Portal de Periódicos da CAPES

S3 Guideline “Screening, Diagnostics, and Treatment of Harmful and Addictive Tobacco Use”

2016; Hogrefe Verlag; Volume: 62; Issue: 3 Linguagem: Inglês

10.1024/0939-5911/a000423

1664-2856

Anil Batra, Kay Uwe Petersen, Eva Hoch, Stefan Andreas, Gabriele Bartsch, H. Gohlke, Andreas Jähne, Christoph Kröger, P Lindinger, Stephan Mühlig, Tim Neumann, Martina Pötschke-Langer, Ulf Ratje, Tobias Rüther, Cornelie Schweizer, Norbert Thürauf, Sabina Ulbricht, Karl Mann,

Tryptophan and brain disorders

Free AccessS3 Guideline "Screening, Diagnostics, and Treatment of Harmful and Addictive Tobacco Use"Short VersionAnil Batra, Kay Uwe Petersen, Eva Hoch, Stefan Andreas, Gabriele Bartsch, Helmut Gohlke, Andreas Jähne, Christoph Kröger, Peter Lindinger, Stephan Mühlig, Tim Neumann, Martina Pötschke-Langer, Ulf Ratje, Tobias Rüther, Cornelie Schweizer, Norbert Thürauf, Sabina Ulbricht, and Karl MannAnil BatraSektion Suchtmedizin des Universitätsklinikums Tübingen, Tübingen, Kay Uwe PetersenSektion Suchtmedizin des Universitätsklinikums Tübingen, Tübingen, Eva HochPsychiatrische Klinik der Universität München, München, Stefan AndreasFachklinik für Lungenerkrankungen Philippsstiftung e.V, Immenhausen, Gabriele BartschDeutsche Hauptstelle für Suchtfragen e.V., Hamm, Helmut GohlkeDeutsche Gesellschaft für Kardiologie, Düsseldorf, Andreas JähneRhein-Jura Klinik, Bad Säckingen, Christoph KrögerInstitut für Therapieforschung, München, Peter LindingerWissenschaftlicher Aktionskreis Tabakentwöhnung e.V., Frankfurt a. M., Stephan MühligKlinische Psychologie und Psychotherapie TU Chemnitz, Chemnitz, Tim NeumannCharité-Universitätsmedizin, Berlin, Martina Pötschke-LangerDeutsches Krebsforschungszentrum, Heidelberg, Ulf RatjeAllgemeinmediziner, Eckernförde, Tobias RütherSpezialambulanz für Tabakabhängigkeit, Klinik für Psychiatrie und Psychotherapie, Klinikum der Universität München, Cornelie SchweizerSektion Suchtmedizin des Universitätsklinikums Tübingen, Tübingen, Norbert ThüraufPsychiatrische und Psychotherapeutische Klinik, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Sabina UlbrichtInstitut für Sozialmedizin und Prävention, Greifswald, and Karl MannZentralinstitut für Seelische Gesundheit, MannheimPublished Online:July 07, 2016https://doi.org/10.1024/0939-5911/a000423PDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinkedInReddit SectionsMoreIntroductionTobacco smoke belongs to the most dangerous substances containing psychotropic ingredients. By inhaling tobacco smoke, regular smoker ingests large amounts of carcinogenic, teratogenic, and atherogenic substances, without experiencing short-term disturbing impairments of their physical, mental, or social functionality. Although nearly all smokers are aware of the medium- and long-term health risks involved with smoking, nearly one quarter of the population (Federal Office of Statistics, 2014) still smokes cigarettes. The reasons are diverse: In about half of the smokers personal and environmental values, behavioral habits developed in connection with cigarette smoking, dealing with cognitive dissonance, and existing physical or mental dependence impede their withdrawal from tobacco use and make it a protracted, often life-long process characterized by relapses.Regardless of this fact, many smokers nevertheless do achieve abstinence during their lifetime through their own intentions and efforts. Health-associated information from their environment, being directly addressed by partners and other close persons, recommendations by physicians as well as concerns about tobacco-associated diseases, existing health problems, or perception of own dependence form the background and motivational factors for smoking cessation. From a medical and psychological point of view, however, smoking cessation would in many cases be imperative at a much earlier time point in life and should therefore be recommended at an early stage. For smokers who fail to achieve abstinence after serious smoking cessation attempts, therapeutic support is indicated.In order to support the motivational process for change, the cessation process itself, and successful coping with relapse, a variety of psychological/psychotherapeutic and pharmacological intervention approaches were developed, some of which have proved to be efficient, whereas others still lack evidence for their efficacy. Different from many other health interventions, the most effective methods according to the scientific state of knowledge are usually not being recommended by medical counsellors to people concerned. Rather, information is gathered by smokers who want to quit from a variety of sparsely regulated offers concerning smoking cessation. It is imperative for all professional counselors and therapists to be able to access successful smoking cessation methods and scientifically established, evidence-based treatment recommendations.For the collection and distribution of knowledge about treatment approaches, the Consortium of Scientific Medical Expert Associations (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF)) developed strict methodological criteria to ensure that treatment guidelines developed according to these quality criteria reflect the present state of knowledge objectively and independently of any other interests.The S3 guideline represents the highest quality standard of the AWMF, as does the present "Interdisciplinary Guideline of Quality S3 for Screening, Diagnostics and Treatment of Harmful and Addictive Tobacco Use! (hereafter referred to as "Tobacco Guideline").MethodThe Tobacco Guideline initiated by the German Society for Psychiatry, Psychotherapy, Psychosomatic, and Neurology (DGPPN) as well as the German Society for Addiction Research and Addiction Therapy (DG-Sucht) was developed by 19 authors. A total of 50 persons were involved in the production process of the text over 4 years, for the most part via voluntary work. For the costs incurred between October 2010 (start of design) and October 2014 (presentation of guideline to the AWMF), only interest-free donations (e. g., financial contributions of the DG-Sucht and the DGPPN) as well as contributions in form of personal support from the Central Institute of Mental Health in Mannheim and the Section of Addiction Research and Addiction Medicine in Tübingen) were applied. No third-party funds from private companies were accepted.The Tobacco Guideline was developed in a methodological process guided by a Steering Committee consisting of prestigious addiction researchers, scientifically supported by the AWMF together with a further S3 guideline for substance-associated disorders: the Alcohol Guideline. The constituent teleconference of this steering group took place on January 10, 2011. During a systematic overview, one or more scientists can elaborate on the state of research and can use their position for the interpretation of the derivation of guidelines, whereas the recommendations of an S3 guideline are negotiated in a much more complicated methodological process. This was also true for the Tobacco Guideline, whre clinical issues were defined in a consensus process and relevant information from systematically researched basic guidelines as well as systematic reviews of the Cochrane Tobacco Addiction Group were obtained. The responsible work groups applied the Scientific Guideline Manager of the Institute for Lung Research as technical tool for this systematic literature review.The basic aim of the guideline process was to formulate treatment recommendations: What should or can generally be offered smokers specifically as motivation or support in smoking cessation? Additionally, questions were answered concerning screening, diagnostics, and documentation as well as adequate settings. Recommendations furthermore address problematic offers that should not be adopted.The level of evidence (LoE) assigned to the recommendations also inform about the quality and reliability of the scientific information in the respective recommendation. Recommendation levels (A = strong recommendation, corresponding to "is to be", B to "should", O to "can") stem from a complex consideration of the LoE regarding the clinical relevance, the benefit-risk profile, patient preferences, implementability into the treatment, and where applicable other relevant variables. If no systematic literature research has been carried out, recommendations considered necessary could also be formulated as "clinical consensus issues" (CCI).All recommendations based on background texts, recommendation levels, and evaluations of evidence levels were presented to the attending experts during the "consensus conferences." During these days-long conferences, moderated by a representative of the AWMF and attended by a representative group of up to 35 delegates of expert societies, professional associations, and representatives of patients and relatives, the suggestions for recommendations were discussed intensively and if necessary modified, until they could either be accepted or refused. The potential influence of conflicts of interests were considered in all votes: Existing declarations of all delegates on potential or actual conflicts of interests were used by an independent third party in order to decide whether delegates were allowed to take part in votes concerning scientific areas in which potential conflicts of interests had been determined.All 78 recommendations of this Guideline and the three clinical algorithms employed to visualize the treatment process according to the Guideline received the approval of at least 75 % (on average 95.2 %) of the delegates of a consensus conference (see Table 1). A detailed description of the methodology may be found in the guideline report of the extended version of the Guideline. ( http://www.awmf.org/uploads/tx_szleitlinien/076-006m_S3_Tabak_2015-02.pdf)Table 1 Overview of recommendations of the Tobacco GuidelinePartial chapterRecommendation levelNumber ofrecommendationsMean consentA(+)B(+)0B(–)A(–)CCINote. The recommendation levels are A (strong recommendation, "are to be offered"), B (recommendation, "should be offered") 0 (unclear recommendation, "can be offered"). (+) is the recommendation to offer something, (–) the recommendation, not to offer something. CCI is a decision of the clinical consent (clinical consensus issue), i. e., not on the basis of a systematic review. Consent rule: > 75 % = consent; > 95 % = strong consent.Diagnostics and documentation2––––13(=) 95 %Motivation treatment and brief interventions25––––796 %Harm reduction-1–––1291 %Psychotherapeutic interventions2–31–17(>) 95 %Medication7–541–1789 %Somatic therapy approaches––11––287 %Women112––1598 %Pregnant women2–11–2699 %Adolescents22––11698 %Older people31–––15100 %Somatic comorbidity41–––1698 %Mental comorbidity33–––3998 %Setting, treatment situation–––––3398 %Total:281412721578(>) 95 %(95.2)Table 1 Overview of recommendations of the Tobacco GuidelineView as image HTML Results and DiscussionWhen people contact the health system as patients, their cigarette smoking status is systematically queried. This information is also included in the patient's documentation. If the severity of the tobacco dependence needs to be assessed in a further diagnostic process, this is done via the Fagerström Test for Tobacco Dependence (FTCD). Smokers who are willing to quit but require external support initially receive offers for low-threshold approaches, especially brief counseling, motivational therapy, and telephone counseling. If more intensive treatment is required, behavioral single or group therapy, possibly combined with medications, can be suggested. In cases involving distinct withdrawal symptoms, medications should be recommended. If a nicotine replacement therapy or a combination of nicotine replacement therapies proves ineffective, varenicline or bupropion should be offered after determining the indications or contraindications. Children, adolescents, and pregnant women should not be prescribed medication for withdrawal treatments.The recommendations of the present Guideline largely comply with other more recent national and international guidelines for smoking cessation. The German Tobacco Guideline, however, puts more emphasis than other international guidelines on the assessment of potential risks and contraindications concerning the pharmacological interventions.Clinical AlgorithmsThe glossary of the AWMF defines "algorithm" as something that "… clearly defines the course of action for the solution of a problem or certain kinds of problems" ( http://www.leitlinien.de/leitlinienmethodik/leitlinien-glossar/glossar/algorithmus). This guideline describes an algorithm that summarizes the available knowledge on how someone using tobacco products can quit smoking.In order to make the logic of the key recommendations of this S3 Guideline more assessable, given the variety of recommendations, graphic depictions (hereinafter referred to as "clinical algorithms") were compiled by using the recommended standard elements (Figure 1) on the website www.leitlinien.de.Figure 1 Standard elements of clinical algorithms (source: http://www.leitlinien.de/ leitlinienmethodik/leitlinien-glossar/glossar/algorithmus). Klinischer Zustand = clinical state; Entscheidung = decision; Handlung = action; logische Sequenz = logical sequence; Numerierung der Symbole = numbering of the symbols.The following three clinical algorithms should be understood as partial algorithms of a single clinical algorithm, divided up for a better overview. All three algorithms refer to one another and complement each other to form a total picture of the evidence-based support for the achievement of tobacco abstinence according to the current state of research.Clinical algorithm 1 describes recommendations on harm reduction for smokers who do not want to or are unable to quit smoking. The recommendations of low-threshold approaches are also addressed.Clinical algorithm 1 Clinical algorithm 2 outlines the recommended clinical pathway for smokers who require a more intensive, psychotherapy-based treatment.Clinical algorithm 2 If the process toward tobacco abstinence is substantially impaired by withdrawal symptoms, psychotropic drugs in addition to counseling or treatment may be considered. The relevant decision process is shown in algorithm 3.Clinical algorithm 3 Recommendations for Diagnostics and DocumentationDiagnostics: Categorical and DimensionalTable 2Table 2 Recommendation statementsRecommendation level1.1Fagerström Test for CigaretteDependence (FTCD) The Fagerström Test is to be applied for further diagnostics to estimate severity of cigarette dependence.CCI1.2Systematic screening All patients are to be asked for their tobacco use.ATable 2 View as image HTML DocumentationTable 3Table 3 Recommendation statementsRecommendation level1.3Assessment in documentation system Systematic assessment for tobacco use in the patient documentation improves the intervention rates. Tobacco use is to be assessed consecutively in the patient documentation.ATable 3 View as image HTML Recommendations for the Treatment of Harmful and Addictive Tobacco UseMotivational Treatment and Brief InterventionsTable 4Table 4 Recommendation statementsRecommendation level2.1Brief counseling In medical and psychosocial healthcare offer brief counseling for smokers to achieve smoking cessation.A2.2Brief counseling (contents) Brief counseling for smokers willing to quit should include a reference to further supportive offers such as single or group therapy or telephone counseling.B2.3Motivational Interviewing Motivational Interviewing should be offered to smokers with low motivation for smoking cessation.B2.4Telephone counseling In medical and psychosocial healthcare, offer telephone counseling to achieve smoking cessation.A2.5Internet-based self-help programs To support achieving smoking cessation, offer internet-based self-help programs.B2.6Mobile self-help programs To support achieving smoking cessation, offer mobile self-help programs.B2.7Self-help materials In medical and psychosocial healthcare, make classical self-help materials available to achieve smoking cessation.BTable 4 View as image HTML Harm ReductionTable 5Table 5 Recommendation statementsRecommendation level3.1Electronic cigarette (E-cigarette) E-cigarettes should not be recommended, before having been examined under the conditions of the drug safety testing concerning their efficacy and tolerability for harm reduction and smoking cessation.CCI3.2Programs for reduction of tobacco use If smokers are unable or unwilling to quit or reduce their tobacco consumption, offer support for reduction of use (NET, counseling, behavioral therapy).BTable 5 View as image HTML Psychotherapeutic InterventionsTable 6Table 6 Recommendation statementsRecommendation level4.1Behavioral group interventions Behavioral group interventions to achieve tobacco abstinence are effective. They are to be offered in medical and psychosocial healthcare.A4.2Behavioral single interventions Behavioral single interventions to achieve smoking cessation are effective. They are to be offered in medical and psychosocial health care.A4.3Psychodynamic therapy No evidence for the efficacy for psychodynamic therapy to achieve smoking cessation. Therefore, no recommendation either for or against psychodynamic therapy approaches can be given. 4.4Hypnotherapy The available data on the efficacy of hypnotherapy to achieve tobacco abstinence are inconsistent and require further attention. Hypnotherapy can be offered.04.5Aversion therapy Studies on the efficacy of aversion therapies as monotherapy are out of date, but the efficacy appears to be questionable, and potential risks exist. Aversion therapy should not be offered.B4.6Relevance of single componentsfor effectivity Insufficient data are available concerning the relevance of single components for the efficacy of behavioral treatment approaches. Behavioral treatment approaches should contain several components. The following are especially recommended: • psychoeducation • motivation enhancement • measures for short-term relapse prevention • interventions to reinforce self-efficacy • counseling, suitable for daily practice with concrete behavioral instructions and practical behavioral coping strategies (problem solving and skills training, stress management).CCI4.7Minimal and optimal duration ofpsychosocial treatments There are no indications for a strong dose-effect relationship of psychotherapeutic interventions. Because of missing data, no recommendation for duration and frequency of sessions can be given. Table 6 View as image HTML Medications for Withdrawal Treatment and Relapse Prevention (e. g., Nicotine Replacement Therapy, Bupropion, Varenicline, Other Antidepressants and Substance Groups Not to Be Considered)Table 7Table 7 Recommendation statementsRecommendation level5.1Nicotine replacement therapy Offer the application of nicotine replacement therapies (nicotine gum, nicotine inhaler, nicotine lozenges, nicotine spray and nicotine patches).A5.1.1Dosage of nicotine gums for strongsmokers For strong smokers 4 mg nicotine gums should be given rather than 2 mg gum.A5.1.2Nicotine replacement therapy,compoundcombination for strong smokers For strong smokers, offer a twofold combination of patch and gum, lozenge, spray or inhaler.A5.1.3Nicotine replacement therapy,combination with bupropion If a guideline-based, implemented pharmaceutical treatment failed to show sufficient effects in strong smokers, offer bupropion under consideration of and after informing about possible risks in combination with a long-term nicotine replacement therapy (patch).05.1.4Nicotine replacement therapy forrelapseprevention Nicotine replacement therapy can be offered for relapse prevention.05.1.5Nicotine replacement therapy for use of smokeless tobacco products Nicotine replacement therapy should not be offered for withdrawal from smokeless tobacco products.B5.2.1Antidepressants: bupropion If a guideline-based, implemented pharmaceutical treatment with nicotine replacement therapy failed to show sufficient effects, offer bupropion as pharmacological monotherapy for smoking cessation under consideration of and after informing about possible risks.A5.2.2Antidepressant: nortriptyline Nortriptyline can be offered for smoking cessation under consideration of possible risks, if approved therapy approaches were unsuccessful. In Germany, however, nortriptyline is not approved for this indication (see Appendix, criteria for off-label use).05.2.3Antidepressants: Others Offer other antidepressants for smoking cessation.A5.3.1Partial nicotine receptor agonists:varenicline If a guideline-based, implemented pharmaceutical treatment with nicotine replacement therapy failed to be effective, offer varenicline for smoking cessation under consideration of and after informing about possible risks.A5.3.2Partial nicotine receptor agonists:cytisine Cytisine can be offered. In Germany, however, it is not approved for this indication (see Appendix, criteria for off-label use).05.3.3Partial nicotine receptor agonists:Others Other partial nicotine receptor agonists should not be offered.B5.4Clonidine A therapy attempt with clonidine can be offered for smoking cessation under consideration of and after informing about possible risks, if guideline-based therapy approaches fail to show any success. In Germany, however, clonidine is not approved for this indication (see Appendix, criteria for off-label-use).05.5All other medications All other substances should not be offered because of a lack of evidence of efficacy and/or adverse benefit-risk profile.B5.6Duration of pharmaceutical relapseprevention If continuation of ongoing pharmaceutical treatment for relapse prevention is being considered, nicotine replacement therapy can be offered for 16 – 24 weeks, varenicline for 24 weeks, and bupropion for 16 – 45 weeks.05.7Combination of counseling andmedication Smokers who want to quit tobacco use and who are offered medication for smoking cessation treatment are to receive concomitant counseling to support smoking cessation.A5.8Behavioral therapy resp. intensive counseling and nicotine replacement therapy If available and appropriate, a combination of medication with behavioral therapy for smoking cessation treatment is to be offered.ATable 7 View as image HTML Somatic Therapy Approaches (e. g., Acupuncture, Magnetic Stimulation, Electronic Cigarette)Table 8Table 8 Recommendation statementsRecommendation level6.1Acupuncture Acupuncture does not have any specific effect on long-term tobacco abstinence. Acupuncture cannot be recommended.06.2Electronic cigarette The data on safety and efficacy of electronic cigarettes for smoking cessation are insufficient. The electronic cigarette should not be offered for smoking cessation.BTable 8 View as image HTML Sex and Age Aspects (e. g., Women, Pregnancy, Adolescents)AdolescentsTable 9Table 9 Recommendation statementsRecommendation level7.1.1Adolescents are to be offered a combination of age-appropriate psychoeducation, motivational enhancement (motivational enhancement, self-efficacy) and behavioral therapies.A7.1.2Low-threshold interventions (brief counseling, self-help material, smoker's handbook, quick guides, information material, skills communication) should be offered to adolescents as recommended in Section 4.1.B7.1.3In certain exceptional cases, nicotine patches can be offered to adolescents, if other recommended interventions were not successful, within the scope of the smoking-cessation treatment under careful consideration of the benefit-risk profile as off-label prescription (see Appendix 1). Other application forms of the nicotine replacement therapy are not to be applied for this age group.CCI7.1.4Further medications for smoking cessation treatment (e. g., bupropion and varenicline; see Section 4.4) are not to be offered to adolescents.A7.1.5Smoking cessation programs with a focus on behavioral therapy, motivational intervention, and enhancement of perceived self-efficacy are to be offered to adolescents.A7.1.6Computer-, internet-, and smartphone-based programs for smoking cessation should be offered to adolescents.BTable 9 View as image HTML WomenTable 10Table 10 Recommendation statementsRecommendation level8.2.1Women are to be offered the complete spectrum of the smoking cessation interventions, recommended in Sections 4.1 – 4.5.A8.2.2Additional gender-specific procedures for smoking cessation (e. g., weight control, coping with fears about weight gain, mood management, coordination of smoking cessation to menstrual cycle) can be offered to women.08.2.3Special low-threshold offers can be offered to women.08.2.4Nicotine replacement compounds, varenicline, and bupropion should be offered to women under consideration of and after informing about possible risks.B8.2.5Psychotherapeutic procedures and counseling are to be offered to women as noted in Section 4.3.CCITable 10 View as image HTML Pregnant WomenTable 11Table 11 Recommendation statementsRecommendation level8.3.1Special procedures for smoking cessation are to be offered to pregnant women.CCI8.3.2Low-threshold offers (self-help manuals, information material, quick-guides) can be offered to pregnant women.CCI8.3.3Because of the evidence of reduced efficacy and concurrently increased risk for adverse effects, medications for smoking cessation should not be offered to pregnant women [B]. In certain exceptional cases and under careful evaluation of benefit-risk, nicotine patches, inhalers, tablets, or nicotine gum can be considered (CCI).B8.3.4Psychotherapeutic procedures and counseling, as recommended in the Section on "Psychotherapy," are to be offered to pregnant women.A8.3.5Pregnant women are especially to be offered intensive counseling, behavioral modification, and motivational enhancement.A8.3.6Pregnancy-specific interventions (state-specific motivation acc. to TTM[please define!], feedback of health status and pollution load of fetus, reinforcement and reward) can be offered.0Table 11 View as image HTML Older PeopleTable 12Table 12 Recommendation statementsRecommendation level8.4.1Older people (50+) are to be offered the complete spectrum of the smoking-cessation interventions, as mentioned in Sections 4.1 – 4.6.A8.4.2In this age group more intensive treatment approaches for tobacco dependence (combined methods incl. psychological counseling, medication, and long-term guidance) should be offered.B8.4.3Low-threshold approaches can be offered for this age group.CCI8.4.4The complete spectrum of pharmacological therapies under consideration of and after informing about possible risks is to be offered, as mentioned in Section 4.4.A8.4.5Psychotherapeutic procedures and counseling are to be offered to older persons, as mentioned in Section 4.3.ATable 12 View as image HTML Somatic ComorbidityTable 13Table 13 Recommendation statementsRecommendation level9.1For patients with physical disorders, tobacco use is to be assessed.A9.2Patients who smoke and are in hospital because of tobacco-associated disorders are to be offered smoking-cessation programs resp. are to be helped in smoking cessation. Smoking cessation is to be started in the hospital, and patients should receive supportive contact over at least 1 month.A9.3Patients who smoke and for whom an operation is scheduled should be offered smoking-cessation programs with pharmaceutical components.B9.4All COPD-patients who smoke are to be offered smoking-cessation programs with pharmaceutical and psychosocial support.A9.5All patients with cardiovascular diseases are to be advised about smoking cessation without restriction and should avoid all exposure to tobacco, if possible.A9.6Patients who smoke and have tobacco-associated diseases are to be offered smoking cessation with pharmaceutical and psychosocial support.CCITable 13 View as image HTML Mental ComorbidityGeneral Key RecommendationsTable 14Table 14 Recommendation statementsRecommendation level10.1.1Tobacco use is to be assessed among patients with mental disorders – presently or in the past.CCI10.1.2Patients with mental disorders who smoke – presently or in the past – are to be offered smoking cessation.CCI10.1.3Under consideration of the acuteness and the particularities of the mental disorder, patients with tobacco dependence and additional mental disorder – presently or in the past – are generally to be offered the same psychotherapeutic and pharmaceutical measures as for smokers without additional mental disorders.CCITable 14 View as image HTML Special Recommendations for Comorbid Depressive DisordersTable 15Table 15 Recommendation statementsRecommendation level10.2.1Depressive patients who smoke or smokers with depression on their record are to be offered treatment for smoking cessation with components related to the depressive symptomatic (e. g., mood management).A10.2.2Depressive patients who smoke or smokers with depression on their record are to be offered bupropion or varenicline under consideration of and after informing about possible risks (see Sections 4.4.5.2 and 4.4.5.3).B10.2.3Depressive patients who smoke or patients with depression on their record are to be offered treatment with nicotine replacement therapy.ATable 15 View as image HTML Special Recommendations for Comorbid Schizophrenic DisordersTable 16Table 16 Recommendation statementsRecommendation level10.3.1Patients who smoke and have stable schizophrenia should be offered bupropion or varenicline under consideration of and after informing about possible risks (see Sections 4.4.5.2 and 4.4.5.3).B10.3.2Schizophrenic patients who smoke are to be offered treatment with nicotine replacement therapy.CCI10.3.3Behavioral (reinforcement-oriented) therapy approaches should be offered to schizophrenic patients for smoking cessation.BTable 16 View as image HTML Setting, Medical Treatment Situation and Aspects of FinancingTable 17Table 17 Recommendation statementsRecommendation levelNote:1The implementation "trained" in recommendation 4.9.3.2 was editorially inserted after termination of the consensus conference and was not voted on.11.1Setting:counseling approaches(face-to-face, via phone) Counseling for smoking cessation should be systematically offered by medical/psychotherapeutic professionals as well as by other trained professional groups in the healthcare system.CCI11.2Setting:therapeutic interventions(with and without pharmacotherapy) Behavioral-orientated single or group therapy for the promotion of smoking cessation or for withdrawal treatment are to be offered by trained medical/psychotherapeutic1 or qualified staff in the healthcare system.CCI11.3Setting:professionalization ofintervention Counseling approaches for the promotion of smoking cessation as well as therapeutic interventions for withdrawal treatment are to be integrated increasingly into the training and advanced training of healthcare professionals.CCITable 17 View as image HTML Conflicts of interestsAndreas: PfizerBartsch: keine InteressenskonflikteBatra: Kath. Fachhochschule, Bezirksärztekammer, Südwürttemberg, Ärztekammer Westfalen‐Lippe, Dtsch. Psychologenakademie, Wissenstransfer Uni Tübingen, Thieme, Kohlhammer, Alkermes, Pfizer, ParexelHoch: Dozententätigkeit Rhein‐Ruhr Universität Bochum, FU Berlin, Deutsche Psychologenakademie, BMG, EMCDDA, Deutscher Ärzteverlag, DesitinGohlke: keine InteressenskonflikteJähne: Daiichi Sankyo, Bristol-Myers Squibb, Johnson & Johnson, Lundbeck, Pfizer, Sanofi, Volkshochschulen, Akademie für ärztliche Fort- und Weiterbildung Südbaden, Ärztekammer Nordrhein, Deutsche Krebshilfe, Institut für Hausärztliche Fortbildung, Ministerium für Arbeit und Sozialordnung, Familie, Frauen und Senioren des Landes Baden-Württemberg.Kröger: Pfizer, BMGLindinger: Krankenkassen, Berufsgenossenschaften, Bundesamt für Gesundheit (Schweiz), Arbeitsgemeinschaft Tabakprävention (Schweiz,) Bundeszentrale für Gesundheitliche Aufklärung (BZgA), Deutsches netz Rauchfreier Krankenhäuser und Gesundheitseinrichtungen (DNRFK), Universität Tübingen, Deutsches Krebsforschungszentrum (DKFZ), Deutsche PsychologenakademieMann: Lundbeck, Pfizer, NovartisMühlig: Mühlig: Vortragstätigkeit bei Pfizer, Mundipharma, Dozententätigkeit in Psychotherapeutenausbildung, bei Psychotherapeuten- und Ärztekammer und Weiterbildungsakademie (TUCed); Forschungsaufträge: AOKplus, Bundesregierung; Versorgung: Leiter Raucherambulanz Chemnitz, Tabakentwöhnungskurse, PsychotherapieNeumann: Dozent für Ärztekammer Brandenburg, Thieme‐Verlag, Südd. Verlagsgruppe, MIC Kongressoprganisation.Petersen: keine InteressenskonfliktePötschke-Langer: keine InteressenskonflikteRatje: Berlin‐Chemie AG, Publikation in "Der Allgemeinarzt", Programmschulung für DGNTF e.V.Rüther: Pfizer, Johnson & JohnsonSchweizer: DGH, MEGThürauf: Alberti‐Konzept‐Gesundheit, Hanns‐Seidel‐Stiftung, Janssen‐Cilag, Klinik BarmelweidUlbricht: keine InteressenskonflikteAppendixAppendix 1: "Off-Label-Use": For Application of Medications for Smoking Cessation, Not Approved in GermanyMedications for smoking cessation approved in Germany for use from the age of 18 years onward are all applications for nicotine substitution (i. e., inhaler, gum, lozenge, mouth spray, patch, sublingual tablet), and bupropion and varenicline. Only certain nicotine-replacement systems have been approved for application with concomitant tobacco use for the gradual reduction of smoking or in combination with nicotine replacement systems (for more information, see the prescription information provided with the products). All other medications or combinations thereof (e. g., bupropion and nicotine gum) and especially their application prior to the age of 18 are not approved. Their application would be considered so-called "off-label-use."To ensure patient safety, in Germany medications can only be brought to the market after authorization by an admission board (e. g. Federal Institute for Drugs and Medical Devices, BfArM). The basis of the admission is an application by the producing pharmaceutical company after the drug has undergone an extensive verification procedure to ensure efficacy and tolerability based on clinical studies. Information on the admission results may be found (among other places) in the package information leaflet. This procedure is applied separately for each product, each indication, and each patient group by the pharmaceutical company and is therefore both extensive and expensive. For many medications only the most frequent fields of application are applied for. Off-label use means going beyond the official application of a medication, especially when applying the licensed medications in fields of application not approved by the admission board (Joint Federal Committee).For many of the substances described here smoking cessation represents only an additional indication, or its efficacy in smoking cessation was examined only after the main indication of the medication had been approved (e. g., a blood pressure medication or antidepressant). These compounds are not licensed for this purpose and can be prescribed only for smoking cessation as off-label compounds. There was no administrative examination of the application, and in most cases only insufficient data concerning the benefit/risk evaluation are available. Because of the limited experiences, a certain risk remains when judging the benefit and/or application risks.The German Federal Ministry of Health (FMH) mandated the Joint Federal Committee in 2005 to establish expert groups to evaluate the state of knowledge concerning off-label use of certain substances and medications, for instance, for their use in oncology, neurology, and pediatrics, but not for smoking cessation.Medications that can be prescribed and refunded following admission were specified by the Federal Social Court of Germany in its verdict, ref. B 1 KR 37/00 R, dated March 19, 2002. It acknowledges the necessity of restricted off-label use under strict premises:"Prescription of a medication for an application field not covered under the admission can be taken into consideration only if1.treatment is for a severe (life-threatening or permanently impairing the quality of life) disorder is concerned,2.if no other therapy is available, and3.based on the data available there is a justified prospect that the respective compound will achieve treatment success (either curative or palliative). In order to assume the latter, research findings have to be available giving sufficient reason to expect that the medication can be applied for the indication in question. This can be assumed if either an extension of the admission has already been applied for and the results of a controlled clinical phase III trial (standard or placebo) have already been published and proved a clinically relevant efficacy or a clinically relevant benefit at justifiable risk; or if findings subsequent to admission procedure have been published allowing for scientifically verifiable statements on the quality and efficacy of the medication in the new application field, and if consent in relevant expert circles exists in the aforementioned sense because of said findings" (Joint Federal Committee).This guideline presents evaluations of efficacy on the basis of clinical studies on smoking cessation and the well-known application risks. Often there are fewer data available for rare applications such as smoking cessation than for the main indication of the compound in question.The decision to apply certain medications lies with the prescribing physician in each individual case. The physician can be held responsible for any consequences if an off-label medication causes damage to a patient. Strict liability on the part of the pharmaceutical company (according to paragraph 84, section 1, no. 1 of the German Drug Law) is explicitly provided only for medications that have already been admitted for that purpose. The prescribing physician has to inform the patient about the precise indication or the absence of admission of a medication as well as all application risks and side effects.Source: http://www.g-ba.de/institution/sys/faq/78/ (February 15, 2014)Prof. Dr. Anil Batra, Section for Addiction Research and Medicine, University Hospital Tübingen, Dept. of Psychiatry and Psychotherapy, Calwer Str. 14, 72076 Tuebingen, Germany, E-mail anil.batra@med.uni-tuebingen.deFiguresReferencesRelatedDetailsCited byCritical appraisal of tobacco dependence treatment guidelines8 September 2020 | International Journal of Clinical Pharmacy, Vol. 43, No. 1Efficacy of a short-term residential smoking cessation therapy versus standard outpatient group therapy ('START-Study'): study protocol of a randomized controlled trial23 June 2020 | Trials, Vol. 21, No. 1Tabakbezogene Störungen – was gibt es Neues?Tobacco-related disorders – is there anything new?Anil Batra and Daniel Kotz23 April 2019 | SUCHT, Vol. 65, No. 1Process Evaluation of a Medical Student–Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster Randomized Trial11 April 2019 | JMIR Research Protocols, Vol. 8, No. 4A Face-Aging Smoking Prevention/Cessation Intervention for Nursery School Students in Germany: An Appearance-Focused Interventional Study4 August 2018 | International Journal of Environmental Research and Public Health, Vol. 15, No. 8Smoking Cessation and Soft Signs of Mental Disorders23 March 2020 | European Psychiatry, Vol. 41, No. S1German Guidelines on Screening, Diagnosis and Treatment of Alcohol Use Disorders9 February 2017 | European Addiction Research, Vol. 23, No. 1 Volume 62Issue 3Juni 2016ISSN: 0939-5911eISSN: 1664-2856 InformationSUCHT (2016), 62, pp. 139-152 https://doi.org/10.1024/0939-5911/a000423.© 2016Hogrefe AGPDF download