P2: GKW/RKP
`P1: GKW/SPH
`Annals of Clinical Psychiatry (ACLI)
`
`QC: GKW/RKP
`PP279-347314
`
`T1: GKW
`October 12, 2001
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`10:49
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`Style file version Nov. 07, 2000
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`Annals of Clinical Psychiatry, Vol. 13, No. 3, September 2001 ( c(cid:176) 2001)
`
`Newly Admitted Psychiatric Patient Prescriptions
`and Pharmaceutical Sales Visits
`
`Thomas L. Schwartz, MD,1,3 Daniel J. Kuhles II, MD, MPH,2 Michael Wade, MS,1
`and Prakash S. Masand, MD1
`
`There is much literature regarding the interaction of pharmaceutical sales representatives
`and physicians. However, there is little information available regarding their interactions with
`psychiatric residents. This paper attempts to quantify the impact of pharmaceutical sales visits
`upon prescriptions written for newly admitted patients in a psychiatric residency training
`clinic. A retrospective chart review of 47 consecutive patients was conducted. At the time
`of review all included patients had been admitted to the clinic for less than 3 months. Their
`psychiatric medication regimens were followed for 3 months. Initiation of new psychotropics
`was recorded. Data was also collected regarding the number of sales visits which typically
`occur at resident luncheons. Statistical analysis compared the number of new medication
`starts to the number of sales visits. Twelve pharmaceutical companies made sales visits. Eleven
`out of 12 companies’ visits were statistically associated with an increase in new medication
`starts (p < 0:05). As the number of sales visits increased, a greater statistical significance
`was noted. This study is one of the first to quantify pharmaceutical industry’s impact on
`psychiatric residents’ prescribing practices. It appears that psychiatric residents preferentially
`start companies’ medications shortly after sales visits. Furthermore, as sales visits increase in
`frequency, more of their medications may be started in newly admitted psychiatric outpatients.
`KEY WORDS: psychiatry; residency training; pharmaceutical sales.
`
`INTRODUCTION
`
`In an era of more expedient drug research and
`approval there has been a large increase in corporate
`budgets allowed for sales and marketing. Sales rep-
`resentatives promote their drugs to psychiatry res-
`idents in group meetings, grand rounds, and social
`gatherings. Some in academic fields are concerned
`that physicians in residency training should not be
`subjected to this type of sales pressure (1, 2). There
`are few papers looking at psychiatry residents’ sub-
`jective attitudes and experiences, and only one study
`
`1Department of Psychiatry, SUNY Upstate Medical University,
`Syracuse, New York.
`2SUNY Stonybrook, Stonybrook, New York.
`3To whom correspondence should be addressed at Department
`of Psychiatry, SUNY Upstate Medical University, Syracuse, New
`York 13210; e-mail: thomas schwartz@yahoo.com.
`
`has quantified the impact of companies’ sales strate-
`gies on residents. This paper examines how sales visits
`may potentially affect prescribing practices of psychi-
`atry residents, especially where newly admitted clinic
`patients are concerned.
`Lexchin (3) investigated interactions between
`sales representatives and physicians in regards to
`corporate-funded clinical trials, CME events, and
`sales information provided. The author concluded
`that physicians are clearly affected by all of these
`interaction types. A few studies have looked specifi-
`cally at sales visits’ impact on residents and attempted
`to quantify the effect of the sales force. Springarn
`et al. (4) in a study using a retrospective cohort
`design have suggested that grand rounds meetings
`change medicine residents’ beliefs about appropri-
`ate antibiotic use. Following grand rounds, newly
`formed residents’ beliefs about antibiotics may not
`
`159
`
`1040-1237/01/0900-0159$19.50/1 C(cid:176) 2001 American Academy of Clinical Psychiatrists
`
`ARGENTUM Exhibit 1192
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`00001
`
`

`
`P2: GKW/RKP
`P1: GKW/SPH
`Annals of Clinical Psychiatry (ACLI)
`
`QC: GKW/RKP
`PP279-347314
`
`T1: GKW
`October 12, 2001
`
`10:49
`
`Style file version Nov. 07, 2000
`
`160
`
`Schwartz, Kuhles, Wade, and Masand
`
`be fully supported by current “unbiased” literature.
`Lurie et al. (5) asked residents if their prescribing had
`changed at least once per year based on sales visit in-
`formation. A majority agreed. Steinman (6, 7), also
`surveyed medicine residents and concluded that resi-
`dents tend to declare no influence exists, but their be-
`haviors following visits are not consistent with their
`claims of noninfluence. Canadian Family Medicine
`residents have also been surveyed and stated they
`did not feel they changed their prescribing based on
`pharmaceutical sales visits (8). Keim et al. and Reeder
`et al. (9, 10) evaluated Emergency Medicine residents
`and concluded that improved training was needed
`to help residents deal with sales issues. In regards
`to psychiatry residents, Hodges’ 1995 study (11) is
`the only MEDLINE indexed paper available to date.
`This study quantified the number of sales lunches,
`gifts, samples left, or received by 74 residents over
`one year. The author also surveyed these residents
`about their beliefs. There was a wide range of meetings
`and gifts/samples received by individuals. About one-
`third of residents felt that sales information was accu-
`rate. One-third felt representatives should be banned
`from meetings and 15% felt they were under-trained
`in dealing with sales pressure. About 34–56% felt
`that interactions with representatives would have no
`impact on prescribing. Interestingly, as residents re-
`ceived more items from representatives, they were
`less likely to feel they would be biased in prescrib-
`ing medication. The authors alluded to there being
`an academic benefit to sales promotions and that ju-
`nior residents may receive the most benefit from this.
`Finally, Schwartz et al. (12) conducted a pilot study
`of a random sample of psychiatry residency train-
`ing clinic patients in which they compared the tim-
`ing of drug sales lunch visits to the number of pa-
`tients started on each company’s medication. There
`was no significant correlation found between sales
`visits and the number of new medication starts over
`a 3-month period. The current study is a follow-up
`study which looks to evaluate a more specific subset
`of clinic patients.
`The authors designed the following study to eval-
`uate the impact of sales lunches on the prescribing
`practices of psychiatry residents on their newly ad-
`mitted clinic patients. Given the information derived
`from previous studies, the authors hypothesized that
`there would be an increase in the number of a drug’s
`prescriptions following a sales encounter with the
`parent company. We predicted that there would be an
`increase in prescribing in patients’ whose visits shortly
`followed a sales visit, where little or no increase would
`
`occur if a patient was not seen shortly after a sales visit.
`Furthermore, we expected that as the number of en-
`counters increased, prescriptions would also increase.
`This patient population is a highly select one in that
`new patient admissions require residents to think di-
`agnostically and to formulate a treatment plan over
`a brief period of time. It is in this time period where
`most prescriptions are written for medication initi-
`ation and where sales pressure may have the most
`impact just following a clinic admission.
`
`MATERIALS AND METHODS
`
`The authors retrospectively reviewed 47 consec-
`utive charts of newly admitted patients from an adult
`psychiatry residency clinic at SUNY Upstate Medical
`Center. The institutional review board allowed the au-
`thors to review charts for a 6-month period during the
`1999–2000 academic year. Residents were not aware
`of this retrospective record review and the authors
`were not members of the training clinic. Information
`gathered included demographic data, psychiatric di-
`agnoses, and prescription data. The prescription data
`included a record of all newly initiated psychiatric
`medications (including changes from one medication
`to another) as well as the starting and discontinuation
`dates for each medication. Information was also col-
`lected regarding each scheduled sales visit from chief
`resident logs, including the company name and the
`specific drug or drugs promoted at the visit. This de-
`partment has an “appointment only” policy for sales
`visits that occur primarily at regularly scheduled busi-
`ness lunch meetings.
`To ascertain the association between sales phar-
`maceutical drug representatives and patient prescrip-
`tions the following design was used. At the time of
`the review, there were new patients enrolled in the
`clinic during distinct 12-week periods where sales vis-
`its did not occur or particular companies did not visit.
`Patients in these periods were defined as control sub-
`jects where sales influences were expected to be ab-
`sent or minimal. New patients who were seen during a
`12-week period where particular pharmaceutical drug
`representatives visited were counted as being in the
`case group, where sales impact was felt to be higher.
`The independent measure studied was the relative
`presence (or absence) of a sales intervention. The
`number of patients who went on a particular drug (de-
`pendent measure) during their 12-week follow-up pe-
`riod was compared between these two groups. Those
`patients who were being treated while one or more
`
`00002
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`

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`P2: GKW/RKP
`P1: GKW/SPH
`Annals of Clinical Psychiatry (ACLI)
`
`QC: GKW/RKP
`PP279-347314
`
`T1: GKW
`October 12, 2001
`
`10:49
`
`Style file version Nov. 07, 2000
`
`Newly Admitted Psychiatric Patient Prescriptions
`
`161
`
`drug representatives visited, were defined as going on
`a drug only if they went on the drug after the drug
`representative gave his/her sales talk.
`The Fisher Exact test was utilized to com-
`pare the proportion of patients who went on each
`drug between the case and control groups. This
`comparison was made for each of the following
`13 drugs: divalproex sodium, risperidone, venlafax-
`ineXR, bupropionSR, sertraline, mirtazapine, fluoxe-
`tine, paroxetine, citalopram, gabapentin, quetiapine,
`olanzapine, and buspirone. Since the same compari-
`son was made for each of the 13 drugs, a Bonferroni
`correction to the type I error rate was employed to
`preserve the overall type I error rate of 0.05.
`
`RESULTS
`
`Twelve companies were evaluated, and 13 med-
`ications were studied (one company sells two prod-
`ucts). There was a statistically significant association
`between individual company sales visits and initiation
`of their medication within 12 weeks of the sales visit
`for 11 out of the 12 companies. Prescription initia-
`tion tended not to occur in the control group (see
`Table 1). Furthermore, a trend in increased statisti-
`cal significance occurred when more sales visits were
`made during the study period.
`
`DISCUSSION
`
`The authors wish to take a fairly unbiased ap-
`proach to the educational, ethical, and financial
`
`dilemma regarding the pharmaceutical industry’s in-
`teraction with the medical profession. We believe that
`sales representatives provide educational and aca-
`demic experiences that at times are unbiased and im-
`prove resident education. For example, information
`about new medication launches, obtaining reprints, in-
`dustry subsidization of subscription to scientific jour-
`nals and annual meetings (usually not affordable on
`resident salaries) are certainly academic. Certainly, in-
`creased sales pressure increases profits. This in turn,
`increases research and development which produces
`cutting edge new drugs that doctors and patients like
`to see. Conversely, there are times when sales tech-
`niques are clearly employed to change prescribing
`practices and that residents may need specific train-
`ing to recognize where the two approaches divide.
`This may occur when specific journal papers are used
`out of context as selling points, minor efficacy or side
`effect issues are inflated into major selling points
`despite more holistic data suggesting equal tolera-
`bility and efficacy amongst agents. This study, like
`our previous study (12) was unfunded and the ulti-
`mate goal is to provide quantifiable, statistically sound
`data to support one side or the other in this ongoing
`debate.
`the editorial
`In accordance with much of
`literature suggesting that sales visits from the phar-
`maceutical industry is altering physicians’, especially
`residents’, prescribing practices, this paper finds sales
`impact occurring primarily when new patients are
`admitted to a resident clinic shortly following a sales
`meeting. In regards to the only previous paper quan-
`tifying psychiatry residents’ prescriptions rates (12)
`it appears that a random sampling of clinic patients
`
`Medication initiated
`Divalproex Sodium
`Risperidone
`VenlafaxineXR
`BupropionSR
`Sertraline
`Mirtazpine
`Fluoxetine
`Paroxetine
`Citalopram
`Gabapentin
`Quetiapine
`Olanzapine
`Buspirone
`
`Table 1. Sales Visits Versus Prescription Initiation
`Sales visit occurred prior
`to medication initiation
`(case group) n (%)
`2 (100) [2]
`9 (90) [10]
`12 (100) [12]
`2 (66.7) [3]
`8 (88.9) [9]
`5 (100) [5]
`9 (100) [9]
`8 (100) [8]
`7 (87.5) [8]
`2 (100) [2]
`3 (100) [3]
`5 (100) [5]
`2 (100) [2]
`
`No sales visit
`(control group) n (%)
`3 (6.7) [45]
`0 (0) [37]
`1 (2.9) [35]
`0 (0) [44]
`1 (2.7) [38]
`0 (0) [42]
`0 (0) [38]
`0 (0) [39]
`0 (0) [39]
`0 (0) [45]
`0 (0) [44]
`1 (2.4) [42]
`0 (0) [45]
`
`Unadjusted
`P-value (Unadj. * 13)
`0.009
`<0.001
`<0.001
`0.003
`<0.001
`<0.001
`<0.001
`<0.001
`<0.001
`<0.001
`<0.001
`<0.001
`<0.001
`
`Adjusted
`P-value
`0.120
`<0.001
`<0.001
`0.036
`<0.001
`<0.001
`<0.001
`<0.001
`<0.001
`0.012
`<0.001
`<0.001
`0.012
`
`Note. Values in square brackets [ ] show total patients possible to initiate.
`
`00003
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`

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`
`162
`
`Schwartz, Kuhles, Wade, and Masand
`
`includes many patients who have been long-term,
`established patients on stable medication regimens.
`It makes sense that sales pressure would not effect
`this subpopulation in that changing medications
`during maintenance treatment is highly unlikely
`regardless of sales pressure. When this established
`population is removed as a confounding variable,
`newly admitted patients are left. This population
`commonly receives the highest rate of medication
`initiations and changes due to the fact they are new to
`treatment and suffering from acute exacerbation of
`a mental illness. During this time in treatment where
`medications are likely to be switched for clinical
`reasons
`(inefficacy/intolerability),
`sales
`influence
`may directly impact which medications residents
`prescribe. Finally, it makes sense that increased sales
`visits, increase new prescription writing via residents.
`This is the purpose of a sales force, whether it is for
`prescription drug sales or automobile sales.
`We should note the limitations of our study. First,
`it is a retrospective design. Second, 47 subjects may
`be too small to allow us to detect minor statistical
`changes between each company’s particular effective-
`ness, though trends were noted as above. Third, sam-
`ple homogeneity may be a biasing factor. The charts
`belonged to one psychiatry department’s residency
`clinic. A more heterogeneous population of residents
`at differing programs could alter results. Fourth,
`12 weeks may not be a long enough period to account
`for medication failures and subsequent changes.
`Finally, it is possible that residents respond to their
`attending, supervisor, or departmental preference
`where medication use is concerned, or other unknown
`confounding variables may intervene. A prospective
`study that takes into account more confounding
`variables would provide the best correlation between
`sales visits and prescribing changes. The authors plan
`to begin a multisite, retrospective study and plan a
`single-site prospective study for replication purposes.
`
`CONCLUSIONS
`
`This study reveals that corporate sales visits
`are associated with increased prescription initia-
`
`in certain patient populations at certain
`tions
`times. The data may also be interpreted in that as
`“face time” with a particular company increases,
`the association with new prescription initiation in-
`creases.
`
`ACKNOWLEDGMENTS
`
`The authors wish to thank Drs. S. Batki, R.
`Gregory, A. Beeber, M. Dewan from SUNY Upstate
`Medical University for their support and input during
`this project.
`
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