Legal limitations on Medicines Marketing and Promotion – PST05105 Rational Use of Medicines
NTA Level 5 • Semester 1 • PST05105 Legal limitations on Medicines Marketing and Promotion Rational Use of Medicines • Source Session/Topic 11 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 11: Legal limitations on Medicines Marketing and Promotion Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Define the terms used in legal limitations on medicines marketing and promotion. • Give general understanding of legal limitations on medicines marketing and promotion. • Identify responsibilities of TFDA on medicines marketing and promotion • Describe pharmaceuticals promotion control • Identify importance of promotion and marketing in pharmacy • Describe pharmaceuticals advertisement control Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |10 Minutes |Presentation |Definition of Terms used in Legal | | | | |Limitations on Medicines Marketing | | | | |and Promotion. | |3 |15 Minutes |Presentation |Introduction to Legal Limitations on| | | | |Medicines Marketing and Promotion. | |4 |30 Minutes |Presentation |Responsibilities of TFDA on | | | |Brainstorming |Medicines Marketing and Promotion | |5 |10 Minutes |Presentation |Pharmaceuticals Promotion Control | |6 |20 Minutes |Presentation |Important of Promotion and Marketing| | | |Buzzing |in Pharmacy | |7 |10 Minutes |Presentation |Pharmaceuticals Advertisement | | | | |Control | |8 |05 Minutes |Presentation |Key Points | | 9 |05 Minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Definition of Terms inLegal limitations on Medicines Marketing and Promotion. (20 Minutes) • Pharmaceuticals Promotion: refers to all informational and convincing activities by manufacturers and distributors, the effect of which is to encourage the prescription, supply, purchase and/or use of medicinal drugs. • The important of Promotion is to create an image, to modify attitudes to support sales increases and to create awareness • Marketing: creating customer value and satisfaction. It is a process by which individuals or groups obtain what they need and want through creating and exchanging products and value with others. i.e. It is simply the delivery of customer satisfaction at a profit • Advertising: Any form of communication using any form of mass media or a controlled message in purchased time or space. It is non-personal and paid. The forms of advertising include journals, direct mail & e-mail, bill boards, newspapers and TV. It includes every form of advertising, whether in a publication, or by the display of any notice or by means of any catalogue, price list, letter, whether circular or addressed to a particular person, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting, or television or any other means of communication. STEP 3: Introduction to Legal Limitations on Medicines Marketing and Promotion. (15 Minutes) • Medicines have the potential for benefit to individuals who use them and to the public health. But all effective medicines may be associated with adverse effects. • The law recognizes that medicines should not be treated as an ordinary general commodity by placing specific restrictions on them. • Activities conducted as part of pharmaceutical marketing and promotions are an important component of educating and informing consumers and health care professionals about new treatments. • Direct-to-consumer (DTC) advertisements aim to inform patients of important treatment options, while pharmaceutical sales representatives work to get accurate, up-to-date information on medicines to health care professionals. STEP 4: Responsibilities of TFDA on Medicines Marketing and Promotion (30minutes) |Activity: Brainstorming (15 Minutes) | |Ask students to brainstorm on the following question: | |What are the responsibilities of TFDA on medicines marketing and | |promotion? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | TFDA is the effective medicines regulatory body which promotes and protects public health by ensuring that: • Medicines are of the required quality, safety and efficacy, medicines are appropriately manufactured, stored, distributed and dispensed, illegal manufacturing and trade are detected and adequately sanctioned, health professionals and patients have the necessary information to enable them to use medicines rationally. • Ensure that promotion and advertising is fair, balanced and aimed at rational drug use, access to medicines is not hindered by unjustified regulatory work. STEP 5: Pharmaceuticals Promotion Control (10 Minutes) • Product promotion means any activity undertaken by a company or individual to promote and encourage the prescription, supply, sale, administration or purchase of food, drugs, herbal drugs, cosmetics, and medical devices. (in relation to products regulated by TFDA such as medicines) • Such promotion can be presented in various forms like: o Brochures, posters, leaflets, TV, radio, newspaper, magazine, and internet advertisement, Journal or direct mail advertising, supply of free samples, sponsorship of promotional meeting and sponsorship of scientific meeting • Product promotion Control section of the TFDA routinely scrutinizes promotional materials before approval is granted. • Promotion of food, drugs, herbal drugs, cosmetics, and medical devices is controlled under the Tanzania Food, Drugs and Cosmetics Act, 2003 sections 95 to 98 and 122(1) (r) regulations, 2010. • No promotional activity should be conducted in Tanzania mainland unless it is approved by the TFDA. • In order to get approval, two copies of the promotional materials should be submitted to the Director General, TFDA. Upon approval, one copy will remain with the TFDA. STEP 6: Importance of Promotion and Marketing in Pharmacy (20 Minutes) |Activity: Buzzing (10 minutes) | |ASK students to pair up and buzz on the following question for 2 | |minutes | |What are