NEW PATIENT INTAKE PACKET...411 Commercial Court, Suite A Venice, FL 34292 941-586-2426 NEW PATIENT...

411 Commercial Court, Suite A

Venice, FL 34292

941-586-2426

NEW PATIENT INTAKE PACKET

Thank you for your interest in our clinic. During your first visit, you’ll be required to supply us with a

valid Florida driver’s license or state ID card. If your state furnished identification does not show proof of

residency greater than 6 months, please bring in a utility bill in your name with a Florida address proving

residency. We are unable to see you as a patient if you are not an established Florida resident.

To streamline your initial appointment, we ask that you print, read, and complete each form within this

packet prior to your scheduled visit.

The forms and paperwork included are:

We would like to see your most current medical records. You can ask your current primary care

physician or specialist to fax or mail us a copy of your records. Our fax number is 941-484-5354. You can

print and complete our medical records form included within this packet and give it to your current

doctor. Note that your doctor’s office may charge you to send us records.

You will also need to complete an intake form that will include personal health history. You can

complete this at our website by going to http://venicecare.com/visit-guide/ and clicking the Online

Intake link.

If you are unable to complete or print this packet at home, you’ll need to fill out all of this information

prior to being seen by the doctor. Please call us at 941-586-2426 or email us at [email protected] if

you have questions or issues.

History of Cannabis as a Medicine

History of Cannabis Acknowledgement

Health Questionnaire

Psychological Health Questionnaire

HIPAA Privacy Policy

Informed Consent

Medical Records Release

VA Medical Records Release

Cancellation No/Show Policy

Controlled Substance Agreement

http://venicecare.com/visit-guide/

mailto:[email protected]

411 Commercial Court, Suite A Venice, FL 34292

(941) 586-2426 venicecare.com

Medical Cannabis Acknowledgement of Disclosure and Informed Consent

Please read each item below and initial in the space provided to indicate that you understand and agree with the information regarding the risks and side effects of using cannabis medicines. Do not sign this agreement and do not use medical cannabis if you have questions about or do not understand the information you have received. Please tell us if you do not understand any of the information provided.

Patient’s Name_______________________________________________________DOB____/____/____ Address______________________________________________________________________________

City________________________________, FL Zip Code_____________________

Warnings

I am being evaluated for a physician’s recommendation for medicinal use of marijuana. The physician will make this recommendation based, in part, on the medical information I have provided. I have not misrepresented my medical condition to obtain this recommendation and it is my intent to use marijuana only as needed for the treatment of my medical condition, not for recreational or non-medical purposes. I understand that it is my responsibility to be informed regarding state and federal laws regarding the possession, use, sale/purchase and/or distribution of marijuana. I have been informed of and understand the following:

I understand possession or use of marijuana is unlawful outside of the state of Florida. I also understand that possession or use of marijuana is unlawful within the state of Florida if not recommended for medical purposes by a licensed medical doctor with the legal ability to do so.

Cannabis-based medicine may have intoxicating effects and has not been analyzed or approved by the United States Food and Drug Administration and was produced without FDA oversight for health, safety, or efficacy. Medical cannabis may contain unknown quantities of active ingredients, impurities, or contaminants.

The efficacy and potency of cannabis may vary widely depending on the cannabis strain and ingestion method.

If cannabis is smoked or vaporized: Smoking may be hazardous to your health. Cannabis smoke contains carcinogens and can lead to an increased risk for cancer, tachycardia, hypertension, heart attack, birth defects, brain damage, and lung disease.

If cannabis is eaten or swallowed: This product has been infused with cannabis or active compounds of cannabis. When eaten, or swallowed, the intoxicating effects of this drug may be delayed by two or three hours or more.



Side effects of medical cannabis can include, but are not limited to:

The scientific basis for the medical use of cannabis is not complete. There is little known regarding how cannabis may, or may not, react with other pharmaceutical or herbal medications.

Some patients can become dependent on cannabis. This means they experience withdrawal symptoms when they stop using cannabis. Signs of withdrawal symptoms can include feelings of depression, sadness or irritability, restlessness or mild agitation, insomnia, sleep disturbance, unusual tiredness, trouble concentrating, and loss of appetite.

Some users develop a tolerance to cannabis. This means higher and higher doses are required to achieve the same symptom relief.

There is limited information on the side effects of using medical cannabis, and there may be associated health risks.

Symptoms of cannabis overdose include but are not limited to nausea, vomiting and disturbances to heart rhythm.

For some patients, chronic cannabis usage can lead to laryngitis, bronchitis, and general apathy.

• Memory loss • Irregular heartbeat • Slower reaction time/inability to concentrate • Poor physical condition • Cough/bronchitis/shortness of breath • Dizziness • Impaired vision • Drowsiness/fatigue/abnormal sleep • Depression • Laryngitis • Low blood pressure • Impairment of motor skills

• Anxiety/Nervousness • Dry mouth • Suppression of immune system • Hunger/Loss of appetite • Dependency • Confusion • Feelings of euphoria • Headache/nausea/vomiting • Numbness • Agitation • Paranoia/psychotic symptoms • Sedation



The possibility exists that cannabis may exacerbate schizophrenia in persons predisposed to that disorder.

Women should not consume cannabis products while planning to become pregnant, during pregnancy, or while breast feeding, except on the advice of the certifying health practitioner, and in the case of breast feeding mothers, on the advice or the infant’s pediatrician.

Using cannabis while under the influence of alcohol is not recommended.

The use of cannabis may affect coordination, cognition, and judgment. While under the influence of cannabis, do not to drive, operate machinery, or engage in potentially hazardous activities.

Please note that medical cannabis will degrade over time. Keep out of reach of children and pets.

Medical Cannabis Patient Agreement

I am over 18 years of age and understand the requirements of the State of Florida’s medical cannabis program.

I have read and understand the foregoing disclosures and have initialed next to each to acknowledge this understanding.

I have been further advised that cannabis smoke contains chemicals known as tars that may be harmful to my health.

I understand that side effects may occur while I am taking cannabis medicines.

In the event that I experience an adverse reaction, I am advised to contact my medical professional. In the event my medical professional is not available, I agree to call 911 for help and I am advised to lie down, relax, and rest until help arrives.

I have never had symptoms of schizophrenia, been psychotic, or attempted suicide; I have never taken medicines for any of these problems.

I have no direct blood relatives (father, mother, siblings) that have had symptoms or has been diagnosed as having schizophrenia or has been psychotic.



I agree to tell my medical professional if I have ever had symptoms of schizophrenia, been psychotic or attempted suicide. I also agree to tell my medical professional if I have ever been prescribed or taken medicine for any of these problems.

I understand that my medical professional does not suggest nor condone that I cease treatment of medications that stabilize my mental or physical condition.

I am not pregnant, intending on becoming pregnant, or breastfeeding.

When under the influence and/or in possession of cannabis in public, a copy of your recommendation should be on your person at all times.

REMEMBER to bring your most current original recommendation with you for every visit! If your original Recommendation is lost or you fail to bring it, there is a $25.00 fee to replace it.

I understand if I give dishonest or untruthful information, I will be discharged.

I understand I must give 48-hours’ notice for cancellation of appointments. I further understand that 2 or more no calls/no shows within a calendar year will result in my discharge from the practice as well as possible revocation of patient recommendation.

I understand there are certain requirements to remain in compliance with Florida law regarding medical marijuana. Some of these requirements include (but are not limited to):

• Patient establishment within our practice for 90 days • Regularly scheduled follow-ups at intervals determined by state law

I further understand that if I am not in compliance with state law and regulations set fourth and enforced by the Office of Compassionate Use, my recommendation may be revoked.

I understand and acknowledge that my patient information must be provided to the Office of Compassionate Use and that my treatment plan (and follow-up treatment plans) must be provided to the University of Florida’s College of Pharmacy by state law.

If I start taking medical cannabis, I agree to tell my medical professional if I experience (any one or more of the following):

• Start to feel sad or have crying spells • Lose my appetite • Become unusually tired • Lose interest in my usual activities

• Have changes in my normal sleep patterns • Become more irritable than usual • Withdraw from family and friends

________



Release of Liability

I hereby acknowledge Compassionate Cannabis Care of Venice, Florida Vacation Telehealth, PA., and its employees are not addressing specific aspects of my medical care nor are any of them my primary care provider. Furthermore, I, for myself, my heirs, assigns, or anyone acting on my behalf, hold Compassionate Cannabis Care of Venice, Florida Vacation Telehealth, PA, and its principals, agents, and employees free of and harmless from any responsibility for any harm resulting to me and/or other individuals because of my cannabis use.

I certify that I fully understand the potential risks and side effects related to the use of cannabis as described above.

In using cannabis for medicinal use, I fully accept responsibility and assume the risks and side effects associated with its use.

I agree that Compassionate Cannabis Clinic of Venice, Florida Vacation Telehealth, PA, and employees shall not be held responsible for any harm resulting to me and/or any other individual(s) because of my medicinal usage of cannabis.

I certify that I have read this document and declare under penalties of perjury that the information contained herein is true, correct, and complete.

Patient’s Signature: _______________________________________ Date: ________________________

Printed Name: ___________________________________________

Name: First M Last

DOB:

Address

City, ST. Zip:

Phone: Cell:

Email:

Low-THC Cannabis derivative products for patients with one or more of the following conditions:

Cancer Epilepsy A physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms.

Cancer Glaucoma AIDS

HIV Epilepsy Multiple Sclerosis

Crohn’s Disease Parkinson’s PTSD

ALS or other debilitating conditions of the same kind or

class as or comparable to those enumerated, and

for which a physician believes that the medical use of marijuana would likely outweigh the potential

health risks for a patient.

Other

How Did You Hear About Us?

The next step is for our office to obtain and review you medical records from your treating physician. We will fax a confidential records request from Florida Vacation Telehealth, PA. Please include your treating physicians name,phone and fax number so we can request your records TODAY!

Main Office I 411 Commercial Court, Suite A I Venice, FL 34292ph: 941-586-2426 | Fax: 941-484-5453 | [email protected] | venicecare.com

NOTE: The three conditions listed in this box are for “The Low-THC Program Only”.

Your Qualifying Conditions for the “The Florida Medical Marijuana Program” (Ballot Initiative Nov. 2016 Not yet signed into law)

Compassionate Cannabis Clinic of VeniceTEL: (941) 586-2426 FAX: (941) 484-5453

I, (PRINT PATIENT NAME)

______/______/______, BIRTHDATE SOCIAL SECURITY #

Authorize (Doctor Name) (Doctors Phone or Fax Number)

to release and discuss any and all medical records and medical information that you have for me in your possession

regarding my medical condition and my medical treatment, including but not limited to, my medical history, my

medical treatment, your findings regarding my medical condition, records of consultations that I have had, records

of medication prescribed for me, x-rays taken of me, my radiology reports, and hospital, and medical records to:

Compassionate Cannabis Clinic of Venice411 Commerical Court, Suite A, Venice, FL 34292

FAX: (941) 484-5453

for the sole purpose of medical records review and certification of my medical condition.

I understand the information to be released or disclosed may include information relating to sexually transmitted

diseases, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV), and alcohol and

drug abuse. I authorize the release or disclosure of this type of information.

This authorization is intended to be an unlimited, full, and complete Authorization for the release of any and all

protected medical information as defined under the Health Insurance Portability and Accountability Act of 1996

(HIPAA) and the Medical Records Access Act, as amended, and under the rules and regulations thereof, and covers

all protected information from primary and secondary providers, health plans, health care clearinghouses,

emergency services, financial and administrative transactions, and business associates. A covered entity may not

condition treatment, payment, enrollment, or eligibility for benefits on whether I sign this authorization when the

prohibition on conditioning of authorizations in 45 CFR 164.508(b) (4) applies. It is understood that the person to

whom this Authorization is given has my permission to use and disseminate this information in his or her sole

discretion.

1. Expiration. This authorization expires 18 months after patient signed this release.

2. Right to Revoke. I have the right to revoke this authorization by signing and dating a written statement revoking

this authorization, and it shall become effective on delivery to you. If this authorization is revoked, any person

or entity acting in good faith in reliance upon it and lacking actual knowledge of its revocation shall be held

harmless.

3. Redisclosure. Information used or disclosed pursuant to this authorization may be subject to redisclosure by the

recipient and is no longer protected by this rule.

4. Administrative Provisions. I revoke any prior authorizations I have made to disclose health information that are

inconsistent with this authorization. This document shall be governed by Florida law, the Health Insurance

Portability and Accountability Act of 1996 (HIPAA), Pub L No 104-191, and the Medical Records Access Act, MCL

333.26261 et seq. However, I intend it to be honored in any jurisdiction where it is presented and for other jurisdictions

to refer to Florida law and HIPAA to interpret and determine the validity and enforceability of this document.

Photocopies or facsimile reproductions of this signed authorization shall be treated as original counterparts. I am

providing this authorization voluntarily and have not been required to give it to obtain treatment. I am at least 18 years

old and of sound mind.

5. Any Billing for Medical Records is solely the patient's responsibility.

PATIENT OR LEGAL REPRESENTATIVE’S SIGNATURE DATE

XXX-XX-

VA FORM

OMB Number: 2900-0260 Estimated Burden: 2 minutes

REQUEST FOR AND AUTHORIZATION TO RELEASE MEDICAL RECORDS OR HEALTH INFORMATION

Privacy Act and Paperwork Reduction Act Information: The execution of this form does not authorize the release of information other than that specifically described below. The information requested on this form is solicited under Title 38, U.S.C. The form authorizes release of information in accordance with the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164, 5 U.S.C. 552a, and 38 U.S.C. 5701 and 7332 that you specify. Your disclosure of the information requested on this form is voluntary. However, if the information including Social Security Number (SSN) (the SSN will be used to locate records for release) is not furnished completely and accurately, Department of Veterans Affairs will be unable to comply with the request. The Veterans Health Administration may not condition treatment, payment, enrollment or eligibility on signing the authorization. VA may disclose the information that you put on the form as permitted by law. VA may make a "routine use" disclosure of the information as outlined in the Privacy Act systems of records notices identified as 24VA10P2 “Patient Medical Record - VA” and in accordance with the Notice of Privacy Practices. You do not have to provide the information to VA, but if you don't, VA will be unable to process your request and serve your medical needs. Failure to furnish the information will not have any affect on any other benefits to which you may be entitled. If you provide VA your Social Security Number, VA will use it to administer your VA benefits. VA may also use this information to identify veterans and persons claiming or receiving VA benefits and their records, and for other purposes authorized or required by law. The Paperwork Reduction Act of 1995 requires us to notify you that this information collection is in accordance with the clearance requirements of section 3507 of the Paperwork Reduction Act of 1995. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a valid OMB number. We anticipate that the time expended by all individuals who must complete this form will average 2 minutes. This includes the time it will take to read instructions, gather the necessary facts and fill out the form.

ENTER BELOW THE PATIENT'S NAME AND SOCIAL SECURITY NUMBER IF THE PATIENT DATA CARD IMPRINT IS NOT USED. TO: DEPARTMENT OF VETERANS AFFAIRS (Print or type name and address of health

care facility)

Veterans Health Administration Location:

PATIENT NAME (Last, First, Middle Initial)

SOCIAL SECURITY NUMBER

NAME AND ADDRESS OF ORGANIZATION, INDIVIDUAL OR TITLE OF INDIVIDUAL TO WHOM INFORMATION IS TO BE RELEASED

Florida Vacation Telehealth, PA., 411 Commercial Court, Suite A, Venice, FL 34292

VETERAN'S REQUEST: I request and authorize Department of Veterans Affairs to release the information specified below to the organization, or individual named on this request. I understand that the information to be released includes information regarding the following condition(s):

DRUG ABUSE ALCOHOLISM OR ALCOHOL ABUSE TESTING FOR OR INFECTION WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV) SlCKLE CELL ANEMIA

INFORMATION REQUESTED (Check applicable box(es) and state the extent or nature of the information to be disclosed, giving the dates or approximate dates covered by each)

COPY OF HOSPITAL SUMMARY COPY OF OUTPATIENT TREATMENT NOTE(S) OTHER (Specify)

Pertinent health information from electronic health records from the last 12 months including information created within 24 months after their signature date of this authorization.

PURPOSE(S) OR NEED FOR WHICH THE INFORMATION IS TO BE USED BY INDIVIDUAL TO WHOM INFORMATION IS TO BE RELEASED

Certification

NOTE: ADDITIONAL ITEMS OF INFORMATION DESIRED MAY BE LISTED ON THE BACK OF THIS FORM

AUTHORIZATION: I certify that this request has been made freely, voluntarily and without coercion and that the information given above is accurate and complete to the best of my knowledge. I understand that I will receive a copy of this form after I sign it. I may revoke this authorization, in writing, at any time except to the extent that action has already been taken to comply with it. Written revocation is effective upon receipt by the Release of Information Unit at the facility housing the records. Redisclosure of my medical records by those receiving the above authorized information may be accomplished without my further written authorization and may no longer be protected. Without my express revocation, the authorization will automatically expire: (1) upon satisfaction of the need for disclosure; (2) on (date supplied by patient); (3) under the following condition(s):

Two years from the date of signature

I understand that the VA health care practitioner's opinions and statements are not official VA decisions regarding whether I will receive other VA benefits or, if I receive VA benefits, their amount. They may, however, be considered with other evidence when these decisions are made at a VA Regional Office that specializes in benefit decisions.

DATE (mm/dd/yyyy) SIGNATURE OF PATIENT OR PERSON AUTHORIZED TO SIGN FOR PATIENT (Attach authority to sign, e.g., POA) (Sign in ink)

FOR VA USE ONLY IMPRINT PATIENT DATA CARD (or enter Name, Address, Social Security Number) TYPE AND EXTENT OF MATERIAL RELEASED

DATE RELEASED RELEASED BY

JUL 2013 10-5345 USE EXISTING STOCK OF VA FORM 10-5345, DATED MAY 2005.



Cancellation/No Show Payment Policy

We understand that there are times when you must miss an appointment due to emergencies or obligations for work or family. However, when you do not call to cancel an appointment, you may be preventing another patient from getting much needed treatment. Conversely, the situation may arise when another patient fails to cancel and we were unable to schedule you for a visit, due to a full schedule.

Cancellations

It is our policy that all appointments must be cancelled at least 48 hours in advance of the appointment. If an appointment is not cancelled 48 hours in advance, you will be charged the full appointment cost. Your credit or debit card on file will automatically be charged on the day of the cancellation if you are cancelling less than 48 business hours prior to your appointment. All patients will have the opportunity to show proof of an "urgent" reason as to why they were unable to make their scheduled appointment. Upon doing so, the patient will be reimbursed the charges incurred for late cancellations.

No Show

Patients who "No Show" their visit will be charged for that visit, AND will need to prepay future appointments. Your credit or debit card on file will automatically be charged on the day you "No Show" your appointment. All patients will have the opportunity to show proof of an "urgent'' reason as to why they were unable to make their scheduled appointment. Upon doing so, the patient will be reimbursed the charges incurred for not showing for their scheduled appointment.

Follow Up Visits

Follow up visits are crucial to maintaining the state mandate of creating and maintaining a bonafide relationship with your provider. Patients who miss the scheduled follow up visits will be charged the $60 for the missed appointment

Scheduled Appointments

We understand that delays can happen, however, we must try to keep the other patients and doctors on time. We request you come 30 minutes early to your appointment to account for traffic and to complete the required paperwork. If you are 15 minutes past your scheduled time, your provider may not be able to complete a full visit or we will do our best to accommodate you and fit you into the schedule later in the day. If you can not complete your visit you will be charged for the full visit and you will be required to book a new visit.



Account Balances

We will require that patients pay their account balances to zero (0) prior to receiving further services by our practice. We also require payment be rendered prior to services.

Acknowledgement of Receipt of Cancellation/No Show Policy

I, ______________________________ do hereby acknowledge receipt of a copy of the Cancellation and No Show Payment Policy of Florida Vacation Telehealth, PA.

Signature: _________________________________________________ Date:______________________

Authorization To Charge My Credit/Debit Card

I, ______________________________ authorize Florida Vacation Telehealth, PA to keep my credit/debit card information on file and charge my credit/debit card in the event that I do not cancel my appointment with a 48 business hour notice OR no show for my scheduled appointment(s).

Signature: _________________________________________________ Date:______________________

Patients not authorizing Florida Vacation Telehealth, PA to keep their credit/debit card information on file will be required to prepay all follow-up and recertification visits.



Controlled Substance Agreement

Between Patient: and Doctor: Barry M. Gordon, MD.

The Florida Legislature has laws governing the prescribing and dispensing of controlled drugs. These drugs include all marijuana related derivatives (such as THC or CBD), narcotics (such as codeine, hydrocodone, and oxycodone), sleeping aids, benzodiazepines (such as Valium, Xanax, and Ativan), and ADHD medications (such as Concerta, Ritalin, and Vyanse). To comply with these laws, I acknowledge and agree to the following:

1. Prescriptions for most controlled substance medications can only be written for a 30 day supply. 2. I agree that only my physician will prescribe controlled substance medication. I will not obtain or use any controlled substances

from a source other than my physician. I will instruct my other physicians to confer with my physician for any changes or need for additional controlled substance medication. If it is discovered that other providers are prescribing medications for me, my physician reserves the right to discontinue prescribing medications and/or discharge me from the clinic.

3. Refills must be written (i.e., they cannot be faxed or phoned in). I will need to come in and pick up the prescription. All medicine should be filled by the dispensing practitioner, when possible.

4. My physician's office requires a 72 hour notice to refill prescriptions. Prescriptions can only be refilled during normal business hours. They will NOT be refilled at night or on weekends. I must provide proof of identity to pick up my prescription for controlled substances.

5. I must be seen by my doctor every 3 months to continue to get refills. 6. My physician's office is not responsible for any controlled substance medications that have been misplaced, lost or stolen.

Controlled substances cannot be refilled before the renewal date. 7. Routine blood work and random urine drug screens may be part of my treatment plan. I agree to have them done on the day my

physician requests it. 8. If I do not follow these policies, my physician will not be able to continue to prescribe these medications for me. 9. It is a crime to obtain narcotics under false pretenses. This could include getting medications from more than one doctor,

misrepresenting myself to obtain medications, using them in a manner other than prescribed, or diverting the medications in any other way (e.g., selling). If my physician has reason to believe that I have violated this agreement, the physician has the right to notify and cooperate with law enforcement. If the responsible legal authorities have questions concerning my treatment, as might occur, for example, if I were obtaining medications at several pharmacies, all confidentiality is waived, and these authorities may be given full access to my records.

10. My physician has the right to discontinue controlled substance medications and discharge me from care if any of the following occur.

• I trade, sell, misuse, or share medication with others; • The clinic discovers I have broken any part of this agreement; • I do not go for blood work or urine tests when asked; • My blood or urine shows the presence of medications that my physician is not aware of, the presence of illegal drugs,

or does not show medications that I am receiving a prescription for; • I get controlled substances from sources other than Florida Center for Integrative Health clinic physicians; • I exhibit any aggressive behavior toward the physicians or staff; • I consistently miss appointments.

I hold Florida Vacation Telehealth PA’s physicians harmless from any liability in the event I am dismissed from the practice for failure to abide by this agreement. I have read and understand the above policy.

Patient/Guardian Signature Date

Printed Patient's Name DOB

DEA statement (Prepared for DEA Administrative Law Judge hearing beginning August 22, 2005, in which Prof. Lyle Craker, UMass Amherst, is suing DEA for refusing to issue him a license to grow marijuana exclusively for federally approved research, funded by a grant from MAPS.) History of Cannabis as a Medicine By Lester Grinspoon, M.D., August 16, 2005 A native of Central Asia, cannabis may have been cultivated as much as 10,000 years ago. It was certainly cultivated in China by 4000 B.C. and in Turkestan by 3000 B.C. It has long been used as a medicine in India, China, the Middle East, Southeast Asia, South Africa, and South America. The first evidence of the medicinal use of cannabis is in an herbal published during the reign of the Chinese Emperor Chen Nung 5000 years ago. It was recommended for malaria, constipation, rheumatic pains, "absentmindedness" and "female disorders." Another Chinese herbalist recommended a mixture of hemp, resin, and wine as an analgesic during surgery. In India cannabis has been recommended to quicken the mind, lower fevers, induce sleep, cure dysentery, stimulate appetite, improve digestion, relieve headaches, and cure venereal disease. In Africa, it was used for dysentery, malaria, and other fevers. Today certain tribes treat snakebite with hemp or smoke it before childbirth. Hemp was also noted as a remedy by Galen and other physicians of the classical and Hellenistic eras, and it was highly valued in medieval Europe. The English clergyman Robert Burton, in his famous work The Anatomy of Melancholy, published in 1621, suggested the use of cannabis in the treatment of depression. The New English Dispensatory of 1764 recommended applying hemp roots to the skin for inflammation, a remedy that was already popular in eastern Europe. The Edinburgh New Dispensary of 1794 included a long description of the effects of hemp and stated that the oil was useful in the treatment of coughs, venereal disease, and urinary incontinence. A few years later the physician Nicholas Culpeper summarized all the conditions for which cannabis was supposed to be medically useful.

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But in the West cannabis did not come into its own as a medicine until the mid-nineteenth century. During its heyday, from 1840 to 1900, more than 100 papers were published in the Western medical literature recommending it for various illnesses and discomforts. It could almost be said that physicians of a century ago knew more about cannabis than contemporary physicians do; certainly, they were more interested in exploring its therapeutic potential. The first Western physician to take an interest in cannabis as a medicine was WB O’Shaughnessy, a young professor at the Medical College of Calcutta, who had observed its use in India. He gave cannabis to animals, satisfied himself that it was safe, and began to use it with patients suffering from rabies, rheumatism, epilepsy, and tetanus. In a report published in 1839, he wrote that he had found tincture of hemp (a solution of cannabis in alcohol, taken orally) to be an effective analgesic. He was also impressed with its muscle-relaxant properties and called it "an anticonvulsant remedy of the greatest value." O’Shaughnessy returned to England in 1842 and provided cannabis to pharmacists. Doctors in Europe and the United States soon began to prescribe it for a variety of physical conditions. Cannabis was even given to Queen Victoria by her court physician. It was listed in the United States Dispensatory in 1854 (with a warning that large doses were dangerous and that it was a powerful "narcotic"). Commercial cannabis preparations could be bought in drugstores. During the Centennial Exposition of 1876 in Philadelphia, some pharmacists carried ten pounds or more of hashish. Meanwhile, reports on cannabis accumulated in the medical literature. In 1860, Dr. RR M’Meens reported the findings of the Committee on Cannabis Indica to the Ohio State Medical Society. After acknowledging a debt to O’Shaughnessy, M’Meens reviewed symptoms and conditions for which Indian hemp had been found useful, including tetanus, neuralgia, dysmenorrhea (painful menstruation), convulsions, the pain of rheumatism and childbirth, asthma, postpartum psychosis, gonorrhea, and chronic bronchitis. As a hypnotic (sleep-inducing drug) he compared it to opium: "Its effects are less intense, and the secretions are not so much suppressed by it. Digestion is not disturbed; the appetite rather increased; ... The whole effect of hemp being less violent, and producing a more natural sleep, without interfering with the actions of the internal organs, it is certainly often preferable to opium, although it is not equal to that drug in strength and reliability." Like O’Shaughnessy, M’Meens emphasized the remarkable capacity of cannabis to stimulate appetite. Interest persisted into the next generation. In 1887, HA Hare extolled the capacity of hemp to subdue restlessness and anxiety and distract a patient’s mind in terminal illness. In these circumstances, he wrote, "The patient, whose most painful symptom has been mental trepidation, may become more happy or even hilarious." He believed cannabis to be as effective a pain reliever as opium: "During the time that this remarkable drug is relieving pain, a very curious

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psychical condition sometimes manifests itself; namely, that the diminution of the pain seems to be due to its fading away in the distance, so that the pain becomes less and less, just as the pain in a delicate ear would grow less and less as a beaten drum was carried farther and farther out of the range of hearing. Hare also noted that hemp is an excellent topical anesthetic, especially for the mucous membranes of the mouth and tongue -- a property well known to dentists in the nineteenth century. In 1890, JR Reynolds, a British physician, summarized 30 years of experience with Cannabis indica, recommending it for patients with "senile insomnia": "In this class of cases I have found nothing comparable in utility to a moderate dose of Indian hemp." According to Reynolds, hemp remained effective for months and even years without an increase in the dose. He also found it valuable in the treatment of various forms of neuralgia, including tic douloureux (a painful facial neurological disorder), and added that it was useful in preventing migraine attacks: "Very many victims of this malady have for years kept their suffering in abeyance by taking hemp at the moment of threatening or onset of the attack." He also found it useful for certain kinds of epilepsy, for depression, and sometimes for asthma and dysmenorrhea. Dr. JB Mattison in 1891 called it... "a drug that has a special value in some morbid conditions and the intrinsic merit and safety of which entitles it to a place it once held in therapeutics." Mattison reviewed its uses as an analgesic and hypnotic, with special reference to dysmenorrhea, chronic rheumatism, asthma, gastric ulcer, and morphine addiction, but for him the most important use of cannabis was treating "that opprobrium of the healing art -- migraine." Revealing his own and earlier physicians’ experiences, he concluded that cannabis not only blocks the pain of migraine but prevents migraine attacks. Years later William Osler expressed his agreement, saying that cannabis was "probably the most satisfactory remedy" for migraine. Mattison’s report concluded on a wistful note: Dr. Suckling wrote me: "The young men are rarely prescribing it." To them I specially commend it. With the wish for speedy effect, it is so easy to use that modern mischief maker, hypodermic morphia, that they [young physicians] are prone to forget remote results of incautious opiate giving. Would that the wisdom which has come to their professional fathers through, it may be, a hapless experience might serve them to steer clear of narcotics shoals on which many a patient has gone awreck. Indian hemp is not here lauded as a specific. It will, at times fail. So do other drugs. But the many cases in which it acts well entitle it to a large and lasting confidence. As he noted, the medical use of cannabis was already in decline by 1890. The potency of cannabis preparations was too variable, and individual responses to orally ingested cannabis seemed erratic and unpredictable. Another reason for the neglect of research on the analgesic properties of cannabis was the greatly

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increased use of opiates after the invention of the hypodermic syringe in the 1850s, which allowed soluble drugs to be injected for fast relief of pain; hemp products are insoluble in water and so cannot easily be administered by injection. Toward the end of the 19th century, the development of such synthetic drugs as aspirin, chloral hydrate, and barbiturates, which are chemically more stable than Cannabis indica and therefore more reliable, hastened the decline of cannabis as a medicine. But the new drugs had striking disadvantages. More than a thousand people die from aspirin-induced bleeding each year in the United States, and barbiturates are, of course, far more dangerous. One might have expected physicians looking for better analgesics and hypnotics to turn to cannabinoid substances, especially after 1940, when it became possible to study congeners (chemical relatives) of tetrahydrocannabinol that might have more stable and specific effects. But the Marihuana Tax Act of 1937 undermined any such experimentation. This law was the culmination of a campaign organized by the Federal Bureau of Narcotics under Harry Anslinger in which the public was led to believe that marihuana was addictive and that its use led to violent crimes, psychosis, and mental deterioration. The film Reefer Madness, made as part of Anslinger’s campaign, may be a joke to the sophisticated today, but it was once regarded as a serious attempt to address a social problem, and the atmosphere and attitudes it exemplified and promoted continue to influence our culture today. Under the Marihuana Tax Act, anyone using the hemp plant for certain defined industrial or medical purposes was required to register and pay a tax of a dollar an ounce. A person using marijuana for any other purpose had to pay a tax of $100 an ounce on unregistered transactions. Those who failed to comply were subject to large fines or prison for tax evasion. The law was not directly aimed at the medical use of marijuana -- its purpose was to discourage recreational marijuana smoking. It was put in the form of a revenue measure to evade the effect of Supreme Court decisions that reserved to the states the right to regulate most commercial transactions. By forcing some marijuana transactions to be registered and others to be taxed heavily, the government could make it prohibitively expensive to obtain the drug legally for any other than medical purposes. Almost incidentally, the law made medical use of cannabis difficult because of the extensive paperwork required of doctors who wanted to use it. The Federal Bureau of Narcotics followed up with "anti--diversion" regulations that contributed to physicians’ disenchantment. Cannabis was removed from the United States Pharmacopeia and National Formulary in 1941. In the 1960s, as large numbers of people began to use marijuana recreationally, anecdotes about its medical utility began to appear, generally not in the medical literature but in the form of letters to popular magazines like Playboy. Meanwhile, legislative concern about recreational use increased, and in 1970 Congress passed the Comprehensive Drug Abuse Prevention and Control Act (also called the Controlled Substances Act), which assigned psychoactive drugs

5

to five schedules and placed cannabis in Schedule 1, the most restrictive. According to the legal definition, Schedule I drugs have no medical use and a high potential for abuse, and they cannot be used safely even under a doctor’s supervision. By that time the renaissance of interest in cannabis as a medicine was well underway. Two years later, in 1972, the National Organization for the Reform of Marijuana Laws (NORML) petitioned the Bureau of Narcotics and Dangerous Drugs (formerly the Federal Bureau of Narcotics) to transfer marijuana to Schedule II so that it could be legally prescribed by physicians. The hearings before the Bureau of Narcotics and Dangerous Drugs (BNDD) were instructive. As I waited to testify on the medical uses of cannabis, I witnessed the effort to place pentazocine (Talwin), a synthetic opioid analgesic made by Winthrop Pharmaceuticals, on the schedule of dangerous drugs. The testimony indicated several hundred cases of addiction, a number of overdose deaths, and considerable evidence of abuse. Six lawyers from the drug company, briefcases in hand, came forward to prevent the classification of pentazocine, or at least ensure that it was placed in one of the less restrictive schedules. They succeeded in part; it became a Schedule IV drug, available by prescription with minor restrictions. In the testimony on cannabis, the next drug to be considered, there was no evidence of overdose deaths or addiction -- simply many witnesses, both patients and physicians, testifying to its medical utility. The government refused to transfer it to Schedule II. Might the outcome have been different if a large drug company with enormous financial resources had a commercial interest in cannabis? In rejecting the NORML petition, the Bureau of Narcotics and Dangerous Drugs failed to call for public hearings, as required by the law. The reason it gave was that reclassification would violate US treaty obligations under the United Nations Single Convention on Narcotic Substances. NORML responded in January 1974 by filing a suit against the BNDD. The US Second Circuit Court of Appeals reversed the bureau’s dismissal of the petition, remanding the case for reconsideration and criticizing both the bureau and the Department Of Justice. In September 1975, the Drug Enforcement Administration (DEA), successor to the BNDD, acknowledged that treaty obligations did not prevent the rescheduling of marijuana but continued to refuse public hearings. NORML again filed suit. In October 1980, after much further legal maneuvering, the Court of Appeals remanded the NORML petition to the DEA for reconsideration for the third time. The government reclassified synthetic tetrahydrocannabinol (dronabinol) as a Schedule II drug in 1985 but kept marijuana itself -- -- and the tetrahydrocannabinol derived from marijuana (a chemical identical to the synthetic version) -- -- in Schedule I. Finally, in May 1986 the DEA Administrator announced the public hearings ordered by the court seven years earlier. Those hearings began in the summer of 1986 and lasted two years. The lengthy hearings involved many witnesses, including both patients and physicians, and thousands of pages of documentation. The record of these

6

hearings constitutes one of the most extensive recent explorations of the evidence on cannabis as a medicine. Administrative law judge Francis L. Young reviewed the evidence and rendered his decision on September 6, 1988. Young said that approval by a "significant minority" of physicians was enough to meet the standard of "currently accepted medical use in treatment in the United States" established by the Controlled Substances Act for a Schedule II drug. He added that "marijuana, in its natural form, is one of the safest therapeutically active substances known to man... One must reasonably conclude that there is accepted safety for use of marijuana under medical supervision. To conclude otherwise, on the record, would be unreasonable, arbitrary, and capricious." Young went on to recommend "that the Administrator [of the DEA] conclude that the marijuana plant considered as a whole has a currently accepted medical use in treatment in the United States, that there is no lack of accepted safety for use of it under medical supervision and that it may lawfully be transferred from Schedule I to Schedule II." In determining what "currently accepted medical use" meant for legal purposes, Judge Young was adopting the view of petitioners and rejecting that of the DEA, whose criteria were the result of a previous legal challenge involving the drug 3,4-methylenedioxymethamphetamine(MDMA). In 1984 the DEA placed this previously unscheduled drug in Schedule I. The placement was challenged by me and some fellow physicians who believed that MDMA had therapeutic potential. After exhaustive hearings, the administrative law judge rejected the DEA’s position that MDMA had no accepted medical use in treatment in the United States and agreed with the challengers that it should be placed in Schedule III rather than Schedule I. The DEA administrator rejected this recommendation. We appealed to the US First Circuit Court of Appeals, which ruled in our favor, finding that formal approval for marketing by the Food and Drug Administration, the DEA’s criterion for "accepted medical use in treatment in the United States," was unacceptable under the terms of the Controlled Substances Act. The DEA administrator responded with the following new criteria for accepted medical use of a drug: (1) scientifically determined and accepted knowledge of its chemistry; (2) scientific knowledge of its toxicology and pharmacology in animals; (3) effectiveness in human beings established through scientifically designed clinical trials; (4) general availability of this substance and information about its use; (5) recognition of its clinical use in generally accepted pharmacopeia, medical references, journals, or textbooks; (6) specific indications for the treatment of recognized disorders; (7) recognition of its use by organizations or associations of physicians; and (8) recognition and use by a substantial segment of medical practitioners in the United States. These were the criteria rejected by Judge Young in his marijuana decision. The DEA disregarded the opinion of the administrative law judge and refused to reschedule marijuana. The agency’s lawyer remarked, "The judge seems to

7

hang his hat on what he calls a respectable minority of physicians. What percent are you talking about? One half of one per cent? One quarter of one percent?" DEA Administrator John Lawn went further, calling claims for the medical utility of marijuana a "dangerous and cruel hoax." In March 1991 the plaintiffs appealed yet again and in April the District of Columbia Court of Appeals unanimously ordered the DEA to re-examine the standards, suggesting that they were illogical and that marijuana could never satisfy them. An illegal drug could not be used by a substantial number of doctors or cited as a remedy in medical texts. As the court pointed out, "We are hard-pressed to understand how one could show that any Schedule I drug was in general use or generally available." The court returned the case to the DEA for further explanation, but it offered no direct challenge to the central dogma that marijuana lacks therapeutic value. The DEA issued a final rejection of all pleas for reclassification in March 1992. Despite the obstructionism of the federal government, a few patients have been able to obtain marijuana legally for therapeutic purposes. State governments began to respond in a limited way to pressure from patients and physicians in the late 1970s. In 1978, New Mexico enacted the first law designed to make marijuana available for medical use. Thirty-three states followed in the late 1970s and early 1980s. In 1992, Massachusetts became the 34th state to enact such legislation, and in 1994 Missouri became the 35th. But the laws proved difficult to implement. Because marijuana is not recognized as a medicine under federal law, states can dispense it only by establishing formal research programs for getting FDA approval for an Investigational New Drug (IND) application. Many states gave up as soon as the officials in charge of the programs confronted the regulatory nightmare of the relevant federal laws. Nevertheless, between 1978 and 1984, 17 states received permission to establish programs for the use of marijuana in treating glaucoma and the nausea induced by cancer chemotherapy. Each of these programs fell into abeyance because of the many problems involved. Take the case of Louisiana, where a law was passed in 1978 establishing a program that allowed a Marijuana Prescription Board to review and approve applications by physicians to treat patients with cannabis. The board would have preferred a simple procedure in which medical decisions would be entrusted to the practicing physician, but federal agencies would not supply cannabis without an IND. That would have required an enormous amount of paperwork and would have made the program intolerably cumbersome. The board therefore decided to use an already approved research program operated by the National Cancer Institute, which was limited to cancer patients and employed only a synthetic THC. Marijuana itself was not made legally available to any patient in Louisiana. With these limitations, the program proved ineffective. Patients felt compelled to use illicit cannabis, and at least one was arrested.

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Only ten states eventually established programs in which cannabis was used as a medicine. Among these New Mexico was the first and most successful, largely because of the efforts of the young cancer patient, Lynn Pierson. In 1978 the state legislature enacted a law allowing physicians to prescribe marijuana to patients suffering from nausea and vomiting induced by cancer chemotherapy. The law was later modified to comply with federal IND regulations requiring a research program. Considerable friction immediately developed between the FDA and the people in charge of the New Mexico program. The FDA demanded studies with placebos (inactive substances) as control; the physicians in the New Mexico program wanted to provide sick patients with care. The FDA wanted to proceed slowly, the attitudes of the physicians reflected the urgency of their patients’ needs. Eventually a compromise was reached: patients would be assigned at random to treatment with marijuana cigarettes or synthetic THC capsules. But the prolonged delay suggested to the New Mexico officials that the FDA was not dealing in good faith, and tensions began to grow. At one point state officials even considered using confiscated marijuana, and the chief of the State Highway Patrol was asked whether it could be supplied. In August 1978, Lynn Pierson, who had made a heroic effort to establish a compassionate program, died of cancer without ever having received legal marijuana. Now the FDA approved the New Mexico IND, only to rescind the approval a few weeks later, after the public furor surrounding Pierson’s death had faded. At that point New Mexico officials considered holding a press conference to condemn federal officials for "unethical and immoral behavior." Finally, in November 1978, the program was approved, supplies of marijuana were promised within a month, but not delivered for two months. The random design of the program was soon violated. Patients discussed among themselves the relative merits of the two types of treatment and switched when they wanted to do so; this also gave them a sense of control over their own care. But many patients believe, despite the denials of the National Institute of Drug Abuse (NIDA), that the cigarettes they received were not of adequate potency. The state never conducted an independent assay. Some patients left the program in order to buy cannabis on the streets, which they felt was better than either government marijuana or synthetic THC. From 1978 to 1986 about 250 cancer patients in New Mexico received either marijuana or THC after conventional medications had failed to control their nausea and vomiting. For these patients both marijuana and THC were effective, but marijuana was superior. More than 90% reported significant or total relief from nausea and vomiting. Only three adverse effects were reported in the entire program -- anxiety reactions that were easily treated by simple reassurance. The successful programs in other states resembled the one in New Mexico. It was understood that "research" was merely a disguise; the aim was to relieve

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suffering. Although the results did not meet the methodological standards for controlled clinical research, they did confirm the effectiveness of cannabis and the advantage of smoked marijuana over oral THC. Incidentally, none of the programs reported problems with abuse or the diversion of either THC or marijuana cigarettes. A New York State Department of Health report on the therapeutic use of cannabis asked why more patients and physicians had not enrolled in the New York program. It concluded that there were several reasons. First, physicians were skeptical because of their limited training and experience. Second, bureaucratic obstacles were enormous. As the report states, "Hospital pharmacists and administrators complain about paperwork and procedures. Physicians complain about burdensome reporting and application requirements. At least 16 physicians have inquired into the availability of marijuana, but have chosen not to enroll in the program because they perceive a large amount of bureaucratic procedure." A third possibility was that many patients and physicians decided it was easier to get marijuana of good quality on the street. At about the same time the state programs were being instituted, growing demand forced the FDA to institute an Individual Treatment IND (commonly referred to as a Compassionate Use IND or Compassionate IND) for the use of individual physicians whose patients needed marijuana. The application process was not easy, because it was designed for an entirely different purpose -- making pharmaceutical companies assure the safety of new drugs. First the patient in need of cannabis had to persuade a physician to apply to the FDA for an IND. The physician had to file a special form with the DEA covering Schedule I drugs. If the application was approved by both agencies, the physician then had to fill out special order forms for marijuana, which were sent to the National Institute on Drug Abuse (NIDA). NIDA grows cannabis on a farm at the University of Mississippi -- the only legal marijuana farm in the United States -- and sends it to North Carolina, where it is rolled into cigarettes that were supposed to have the same potency as street marijuana (at that time 2%, presently 3.5%). NIDA then shipped the marijuana to a designated pharmacy that had to comply with stringent DEA regulations for drug security. The application process took four to eight months. Both the FDA and the DEA required constant prodding and rarely responded within the time specified by law. According to the (now defunct) Alliance for Cannabis Therapeutics, which helped a number of patients and physicians through the process, government agencies routinely seemed to lose some of the application forms, and the doctor had to resubmit them, sometimes more than once. Understandably, most physicians did not want to become entangled in the paperwork, especially since many also believe there is some stigma attached to prescribing marijuana. In 1976 Robert Randall, who suffered from glaucoma, became the first patient to receive a Compassionate IND for the use of marijuana. Over the next 13 years the government reluctantly awarded a half dozen more. Then, in 1989 the FDA

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was deluged with applications from people with AIDS. The case that called attention to the absurd and appalling consequences of the medical ban on marijuana was the government assault on Kenneth and Barbra Jenks, a Florida couple in their 20s who contracted AIDS through a blood transfusion given to the husband, a hemophiliac. Both were suffering from nausea, vomiting, and appetite loss caused by AIDS or AZT; their doctor feared that Barbra Jenks would die of starvation before the disease killed her. In early 1989 the Jenkses learned about marijuana through a support group for people with AIDS. They began to smoke it and for a year they led a fairly normal life. They felt better, regained lost weight, and were able to stay out of the hospital; Kenneth Jenks even kept his full-time job. Then someone informed on them. On March 29, 1990, 10 armed narcotics officers battered down the door of their trailer home, held a gun to Barbra Jenks’s head, and seized the evidence of crime, two small marijuana plants they had been growing because they could not afford to pay the street price of the drug. Cultivation of marijuana is a felony in Florida; the Jenkses faced up to five years in prison. At their trial in July they used the defense of medical necessity, which is rarely successful. The judge rejected this defense and convicted the Jenkses, although he imposed only a suspended sentence. The conviction was later overturned by a higher court and the defense of medical necessity was sustained. The case received national publicity and the Jenkses were able to obtain a Compassionate IND. Now the FDA was inundated with new requests from AIDS sufferers. The number of extant Compassionate IND’s rose from five to thirtyfour in a year. Then James O. Mason, chief of the Public Health Service, announced that the program would be suspended because it undercut the Bush administration opposition to the use of the illegal drugs. "If it is perceived that the Public Health Service is going around giving marijuana to folks, there would be to a perception that this stuff can’t be so bad," Mason said. He went on, "It gives a bad signal. I don’t mind doing that if there is no other way of helping these people... But there is not a shred of evidence that smoking marijuana assists a person with AIDS." After keeping the program "under review" for nine months, the Public Health Service discontinued it in March 1992. Twenty eight patients whose applications had already been approved were denied the promised marijuana. Thirteen patients already receiving marijuana were allowed to continue receiving it. Presently, the number has fallen to seven. After more than 20 years in which hundreds of people have worked through state legislatures, federal courts, and administrative agencies to make marijuana available for suffering people, these seven are the only ones for whom it is not still a forbidden medicine. With the demise of the Compassionate IND program, the last flicker of compassion toward medical marijuana patients on the part of the federal

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government disappeared. Now there was no hope of any kind of legal access to a drug that thousands of Americans had come to believe was the best treatment for their particular medical problems. Again, some of the states began to try to fill the vacuum beginning with California which in 1996 passed Proposition 215. This voter initiative made it possible for patients with specified symptoms and syndromes for which cannabis is useful to obtain from a physician a letter which is the functional equivalent of a prescription for marijuana. These "prescriptions" are "filled" at one of the many nonprofit "Compassion Clubs" which have sprung up in the 10 states which, through legislation or voter initiative, have now made similar allowances for medical marijuana patients. The government has responded with a determined campaign aimed at closing down the Compassion Clubs, and many patients who had finally found a legitimate way to obtain this medicine were again dependent on illicit sources or forced to grow their own, and some were prosecuted. If herbal marihuana is without any medical utility, as the US government claims, why would thousands of patients risk running afoul of the law to obtain and use it? They use it for one or more of three reasons: (1) herbal marihuana is, even with the prohibition tariff, less expensive than either the conventional medicine it replaces or Marinol; (2) because its toxicity is so low, they suffer fewer "sideeffects" (toxic effects) than they do with the conventional medicine for which cannabis has been substituted; and (3) because it is remarkably versatile-- it is useful in the treatment of a number of syndromes and symptoms. Today, herbal marihuana is most commonly, but certainly not exclusively, used in the treatment of: The Severe Nausea and Vomiting of Cancer Chemotherapy Glaucoma Epilepsy Multiple Sclerosis The Spasm and Pain of Paraplegia and Quadriplegia AIDS Chronic Pain Migraine Rheumatic Diseases (Osteoarthritis and Ankylosing Spondylitis) Premenstrual Syndrome, Menstrual Cramps, and Labor Pains Ulcerative Colitis Crohn’s Disease Phantom Limb Pain Depression Hyperemesis Gravidarum There are several reasons why medicine has not been quicker to recognize the value of readmitting cannabis to the pharmacopeia. One is the lack of incentive of pharmaceutical companies to develop it as a medicine because it is not

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possible to patent a plant. In fact, there is a disincentive because this versatile medicine would successfully compete with many of their extant products. But the most important reason is the low regard with which medicine holds anecdotal data, and almost all that we know about herbal marijuana as a medicine is anecdotal. Anecdotal data is less reliable than that derived from double-blind controlled studies which were introduced in the early 60s and which modern medicine now relies on. Still, it must not be forgotten that modern medicine was built upon a foundation of anecdotal data and it continues to point to new therapeutic possibilities, some of which, as in the case of cannabis, turn out to be valuable. Now, attitudes toward the anecdotal nature of most of the data on cannabis are slowly changing. In a paper recently published in Trends in Neurosciences (May, 2005) the authors write as follows: Use of cannabis as a medicine for numerous conditions has a well documented history stretching back thousands of years. With the identification of an endogenous system of receptors and ligands in recent years, abundant experimental data have reinforced the anecdotal claims of people who perceive medicinal benefit from the currently illegal consumption of cannabis. This, combined with data from recent clinical trials, points to the prospect of cannabis as a medication in the treatment of multiple sclerosis and numerous other medical conditions. In the 19th century cannabis was dispensed as an orally administered medicine in the form of an alcohol-based extract generically known as Cannabis indica. Dosage was a matter of guesswork in as much as there were no bioassays at that time. Physicians were not much concerned about over-dosage because while an especially large dose might make a patient uncomfortable until the drug effect wore off, it would not in any way harm the patient. What distressed physicians of this era was the time delay between having the patient take, say, two minems of Tilden’s Solution (a commonly used proprietary form of Cannabis indica) and the onset of symptom relief -- -- about an hour and a half. Nineteenth-century physicians were unaware of one of the remarkable properties of herbal marijuana e.g. that it could be smoked and when delivered in this way it would provide symptom relief within minutes. This was a discovery made by early twentieth-century recreational users who passed it on to patients who used marijuana as a medicine. It is a critically important medicinal property of cannabis because it allows patients to quickly determine just how much of the drug they need to achieve their medical objective. Additionally, it provides the patient, who is in the best position to determine this dose, the ability to be in control of the relief of his pain, nausea, or other symptom. While there has never been reported a case of lung cancer or emphysema attributable to the smoking of cannabis, there is in today’s widespread antismoking climate concern about the effect of the smoke on the pulmonary system. Another fortuitous property of marijuana is that there is a temperature window which is below the ignition point of cannabis, but within which the cannabinoids will vaporize. There is now generally available a device known as

13

a vaporizer which takes advantage of this property. It holds herbal marihuana at a temperature of between 284 F and 392 F, thus allowing the patient to inhale the therapeutic cannabinoids free of any of the products of the burning plant material, including putative carcinogens. The medical marijuana problem is a Janus-like conundrum; one view of the problem is seen through the eyes of patients and another through those of their government. One face regards with dismay the problem of denying herbal marihuana to the growing number of pained, impatient patients who find it useful, often more useful, less toxic and cheaper than the legally available medications. Through the patients’ eyes the problem is, of course, how to acquire and use this medicine without swelling the ranks (already more than 750,000 annually) of those who are arrested for using this illegal substance and how to avoid jeopardizing job security through random urine testing. The other face, the backward looking one, is that of an obdurate government as it defensively and inconsistently insists that "marijuana is not a medicine", and backs up this illinformed, arrogant position with the full force of its vast legal power as it is presently doing in the state of California. In 1985 the Food And Drug Administration (FDA) approved dronabinol (Marinol) for the treatment of the nausea and vomiting of cancer chemotherapy. Dronabinol is a solution of synthetic tetrahydrocannabinol in sesame oil (the sesame oil is meant to protect against the possibility that the contents of the capsule could be smoked). Dronabinol was developed by Unimed Pharmaceuticals Inc. with a great deal of financial support from the United States government. This was the first hint that "pharmaceuticalization" of cannabis might be what the government hoped would solve its problems with marijuana as medicine, the problem of how to make the medical properties of cannabis (in so far as the government believes such properties exist) widely available as a medicine while at the same time prohibiting its use for any other purpose. But Marinol did not displace marijuana as "the treatment of choice"; most patients found the herb itself much more useful than dronabinol in the treatment of the nausea and vomiting of cancer chemotherapy. In 1992, the treatment of the AIDS wasting syndrome was added to dronabinol’s labeled uses; again, patients reported that it was inferior to smoked herbal marihuana. Because it was thought that it would sell better if placed in a less restrictive Drug Control Schedule, it was moved from Schedule II to Schedule III in the year 2000. But Marinol has not solved the marijuana-as-a-medicine problem because so few of the patients who have discovered the therapeutic usefulness of marijuana use dronabinol. In general, they find it less effective than smoked marijuana, it cannot be titrated because it has to be taken orally which causes a long delay in the manifestation of its therapeutic utility, and even with the prohibition tariff on street marijuana, Marinol is more expensive. Thus, the first attempt at pharmaceuticalization proved not to be the answer. In practice, for many patients who use marijuana as a medicine the doctor-prescribed Marinol serves primarily as a cover from the threat of the growing ubiquity of urine tests.

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More recently, the Institute of Medicine (IOM) Report (1999), which acknowledged marijuana’s usefulness as a medicine, proposed that the solution was the "pharmaceuticalization" of cannabis: prescription of isolated individual cannabinoids, synthetic cannabinoids and cannabinoid analogs. The IOM Report states that "... if there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids, and their synthetic derivatives." It goes on: "Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug, but such trials could be a first step toward the development of rapid onset, non-smoked cannabinoid delivery systems." Some cannabinoids and analogs may indeed have advantages over whole smoked or ingested marijuana in limited circumstances. For example, cannabidiol may be more effective as an anti-anxiety medicine and an anticonvulsant when it is not taken along with tetrahydrocannabinol (THC), which sometimes generates anxiety. Other cannabinoids and analogs may prove more useful than herbal marijuana in some circumstances because they can be administered intravenously. For example, 15 to 20% of patients lose consciousness after suffering a thrombotic or embolic stroke, and some people who suffer brain syndrome after a severe blow to the head become unconscious. The new analog Dexanabinol (HU-211) has been shown to protect brain cells (in anaimals) from damage when given immediately after a stroke; if this proves to be true in humans, it will be possible to give it intravenously to an unconscious person. Presumably other analogs may offer related advantages. Some of these commercial products may also lack the psychoactive effects which make marijuana useful to some for nonmedical purposes. Therefore, they will not be defined as "abusable" drugs subject to the constraints of the Comprehensive Drug Abuse and Control Act. Nasal sprays, vaporizers, nebulizers, skin patches, pills, and suppositories can be used to avoid exposure of the lungs to the particulate matter in marijuana smoke. The question is whether these developments will make herbal marijuana itself medically obsolete. Surely many of these new products would be useful and safe enough for commercial development. It is uncertain, however, whether pharmaceutical companies will find them worth the enormous development costs. Some may be (for example a cannabinoid inverse agonist that reduces appetite might be highly lucrative), but for most specific symptoms, analogs or combination of analogs are unlikely to be more useful than natural herbal marijuana. Nor are they likely to have a significantly wider spectrum of therapeutic uses, since the natural product contains the compounds (and synergistic combinations of compounds) from which they are derived. For example, the naturally occurring THC and cannabidiol of marijuana, as well as Dexanabinol, protect animal brain cells after a stroke or traumatic injury. Furthermore, any new analog will have to have an acceptable therapeutic ratio. The therapeutic ratio (an index of the drug’s safety) of marijuana is not known

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because it has never caused an overdose death, but it is estimated, on the basis of extrapolation from animal data, to be an almost unheard of 20,000 to 40,000. The therapeutic ratio of a new analog is unlikely to be higher than that; in fact, new analogs may be much less safe than plant marijuana because it will be physically possible to ingest more of them. One is compelled to ask, what is the government’s problem with medical herbal marijuana? The problem as seen through the eyes of the government is the belief that as growing numbers of people observe relatives and friends using marijuana as a medicine, they will come to understand that this is a drug which does not conform to the description the government has been pushing for years. They will first come to appreciate what a remarkable medicine it really is; it is less toxic than almost any other medicine in the pharmacopeia; it is, like aspirin, remarkably versatile; and it is less expensive than the conventional medicines it displaces. They will then begin to wonder if there are any properties of this drug which justify denying it to people who wish to use it for any reason, let alone arresting more than 750,000 citizens annually. The federal government sees the acceptance of marijuana as a medicine as the gateway to catastrophe, the repeal of its prohibition. In so far as the government views as anathema any use of plant marijuana, it is difficult to imagine it accepting a legal arrangement that would allow its use as a medicine, while at the same time vigorously pursuing a policy of prohibition of any other use. Yet, there are many who believe this type of arrangement is possible and workable. In fact, this is the option the Canadian and Dutch governments are presently pursuing, as are various states in the United States. But it will not be possible to do this in the United States in the absence of large double-blind studies which make use of the medicine that thousands of patients now use, e.g. herbal marijuana.

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The History of Cannabis as a Medicine contains important information about Cannabis, and I

understand that I should consult Compassionate Cannabis Clinic of Venice regarding any questions not

answered in the handbook. I understand that I may ask Dr. Barry M. Gordon or any employee of

Compassionate Cannabis Clinic of Venice or Florida Vacation Telehealth, PA. for any questions I might

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Cannabis Clinic of Venice. I understand that this form will be retained in my patient chart.

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Reference:

History of Cannabis as a Medicine

By Lester Grinspoon, M.D.,

August 16, 2005

PHQ 1/3

PATIENT HEALTH QUESTIONNAIRE (PHQ)

This questionnaire is an important part of providing you with the best health care possible. Your answers will help in understanding problems that you may have. Please answer every question to the best of your ability unless you are requested to skip over a question. Name______________________ Age_____ Sex: Female Male Today’s Date________

1. During the last 4 weeks, how much have you been

bothered by any of the following problems?

Not bothered

Bothered a little

Bothered a lot

a. Stomach pain

b. Back pain

c. Pain in your arms, legs, or joints (knees, hips, etc.)

d. Menstrual cramps or other problems with your periods

e. Pain or problems during sexual intercourse

f. Headaches

g. Chest pain

h. Dizziness

i. Fainting spells

j. Feeling your heart pound or race

k. Shortness of breath

l. Constipation, loose bowels, or diarrhea

m. Nausea, gas, or indigestion

2. Over the last 2 weeks, how often have you been bothered

by any of the following problems? Not at all

Several days

More than half the days

Nearly every day

a. Little interest or pleasure in doing things

b. Feeling down, depressed, or hopeless

c. Trouble falling or staying asleep, or sleeping too much

d. Feeling tired or having little energy

e. Poor appetite or overeating

f. Feeling bad about yourself — or that you are a failure or have let yourself or your family down

g. Trouble concentrating on things, such as reading the newspaper or watching television

h. Moving or speaking so slowly that other people could have noticed? Or the opposite — being so fidgety or restless that you have been moving around a lot more than usual

i. Thoughts that you would be better off dead or of hurting yourself in some way

FOR OFFICE CODING: Som Dis if at least 3 of #1a-m are “a lot” and lack an adequate biol explanation. Maj Dep Syn if answers to #2a or b and five or more of #2a-i are at least “More than half the days” (count #2i if present at all). Other Dep Syn if #2a or b and two, three, or four of #2a-i are at least “More than half the days” (count #2i if present at all).

PHQ 2/3

3. Questions about anxiety. a. In the last 4 weeks, have you had an anxiety attack ––

suddenly feeling fear or panic? If you checked “NO”, go to question #5.

NO

YES

b. Has this ever happened before?

c. Do some of these attacks come suddenly out of the blue –– that is, in situations where you don’t expect to be nervous or uncomfortable?

d. Do these attacks bother you a lot or are you worried about having another attack?

4. Think about your last bad anxiety attack.

NO

YES

a. Were you short of breath?

b. Did your heart race, pound, or skip?

c. Did you have chest pain or pressure?

d. Did you sweat?

e. Did you feel as if you were choking?

f. Did you have hot flashes or chills?

g. Did you have nausea or an upset stomach, or the feeling that you were going to have diarrhea?

h. Did you feel dizzy, unsteady, or faint?

i. Did you have tingling or numbness in parts of your body?...

j. Did you tremble or shake?

k. Were you afraid you were dying?

5. Over the last 4 weeks, how often have you been bothered by

any of the following problems? Not at all Several

days

More than half the

days

a. Feeling nervous, anxious, on edge, or worrying a lot about different things.

If you checked “Not at all”, go to question #6.

b. Feeling restless so that it is hard to sit still.

c. Getting tired very easily.

d. Muscle tension, aches, or soreness.

e. Trouble falling asleep or staying asleep.

f. Trouble concentrating on things, such as reading a book or watching TV.

g. Becoming easily annoyed or irritable.

FOR OFFICE CODING: Pan Syn if all of #3a-d are ‘YES’ and four or more of #4a-k are ‘YES’. Other Anx Syn if #5a and answers to three or more of #5b-g are “More than half the days”.

PHQ 3/3

6. Questions about eating. a. Do you often feel that you can’t control what or how much you

eat?

NO

YES

b. Do you often eat, within any 2-hour period, what most people would regard as an unusually large amount of food?

If you checked “NO” to either #a or #b, go to question #9.

c. Has this been as often, on average, as twice a week for the last 3 months?

7. In the last 3 months have you often done any of the following in order to

avoid gaining weight?

NO

YES

a. Made yourself vomit?

b. Took more than twice the recommended dose of laxatives?

c. Fasted –– not eaten anything at all for at least 24 hours?

d. Exercised for more than an hour specifically to avoid gaining weight after binge eating?

8. If you checked “YES” to any of these ways of avoiding gaining weight,

were any as often, on average, as twice a week?

NO

YES

9. Do you ever drink alcohol (including beer or wine)?

If you checked “NO” go to question #11.

NO

YES

10. Have any of the following happened to you more than once in the last 6 months? NO YES

a. You drank alcohol even though a doctor suggested that you stop drinking because of a problem with your health.

b. You drank alcohol, were high from alcohol, or hung over while you were working, going to school, or taking care of children or other responsibilities.

c. You missed or were late for work, school, or other activities because you were drinking or hung over.

d. You had a problem getting along with other people while you were drinking.

e. You drove a car after having several drinks or after drinking too much.

11. If you checked off any problems on this questionnaire, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?

Not difficult

at all

Somewhat

difficult

Very

difficult

Extremely

difficult

FOR OFFICE CODING: Bul Ner if #6a,b, and-c and #8 are all ‘YES’; Bin Eat Dis the same but #8 either ‘NO’ or left blank. Alc Abu if any of #10a-e is ‘YES’.

Developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc. No permission required to reproduce, translate, display or distribute.

P A T I E N T H E A L T H Q U E S T I O N N A I R E - 9 ( P H Q - 9 )

Over the last 2 weeks, how often have you been bothered by any of the following problems? (Use “✔” to indicate your answer) Not at all

Several days

More than half the days

Nearly every day

1. Little interest or pleasure in doing things 0 1 2 3

2. Feeling down, depressed, or hopeless 0 1 2 3

3. Trouble falling or staying asleep, or sleeping too much 0 1 2 3

4. Feeling tired or having little energy 0 1 2 3

5. Poor appetite or overeating 0 1 2 3

6. Feeling bad about yourself — or that you are a failure or have let yourself or your family down

0 1 2 3

7. Trouble concentrating on things, such as reading the newspaper or watching television

0 1 2 3

8. Moving or speaking so slowly that other people could have noticed? Or the opposite — being so fidgety or restless that you have been moving around a lot more than usual

0 1 2 3

9. Thoughts that you would be better off dead or of hurting yourself in some way

0 1 2 3

FOR OFFICE CODING 0 + ______ + ______ + ______

=Total Score: ______

If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?

Not difficult at all

Somewhat difficult

Very difficult

Extremely difficult

Developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc. No permission required to reproduce, translate, display or distribute.

Florida Vacation Telehealth, PA | HIPAA Privacy Statement

1 411 Commercial Court, Suite A | Venice, FL 34292 | 941-586-2426 | venicecare.com

Your Information. Your Rights. Our Responsibilities.

This notice describes how medical information about you may be used and disclosed and how you can get access to this information.

Please review it carefully.

Your Rights You have the right to:

• Get a copy of your paper or electronic medical record

• Correct your paper or electronic medical record

• Request confidential communication

• Ask us to limit the information we share

• Get a list of those with whom we’ve shared your information

• Get a copy of this privacy notice

• Choose someone to act for you

• File a complaint if you believe your privacy rights have been violated

Your Choices You have some choices in the way that we use and share information as we:

• Tell family and friends about your condition

• Provide disaster relief

• Include you in a hospital directory

• Provide mental health care

• Market our services and sell your information

• Raise funds

Our Uses and Disclosures We may use and share your information as we:

• Treat you

• Run our organization

• Bill for your services

• Help with public health and safety issues

• Do research

• Comply with the law

• Respond to organ and tissue donation requests

• Work with a medical examiner or funeral director

• Address workers’ compensation, law enforcement, and other government requests

• Respond to lawsuits and legal actions



Your Rights

When it comes to your health information, you have certain rights. This section explains your rights and some of our

responsibilities to help you.

Get an electronic or paper copy of your medical record

• You can ask to see or get an electronic or paper copy of your medical record and other health information we have about

you. Ask us how to do this.

• We will provide a copy or a summary of your health information, usually within 30 days of your request. We may charge a

reasonable, cost-based fee.

Ask us to correct your medical record

• You can ask us to correct health information about you that you think is incorrect or incomplete. Ask us how to do this.

• We may say “no” to your request, but we’ll tell you why in writing within 60 days.

Request confidential communications

• You can ask us to contact you in a specific way (for example, home or office phone) or to send mail to a different address.

• We will say “yes” to all reasonable requests.

Ask us to limit what we use or share

• You can ask us not to use or share certain health information for treatment, payment, or our operations. We are not

required to agree to your request, and we may say “no” if it would affect your care.

• If you pay for a service or health care item out-of-pocket in full, you can ask us not to share that information for the

purpose of payment or our operations with your health insurer. We will say “yes” unless a law requires us to share that

information.

Get a list of those with whom we’ve shared information

• You can ask for a list (accounting) of the times we’ve shared your health information for six years prior to the date you ask,

who we shared it with, and why.

• We will include all the disclosures except for those about treatment, payment, and health care operations, and certain

other disclosures (such as any you asked us to make). We’ll provide one accounting a year for free but will charge a

reasonable, cost-based fee if you ask for another one within 12 months.

Get a copy of this privacy notice

You can ask for a paper copy of this notice at any time, even if you have agreed to receive the notice electronically. We will provide

you with a paper copy promptly.

Choose someone to act for you



• If you have given someone medical power of attorney or if someone is your legal guardian, that person can exercise your

rights and make choices about your health information.

• We will make sure the person has this authority and can act for you before we take any action.

File a complaint if you feel your rights are violated

• You can complain if you feel we have violated your rights by contacting us using the information on page 1.

• You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to

200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting

www.hhs.gov/ocr/privacy/hipaa/complaints/.

• We will not retaliate against you for filing a complaint.

Your Choices

For certain health information, you can tell us your choices about what we share. If you have a clear preference for how we share

your information in the situations described below, talk to us. Tell us what you want us to do, and we will follow your instructions.

In these cases, you have both the right and choice to tell us to:

• Share information with your family, close friends, or others involved in your care

• Share information in a disaster relief situation

• Include your information in a hospital directory

If you are not able to tell us your preference, for example if you are unconscious, we may go ahead and share your information if

we believe it is in your best interest. We may also share your information when needed to lessen a serious and imminent threat

to health or safety.

In these cases we never share your information unless you give us written permission:

• Marketing purposes

• Sale of your information

• Most sharing of psychotherapy notes

In the case of fundraising:

• We may contact you for fundraising efforts, but you can tell us not to contact you again.

Our Uses and Disclosures

How do we typically use or share your health information? We typically use or share your health information in the following ways.



Treat you

We can use your health information and share it with other professionals who are treating you.

Example: A doctor treating you for an injury asks another doctor about your overall health condition.

Run our organization

We can use and share your health information to run our practice, improve your care, and contact you when necessary.

Example: We use health information about you to manage your treatment and services.

Bill for your services

We can use and share your health information to bill and get payment from health plans or other entities.

Example: We give information about you to your health insurance plan so it will pay for your services.

How else can we use or share your health information? We are allowed or required to share your information in other ways – usually in ways that contribute to the public good, such as

public health and research. We have to meet many conditions in the law before we can share your information for these purposes.

For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html.

Help with public health and safety issues

We can share health information about you for certain situations such as:

• Preventing disease

• Helping with product recalls

• Reporting adverse reactions to medications

• Reporting suspected abuse, neglect, or domestic violence

• Preventing or reducing a serious threat to anyone’s health or safety

Do research

We can use or share your information for health research.

Comply with the law

We will share information about you if state or federal laws require it, including with the Department of Health and Human

Services if it wants to see that we’re complying with federal privacy law.

Respond to organ and tissue donation requests

http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html



We can share health information about you with organ procurement organizations.

Work with a medical examiner or funeral director

We can share health information with a coroner, medical examiner, or funeral director when an individual dies.

Address workers’ compensation, law enforcement, and other government requests

We can use or share health information about you:

• For workers’ compensation claims

• For law enforcement purposes or with a law enforcement official

• With health oversight agencies for activities authorized by law

• For special government functions such as military, national security, and presidential protective services

Respond to lawsuits and legal actions

We can share health information about you in response to a court or administrative order, or in response to a subpoena.

Our Responsibilities

• We are required by law to maintain the privacy and security of your protected health information.

• We will let you know promptly if a breach occurs that may have compromised the privacy or security of your information.

• We must follow the duties and privacy practices described in this notice and give you a copy of it.

• We will not use or share your information other than as described here unless you tell us we can in writing. If you tell us we

can, you may change your mind at any time. Let us know in writing if you change your mind.

For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/noticepp.html.

Changes to the Terms of this Notice We can change the terms of this notice, and the changes will apply to all information we have about you. The new notice will be

available upon request, in our office, and on our web site.

Effective Date

The effective date of this Notice is December 14, 2016.

Contact Information

Florida Vacation Telehealth, PAEmail: [email protected]: 941-586-2426

http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/noticepp.html

mailto:[email protected]

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