The Role of Pharmacist in Pharmaceutical Industry PDF

The role of pharmacist in pharmaceutical industry Tuan Mazlelaa Tuan Mahmood, PhD Faculty of Pharmacy, UKM  Pharmaceutical Manufacturing — Cosmetics — Traditional medicines — Pharmaceuticals  Cosmetics — Any substance or preparation intended to be p...

The role of pharmacist in pharmaceutical industry Tuan Mazlelaa Tuan Mahmood, PhD Faculty of Pharmacy, UKM  Pharmaceutical Manufacturing — Cosmetics — Traditional medicines — Pharmaceuticals  Cosmetics — Any substance or preparation intended to be placed in contact with the various external parts of the human body — Including epidermis, hair systems, nails, lips and external genital organs — Or with the teeth and the mucous membranes of the oral cavity — With a view exclusively or mainly to cleaning them, perfuming them, changing their appearance or correcting body odours, protecting them or keeping them in good condition  Traditional medicines — Any product used in the practice of indigenous medicine — In which the drug consist solely of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof, — In the unextracted or crude extract form, and a homeopathic medicine — Indigenous medicine: a system of treatment and prevention of disease established through traditional use of naturally occurring substances  Pharmaceuticals — Brand name — Proprietary name — Generic name — Non proprietary name  Brand name — The name given to a medicine by the pharmaceutical company that makes it — Also called the ‘proprietary name’ — Pharmaceutical companies take out patent (exclusive rights) for each new medicine they discover. — This patent lasts for up to 20 years, during which time the medicine is studied in clinical trials and the approved for sale by expert committee, e.g. MHRA (the Medicines and Healthcare products Regulatory Agency) — When the medicine becomes available, only the pharmaceutical company that discovered it is able to sell it using their brand name, until the patent runs out  Generic name — Or scientific name — The term given to the active ingredient in the medicine that is decided by an expert committee (e.g. INN) and is understood internationally — Also called the ‘non-proprietary name’. — After the patent runs out, other companies can produce their own version of the medicine. — For example, ibuprofen is the generic name of a medicine used to treat pain. — Some companies will sell ibuprofen as branded version e.g. Nurofen, Brufen — Other manufacturers, e.g. Tesco, sell it under the generic name ‘ibuprofen’ — Medicines sold under their generic name are usually cheaper – why? — However, they contain the same active ingredient as the equivalent branded medicines. — Generic medicines also go through detailed safety and quality requirements.  Other example — Sildenafil – generic name of a medicine used to treat erectile dysfunction — Pfizer, the company that makes sildenafil, sells it under the brand name Viagra  Pharmaceuticals — Generic name – International Nonproprietary Name (WHO), national names: USAN (US Adopted Names), BAN — Proprietary name – protected brand name or trademark. Usually written with capital initial letter and an R in a circle — Brand name – Panadol — Patent- exclusive right given to the one who came up with a novel invention that is industrially applicable. — Generic products – Paracetamol, Uphamol  Pharmacists in the pharmaceutical industry — Research and development — Pharmacist contribute to research and our expertise in formulation development is of particular relevance to the biological availability of active ingredients. — Manufacture and quality assurance — The pharmacist’s broad knowledge of the pharmaceutical sciences ensures the integrated approach to quality assurance (including good manufacturing practice) through the validation of the various stages of production and the testing of products before release.  Pharmacists in the pharmaceutical industry (cont) — Drug information — The pharmacist has the knowledge and expertise to provide detailed information on medicines to members of the health professions and the public. Also, pharmacists provide an information service within the company. — Patent applications and drug registration — The pharmacist is ideally qualified to understand and collate the diverse information required for patent and authorization submissions.  Pharmacists in the pharmaceutical industry (cont) — Clinical trials and post marketing surveillance — The pharmacist has the knowledge of drugs and health care provision required to facilitate collaboration between companies, health professionals and governments in relation to clinical trials and surveillance. — Sales and marketing — The pharmacist, whose professional ethics demand a concern for the interest of patients, can make a contribution to proper marketing practices related to health care and to the provision of appropriate information to health professionals and the public. — Management — The inclusion of pharmacists in all levels of management promotes an ethical approach within management policies.  Production Manager — Must be a pharmacist — Good knowledge of Good Manufacturing Practice — Prepares manufacturing schedules — Ensures proper workflow, follows SOPs — Keeps records — Consistent quality — No errors in production – raw material, weighing, label reconciliation  Quality Control Manager — Responsible to top management — Free to ensure quality – raw materials, water, air etc — Good at analytical methods — Monitoring of quality — Stability studies — Microbial contamination — Levels of heavy metals — Release of final products for sale — Product complaints and recalls  Regulatory Manager — Registration of new products and re-registration of existing products — Compliance with regulatory requirements – licensing, reports of ADRs — Harmonisation – registration in different countries and different regions  Research Scientist — Not much basic research in Malaysia — Problem solving, new formulations, new dosage forms, improve stability 1. Synthesis of new compounds 2. Isolation & purification of active principles 3. Cultivation of medicinal plants 4. Standardisation of drugs 5. Toxicology of new drugs  Sales — Good knowledge about products — Outgoing personality — Convincing — Good communicator — Performance-based – good rewards  Marketing — Develop strategies for marketing the products — Plan the launch of the product — How to market – position the product — To whom to market — Package design and advertisement Thank you!