IFPMA Research Articles

Perceptions of and barriers to ethical promotion of pharmaceuticals in Pakistan: perspectives of medical representatives and doctors

BackgroundIn Pakistan, drug promotion practices, ethical or unethical, have rarely been in the spotlight. We aimed to assess the perception and barriers of medical representatives (MRs) and doctors (MDs) regarding ethical promotion of pharmaceuticals in Pakistan.MethodsA cross sectional survey was conducted in seven major cities of Pakistan for 6-months period. Self-administered questionnaire was used for data collection. Logistic regression and five-point Likert scale scoring was used to estimate the perceptions and barriers.ResultsCompared to national companies (NCs), the medical representatives (MRs) of multinational companies (MNCs) strongly believed that their companies follow World Health Organization (WHO) (OR; 5.31, p = 0.0005), International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (OR; 6.45, p = 0.0005) and national codes of ethics (OR; 5.84, p = 0.0005). MNCs trained their MRs (OR; 6.68, p = 0.0005), provide accurate and valid scientific data (OR; 4.01, p = 0.007) with adequate system of accountability and controls on product samples (OR; 1.96, p = 0.047), while, NCs sponsor social or entertainment activities, seminars and conferences, and all sort of facilitation in form of gifts of their choice and clinic renovation for medical doctors (MDs). MDs perceptions were similar to MRs mentioned above, yet strongly agreed that companies offer cash payments or equivalents to MDs. The MRs of NCs/MNCs and MDs agreed/strongly agreed that no external accountability, profiteering, pressure on sale targets, job insecurity, condoning unethical promotion by high-ups’ and business promotion by junior MDs were the predominant barriers.ConclusionIn conclusion, MRs of MNCs and MDs believed that MNCs follow certain codes of ethics in the promotion of pharmaceuticals, while NCs tend to be more profit oriented and even condone unethical promotion. All stakeholders, MRs, MDs and companies, might pose certain barriers, intentionally or unintentionally, in ethical promotion.

Intraoperative local anaesthesia for reduction of postoperative pain following general anaesthesia for dental treatment in children and adolescents.

Intraoperative local anaesthesia for reduction of postoperative pain following general anaesthesia for dental treatment in children and adolescents.

Complex Analysis of Counterfeits and New Synthetic Drugs in Forensic Practice

Counterfeit drugs began to appear on the world market in 90-ies of the 20th century and their number is significantly increasing. It applies not only to dietary (food) supplements, but also for vitally important preparations. The definition of a counterfeit is not entirely uniform, some drugs can be determined in some countries as counterfeits but not in other countries. World Health Organization defines counterfeits as medicines (drugs) "which are deliberately fraudulently mislabelled with respect to identity and/or sources". IFPMA (International Federation of Pharmaceutical Manufacturers Associations) states that 7% of all medicines (drugs, pharmaceuticals) sold around the world are counterfeits and estimates that the value of the trade in counterfeit products is more than USD 30 billion. Forensic analysis deals with these materials comprehensively, besides standard quantitative analysis of content components, examined the shape and form of tablets and logo embossing, measured quantitatively colour, characterized surface, etc. Content substances, in addition to (apart from) techniques of organic analysis, are tested also by methods of X-ray powder diffraction. The advantage is the possibility of non-destructive analysis of tablets directly in the blister and complex analyses of organic and inorganic phases. Automated divergence slits and collimators are use to on a primary x-ray beam. Methods of image analysis are employed for correct adjustment of surface analysed. Phase analysis is carried out using both commercially available databases and as well data of own standards. So-called "Legal Highs" - new synthetic drugs emerging on the world market pose a similarly relevant problem. These are structural variants of known substances with psychomimetic effects, which are not included on the lists of controlled substances. An array of these substances are legally sold not only on the internet, but also in newly established stores called Amsterodam Shops or Smart Shops. Analysis, identification and quantification of these substances are rather complex as they are not included in identification databases. The methods of x-ray diffraction are very suitable complementary techniques to common methods of organic analysis - GC-MS, MS/MS, MSn, NMR, etc. The occurrence of "Legal Highs" on the market can be regarded as very dangerous also considering that toxicity in these substances has not been known so far.

Overview of the Fourth International Conference on Harmonization

This overview of the Fourth International Conference on Harmonization (ICH 4), held in Brussels, Belgium, 16-18 July 1997, summarizes results and provides information regarding the nonclinical workshop and issued nonclinical testing guidelines [Draft Final (Step 4) Guidelines recommended for adoption to the regulatory bodies of the EU, Japan, and the USA]. ICH 4 completed the initial harmonization targets for the three ICH Regions [European Commission-European Union (EU) and European Federation of Pharmaceutical Industries' Association (EFPIA); Ministry of Health and Welfare (MHW) Japan and Japan Pharmaceutical Manufacturers Association (JPMA); and the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America (PhRMA)] and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). Proceedings will be available in book form. Earlier conferences, guidelines, and proceedings are available on CD-ROM and in print and diskette form from the ICH Secretariat, c/o IFPMA, 3 rue de St.-Jean, P.O. Box 9, 1211 Geneva 18, Switzerland; Tel +41 (22) 340 12 00; Fax +41 (22) 345 82 75. Similar information is obtainable from the ICH Home Page (http://www.ifpma.org/ich1.html) and the Pharm Web home page (http://www.pharmweb.net).

Prospects for future supplies of vaccines.

The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) represents virtually all the major manufacturers of sera and vaccines in Australia, Belgium, the Federal Republic of Germany, France, Switzerland, the United Kingdom, and the United States. The IFPMA has become increasingly concerned by the withdrawal of many companies from the vaccine field, and the consequent sharp reduction in available usable capacity. This reduction in usable capacity is especially significant for those vaccines included in the Expanded Programme on Immunization (EPI) of the World Health Organization. IFPMA has advised the United Nations Children's Fund and the Pan American Health Organization that the economic viability of the industry can be improved, without affecting the principle of free competition, by changing procedures for procurement and forecasting by United Nations' agencies. In particular, the IFPMA believes that by using data on world population trends, world estimated forward requirements can be projected for the industry's use in planning future production requirements.