Presentation is loading. Please wait.

Presentation is loading. Please wait.

Faculty of Medicine Gadjah Mada University

Published byReynard Mosley Modified over 6 years ago

Similar presentations

Presentation on theme: "Faculty of Medicine Gadjah Mada University"— Presentation transcript:

1 Faculty of Medicine Gadjah Mada University
DRUG INFORMATION DRUG ADS TARGETED TO PHYSICIAN, CONSUMERS, AND CHILDREN Faculty of Medicine Gadjah Mada University 2017 – Drug Information

2 WHO definition of promotion
"all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs"

3 Examples of promotional tools and target audiences
Prescribers Sales Representatives Education events Journal advertisements Gifts Samples Enter patients in clinical trials against payment Physicians or opinion leaders paid as speakers Discounts Gifts Educational events Monitoring of prescriptions Pharmacies Consumers Direct to consumer advertising (DTCA) Medicalisation or "illness promotion" Support to patient-help organizations

4 "Imbalance between commercially produced and independent drug information" (1)
Large amount spent around the world for drug promotion: US: US$ 13 – 15 billion (2000) (1) Australia: US$ 1.3 – 2 billions per year (2) Italy: US$ 1.1 billion (1998) (1) Low-income countries: 20 – 30% of sales revenue (1) Growth spending on DTCA for prescription drugs US: US$ 55 million (1991) to US $ 2.4 billion (2001) (3) Others figures (US): currently 80,000 sales reps (1) 314,000 physician events in 2003 (sponsored industry) (1) free samples: $ 11 billion (retail value) or $ 2-3 billion (prod. cost) Only 50% countries have drug information centres (1999) (1) (1) WHO Medicines Strategy 2004 – 2007 (2) (3) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001

5 Sales representatives too often only source of information for health professionals
Interactions start during medical school (2) 80 – 95% doctors see sales reps regularly (1) average 4 times a month (2) US: 1 sales rep for 15 to 30 physicians (3) Seen as important source of info (new drugs) (3) 10% sales reps statements are inaccurate (3) 25% doctors recognize inaccurate statements (3) Impacts prescribing costs irrational prescribing preference of new drugs decreased prescription of generics (2) (1) Moynihan R. Who pays for the pizza? BMJ 2003; 326: (2) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283: (3) Ziegler M. & al.. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273:

6 Gifts, trips, dinners influence prescribing habits & power needs to be acknowledged
Most doctors deny gifts influence their prescribing (1) Recognized as conflict of interest and established "ceilings" (e.g. $ 100 in US) (2) Small gifts play important role (2) Pens, note pads, etc. act as "reminder items" (2) Sole or among top reasons to see sales reps (1) Psychological aspects: indebtedness, reciprocity(2) Food, flattery and friendships: powerful tools of persuasion (1) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283: (2) Katz D & al. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. AM J Bioethics.2003;3:39-46

7 Increasing evidence that promotion techniques influence physicians' prescribing
Medical journals ads: information content generally poor (1) Headlines can be misleading (32%) Lead to improper prescribing if no additional information (44%) Little or no educational value (57%) Often minimize risks and harmful effects (50% to 60%) Advertisement material: only 6% material supported by scientific evidence (2) 15% of brochures did not contain any citations 22% citations listed could not be found 63% info correctly referenced but articles did not reflect results Sponsored medical conferences Attendance associated with increased prescribing of sponsored product (3) (1) Wilkes M. Pharmaceutical Advertisements in Leading Medical journals: Experts' Assessment. Ann Intern Med. 1992;116:912-9 (2) Tuffs A. Only 6% of drug advertising material is supported by evidence [news]. BMJ 2004; 328: 485 (3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:

8 Direct-to-consumer advertising
Department of Clinical Pharmacology Faculty of Medicine Gadjah Mada University 2016 – Drug Information

9 Direct-to-consumer advertising :
DTCA of prescription-only medicines is legal only in US and New Zealand Direct-to-consumer advertising : US since 1980s FDA decision 1997: relax restrictions on radio and TV 2003: US$ 3 billion per year 8.5 m. people request & receive prescription after advertisement New Zealand 2003: GPs launched campaign for ban Rejected by EU health ministers in June 2003 and EU parliament in December 2003 All other countries (internet, satellite, etc.) Increases prescription drugs costs (1) Only new blockbusters medicines are advertised Reliance on newer medicines Misleading statements leading to irrational use and undue risks (1) Exaggeration of benefits & false expectations about safety and efficacy No mention of other helpful activities (e.g. diet or exercise) Breach regulation (1) USFDA sent 94 notices to companies between 1997 and 2001 1998, half products advertised on TV Strains on physician-patient relation (1) No evidence of health benefits (2) Promotes medicalisation of normal life (1) (1) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001 (2) Mansfield P. & al. DTCA is more profitable if it is misleading. NZ Med J 2003; 116 (1182)

10 DTCA example

11 WHO ethical criteria (1988) still relevant today, more than ever
Objective to promote "proper behaviour" Reliable, accurate, truthful, informative, balanced, up-to date, and in good taste NOT misleading or unverifiable or omissions Scientific data available in public domain No financial/material benefit offered to health professional Scientific and educational activities not used for promotional purposes

12 WHO ethical criteria cover wide arrange of promotional activities
Advertising: Professionals: min. summary scientific information Consumers: help make rational decisions, no DTCA Medical representatives Technical knowledge and ethical conduct Complete/unbiased information and no offer of inducement Samples Modest quantities for prescription drugs Difficult to justify for non-prescription drugs Symposia and scientific meetings Objective scientific content & independent scientists Sponsorship clearly stated, gifts secondary to main purpose Post-marketing scientific studies Inform health authorities and validated relevant committees "… not be misused as a disguised form of promotion."

13 DRUG ADV IN CHILDREN Department of Clinical Pharmacology Faculty of Medicine Gadjah Mada University 2016 – Drug Information

14 WHO Ethical Criteria for Medicinal Drug Promotion, 1988
While health education aimed at children is highly desirable, drug advertisements should not be directed at children. When lay language is used, the information should be consistent with the approved scientific data sheet or other legally determined scientific basis for approval. Language which brings about fear or distress should not be used. Faculty of Medicine Gadjah Mada University 2016 – Drug Information

15 Faculty of Medicine Gadjah Mada University
SK Menkes 386, 1994 8. Iklan obat tidak boleh ditujukan untuk khalayak anak-anak atau menampilkan anak-anak tanpa adanya supervisi orang dewasa atau memakai narasi suara anak-anak yang menganjurkan penggunaan obat. Iklan obat tidak boleh menggambarkan bahwa keputusan penggunaan obat diambil oleh anak-anak.. 17. Iklan obat harus mencantumkan informasi mengenai: Komposisi zat aktif obat dengan nama INN (khusus untuk media cetak); untuk media lain, apabila ingin menyebutkan komposisi zat aktif, harus dengan nama INN Indikasi utama obat dan informasi mengenai keamanan obat Nama dagang obat Nama industri farmasi Nomor pendaftaran (khusus untuk media cetak) Faculty of Medicine Gadjah Mada University 2016 – Drug Information

16 Komisi Periklanan Indonesia, 1996
Bab II Tatakrama butir C.1. : a. Iklan tidak boleh memperlihatkan anak-anak dalam adegan berbahaya, menyesatkan atau tidak pantas dilakukan oleh anak-anak b. Anak-anak tidak boleh digunakan untuk mengiklankan produk yang tidak layak dikonsumsi oleh anak-anak Bab II Tatakrama butir C.10.d. : d. Iklan harus memperhatikan keamanan dari penggunaan obat-obat yang diiklankan, terutama terhadap anak-anak Faculty of Medicine Gadjah Mada University 2016 – Drug Information

17 Faculty of Medicine Gadjah Mada University
ads. 1 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

18 Faculty of Medicine Gadjah Mada University
ads. 2 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

19 Faculty of Medicine Gadjah Mada University
ads. 3 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

20 Faculty of Medicine Gadjah Mada University
ads. 5 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

21 Faculty of Medicine Gadjah Mada University
ads. 7 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

22 Faculty of Medicine Gadjah Mada University
ads. 8 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

23 of Medicine Gadjah Mada University
ads. 9 of Medicine Gadjah Mada University 2016 – Drug Information

24 Faculty of Medicine Gadjah Mada University
Ads. 10 Faculty of Medicine Gadjah Mada University 2016 – Drug Information

25 Examples of country practices include regulation, policy and training interventions
Increase awareness of physicians (e.g. "no free lunch") Independent drug information centres (professionals and consumers) Code of conduct (professional associations, pharmaceutical industry) Publicly funded continuing education of staff Training of medical students to critically assess pharmaceutical promotion successful experience in Indonesia with long-term impact (1) Others… (1) Drug advertisements: a critical lesson for Indonesian students, WHO, Essential Drugs Monitor, 1997, Issue n° 23

26 TERIMA KASIH

Download ppt "Faculty of Medicine Gadjah Mada University"

Similar presentations

The Role of Government in Encouraging a High Standard of Ethics in the Healthcare Sector: Indonesia Experience Prof. Agus Purwadianto Senior Adviser to.

The Role of Government in Encouraging a High Standard of Ethics in the Healthcare Sector: Indonesia Experience Prof. Agus Purwadianto Senior Adviser to.
Perspectives Authors and editors perspective Is there much difference between perspectives of different stakeholders? –authors, readers, editors, clinicians,

Perspectives Authors and editors perspective Is there much difference between perspectives of different stakeholders? –authors, readers, editors, clinicians,
Understanding Private Payers & Maximizing Private Payer Reimbursement Strategies: Understanding the Process Barbara Grenell, Preferred Health Strategies.

Understanding Private Payers & Maximizing Private Payer Reimbursement Strategies: Understanding the Process Barbara Grenell, Preferred Health Strategies.
Ethical Criteria for Promotion of Medicines Technical Briefing Seminar 21 September 2005 Dr Guitelle Baghdadi, World Health Organization, Geneva.

Ethical Criteria for Promotion of Medicines Technical Briefing Seminar 21 September 2005 Dr Guitelle Baghdadi, World Health Organization, Geneva.
London Medicines Information Service (Northwick Park Hospital) - June 2008 Drug Promotion: The Pharmaceutical Representative. Making the most of Promotional.

London Medicines Information Service (Northwick Park Hospital) - June 2008 Drug Promotion: The Pharmaceutical Representative. Making the most of Promotional.
Continuing Professional Development Conflict of Interest This presentation has been developed by the COI Working Group to assist in the implementation.

Continuing Professional Development Conflict of Interest This presentation has been developed by the COI Working Group to assist in the implementation.
Drug Promotion And Dealing With The ‘Reps’ Neena Lakhani.

Drug Promotion And Dealing With The ‘Reps’ Neena Lakhani.
The Changing Regulatory Environment for Industry Support The accreditation bodies’ point of view. Ian Starke (UK)

The Changing Regulatory Environment for Industry Support The accreditation bodies’ point of view. Ian Starke (UK)
Canadian Nurse Practitioners and Pharmaceutical Influences

Canadian Nurse Practitioners and Pharmaceutical Influences
Pharmaceutical Sales representatives July 2014 Tim Reed Health Action International This document arises from HAI Europe’s Operating Grant 2014, which.

Pharmaceutical Sales representatives July 2014 Tim Reed Health Action International This document arises from HAI Europe’s Operating Grant 2014, which.
Enforcement in the Pharmaceutical Industry Michael K. Loucks First Assistant U.S. Attorney United States Attorney’s Office District of Massachusetts October.

Enforcement in the Pharmaceutical Industry Michael K. Loucks First Assistant U.S. Attorney United States Attorney’s Office District of Massachusetts October.
International Experience in Pharmaceutical Services for Promoting Access to Medicines: Canada, Cuba, England, Mexico International Seminar on the Challenges.

International Experience in Pharmaceutical Services for Promoting Access to Medicines: Canada, Cuba, England, Mexico International Seminar on the Challenges.
Towards an Integrity Standard in the Pharmaceutical Industry IACC Conference, May 27, 2003 Seoul, Korea Dr. Jillian Clare Cohen Assistant Professor, Leslie.

Towards an Integrity Standard in the Pharmaceutical Industry IACC Conference, May 27, 2003 Seoul, Korea Dr. Jillian Clare Cohen Assistant Professor, Leslie.
Promotional Material & The Pharmaceutical Representative. Bridget Rankin, Principal Pharmacist – Medicines Information Maidstone & Tunbridge Wells NHS.

Promotional Material & The Pharmaceutical Representative. Bridget Rankin, Principal Pharmacist – Medicines Information Maidstone & Tunbridge Wells NHS.
1 1 PDUFA & FDA Legislation FDA Regulatory & Compliance Symposium August 2006 Marc Wilenzick, Moderator for Panel: Dan Carpenter, Harvard Dept. of Government.

1 1 PDUFA & FDA Legislation FDA Regulatory & Compliance Symposium August 2006 Marc Wilenzick, Moderator for Panel: Dan Carpenter, Harvard Dept. of Government.
External Influences on Prescribing Practice Karen Ford.

External Influences on Prescribing Practice Karen Ford.
MONITORING THE VALUE OF TRIAL REGISTER INFORMATION Thomson Pharmaceutical Services LAWRENCE LIBERTI MS, RPh, RAC JULY 16, 2008.

MONITORING THE VALUE OF TRIAL REGISTER INFORMATION Thomson Pharmaceutical Services LAWRENCE LIBERTI MS, RPh, RAC JULY 16, 2008.
Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and.

Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and.
3rd Baltic Conference on Medicines Economic Evaluation, Reimbursement and Rational Use of Pharmaceuticals Pricing and Reimbursement of Pharmaceuticals.

3rd Baltic Conference on Medicines Economic Evaluation, Reimbursement and Rational Use of Pharmaceuticals Pricing and Reimbursement of Pharmaceuticals.
CEMA-community to Improve Knowledge and Skills in Evaluating Medicine Advertisements Chairun Wiedyaningsh Nunung Priyatni Siti Munawaroh Sri Suryawati.

CEMA-community to Improve Knowledge and Skills in Evaluating Medicine Advertisements Chairun Wiedyaningsh Nunung Priyatni Siti Munawaroh Sri Suryawati.

Similar presentations

Ads by Google