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ROB O ER E T M. M GOL O DM DMAN, N MD MD, PhD, D DO, O FA F ASP W rld Ch Wo C airman-International Me M dical Commis i sion Co-Fo F under & Ch C airman of o the Board r -A4M F under & Ch Fo C airman-International Sp S orts t Ha H ll of o Fa F me Co-Fo F under & Ch C airman-Wo W rld Academy m of o Anti-Aging Me M dicine Pre r sident Emeritus-Na N tional Academy m of o Sp S orts Me M dicine (N (NASM SM) DR. RON ONALD KL K ATZ TZ, MD MD, DO, O is the phy hysician fo f under and Pre r sident of o the American Academy m o Anti-Aging Me of M dicine. In 1984, Dr.r Klatz t was a pioneer in the clinical sp s ecialty t of o pre r ventative medicine: as a princip i al fo f under of o the Na N tional Academy m of o Sp S orts t Me M dicine and re r searc r her into elite human perf rformance and phy hysiolog og y. Dr.r Klatz t is i a best-selling author,r and is i columnis i t or Senior Me M dical Editor to several international medical journals l . He H is the inventor,r develop o er,r or adminis i trator of o 100-p - lus scientifific patents t , including those fo f r technolog o ies fo f r brain r suscitation, trauma and emerg re rgency c medicine, e org rgan transp s lant and blood pre r servation. DAVI D VID B. MA M ND NDELL, JD JD, MB MBA, is i a fo f rmer attorney e and author of o ten books fo f r clients t, including Fo F r Doctors r Only l : A Guide to Wo W rking Less & Building Mo M re r , as well a number of o state books. He H is i a princip i al of o the fifnancial consulting n fifrm OJ OJM Gro r up u. H has co-authore He r d the Categ egory r I CM CME Mo M nog o rap a h Ris i k Ma M nage g ment fo f r the Practicing Phy hysician which has go g ne thro r ug ugh 5 editions since 1998 & is i certifified fo f r 5-hour business of o medicine CM CME. MANO M NON PI PILON ON, Sp S eaker,r International Educator,r SP SPA & Me M dical SPA P Sp S ecialis i t – Mrs r . Ma M non Pilon’s backg k ro r und sp s ans over twenty t -seven years r of o prof ofessional exp x erience in SP SPA and MEDICA ME C L SP SPA op o eration and manage g ment,t marketing n strateg e ies, Me M dical Sp S a concep e t and develop o ment,t and motivation methods d . She is holding n senior manag agement positions in comp m anies such as Euro rope CosmÊtiques, CurA r ge g Me M d, d CurA r ge g Sp S a, and Euro ropelab. Fo F under of o a private Aesthetics Pro rofessional School in Mo M ntre r al,l Canada.
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MEDI CAL SPAS
History Pharma
MEDICINAL CANNABIS: HISTORY, PHARMACOLOGY, AND IMPLICATIONS FOR THE ACUTE CARE SETTING Medicinal cannabis, or medicinal marijuana, is a therapy that has garnered much national attention in recent years. Controversies surrounding legal, ethical, and societal implications associated with use; safe administration, packaging, and dispensing; adverse health consequences and deaths attributed to marijuana intoxication; and therapeutic indications based on limited clinical data represent some of the complexities associated with this treatment. Marijuana is currently recognized by the U.S. Drug Enforcement Agency’s (DEA’s) Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act) of 1970 as a Schedule I controlled substance, defined as having a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety data for use of the treatment under medical supervision.1 7–9
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MEDICINAL CANNABIS: HISTORY, Y PHARMACOLOGY, Y AND IMPLICAT A IONS FOR THE ACUTE CARE SETTING that standardization in potency or quantity of pharmacologically active constituents is absent; that adverse health eff ffects relate not only to smoking cannabis but to unmasking mental health disorders, impairing coordination, and aff ffecting judgment; that standardization does not exist fo f r product packaging and controls to prevent inadvertent use by minors or pets; that there is a potential fo f r dependence, addiction, and abuse; and that costs pose a potential burden.23–25 Regardless of personal views and perceptions, to deny n or disregard the implications of use of this substance on patient health and the infr f astructure of the health care system is irresponsible; clinicians must be aw a are of these implications and info f rmed about how this therapy may a inflfuence practice in a variety of health care settings, including acute care. PHARMACOLOGY Endocannabinoids (eCBs) and their receptors are fo f und throughout the human body: nervous system, internal organs, connective tissues, glands, and immune cells. The eCB system has a homeostatic role, having been characterized as “eat, sleep, relax, fo f rget, and protect.”26 It is known that eCBs hav a e a role in the pathology of many n disorders while also serving a protective fu f nction in certain medical conditions.27 It has been proposed that migraine, fi f bromyalgia, irritable bowel syndrome, and related conditions represent clinical eCB defi f ciency syndromes (CEDS). Defi f ciencies in eCB signaling could be also inv n olved in the pathogenesis of depression. In human studies, eCB system defifciencies hav a e been implicated in schizophrenia, multiple sclerosis (MS), Huntington’s disease, Parkinson’s disease, anorexia, chronic motion sickness, and fa f ilure to thrive in infa f nts.28
CB1 is also expressed in non-neuronal cells, such as adipocytes and hepatocytes, connective and musculoskeletal tissues, and the gonads. CB2 is principally associated with cells governing immune fu f nction, although it may a also be expressed in the central nervous system. The most well-known eCB ligands are N arachidonylethanolamide (anandamide or AEA) and sn-2arachidonoylglycerol (2-AG). AEA and 2-AG are released upon demand fr f om cell membrane phospholipid precursors. This “classic” eCB system has expanded with the discovery of secondary receptors, ligands, and ligand metabolic enzymes. For example, AEA, 2-AG, Narachidonoyl glycine (NA N Gly), and the phy h tocannabinoids Δ9-THC and CBD may a also serve, to diff fferent extents, as ligands at GPR55, GPR18, GPR119, and several transient receptor potential ion channels (e.g., TRPV1, TRPV2, TRPA P 1, TRPM8) that hav a e actions similar to capsaicin.28 The eff ffects of AEA and 2-AG can be enhanced by “entourage compounds” that inhibit their hydrolysis via substrate competition, and thereby prolong their action through synergy and augmentation. Entourage compounds include N-palmitylethanolamide (PEA), N-oleoylethanolamide (SEA), and cis-9-octadecenoamide (OEA or oleamide) and may a represent a novel route fo f r molecular regulation of endogenous cannabinoid activity. y 29
The eCB system represents a microcosm of psychoneuroimmunology or “mind–body” medicine. The eCB system consists of receptors, endogenous ligands, and ligand metabolic enzymes. A variety of physiological processes occur when cannabinoid receptors are stimulated. Cannabinoid receptor type 1 (CB1) is the most abundant G-protein–coupled receptor. It is expressed in the central nervous system, with particularly dense expression in (ranked in order): the substantia nigra, globus pallidus, hippocampus, cerebral cortex, putamen, caudate, cerebellum, and amyg y dala. www.medicalspasreview.com
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MEDICINAL CANNABIS: HISTORY, Y PHARMACOLOGY, Y AND IMPLICAT A IONS FOR THE ACUTE CARE SETTING The time courses of plasma concentrations and clinical “high” h were of the same order fo f r intravenous injection and smoking, with prompt onset and steady decline over a fo f urhour period.Aft f er oral THC, the onset of clinical eff ffects was slower and lasted longer, but eff ffects occurred at much lower plasma concentrations than they did aft f er the other two 38 methods of administration.
Limited clinical trials quantify f ing the eff ffect of the exogenous cannabinoids on the metabolism of other medications exist; however, drug interaction data may a be gleaned fr f om the prescribing info f rmation fr f om cannabinoid-derived pharmaceutical products such as Sativex (GW Pharmaceuticals, United Kingdom) and dronabinol (Marinol, AbbVie [Un U ited States]).41,42
Cannabinoids are usually inhaled or taken orally; the rectal route, sublingual administration, transdermal delivery, y eye drops, and aerosols hav a e been used in only a fe f w studies and are of little relevance in practice today. y The pharmacokinetics of THC vary as a fu f nction of its route of administration. Inhalation of THC causes a maximum plasma concentration within minutes and psychotropic eff ffects within seconds to a fe f w minutes. These eff ffects reach their maximum aft f er 15 to 30 minutes and taper off f within two to three hours. Following oral ingestion, psychotropic eff ffects manife f st within 30 to 90 minutes, reach their maximum eff ffect aft f er two to three hours, and last fo f r about f ur to 12 hours, depending on the dose.39 fo
Concomitant administration of ketoconazole with oromucosal cannabis extract containing THC and CBD resulted in an increase in the maximum serum concentration and area under the curve fo f r both THC and CBD by 1.2-fo f ld to 1.8-fo f ld and twofo f ld, respectively; coadministration of rifa f mpin is associated with a reduction in THC and CBD levels.40,41 In clinical trials, dronabinol use was not associated with clinically signifi f cant drug interactions, although additive pharmacodynamic eff ffects are possible when it is coadministered with other agents hav a ing similar phy h siological eff ffects (e.g., sedatives, alcohol, and antihistamines may increase sedation; tricyclic antidepressants, stimulants, and sympathomimetics may a increase tachy h cardia).41 Additionally, y smoking cannabis may a Within the shift f ing legal landscape of medical cannabis, increase theophy h lline metabolism, as is also seen aft f er diff fferent methods of cannabis administration have smoking tobacco.40,42 important public health implications. A survey using data f om Qualtrics and Facebook showed that individuals in ADVERSE EFFECTS fr states with medical cannabis law a s had a signifi f cantly higher Much of what is known about the adverse eff ffects of likelihood of ever hav a ing used the substance with a history medicinal cannabis comes fr f om studies of recreational users of vaporizing marijuana (odds ratio [OR], 2.04; 99% of marijuana.43 Short-term use of cannabis has led to confifdence interval [CI], 1.62–2.58) and a history of oral impaired short-term memory; impaired motor administration of edible marijuana (OR, 1.78; 99% CI, coordination; altered judgment; and paranoia or psychosis 1.39–2.26) than those in states without such law a s. Longer at high doses.44 Longterm or heavy use of cannabis, duration of medical cannabis status and higher dispensary especially in individuals who begin using as adolescents, has density were also signifi f cantly associated with use of lead to addiction; altered brain development; cognitive vaporized and edible fo f rms of marijuana. Medical cannabis impairment; poor educational outcomes (e.g., dropping out law a s are related to state-level patterns of utilization of of school); and diminished life f satisfa f ction.45 Long-term or heavy use of cannabis is also associated with chronic alternative methods of cannabis administration.34 bronchitis and an increased risk of chronic psychosis related DRUG INTERACTIONS health disorders, including schizophrenia and variants of Metabolic and pharmacodynamic interactions may a exist depression, in persons with a predisposition to such between medical cannabis and other pharmaceuticals. disorders.46–48 Va V scular conditions, including myocardial Quantifi f cation of the in vitro metabolism of exogenous infa f rction, stroke, and transient ischemic attack, hav a e also cannabinoids, including THC, CBD, and cannabinol (CBN), been associated with cannabis use.49–51 The use of cannabis indicates hepatic cytochrome 450 (CYP450) isoenzymes fo f r management of symptoms in neurodegenerative 2C9 and 3A4 play a signifi f cant role in the primary diseases, such as Parkinson’s, Alzheimer’s, and MS, has metabolism of THC and CBN, whereas 2C19 and 3A4 and provided data related to impaired cognition in these may a be responsible fo f r metabolism of CBD.40 individuals.52,53
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MEDICINAL CANNABIS: HISTORY, Y PHARMACOLOGY, Y AND IMPLICAT A IONS FOR THE ACUTE CARE SETTING Cannabis-based medications may a be usefu f l fo f r treating chemotherapy-induced nausea and vomiting that responds poorly to conv n entional antiemetics. However, the trials produced low to moderate quality evidence and reflfected chemotherapy agents and antiemetics that were av a ailable in the 1980s and 1990s. With regard to the management of neurological disorders, including epilepsy and MS, a Cochrane review of fo f ur clinical trials that included 48 epileptic patients using CBD as an adj d unct treatment to other antiepileptic medications concluded that there were no serious adverse eff ffects associated with CBD use but that no reliable conclusions on the eff fficacy and safe f ty of the therapy can be draw a n fr f om this limited evidence.57 The American Academy of Neurology (AAN) has issued a Summary of Systematic Reviews fo f r Clinicians that indicates oral cannabis extract is eff ffective fo f r reducing patient-reported spasticity scores and central pain or painfu f l spasms when used fo f r MS.58 THC is probably eff ffective fo f r reducing patient-reported spasticity scores but is likely ineff ffective fo f r reducing objective measures of spasticity at 15 weeks, the AAN f und; there is limited evidence to support the use of fo cannabis extracts fo f r treatment of Huntington’s disease, levodopa-induced dy d skinesias in patients with Parkinson’s disease, or reducing tic severity in To T urette’s.58 In older patients, medical cannabinoids hav a e shown no eff fficacy on dyskinesia, breathlessness, and chemotherapyinduced nausea and vomiting. Some evidence has shown that THC might be usefu f l in treatment of anorexia and behav a ioral symptoms in patients with dementia. The most common adverse events reported during cannabinoid treatment in older adults were sedation-like symptoms.59 Despite limited clinical evidence, a number of medical conditions and associated symptoms hav a e been approved by state legislatures as qualify f ing conditions fo f r medicinal cannabis use. TABLE 1 contains a summary of medicinal cannabis indications by state, including select disease states and qualify f ing debilitating medical conditions or symptoms.10,60,61 The most common conditions accepted by states that allow medicinal cannabis relate to relief of the symptoms of cancer, glaucoma, human immunodefi f ciency virus/acquired immunodefifciency syndrome, and MS.
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A total of 28 states, the District of Columbia, Guam, and Puerto Rico now allow comprehensive public medical marijiuana and cannabis programs.10 The National Confe f rence of State Legislatures uses the f llowing criteria to determine if a program is fo comprehensive: 1. Protection fr f om criminal penalties fo f r using marijiuana fo f r a medical purpose; 2. Access to marijiuana through home cultivation, dispensaries, or some other system that is likely to be implemented; 3. Allows a variety of strains, including more than those labeled as “low THC;” and 4. Allows either smoking or vaporization of some kind of marijiuana products, plant material, or extract. Some of the most common policy questions regarding medical cannabis now include how to regulate its recommendation and indications fo f r use; dispensing, including quality and standardization of cultivars or strains, labeling, packaging, and role of the pharmacist or health care profe f ssional in education or administration; and registration of approved patients and providers.
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MEDICINAL CANNABIS: HISTORY, Y PHARMACOLOGY, Y AND IMPLICAT A IONS FOR THE ACUTE CARE SETTING In 2009, U.S. At A torney General Eric Holder recommended that enfo f rcement of fe f deral marijuana law a s not be a priority in states that have enacted medicinal cannabis programs and are enfo f rcing the rules and regulations of such a program; despite this, concerns persist. The argument fo f r or against the use of medicinal cannabis in the acute care setting encompasses both legal and ethical considerations, with the argument against use perhaps seeming obvious on its surfa f ce. States adopting medical cannabis law a s may a advise patients to utilize the therapy only in their own residence and not to transport the substances unless absolutely necessary. y 66 Further,r many acute care institutions hav a e policies prohibiting smoking on ffacility grounds, thus restricting the smoking of cannabis, regardless of purpose or indication. Of note, several Canadian hospitals, including Montreal’s Jewish General Hospital and Quebec’s Centre Hospitalier U Universitaire de Sherbrooke, hav a e permitted inpatient cannabis use via vaporization; the pharmacy departments of the respective institutions control and dispense cannabis much like opioids fo f r pain. Canada has adopted national regulations to control and standardize dried cannabis fo f r medical use.67,68 There are complicated logistics ffor selff administration of medicinal cannabis by the patient or caregiver; in particular, many hospitals have policies on selff administration of medicines that permit patients to use their own medications only aft f er identififcation and labeling by pharmacy personnel. The argument can be made that an herb- or plant-based entity cannot be identifi f ed by pharmacy personnel as is commonly done ffor traditional medicines, although medicinal cannabis dispensed through state programs must be labeled in accordance with state law a s.
The therapy cannot be prescribed, and states may a require phy h sicians authorizing patient use to be registered with local programs. In a transition into the acute care setting fr f om the community setting, a diff fferent clinician who is not registered could be responsible fo f r the patient’s care; that clinician would be restricted in ordering continuation of therapy. y Despite the complexities in the logistics of continuing medicinal cannabis in the acute care setting, proponents of palliative care and continuity of care argue that prohibiting medicinal cannabis use disrupts treatment of chronic and debilitating medical conditions. Patients hav a e been denied this therapy during acute care hospitalizations fo f r reasons 69 stated above. Permission to use medicinal cannabis in the acute care setting may a be dependent on state legislation and restrictions imposed by such law a s. Legislation in Minnesota, as one example, has been amended to permit hospitals as f cilities that can dispense and control cannabis use; similar fa legislative actions protecting nurses fr f om criminal, civil, or disciplinary action when administering medical cannabis to qualififed patients have been enacted in Connecticut and Maine.70–73 Proposed legislation to remove restrictions on the certifi f cation of patients to receive medicinal cannabis by doctors at the Department of Ve V terans Aff ffairs was struck down in June; prohibitions continue on the use of this therapy even in fa f cilities located in states permitting medicinal cannabis use.74
Dispensing and storage concerns, including an evaluation of where and how this product should be stored (e.g., within the pharmacy department and treated as a controlled substance, by security personnel, or with the patient); who should administer it, and implications or violations of f deral law by those administering treatment; what fe pharmaceutical preparations should be permitted (e.g., smoked, vaporized, edible); and how it should be charted in the medical record represent other logistical concerns. Inpatient use of medicinal cannabis also carries implications fo f r nursing and medical staff f members. www.medicalspasreview.com
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REFERENCES
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MEDICINAL CANNABIS: HISTORY, Y PHARMACOLOGY, Y AND IMPLICAT A IONS FOR THE ACUTE CARE SETTING 11. Food and Drug Administration. FDA and marijuana. July 7, 2016. Av A ailable at: www. w fd f a.gov/NewsEv E ents/PublicHealthFocus/ ucm421163.htm. Accessed August 5, 2016. 12. Throckmorton DC. FDA work on medical products containing marijiuana. Food and Drug Administration. March 2015. Av A ailable at: www. w fd f a.gov/downloads/AboutFDA/CentersOff ffices/Off fficeof -MedicalProductsandTo T bacco/CDER/UCM438966.pdf.f Accessed August 5, 2016. 13. Bennett C. Early/ancient history. y In: Holland J, ed. T e Pot Book: A Comp Th m lete t Guide to Cannabis. Rochester, Ve V rmont: Park Street Press; 2010. 14. Zias J, Stark H, Sellgman J, et al. Early medical use of cannabis. Na N ture r 1993;363:215. 15. Malmo-Levine D. Recent history. y In: Holland J, ed. T e Pot Book: A Comp Th m lete t Guide to Cannabis. Rochester, Ve V rmont: Park Street Press; 2010. 16. Musto DF. F The Marihuana Ta T x Act of 1937. Arc r h Gen Ps Psychiatry r 1972;26:101–108. 17. Giancaspro GI, Kim N-C, Ve V nema J, et al. The advisability and fe f asibility of developing USP standards f r medical cannabis. U.S. Pharmacopeial Conv fo n ention. A ailable at: Av www. w usp.org/sites/defa f ult/fifles/usp_pdf/ f EN/USPNF/usp-nf notices/usp_stim_article_ medical_cannabis.pdf.f Accessed August 5, 2016. 18. Cameron JM, Dillinger RJ. Narcotic Control Act. In: Kleiman MAR, Haw a don JE, eds. Ency c clop o edia of o Drug u Policy cy. Thousand Oaks, Califo f rnia: SAGE Publications, Inc.; 2011:543–545. 19. State marijuana law a s in 2016 map. Governing. g November 11, 2016. Av A ailable at: www. w governing.com/gov-data/statemarijuana-law a smap-medical-recreational.html. Accessed November 29, 2016. 20. Sidney S. Comparing cannabis with tobacco–again. BMJ M .2003;327:635–636.
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21. Norml. About marijuana. A ailable at: http://norml.org/aboutmarijuana. Av Accessed August 9, 2016. 22. Clark PA P , Capuzzi K, Fick C. Medical marijuana: medical necessity versus political agenda. M d Sci Mo Me M nit 2011;17:RA249–RA261. 23. National Institute on Drug Ab A use. Drug fa f cts: is marijuana medicine? July 2015. Av A ailable at: www. w drugabuse.gov/publications/drugfa f cts/marijuanamedicine. Accessed February 11, 2016. 24. Should marijiuana be a medical option? ProCon.org. December 28, 2016. Av A ailable at: http://medicalmarijiuana.procon.org. Accessed February 11, 2016. 25. MacDonald K, Pappas K. Why h not pot? Innov Clin Ne N urosci 2016;13:13–22.
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MEDICINAL CANNABIS: HISTORY, Y PHARMACOLOGY, Y AND IMPLICAT A IONS FOR THE ACUTE CARE SETTING 47. Blanco C, Hasin DS,Wa W ll MM, et al. Cannabis use and risk of psychiatric disorders: prospective evidence fr f om a U.S. national longitudinal study. y J MA JA M Ps Psychiatry r 2016;73:388–395. 48. de Graaf R, Radovanovic M, van Laar M, et al. Early cannabis use and estimated risk of later onset of depression spells: Epidemiologic evidence fr f om the population-based W rld Health Organization Wo Wo W rld Mental Health Survey Initiative. Am J Ep E idemiol 2010;172:149–159. 49. Hackam DG. Cannabis and stroke: systematic appraisal of case reports. Stroke 2015;46:852–856. 50. Barber PA P , Pridmore HM, Krishnamurthy h V, V et al. Cannabis, ischemic stroke, and transient ischemic attack: a case-control study. y Stroke 2013;44:2327–2329. 51. Barber PA P , Roberts S, Spriggs DA, et al. Adverse cardiovascular, cerebrovascular, and peripheral vascular eff ffects of marijuana: what cardiologists need to know. w Am J Card r iol 2014;113:1086. 52. Karila L, Roux P, P Rolland B, et al. Acute and long-term eff ffects of cannabis use: a review. w Curr Pharm Des 2014;20:4112–4118. 53. Tu T rcotte D, Le Dorze JA, Esfa f hani F, F et al. Examining the roles of cannabinoids in pain and other therapeutic indications: a review. w Expert Op Ex O in Pharmacoth t er 2010;11:17–31. 54. Wa W ng T, T Collet JP, P Shapiro S, Wa W re MA. Adverse eff ffects of medical cannabinoids: a systematic review. w CMAJ 2008;178:1669–1678. CM
58. American Academy of Neurology. y Eff fficacy and safe f ty of the therapeutic use of medical marijiuana (cannabis) in selected neurologic disorders. Av A ailable at: www. w aan.com/Guidelines/home/GetGuidelineContent/651. Accessed Au A gust 16, 2016. 59. van den Elsen GA, Ahmed AI, Lammers M, et al. Eff fficacy and safe f ty of medical cannabinoids in older subjects: a systematic review. w Age g ing n Res Rev 2014;14:56– 64. 60. Marijiuana Policy Project. State-by-state medical marijuana law a s 2015. Av A ailable at: www. w mpp.org/issues/medical-marijuana/stateby- statemedical-marijuana-law a s/state-by-state-medicalmarijuanalaw a s- report. Accessed August 10, 2016. 61. 25 legal medical marijiuana states and DC: law a s, fe f es, and possession limits. Av A ailable at: http://medicalmarijuana.procon.org/view. w resource.php?re sourceID=000881#DC. Accessed August 10, 2016. 62. Cole JM. Guidance regarding marijuana enfo f rcement. August 29, 2013. w justice.gov/iso/opa/resources/ A ailable at: www. Av 3052013829132756857467.pdf.f Accessed August 8, 2016. 63. DEA Diversion Control Division. DEA Form 225— New application fo f r registration. Av A ailable at: www. w deadiversion.usdoj.gov/drugreg/reg_apps/225/225_instruc t.htm. Accessed August 10, 2016.
55. Ly L nch ME, Campbell F. F Cannabinoids fo f r treatment of chronic noncancer pain: a systematic review of randomized trials. Br J Clin Pharmacol 2011;72:735–744. 56. Smith LA, Azariah F, F Lav a ender VTC, et al. Cannabinoids f r nausea and vomiting in adults with cancer receiving fo chemotherapy. y Cochrane Database Sy Syst Rev 2015 Nov 12;(11):CD009464. 57. Gloss D, Vickrey B. Cannabinoids fo f r epilepsy. y Cochrane Database Sy Syst Rev 2014 Mar 5;(3):CD009270.
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Sex & Marijuana
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Brand Design
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MOST MEDICAL SPA PATIENTS ARE PLEASANT PEOPLE
Legal Headaches
THE LEGALITIES OF PROBLEMATIC PATIENTS By ALEX R. THIERSCH
Alex R. Thiersch is the founder and director
Developing strong relationships with loyal clients can be one of the most rewarding aspects
of the American Med Spa
of being in the medical aesthetics business. Most prospective and ongoing clients of
Association (AmSpa), an
medical
organization created for
spas
are
likely
to
be
perfectly
pleasant
people
who
have
reasonable expectations of the results of treatment. At some point, however, you will almost
the express purpose of providing comprehensive,
certainly encounter the problem patient. This can be a person who has
relevant and timely
unrealistic expectations, and is guaranteed to be disappointed and upset with the results of
legal and business
treatment. Or, it may simply be someone whose demands are too much for you or your
resources for the medical
practice. The unfortunate reality of today’s society is that, whether by complaining to
aesthetic industry
regulatory authorities or posting negative comments on social media, it is within that
throughout the United States.
person’s power to make your life difficult. This article offers several suggestions in regard to
For more information
avoiding problematic patients, dealing with them when they appear, maintaining your
about becoming a member,
medical spa’s good reputation, and saving yourself from potential legal headaches.
log on to www.americanmedspa.org
THE NATURE OF THE BEAST
M
edical spa owners and operators, and physicians who offer medical aesthetic services in their practice, face unique challenges due to the nature of their
business. “Because patients are paying out of their own pockets for services, in contrast to using insurance benefits as with most health-related services, they often feel a heightened sense of entitlement,” says Harry Nelson, co-founder and managing partner of Nelson Hardiman, a California-based health care law firm. “The patient population is much more demanding than the typical patient in a managed care or nsurance-based setting. They are spending their own
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money, not the insurance company’s, and they expect a high level of service and accommodation. As a result, there’s a greater risk of the relationship ending badly, and the patient being offended if the provider terminates a relationship in a medical spa context. You’re simply dealing with a more incendiary population of patients who are much more likely to make complaints to medical boards, become litigious and use social media against you,” explains Nelson. Disgruntled patients are an unfortunate part of the industry. In many cases, the underlying grievance can be resolved; however, in some cases, difficult patients simply cannot be reasoned with and are committed to being—and trying to make you—miserable. • MEDI CAL SPAS REVIEW
Alex can be contacted at alex@americanmedspa.org
americanmedspa.org
MEDI CAL SPAS
Legal Headaches
americanmedspa.org
SOME PATIENT’S POWER MAKE YOUR LIFE DIFFICULT “Because the nature of medical aesthetics services is to help people with their outward appearance, you have a small subset of people who have serious mental health issues related to their appearance, and who are fundamentally unhappy and have unrealistic expectations,” says Nelson. “In some cases, the underlying reason the patient is drawn to medical spas relates to a broad dissatisfaction that permeates their lives. In one case, we had a client—a physician—who told a patient that he didn’t think she was a good candidate, and she responded angrily by telling the doctor, ‘How can you tell when you yourself are so sleepy? Since it’s only10 am in the morning, I’m guessing you have some kind of drug problem.’ She literally filed a complaint with the medical board against the doctor suggesting to the board that he had a substance abuse problem, and made the same complaint on social media sites.” As silly as a situation like this might seem, patient complaints to medical boards are no laughing matter. Even if such a claim is ultimately unsuccessful and eventually dismissed, physicians still must take the time to hire a lawyer and spend the money to defend themselves against it. In some cases, complaints can require an interview and come to the attention of employees, other patients or colleagues. And even if physicians are cleared of professional misconduct, their businesses can still be harmed by a disgruntled ex-client. “Cosmetic patients are uniquely likely to vent online in ways that can be professionally damaging using various doctor-rating websites or sites such as Yelp,” says Nelson. “I’ve had a number of clients who have had their professional reputations badly damaged by troubled or difficult patients from medical spas.”
confront issues concerning disgruntled people is to make sure that you don’t associate with them in the first place. “The key is to identify potential problem patients early on and figure out how to reroute them away from your practice without offending them,” states Nelson. “It’s critical that frontline employees who are dealing with prospective patients need to be trained to screen for red flags, such as patients who vent frustrations about previous doctors and patients who have unrealistic expectations about changes in their appearance. It’s essential to limit your practice to people who have realistic expectations, who are appreciative, and who listen to and follow advice. If you only listen to people up front, they’ll tell you everything you need to know.” It is also important that medical spas and aesthetic practices explain their policies as explicitly as possible. Each medical spa or practice should team with an attorney to produce a contract that clearly presents the conditions under which a service will be provided for patients to sign prior to the administration of any procedures. Although complaints to government agencies are unpreventable, contracts can be potentially effective, depending on the jurisdiction, in conditioning service on not posting negative statements online. “Patients need to understand the expectations of the medical spa or practices,” says Nelson.“These include: • Patients who are disrespectful in terms of not showing up for appointments; • Patients who don’t adhere to instructions for preoperative treatment; • Patients who make threats or are disruptive in the office; and, • Patients who don’t pay.
PROPER PRIOR PLANNING Ideally, a medical spa that screens patients carefully can minimize its exposure to problematic patients. It stands to reason that the best way to avoid having to MEDI CAL SPAS REVIEW •
“It’s critical that medical spas and medical aesthetic pracitces are very clear with their patients about what the expectations are and to actually enforce them.” www.medicalspasreview.com
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AVOID PROBLEMATIC PATIENTS–DEAL WITH THEM WHEN THEY APPEAR Medical spas, medical aesthetic practices and their employees can also prepare themselves for the possibility of problem patients by making sure that their insurance policies contain provisions that can help to protect them from spurious legal action. “If a complaint is filed against a person and a governing board or body conducts an investigation, many malpractice policies will include a provision referred to as administrative defense or disciplinary proceedings coverage,” says David Shaffer, vice president of Professional Medical, the health care division of Insurance Office of America.“This coverage provides an insured with reimbursement for the costs they incur during an investigation. The amount of coverage varies by insurer, but it typically ranges from $5,000 to $25,000.” An aesthetics practice would need to review their policy and consult with their insurer and/or broker to determine if this coverage is being extended by their policy. Medical aesthetic professionals can also purchase targeted coverage that can help to protect them against unwarranted social media attacks. According to Shaffer, “Although stand-alone reputational harm insurance policies do now exist to help combat attacks to your reputation, these policies seem to be geared toward larger, Fortune 500 organizations. For the aesthetics industry, locating such a policy could be a daunting and costly task.” However, those AmSpa members who have taken advantage of the AmSpa Medical Spa Insurance Program are already being provided with some reputational harm protection. “One of the perks built into the AmSpa Medical Spa Insurance Program is a $15,000 sub-limit for reputational harm claims,” explains Shaffer. “When coverage is triggered by an adverse media event, such as a detrimental comment published by a disgruntled patient or another non-insured third party, a consultant is made available to help an insured perform the necessary steps to rebuild their reputation.”
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It is important to note that the AmSpa Program’s reputational harm coverage can only be triggered when there is a malpractice or general liability claim—assuming general liability is being provided through the AmSpa Program policy—filed in conjunction with the reputational harm claim. “Some insurers who offer cyber liability insurance have also begun to incorporate sub-limits for reputational harm, as well. Like the AmSpa Medical Spa Insurance Program, there needs to be an accompanying cyber liability claim associated before coverage will apply.” (Author’s note: The AmSpa Medical Spa Insurance Program is one of the many benefits available to AmSpa members. Learn more and become a member at www.americanmedspa.org) Even with some insurance options available, your best defense is to avoid treating patients such as these.
EXPRESSING EMPATHY Even if you implement strict upfront screening practices, and provide explicit terms and conditions for your services that protect your medical spa or practice, you may still find yourself with a patient with whom you feel you need to part ways. If this happens, make sure that the patient understands that you feel you are working in his or her best interests. “The key is to try to handle the process as gently as possible, so that patients don’t leave so agitated that they want to keep their grievance alive,” says Nelson. “It’s important to convey regret that you’re unable to treat the patient and to let the patient know that you wish them the best. It’s ideal to recommend alternatives to them, and I think it’s better to do it in person and to do it informally.You should try to be an active listener and to be firm in your decision, but sincere in saying that you’re sorry that it came to this. There is evidence that, if doctors are empathetic in how they terminate patients, they’re much less likely to encounter the type of destructive, angry behavior that is sometimes seen.” I • MEDI CAL SPAS REVIEW
Legal Headaches
americanmedspa.org
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MEDI CAL SPAS
21ST CENTURY CONSUMERS ARE ON A HEALTH KICK
THE WELLNESS CHALLENGE
THE WELLNESS INDUSTRY HAS REACHED A MIND-BOGGLING $3.7 TRILLION WORLDWIDE. ARE YOU IN OR OUT? By
VIVIENNE O’KEEFFE
Wellness
VIVIENNE O’KEEFFE, AAD, PEA, CIBTAC, is President of Spa Profits Consulting Inc., and an expert in designing successful spa concepts. She is also an international consultant in developing product lines, treatment plans and training programs, a member of ISPA and Spa Industry Association of Canada (for which she won an Outstanding Service Award in 2012),
I
t might be the best thing since sliced (organic) bread.
wellness movement. Your choice – to climb aboard or be
After decades of indulging in Twinkies and
swept aside – will have a profound impact on the fate of
three-martini lunches, first world consumers are
your spa business.
International Management Consultants Inc.
www.spaprofits.com
suddenly on a health kick. I have just returned from a most impressive Global Wellness And it’s not just about diet. Demands for filtered water and
Summit in Kitzbühel, Austria, an invitation-only gathering
air, yoga and TM classes and even wristwatches that record
of wellness industry providers put on by the Global Wellness
your heart rate and sleep patterns are part of a
Institute (GWI), and was privileged to come away with what
tsunami-sized shakeup we will loosely describe as the
I believe is a glimpse at the future of the spa industry.
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and a member of
• MEDI CAL SPAS REVIEW
MEDI CAL SPAS
Wellness
IT IS NOT JUST ABOUT DIET The traditional spa is about to get a giant makeover. Instead
The irrefutable need for wellness is evident in the alarming
of a place for the occasional massage, pedicure or facial, it’s
spread of such modern ailments as obesity, depression and
poised to become a refuge from the noise and stress of
diabetes. People around the world suffering from higher
technology, traffic and crammed schedules. Armed with
stress and chronic disease are turning to wellness to
mounting evidence linking general wellness to improved
maintain and improve their health. Just as people have
disease prevention, happiness, and longevity – brought
largely rejected smoking, consumers are increasingly
about by factors including healthier eating, better sleep,
spurning chemical additives, sugar, poor-quality sleep and
meditation and spirituality – the spa could experience a
other evils in favour of healthier physical and spiritual
consumer-driven convergence of suppliers – a melding of
living.
traditional skills incorporating aspects of the traditional gym, doctor’s office and drug store.
In his hour-long keynote speech at last year’s GWI summit in Mexico City, internationally acclaimed physician, guru
The trend is well under way. According to the GWI’s
and author Deepak Chopra talked about an exploding area
numbers, while the world economy shrank by 3.6% in the
of modern medical research: epigenetics – the body’s
years 2013-2015, the wellness industry in all its forms grew
amazing ability to literally respond and adapt to external
by an astounding 10.6%. The most active areas were:
forces in a way that strengthens it against disease and degeneration. The epigenome – the body’s chemical record
1) Preventative/personalized medicine and public health (+23.5%),
of changes to DNA and histone proteins – is like a light switch and thermostat that regulates the body.
2) Fitness and mind-body (+21.4%) 3) Wellness lifestyle real estate (+18.6%)
“We can prevent most chronic illnesses and even reverse a
4) Wellness tourism (+14%)
lot of diseases,” Chopra told a rapt audience.
5) Healthy eating, nutrition and weight loss (+12.8%).
MEDI CAL SPAS REVIEW •
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MEDI CAL SPAS
IT IS A WELLNESS MOVEMENT SHAKE UP In her book The Hunger Fix, American MD Pamela
These services will be but one component of a paradigm
Peeke says effective epigenetic management can
shift – from the concept of the spa as a mere location to the
produce powerful outcomes anytime, even before birth.
spa as a department store stocked with a panoply of
In lab tests, supplementing the diets of overweight,
wellness products and services.
yellow-colored mice called agouti with healthy substances like vitamin B12 and folic acid caused the
I believe educated and evolving consumers will inevitably
epigenetic controllers in their foetuses to spawn
cast aside the many culprits in our disease-ridden society –
completely normal babies – lean, brown and
chemical-laced processed food, sedentary lifestyles, sleep
disease-free. The histones – proteins surrounding
deprivation and addictions to devices, to name a few – in
genes that tell them how to behave – can themselves be
favour of a new commitment to healthier physical and
managed by healthier actions to deliver more beneficial
spiritual living. I see no reason why spas – particularly
instructions to the genes via a process called
medical spas – can’t be major deliverers of these new types
methylation, where methyl groups are added to DNA.
of services.
It’s complicated biochemistry, but the results are plain to
The GWI apparently agrees. Says GWI’s senior research
see: ditching bad habits for good habits can make
fellow Ophelia Yeung: “We predict that consumers,
permanent improvements in our future genetic makeup –
governments and employers will continue to spend big on
meaning we are no longer prisoners of the genes we were
wellness because of these megatrends: an emerging global
born with. This and other equally astounding discoveries
middle class, a rapidly aging world population, a chronic
are dramatically changing the strategies that societies and
disease and stress epidemic, the failure of the ‘sick-care’
individuals will be using to deal with their health issues.
medical model (resulting in uncontrollable healthcare costs), and a growing subset of (more affluent, educated)
The more science unravels the incredible mysteries of
consumers seeking experiences rooted in meaning,
epigenetics, the greater will be the need for carefully
purpose, authenticity and nature.
structured, epigenetics-based dietary and lifestyle therapy.
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• MEDI CAL SPAS REVIEW
Wellness
MEDI CAL SPAS
Wellness
TRADITIONAL SPA IS ABOUT TO GET A GIANT MAKEOVER “As people around the world suffer from higher stress and
“The staffing crisis gets bigger every year, making it harder
chronic disease, they are turning to wellness approaches to
to recruit and retain qualified, motivated spa managers and
maintain and improve their health,” she says. “Wellness is
directors,” he warns. “As savvy clients request more
preventive; it relies on individual responsibility to integrate
therapists trained in high touch and wellness modalities,
a holistic health paradigm into everyday life – how we live,
we need to attract more talents and offer careers, not simply
eat, work, play, travel, maintain vitality, deal with stress, and
9 to 5 jobs. Exciting compensation plans, better incentives
respond to the first signs of illness.”
and advanced training programs are essential to retain the best people and help them thrive and flourish into Spa and
In the GWI’s Wellness Economy Report coming out next
Wellness therapists. This new breed of professionals can
January, to which the conference attendees were treated to a
lead more loyal clients into transformational experiences
sneak preview, Yeung and fellow GWI researcher Katherine
and programs.”
Johnston project the spa industry will grow over the next 5 years by an estimated 2.8 million persons (1 million in
Wellness is changing the way buildings and even whole
Asia-Pacific, 950,000 in Europe and 540,000 in North
communities are designed. Wellness-themed resorts and
America), with an additional 400,000 trained therapists
retirement communities springing up in the UK, Australia,
and 70,000 experienced spa managers/directors needed by
China, Malaysia, Dubai, the Yucatan, Canada, the U.S. and
2020.
other countries come with features like eco-friendly materials and energy use, community gardens, fitness and
With wellness sectors already representing a $3.7 trillion
aquatic centers, spa and medical facilities and social areas
economy, the demand for services is outpacing their supply.
where neighbors can meet and greet.
Jean-Guy de Gabriac, founder of Tip Touch and Chairman of GWI’s Global Career Development initiative, says spas will require an additional 400,000 trained therapists and 70,000 experienced managers/directors by 2020.
MEDI CAL SPAS REVIEW •
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MEDI CAL SPAS
WELLNESS & MEDICAL WILL TAKEOVER
Wellness
ACCORDING TO THE GLOBAL WELLNESS INSTITUTE, THE SPA INDUSTRY ACCOUNTED FOR 2.7% OF THE WORLD WELLNESS ECONOMY IN 2018. SPA CONSULTANT AND THERAPEUTIC PROGRAM DESIGNER VIVIENNE O’KEEFFE THINKS THAT FIGURE COULD BE MUCH HIGHER.
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• MEDI CAL SPAS REVIEW
MEDI CAL SPAS
Wellness
SPA OF THE FUTURE: GYM - CLINIC - PHARMACY In downtown Toronto, the newly renovated offices of the TD
A second –‘gamification’ – will bring more adult play into
Bank are the first in the world to be WELL Certified™
the workplace to foster a healthier work environment and to
(under v1 of the WELL Building Standard™ as applied to
attract more dedicated, socially aware employees. The third
new and existing interiors). The facility promotes health
is eco-consciousness: authentically and holistically
and wellness by including more than 60 WELL features in
leveraging the value proposition of a product or service,
its design, including optimal lighting, enhanced water and
taking into account where it is produced, how it is sourced,
air filtration, vending machines that dispense nutritious
who builds it, how it is shipped, and how it is disposed of. In
items, custom-designed, more ergonomic chairs and desks,
other words, giving back more to the environment than you
and something called a tranquility lounge.
take out.
It's easy to get so absorbed in the details of your business
As Yeung asserts, there’s a lot people can do on their own to
that you completely lose track of the big picture. The big
benefit from new advances in wellness – but also a huge
picture, in this case, consists of the global trends that will
role for spas to fill. I believe it is imperative for us as an
affect every entrepreneur – no matter how far removed
industry to recruit talented individuals who can take up the
from them, or how 'safe' your company seems to be. In a
torch and walk forward to enlighten and empower
speech at New York University's Women Entrepreneurs
themselves and our valued patients with the knowledge of
Festival, trend consultant Erica Orange of The Future
the power we hold within ourselves.
Hunters corporate think tank identified no fewer than three wellness-related movements in her top 10 themes affecting
In their quest to strengthen their personal five pillars of
business in the future. One is design, which will evolve from
wellness – sleep, meditation, movement, emotions and
merely "good" or "bad" to design that is (or is not)
nutrition – customers will be clamoring for services far
considered age-friendly, female-friendly, cultural, or
beyond traditional treatments.
sustainable. And they’ll go where they have to get them. Will that place be your spa?
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PRIVATE LABEL AVAILABLE
info@shiraesthetics.com | www.shiraesthetics.com | Toll-Free 1.800.957.4472
INTRODUCING A NEW, NON-OPIOID PAIN SOLUTION:
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The report “World Analgesics Market - Opportunities and Forecasts, 2015-2022” projects that the world analgesics market would reach $26.4 billion by 20221. Pain sufferers have long regarded plant botanicals as a source of healing; there are more than 100 plants known to have pain relieving properties2. Consumers have sought retail brands of topical pain relief with menthol as an active ingredient3. There is a “new” botanical that consumers need to be aware of for pain relief: cannabidiol. In a study published by the National Institutes of Health4, it is stated that, “The nonpsychoactive cannabinoid, cannabidiol (CBD), has great potential for the treatment of chronic and 'breakthrough’ pain.” The study also states, “Chronic pain relief can be best achieved through the transdermal route.” Today, the United States faces a health epidemic: prescription opioid addiction. To address this problem, manufacturers are producing a new topical combination of CBD with menthol. These non-habit forming ingredients are a welcome solution for consumers who do not wish to pursue prescription opioid pain medications or are looking for an alternative to prescription pain medicine. The irony is that CBD is anything but “new”. CBD is a naturally occurring component of the hemp plant. Hemp is from the cannabis genus and cannabis for medicinal use dates back to the ancient Chinese emperor, Shen-Nung (c.2700 B.C.). Having compiled the medical encyclopedia called, Pen Ts'ao,5 Shen-Nung is regarded as the Father of Chinese Medicine. Cannabis or “Ma”was used by the Chinese to treat weaknesses (menstruation), gout, rheumatism, malaria, beri-beri, constipation, and absentmindedness. During the second century A.D., the Chinese surgeon, Hua T'o, began to use cannabis as an anesthesia. CBD is activated in the body through CB2 receptors located in the skin. CB2 receptors play a role in antinociception, or the relief of pain.6 Menthol is a known active ingredient with cooling properties. Working similar to ice, menthol binds with temperature-sensitive receptors in the skin and is thought to modulate pain signals within the body’s natural pain relieving systems. CBD, known to be hydrophobic and lipophilic, does not dissolve or emulsify readily in water, but will dissolve in fat. Bioavailability of CBD depends on the way that the cannabinoid is delivered into the human body. Today, science has enabled CBD to be water soluble as well as time-release. The new topical pain cream, RapidCBD™, delivers a powerful combination of micro-encapsulated time-released CBD called Cebidiol™. In Cebidiol™, consumers will benefit from menthol plus eight additional homeopathic ingredients including lavender and rosemary essential oils to relieve pain. The RapidCBD™ Cooling Pain Cream is ideal after strenuous activity and has been proven to be as effective and work as fast as an FDA approved OTC topical pain relief solution. The immediate availability of RapidCBD™ is welcome news for consumers who are seeking a non-opioid solution for muscle aches, strains and joint pain. 1 -http://www.prnewswire.com/news-releases/analgesics-market-is-expected-to-reach-264-billion-globally-by-2022-575688921.html 2 -http://www.motherearthliving.com/health-and-wellness/the-best-herbs-for-pain-relief.aspx 3 -http://health.usnews.com/health-products/top-rec-topical-analgesics-arthritis-joint-pain-135 4 -http://www.ncbi.nlm.nih.gov/pubmed/20545522 5 -https://www.psychologytoday.com/blog/the-teenage-mind/201105/history-cannabis-in-ancient-china 6 -https://en.wikipedia.org/wiki/Cannabinoid_receptor
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