Nevada Draft Dispensary Regulations Incorporate AHPA and AHP Best Practices

December 20, 2013 | Mike Liszewski

nevada-agency-hbtv-hemp-beach-tv-300x199.jpgThe Nevada Division of Public and Behavioral Health recently issued draft regulations regarding the implementation of SB 374 (2013), the bill passed earlier this year authorizing dispensaries, cultivation sites, and testing labs in the state. From the perspective of medical cannabis quality assurance and product safety, these proposed regulations would be among the most comprehensive in the nation. This is due in large part to the Division utilizing much of the wisdom of the American Herbal Products Association’s (AHPA) recommendations for best practices of medical cannabis providers, as well as a requirement that testing laboratories are to meet standards set by the American Herbal Pharmacopoeia (AHP) monograph, which was issued earlier this month. 

While ASA is largely encouraged by what we saw in the draft regulations, there are areas where we wish to see improvement. We will be submitting the following comments to the Division, and we encourage others to do so before the December 23 deadline. Please feel free to copy, borrow, or add to our comments when writing your own.

Comments should be submitted to medicalmarijuana@health.nv.gov by 9am PST on Monday December 23rd.

SECTION 137

1..  The Division shall register and track the attending physicians licensed in
this State who advise a patient that the medical use of marijuana may mitigate the
symptoms or effects of the patient’s medical condition. To the extent possible, the
Division shall maintain a confidential record of:
(a) The number of patients to whom a physician advises that the medical use of
marijuana may mitigate the symptoms or effects of the patients’ medical conditions;
(b) The chronic or debilitating medical conditions of such patients;
(c) The number of times a physician advises each patient that the medical use of
marijuana may mitigate the symptoms or effects of the patient’s medical condition;
(d) The number of different chronic or debilitating medical conditions for which a
physician advises each patient that the use of medical marijuana may mitigate the
symptoms or effects of the patient’s medical conditions; and
(e) How frequently a physician advises each patient that the medical use of
marijuana may mitigate the symptoms or effects of the patient’s medical condition.
2.  Based on its evaluation of the records maintained pursuant to subsection 1, if
the Division determines that an attending physician is advising patients that the medical
use of marijuana may mitigate the symptoms or effects of the patients’ medical conditions
at a rate that is unreasonably high, the Division shall notify the Board of Medical
Examiners or the State Board of Osteopathic Medicine, so that the appropriate Board
may subject the physician to the progressive discipline process of that Board.
3.  The Division shall, for each calendar year, submit to the Board of Medical
Examiners and the State Board of Osteopathic Medicine the number of patients to whom
each physician licensed by that Board recommended the medical use of marijuana.
4.  If the Division has reason to believe that the public health, safety or welfare
imperatively requires action, the Division may refer a case involving an alleged violation
by a physician of any provision of Nevada law or regulation related to the medical use of
marijuana to the Board of Medical Examiners or the State Board of Osteopathic
Medicine.

Problem: When a state requires that physicians register with a state agency in order to recommend medical marijuana, there is a chilling effect on the number of physicians willing to write recommendations. This can create undesirable consequences for patients. First, it makes significantly more difficult for patients to find physicians who are willing to recommend medical marijuana, meaning patients may have a hard time obtaining a recommendation from their primary care physician. By artificially shrinking the pool of available physicians willing to write a medical marijuana recommendation, the state would be creating the set of circumstances in which a small number of physicians are willing to recommend, and therefore may be responsible a large proportion of the recommendations in the state. Physicians are already held responsible for maintaining a practice in conformity with Board of Medical Examiners and the State Board of Osteopathic Medicine requirements. Physicians do not need additional requirements in order to recommend medical marijuana.

Suggested Solution: Strike this provision in its entirety.  

SECTION 73

1.  Any product containing marijuana must be packaged in child resistant
packaging in accordance with Title 16 C.F.R. § 1700 of the Poison Prevention Packaging
Act or use standards specified in subsection 2 or 3 of this section.
2.  Marijuana-infused products in solid or liquid form may be packaged in plastic
four millimeters or greater in thickness and be heat sealed with no easy-open tab, dimple,
corner, or flap as to make it difficult for a child to open and as a tamperproof measure.
3.  Marijuana-infused products in liquid form may also be sealed using a metal
crown cork style bottle cap.
4.  Any container or packaging containing usable marijuana or marijuana
products must protect the product from contamination and must not impart any toxic or
deleterious substance to the usable marijuana or marijuana product.

Problem: Adult patients with severe pain, movement disorders, and other conditions may experience difficulty or even inability to open medical marijuana packages in accordance with Section 73 requirements.

Suggested Solution: Allow for patients who may have difficulty opening products to affirmatively opt into purchasing medical marijuana products with easy-to-open packaging. Patients or their caregivers who opt to purchase easy-to-open packages should sign a statement similar to the following, “I understand that this product is in an easy-open package and should be kept away from children and others who are not authorized to handle it.”

SECTIONS 57(5)(a), 59(2), and 67(1)(g)

57(5)(a) Maintain the documentation required in subsections 3 and 4 at the
establishment for at least 5 years after the date on the document
 
59(2) Maintain copies of any documentation required pursuant to chapter 453A of
NRS or this chapter for at least 5 years after the date on the documentation and provide
copies of the documentation to the Division for review upon request.
 
67(1)(g) A patient record is maintained for at least 5 years after the date on which the
patient or his or her designated primary caregiver last requested medical marijuana from
the dispensary.  

Problem: Retaining all the information required for these three provisions puts patients at greater risk of having their medical information become known to unauthorized parties. Requiring maintenance of records for five years means patients are more likely to have their information divulged to law enforcement, who in turn may use the information to harass patients. Additionally, even if the information is electronically protected, breaches by hackers or other unauthorized parties may be possible.

Suggested Solution: Reduce the required length of record retention from five (5) years to one (1) year.

SECTION 39(2)

2.  The Division must revoke a medical marijuana establishment registration
certificate if:
(a) The establishment engages in an activity set forth in NRS 453A.340;
(b) An owner, officer or board member of the establishment has been convicted of
an excluded felony offense; or
(c) The Division receives formal notice from the applicable local government that
the establishment has had its authorization to operate terminated.
 

Problem: It is important to make sure that medical marijuana establishments are overseen by reputable people; however, under the proposed regulations, an entire medical marijuana establishment MUST be terminated if merely a single officer or board member engages in banned or felonious conduct, even if each of the other owners, officers and board members are in strict compliance. Worse still, if an owner, officer or board member becomes aware of revocation conduct by a fellow owner, officer or board member, and immediately takes action to notify the authorities of the offending partner’s activity, the medical marijuana establishment still must be terminated. This harms patients because it could result in an interrupted supply of their physician-recommended medicine.

Suggested Solution: Strike “must revoke,” and replace with “may revoke or suspend.” This change would give the Division greater discretion as to when to utilize its revocation powers in the best interests of patients and law abiding owners, officers, and board members. Moreover, this language would be consistent with NRS 453A.340, which simply establishes that certain conduct is grounds for immediate revocation but does not require the Division to indiscriminately revoke registration certificates of medical marijuana establishments operating in compliance with the exception of a single bad apple, thereby preventing patients from unnecessarily losing their source of medicine.

SECTIONS 78(g) and 79(m)

Warnings that state: “This product has intoxicating effects and may be habit
forming”

Problem: Some forms of medical marijuana, such as high-CBD/low-THC strains, lotions, and balms, do not cause the patient to become intoxicated. While patients should be warned that the medication may cause intoxication, patients who use high-CBD/low-THC strains, lotions, or balms, and then later have their physician suggest a different form of medical marijuana that is more likely to cause intoxication, may be under the false impression that they are familiar with marijuana intoxication.

Suggested Solution: Strike “has” and insert “may have” and strike “may be habit forming.”

SECTION 26(3)

3.  Documentation from an in-state or out-of-state financial institution which
demonstrates:
(a) That the applicant has at least $250,000 in liquid assets as required pursuant
to sub-subparagraph (III) of subparagraph (2) of paragraph (a) of subsection 3 of NRS
453A.322 , which are unencumbered and can be converted within 30 days after a request
to liquidate such assets; and
(b) The source of those liquid assets.

Problem: Under current federal law, financial institutions are prohibited from dealing with medical marijuana establishments, therefore applicants may have difficulty producing the required documents.

Suggested SolutionAmend the opening provision to read, “Verifiable documentation which demonstrates…


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