forms of marijuana, and record keeping. Scenarios discuss ethical issues attorneys may face, such as using medical marijuana themselves, advising dispensary clients, and investing in dispensaries. Attorneys must be aware of conflicts between state medical marijuana laws and ABA rules regarding illegal conduct.
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Ethics of advising medical marijuana practitioners 4.13.18
1. THE ETHICS OF
ADVISING MEDICAL
MARIJUANA
PRACTITIONERS
Darshan Kulkarni
Pharm.D, MS, Esq.
VP of Regulatory Strategy – Synchrogenix
Principal Attorney – Kulkarni Law Firm
6. CONGRESS The federal government
regulates drugs through the
Controlled Substances Act
(CSA) (21 U.S.C. § 811).
1
Under the CSA, cannabis is
classified as a Schedule I
drug, which means that the
federal government views
cannabis as highly addictive
and having no medical
value.
2
CSA does not recognize the
difference between medical
and recreational use of
cannabis.
3
8. DEPT. OF JUSTICE
On August 29, 2013 the Department of Justice (DOJ)
issued a guidance memo to prosecutors concerning
marijuana enforcement under the Controlled Substance
Act (CSA)
Prosecuting state legal medical marijuana cases is not
a priority.
The memo included eight guidelines for prosecutors to
use to determine current federal enforcement priorities.
Most medical cannabis program’s regulations require
the same guidelines ensuring that any business with a
licenses are meeting these requirements as well.
9. ENFORCEMENT PRIORITIES
Preventing of distribution of marijuana to minors;
Preventing revenue from the sale of marijuana from going to criminal enterprises, gangs or
cartels;
Preventing the diversion of marijuana from states where it is legal under to state law in some
form to other states;
Preventing state-authorized marijuana activity from being used as a cover or a pretext to traffic
other illegal drugs or other illegal activity;
Preventing violence or the use of firearms in cultivation and distribution of marijuana;
Preventing drugged driving and the exacerbation of other adverse public health consequences
associated with marijuana use;
Preventing the growing of marijuana on public lands and the attendant public safety and
environment dangers posed by marijuana production on public lands;
Preventing marijuana possession or use on federal property.
12. FDA
Typically comes down to claims made
FDA Jurisdiction:
•Interstate Commerce
• Safety | Efficacy | Adulteration |
Misbranding
13. CONGRESS
Rohrabacher-Blumenauer
Amendment
Prohibit the Justice Department from
spending funds to interfere with the
implementation of state medical
cannabis laws.
Passed the House in May 2014 after
six previously failed attempts,
becoming law in December 2014 as
part of an omnibus spending bill.
18. QUALIFIED PHYSICIAN
Be currently licensed and in good standing
Be responsible for the ongoing care of the patient
Include in the medical records of the patient a diagnosis of a qualifying
condition
Complete a four-hour course developed by the Department of Health
(DOH)
Register with the health department
19. QUALIFIED PHYSICIAN
Report to the DOH if a patient no longer needs access to medical
cannabis as a result of improved health or death.
S/he must issue a certification during an in-person visit.
Certification must state that the patient has
a qualifying medical condition
Physician believes he or she could benefit
from medical cannabis,
Physicians must register, complete a four-hour course
20. Prescribers cannot:
•Conduct an exam using
telemedicine technology
•Receive pay from or refer patients
to marijuana businesses
•Conduct an exam at a location
where medical marijuana is sold
•Have a direct or indirect economic
interest in a cultivator or dispensary
•Advertise in a cultivation center or
dispensary
•Cannot prescribe medical
marijuana
Cannot dispense medical marijuana
21. Informed Consent Minimum
• Side effects,
• Possibility of addiction,
• short- and long-term cognitive effects,
• psychiatric conditions ranging from
anxiety and depression to psychosis,
• obstructive lung disease,
• lung cancer,
• motor vehicle accidents, and
• reproductive risks.
Do it yourself
(Shinal case)
Should include a
review form
22. ABUSING MARIJUANA RECOMMENDATIONS?
Physician caseload as determined by the number of patients for
whom marijuana is recommended. (>3,521 or more patient
recommendations in one year for a general practitioner.)
The plant and ounce recommendations by the physician.
Age demographics of the patient caseload.
Other circumstances determined by the overseeing agency. E.g.
evidence of potential violation of the constitution, statutes, state
medical board regulations or any violation of the Medical Practice Act
Model Guidelines for the Recommendation of Marijuana in Patient Care,
Federation of the State Boards of Medicine (April 2016)
23. QUALIFIED DISPENSARY
Issue permits to <=50 dispensaries,
•Each have three locations,
•Up to 150 total dispensaries.
•Applicants will pay $5,000 per dispensary application.
•Medical cannabis business licensees will pay registration fees of $30,000.
Dispensaries must have a physician or pharmacist there at all times
•2nd and 3rd locations may have NP or PA onsite
A physician who is properly registered is able to issue medical marijuana
certifications/cards to patients at their practice
Physicians involved in dispensing can not issue medical certifications
Physicians cannot treat patients at dispensaries
Can be dispensed to patients or caregiver with a valid medical card
24. DISPENSING PROCESS
Step 1:
Review Department
Database prior to each
dispense
Step 2:
Confirm to any
requirements or
limitations (ie. dosage
form)
Step 3:
If practitioner does not
set forth any
requirements or
limitations: Physician,
Pharmacist, PA or NP
employed at dispensary
“Shall consult with the
patient or the caregiver
regarding the
appropriate form and
dose of medical
marijuana to be
provided”
Step 4:
Dispense < 30 day
supply, but not until all
but 7 days remain
Step 5:
***Dispensary shall
delete any internal
electronic record after
the receipt has been
generated ****
25. ADVERTISING REQUIREMENTS
Must: Follow federal law guiding prescription drug advertising
Marketing materials must be approved by the Department prior to use.
Must not
advertise:
Medical marijuana as promotional item
Medical marijuana as a give away
Medical marijuana as part of a coupon program
By giving product away for free (unless approved for financial assistance by the Dept)
By dispensing conditional upon another purchase
By offering delivery
26. LIMITATIONS
Dispensaries
cannot be
located
near:
Within 1,000 feet of the property line of a public, private, or parochial school, or
a day care center.
At the same site used for growing and processing medical marijuana.
In the same office space as a practitioner or other physician.
The Department may waive or amend these prohibitions if necessary to ensure
patient access, but may require additional security
Dispensaries
must be:
Indoor
Enclosed
Secure
28. RECORD KEEPING REQUIREMENTS
The applicant must demonstrate that they can implement and maintain:
•security,
•tracking,
•recordkeeping and surveillance systems
Must apply to the
•acquisition,
•possession,
•growth,
•manufacture,
•sale,
•Delivery (and receipt),
•transportation,
•distribution or the dispensing of medical marijuana
29. DISPENSARY RECORD KEEPING REQUIREMENTS
“Right to Know” Laws
•Recognize that a lot of information (e.g.
application)recorded is available under the “right to
know” laws
Tracking
•The dispensary shall file the receipt information with
the department utilizing the electronic tracking
system.
•When filing receipts under this subsection, the
dispensary shall dispose of any electronically recorded
certification information as provided by regulation.
32. PATIENTS
No access for out-
of-state patients.
Marijuana can not
be “self-
administered” at
dispensary
33. Look, but don't
touch.
Touch, but don't
taste.
Taste, but don't
swallow.
Dispensaries cannot sell
edibles.
Vaporization is allowed.
Can be mixed with
food.
Smoking is not
permitted.
34. Visit Dept. of Health
“Patients and Caregivers
Registry” and create a
patient profile.
Obtain physician
certification
Return to registry and
pay for marijuana ID
card for $50
Get card from approved
PA dispensary
35. ABILITY TO PAY
5% grower/processor
tax
•Can be waived for financial
hardship.
Patients are initially
charged $50 for an
identification card, •Government medical
assistance programs not
required to reimburse
•Private health insurers are
not required to reimburse
Self Pay
36. UPDATES
“ FDA “is requesting interested persons to submit comments concerning abuse
potential, actual abuse, medical usefulness, trafficking and impact of scheduling
changes on availability for medical use of five drug substances,” including cannabis
and its compounds”
- Federal Register (April 2, 2018)
37. WHAT IS THE OPPORTUNITY?
I am a consultant who wants to advise on medical
marijuana
I want to create an advocacy group for patient rights on
medical marijuana and get the laws changed
I am a pharmacist who wants to talk to doctors about
the use of marijuana in patients
I want to do clinical trials in medical marijuana
May be
prosecuted
May be
prosecuted
First
amendment
right
Possible, will
need FDA/DEA
permissions
38. RECENT RELEVANT COURT DECISIONS
Russell Gilmore and Richard Hemsley, who were charged with conspiracy and growing
marijuana illegally on land under control of the Bureau of Land Management in El Dorado
County, east of Sacramento.
Ninth Circuit Court of Appeals: Although Congress has prohibited the U.S. Department of
Justice from using appropriated funds in ways that prevent states from implementing
medical marijuana laws, it didn’t bar it from prosecuting marijuana cases altogether.
Marijuana is still illegal under federal law in all instances and that Congress “could restore
funding tomorrow, a year from now, or four years from now, and the government could
then prosecute individuals who committed offenses while the government lacked funding.”
Holding: Government can enforce federal drug laws on federal lands, even in a state that’s
legalized medical marijuana such as California.
39. KETTLE FALLS FIVE
2012: Raid on their farm in Northeast Washington for collectively growing
medical cannabis plants in an amount permitted by state law.
The federal government vigorously prosecuted the Kettle Falls Five over the last
five years.
The feds originally sought 10-year mandatory prison terms.
The feds dropped charges against Larry Harvey who
was battling stage four pancreatic cancer. Mr. Harvey
passed away in August 2015.
Jason Zucker pleaded guilty and testified against the
other defendants prior to trial. He was sentenced to
16 months of prison time based on his cooperation.
Rhonda, Rolland, and Michelle were acquitted of all
charges except growing cannabis.
Michelle and Rhonda received a sentence of one year
and a day and Rolland received a sentence of 33
months.
Nov. 2017: DOJ “This motion is based upon Congress
denying funding to the Department of Justice for the
prosecution of medical marijuana patients in states
where medical marijuana is lawful. The purpose of
this motion is to acknowledge that the United States
was not authorized to spend money on the
prosecution of the defendants after December of
2014 because the defendants strictly complied with
the Washington State medical marijuana laws.”
(Rohrabacher-Blumenauer Amendment)
The DOJ’s motion also cites United States v.
McIntosh, in which the Ninth Circuit decided the
Rohrabacher-Blumenauer Amendment prohibited the
DOJ from “spending funds for the prosecution of
individuals who engaged in conduct permitted by the
state medical marijuana laws and fully complied with
the laws.” The DOJ’s motion states that the
“prohibition regarding DOJ expenditure of funds
applies even though the prosecution was properly
initiated prior to [Rohrabacher-Blumenauer’s]
enactment.”
41. SCENARIO 1
Attorney Abe comes to you and says that he has significant pain
problems and is considering switching to medical marijuana to
address these pain issues. He is about to renew his license to practice
law. Is he allowed to practice law?
ABA Model Rule 8.4 (Misconduct) provides: “It is professional
misconduct for a lawyer to: . . . (b) commit a criminal act that reflects
adversely on the lawyer’s honesty, trustworthiness or fitness as a
lawyer in other respects . . . .”
Many kinds of illegal conduct reflect adversely on fitness to practice
law, such as offenses involving fraud and the offense of willful failure
to file an income tax return. However, some kinds of offenses carry
no such implication. Traditionally, the distinction was drawn in terms
of offenses involving “moral turpitude.” That concept can be
construed to include offenses concerning some matters of personal
morality, such as adultery and comparable offenses, that have no
specific connection to fitness for the practice of law. Although a
lawyer is personally answerable to the entire criminal law, a lawyer
should be professionally answerable only for offenses that indicate
lack of characteristics relevant to the law practice. Offenses involving
violence, dishonesty, breach of trust, or serious interference with the
administration of justice are in that category. – Comment 2
Smoking or otherwise consuming marijuana, without more, rises to
the level of “moral turpitude.” The general view is that it does not.
Assume now that the lawyer has an outbreak of acute pain at noon
and consumes medical marijuana at 12:30 and begins working on a
client brief after lunch.
ABA Model Rule 1.1 (Competence) requires lawyers to be competent.
A lawyer under the influence of marijuana likely is not.
ABA Model Rule 1.16 (Declining or Terminating Representation),
which requires the lawyer to terminate representation when “the
lawyer’s physical or mental condition materially impairs the lawyer’s
ability to represent the client.” A lawyer under the influence of
marijuana is materially impaired, and thus must not practice law while
in that condition.
A lawyer’s use of marijuana may also affect the lawyer’s colleagues.
ABA Model Rule 8.3 (Reporting Professional Misconduct) requires that
a colleague report the ethical violations of another attorney when “a
lawyer . . . knows that another lawyer has committed a violation of
the rules of professional conduct that raises a substantial question as
to that lawyer’s . . . fitness as a lawyer in other respects.” Substance
abuse is one area where reporting a colleague may be required.
42. SCENARIO 2
A client wants to open up a marijuana dispensary.
ABA Model Rule 1.2(d): a lawyer “shall not counsel
a client to engage, or assist a client, in conduct
that the lawyer knows is criminal or fraudulent. . .
.”
16 states’ lawyer disciplinary offices as of July
have modified the rule, adding official
commentary and issuing binding ethics opinions,
or announced a policy to permit counseling and
assistance of a client with conduct permitted by
state marijuana laws. Those states are Arizona,
Colorado, Connecticut, Florida, Hawaii, Illinois,
Maryland, Minnesota, Nevada, New York, Ohio,
Oregon, Pennsylvania, Vermont and Washington,
along with the District of Columbia.
43. SCENARIO 3
Client asks you to invest in his marijuana dispensary business.
it is not against the law
The academic view is that a lawyer’s
financial participation violates Rule 8.4
(b)
8.4(b) commit a criminal act that
reflects adversely on the lawyer’s
honesty, trustworthiness or fitness as a
lawyer in other respects
ABA Model Rule 1.8(a) states that “a
lawyer shall not enter into a business
transaction with a client or knowingly
acquire an ownership, possessory,
security or other pecuniary interest
adverse to a client unless. . . ”
DEA formal letter Denying request to Reschedule Cannabis
(1) Marijuana has a high potential for abuse.
The DHHS evaluation and the additional data gathered by DEA show that marijuana has a high potential for abuse.
(2) Marijuana has no currently accepted medical use in treatment in the United States.
According to established case law cites the drug's chemistry is not known and reproducible;
there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.
(3) Marijuana lacks accepted safety for use under medical supervision.
At present, there are no FDA-approved marijuana products, nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication.
Marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.
“no currently accepted medical use in treatment in the United States.,” thereby making it a “controlled substance.”
The CSA makes it unlawful to manufacture, distribute, dispense, or possess a controlled substance.
Informed Consent
The Pennsylvania Supreme Court revived a malpractice suit against a Geisinger Health System physician over a botched brain surgery, ruling that physicians must take personal responsibility for obtaining the informed consent of their patients in advance of medical procedures.
Shinal Case: A physician’s duty to obtain informed consent was “non-delegable.” (Megan Shinal et al. v. Steven Toms)
What is it?
Collects information about controlled substance prescription drugs that are dispensed to patients within the state.
Goal
To be used as a tool to increase the quality of patient care by giving prescribers and dispensers access to a patient's controlled substance prescription medication history, which will alert medical professionals to potential dangers for purposes of making treatment determinations; and
To aid regulatory and law enforcement agencies in the detection and prevention of fraud, drug abuse and the criminal diversion of controlled substances.
Dispensers
As of January 1, 2017, all Schedule II-V dispensed prescriptions must be reported to the system no later than the close of the subsequent business day.
Implications
A practitioner shall review the prescription drug monitoring program prior to:
Issuing a certification to determine the controlled substance history of a patient.
Recommending a change of amount or form of medical marijuana.
A practitioner may also access the prescription drug monitoring program to do any of the following:
Determine whether a patient may be under treatment with a controlled substance by another physician or other person.
Allow the practitioner to review the patient's controlled substance history as deemed necessary by the practitioner.
Provide to the patient, or caregiver on behalf of the patient if authorized by the patient, a copy of the patient's controlled substance history.
References
Prescription Drug Monitoring Plan: ACHIEVING BETTER CARE BY MONITORING ALL PRESCRIPTIONS PROGRAM (ABC-MAP) ACT - ENACTMENT Act of Oct. 27, 2014, P.L. 2911, No. 191
Act No. 16 of 2016 MEDICAL MARIJUANA ACT - ENACTMENT