trends in tobacco use 1990

Volume 90 No. 6 June 2007

�Risk Management

169VOLUME 90 NO. 6 JUNE 2007

Medicine and Health/Rhode Island (USPS 464-820), a monthly publication, is owned and published by the Rhode Island Medical Society, 235Promenade St., Suite 500, Providence, RI 02908, Phone: (401) 331-3207. Single copies $5.00, individual subscriptions $50.00 per year, and $100per year for institutional subscriptions. Published articles represent opinions of the authors and do not necessarily reflect the official policy of the Rhode IslandMedical Society, unless clearly specified. Advertisements do not imply sponsorship or endorsement by the Rhode Island Medical Society. Periodicals postagepaid at Providence, Rhode Island. ISSN 1086-5462. POSTMASTER: Send address changes to Medicine and Health/Rhode Island, 235 Promenade St.,Suite 500, Providence, RI 02908. Classified Information: RI Medical Journal Marketing Department, P.O. Box 91055, Johnston, RI 02919,phone: (401) 383-4711, fax: (401) 383-4477, e-mail: [email protected]. Production/Layout Design: John Teehan, e-mail: [email protected].

UNDER THE JOINTEDITORIAL SPONSORSHIP OF:

The Warren Alpert Medical School ofBrown UniversityEli Y. Adashi, MD, Dean of Medicine& Biological Science

Rhode Island Department of HealthDavid R. Gifford, MD, MPH, Director

Quality Partners of Rhode IslandRichard W. Besdine, MD, ChiefMedical Officer

Rhode Island Medical SocietyBarry W. Wall, MD, President

EDITORIAL STAFFJoseph H. Friedman, MD

Editor-in-ChiefJoan M. Retsinas, PhD

Managing EditorStanley M. Aronson, MD, MPH

Editor Emeritus

EDITORIAL BOARDStanley M. Aronson, MD, MPHJay S. Buechner, PhDJohn J. Cronan, MDJames P. Crowley, MDEdward R. Feller, MDJohn P. Fulton, PhDPeter A. Hollmann, MDSharon L. Marable, MD, MPHAnthony E. Mega, MDMarguerite A. Neill, MDFrank J. Schaberg, Jr., MDLawrence W. Vernaglia, JD, MPHNewell E. Warde, PhD

OFFICERSBarry W. Wall, MD

PresidentK. Nicholas Tsiongas, MD, MPH

President-ElectDiane R. Siedlecki, MD

Vice PresidentMargaret A. Sun, MD

SecretaryMark S. Ridlen, MD

TreasurerKathleen Fitzgerald, MD

Immediate Past President

DISTRICT & COUNTY PRESIDENTSGeoffrey R. Hamilton, MD

Bristol County Medical SocietyHerbert J. Brennan, DO

Kent County Medical SocietyRafael E. Padilla, MD

Pawtucket Medical AssociationPatrick J. Sweeney, MD, MPH, PhD

Providence Medical AssociationNitin S. Damle, MD

Washington County Medical SocietyJacques L. Bonnet-Eymard, MD

Woonsocket District Medical Society

RHODE ISLANDPUBLICATION OF THE RHODE ISLAND MEDICAL SOCIETY

Medicine � Health VOLUME 90 NO. 6 June 2007

COMMENTARIES

170 “…But I can still sue you, can’t I?”Joseph H. Friedman, MD

171 A Brief Chronicle of AppendicitisStanley M. Aronson, MD

CONTRIBUTIONS

SPECIAL ISSUE: Risk ManagementGuest Editors: Patricia R. Recupero, JD, MD, and Lawrence W. Vernaglia, JD, MPH

172 Risk Management: IntroductionPatricia R. Recupero, JD, MD, and Lawrence W. Vernaglia, JD, MPH

173 Websites and E-mail In Medical Practice: Suggestions for Risk ManagementPatricia R. Recupero, JD, MD, and Samara E. Rainey

178 Dangers of Self-Prescribing and Prescribing for Family MembersMarilyn Price, MD, and Bruce W. McIntyre, JD

182 Patient Safety Efforts Target Communication at Rhode Island HospitalsMelinda Morin, MD

187 Rhode Island Supreme Court Affirms Limited Nature of Peer-Review PrivilegeLawrence M. Kraus, JD, and Lawrence W. Vernaglia, JD, MPH

COLUMNS

189 HEALTH BY NUMBERS – Trends In Tobacco Use (1990-2006) and Patterns of TobaccoUse Among Rhode Island Adults in 2006Jana Hesser, PhD, Yongwen Jiang, PhD, and Seema Dixit, MS, MPH

191 ADVANCES IN PHARMACOLOGY – Atypical Antipsychotics for the Treatment ofDementia-Related Behaviors: An UpdateLori A. Daiello, PharmD

195 GERIATRICS FOR THE PRACTICING PHYSICIAN – The Management of Insomnia in theOlder AdultAna C. Tuya, MD

197 IMAGES IN MEDICINE – Ocular MelanomaIkue Shimizu, MD, Richard Gold, MD, and Edward Feller, MD

198 PHYSICIAN’S LEXICON – The Vocabulary of Pathogenic BacteriaStanley M. Aronson, MD

198 Vital Statistics

200 June Heritage

Cover: “Birch Tree,” linoleum and hand-stamped print #2/5, by Gina M. Dimitri.Ms. Dimitri exhibited at The State of Artin RI (2005) and won Honorable Mentionin the Annual Juried Student Exhibition atURI (2005). She specializes in costume jew-elry design, acrylic and fabric print design,ceramics, faux finishing and printmaking.E-mail: [email protected].

170MEDICINE & HEALTH/RHODE ISLAND

gling, chest pain and shortness of breath.He had the unfortunate concurrence ofsevere psychiatric and neurological diag-noses, one interfering with the other. Pa-tients with personality disorders sufferfrom these difficulties all the time. Theirpersonalities make them untreatable.

When mentally ill patients seek treat-ment, their mental illness sets the stagefor treatment options. In the case of aparanoid person, since the paranoia is ir-rational, one can’t convince a patient, onecan only hope that the psychiatrist willeventually control the problem so that themedical illness can be treated. This is, ofcourse, a paradox for advocates for thementally ill, the reluctance to force treat-ment in someone who is legally compe-tent but clearly, by choosing to not treatan illness, endures severe and long-termsuffering. Witness the mentally ill home-less who choose no treatment over a stable,physically comfortable life.

In the case of Mr X, one of life’smiracles occurred. I lost track of him (butthat was not the miracle), until a few yearslater when my secretary received a call.“This is Mr X. Please tell Dr Friedmanthat I got put on clozapine when theFDA approved it. My movement disor-der went away and my schizophrenia gotbetter too. I got my life together. Tell himthat I thank him for trying to help me.”

Would all life’s stories end so well.Although a true story, it remains apocry-phal as well. You never know what yournext “problem patient” may metamor-phose into.

– JOSEPH H. FRIEDMAN, MD

“…But I can still sue you, can’t I?”�

Commentaries

“Sure you can. This is America. Any-one can sue anyone else. But you couldn’twin. I’m doing you a favor.”

“If I can’t sue you, then I won’t take it.”

Mr X was a 35 year-old man in a veryunfortunate situation. I met him in theforensic unit of the state hospital. He hadbeen arrested after he stabbed a close rela-tive because he thought the relative wasinvolved with his girl friend. Since thepatient suffered from paranoid schizo-phrenia, I had no idea whether this wasa real concern or not, but it hardly mat-tered. To get transferred from the jail tothe Institute of Mental Health requireda severe degree of mental illness.

I was evaluating Mr X because of asevere movement disorder induced by hisantipsychotic medication. The medica-tion he required to control his paranoiahad caused tardive dystonia (TD). Withthe drugs available to treat his psychosisat the time this occurred, TD was notuncommon, and all had the potential forcausing the problem. In most cases, theTD was so mild that it was not even no-ticed by the patient. In cases where it wasnoticed it was not usually disabling, buton rare occasion it was. The tardive dys-tonia was, in fact, disabling for Mr X. Hehad involuntary spasms that caused himto look up at the ceiling, grimace violentlyand close his eyes. The spasms occurredabout every 10 seconds or so. He was aliving figure from a Breughel painting.

As a result of this disorder he hadsued his doctors. Since he was on Medic-aid, his options for doctors were even morelimited than the choices his doctors hadfor treating him. His doctors had quitegenerously arranged for him to be treatedat a different mental health center so asto avoid the conflicts of treating a patientwho was suing his treating physicians.

At the time that I met him therewere no good treatment options. Treat

the psychosis and make the movementdisorder worse, or don’t treat the psychosisand hope that the movement disorderresolved. I, however, had a compassion-ate use protocol for clozapine, not yetapproved by the FDA, an antipsychoticmore effective than any other, and com-pletely free of movement disorder sideeffects, a drug that might treat the psy-chosis without worsening the TD. But itwas considered experimental in the1980s and required informed consent.Obviously a patient in the forensic unitis incapable, by definition, of providinginformed consent.

I told Mr X to see me in my outpa-tient office after discharge so he could betreated with clozapine. When he showedup, he was better than he had been, psy-chiatrically, but still a long ways fromnormal. His facial and neck spasms werepainful to watch. When we discussed theadvantages of the drug he was quiet. “Butwhat about the side effects?”

There used to be a “problem patientclinic” at Rhode Island Hospital. It was forpatients who complained a lot, and didn’thave identifiable medical problems to ex-plain their symptoms. Or they had an or-ganic disorder but uncontrollable symp-toms. I’m unsure if the “problem” part ofthe “problem-patient” was the problem ofthe patient or the problem caused by thepatient. A somatoform disorder clinic, if youwill. A lot of smoke, not much fire.

There are lots of types of problempatients. A famous article in the NewEngland Journal of Medicine many yearsago was entitled, The Hateful Patient.There are hateful patients, ungratefulpatients, demanding patients, drug- seek-ing patients, hopelessly depressed pa-tients. Mr X was not a hateful patient.He was not seeking drugs and he wasn’tdepressed. He did not have a somatoformdisorder, complaining of dizziness, backpain, headache, nausea, diarrhea, tin-


A Brief Chronicle of Appendicitis�

Ehrich Weiss was born on March 24, 1871, inBudapest, Hungary, one of seven Weiss children. His fa-ther, a rabbi, was recruited by a congregation in Appleton,Wisconsin; and so, in 1889, the family left Europe andmigrated to the American Midwest. Ehrich, called Harryby his family, was short, five feet and five inches, but oth-erwise physically active with a love of sports and a fasci-nation for traveling circuses. When the family moved toNew York City, a youthful Ehrich worked briefly as alocksmith’s apprentice; and in his free time he sought em-ployment as a trapeze-artist with one of the local circuses.

In 1892, at age 21, Ehrich Weiss, declared himself to be amagician and, accordingly, changed his name to Harry Houdiniafter the renown 19th Century French magician, Jean Robert-Houdin.

Houdini’s career blossomed, particularly because of hisinventive escape acts, freeing himself from jails, chains, hand-cuffs, straitjackets and even from locked, water-filled tanks.

By 1914 Houdini had reached the pinnacle of his careeras an illusionist and escape artist, performing to enthusiasticaudiences throughout Europe and North America. He nowadded two parallel vocations: He shared his prestidigitationalsecrets with both the British and American Secret Services dur-ing the first World War; and, by 1920, he invested his energiesand resources in debunking so-called psychics and mentalists.This pursuit cost him the friendship of Arthur Conan Doyle,who was an implacable believer in spiritualism.

Houdini’s final performance took place in Detroit’sGarrick Theater on October 24, 1926. After a strenuous per-formance he retired to his dressing room couch. A student fromMcGill University, J. Gordon Whitehead, entered and askedHoudini if it was true that his abdominal muscles were strongenough to withstand blows of a human fist. Without waitingfor a reply, Whitehead struck Houdini’s abdomen repeatedlywith his fists until others restrained him. On the following dayHoudini complained of nausea and abdominal pain. He soughtadmission to Grace Hospital. A diagnosis of appendicitis wasmade and surgery revealed an inflamed, ruptured appendix.Peritonitis developed and Houdini died on the afternoon ofOctober 31 [Halloween], 1926. He was 52 years old. Mostphysicians declared that the blows to his abdomen played littleif any role in his encounter with appendicitis.

During the last few centuries, appendicitis [inflammationof the appendix] has been a common occurrence. In the UnitedStates, the lifetime risk of developing acute appendicitis is about8.6% in males and 6.7% in females. Thus approximately onein 400 Americans develops appendicitis each year with a totalof close to 700,000 Americans who are its annual victims. Fewerthan 400 per year, however, die of the disease.

The human appendix, a vestigial structure with no knowncurrent function, is an inconspicuous worm-like extension ofthe ascending segment of the large intestine. It is rarely morethan three inches in length. And while the appendix was clearlyillustrated in the anatomical drawings of da Vinci [1492] andin the anatomy texts of Vesalius [published in 1543], the struc-ture was not specifically named in any anatomy publicationuntil the writings of the Italian anatomist, Berengario Da Carpiin 1521.

The first clinical recognition of disease of the appendix isassigned to an 1812 scientific paper written by a London phy-sician, James Parkinson [1755 - 1824], who described a fiveyear-old boy suffering from acute abdominal pain associatedwith nausea. The child died within two days of the onset of thepains. An autopsy disclosed intense inflammation confined tothe appendix and Parkinson coined the word appendicitis togive the disease an identity. This was the same physician whowrote extensively on the need for democratic reform in En-gland [he was charged with high treason by King George III].He also published extensively on geology, paleontology andauthored, in 1817, An Essay on the Shaking Palsy, now com-monly known as Parkinson’s disease.

A brief paper by Francois Melier added further autopsy-derived verification of appendiceal inflammation as a cause forpain in the right lower quadrant of the abdomen. But it wasn’tuntil June, 1886, when Reginald Heber Fitz, MD, [1843 –1913], Professor of Pathological Anatomy at Harvard, offereda scientific paper, “Perforating Inflammation of the VermiformAppendix: With Special Reference to its Early Diagnosis andTreatment,” that the disease became widely recognized. Therecognition was not total, however. In 1897, Dr. HarveyCushing, then in training in surgery at Johns Hopkins Hospi-tal in Baltimore, made the diagnosis of acute appendicitis onhimself. Few of his superiors believed it and Cushing, after 22hours of searching, finally found a surgeon brave enough tooperate. The diagnosis was confirmed and Cushing went onto become this nation’s most prominent surgeon in the earlydecades of the 20th Century.

Well-documented epidemiological studies indicate that thefrequency of acute appendicitis is gradually diminishing. De-spite this, an estimated 2,300 Rhode Islanders will require sur-gery for the disease in the coming twelve months. Fortunately,few will be inconvenienced more that the usual four days ofhospital stay.

– STANLEY M. ARONSON, MD


“Risk management” in medicine meansdifferent things to different people. Tosome physicians, it represents a hospital-imposed bureaucratic hassle interferingwith time that should be spent in directpatient care activities. Other physicianshave come to recognize that risk manage-ment is not just about avoiding legal li-ability, but about improving patient careby optimizing procedures and avoidingcertain known or anticipated risks. Riskmanagement means better patient careand improved outcomes, with better re-sults for all.

This issue, which we guest edited atthe request of the Journal, represents sev-eral perspectives on risk management inmedicine. These are far from the onlyissues facing modern healthcare. Rather,they represent what we believe are voicesand approaches worthy of serious con-sideration, and which also provide someinsights into other ways that risk manage-ment may prove helpful in the healthcaresetting.

Risk Management: IntroductionPatricia R. Recupero, JD, MD, and Lawrence W. Vernaglia, JD, MPH�

In these pages, you will find discus-sions about risk management strategiesrelating to new models of physician-pa-tient communications and the impact ofnew technology on practice patterns.These articles focus on industry-driven aswell as technology-driven changes tomedical practice. We have also includeda thoughtful piece on the dangers of pre-scribing for oneself or one’s associates –not a new problem, but one which hasspecial implications for risk managementin the increasingly-regulated healthcaremarket. Finally, as the courtroom is thereal overlap between law and medicinein “risk management,” we focus on animportant decision from the Rhode Is-land Supreme Court that challengesmany commonly-held notions about thebreadth of the “peer review” privilege.

These articles not only showcase sev-eral valuable specific topics in risk man-agement; they each offer insights into howthoughtful risk management practicesimprove patient outcomes and quality of

care. We hope you find these articleshelpful to your practice. We look for-ward to continuing this dialogue in theJournal as well as in the community.

Patricia R. Recupero, JD, MD, is Presi-dent/CEO of Butler Hospital and ClinicalProfessor of Psychiatry, The Warren AlpertMedical School of Brown University.

Lawrence W. Vernaglia, JD, MPH, isan attorney specializing in health carewith Foley & Lardner LLP.

CORRESPONDENCEPatricia R. Recupero, JD, MDButler Hopsital345 Blackstone BoulevardProvidence, RI 02906Phone: (401) 455-6360e-mail: [email protected]

Lawrence W. Vernaglia, JD, MPHFoley & Lardner LLP111 Huntington AvenueBoston, MA 02109Phone: (617) 342-4079e-mail: [email protected]


Websites and E-mail In Medical Practice:Suggestions for Risk Management

�Increasing numbers of patients seek in-formation online before consulting theirphysicians.1 Over 70% of Americaninternet users go online for health infor-mation; 90% of them find the informa-tion reliable.2 Some health organizations,such as Dartmouth-Hitchcock MedicalCenter in Lebanon, NH, offer onlineconsultations for patients frustrated withthe difficulties of phone tag.2 Some phy-sicians, too, now have websites, and manyphysicians e-mail their patients. With thebenefits of new technology comes the ne-cessity for newer safeguards and strate-gies to reduce risk. This article aims topresent some of the legal risks associatedwith the use of websites and e-mail inclinical practice, along with some sugges-tions for risk management.

WEBSITES IN MEDICAL PRACTICEIn 2004, 28% of internet users had

researched a specific doctor or hospitalonline.2 Websites may be an inexpensivemarketing tool, attracting new patients.On websites providers can post informa-tion about their practices, links to healthinformation sites, and resources to in-crease patients’ and families’ understand-ing of health issues.

When designing a website, the phy-sician should consider the complex legalramifications. Typically, the more inter-active a website is, the greater the num-ber of legal risks and concerns its ownershould anticipate. We begin with a dis-cussion of the classification of websitesunder the law.

Website Design and InteractiveFeatures

In cyberspace, activities normallygoverned by state law, such as businesstransactions, may frequently cross stateboundaries. The courts have adopted a“sliding scale” test for determiningwhether a particular state court may ex-ercise jurisdiction over a website’s owner.3

According to this test, a website may be-long to one of three categories: passivewebsites, interactive websites, and busi-ness websites. These categories differen-

tiate websites according to their levels ofinteractivity, ranging from minimal toextensive, and the likelihood of sufficientcontacts for jurisdiction correspondinglyincreases. Passive websites amount to littlemore than advertisements. Interactivewebsites might contain feedback formsor self-screening tests. Business websites,such as online pharmacies, facilitate fi-nancial transactions or contracts online.The degree of interactivity on a site, asidefrom possibly subjecting it to the juris-diction of a distant court, may also affectthe perception of a physician-patient re-lationship and the corresponding duty ofcare.

Suppose that Dr. Smith creates apassive website that displays her curricu-lum vitae, a brief biography, a descrip-tion of her practice, directions to her of-fice, and contact information. The fol-lowing activities may directly affect thelevel of interactivity and risk in herwebsite:

• posting hyperlinks to other healthinformation websites, especiallythose designed to promote particu-lar treatments or practices

• hosting, and receiving money for,banner advertisements or other ad-vertisements or implied endorse-ments of pharmaceutical companiesor other health companies

• posting a hyperlink to her e-mailaddress, such that patients can clickon the link and e-mail her directly

• encouraging, or soliciting, requestsfor advice

• self-screening tests (e.g., “Am I atrisk for skin cancer? Take our free,confidential online screening.”)

• invitations for site visitors to pur-chase her books (with a link to thewebsite selling the books)

• a form through which patients orvisitors can message her directly

When she adds an “intake form” toher website, and individuals from dis-tant states contact her for advice, her li-ability risk may increase. Laws regulat-

ing telemedicine and cybermedicinechange frequently, and state laws are notuniform. Staying current on the rel-evant laws would require additional re-search and time. When designing awebsite, it would be prudent to investi-gate your state’s law, ethical obligations,professional society requirements, andgeneral health law principles applicableto the website you are planning, in or-der to understand how different featuresmight affect levels of risk.

AdvertisingIn many cases, websites are adver-

tisements. Because they can be more in-teractive than simple media advertise-ments (e.g., television ads, brochures,etc.), and because they are usually acces-sible through internet search engines,they may be an attractive networking toolfor professionals. However, like otherforms of advertising, websites are subjectto regulation by the Federal Trade Com-mission (FTC) and other regulatory bod-ies, such as the United States Food andDrug Administration (FDA), if they con-tain claims regarding particular medi-cines or treatments. The FTC has takenaction against advertisers for false claimson websites about health treatments andfalse representations about privacy poli-cies.4 The presence of hosted advertise-ments, as well as the choice of domain or“domain extension” (for example,whether it is a .com, .org, or .edu site)may affect the credibility of the website.5

When creating a website, physiciansshould be conscious of the advertisinglaws and avoid unsubstantiated claims,misleading statements, and trademark orcopyright infringement. For more infor-mation about legal risks related to adver-tising, see Professor Ronald L. Scott’s re-view, “Cybermedicine and Virtual Phar-macies.”6

Disclaimers and Click-WrapAgreements

Many websites contain disclaimersto discourage unrealistic expectations onthe part of the visitor. Dr. Smith’s website,

Patricia R. Recupero, JD, MD, and Samara E. Rainey


for example, might offer the following dis-claimer above a hyperlinked e-mail ad-dress: “Please note that not all e-mails willreceive replies. If you are not a patient,please call our office at [phone number]to set up an appointment. If you are anexisting patient, and this is an urgent mat-ter, please call [phone number] immedi-ately.” Physicians should not assume,however, that a disclaimer will necessar-ily protect them from liability, nor reducetheir ethical duties to patients. Simplyposting a disclaimer may not prevent amalpractice action if the physician pro-vides advice upon which the patient re-lies to his detriment, or if the physiciandisregards communications concerningexisting patients. However, disclaimersmay clarify for patients and visitors thepurposes and limits of the physician’swebsite.

Websites may also use click-wrapagreements (CWAs): electronic con-tracts in which a visitor indicates his ac-ceptance to the terms by clicking an “Iaccept” button. CWAs may be legallybinding and are typically enforceable.7

However, CWAs, like other contracts,may be invalidated by courts if they con-tain objectionable terms or do not suffi-ciently warn the reader of rights or privi-leges he may be surrendering. For ex-ample, in Sanchez v. Sirmons,8 the Su-preme Court of New York invalidated acontract (not a CWA) requiring arbitra-tion for medical malpractice claimsagainst a physician, since the contracthad not adequately alerted the patientthat she was surrendering her right to ajury trial. Although the contract hadwarned that claims would have to be ad-dressed through arbitration, the courtfound that the patient had not been af-forded adequate time to fully considerand agree to the contract’s terms, andthat the contract did not call sufficientattention to the arbitration clause.While click-wrap agreements may helpto add an additional layer of protectionand may provide a forum to warn pa-tients or visitors of some risks, they can-not prevent lawsuits or insulate provid-ers from all liability. For some activities,thorough informed consent is more ap-propriate, and physicians are cautionedto recognize that CWAs and disclaim-ers cannot substitute for a complete in-formed consent discussion.

E-MAIL IN MEDICAL PRACTICEIn a recent study of family physicians

and their patients, e-mail communicationbetween patients and physicians wasfound to improve satisfaction by bothphysicians and patients without affectingthe time required for physician-patientcommunication.9 Some commentatorshave even speculated that increased pa-tient involvement through e-mail mightlessen the practice of medical paternal-ism and its associated legal risks.10 In theearly days of medicine, physicians oftencorresponded with distant patients bymail and frequently relied on patients’written descriptions of their conditionsin formulating diagnoses and treatmentplans.11

ConfidentialityThe duty to protect a patient’s con-

fidentiality has its roots in the HippocraticOath. Confidentiality is a significant con-cern with websites, e-mail, and electronicmedical records. Scholars have noted anincreasing number of tort lawsuits forbreach of confidentiality,12 and stories ofprivacy violated as a result of computingerrors and hackers have attracted con-siderable attention from the media.13

Confidentiality risks abound whenusing e-mail with patients. While theserisks do not necessarily outweigh the po-tential benefits of e-mail, sound risk man-agement stresses the importance of ob-taining patients’ understanding and con-sent to these risks prior to correspondingwith them by e-mail. Among some of therisks to patient confidentiality are the fol-lowing:

• family members may read patients’e-mail if the computer is shared

• a patient may check his e-mail atwork, not considering the possibil-ity that his employer may be moni-toring his e-mail

• a patient, or the physician, may beusing an insecure internet connec-tion and may be vulnerable to hack-ers, viruses, worms, or other tech-nological errors or problems thatmay lead to breached confidential-ity

• e-mails may be misdirected to un-intended recipients

• e-mails may be intercepted by soft-ware or surveillance

• “deleted” e-mails frequently remainaccessible on servers or hard driveslong after users believe they havecompletely deleted them

• e-mails may be subject to disclosurethrough legal process, such asthrough search warrants or subpoe-nas

• e-mails sent through a patient’semployer’s computer system may beaccessible to the employer

HIPAA14 applies to e-mail contain-ing protected health information (PHI),and additional state laws may also apply.Patients should be informed that there isno way to guarantee patient confidenti-ality when transmitting PHI online, andthat there is always a risk of breached con-fidentiality. Patients may then choosewhether to consent to this risk, and withtheir physicians they can discuss safe-guards, such as firewalls, encryption, andother safe practices, to help reduce risk.Physicians can then document thepatient’s understanding and consent inthe patient record.

Many physicians are accustomed topresenting themselves as experts, but adistinction must be drawn between ex-pertise in medicine and expertise in in-formation technology. Physicians shouldnot be afraid to admit that their knowl-edge of technology and technologicalrisks is limited; understanding this, pa-tients may be able to help physicians toimprove safeguards for the confidential-ity of e-mail communications.

“Matters of Business”E-mail communication may not be

suitable for some patients, or for somesubjects. As one scholar explains, “…a

Simply posting adisclaimer may not

prevent amalpractice action

if the physicianprovides adviceupon which the

patient relies to hisdetriment…


paranoid schizophrenic who has delu-sions of thought insertion through the TVis definitely not a good candidate [fortelemedicine].”15 Similarly, a patient un-dergoing treatment for carpal tunnel syn-drome may not be the best candidate forcorrespondence via computer keyboards.Physicians should exercise special cautionregarding the communication of test re-sults and other sensitive information bye-mail. Some tests warrant face-to-facecounseling about the meaning of the re-sults. With the patient’s written permis-sion, pre-test HIV counseling may ben-efit from additional e-mail communica-tion, such as sending patients links towebpages with general information aboutHIV and HIV testing. With the patient’sinformed consent, follow-up e-mails canprovide a written record to help patientsremember advice, questions, and infor-mation communicated during an officevisit and, in some cases, may result in im-proved patient compliance and qualityof care. Communicating the actual testresults for conditions such as HIV, how-ever, is not ideally suited to a perfunc-tory e-mail. Nor is e-mail thread is thebest substitute for discussions that wouldotherwise take place in the office or onthe phone, in part because e-mail removesmany of the cues that signal patient dis-tress or clinician compassion.

Unsolicited E-MailsSurprisingly, some physicians cannot

resist temptation when receiving e-mailrequests for advice from non-pa-tients.16 ,17 Prudence suggests, however,that providing medical advice to an indi-vidual who is not already a patient mayincrease risk. Physicians receiving suchrequests should be wary of providing in-formation that might foster the percep-tion of a physician-patient relationshipand the corresponding duty of care.Physicans may also receive e-mails fromthird parties, such as a patient’s familymembers. Special risks may apply to thesee-mails. Providing information to thirdparties, answering their questions with-out the patient’s consent, and corre-sponding with them without informingthe patient may increase risk. E-mail cre-ates a written record of the content ofthe communications, a factor absent frommost phone conversations. E-mails con-cerning existing or possible future pa-

tients (e.g., initial e-mails requesting anappointment or consultation and de-scribing a complaint or presentation) canbe saved in the patient’s medical record.Keeping e-mails in the medical recordmay reduce risk. If the practice uses elec-tronic medical records, the process of sav-ing e-mails to the record may be doneautomatically.

Unavailability & Unanswered E-Mails

Physicians should not assume that allpatients understand that e-mail is an in-appropriate means to communicate ur-gent matters. Furthermore, patientsmight have different expectations aboutthe timeliness of replies or message re-ceipt. It may be useful to create a policywith respect to timeliness for e-mails, andto adhere to it. Physicians may wish tocreate a separate e-mail account for usewith patients and to apply settings thatsend automatic replies to patients, includ-ing the expected response time and aphone number patients may call if a con-cern is urgent, or if it takes longer thanexpected for them to receive a reply.When traveling, an “out of office” auto-reply message may alert patients how tocontact the covering physician. One mayalso encourage patients to request “readreceipts” on e-mails so that patients mayknow whether or not their doctor hasread a message. You may wish to avoidusing this feature if there is a chance thatthe receipt could be triggered inadvert-ently, such as by office staff.

Additional risks with e-mail are nu-merous and may grow more complicated.However, if patients understand the risks,they may consent to them, and in manycases the benefits will outweigh the risks.Allowing patients to decide whetherthese risks are acceptable, which safe-guards they want and what benefits theywill enjoy as a result of e-mail communi-cation, may facilitate a dialogue and acooperative approach to risk managementthat involves the patient in the process,thereby further reducing risk through astronger treatment alliance. With his

physician’s help, the patient who takessteps to protect his own safety may be lesslikely to blame the physician if a disclosedrisk occurs.

IMPORTANT CONCERNSLicensing, Advice, and thePhysician-Patient Relationship

If Dr. Smith provides advice to astranger, there is a risk that patients, andpossibly courts, may view this as creatinga physician-patient relationship, givingrise to additional responsibilities and risks.If the “patient” resides in a state whereDr. Smith is not licensed, she might beargued to be practicing medicine with-out a license. In such a case, her mal-practice liability insurance may not re-imburse her defense counsel fees andmay not reimburse her for any judgmentsassociated with a malpractice action in adistant state. Even if Dr. Smith is licensedin the distant state, being sued in anotherstate for malpractice proceedings or otherlegal issues can be costly and time-con-suming. Even when fully licensed in thestate, physicians should be sensitive tolaws and regulations that apply specifi-cally to telemedicine or cybermedicinepractices within that state; such regula-tions may specify activities which may notbe conducted online.

Treating and Communicatingwith the Wired Patient

Scholars have noted both benefitsand risks associated with the disinhibitingeffect of internet communication.18 Thevolume of “spam” from online pharma-cies advertising medicines for erectile dys-function suggests that some patients mayfeel uncomfortable requesting such medi-cines in the physician’s office; indeed, theHarris Poll found that among the six mil-lion US adults who had bought prescrip-tion medicines online, Sildenafil (a drugfor treating erectile dysfunction) was oneof the most frequently purchased.19

Some patients may feel more comfortablebroaching uncomfortable subjects in thecontext of an e-mail discussion with theirphysicians.

Also, some patients purchase medi-cines online without prior prescriptionsand without informing their doctors. InThe Lancet physicians report treating a64-year-old woman for bilateral cataractsand glaucoma resulting from overuse of

Keeping e-mails inthe medical recordmay reduce risk.


oral steroids she had purchased onlineafter diagnosing herself with myalgic en-cephalomyelitis.20 Further complicatingthis problem is the prevalence of coun-terfeit medicines sold online21 and thepatients who self- diagnose through theinformation and diagnostic tools on theworld-wide web.22 These developmentsunderscore the importance of obtaininga full history of a patient’s use of prescrip-tion and over-the-counter medicines, in-cluding nutraceuticals and supplements.Additional questions about patients’ ex-perience with web-based health and druginformation may improve communica-tion between physicians and web-savvypatients.

Practicing Online?Some activities, such as online pre-

scribing, carry a very high degree of risk.Indeed, penalties have ranged fromwarning letters to disciplinary action bymedical boards, loss of license, and even,in some cases, prison terms.23 However,even providing advice often constitutesthe practice of medicine, so experts ad-vise physicians to exercise caution in theirinternet activities. Some physicians know-ingly provide medical services over theinternet or through other telecommuni-cations technology. While doing so is not,in itself, illegal or unethical, circum-stances vary greatly. Such practices arecommon in radiology, for example, but“questionnaire prescribing” online topatients not examined in person has sub-jected physicians to sanctions. While thepractices of cybermedicine andtelemedicine are beyond the scope of thisarticle, we encourage readers to consulttheir malpractice insurance providers forguidance regarding practice-related ac-tivities online.

ETHICAL GUIDELINES AND FURTHERREADING

For physicians seeking to enhancetheir practice through the use of websitesor e-mail with patients, there are manyhelpful guidelines. The AMA’s Code ofEthics, which is accessible at the AMA’swebsite (http://www.ama-assn.org/ama/pub/category/2498.html), has sectionsspecifically applicable to e-mail andwebsites. With respect to websites, theAMA urges informed consent for inter-active features, as well as minimization of

conflicts of interest and commercialbias.24 Physicians might go about thesesafeguards by clearly disclosing sponsor-ship and being sure that their websitesponsorship (such as advertisements) doesnot trump patient interests. The AMAalso stresses the importance of technologi-cal safeguards for patient privacy and con-fidentiality on sites where patient-specificinformation is involved. For physiciansseeking to develop practice websites, theAMA has additional resources to helpguide decisions and decrease risk.25 ,26

With respect to e-mail, the AMA’sCode of Ethics cautions that “E-mail cor-respondence should not be used to estab-lish a physician-patient relationship” andthat physicians should adequately notifypatients of e-mails’ “inherent limitations,”such as risks to confidentiality or privacy,“difficulties in validating the identity of theparties,” and delayed responses.27 TheAmerican Medical Informatics Associationalso has a helpful white paper on the useof e-mail with patients.28

The Federation of State MedicalBoards has also produced a helpful guidefor the use of the internet in clinical prac-tice.29 This general guide covers aspectsof both e-mail and websites, as well asother areas of the internet that may ap-ply to different physicians.

CONCLUSIONThis article presents only some of the

legal risks associated with passive websitesand incidental e-mails with patients. Nu-merous additional risks arise with respectto more interactive sites and businesswebsites, and with more extensive use ofe-mail. Readers interested in a morethorough discussion of these issues withrespect to websites,30 e-mail,31 orinternet-based treatment activities32 areencouraged to consult references fromthe literature, malpractice insurance pro-viders, professional organizations or affili-ations (e.g., the AMA), state licensingboards, and official policies or guidelinesof their employers, institutions, and otherprofessional memberships.

REFERENCES1. Hesse BW, Nelson DE, et al. Arch Intern Med

2005;165:2618-24.2. Krane D. Healthcare News 2005;5(8): no page numbers.

Accessed August 29, 2006 from http://www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2005Vol5_Iss08.pdf

3. Haugh R. Direct connect at Dartmouth-Hitchcock.Hospitals & Health Networks Most Wired Maga-zine online, August 15, 2005. Accessed 10/5/05from http://www.hhnmostwired.com/

4. Fox S. Health information online. Pew Internet &American Life Project, May 17, 2005. Accessed Au-gust 29, 2006 from http://www.pewinternet.org/pdfs/PIP_Healthtopics_May05.pdf

5. Zippo Manufacturing Co. v. Zippo Dot Com,Inc., 952 F. Supp. 1119 (W.D. Pa. 1997)

6. Neumeier MM, Kidwell BE. The Practical Law-yer 2001;47:21-38.

7. Walther JB, Wang Z, Loh T.. J Med Internet Res2004;6:e24.

8. Scott RL. West Virginia Law Review2001;103:407-502.

9. Grossman M, Hift AK, Rothman B. Click-wrapagreements: enforceable contracts or wasted words?Becker and Poliakoff, PA. Accessed June 23, 2005from http://www.becker-poliakoff.com/publica-tions/articlearchive/clickwrap.htm

10. Sanchez v. Sirmons, 467 N.Y.S.2d 757 (N.Y. Sup.Ct. 1983)

11. Leong SL, Gingrich D, et al.. J Amer Board FamPract 2005;18:180-8.

12. Slack WV. JAMA 2004;292:2255-62.13. Spielberg AR.. Amer J Law Med 1999;25:267-

95.14. Terry NP. Amer J Law Med 2001;27:361-419.15. Wells J. Wrong MDs got patient records. San Fran-

cisco Chronicle, December 30, 2003.16. Health Insurance Portability and Accountability

Act of 1996, 42 U.S.C. 1320d et seq.17. Stamm BH. Professional Psychology: Res Practice

1998;29:536-542.18. Eysenbach G, Diepgen TL. JAMA

1998;280:1333-5.19. Oyston J. J Med Internet Res 2000;2(3):e16.20. Suler J. CyberPsychology & Behavior 2004;7:321-6.21. Harris Interactive. Six million people have bought

prescription drugs online. Press release, March 23,2004. Accessed April 12, 2005 from http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=779.

22. Severn PS, Fraser SG. The Lancet 2006;368:618.23. Food and Drug Administration. FDA warns con-

sumers not to buy or use prescription drugs fromvarious Canadian websites that apparently sellcounterfeit products. FDA press release, August30, 2006. Accessed September 6, 2006 fromhttp://www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html.

24. Authors’ own research, 2006.25. Gunter TD, Srinivasaraghavan J, Terry NP. J Amer

Acad Psychiatry Law 2003;31:10-426. American Medical Association Code of Ethics, E-

5.-27, “Use of Health-Related Online Sites,” up-dated September 6, 2005. Accessed September8, 2006 from http://www.ama-assn.org/ama/pub/category/11965.html.

27. Winker MA, Flanagin A, et al. Guidelines for medi-cal and health information sites on the internet:principles governing AMA web sites. AmericanMedical Assocation, 2001. Accessed September8, 2006 from: http://www.ama-assn.org/ama/pub/category/1905.html.


28. Rothschild MA. Building and implementingphysician practice wesites. Chicago: AmericanMedical Association, 2001.

29. American Medical Association Code of Ethics, E-5.026, “The Use of E-mail,” updated August23, 2005. Accessed September 8, 2006 fromhttp://www.ama-assn.org/ama/pub/category/10828.html.

30. Kane B, Sands DZ. J Amer Med Informatics Asso-ciation 1998;5:104-111. Accessed September 8,2006 from http://www.amia.org/mbrcenter/wg/kim/docs/email_guidelines.html.

31. Federation of State Medical Boards of the UnitedStates: Model guidelines for the appropriate use ofthe internet in medical practice, 2002. AccessedSeptember 8, 2006 from http://www.fsmb.org/pdf/2002_grpol_Use_of_Internet.pdf

32. Recupero PR.. Psychiatric Services 2006;57:450-2.33. Recupero PR. J Amer Acad Psychiatry Law

2005;33:465-75.34. Recupero PR, Rainey SE. Amer J Psychotherapy

2005;59:319-31.

Patricia R. Recupero, JD, MD, isPresident/CEO, Butler Hospital, andClinical Professor of Psychiatry, The War-ren Alpert Medical School of Brown Uni-versity.

Samara E. Rainey is a Paralegal / Re-search Assistant at Butler Hospital.

CORRESPONDENCEPatricia R. Recupero, JD, MDButler Hospital345 Blackstone BoulevardProvidence, RI 02906phone: (401) 455-6360e-mail: [email protected]


Dangers of Self-Prescribing and Prescribingfor Family Members

Marilyn Price, MD, and Bruce W. McIntyre, JD

�Physicians prescribe for themselves andtheir family members despite ethicalguidelines that discourage the practiceand stress the need to avoid treatmentsituations in which objectivity may becompromised.1 Many physicians are un-aware that state medical licensing boardshave regulations vis a vis treating and/orprescribing for themselves and familymembers absent an emergency. Addi-tional regulations govern the prescribingof controlled substances. While manyjurisdictions do not have explicit prohi-bitions, there will be regulations relatedto the doctor/patient relationship suchas those requiring that a history and physi-cal exam be performed and documented.Rhode Island law and regulation do notexplicitly prohibit self-prescribing, al-though a number of legal requirementsplace restrictions on the practice. 2, 3

In spite of the ethical considerationsand regulations discouraging the prac-tice, Toyry noted that self-treatment wascommon and physicians begin self-pre-scribing early in their careers.4 A surveyof internal medicine residents demon-strated that 52% had self-prescribed inthe past year. Convenience and the readyavailability of medication have beenviewed as factors promoting this prac-tice.5 Christie and colleagues noted that42% of the residents who had self-pre-scribed medications, obtained the medi-cations from a sample cabinet; and 11%had obtained medications directly froma pharmaceutical representative.5

Self-prescribing appears to extendbeyond the first years of practice. Hemet al) surveyed all the medical graduatesfrom all 4 medical schools in Norway atone-year post graduation and then againat 4 and 10 years post graduation. 6 Ofthe physicians who had used any prescrip-tion medications over the past year, 90%of those who were one year post gradua-tion, 86% of those 4 years post gradua-tion and 84% of those who were 10 yearspost graduation had self-prescribed. Themost frequently prescribed medicationswere antibiotics, contraceptives, analge-

sics and hypnotics. Those who had a men-tal health problem needing treatmentwere more likely to self-prescribehypnotics and sedatives than those with-out perceived health problems. In thestudy by Christie the most commonly self-prescribed medications included antibi-otics, allergy medication and contracep-tives.5 Westfall et al found that only 2 of55 physicians or staff members in a resi-dent training setting had not takensamples for their personal or a familymember’s use in the past year. 7

Self-prescribing can result in a de-lay in obtaining appropriate treatment.This can be seen as especially problem-atic when a mental illness could be af-fecting the judgment of the physician.While only 2% of the residents inChristie’s sample admitted to self-pre-scribing psychotropic medications, Toyryreported that two thirds of the physicianswho acknowledged having a mental dis-order had self-treated.4 McCauliffe et alfound that 25% of their sample of physi-cians in practice had treated themselveswith a psychotropic medication in thepast year. 8 Reinhardt and colleaguesfound that 5% of their sample of housestaff admitted using a sedative or hyp-notic without a prescription in the previ-ous year. While the prevalence of recentdepressive symptoms was 30%, only 11%had consulted with a mental health pro-fessional during that same time period.9

The American Medical Association’sCode of Ethics, Opinion E-8.19 articu-lates the very real dangers inherent in pre-scribing for self or family members. 1 TheAMA recommends that: “Physicians gen-erally should not treat themselves or mem-bers of their families.” The rationale isthat:

Professional objectivity may becompromised when an imme-diate family member or thephysician is the patient; thephysician’s personal feelingsmay unduly influence his or herprofessional medical judgment,

thereby interfering with thecare being delivered. Physiciansmay fail to probe sensitive areaswhen taking the medical historyor fail to perform intimate partsof the physical exam. Similarlypatients may feel uncomfort-able disclosing sensitive infor-mation or undergoing an inti-mate examination when thephysician is an immediate fam-ily member.

These factors are seen as especiallypertinent when the patient is a child.1

There are further fears that when treat-ing themselves or family members, phy-sicians may be more likely to treat prob-lems outside expertise. Physicians arewarned that if problems arise as a resultof a negative medical outcome, therecould be ramifications in the personalrelationship. In addition Opinion E-8.19points out that the process of informedconsent is significantly impacted. Familymembers may feel that by seeking a sec-ond opinion they are insulting the physi-cian or indicating a lack of confidence inhis/her ability.

The AMA does allow for exceptions.“In emergency settings or isolated settingswhere there is no other qualified physi-cian available, physicians should not hesi-tate to treat themselves or their familymembers until another physician be-comes available. In addition while physi-cians should not serve as a primary orregular care provider for immediate fam-ily members, there are situations in whichroutine care is acceptable for short-term,minor problems. Except in emergencies,it is not appropriate for physicians towrite prescriptions for controlled sub-stances for themselves or immediate fam-ily members (I, II, IV).”

The medical licensing boards havetaken various approaches in dealing withphysicians who prescribe for themselvesor family members. The College of Phy-sicians and Surgeons of Ontario recentlyrevised the policy about treating self and


family members.10 The provincial regu-lation states that:

Physicians should not treat ei-ther themselves or family mem-bers, except for a minor condi-tion or in an emergency situa-tion, and only when anotherqualified health care profes-sional is not readily available.Where it is necessary to treatthemselves or family members,physicians must transfer care toanother qualified health profes-sional as soon as is practical.Physicians are advised that ifthey do not comply with thispolicy, they may be subject toallegations of professional mis-conduct.

Even in states such as Rhode Islandthat do not explicitly ban this practice,the prescribing physician must meetpractice guidelines set by the state andthe United States Drug EnforcementAgency (DEA). A physician may not pre-scribe for a non therapeutic purpose andthere needs to be an adequate medicalrecord justifying the use of the medica-tion. Rhode Island has a medical recordregulation, R5-37 MD/D0 sec 11.4which requires that the course of treat-ment be justified. 11 There needs to bedocumentation of the history, test results,drug prescribed or administered, reportsof consultations and hospitalizations. 11

Physicians need to consider that the ad-equacy of their documentation will be animportant issue should there be a com-plaint. Documentation requirements arerarely considered by physicians prescrib-ing for themselves or a family member.12

When the prescribed medication isa controlled substance there could be fur-ther requirements or restrictions. TheRhode Island Board of Medical Licen-sure and Discipline has issued guidelinesfor the administration of controlled sub-stances that require the following be pro-vided; history and physical examinations,treatment plan and objectives, informedconsent, periodic review of plan andtreatment, consultations with experts, ac-curate and complete records, and com-pliance with State and Federal Laws(Rhode Island-225 ILCS60/MedicalAct of 1987).

There are usually grounds for disci-plining a physician who prescribes a con-trolled substance other than for a legiti-mate medical purpose. Under Rhode Is-land General Laws § 21-28-3.04 (2006)one of the conditions for suspension orrevocation of registration includes “pos-sessing, using, prescribing, dispensing, oradministering controlled substances ex-cept for a legitimate medical or scientificpurpose.” 2 In addition, in defining un-professional conduct of a physician, R.I.General Laws §5-37-5.1 (2006) one ofthe behaviors noted is “violating any stateor federal law or regulation relating tocontrolled substances.” 3

In Kentucky prescribing to self or tofamily members is not a violation of Ken-tucky law, but KRS 311.597 (1) statesthat “self-prescribing and prescribing toimmediate family members is contrary tothe law when the physician knows or hasreason to know that an abuse of con-trolled substances is occurring, or mayresult from such a practice.” 13

The College of Physicians and Sur-geons of Ontario also makes it clear thatphysicians should never write a prescrip-tion for themselves or family members fornarcotics, controlled drugs, psychotropicdrugs, or any drugs that are addicting orhabituating, even when another physi-cian is in charge of managing those medi-cations. 10

In 2001, The Commonwealth ofMassachusetts Board of Registration inMedicine issued “Prescribing Practices:Policy and Guidelines.” Physicians are ad-vised to “maintain records that are de-tailed enough in nature that thephysician’s clinical reasoning is implicit inhis or her documentation. Treatmentplans should be explicitly recorded. Allpatients visit and telephone calls relatingto treatment should be documented. Pre-scriptions should be documented and

changes in medication dosage should beexplained.” 14 The Massachusetts guide-lines (2001) warn:

Prescribing to immediate fam-ily members is frequently asso-ciated with problems of self-medication and chemical de-pendency by physicians and istherefore carefully scrutinizedby the Board. Treatment of im-mediate family members withcontrolled substances over a sus-tained period of time may indi-cate a lack of objectivity andclinical detachment on the partof the physician. Physicians whoprescribe controlled substancesfor family members must takeextra precautions to insure thatthis privilege is not abused.

The guideline/policy further cau-tions that “[t]he same examination re-quirements applicable to patients whoare not related to the physician applywhen the physician is prescribing con-trolled substances to the physician’s im-mediate family. Physicians should docu-ment examination results carefully andaccurately.”

Massachusetts prohibits the prescrip-tion of Schedule II Controlled Sub-stances to family members. “Schedule IIcontrolled Substances, because of theirhigh potential for abuse, may not be pre-scribed to a member of a licensee’s im-mediate family, including a parent, child,sibling, parent-in-law, son/daughter-in-law, brother/sister-in-law, step-parent, orspouse or equivalent, except in an emer-gency.” This prohibition includes otherrelatives permanently residing in the sameresidence as the licensee. The Board sug-gests that physicians consider refrainingfrom prescribing all controlled substancesfor family members and significant oth-ers in non-emergency situations.14

The Board of Registration in Medi-cine in Massachusetts has even graverconcerns about self-prescribing. 14 Thesame document advises:

Physician self-prescribing pre-sents even deeper concernsthan prescribing to family mem-bers. The prescription of drugsto oneself creates an enormous

Physicians who self-prescribe controlledsubstances such as

sedatives andnarcotics raise

suspicion of drugabuse/dependence.


potential for abuse and places adifficult burden on the pharma-cist, who is equally responsibleunder the law to determinewhether a prescription is valid.The Board has concluded thatthe potential for abuse of lowerschedule drugs far outweighsthe relatively minor inconve-nience that is caused by requir-ing physicians to obtain pre-scriptions for their own use fromother physicians. For this rea-son, the Board has prohibitedphysicians from prescribingcontrolled substances in Sched-ule II through IV for their ownuse.

Massachusetts is not alone in the abso-lute prohibition of self-prescribed controlledsubstances. In Georgia self-prescribing ofcontrolled medication is prohibited as a vio-lation of Board Rule 360-3-.02(7). 15

Of course physicians in all states arerequired to adhere to the DEA regula-tions. According to DEA regulation 21CFR 1306.04 (a) 16 the physician mustdetermine that there is a legitimate medi-cal purpose for the patient to be pre-scribed the controlled substance and theindividual practitioner must be acting inthe usual course of his/her professionalpractice as described in U.S. v Moore,U.S. 122, 1975.

The DEA has developed aPractitioner’s Manual that offers guidanceon how the DEA determines that the pre-scribing practice meets that the legal stan-dard that a controlled substance may onlybe prescribed, administered, or dispensedfor a legitimate medical purpose. TheManual provides examples of recurringpatterns that may be indicative of inap-propriate prescribing or diversion.17 Manyof these factors had been articulated in USvs. Rosen, 1978, 18 a Fifth Circuit Deci-sion in which the court upheld the con-viction of a Louisiana Physician on chargesof dispensing and distributing controlledsubstances, a violation of 21 U.S.C.S. §841(a) and were reviewed again in U.S. vs.Rottschaefer 2006 a Third Circuit deci-sion. 19 These include

• An inordinately large quantity ofcontrolled substance prescribed orlarge numbers of prescriptions is-

sued compared to other physiciansin the area;

• No physical exam was given;• Issuing prescriptions knowing that

the patient was delivering the drugsto others;

• Issuing prescriptions in exchangefor sexual favors or for money;

• The use of street slang rather thanmedical terminology for the drugsprescribed

• No logical relationship between thedrugs prescribed and the treatmentof the condition allegedly existing

States can track prescriptions in theevent of a complaint. “Prescription Moni-toring Programs” are state programs thatcollect prescription information electroni-cally from the pharmacies. States vary in theextent of information received and whetheror not they perform trend analysis in a pro-active approach. In Rhode Island a reportto the Board can generate an investigationusing the database to verify that there is apattern and to determine the extent of thediversion or abuse.20, 21 Rhode Island’s Elec-tronic Data Transfer System, initiated in1997, allows the tracking of controlled sub-stance prescribing by patient, by prescrib-ing physician or by pharmacy. This can bea valuable tool when there has been a com-plaint or inquiry concerning prescribingpractices.

The following vignette describes asituation that led to a complaint broughtbefore the Board. It was created for illus-trative purposes only and is not intendedto refer to any actual individual, event oroutcome.

Dr. A had always been very close tohis younger brother who was an excel-lent student and always dependable. Dr.A was aware that his brother had been ina car accident 6 months earlier. Hisbrother had complained of back painfollowing the accident but had not beenadmitted to hospital. His brother re-ported to him that he still had severe re-sidual pain. Because of his exam sched-ule he had missed an appointment withhis own physician and had run out ofOxycontin. He asked Dr. A if he wouldbe willing to write a prescription for aone-month supply. Dr. A. was hesitantbut nevertheless agreed to prescribe themedication. Dr. A was not aware that hisbrother was abusing Oxycontin as well

as other medications. The followingmonth his brother demanded that he fillthe prescription again. When Dr. A. re-fused, his brother threatened to reporthim to the Board. Dr. A. felt trapped andgave his brother another prescription oncondition that this would be the last time.When Dr. A. subsequently refused tocontinue the Oxycontin and suggestedthat his brother seek treatment for anaddiction, his brother filed a complaintwith the Board.

Dr. A. could not produce a medicalrecord documenting that he had takenan appropriate history, performed aphysical exam, considered a treatmentplan, ordered or reviewed diagnostic testresults, or monitored the response totreatment. He had never documentedwhy he had arrived at the decision to treathis brother with Oxycontin. His brotheradmitted in his letter to the Board thathe had abused Oxycontin. The ElectronicData Transfer System indicated that hisbrother had filled numerous prescrip-tions of Oxycontin from other providers.Dr. A. could not produce documenta-tion that he had prescribed for a legiti-mate medical purpose. He was asked tomeet with the Board.

Physicians are well advised to havetheir own treating physicians. Self-treat-ment has been viewed as a symptom ofpoor health care for physicians.22 Physi-cians who self-prescribe controlled sub-stances such as sedatives and narcoticsraise suspicion of drug abuse/ depen-dence. Self-prescribing of controlled sub-stances including pain medication,stimulants and sedatives can influence thedevelopment of drug abuse and depen-dence on these medications.

While self-prescribing may be con-venient and time-saving, the lack of ob-jectivity may result in inappropriate andeven dangerous self-treatment. Diagno-sis may be delayed affecting prognosis.The lack of objectivity and concernsabout the absence of proper informedconsent should be considered when treat-ing a family member. It is important fortraining programs to foster discussionabout this issue which will allow traineesto consider the implications when pre-scribing for themselves or for family mem-bers and to learn to maintain appropri-ate professional boundaries.5


REFERENCES1. The American Medical Association Code of Ethics,

Ethics Opinion E-8.19, Issued June 1993, Last up-dated August 26, 2005. Last accessed 9/20/06 htttp;/www.ama-assn.org/ama/pub/category/8510.html

2. R.I. General Laws §5-37-5.1 (2006)3. R.I. General Laws § 21-28-3.04 (2006)4. Toyry S, Rasanen K, et al. Self-reported health,

illness and self-care among Finnish Physicians.Arch Fam Med 2000; 9:1079-85.

5. Christie JD, Rosen IM, et al. Prescription druguse and self-prescribing among resident physi-cians. JAMA 1998; 280:1253-5.

6. Hem E, Stokke G, et al. Self-prescribing among youngNorwegian doctors, a follow-up study of a nation-wide sample BMC Medicine 2005 available at htto:/www.biomedcentral.com/1741-7015/3/16

7. Westfall JM, McCabe J, Nicholas RA. JAMA1997; 278:141-3.

8. McCauliffe WE, Rohman M, Santangelo S. NEJM1986; 315:895-910.

9. Reinhardt T, Chavez E, et al. Survey of physicianwell-being and health behaviors at an academic medicalcenter. Med Edu Online [serial online] 2005;10:6available from http://www.med-ed-onlin.org

10. College of Physicians and Surgeons of OntarioPolicy #7-06 Treating Self and Family Members,Last updated February 2007. Last accessed 3/07http://cpso.on.ca/Policies/drug_self.htm

11. Rhode Island Board of Medical Licensure andDiscipline, Rules and Regulations Pertaining tothe Licensure and Discipline of Physicians Medi-cal Record Regulations R-5-37 MD/DO sec 11.4.Last accessed 3/07 http://www.health.rigov/hst/bmld/records.php Medical Records

12. Nist JB: Liability for over-prescription of con-trolled substances. J Legal Med 2002; 23:85-113

13. KRS 311.597 (1)14. Commonwealth of Massachusetts Board of Reg-

istration in Medicine, Prescribing Practices: Policyand Guidelines Adopted August 1, 1989,Amended December 12, 2001

15. Georgia Composite State Board of Medical Exam-iners Rule 360-3-.02(7) Last accessed 3/07 http:/www.rules.sos.state.gov.ga.us/doc/360/3/02

16. DEA regulation 21 CFR 1306.04 (a)17. United States Department of Justice Drug En-

forcement Administration Practitioner’s Manual:An Informational Outline of the Controlled Sub-stance Act, 1-61, 2006

18. U.S. v. Rosen, 582 F.2D 1032; 1978 U.S. App19. U.S. v. Rottschaefer, 127 S.Ct 274; 166 L. Ed.

2d 152; 200620. Heinrich J. United States General Accounting

Office Report to the Subcommittee on Oversightand Investigations, Committee on Energy andCommerce, House of Representatives, Prescrip-tion Drugs, State monitoring programs provideuseful tool to reduce diversion GAO-02-634,May 2002

21. United States Department of Justice, Drug En-forcement Agency. A closer look at state prescrip-tion monitoring. Last accessed 8/2/062006deadiversion.usdoj.gov/faq/rx_monitor.htm

22. Rosvold EO, Tyssen R. Lancet 2005; 365:1375-365

Marilyn Price, MD, is Director, TheLaw and Behavioral Health Program,Butler Hospital, and Assistant ClinicalProfessor of Psychiatry, The Warren AlpertMedical School of Brown University.

Bruce W. McIntyre, JD, is LegalCounsel, Rhode Island Board of MedicalLicensure and Discipline.

CORRESPONDENCEMarilyn Price, MDButler Hospital345 Blackstone BoulevardProvidence, RI 02906Phone: (401) 455-6382e-mail: [email protected]


Patient Safety Efforts Target Communication atRhode Island Hospitals

Melinda Morin, MD

�The 1999 Institute of Medicine (IOM)Institute of Medicine (IOM)Institute of Medicine (IOM)Institute of Medicine (IOM)Institute of Medicine (IOM)report, To Err Is Human,1 sparked a pub-lic outcry over patient safety in US hos-pitals. This has resulted in attention tosystem factors as well as accountability atan individual level. Although technologicadvances have soared in many of ourhospitals, communication - a basic tenetof patient care - has suffered. This articleadvocates for a change in proceduresaround patient “hand-offs” and describesthe efforts at Rhode Island Hospital toreduce iatrogenic injury and liability forpractitioners and the hospital. These ef-forts include standardizing the process,improving communication, and minimiz-ing reliance on the memory of patients,families and practitioners.

The accurate transfer of informationbetween teams of caregivers is essentialfor the seamless continuity of care. How-ever, “hand-off ” communication hasbeen identified as the major cause of sen-tinel error events and delay in treatmentwithin US hospitals.2 Too often key in-formation is misstated or misunderstood.Five-year data from CRICO/RMF, themedical malpractice company for theHarvard Medical Institutions, indicatethat handoffs were involved in 268 claimsand suits, with more than half involvinga high severity patient injury.3 As a re-sult, the Joint Commission has includedthe implementation of a standardizedapproach to hand-off communications,with an opportunity to ask and respondto questions, as one of the required goalsfor 2006 and 2007.4

Communication strategies successfulin other high risk settings are being in-troduced into the setting of medical care.Patterson et al5 evaluated communicationmethods at NASA Johnson Space Cen-ter, nuclear power plants in Canada andrailroad and ambulance dispatch centers.Techniques found to be effective in-cluded: 1) Face-to-face verbal updateswith interactive questioning; 2) Unam-biguous transfer of responsibility; 3)Overhearing others’ updates; and 4) Lim-iting interruptions during update. Al-

though logical, these methods are rarelyutilized in current medical practice andshould be mandatory in sign-out at alllevels.

In the United States, resident-physi-cians provide much of the direct patient-care. Previous work has identified cover-age by house staff not primarily responsiblefor the patient (cross-coverage) as a signifi-cant correlate of risk for preventable ad-verse events.6 Cross-coverage by a differ-ent physician, principally at night, was afar better predictor of hospital complica-tions and errors than was the severity ofthe patients’ illness. With the 2003 man-date of an 80-hour work-week for resi-dents, the number of handoffs has substan-tially increased. While targeting fatigue-related errors, this change has exacerbatedcommunication problems involving thehandoff of patient information.

Table 1. SBAR Method of Communication SBAR Tool, Institute for HealthcareImprovement, Copyright Institute for Healthcare Improvement, 2007.

Studies of thephysician sign-outprocess reveal it to

be a haphazardevent with great

variation ininformation content

and process.


Studies of the physician sign-out pro-cess reveal it to be a haphazard event withgreat variation in information content andprocess.7 The typical resident sign-out is a“one-liner” including diagnosis and theclinical impression, e.g. the patient is allright. It is often purely task-oriented. Thus,effectiveness of sign-out is currently re-stricted by its inadequate content, particu-larly regarding the plan of care for patients.

Six Sigma is a process-focused businessstrategy aimed at improving quality, reduc-ing costs and improving efficiency. Thesigma level indicates the defect rate in agiven production or service process. In an

effort to achieve Six Sigma performanceand diminish the incidence of errors, theLifespan Health System, including RhodeIsland Hospital, Miriam Hospital and New-port Hospital, is currently utilizing CPOE(computerized provider order entry sys-tem). CPOE is the portion of a clinical in-formation system that enables a patient’sprovider to enter an order for a medica-tion, laboratory or radiology test, or proce-dure using a computer system that providessome level of clinical alerts. CPOE allowsrapid, up-to-date, intra-hospital informationtransfer that is available, and HIPAA pro-tected, at any computer terminal within any

of the hospitals. Rhode Island Hospital isimplementing a standardized sign-out sys-tem for resident sign-out that is electroni-cally linked to CPOE. This system offers areadily available, cost-effective and user-friendly sign-out method, which could beinstrumental in decreasing reliance on vigi-lance and memory, while communicatingthe plan of care.

Another identified area of frequentcommunication failures centers aroundthe nurse-physician interaction. SBAR(Situation-Background-Assessment-Rec-ommendation) is a situational briefingtechnique that conveys only the most criti-cal information and is one of several com-munication models gaining momentum inAmerican healthcare. The SBAR model,which has proven successful in the nuclearsubmarine industry, has been adopted bythe Kaiser Permanente system. (Table 1).SBAR requires that information be com-municated in a standardized, consistentmanner. This method emphasizes the an-ticipation of what information the otherperson will need, the use of critical think-ing and assessment skills and, of particu-lar import, the goal of reaching a mutu-ally acceptable plan.

Undoubtedly, the change to an ef-fective model of communication requiresan enormous change in the very cultureof medicine. It requires a change to con-cerns about an abnormality seen, not theperformance of specific tasks. It requiresa team approach, where nurses are notafraid to be wrong and are not afraid tostate that they are worried. It requireschange in the hierarchy of medicine. Phy-sicians would still be the de facto leaders inpatient management, but would need tobe more accepting of nursing input. Suc-cessful implementation would ablate thecurrent system of hinting and hoping bynon-physicians. The use of SBAR couldalso be expanded to the other healthcaresettings (e.g. outpatient office or nursinghome settings); incorporation into otherpractice situations (daily rounds, dischargesummaries); or incorporation into othertypes of hospitals outside of academic medi-cine (community hospitals).

SBAR is being introduced into an-other vital area of communication atRhode Island Hospital: nursing sign-out.Traditionally, shift change sign-out hasrelied on taped or written report whilephysically separated from the patient.

Table 2. SPEAK UP - Poster, The Joint Commission, 2007


There is minimal opportunity to ask ques-tions and the content is highly variableand inconsistent. It is an inefficientmethod, frustrating to both nurses andtheir patients. The Joint CommissionNational Patient Safety Goal #24 includesthe opportunity to ask questions duringsign out; thus, listening to taped reportafter the previous shift of nurses has de-parted will no longer be adequate.8 Theprinciples of SBAR communication, in-cluding a standardized content, use ofcritical thinking and an emphasis on planof care, offer the promise of decreasedadverse advents as well as improved pa-tient satisfaction. The focus for nursingsign-out becomes the anticipated patientcourse and what should be done, not sim-ply a description of what has already hap-pened. Paid time for handoffs involvingboth participants is already included inthe RN budgets at many hospitals (per-sonal communication).

There are additional hurdles to theintroduction of a standardized model ofnursing sign-out. Nurses traditionally usea narrative style and are not trained tomake diagnoses. Nurses are often notcomfortable discussing difficult or sensi-tive issues in front of patients. Sign-outtime is often utilized as a time for socialinteraction. These differences must beconsidered when SBAR is introduced andstaff must be involved in addressing thesebarriers.

Although the use of SBAR in UShospitals is growing, there is minimalpublished data of its effectiveness. Hos-

pitals utilizing SBAR report increasedsatisfaction from all participants and hos-pital-wide use of the technique has beenshown to improve medication reconcili-ation and decrease the rate of adverseevents.9 Although SBAR is likely to re-sult in improved information transfer,long-term advantages remain ill defined.

Communication between medicalprofessionals and their patients and fami-lies has also suffered. In the hectic pace oftoday’s hospital medicine, the simple act ofupdating patients is too often overlooked.Patient satisfaction data routinely cites com-munication with the healthcare team asproblematic.10 A recent study evaluatingcommunication in the outpatient settingrevealed that physician-patient communi-cation errors were associated with a lack ofpatient participation in the decision-mak-ing process in terms of voicing expectationsor responses to their doctor’s recommen-dations.11 In response to the Joint Com-mission recommendation, Rhode IslandHospital has launched a Speak UpTM (Table2) campaign urging patients to participateactively in their healthcare. Posters and bro-chures in multiple languages throughoutthe hospital advertise these efforts.

A laudable practice gaining momen-tum in the United States is nursing sign-out at the patient bedside, including a dis-cussion with the patient to make sure s/heunderstands the discharge plan and post-discharge treatment plan. Such a standardwould not only improve patient satisfaction,but also patient safety. Bedside rounds inthe ICU with the entire healthcare team12

have had an equally positive impact and isthe practice at Rhode Island Hospital.

Although nursing and physicianleadership recognizes the importance ofcommunication, the front-line worker isoften unaware of its role in patient safety.Education remains the key to successfulimplementation of any change in prac-tice; thus, efforts must be aimed at im-proving communication at all levels toaffect a change to a culture of patientsafety. This represents a significantchange in the culture of medicine, na-tionally, as well as locally in Rhode Island.Incorporation into daily practice will bea slow, but ultimately successful process.

REFERENCES1. Institute of Medicine. To err is human: Building

a safer health system. Washington, DC: NationalAcademy Press; 1999.

2. VA National Center for Patient Safety. NCPSMedical Team Training Program, Executive Sum-mary, April 2006.

3. Hoffman J. CRICO’s Handoff-related Malprac-tice Cases. CRICO/RMF Forum, March 25(1):4,2007.

4. Joint Commission on Accreditation of HealthcareOrganizations. National Patient Safety Goals for2006 and 2007.

5. Patterson ES, Roth EM, et al. Handoff strategiesin settings with high consequences for failure:lessons for heath care operations. Internat J forQuality Health Care 2004; 16:125-32.

6. Petersen LA, Brennan TA, et al. Does housestaffdiscontinuity of care increase the risk for prevent-able adverse events? Ann Intern Med 1994; 121:866-72.

7. Cook RI, Render M, Woods DD. Gaps in thecontinuity of care and progress on patient safety.BMJ 2000;320:791-4.

8. JCAHO’s 2006 National Patient Safety Goals:Handoffs are biggest challenge. Hospital Peer Re-view 2005;30:89-93.

9. Leonard M, Graham S, Bonacum D. The humanfactor. Qual Saf Health Care.2004 Oct;13 Suppl1:i85-90.

10. Boyle DK, Miller PA, Forbes-Thompson SA. Com-munication and end-of-life care in the intensivecare unit: patient, family, and clinician outcomes.Crit Care Nurs Q. 2005;28:302-16.

11. Barry CA, Bradley CP, et al. Patients’ unvoicedagendas in general practice consultations. BMJ2000;320(7244):1246-50. Erratum in: BMJ2000;321(7252):44.

12. Anderson CD, Mangino RR. Nurse shift report.Nurs Adm Q. 2006;30:112-22.

Melinda Morin, MD, is Director,Patient Safety Program, Rhode Island Hos-pital.

CORRESPONDENCE:Melinda Morin, MDRhode Island Hospital593 Eddy StProvidence, RI 02903Phone: (401) 444-4201e-mail: [email protected]


Rhode Island Supreme Court Affirms Limited Natureof Peer-Review Privilege

Lawrence M. Kraus, JD, and Lawrence W. Vernaglia, JD, MPH�In its recent opinion in Pastore v. Samson1,the Rhode Island Supreme Court reaf-firmed its view that the “peer-reviewprivilege” offers a limited protection tocertain information created by properlyconstituted peer-review boards. Theopinion provides useful guidelines as tothe type of information that may be pro-tected from disclosure to plaintiffs andother parties seeking information pre-sented at and created by peer-reviewboards. As will be discussed, the prin-ciple message from Pastore is that thepeer-review privilege is quite limited, andthat physicians and hospitals should bemindful that not everything they mayconsider as “peer-review privileged” ma-terial actually is protected from discov-ery.

A “Discovery Melee”Pastore’s estate commenced this law-

suit against Dr. Samson, a fellow doctor,and Kent County Memorial Hospital fol-lowing Mr. Pastore’s death on July 12,1998. The plaintiff ’s complaint allegedthat Pastore died as a result of negligentcare delivered by the defendant doctors.In addition to the medical malpracticeclaims against the doctors, the plaintiffalleged that the Hospital had negligentlycredentialed and granted privileges toDr. Samson.

The lawsuit descended in what theCourt termed a “discovery melee,” inwhich the “discovery phase stalled asplaintiff and the hospital engaged in alengthy battle over certain hospitaldocuments concerning Dr. Samson.” Atissue were 750 pages that the Hospitalclaimed were protected by the peer-re-view privilege, as well as other confiden-tiality protections. The dispute reachedthe Supreme Court after numerous pro-ceedings in the lower court, stretching-out over more than two and a half years.The specific ruling on appeal was thetrial court’s order rejecting theHospital’s claims of privilege, and order-ing that all 750 pages be turned over toplaintiff.

The Supreme Court affirmed theproduction of all but one page of thedocuments—and even that one page wasordered to be produced with certain in-formation removed.

THE PEER-REVIEW PRIVILEGE IS“STRICTLY CONSTRUED” ANDLIMITED

In its analysis, the Court first re-viewed the Rhode Island statutes thatcreate the peer-review privilege as well asits past opinions interpreting the privi-lege. The Court noted that “two similaryet distinct Rhode Island statutes affordproviders of health care the peer-reviewprivilege,” “which create a privilege forthe ‘proceedings’ and ‘records’ of peer-review boards, such that those documentsshall not be subject to discovery or beadmissible in evidence.” The Court iden-tified the principle underlying the peer-review privilege as “the social importanceof open discussions and candid self-analy-sis in peer–review meetings to ensure that

medical care of high quality will be avail-able to the public.” Based on this prin-ciple, the Court has ruled in the pastthat—in the proper circumstances—ahospital is entitled to withhold “all recordsand proceedings before a peer-reviewboard,” even as pertaining to the alleg-edly negligent treatment delivered to aplaintiff himself.

Having done so, however, the Courtfocused the bulk of its opinion on justhow limited this protection is. Relying

in part on past precedent, the Courtstressed that this privilege is to be “strictlyconstrued” because it prevents potentiallyrelevant evidence from being brought tolight.2 “The privilege must not be per-mitted to become a shield behind whicha physician’s incompetence, impairment,or institutional malfeasance resulting inmedical malpractice can be hidden fromparties who have suffered because of suchincompetence, impairment, or malfea-sance.” In doing so, the Court explicitlyrejected the Hospital’s argument thatbecause the privilege serves the sociallybeneficial “remedial” purpose of improv-ing the quality of medical care, it shouldbe broadly interpreted and applied.

SPECIFIC EXAMPLES OFAPPLICATION OF PEER-REVIEWPRIVILEGE

Having interpreted the scope of theprivilege in general, the Court thenturned to the specific examples presentedby the case.3 The results are instructiveas to how limited the privilege is.

The first document considered wasa 51-page transcript of the proceedingsof a committee meeting “arising from acomplaint about Dr. Samson’s bedsidemanner while working in the emergencyroom[,]” much of which focused on in-teractions with the patient and familymembers. Despite conceding that thetranscript was from a proceeding beforea hospital committee—a necessary pre-requisite for the privilege to apply—theCourt examined “whether a committeeinvestigating the bedside manner of adoctor qualifies as a peer-review board.”

It does not. The Court held that thebedside manner of the Doctor was insuf-ficiently related to the purposes of thestatute to protect the transcript by theprivilege. “The [lower court’s] distinc-tion between a doctor’s bedside mannerand the actual medical care that a doctoradministers strikes us as sensible. Thepeer-review privilege was designed to al-leviative an increase in medical malprac-tice lawsuits for substandard health care,

You should notbelieve that extensive

documentation orinformation can beprotected merely

because it is labeled“peer-review

privilege.”


not to reduce the number of rude oruncompassionate health-care profession-als – although the latter is certainly a com-mendable objective.” Because the com-mittee was not engaged in the sort of in-vestigation that sufficiently met the ob-jectives of the statute, the Court agreedthat it was not a “peer-review board,” andordered the transcript to be produced.

The second document consideredwas a one-page report from a peer-reviewboard that “focused not on Dr. Samson’sbedside manner, but on whether or nothe timely responded to a patient whoneeded care.” This document thereforeclearly constituted a “record” of a peer-review board, and certain information init was therefore protected by the peer-review privilege.

Notably, however, even here theCourt did not say that the entire singlepage document could be withheld. In-stead, it held that any restriction of thephysician’s privileges, as well as the list ofdoctors attending the meeting, were allsubject to disclosure. “Accordingly, thisreport is not privileged, and is discover-able, so long as it is redacted to cloak thesummary of key items discussed in themeeting.”

GUIDELINES REGARDING SCOPE OFPRIVILEGE

Pastore highlights the limited natureof the peer-review privilege. The follow-ing are some guidelines to be aware of:

• While the peer-review privilege ex-ists, it is strictly construed. Youshould not believe that extensivedocumentation or information canbe protected merely because it is la-beled “peer-review privilege.”

• Only “records” and “proceedings”of peer-review boards are pro-tected, and not “documents orrecords otherwise available fromoriginal sources.” In other words,materials that were created outsidethe peer-review body – including,for example, patient records – arenot protected merely because theyhave been brought into peer-re-view.4

• Similarly, the privilege only appliesto information generated by peer-review bodies, and not, for example,“records made in the regular courseof business by a hospital.”

• The identities of persons participat-ing in peer-review are discoverable.

• The privilege prevents peer-reviewparticipants from testifying as to“findings, recommendations, evalu-ations, opinions, or other actions ofthe board,” but the imposition of arestriction of privileges or a require-ment of supervision is not privi-leged and is subject to discovery.

In short, Pastore demonstrates thatthe peer-review privilege is alive in RhodeIsland—it just might not be as protec-tive as you think.

REFERENCES1. The case citation is 900 A.2d 1067RI2006.2. The Court noted that “[p]rivileges, by their na-

ture, ‘shut out the light’” on “the ascertainmentof the truth.”

3. The Court noted with some chagrin the fact that750 pages of materials were at issue, the hospital’slawyers only discussed 2 documents, as a resultlimiting the Court’s analysis to those two docu-ments.

4. In fact, the Court ruled that if the hospital hassuch original documents in its possession, it shouldbe required to produce them, and that the Plain-tiff was not required to seek them from anotheroriginal source.

Lawrence M. Kraus, JD, is a partnerwith Foley & Lardner LLP.

Lawrence W. Vernaglia, JD, MPH, isan attorney specializing in health carewith Foley & Lardner LLP.

CORRESPONDENCELawrence W. Vernaglia, JD, MPHFoley & Lardner LLP111 Huntington AvenueBoston, MA 02199Phone: (617) 342-4070e-mail:[email protected]


Trends In Tobacco Use (1990-2006) and Patterns ofTobacco Use Among Rhode Island Adults in 2006

Jana Hesser, PhD, Yongwen Jiang, PhD, and Seema Dixit, MS, MPH

RHODE ISLAND DEPARTMENT OF HEALTH • DAVID GIFFORD, MD, MPH, DIRECTOR OF HEALTH EDITED BY JAY S. BUECHNER, PHD

Tobacco use is the single leading cause of preventable illnessand death in the United States and in Rhode Island.1 Eachyear, more than 435,000 Americans and approximately 1,900Rhode Islanders die prematurely from smoking- related dis-eases. Annual health care costs in Rhode Island directly causedby smoking are estimated to be $506 million,2 not countingcosts linked to exposure to secondhand smoke, smoking-causedfires, spit tobacco use, or cigar and pipe smoking.2

This report presents survey data on the trend in cigarettesmoking among Rhode Island adults from 1990 – 2006, andon the patterns of adult tobacco use and associated health risksin Rhode Island in 2006.

METHODSTobacco use rates were calculated using self-reported data

from Rhode Island’s Behavioral Risk Factor Surveillance Sys-tem (BRFSS), a telephone survey administered in all 50 statesand 4 US territories with funding and specifications from theCenters for Disease Control and Prevention (CDC).3 TheBRFSS monitors the population ages 18 and older for access tohealth care, certain health conditions, and behaviors that con-tribute to the leading causes of disease and death in the US,including tobacco use. Rhode Island has participated in theBRFSS since 1984.

From 1990 to 1997, Rhode Island’s BRFSS had an an-nual sample size of approximately 1,800. Between 1998 and2005, RI’s BRFSS sample size varied between 3,600 and 4,500.Each year’s data are weighted to be representative of the age,sex and race composition of Rhode Island’s adult population.

The BRFSS has asked the same “core” tobacco questionseach year since 1990. A person is identified as a “currentsmoker” if he/she had ever smoked 100 cigarettes and nowsmokes every day or some days. “Sedentary lifestyle” is de-fined as engaging in no leisure time physical activ-ity or exercise in the past 30 days. “Chronic drink-ing” is defined for men as consuming 2 or morealcoholic drinks each day; for women, 1 or morealcoholic drinks each day. Indicators of poor qual-ity of life or poor mental health include: 14 or moredays in the past month of pain-related activity limi-tations, lack of sleep, lack of energy, poor mentalhealth, feeling sad/blue/depressed, and feeling wor-ried/tense/anxious.4 Two other mental health in-dicators are having “ever been told you have ananxiety disorder”, and having “ever been told youhad a depressive disorder”. “Error” bars on thecharts represent the 95% confidence limits aroundthe estimates.

RESULTSSmoking trend, 1990 - 2006

From 1990 to 2006, smoking rates among RI adultsdropped from 25.6% to 19.2%. (Figure 1) Between 1992and 2001, annual rates fluctuated between 22% and 25%.Since 2001 smoking rates have dropped in each successive year.

Current smoking in 2006About 1 of every 5 adults in Rhode Island, or roughly

160,000 persons, is a current cigarette smoker. There is nosignificant difference in smoking rates between men andwomen. Smoking rates are highest among adults ages 18 – 24(35%), non-White non-Hispanics (26%), adults who are notcollege graduates (25%), adults in households with incomesless than $25,000 (28%), never married and divorced/sepa-rated adults (28%), and among persons either unemployed(28%) or unable to work (37%). The lowest smoking rates areassociated with being 65 or older (9%), being a college gradu-ate (10%), or having a household income of $50,000 or more.(Figure 2) More than half (60%) of all smokers reported thatthey quit smoking for one day or longer during the past year.(Figure 3)

Smokers are at greater risk than non-smokers for having asedentary lifestyle (35% vs 22%). Eleven percent of smokersare chronic drinkers compared with 5% of other adults. Agreater proportion of smokers than non-smokers lack access todental care (29% vs 17%) and to a regular medical provider(25% vs 11%). (Figure 3)

Smokers have higher rates than non-smokers for each of 8 in-dicators of poor quality of life and poor mental health. (Figure 3)Almost one-third of smokers had been told they had a depres-sive disorder at some time in their lives; nearly one-quarter hadbeen told they had an anxiety disorder at some time in their life.

Figure 1. Annual current smoking prevalence, ages 18 and older,Rhode Island, 1990 – 2006.


bacco use, aiming specifically to reduce youth initiation of to-bacco use, to eliminate exposure to second hand smoke, and topromote cessation.

REFERENCES1. Mokdad, AH, Marks JS, et al. Actual Causes of Death in the United States,

2000. JAMA 2004; 291, ( 10).2. The Toll of Tobacco in Rhode Island. Campaign for Tobacco Free Kids Website

http://tobaccofreekids.org/reports/settlements/toll.php?StateID=RI3. Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor

Surveillance System. http://www.cdc.gov/brfss4. CDC Health-Related Quality of Life: http:// www.cdc.gov/hrqol.5. Lasser K, Booyd JW, et al. Smoking and Mental Illness. A Population-Based

Prevalence Study. JAMA 2000; 284, (20).

ACKNOWLEDGEMENTData Source: Rhode Island Behavioral Risk Factor Surveil-

lance System, 1990 - 2006, Center for Health Data and Analysis,Rhode Island Department of Health, and supported in part bythe National Center for Chronic Disease Prevention and HealthPromotion, Centers for Disease Control and Prevention Coopera-tive Agreements U58/CCU100589 and U58/CCU122791.

Jana Hesser, PhD is Program Director, Health Surveys, andBRFSS Project Director, Center for Health Data and Analysis,Rhode Island Department of Health, and a Clinical AssistantProfessor of Community Health, The Warren Alpert MedicalSchool of Brown University.

Yongwen Jiang, PhD is a Public Health Epidemiologist, Cen-ter for Health Data and Analysis, Rhode Island Department ofHealth and a Clinical Assistant Professor of Community Health,The Warren Alpert Medical School of Brown University.

Seema Dixit, MS, MPH, is Program Manager, Tobacco Con-trol Program, Division of Community Health and Equity, RhodeIsland Department of Health.

Figure 2. Current smoking among Rhode Island adults (ages 18and older) within demographic subgroups, 2006.

More than a third of smokers, compared with about a quarter ofnon-smokers, reported not getting enough sleep for 14 or moredays in the past month or not feeling very healthy or full of en-ergy. (Figure 3)

DISCUSSIONThe state of Rhode Island has enacted measures to dis-

courage tobacco use. The state has increased cigarette taxes eachyear since 1994. The most recent increase of $.75 per pack,enacted in 2004, brought the retail price to $6.10 per pack in2005 (compared to $1.84 in 1994). The Rhode Island SmokeFree Public Place and Workplace Law, which went into effectMarch 1, 2005, banned smoking in all public and workplaces.Rhode Island was the seventh state to do so. In 2006 the legis-lature mandated tobacco treatment coverage by all state healthinsurers, both public and private. During February 2005, justprior to implementation of the public and workplaces smok-ing ban, and during March 2005, the Health Department’s1-800-Try-To-Stop line received about 1,500 calls each month,an eight-fold increase in the number of calls received frompeople wanting to stop smoking.

Although smoking rates in Rhode Island’s adult popula-tion overall have been decreasing since 1990, smoking ratesamong some demographic groups remain high. Smokers areat increased health risk due to sedentary lifestyles, chronic drink-ing, and poor mental health. The poor mental health of smok-ers observed in the BRFSS data is substantiated by other stud-ies. 5 One report estimates that “the mentally ill carry the bur-den of nearly half of all US tobacco consumption”.5

Using nationally proven best practices, the Rhode IslandTobacco Control Program (RITCP) works in partnership withcommunity based organizations, voluntary agencies, health careproviders, and state-wide partners to prevent and control to-

Figure 3. Health risks among Rhode Island adults by smokingstatus, 2006.


Atypical Antipsychotics for the Treatment ofDementia-Related Behaviors: An Update

Lori A. Daiello, PharmD

ADVANCES IN PHARMACOLOGY

Dementing illnesses are frequently associated with agitation,hallucinations, delusions and aggression. While loss of cogni-tive and functional abilities is distressing both to patients withAlzheimer’s Disease (AD) and their caregivers, the psychiatricaspects are often cited as the precipitating factor for nursinghome placement.1

The most frequently used, but least descriptive, term forthe behavioral symptoms of dementia is “agitation.” Cohen-Mansfield describes agitation as inappropriate verbal, vocal, ormotor activity that does not result from identified need.2 “Agi-tated” behaviors may include aggression, anxiety, phobias, di-urnal rhythm disturbance, and motor restlessness.

Antipsychotic drugs have been the primary treatment forpsychosis, agitation, and aggression in AD and other dementiasfor decades, although it was never clear if the drugs improvedthe behavior or provided a “chemical straitjacket” that reducedall behavior. The conventional antipsychotics such as haloperi-dol have been supplanted by four of the newer or “atypical”antipsychotic drugs (risperidone, olanzapine, quetiapine,aripiprazole), although no medication has an FDA indicationfor the treatment of behavioral symptoms in patients with de-mentia.

The prescribing of antipsychotics for neuropsychiatricsymptoms was stimulated by observations that psychosis ispresent in many patients with AD who exhibit agitated andaggressive behaviors. However, the biological basis of psychoticsymptoms in dementia is not well understood and likely differsfrom underlying mechanisms hypothesized for psychotic dis-orders such as schizophrenia.3

Widespread use of atypical antipsychotics for psychosis andother dementia-related behaviors preceded the availability ofan evidence base because of the perception of superior effec-tiveness and safety of these drugs over the older antipsychotics.Over the past 3 years, some placebo-controlled clinical trials ofatypical antipsychotics for behavioral symptoms reported smalltreatment effects coupled with troubling adverse effects at ratesthat exceeded those observed in placebo-treated patients. Re-ports of increased risk of mortality and cerebrovascular acci-dents in some trials of atypical antipsychotics in dementia popu-lations resulted in FDA-mandated changes to product label-ing for all atypical antipsychotic medication despite the factthat not all of drugs in the class have been studied in dementiapopulations.4, 5 Controversies sparked by these changes andrecent clinical trial results fuel debate about the appropriateprescribing of these medications.

Other classes of psychoactive medications (typicalantipsychotics, antidepressants, benzodiazepines, andanticonvulsants) are utilized in the treatment of neuropsychi-

atric symptoms, but have not been as well studied as atypicalantipsychotics in dementia patients.6 In light of the FDA warn-ings, potential medico-legal implications, and new clinical data,clinicians should understand the current data for atypical an-tipsychotic prescribing in patients with dementia. This articlesummarizes the 2 most recent publications on the efficacy andsafety of atypical antipsychotic medications used in the treat-ment of agitation, psychosis and other behavioral symptoms.

CLINICAL ANTIPSYCHOTIC TRIALS OF INTERVENTIONEFFECTIVENESS – ALZHEIMER’S DISEASE (CATIE-AD)

CATIE-AD is the first head-to-head, prospective, random-ized, double-blind, placebo-controlled effectiveness trial of an-tipsychotic therapy in AD. The unique design measured out-comes associated with real-world prescribing of these medica-tions to treat behavioral symptoms.7 In the initial, 36-week phaseof the study, community-dwelling patients with mild-severe ADand behavioral symptoms (delusions, hallucinations, aggression,

Table 1.Outcomes- EffectivenessOverall effectiveness (as measured by the time to drug dis-continuation) was similar for olanzapine, risperidone,quetiapine, and placebo• Time to discontinuation for lack of efficacy was signifi-

cantly longer for olanzapine (22.1 weeks) andrisperidone (26.7 weeks) groups than in the placebogroup (9.0 weeks)

• Discontinuation for intolerance of study drug, adverseeffects or death was greater for all groups receivingactive treatment (olanzapine (24%); risperidone (18%);quetiapine (16%)) than placebo (5%) treated patients

• Except for quetiapine (56.5 mg), mean daily dosagesfor olanzapine (5.5 mg) and risperidone (1.0 mg) atendpoint were within the usual dose range for treat-ment of neuropsychiatric symptoms in dementia stud-ied in earlier trials. The optimal therapeutic dose ofquetiapine remains unclear. While daily doses of 75-150mg are often prescribed, the dose range in 3 de-mentia clinical trials varied from 25-600mg.8

Outcomes-Safety• Confusion and psychotic symptoms were observed at

significantly higher rates with olanzapine than with pla-cebo or the other antipsychotics.

• Treatment emergent Parkinsonism was more commonin patients receiving olanzapine or risperidone.

• Sedation occurred more frequently with active treat-ment than with placebo for all antipsychotics.

• Despite higher rates of Parkinsonism and sedation inthe treatment groups, there were no differences in theincidence of falls, fractures or injuries across all treat-ment groups.


agitation) of at least moderate severity were randomized to ei-ther olanzapine (N=100), risperidone (N=85), quetiapine (n=94)or placebo (N=142). Aripiprazole and ziprasidone were not in-cluded in the study because they were not available in the US atthe time the trial was designed. The multi-center trial was fundedby the National Institutes of Mental Health.

Physicians could adjust the dosage throughout the trial.Participants who adequately responded could continue the trialup to 36 weeks. If the patient’s response assessed as inadequatefor any reason after the initial 2 weeks of therapy, treatmentcould be discontinued. Patients whose therapy was discontin-ued could enter phase 2 of the trial to be randomized to one ofthe other antipsychotics or citalopram under double-blind con-ditions. To date, only phase 1 data have been published.

The primary outcome was time to discontinuation of treat-ment for any reason in Phase 1 of the study. This type of novel out-come allowed the composite effect (efficacy, tolerability, caregiverburden) of the interventions to be evaluated and compared.

The study population was moderately cognitively impaired(MMSE 15±5.8) with a mean age of 77.9 ±7.5 years. Baselinebehavioral symptoms were moderately severe and 60% of thesubjects received adjunctive cholinesterase inhibitor therapyupon study entry.

Treatment of psychiatric illness such as schizophrenia orbipolar disorder with some atypical antipsychotics has beenassociated with weight gain and metabolic abnormalities suchas hyperglycemia, hyperosmolar coma, Type 2 diabetes, andhyperlipidemia in younger individuals. It is unknown whetherthis phenomenon is a class effect, or a consequence of an inter-

action of antipsychotics with thecomplex diathesis of psychiatric ill-ness, genetics, and dietary factors.Clozapine and olanzapine appearto be most commonly associatedwith metabolic adverse effects andaripiprazole and ziprasidone theleast implicated. In schizophreniaand bipolar disease trials,risperidone and quetiapine haveintermediate effects on weight gainand metabolic parameters.9

CATIE-AD was the first head-to-head trial to explore the associa-tion between atypical antipsychotictreatment and development ofmetabolic adverse effects in olderadults with AD. Subjects receivingolanzapine, quetiapine, orrisperidone averaged a monthlyweight gain of 1.0, 0.7 and 0.4pounds on treatment, compared toweight loss among placebo-treatedpatients. Neither the changes inweight nor the mean changes inblood glucose, total cholesterol, ortriglyceride levels were statisticallysignificant for the active treatmentgroups compared with changes in

the placebo group. The modest weight gain and lesser changesin metabolic indices are consistent with data from other pla-cebo-controlled clinical trials of atypical antipsychotics in de-mentia and may reflect the dementia-related changes in pro-tein and carbohydrate metabolism that blunt antipsychotic ef-fects on appetite, weight, and lipid metabolism.10

Analyses of pooled clinical trial data have linked atypicalantipsychotic treatment of behavioral symptoms in patients withdementia to an increased risk of cerebrovascular adverse events(CVAE) and increased mortality. The discovery of the increasedrisk of mortality in pooled data from risperidone, olanzapine,quetiapine, and aripiprazole placebo-controlled dementia tri-als led the FDA to add a black box warning to the productlabeling for all atypical antipsychotics in 2005. The labelingfor olanzapine and risperidone also includes a warning aboutthe increased risk of CVAE.

There were no observed differences in the rates of strokeor sudden death between the groups receiving atypical antip-sychotic treatment and placebo-treated patients in CATIE-AD.The lack of a signal for increased incidence of stroke or risk ofmortality with atypical antipsychotic therapy is not surprisingwhen considering the differences between the dementia popu-lation studied in CATIE-AD and the populations under studyin the short-term (6-12 week) antipsychotic dementia trials.Many of the atypical antipsychotic trials included dementiapatients with significant cardiovascular risk factors; some in-cluded frail nursing home patients who were likely at higherrisk of adverse medication-related outcomes.8


AGENCY FOR HEALTHCARE RESEARCH AND QUALITY(AHRQ) EFFICACY AND COMPARATIVEEFFECTIVENESS OF OFF-LABEL USE OF ATYPICALANTIPSYCHOTICS

This AHRQ analysis, published online in January 2007,retrospectively reviewed efficacy and safety data related to the4 most common off-label uses for the atypical antipsychotics -treatment of agitation in dementia, depression, obsessive-com-pulsive disorder, posttraumatic stress disorder, personality dis-orders, and Tourette’s syndrome.11

Data for the agitation in dementia analysis were drawnfrom randomized, controlled trials in dementia, including theCATIE-AD trial. Conclusions about the relative effectivenessof risperidone, olanzapine, quetiapine, and aripirazole were ingeneral agreement with results of a recently published meta-analysis of 15 placebo-controlled atypical antipsychotic trialsthat reported small but significant benefits on agitation andpsychosis for risperidone and aripiprazole.A trend favoring the effectiveness ofolanzapine for psychosis in dementia thatdid not reach statistical significance wasalso noted. The 3 quetiapine trials weretoo different in design and outcome mea-sures to be analyzed and compared. Therewere no trials of ziprasidone in patientswith dementia.

Table 2 summarizes the AHRQanalysis of safety data. The group did notanalyze trial-related mortality data, butcited a recently published meta-analysisthat included15 placebo-controlled trialsof risperidone, olanzapine, quetiapine, and aripiprazole. Riskof death was increased relative to placebo (odds ratio = 1.54(95% CI 1.06-2.23)) for patients with dementia randomizedto one of the four antipsychotics. The authors concluded thata small, but statistically significant increase in risk of death isassociated with use of atypical antipsychotics in dementia; how-ever, there is insufficient evidence to determine differential riskbetween antipsychotics.

Conventional antipsychotics may also increase the risk ofdeath in older adults. AHRQ’s Developing Evidence to In-form Decisions (DEcIDE) program analyzed health care uti-lization data for British Columbia adults > 65 years to studythe association between use of conventional and atypicalantipsychotics and death. Those who were prescribed conven-tional antipsychotics had a 35% greater mortality risk fromfatal outpatient cardiac events, pneumonia, and stroke com-pared to patients who were prescribed atypical antipsychotics.11

PARSING POTENTIAL BENEFITS VERSUS RISKSSubgroup analyses across atypical antipsychotic trials in-

dicate that larger effect sizes are associated with greater cogni-tive impairment, residence in nursing home, and the presenceof severe agitation without psychosis. These results concur witholder studies of conventional antipsychotics in hospitalized pa-tients with dementia which reported that more robust treat-ment effects were associated with greater severity of agitationand aggression at baseline.8

A post hoc analysis of pooled data from 6 trials comparingolanzapine to placebo, risperidone, or haloperidol is the onlypublication that has attempted to identify the patient-specificrisk factors associated with mortality and CVAEs in dementiaclinical trials.5 Kryzhanovskaya et al reported that advancedage (age=80), treatment emergent sedation, benzodiazepineuse, and treatment-emergent pulmonary conditions were ad-ditional risk factors for mortality in olanzapine-treated patients.

The group’s analysis of the CVAE data revealed that forpatients receiving either olanzapine or placebo, age > 80 yearsand diagnosis of mixed or vascular dementia were significantlyassociated with CVAE. Orthostatic hypotension and genderwere not significant risk factors.

SUMMARYAtypical antipsychotics will continue to be prescribed for

the behavioral symptoms of dementia in the absence of moreeffective, better tolerated, and safer alter-natives. The evidence base, although in-complete, suggests that modest treatmenteffect sizes are offset by risk of considerableadverse effects. How might this informa-tion be best applied to clinical practice?

Non-pharmacologic strategies shouldbe implemented in routine clinical prac-tice. Placebo-controlled clinical trials ofindividual antipsychotic agents have his-torically reported high placebo responserates; CATIE-AD reported that the sumtotal of the risk/benefit equation of atypi-cal antipsychotic therapy was no greater

than that achieved by placebo.CATIE-AD was designed to study the effectiveness of atypi-

cal antipsychotic treatment in community dwelling patients withAD. It is uncertain whether the results can be generalized to thepopulations of dementia patients residing in nursing homes withmore severe cognitive and behavioral impairment. There is somesuggestion that nursing home patients with dementia compli-cated by severe behavioral symptoms, particularly agitation andaggression without accompanying psychosis, might achievegreater benefit from atypical antipsychotic treatment than pa-tients with milder behavioral symptoms. The finding that de-mentia patients without psychosis may respond more robustly toantipsychotic treatment seems counterintuitive, but may supportthe hypothesis that the neurobiology of the “psychosis of AD”differs from the psychosis of schizophrenia or bipolar disease.3, 8

Adverse effects associated with antipsychotic therapyshould be aggressively monitored throughout therapy. Treat-ment-emergent sedation was associated with all of the atypicalantipsychotics in CATIE-AD and is probably an importantmediator of mortality risk in patients with dementia. Sedationexacerbates pre-existing cognitive impairment and increases therisk of complications such as aspiration pneumonia, so con-comitant use of benzodiazepines should be discouraged or lim-ited to short periods with careful observation.5

Once initiated, the effectiveness and tolerability of antip-sychotic therapy should be evaluated routinely. In Alzheimer’sdisease, the severity and frequency of behavioral symptoms of-

The evidence base,although incomplete,

suggests thatmodest treatment

effect sizes areoffset by risk of

considerable adverseeffects.


ten decreases as illness progresses. In a stable patient, it is pru-dent to attempt to taper and discontinue the antipsychotic af-ter 2-8 months of therapy.12

Better understanding of the potential adverse effects ofantipsychotic therapy has increased interest in the effects ofthe dementia-specific medications on behavioral symptoms.Reductions in neuropsychiatric symptoms have been reportedfrom trials of individual cholinesterase inhibitors, memantinemonotherapy, and memantine combined with donepezil in ADpatients.13, 14 Studies of small numbers of patients in open trialsof cholinesterase inhibitors (donepezil, rivastigmine,galantamine) and one double-blind placebo controlled trial(rivastigmine) have reported varying degrees of improvementof behavioral symptoms and psychosis of dementia with Lewybodies (DLB).15 Delusions, hallucinations, apathy, and agita-tion/aggression are cited as the symptom categories most likelyto show significant improvement.13 Since few of these studieswere prospectively designed to study behavioral symptoms, re-sults must be interpreted cautiously.

Treatment of behavioral symptoms in AD and otherdementias is challenging. The limitations of current approachesdrive the search for effective, well tolerated therapies.

REFERENCES1. Franco KN, Messinger-Rapport B. Pharmacological treatment of neuropsy-

chiatric symptoms of dementia. J Am Med Dir Assoc 2006;7:201-2.2. Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a

nursing home. J Gerontol 1989;44:M77-84.3. Meeks TW, Ropacki SA, Jeste DV. The neurobiology of neuropsychiatric syn-

dromes in dementia. Curr Opin Psychiatry 2006;19:581-6.4. Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic

drug treatment for dementia. JAMA 2005;294:1934-43.5. Kryzhanovskaya LA, Jeste DV, et al. A review of treatment-emergent adverse

events during olanzapine clinical trials in elderly patients with dementia. J ClinPsychiatry 2006;67:933-45.

6. Sink KM, Holden KF, Yaffe K. Pharmacological treatment of neuropsychiatricsymptoms of dementia. JAMA 2005;293:596-608.

7. Schneider LS, Tariot PN, et al. Effectiveness of atypical antipsychotic drugs inpatients with Alzheimer’s disease. NEJM 2006;355:1525-38.

8. Schneider LS, Dagerman K, Insel PS. Efficacy and adverse effects of atypicalantipsychotics for dementia. Am J Geriatr Psychiatry 2006;14:191-210.

9. Newcomer JW, Nasrallah HA, Loebel AD. The Atypical Antipsychotic Therapy andMetabolic Issues National Survey. J Clin Psychopharmacol 2004;24(5 Suppl 1):S1-6.

10. Fillit H, Ding WH, et al. Elevated circulating tumor necrosis factor levels inAlzheimer’s disease. Neurosci Lett 1991;129:318-20.

11. Shekelle P MM, Bagley S, et al. Comparative effectiveness of off-label use ofatypical antipsychotics. Comparative Effectiveness Review No. 6.: Agency forHealthcare Research and Quality. Rockville, MD; 2007.

12. Alexopoulos GS, Katz IR, et al. The expert consensus guideline series. Pharma-cotherapy of depressive disorders in older patients. Postgrad Med 2001;SpecNo Pharmacotherapy:1-86.

13. Cummings JL, Schneider E, et al. Behavioral effects of memantine in Alzheimerdisease patients receiving donepezil treatment. Neurol 2006;67:57-63.

14. Birks J. Cholinesterase inhibitors for Alzheimer’s disease. Cochrane DatabaseSyst Rev 2006:CD005593.

15. Bhasin M, Rowan E, et al. Cholinesterase inhibitors in dementia with Lewybodies-a comparative analysis. Int J Geriatr Psychiatry 2007.

Lori A. Daiello, PharmD, BCPP, is a Postdoctoral Demen-tia Research Fellow, at The Warren Alpert Medical School ofBrown University, and at The Alzheimer’s Disease and MemoryDisorders Center, Rhode Island Hospital.

CORRESPONDENCELori A. Daiello, PharmD, BCPPAPC 670Rhode Island Hospital593 Eddy St.Providence, RI 02903Phone: (401) 444-3337e-mail: [email protected]


The Management of Insomnia in the Older AdultAna C. Tuya, MD

GERIATRICS FOR THEPRACTICING PHYSICIANDivision of Geriatrics Quality Partners of RI

Department of Medicine EDITED BY ANA C. TUYA, MD

An 88 year-old man contacts the on-call physician on aSaturday afternoon with a chief complaint of being unable to fallasleep for three nights; he requests a new prescription to help himsleep. He has been on trazodone 75 mg for several years and takes itnightly, but it has not been effective for sometime. He has a medicalhistory of hypertension and hyperlipidemia, for which he takesmetroprolol, aspirin, atorvastatin, and a daily multivitamin. He is ac-tive, walks 2-miles daily, drives and is independent in ADL and IADL.He does not smoke or drink alcohol. What should the on-call physi-cian do—increase the trazodone? Start a new sleep medication? Askthe patient to wait until Monday when he can talk to his physician?

Insomnia is exceedingly common in the older adult popu-lation; up to 33% use over the counter or prescription sleepaids, and close to 40% describe difficulty falling asleep.1 Con-tributing factors include changes in sleep architecture and cir-cadian rhythm, increased incidence of sleep disorders, and lifestressors unique to the older adult. As with so many other de-cisions in geriatrics care, the treatment must consider patients’multiple co-morbid diagnoses and long medication lists.

The first step in evaluating a patient with insomnia is to take adetailed sleep history—duration of symptoms, nap history, life situ-ation at start of symptoms, wake up times, bedtime, caffeine/alco-hol/fluid intake, activities done in bed before and after trouble sleep-ing, sleep room characteristics, medication use, and detailed reviewof systems and family history. Also useful is a review of the sleephygiene “do’s and don’ts”.2,3 Important medical diagnoses to ruleout by history and/or workup include sleep disorders (sleep apnea,restless leg syndrome, REM sleep behavior disorder) that are morecommon with aging. This evaluation may point toward focusedinterventions to improve sleep hygiene, or the need for diagnosticworkup to treat a sleep disorder. If neither of these results obtains,the next step is to decide whether to treat. If treatment is indicated,the choice is non-pharmacological versus pharmacological.

Studies showing that non-pharmacological treatment is effec-tive and long lasting abound. Interventions that have been proveneffective include stimulus control, bright light therapy, regular exer-cise, bathing before bed, cognitive therapy, sleep hygiene improve-ment, warm milk, back rub, and relaxation techniques. One par-ticularly interesting study evaluated patients with Alzheimer’s de-mentia and insomnia. In this randomized trial, one group of pa-tients and caregivers received extensive training and support on sleephygiene interventions, while the other group received one informa-tion session only, at the start of the study. After six months, theintervention group showed a significant trend toward increased sat-isfaction, with 50% reporting substantial benefit. The benefit con-tinued throughout the follow up period.4 The benefit was not onlyin satisfaction and self-reported benefit, but also in caregiver reportsof time awake and number of nighttime awakenings.

When non-pharmacologic therapy fails, or when urgent inter-vention is required to temporarily alleviate sleeplessness while non-pharmacologic therapy is being instituted, medications are oftenprescribed. There are several drug classes from which to choose;adverse reactions, efficacy, safety and interactions vary significantly.These sedative hypnotic medications are for short-term use. Moststudies follow patients for only a few months – long-term use by anygroup has not been evaluated in detail. One meta-analysis demon-strated that effectiveness of the benzodiazepines waned after twoweeks.5 Older, but still often used, these drugs are plagued by ad-verse reactions in the older adult population; for example, next-daysomnolence, dependence, dizziness, drug interactions, and increasedrisk of falls. This group is one of the drug classes listed among theBeer’s criteria of drugs to avoid using in the elderly due to unaccept-ably high adverse effects.6 For patients who have been on them foryears, it is recommended to wean them gradually.

Another popular choice among sedative hypnotics for sleephas been trazodone. Its use has exceeded that of zolpidem (Ambien),which is estimated at over 27 million prescriptions.7 It is reputedto be safe, effective, non-habit forming and more cost-effective.Of note, the use of trazodone (and mirtazepine, mentioned later)is off-label. A systematic review published in 2005 8 found 18studies in the literature for the period of 1980-2003 and includedall 18, regardless of inclusion or exclusion criteria, because of thesmall number. Of the studies included, only one was a random-ized placebo control trial on the use of trazodone in patients withprimary insomnia. The majority of the remaining studies evalu-ated its use in depression, and revealed improvement of insomniaas a secondary outcome.

The primary insomnia study examined 306 patients ages to 65who were randomized to zolpidem 10 mg, trazodone 50 mg, orplacebo. The effect of the drug was measured using a subjectivesleep questionnaire; follow up was for two weeks. At week one,there was improvement in both the zolpidem and trazodone group,compared with placebo. By week two, zolpidem was better thanplacebo, but trazodone improvement was not statistically significantcompared with placebo.8 In this study, follow up was short; and nopatients over age 65 were included. The remaining studies evalu-ated in this systematic review had small sample sizes, used muchhigher doses of trazodone (>150 mg) and were in depressed pa-tients. These results may not apply when trazodone is prescribed forprimary insomnia, especially in view of the much lower doses used.Safety analysis revealed several important side effects in significantproportions of subjects: drowsiness in 29%, dizziness in 21% andnext day fatigue in >10%. Less common but still disturbing adversereactions included orthostatic hypotension, priapism and QT inter-val prolongation. The question of tolerance, and whether increasingthe dose would restore the initial effect, was not addressed by this or

THE WARREN ALPERT MEDICAL SCHOOLOF BROWN UNIVERSITY


any study reviewed. Therefore, the evidence does not support thebenign profile that providers and the public have accepted.

Another commonly used medication is mirtazapine, an antide-pressant found to have significant sedation effect when used in de-pressed patients. It is similar to trazodone, and is used for insomniato capitalize on its side effect profile. It has also become a popularchoice among those who care for dementia patients who suffer fromboth insomnia and anorexia – increased appetite was another sideeffect noted when the drug was used in depressed patients. Ofnote, the side effects of increased appetite and sedation are typicallyseen with the lowest doses (7.5 mg or 15 mg). Case reports havedemonstrated clinical improvement in both insomnia and anorexiawhen the medication is used in Alzheimer’s patients.9 However, morerigorous studies of mirtazapine’s tolerance and safety profile in eld-erly patients are limited. A small study, examining its efficacy, notedthat 11% of patients discontinued use due to adverse events, 18%of which were falls.10 Caution should be used when prescribing thisagent for insomnia in older adults.

The newer drugs that capture the most media attention,and that patients request by name, are the “Z drugs,” whichinclude zaleplon (Sonata), zolpidem, and eszopiclone (Lunesta).One randomized trial compared zaleplon at 5 mg and 10 mgdoses to zolpidem 10mg and to placebo in 549 patients, all overthe age of 65.11 The results demonstrate better sleep quality inboth groups as compared to placebo. Adverse events were simi-lar in the four groups, with no increased adverse effects as com-pared to placebo. However, the follow up time was only twoweeks. Another group of authors reviewed the literature to com-pare the effectiveness of the Z drugs to placebo, and included24 trials.12 Their final conclusions reflected disappointment: moststudies had small sample size, poor methodologic quality, and inmost, pharmaceutical funding. They recommended further stud-ies in the elderly, with more rigorous methodologic adherencebefore drawing clinical conclusions.12

Finally, ramelteon (Rozerem) warrants discussion. In the lim-ited but promising existing studies, this melatonin receptor ago-nist was found to produce improvements in all sleep components(latency, efficiency, and duration). 13 The agent has been found tobe effective and safe, with no concerns of dependence or next daysomnolence. It is best used for patients who have difficulty initiat-ing sleep. However, as a newer agent, more time and study inpost-marketing surveillance must be awaited before recommen-dations can be made in vulnerable very old persons. Yet, amongthe options, this one t seems preferable for use in the older adultpopulation, and some studies have demonstrated that elderly pa-tients can use it safely without increased risk of falls or drowsinessthe following day.14 Only time and clinical use will tell how trulysafe and effective it is. This agent has recently been added to theformulary at the Lifespan hospitals.

In summary, the evidence supports the use of non-phar-macologic treatments as first line due to their proven efficacy,and for the long-term effects. Pharmacologic therapy has animportant role, but only for the short-term, and carries with itsignificant risk of adverse reactions. The newer agent ramelteonis promising, but will require further study and use in practice.Trazodone did not prove to be as safe and harmless as initiallythought, and its efficacy is also in question. The newer Z drugsalso proved efficacious, but had limited data in the older adult

population, are expensive, and are scheduled drugs, makinguse in long-term care settings more troublesome.

For the patient presented at the beginning of this article, thefirst assessment the clinician must make is whether the situation isa sleep emergency or not. If the patient can wait, it would bebetter for him to discuss the problem and options with his pri-mary physician, who knows him and his history best. This patienthas had three days of symptoms, but is retired and able to napduring the day; he should continue his current regimen untilMonday, when he can call his primary care doctor. Options atthat point include a more detailed review of sleep hygiene andrecommendations to discontinue drinking coffee after breakfast,to decrease caffeine intake and substitute a glass of warm milk orherbal tea after dinner. He should avoid napping during the dayand evaluate the quality of his bedroom for sleep promotion. Thetrazodone dose can remain the same, since there is no evidencebase for increasing the dose to regain initial effect, and strong con-sideration should be given to discontinuing it altogether due tothe poor evidence base for its use in primary insomnia

REFERENCES1. Alessi, C. Sleep Problems. In: Pompei P, Christmas C, Counsell SR, et al, eds, Geriatrics

Review Syllabus, 6th Edition, NY: American Geriatric Society, 2006: 249-57.2. Stanford University patient education webpage “How to Sleep Well” Link:

http://www.stanford.edu/~dement/howto.html3. WebMD patient education webpage “How to Sleep Better” Link: http://

www.webmd.com/sleep-disorders/guide/sleep-hygiene4. McCurry SM, Gibbons LE, et al. Nighttime insomnia treatment and educa-

tion for Alzheimer’s disease. J Am Geri Soc 2005; 53: 793-802.5. Holbrook A, Crowther R, et al. The role of benzodiazepines in the yreatment

of Insomnia. J Am Geri Soc 2001; 49: 824-6.6. Fick DM, Cooper JW, et al. Updating the Beers criteria for potentially inappro-

priate medication use in older adults. Arch Intern Med 2003;163:2716-24.7. IMS intelligence applied pharmaceutical marketing website. Link: http://

www.imshealth.com8. Mendelson WB. A review of the evidence for the efficacy and safety of

trazodone in insomnia. J Clin Psychiatry 2005; 66: 469-76.9. Raji MA, Brady SR. Mirtazapine for treatment of depression and comorbidities

in Alzheimer’s Disease. Ann Pharmacother 2001; 35:1024-7.10. Roose SP, Nelson JC, et al. Open-label study of mirtazapine orally disintegrating tablets

in depressed patients in the nursing home. Curr Med Res Opin 2003; 19: 737-46.11. Ancoli-Israel S, Walsh JK, et al. Zaleplon a novel nonbenzodiazepine hyp-

notic effectively treats insomnia in elderly patients without causing reboundeffects. Primar Care Comp J Clin Psyc 1999; 1: 114-12.

12, Dundar Y, Dodd S, , et al. Comparative efficacy of newer hypnotic drugs for theshort-term management of insomnia. Hum Psychopharmacol 2004; 19: 305-22.

13. Brzezinski A, Vangel MG, et al. Effects of exogenous melatonin on sleep.Sleep Med Rev 2005 ; 9: 41-5.

14. CenterWatch clinical trials listing service website. Link: http://www.centerwatch.com/patient/drugs/dru882.html

Ana C. Tuya, MD, is Assistant Professor of Geriatrics, Rhode IslandHospital, The Warren Alpert Medical School of Brown University.

8SOW-RI-GERIATRICS -062007

THE ANALYSES UPON WHICH THIS PUBLICATION IS BASED wereperformed under Contract Number 500-02-RI02, funded bythe Centers for Medicare & Medicaid Services, an agency ofthe U.S. Department of Health and Human Services. The con-tent of this publication does not necessarily reflect the viewsor policies of the Department of Health and Human Services,nor does mention of trade names, commercial products, ororganizations imply endorsement by the U.S. Government.The author assumes full responsibility for the accuracy andcompleteness of the ideas presented.


Ocular MelanomaIkue Shimizu, MD, Richard Gold, MD, and Edward Feller, MD

Images In Medicine

A 71 year-old man presented with severe nausea and vomit-ing for several days. He had no visual complaints. Physicalexam was normal except for an enlarged, tender liver. Ab-dominal CT scan revealed a 12cm mass in the right liverlobe, shown to be melanoma by biospy. Skin exam did notreveal a primary cutaneous lesion. An ophthalmologic con-sult to evaluate for ocular melanoma demonstrated a lesionin the left choroid. Magnetic resonance imaging of the or-bit showed two choroidal masses in the left eye consistentwith melanoma: slightly hyperintense on the T1-weightedimage (Figure 1a), hypointense on the T2-weighted image(Figure 1b), and enhancement on the T1 post-gadoliniumimage with fat saturation (Figure 1c). The patient receivedright hepatic artery chemoembolization, and was dischargedon anti-emetics.

The eye and orbit are the most common non-skin sites ofprimary or metastatic melanoma.1 The most frequent locationis uveal, the majority are choroidal. Presentation of ocular mela-noma is diverse, including visual disturbance, ocular mass, cra-

nial nerve palsy, orbital myopathy, or uveitis or vitritis. Severepain is uncommon. Some are detected by routine exam or dis-covered during evaluation of known extra-ocular melanoma.Uveal melanomas tend to spread hematogenously, most oftento the liver; as many as 60% of these melanomas have livermetastases at presentation. Diagnosis of uveal melanoma is usu-ally established by an indirect fundoscopic exam. Fluorosceinangiography and ultrasound studies are also used to diagnoseuveal melanoma.2 Magnetic resonance imaging can be helpfulin uveal melanoma staging and the evaluation of prognosticfactors such as tumor pigmentation, size, shape, location, reti-nal detachment, extrascleral extension.3

REFERENCES1. Grin JM, et al. Ocular melanomas and melanocytic lesions of the eye. J Am

Acad Dermatol 1998; 38:716-30.2. Char DH. Ocular melanoma. Surg Clin N Am 2003; 83:253-74.3. Lemke AJ, et al. Uveal melanoma. Radiol 1999;210:775-83.

Ikue Shimizu, MD, is a 2007 graduate of The Warren AlpertMedical School of Brown University.

Richard Gold, MD, is Clinical Associate Professor of Diag-nostic Imaging at The Warren Alpert Medical School of BrownUniversity.

Edward Feller, MD, is a Clinical Professor of Medicine atThe Warren Alpert Medical School of Brown University.

CORRESPONDENCEEdward Feller, MDe-mail: [email protected]

Figure 1a. Figure 1b. Figure 1c.


The Vocabulary of Pathogenic Bacteria�

Physician’s Lexicon

Number (a)201176233428

Number (a) Rates (b) YPLL (c)2,712 253.5 3,828.52,270 212.2 6,239.0

436 40.8 615.0427 39.9 6,512.5476 44.5 367.5

Reporting Period

12 Months Ending with June 2006June2006

UnderlyingCause of Death

Live BirthsDeaths

Infant DeathsNeonatal Deaths

MarriagesDivorces

Induced TerminationsSpontaneous Fetal Deaths

Under 20 weeks gestation20+ weeks gestation

Number Number Rates948 12,831 12.0*894 9,885 9.2*(16) (89) 6.9#

(4) (64) 5.0#443 6,974 6.5*229 3,169 3.0*491 4,788 373.2#120 802 62.5#

(109) (743) 57.9#(11) (59) 4.6#

Reporting Period12 Months Ending with

December 2006December

2006Vital Events

Rhode Island MonthlyVital Statistics Report

Provisional OccurrenceData from the

Division of Vital Records

(a) Cause of death statistics were derived fromthe underlying cause of death reported byphysicians on death certificates.

(b) Rates per 100,000 estimated population of1,069,725

(c) Years of Potential Life Lost (YPLL)

Note: Totals represent vital events which occurred in RhodeIsland for the reporting periods listed above. Monthly pro-visional totals should be analyzed with caution because thenumbers may be small and subject to seasonal variation.

* Rates per 1,000 estimated population# Rates per 1,000 live births

RHODE ISLAND DEPARTMENT OF HEALTH

DAVID GIFFORD, MD, MPHDIRECTOR OF HEALTH EDITED BY COLLEEN FONTANA, STATE REGISTRAR

V ITAL STATISTICS

Diseases of the HeartMalignant Neoplasms

Cerebrovascular DiseasesInjuries (Accidents/Suicide/Homicde)

COPD

The binomial words defining the variousgenera and species of bacteria pathogenicto humans derive from two principalsources: first, as eponyms of the scientistswho laid claim to their initial identifica-tion; and second to a series of Greek rootsserving to describe some morphologicalfeature of the microbes.

The numerous eponyms includeBrucella, Ehrlichia, Escherichia, Kleb-siella, Listeria, Neisseria, Nocardia, Pas-teurella, Salmonella, Shigella, andYersinia. Curiously, the discoverer of thetubercle bacillus and cholera vibrio, Rob-ert Koch, has no genus bearing his name.

The word, bacterium, derives froma Greek word meaning little staff or rodand gave rise to the Latin bacculum mean-ing grape-like [but is only remotely re-lated to the word, bacciferous, meaningbearing grapes which is directly related

to Bacchus, the Greek god of grapes.]Coccus is yet another Greek word

meaning berry-like. A number of Greekprefixes define it further: gono- meaningsexual or reproductive [as in the word,gonad], crypto- meaning hidden [as incryptogram], diplo- meaning double [asin diplopia or diplomat; it should be hast-ily stressed that diplomat does not meandouble-dealing but rather one who car-ries a sanctioned diploma, which is afolded, or doubled, document], staphylo-meaning clustering or grape-like, strepto-meaning pliant or chain-like, andmeningo-, meaning membranous.

Diphtheria was coined from a Greekroot meaning leather-like referring to thecharacteristic pharyngeal pseudo-mem-brane. Corynobacterium stems from aGreek root meaning club-like.Clostridium uses a Greek root meaning

spinning or thread-like; the Greek Fate,Clotho , is a spinner of fabric. Botulismstems from a Latin word meaning sau-sage [from whence the bacteria were firstisolated.]

Proteus is the name of the Greek sea-god who had the skill of easily changingform. Vibrio comes from a Latin wordmeaning to vibrate. Anthrax is from aGreek word meaning coal [as in anthra-cosis or anthracite]; and Chlamydia isderived from the Greek word for cloakor upper garment.

– STANLEY M. ARONSON, MD


a d v e r t i s e m e n t


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�VOLUME 1 PER YEAR $2.00NUMBER 1 SINGLE COPY, 25 CENTSPROVIDENCE, R.I., JANUARY, 1917

The Official Organ of the Rhode Island Medical SocietyIssued Monthly under the direction of the Publications Committee

NINETY YEARS AGO, JUNE 1917In “The Liver,” Charles F. Peckham, MD, discussed spe-

cifics, including liver cells, bile, enzymes, parasitic microorgan-isms, and dead protein.

H.P. Lovewell, MD, in “A Study of Cardiorenal Types,”presented a review of 250 cases from a course in “Medicineand Pathology” at the Massachusetts General Hospital, using aclassification of Dr. R. Cabot, from a paper read before theAmerican Medical Association in 1914.[Dr. Cabot had foundthat 93% of “failing hearts” fell into 4 groups: rheumatic, arte-riosclerotic, nephritic, syphilitic.] Of the 250 cases reviewed,Dr. Lovewell would put 70 under one of the 4 types.

An Editorial urged “More Men for the Medical ReserveCorps.” “It is evident that the local profession is not sufficientlyimpressed with the fact that we are engaged in a real war.” TheEditorial warned that an army of 2 million soldiers would need20,000 physicians. “It should be a patriotic duty for us to [vol-unteer].”

A Second Editorial, “Scientific Feeding of the People inWaiting,” cautioned readers that because of the war, Ameri-cans were receiving less food from Europe (less acreage de-voted to crops, poor crops, submarines). Consequently, physi-cians needed to counsel patients on how to achieve better nu-trition with less food. Physicians should “…offer gratuitousadvice on the proper feeding of the family in every home wevisit.”

FIFTY YEARS AGO, JUNE 1957Herbert Fanger, MD, YS Song, MD, and Thomas H.

Murphy, MD, contributed “Uterine Cancer: A Report of theFirst 2000 Cases of the State Cytology Program for UterineCancer.” The report drew from 2000 patients, submitted by210 physicians. In the first 3 months of testing, 40 tested inthe “positive and suspicious group;” 152, in the “atypical group.”Most (83.6%) tested negative.

Charles L. Farrell, MD, president, Rhode Island MedicalSociety, in “Retrospect and Prospect – 1957,” in describingMedicare, warned: “National Socialism is being fed to youpiecemeal.”

Francis P. Catanzaro, MD, and Anthony Merlino, MD,in “Adenomatous Polyps of the Gastrointestinal Tract,” sum-marized data from 49 patients, seen at St. Joseph’s from 1946-1957.

TWENTY-FIVE YEARS AGO, JUNE 1982Joseph R. Salvatore, MD, and LR Jenkyn, MD, in “Progress

in Neurology,” contributed “Prophylactic Cranial Irradiationin Small Cell Carcinoma of the Lung,” which they called “acontroversial treatment.”

Irving A. Beck, MD, in “The Providential Visits of Dr.Osler: The Great Master Keeps Alive Rhode Island Connec-tions,” drew from the papers of Dr. Frank T. Fulton, includinghis correspondence with Dr. Osler.

Frank M. D’Allessandro, MD, in “Diabetes Mellitus –Practical Aspects,” discussed the “serial determination of plasmainsulin levels” as a way to delineate the type of diabetes.

Michael G. Pierik, MD, in “Fatal Staphylococcal Septice-mia Following Acupuncture: Report of 2 Cases [from St. Joseph’sHospital]” emphasized the “need for thorough medical evalu-ation before such procedures.”

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