Generic Professional Practice Guidelines - British Psychological: Fill & Download for Free

First Chemical then Generic/Non-Proprietary then Brand/Proprietary, the three stages in the life of an approved medicine, each subject to different regulatory constraints and geared for different target audiences,Chemical, largely the domain of chemists.Generic/Non-Proprietary that of pharmacists, doctors and nurses. However, everyone can familiarize themselves with generics if they so choose.Brand/Proprietary, specifically designed, and explicitly and aggressively marketed for use by all.Most approved drugs get their generic and brand names years from the time they're first discovered or developed. Starting their lives in labs, most languish for years with long unpronounceable chemical names or just alphabets and numbers.Chemical, obviously based on the chemical formula of the active substance, is designated by the International Union of Pure and Applied Chemistry - Wikipedia (IUPAC).Generic/Non-Proprietary or INN (International Nonproprietary Name) is globally assigned by the WHO (1).Effort tries to ensure proposed names don't overlap with existing generic or brand names. National generic names are also often assigned by national regulators in each country where it's approved for use. Though global and national generic names should be the same, in the past often they weren't (2).~150 names are designated each year, first in Latin and then translated into the six official languages of the UN: Arabic, Chinese, English, French, Russian and Spanish (3).Unlike copyright-protected brand names, originating companies don't 'own' generic names which are instead in the public domain.Assigning generic names is a rapidly evolving process. Initially generics attempted to shorten the drug's chemical name (1), ultimately untenable since many molecules have common elements in their chemical structures. Thus, the process evolved to identify such common elements and group names accordingly. This is how pharmacologically related substances came to share a common stem in the INN (4) anywhere in the name as a prefix, infix or suffix.Stems could allude to a drug's structure, function or target.Some stems are easy to decipher, arte- for antimalarials related to artemisinin, -coxib for selective cyclo-oxygenase inhibitors, -formin for anti-hyperglycemics, -cillin for some antibiotics, -vir for antiviral drugs, -mab for monoclonal antibodies, -olol for beta-blockers/beta-adrenoreceptor antagonists, etc.United States Adopted Names (USAN), the entity responsible for assigning generic names in the US, provides an exhaustive stem list as a downloadable spreadsheet (5).Generics focus on naming active ingredients in drugs, biologics, vaccines, and even contact lenses and sunscreens (6).With the internet and globalization increasing connectivity and global pharma trade, necessary to ease usage across languages. Thus, pronunciation is an important consideration and phonetic simplification the tool.Using f instead of ph, t instead of th, e instead of ae or oe, i instead of y (4).h, j, k, w are now off-limits after it was noted they lead to pronunciation problems in other languages, including some of the 130 countries that use USANs (6, 7).See some of these and other USAN naming considerations and their rationale below from 6.Rationale and mandate for Generic/INN below from 4, emphasis mine'Since the number of drug substances being registered during the last decades is constantly increasing, there is a strong need to ensure the identification of each pharmaceutical compound by a unique, universally available and accepted name. The existence of an international nomenclature system for pharmaceutical products is crucial for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.An International Nonproprietary Name (INN) identifies a pharmaceutical substance by a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Generic names are intended to be used in pharmacopoeias, labeling, advertising, drug regulation and scientific literature.WHO has a constitutional mandate to offer recommendations to its Member States on any matter that falls within its competence. This includes setting norms and standards for pharmaceutical products moving in international commerce.The INN system as it exists today was initiated in 1950 by the World Health Assembly resolution WHA3.11 and began operating in 1953, when the first list of International Nonproprietary Names for pharmaceutical substances was published.So far, some 8500 names have been designated as INNs, and this number is growing every year by some 120 – 150 new INNs.INNs are selected in close collaboration with national nomenclature commissions (e.g. BAN British Approved name, JAN Japanese Accepted Name, USAN United States Adopted Name etc.). Today, the INN Committee assumes the leading role in assigning generic names to drug substances. Instances where a national generic name for a new pharmaceutical substance is different from the INN are rare exceptions.As unique names, INNs have to be distinctive in sound and spelling, and should not be liable to confusion with other names in common use (e.g. trade marks). To make INNs universally available they are formally placed by WHO in the public domain, hence their designation as “nonproprietary”. They can be used without any restriction whatsoever to identify pharmaceutical substances. The clear depiction of INNs on labels assures that prescribers and users alike can easily identify the nature of the pharmacologically active substance in a brand product. The use of INNs is already common in research and clinical documentation, while the importance of the Programme is growing further due to the expanding use of generic names for pharmaceutical products.'Brand /Proprietary name is chosen by the drug originator subject to regulator’s approval, the latter being the FDA in the US, the EMEA in Europe, etc.Conjured through marketing, linguistic and commercial imperatives, drug brand names are legally bound to not imply direct therapeutic benefit. Instead they often do so subtly, subliminally.Process is long, convoluted, secretive, expensive as in costing millions of US $, as well as restrictive since regulators not only have final say but also strict rules and guidelines.For example, the US FDA does not allow use of USAN stems in the same position in the brand name (8, 9), a clear nod to the underlying, ever-present tug of war between profit motive and public interest. By (ab)using INN stems that way in brand names, drug companies could assert intellectual ownership over a crucial piece of the entire molecular landscape of drugs and appropriate away an entire stem, i.e., class of drugs, from the public domain.Brand name pronunciation is obviously an important safety consideration.Rather than ambiguous, should be clearly, unmistakably understood verbally, via telephone or voicemail. Consider scope for medical errors especially in emergencies or surgeries.Some regulators such as the US FDA even insist on submission of written transliteration of the intended pronunciation (8).Regulators' task is to carefully scrutinize and reject submitted names that overstate efficacy, minimize risk, broaden indication, claim unsubstantiated superiority over competitors or are overly similar, etc. (6).Constrained as it is by regulatory imperatives of fair use and safety, Drug Brand name coinage strives for a difficult, maybe even impossible, balance between ease and impression, goal being similar to brands in all areas of life, be easily pronounced yet memorable. Aggressive marketing then helps drive user brand loyalty.Obviously, as happens with marketing in general, a few cases are standout successes while far more either underwhelm or mystify. Some examples of the former,Sleep aid, Sunovion's Lunesta implies the latin word for moon (10).Erectile dysfunction aid, Pfizer's Viagra (sildenafil citrate) is the melding of 'vigorous' and 'Niagara' (11, 12, 13).The US FDA lists some do's and don'ts essential in coining US Drug Brand/Proprietary names (see below from 9).Unfortunately, none of this prevents LASA, look-alike sound-alike drugs, a major cause of medication errors (14, 15). LASA scope only increases with time asMore drugs enter an increasingly crowded marketplace,Safety and public interest-driven regulatory constraints crimp naming scope, andBrand naming fads take root as part of a bandwagon to replicate a success story. For example, one 2010 study noted the dramatic increase in drug names starting with z, especially since 2002 (16).Since 2008, the Institute for Safe Medication Practices (ISMP) maintains a list of look-alike, easily confused drug name pairs (17). Recommended by the WHO, US FDA, ISMP, the IMSN (International Medication Safety Network) and other national and international organizations, Tall Man (uppercase) lettering in Drug Brand names highlights distinctive parts of confusing drug name pairs (18; see below the 2016 joint US FDA and ISMP list of such confusing drug pairs with recommended Tall Man lettering to reduce confusion, 19).Bibliography1. Gopakumar, K. M., and Nirmalya Syam. A Study on the Use of International Nonproprietary Names in India. Centre for Trade & Development (Centad), New Delhi, 2007. http://cdrwww.who.int/medicines/services/inn/InternationalNonproprietaryNameinindia.pdf2. Pharmacopeia, U. S. "USP dictionary of USAN and international drug names." (2000).3. Marecková, Elena, Frantisek Simon, and Ladislav Cerveny. "Latin as the language of medical terminology: some remarks on its role and prospects." Swiss medical weekly 132.41/42 (2002): 581-587. https://www.researchgate.net/profile/Frantisek_Simon/publication/10913254_Latin_as_the_language_of_medical_terminology_Some_remarks_on_its_role_and_prospects/links/0046352e64fedab908000000.pdf4. WHO, 2011. http://www.who.int/medicines/services/inn/StemBook_2011_Final.pdf5. USAN Council-approved Stems | AMA6. Wick, Jeannette. "why is it called That? Tongue-Twisting Taxonomy." The Consultant Pharmacist® 26.8 (2011): 544-552.7. Chemical and Engineering News, Carmen Drahl, January 16, 2012. Chemical & Engineering News8. FDA, April 2016. https://www.fda.gov/downloads/Drugs/Guidances/ucm075068.pdf9. FDA, May 2014. https://www.fda.gov/downloads/drugs/guidances/ucm398997.pdf10. Williamson, Celina M. "A Morphological Study of Drug Brand Names." (2013). http://scholars.unh.edu/cgi/viewcontent.cgi?article=1103&context=honors11. Russell, J. "For drugmakers, finding a name is more art than science." USA Today (2007).12. Wick, Jeannette Y. "What's in a drug name?." Journal of the American Pharmacists Association 44.1 (2004): 12-14. http://fermatapharma.com/wick2004.pdf;13. CNN, Susan Scutti, November 25, 2016. The art and science of naming drugs14. Hoffman, James M., and Susan M. Proulx. "Medication errors caused by confusion of drug names." Drug Safety 26.7 (2003): 445-452.15. Ostini, Remo, et al. "Quality Use of Medicines–medication safety issues in naming; look‐alike, sound‐alike medicine names." International Journal of Pharmacy Practice 20.6 (2012): 349-357. https://www.researchgate.net/profile/Remo_Ostini/publication/233326084_Quality_Use_of_Medicines_-_Medication_safety_issues_in_naming_Look-alike_sound-alike_medicine_names/links/0deec526861a7f1441000000.pdf16. Stepney, Rob. "A dose by any other name would not sell as sweet." BMJ: British Medical Journal 341 (2010).17. Institute for Safe Medication Practices (ISMP), 2015. https://www.ismp.org/Tools/confuseddrugnames.pdf18. Lambert, Bruce L., Swu-Jane Lin, and HiangKiat Tan. "Designing safe drug names." Drug Safety 28.6 (2005): 495-512. http://brucelambert.soc.northwestern.edu/journal_art/Designing.pdf19. https://www.ismp.org/Tools/tallmanletters.pdf