(BQ) Part 2 book Prescribing mental health medication the practitioner''s guide presents the following contents: Medication dilemmas and their clinical management, competent clinical practice.
Part IV Medication dilemmas and their clinical management Chapter 17 Psychotropic medications and side effects N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N During the initial evaluation Useful advice to patients Side-effect assessment in follow up visits How much of a problem is it? Other issues to consider in evaluating side effects Changing medication due to side effects Severity of side effects Side effects and clinical response The novice clinician and side effects Side effects seen most frequently Sedation Overactivation/anxiety Nervousness Akathisia Hypomania Sleeplessness as a side effect Tremor Nausea and gastrointestinal problems Sexual interference Weight gain “It must be the medication ” Intervention helps Approaches to medication-induced weight gain Headaches Asthenia Dry mouth Hair loss Skin reactions Prolactin elevation Hypotension Falls Elevation of blood sugar and lipids Hyponatremia Suicidality Side effects and medication combinations References 275 276 278 279 280 280 281 282 283 283 284 285 286 287 288 289 290 291 293 300 302 304 304 307 308 308 308 310 312 314 314 315 317 318 319 320 276 MEDICATION DILEMMAS AND MANAGEMENT Any healthcare practitioner who is legally authorized to prescribe medication can write a prescription for a psychotropic One of the distinguishing characteristics of the knowledgeable practitioner, who will maintain greater success with mental health patients, is the practitioner who can successfully manage the side effects of a medication The manner in which a practitioner discusses side effects can have a major effect on whether the person takes the medication, or becomes a frightened, non-compliant patient Some practitioners will ignore or fail to assess side effects because they don’t know how to offer solutions if the patient admits to having them This chapter will discuss the common and potentially uncomfortable side effects that occur with psychotropic medications, and how the astute clinician can manage them Less common, but potentially more serious, adverse reactions are discussed in Chapter 18 During the initial evaluation For many patients, the risk of side effects is a major, or in some cases, the major issue in taking psychotropic medications The popular press now describes many mental health medications in detail, including possible side effects With the vast amount of information available on the Internet, patients often come to the office armed with a series of questions about what potential unwanted effects may be associated with a prescribed medication If a patient brings up the issue of side effects early in the initial interview, it is wise to suggest that the evaluation first be completed to determine if medication is needed and which medication might be most helpful The clinician should reassure the patient that side effect issues will be covered before treatment decisions are made Discussing the side effects of a medication For the typical physically healthy individual, serious side effects with psychotropics are remarkably rare and the clinician can be genuinely optimistic that medications prescribed are unlikely to cause significant harm For physically compromised patients, or for patients taking a complicated medical regimen, there may be some risk of adding a psychotropic When present, these risk issues need to be individualized and discussed with each patient as their situation dictates Table 17.1 lists some facts regarding psychotropics and side effects When it comes time to introduce the issue of side effects, toward the end of the initial evaluative session for a routine patient without special risk factors, the concept can be introduced as suggested here Table 17.1 Facts regarding psychotropics and side effects N N N Most side effects of psychotropics are more annoying than serious Life-threatening or irreversible side effects are rare Many side effects are remediable or pass with time PSYCHOTROPIC MEDICATIONS AND SIDE EFFECTS TALKING TO PATIENTS “Most people take this medication without side effects, and that is what I expect for you As with any medication, however, there can be some unwanted effects Fortunately, if these unwanted effects occur, they are usually of the annoying, short-term variety, and are not serious or life-threatening If anything is not mild or is not going away, I want you to call me, so together we can decide how to proceed.” If patients have read about or heard of specific side effects, or are especially fearful of a particular adverse reaction, these possibilities must be addressed specifically Many times the patient’s concerns can be alleviated with simple reassurance, and in fact the side effect of concern may be of minimal likelihood with the medication to be prescribed If the side effect the patient is concerned about is a possibility with the particular medication chosen, acknowledge this with: TALKING TO PATIENTS “Yes, that has been reported with some, but not most, patients [Include any data or statistics to approximate the frequency, if known.] I know you are concerned about this and we will be watching for this possibility carefully If it emerges as a problem, we will deal with it at that time However, I not believe the small possibility of the problem should stop you from beginning the medication How you feel about this plan?” Usually this is sufficient to have the patient begin treatment If the patient does remain resistant or highly skeptical, the clinician should outline what, if any, other medication alternatives might be tried and the reasons the initial recommendation has been made Often, having heard the clinician’s thinking and rationale, the patient can proceed with a trial of the first-choice medication On occasion, a patient may insist on a second-line choice, even when its therapeutic potential is less, because it avoids or minimizes a particular side effect As long as the clinician feels the choice has some reasonable chance of success, it is a good idea to form a contract to use a second choice of medication initially if it means the patient can be compliant If because of side effect fears a patient is requesting a clinically inappropriate medication, of course the clinician needs to discuss why he or she will not agree to this prescription The death of singer Michael Jackson when he was inappropriately prescribed proprofol for sleep shows the potentially serious problems which can result when a clinician agrees to prescribe an inappropriate medication at a patient’s request Even if the patient brings no information about side effects, it is important to cover a few common side effects that might occur with any medication prescribed The key to success is striking a balance between identifying some possible side effects while refraining from frightening the patient with a litany of possible, but unlikely, adverse consequences 277 278 MEDICATION DILEMMAS AND MANAGEMENT TALKING TO PATIENTS For example, when prescribing an SSRI antidepressant you might say: “Most people take these medicines without problem If there are going to be any side effects, the most common ones tend to be upset stomach, diarrhea, headaches, sleepiness, agitation or some interference with sexual arousal If you get any of these problems and they are mild, bear with them because they will often pass within several days to a week If the side effects are not mild or are not passing, be sure to let me know so that we can decide how to fix the problem.” For a discussion of a side effect that is serious and carries significant risk for this patient, the representative presentations shown here can serve as models TALKING TO PATIENTS To an elderly schizophrenic patient in the hospital who might be at risk for a fall: “Mrs Fisher, I am going to prescribe [name of medication] to help decrease the voices in your head that you have told me about This medicine is a good choice for you However, the medicine has the possibility of making you somewhat sleepy or lightheaded Therefore, we will start with a small dose and evaluate how you tolerate it I not want you to fall or lose your balance Please get up slowly when you have been lying down or sitting, or ask for assistance from the nursing staff Also, tell them if you feel light-headed or dizzy.” When prescribing carbamazepine (which could lower the estrogen levels via P-450 enzyme induction – see Chapter 18) to a patient on birth control pills: “In prescribing carbamazepine, there is a possibility that this medication may cause your body to break down estrogen more quickly and could lower the birth control protection from your low-dose estrogen pills We have tried several other mood stabilizers without success, and your symptoms remain significant I believe carbamazepine is now the best choice to help you feel more stable I want you to contact your Ob/Gyn practitioner to change your birth control pill to one with a higher strength of estrogen before we begin this medication If you like, I will call him/her to explain why I am suggesting this.” Useful advice to patients While some side effects will occur despite the best efforts of the prescriber and the patient, two useful recommendations should be made to all patients These can prevent inadvertent side effects or in rare cases, serious danger zones as discussed in the next chapter: PSYCHOTROPIC MEDICATIONS AND SIDE EFFECTS “Before you leave the pharmacy (or when you receive the medication in the mail), be sure your name is on each container’s label.” “Be sure the right drug name and dose is on the label.” “If the pills look different or unfamiliar, or if you have any questions or concerns, speak with the pharmacist or call the mail-order pharmacy service before taking any dose.” Some practitioners hand out a small sheet with these precautions to patients when they are given prescriptions Others have ancillary staff make these reminders or large-lettered signs are posted where they can be seen as the patients exit the office Side-effect assessment in follow-up visits If a clinician does not ask about side effects and intervene when necessary, the patient will stop the medication or drop out of treatment! Asking the patient if he or she is experiencing any unwanted effects from the medicine is mandatory for each of the first several follow-up appointments, at least until such time as the patient is stabilized and is clearly tolerating the medicine without problem Do not assume that the patient will spontaneously volunteer side effect information When the practitioner learns of any side effects, the following questions will help to identify a course of action and/or remedy: N N N N N N N What changes, sensations or symptoms are you experiencing? (Have the patient first describe facts, not their own assessment, beliefs or assumptions about the cause.) How often you feel this? Is there any pattern to when this occurs? When, in relation to taking the medication, does the problem occur? Is the problem diminishing or intensifying with time? Does anything make the problem better or worse? How troublesome is this for you? (Use a 1–10 numerical scale.) For example, if a patient complains of nausea, this fact alone is insufficient information The clinician needs to know when the nausea occurs Is it constant? Does it occur at specific times of the day? Does it occur within an hour or two of taking the pill, or at other times as well? Does it interfere with sleep, or occur in the middle of the night? Is it accompanied by vomiting? Have the patient’s eating habits been affected by the nausea? Only with these data can the clinician decide to lower or split the dose, prescribe it at bedtime, add an antinauseant, or change the psychotropic medication 279 280 MEDICATION DILEMMAS AND MANAGEMENT How much of a problem is it? With any given side effect, it is crucial to find out how severe and troublesome this particular side effect is to this particular patient Individuals have very different tolerances for adverse effects of medication For example, some people are remarkably tolerant of gastrointestinal side effects and others are intensely bothered Likewise, headache, sexual interference and weight gain may be acceptable consequences for some individuals, and be absolutely intolerable, even when mild, to others As discussed in Chapter 6, quantification of the patient’s words is often helpful to the clinician in evaluating side effects as well CLINICAL TIP It is useful to have the patient quantify the amount of the particular side effect on a scale of 0–10, with being no side effects at all,1 being minimal and 10 being maximal Such clarification can help the clinician decide if a side effect is of a magnitude to require intervention or a change of medications TALKING TO PATIENTS Ask the patient: “On a scale of to 10, where zero is ‘I am never bothered by this problem’ and 10 is ‘I am extremely, bothered by this problem all the time,’ how does this affect you?” In general, side effects rated by the patient as a or above will almost always require intervention A patient rating of to 3, particularly if the side effect is beginning to wane, is often tolerable, at least for a short time Mentally, the clinician may adjust the patient’s rating of a side effect up or down the scale depending on the clinician’s assessment of the consequences of the side effect For example, headache, fatigue or sexual interference are bothersome, but usually not have serious imminent sequelae for healthy patients The clinician may mentally move the patient’s rating down slightly, even though it is bothersome to the patient The occurrence of a seizure, changes in blood cell counts, severely decreased or increased blood pressure, repetitive vomiting, marked changes of liver function or the onset of tardive dyskinesia have potential serious outcomes and sequelae The clinician may mentally move the rating of this type of side effect higher, even if the patient’s rating is not particularly high (patients not always appreciate the gravity of some side effects) Other issues to consider in evaluating side effects Just because a patient complains of a side effect that he or she believes is a direct effect of the medication, this may or may not be the case Further detailed inquiry PSYCHOTROPIC MEDICATIONS AND SIDE EFFECTS is essential The clinician should first look for other causes besides the prescription that may account for the unwanted effect Inquire about any recent medications prescribed by other practitioners, herbal or over-the-counter medications, food intolerances or changes in sleep and/or activity schedules that correlate in time with the onset of the complaint The clinician should next consider possible indirect effects relative to the medication prescribed For example, P-450 interactions may change the blood levels of other medications the patient is taking, and these blood level changes can result in the patient experiencing adverse effects without actually being a direct side effect of the medication prescribed (see Chapter 18) Third, the practitioner should assess the frequency of the particular side effect described: Is it continuous or intermittent? Does it occur most or all days, or relatively infrequently? Fact: most psychotropic medication side effects are typically continuous or very frequent Side effects that occur once a week or several times a month are often, at least in part, related to other causes, and are not solely due to the psychotropic Side effects that occur for several days and then are totally absent for weeks or months are again much less likely to be related directly to the psychotropic Occasionally a psychotropic can predispose an individual to a side effect that can then be precipitated by a second independent cause If this is the case, modifying the second external cause may allow the patient to continue taking the psychotropic without a need to change medication For example, a psychotropic may cause loose bowel movements While this may be tolerable in general to the patient, significant diarrhea occurs only when certain foods are eaten Rather than discontinuing the psychotropic, the simple solution is to identify and temporarily avoid the offending food while the medication is being prescribed Fourth, the timing of the side effect in relation to ingestion should be assessed Side effects that occur within 30 minutes to an hour after taking the pills are often related to a rapid rise in blood concentration to a high peak level Symptoms such as an upset stomach, headache, nausea or nervousness that only occur shortly after taking the pill may be minimized if the medication is taken at bedtime As long as the side effect is not severe enough to awaken the patient, the problem may have diminished enough to be tolerable upon waking Side effects from high peak blood levels can also be improved by lowering the total daily dose, or dividing the dose into two or more smaller quantities taken at different times of the day Changing medication due to side effects A frequent dilemma facing a clinician is whether or not to change medications because of side effects In addition to the severity of the side effect, the clinician should take into account: N N the patient’s therapeutic response to the medication so far the presence or absence of suitable alternatives 281 282 MEDICATION DILEMMAS AND MANAGEMENT N N the length of time that the patient has been on the medication the patient’s individual concerns and wishes Severity of side effects Side effects can be classified as mild, moderate, significant or serious The clinician’s response will vary depending upon the classification For mild side effects (1 to on the scale previously mentioned), education and labeling the symptom as a side effect, along with reassurance, is all that is usually necessary Sometimes a watch-and-wait approach will allow the symptom to disappear, but in any case the course of the side effect should be re-evaluated at follow-up visits For moderately intrusive side effects (3 to on the scale), there may be ways to remedy the problem without actually changing medications These may include splitting the dosage, taking the medication at a different time of day, changing to a long-acting formulation of the medication or recommending changes in diet and/or exercise For more significant side effects, either because of the patient’s discomfort or the clinician’s assessment of possible risk (6 to on the scale), it is absolutely essential that the side effects be addressed specifically and promptly If not, the patient may drop out of treatment or, at the very least, stop the medication, sometimes without telling the clinician For serious side effects, again either because of the patient’s discomfort or the clinician’s assessment of risk (9 or 10 on the scale), it is imperative that the clinician responds quickly and decisively For example, with the onset of a seizure or fainting episode leading to unconsciousness, it is essential to address the issue, discontinue the medication or significantly reduce the dosage Specialty consultation with a neurologist or internist may be necessary to evaluate other causes for such symptoms Other examples requiring prompt action would be serious abnormalities of laboratory testing, such as drops in white blood count (to less than 1500 absolute neutrophil count),1 platelet count (below 100 000 per cubic millimeter) or a marked increase in liver function tests (above two or three times normal) The clinician needs to communicate the need for a prompt evaluation to the patient and, if appropriate, to the patient’s family These more serious risk issues will be covered in more detail in Chapter 18 Even if the medical risk of the side effect is small, when a patient rates a side effect at or above on the basis of discomfort and/or frequency, the clinician should act promptly if adherence is to be maintained When serious side effects occur, the clinician’s written records are crucial and provide documentation of his or her assessment, thinking and interventions In the event of medico-legal action because of serious adverse consequences from medication, the written medical record provides the best defense Such documentation should reflect: N N N the onset of the symptoms/side effects, i.e., when did they start? when the clinician was made aware of these complaints exactly what recommendations were made regarding remediation Appendix Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals (2008) Preamble The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-based pharmaceutical and biotechnology companies Our members develop and market new medicines to enable patients to live longer and healthier lives Ethical relationships with healthcare professionals are critical to our mission of helping patients by developing and marketing new medicines An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines, which play an ever-increasing role in patient healthcare This document focuses on our interactions with healthcare professionals that relate to the marketing of our products Appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit Our relationships with healthcare professionals are critical to achieving these goals because they enable us to: N N N N inform healthcare professionals about the benefits and risks of our products to help advance appropriate patient use, provide scientific and educational information, support medical research and education, and obtain feedback and advice about our products through consultation with medical experts 538 APPENDICES In interacting with the medical community, we are committed to following the highest ethical standards as well as all legal requirements We are also concerned that our interactions with healthcare professionals not be perceived as inappropriate by patients or the public at large This Code is to reinforce our intention that our interactions with healthcare professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine The Code is based on the principle that a healthcare professional’s care of patients should be based, and should be perceived as being based, solely on each patient’s medical needs and the healthcare professional’s medical knowledge and experience Therefore, PhRMA adopts this updated and enhanced voluntary Code on relationships with U.S healthcare professionals This Code reflects and builds upon the standards and principles set forth in its predecessor, the PhRMA Code on Interactions with Healthcare Professionals that took effect on July 1, 2002 Like the 2002 edition, this Code addresses interactions with respect to marketed products and related pre-launch activities PhRMA member companies’ relationships with clinical investigators and other individuals and entities as they relate to the clinical research process are addressed in the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results This updated Code will take effect in January 2009 Basis of interactions Our relationships with healthcare professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information, and supporting medical education Promotional materials provided to healthcare professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications Informational presentations by pharmaceutical company representatives and accompanying meals Informational presentations and discussions by industry representatives and others speaking on behalf of a company provide healthcare providers with valuable scientific and clinical information about medicines that may lead to improved patient care In order to provide important scientific information and to respect healthcare professionals’ abilities to manage their schedules and provide patient care, company representatives may take the opportunity to present information during healthcare professionals’ working day, including mealtimes In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business courtesy to the healthcare professionals as well as members of their staff attending presentations, so long as the presentations provide APPENDICES scientific or educational value and the meals (a) are modest as judged by local standards; (b) are not part of an entertainment or recreational event; and (c) are provided in a manner conducive to informational communication Any such meals offered in connection with informational presentations made by field sales representatives or their immediate managers should also be limited to in-office or in-hospital settings Inclusion of a healthcare professional’s spouse or other guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate Offering “take-out” meals or meals to be eaten without a company representative being present (such as “dine & dash” programs) is not appropriate Prohibition on entertainment and recreation Company interactions with healthcare professionals are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the company engages the healthcare professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose Modest, occasional meals are permitted as long as they are offered in the appropriate circumstances and venues as described in relevant sections of this Code Pharmaceutical company support for continuing medical education Continuing medical education (CME), also known as independent medical education (IME), helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine Accordingly, a company should separate its CME grant-making functions from its sales and marketing departments In addition, a company should develop objective criteria for making CME grant decisions to ensure that the program funded by the company is a bona fide educational program and that the financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment Since the giving of any subsidy directly to a healthcare professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the CME provider, which, in turn, can use the money to reduce 539 540 APPENDICES the overall CME registration fee for all participants The company should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME When companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the organizers of the conferences or meetings in accordance with their guidelines The company should not provide any advice or guidance to the CME provider, even if asked by the provider, regarding the content or faculty for a particular CME program funded by the company Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section below) Similarly, funding should not be offered to compensate for the time spent by healthcare professionals participating in the CME event A company should not provide meals directly at CME events, except that a CME provider at its own discretion may apply the financial support provided by a company for a CME event to provide meals for all participants Pharmaceutical company support for third-party educational or professional meetings Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate A conference or meeting is any activity, held at an appropriate location, where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented Since the giving of any subsidy directly to a healthcare professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the conference’s sponsor, which, in turn, can use the money to reduce the overall conference registration fee for all attendees When companies underwrite medical conferences or meetings other than their own, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the organizers of the conferences or meetings in accordance with their guidelines Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending third-party scientific or educational conferences or professional meetings, either directly to the individuals attending the conference or indirectly to the conference’s sponsor (except as set out in Section below) Similarly, funding should not be offered to compensate for the time spent by healthcare professionals attending the conference or meeting APPENDICES Consultants Consulting arrangements with healthcare professionals allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas and the needs of patients Companies use this advice to inform their efforts to ensure that the medicines they produce and market are meeting the needs of patients Decisions regarding the selection or retention of healthcare professionals as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area Companies should continue to ensure that consultant arrangements are neither inducements nor rewards for prescribing or recommending a particular medicine or course of treatment It is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services Any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value Token consulting or advisory arrangements should not be used to justify compensating healthcare professionals for their time or their travel, lodging, and other out-ofpocket expenses The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement): N N N N N N a written contract specifies the nature of the consulting services to be provided and the basis for payment of those services; a legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants; the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria; the number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; the venue and circumstances of any meeting with consultants are conducive to the consulting services and activities related to the services are the primary focus of the meeting; specifically, resorts are not appropriate venues While modest meals or receptions may be appropriate during company sponsored meetings with healthcare professional commercial consultants, companies should not provide recreational or entertainment events in conjunction with these meetings It is not appropriate to pay honoraria or travel or lodging expenses to non-faculty and non-consultant healthcare professional attendees at company-sponsored meetings, including attendees who participate in interactive sessions 541 542 APPENDICES Speaker programs and speaker training meetings Healthcare professionals participate in company-sponsored speaker programs in order to help educate and inform other healthcare professionals about the benefits, risks and appropriate uses of company medicines Any healthcare professional engaged by a company to participate in such external promotional programs on behalf of the company will be deemed a speaker for purposes of this Code, and the requirements of Section apply to company interactions with that healthcare professional in his or her capacity as a speaker Company decisions regarding the selection or retention of healthcare professionals as speakers should be made based on defined criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills Companies should continue to ensure that speaking arrangements are neither inducements nor rewards for prescribing a particular medicine or course of treatment Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers It is appropriate for healthcare professionals who participate in programs intended to train speakers for company-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses Such compensation and reimbursement should only be offered when (1) the participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications; (2) this training will result in the participants providing a valuable service to the company; and (3) the participants meet the general criteria for bona fide consulting arrangements (as discussed in Section above) Speaker training sessions should be held in venues that are appropriate and conducive to informational communication and training about medical information; specifically, resorts are not appropriate venues Any compensation or reimbursement made to a healthcare professional in conjunction with a speaking arrangement should be reasonable and based on fair market value Each company should, individually and independently, cap the total amount of annual compensation it will pay to an individual healthcare professional in connection with all speaking arrangements Each company also should develop policies addressing the appropriate use of speakers, including utilization of speakers after training and the appropriate number of engagements for any particular speaker over time Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication While speaker programs offer important educational opportunities to healthcare professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines Beyond providing APPENDICES all speakers with appropriate training, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines Healthcare professionals who are members of committees that set formularies or develop clinical practice guidelines Healthcare professionals who are members of committees that set formularies of covered medicines or develop clinical practice guidelines that may influence the prescribing of medicines often have significant experience in their fields That experience can be of great benefit to companies and ultimately to patients if these individuals choose to serve as speakers or commercial consultants for companies To avoid even the appearance of impropriety, companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement Upon disclosure, healthcare professionals who serve as speakers or consultants for companies should be required to follow the procedures set forth by the committee of which they are a member, which may include recusing themselves from decisions relating to the medicine for which they have provided speaking or consulting services Scholarships and educational funds Financial assistance for scholarships or other educational funds to permit medical students, residents, fellows, and other healthcare professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution “Carefully selected educational conferences” are generally defined as the major educational, scientific, or policymaking meetings of national, regional, or specialty medical associations 10 Prohibition of non-educational and practice-related items Providing items for healthcare professionals’ use that not advance disease or treatment education – even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) – may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues Such non-educational items should not be offered to healthcare professionals or members of their staff, even if they are accompanied by patient or physician educational materials 543 544 APPENDICES Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs or tickets to a sporting event) likewise should not be offered Payments in cash or cash equivalents (such as gift certificates) should not be offered to healthcare professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections and 7) Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest It is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act 11 Educational items It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and not have value to healthcare professionals outside of his or her professional responsibilities For example, an anatomical model for use in an examination room is intended for the education of the patients and is therefore appropriate, whereas a DVD or CD player may have independent value to a healthcare professional outside of his or her professional responsibilities, even if it could also be used to provide education to patients, and therefore is not appropriate Items designed primarily for the education of patients or healthcare professionals should not be offered on more than an occasional basis, even if each individual item is appropriate 12 Prescriber data Companies use non-patient identified prescriber data to facilitate the efficient flow of information to healthcare professionals Such prescriber data, which does not identify individual patients, may serve many purposes, including enabling companies to: (a) impart important safety and risk information to prescribers of a particular drug; (b) conduct research; (c) comply with FDA mandated risk management plans that require drug companies to identify and interact with physicians who prescribe certain drugs; (d) track adverse events of marketed prescriptions drugs; and (e) focus marketing activities on those healthcare professionals who would most likely benefit from information about a particular drug Companies that choose to use non-patient identified prescriber data to facilitate communications with healthcare professionals should use this data responsibly For example, companies should (a) respect the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about those policies; (d) maintain an internal contact person to handle inquiries regarding the use of the data; and (e) identify appropriate disciplinary actions for misuse of this data In addition, companies should respect and abide by the wishes of any healthcare professional who asks that his APPENDICES or her prescriber data not be made available to company sales representatives Companies may demonstrate this respect by following the rules of voluntary programs that facilitate prescribers’ ability to make this choice 13 Independence and decision making No grants, scholarships, subsidies, support, consulting contracts, or educational or practice related items should be provided or offered to a healthcare professional in exchange for prescribing products or for a commitment to continue prescribing products Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a healthcare professional’s prescribing practices 14 Training and conduct of company representatives Pharmaceutical company representatives play an important role in delivering accurate, up-to-date information to healthcare professionals about the approved indications, benefits and risks of pharmaceutical therapies These representatives often serve as the primary point of contact between the companies who research, develop, manufacture and market life-saving and life-enhancing medicines and the healthcare professionals who prescribe them As such, the company representatives must act with the highest degree of professionalism and integrity Companies should ensure that all representatives who are employed by, or acting on behalf of, the companies and who visit healthcare professionals receive training about the applicable laws, regulations and industry codes of practice, including this Code, that govern the representatives’ interactions with healthcare professionals In addition, companies should train their representatives to ensure that they have sufficient knowledge of general science and product-specific information to provide accurate, up-to-date information, consistent with FDA requirements Companies should provide updated or additional training in all of these areas as needed for their representatives who visit healthcare professionals Companies should also assess their representatives periodically to ensure that they comply with relevant company policies and standards of conduct Companies should take appropriate action when representatives fail to comply 15 Adherence to code All companies that interact with healthcare professionals about pharmaceuticals should adopt procedures to assure adherence to this Code Companies that publicly announce their commitment to abide by the Code and who complete an annual certification that they have policies and procedures in place to foster compliance with the Code will be identified by PhRMA on a public web site The certification must be signed by the company’s Chief Executive Officer and Chief Compliance Officer The web site will identify the companies who commit to 545 546 APPENDICES abide by the Code; provide contact information for their Chief Compliance Officers; and, at the appropriate time, publish the status of each company’s annual certification Any comments received by PhRMA relating to a company’s observance of the Code or conduct that is addressed by the Code will be referred by PhRMA to the relevant company’s Chief Compliance Officer In addition, companies are encouraged to seek external verification periodically, meaning at least once every three years, that the company has policies and procedures in place to foster compliance with the Code PhRMA will prepare general guidance for such external verification and will identify on its web site if a company has sought and obtained verification of its compliance policies and procedures from an external source The following is a list of all signatory companies that have announced as of March 23, 2012 that they intend to abide by the Code: Abbott Allergan, Inc Amgen Inc Amylin Pharmaceuticals, Inc Astellas US LLC AstraZeneca LP Bayer HealthCare Pharmaceuticals Biogen Idec Boehringer Ingelheim Pharmaceuticals, Inc Bristol-Myers Squibb Company Celgene Corporation Cell Therapeutics, Inc Cephalon, Inc Corcept Therapeutics Covidien Cubist Pharmaceuticals, Inc Cumberland Pharmaceuticals Inc CV Therapeutics, Inc Daiichi Sankyo, Inc Eisai Inc EMD Serono Endo Pharmaceuticals, Inc Enzon Pharmaceuticals, Inc Ferring Pharmaceuticals, Inc Forest Laboratories, Inc Genentech, Inc Genzyme Corporation GlaxoSmithKline Ikaria, Inc Inspire Pharmaceuticals, Inc Johnson & Johnson (Pharmaceutical Companies) APPENDICES LEO Pharma Inc Eli Lilly and Company Lundbeck Inc Merck & Co., Inc Millennium Pharmaceuticals, Inc Novartis Pharmaceuticals Corporation Noven Pharmaceuticals, Inc Novogyne Pharmaceuticals Novo Nordisk Inc Optimer Pharmaceuticals, Inc Otsuka America Pharmaceuticals Pfizer Inc Purdue Pharma L.P Regeneron Pharmaceuticals, Inc sanofi-aventis U.S Shionogi Inc Shire Pharmaceuticals, Inc Sigma-Tau Pharmaceuticals, Inc Solstice Neurosciences, Inc Sucampo Sunovion Pharmaceuticals Inc Takeda Pharmaceuticals North America, Inc Talecris Biotherapeutics Theravance, Inc UCB, Inc Victory Pharma, Inc Zogenix,Inc 547 Index abnormal movement scale see AIMS scale abuse of medication: what to when medication abuse is suspected 395; what to when medication abuse occurs 396; see also misuse of medication access to medical records online 359 addiction: defined 385 adequate trial of medication 82 ADHD see Attention Deficit Hyperactivity Disorder adherence: methods to increase 89 adolescents see children and adolescents advertising of medication 480 agranulocytosis see blood dyscrasias AIMS scale for abnormal movements 534 akathisia as a side effect 288 alcohol abuse: signs of 218; laboratory tests in 219; treatment with medications 225 alcohol and psychotropic medication 222–8; routine warnings 216 alcohol detoxification: sample protocol for 228; withdrawal 229 allergy: from medication 373; signs and symptoms of 376; treatment of 377 alliance with the patient 79 alopecia as a side effect see hair loss Alzheimer’s dementia see Alzheimer’s disease Alzheimer’s disease: causes of 243; medical work-up of 241; medications for 245; symptoms of 239 anti-anxiety medication: breastfeeding and 177; confused patient and 247 anticholinergic intoxication: causes of 336–7; prevention of 339; signs and symptoms of 337; situations of risk for 337; treatment of 337 anticonvulsants: use in the confused patient 243 antipsychotic medication: confused patient and 176; discontinuation syndrome and 111; P-450 issues and 333 anxiety: as a side effect 287; checklist for 41; evaluation 41; panic attacks as a symptom of 287 anxious patient: managing 403–4 appointments by telephone see telephone; appointments by aspirin sensitivity: related to tartrazine allergy 379 asthenia see weakness atropine psychosis see anticholinergic intoxication Attention Deficit Hyperactivity Disorder 251–62; in adults 257; in children 255; causes of 254–5; medications for 259–61; non-medication treatments for 262; treatments without evidence of efficacy 266 atypical: meaning of 135–7 bias: diagnostic 42; medication 42–3 bipolar disorder: checklist for evaluation 135–7; metaphor use in treatment of 51 INDEX bleeding and blood dyscrasias as a side effect 364–6 blood levels of medication 433; instructions for 435 blood sugar: elevation of as a side effect 315 borderline patient 414–17; principles of medication treatment 415 breast feeding and psychotropics 173; antianxiety medications and 177; antidepressants and 175; antipsychotic medication and 176; mood stabilizers and 176 changeover sheet for changing medication 85, 86, 87 changing medication: because of side effects 281, 285, 286, 287 cholinesterase inhibitors 57, 292, 308, 339 choosing medication 59, 245–8; when the patient has previously been on medication 61; for kidney impaired patient 64; for liver impaired patient 62 cognitive disorders see delirium; dementia; confused patient cognitively impaired patient see confused patient compliance see adherence confidentiality of records: possible breaches of 430 conflicting advice see information from non-patients confused patient 234–6; antianxiety medication and 242; anticonvulsants and 243; antidepressant medication and 243; antipsychotic medication and; causes of 235; principles of treating 235; signs and symptoms of 235 constipation as a side effect 292–3 consultation: in managing difficult patients 418; psychiatric in primary care 92, 95, 129 crisis in a stable patient; getting on TRACCCC 126–9 delirium: causes of 238; in the elderly 192; medical work-up of 241; symptoms of 237 dementia: Alzheimer’s type see Alzheimer’s disease; causes of 241; management of 241–3; medication for 241–2 depression: checklist for evaluation 39–40; pregnant patient and 268; use of metaphor in 51 diagnosis: bias in 42 diarrhea as a side effect 291, 293 difficult medication patients 399–419; positive approaches to 401; practitioner generated issues 411; principles of management 400; stopping treatment with 418; team approach to 401 digital prescriber 453–67 discontinuation syndromes: antipsychotic medication and 333; benzodiazepines and 332; management of 116; medications that cause 110; medications that not cause 110; new episode of illness or not 118; SSRI’s and 110; stimulants and 112; TCA’s and 110; versus relapse 118 dry mouth as a side effect 308 dual diagnosis patient 222–5 electronic medical records (EMR) 459 electronic prescriptions 460 e-mail and the medication prescriber 454–6 EPS see extrapyramidal symptoms expiration dates of medication 96–7 extrapyramidal symptoms 350–9; causes of 350 falls as a side effect 315 follow-up appointments 72–98; feedback from others in 89; goals of 75; inpatient 74; length of 73; quantification of response in 77; side effect assessment in 83 fraud in obtaining medication 391; practitioner protection against 392 gastrointestinal problems as side effects see constipation; diarrhea; nausea generic medication 440–4; blood levels with 444; changes without clinician’s knowledge 443; common generic psychotropics Appendices 2, 3,4, 5; tips for using 443 genetics and psychotropic medication 489–90 geriatric patients see older adults gifts to practitioners: AMA guidelines for 537 hair loss as a side effect 308 headaches as a side effect 307 hepatotoxicity see liver toxicity 549 550 INDEX hyperprolactinemia as a side effect see prolactin elevation hypomania as a side effect 289 hyponatremia as a side effect 317 hypotension as a side effect 314 indigent care medication programs 479 informational websites maintained by practitioners 464; mental health sites for the patient 467 information from non-patients in medication management 31 informed consent: for medication 68 initial evaluation for medication 24, 43; medical work up in 32–3; mental status exam in 29; optional elements 36–7; required elements 28–9 initial prescriptive interview: time for 36–8; assessment and formulation in 34–6; information from others in 31 inpatient medication follow-up see follow up inpatient insufficient sleep syndrome 196 Internet and prescribers 453–73; risks and 473; security and 470; treatment protocols and 469, 488 intoxicated patient: evaluating 221 involuntary medication 69 kidney impaired patient: choosing medication for 69 lactation see breast-feeding levers for trying medication 48–9 lifestyle prescribing 490–1 lightheadedness as a side effect see hypotension lipid elevation as a side effect 315 lists: medication see medication lists lithium toxicity: causes of 340–3 liver impaired patient: choosing medication for 64 liver toxicity as a side effect 366–7 long-term medication: who should receive 123 low blood pressure see hypotension low sodium as a side effect see hyponatremia MAOI reactions see monoamine oxidase inhibitor reaction to MAOI’s see monoamine oxidase inhibitors media advertising see advertising of medication medical workup for medication 32; with children and adolescents 152 medication allergy see allergy: from medication medication bias 42–3 medication lists 427 medication: adequate trial of 82; blood levels of see blood levels of medication; borderline patient and 416–18 mental health medication statistics mental health referral see referral to a mental health specialist mental illnesses: practice guidelines for see practice guidelines for mental health treatment mental status exam: during initial evaluation 29; 493 metaphor use of 51 Mild Cognitive Impairment (MCI) 247 missed appointments 131 missed doses of medication 93 misuse of medication 383–96; accidental overdose 396; fraud and abuse 391; intentional overdose 387; minor overdose 390 monoamine oxidase inhibitors (MAOIs): reactions to 360; diet while taking 361 monotherapy 34, 54, 187 movement disorders as side effects 98, 243, 250 myths of mental health medication 9–18 narcolepsy 195 “naturalist” patient 412 nausea as a side effect 291 nervousness as a side effect see anxiety neuroleptic malignant syndrome (NMS) 349 NMS see neuroleptic malignant syndrome non-adherence: managing the noncompliant patient 407; older adults and 185–6 note taking: systems of 426; style elements of 427 number of pills to prescribe 64 office for mental health prescribing: setting up 481–6 older adults: medication interactions in 188; principles of medication 186 over activation as a side effect 286 ... and medication combinations References 27 5 27 6 27 8 27 9 28 0 28 0 28 1 28 2 28 3 28 3 28 4 28 5 28 6 28 7 28 8 28 9 29 0 29 1 29 3 300 3 02 304 304 307 308 308 308 310 3 12 314 314 315 317 318 319 320 27 6 MEDICATION. .. to the medication so far the presence or absence of suitable alternatives 28 1 28 2 MEDICATION DILEMMAS AND MANAGEMENT N N the length of time that the patient has been on the medication the patient’s... having the patient omit the medication dosage on the morning before planned sexual contact, which permits the blood level of medication to drop over the ensuing 12 18 hours The amount of medication