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Methods: A consecutive sample of 85 unique advertisements from each country was selected from the advertisements published between January to December in three widely circulated medical journals and one prescribing reference manual. The availability of brand name and generic name, indication, contraindications, dosage, side-effects, warnings, interactions and precautions was compared between the three countries.
Results: We examined distinct advertisements for pharmaceutical products.
Similar trends in the provision of product information for the same medicines published in these countries were noted. However, information on the negative effects of medicines was less frequently provided in Malaysia than in Australia and the US.
Conclusions: Journal advertising in Australia, Malaysia and the US failed to provide complete product information. Low quality of information provided in Malaysia indicates the need for effective regulation of provision of medicines information in journal advertising. Different standards of medicines information provided in these three countries suggest that pharmaceutical promotion needs to be better controlled at the international level.
Keywords: Pharmaceutical advertisements, promotion, regulation, Malaysia, Australia Introduction Journal advertising is used by pharmaceutical companies as a marketing strategy to promote pharmaceutical products to health professionals. The Ethical Criteria for Medicinal Drug Promotion was established to support and encourage the improvement of health care through the rational use of medicinal drugs [ 7 ].
It sets out the general standards for ethical promotion of pharmaceutical products that can be used as a model bygovernments [ 7 ]. Contrary to the WHO Ethical Criteria, the IFPMA code does not require information on warnings, major interactions, and content of active ingredient per dosage form or regimen and name of other ingredients known to cause problems to be provided in advertisements.
The IFPMA code requires that all promotional material should be consistent with locally approved product information [ 8 ]. The US is a country with a long-established control system by governmental agencies [ 9 ]. Australia [ 11 ] and Malaysia [ 12 ] are examples of developed and emerging countries, respectively, where pharmaceutical companies self-regulate their promotional activities by implementing voluntary codes of conduct which complement the requirements set by government legislation.
The codes, regulations and legislation provide standards for all types of promotional materials for prescription medicines including all printed and audiovisual promotional materials. In Australia, pharmaceutical advertising is regulated by government legislation through the Therapeutic Goods Act [ 13 ].
Medicines Australia, which represents research-based pharmaceutical companies, administers a code of conduct for promotional practice [ 11 ]. Similarly, in Malaysia pharmaceutical advertising for prescription medicines is regulated by government legislation through the Medicine Advertisement and Sale Act [ 14 ].
The Pharmaceutical Association of Malaysia PhAMA , which represents pharmaceutical companies, administers a code of conduct as a guide for the advertising of prescription medicines [ 12 ].
Failure to comply with the codes will result in sanctions including discontinuation or modification of any practice that is determined to breach the code, the issuance of retraction statements, fines, suspension or expulsion from Medicines Australia or the PhAMA [ 11 , 12 ].
FDA may issue regulatory letters to any pharmaceutical company that is found to be in breach of the laws. The letters may serve as a basis for additional regulatory action including recalls or seizures of promotional materials or activities, and criminal prosecution [ 16 ].
Most pharmaceutical companies are international companies. Generally, every pharmaceutical company has their own set of ethical standards based on the standards set forth in the IFPMA code of conduct.
According to the codes that are publicly available [ 17 - 19 ], promotional materials should support the appropriate use of medicines by presenting information accurately, without exaggeration and must follow all relevant local laws and company policies and procedures. Despite the existence of regulations and control of medicine promotion, the quality of medicines information in journal advertising has been questioned.
A systematic review [ 20 ] identified nine studies that evaluated provision of medicines information. Three were multinational comparative studies and seven studies were single country studies. The multinational comparative studies revealed that the provision of balanced medicines information in journal advertising was a problem both in developed and developing countries.
The negative effects of a medicine, which may discourage use of that medicine, less commonly appeared in advertisements.
All of the multinational comparative studies were published before Several studies and reviews5—7,10—12 have highlighted the issue defined as children younger than 12 years of age. Dosing after the early studies by Shirkey,3,4 yet pediatric drug labeling information for each PI was collected based on physiological and dosing information fail to improve to date.
PI that mentioned use in pediatrics was further Drug information resources, such as the Monthly Index reviewed for the availability of pediatric dosage formulations. However, the powders e. Poison from one nation to another.
It is noteworthy that where a product Group A are drugs categorized as dangerous drugs and psycho- has an indication in pediatrics and dosing information is avail- tropics. Whereas, Poison Group B are drugs that can be dispensed able, there is corresponding need to manufacture pharmaceutical only per the prescription of a registered medical practitioner, dosage formulations suitable for this age group.
Has there been dentist, or veterinary surgeon. Poison Group C are drugs that any change in what we know about this phenomenon over the can be sold only in a pharmacy as dispensed medications with past several decades?
Information about the availability of suitable pediatric product belonged to any of the seven major therapeutic cate- dosage forms is also scanty. The results were analyzed using spss, version Descriptive statistics includ- PI for prescription medications contained in the MIMS Annual ing frequencies and percentages were mainly used for the data was reviewed for pediatric use. Pediatric patients were analysis.
A total of between the therapeutic categories for all of the age groups, PI items from seven categories of therapeutic classes that except for the adults Table 2. Furthermore, there were no significant belonged to legal category C.
About The of dosing information for the neonatal and infant age groups. Detail is provided in Table 3. This therapeutic category group. The adult age category had the highest proportion On the wider international scope, however, there is no 42 9. Perhaps this was not an unexpected finding, given that vaccines and antibiotics are frequently prescribed for children. Respiratory, 33 7. Neonates 42 Infants 68 Children 85 Adolescents 73 Adults PI had adequate pediatric dosing information.
Pediatric drug important implications on policy and clearly suggests a closer labeling: Improving the safety and efficacy of pediatric therapies. JAMA ; — Changes in availability of paediatric peutically neglected population. Drug regulatory authorities in medicines in Australia between and Phar- Malaysia and other countries need to introduce an obligatory macol.