Monday, April 1, 2019
Strength And Weakness Of Drug Facts Economics Essay
Strength And Weakness Of medicine Facts economic science EssayIn non prescription medicine(prenominal)(a) doses, at that place is variation in tracking oer-the-counter(prenominal) medicines. Those over-the-counter(a) drugs which be exported to foreign countries be noteed in perfective aspect manner, but that is in revise in Indian market. In India, otc drugs atomic deem 18 distributed in pitiable manner and it exhibits the lack of regulations in labeling. It is mandatory to correct the labeling of otc drugs. For achieving high-quality labeling, the adjacent tuition should be implyd in the labeling requirements of OTC drugs.1. The purpose of the drug2. Detailed warning messages3. Inactive ingredients4. social disease instructions5. Users Contact data, equipped to get information for their queriesThe drug and enhancive Act was executed in 1945. At that clip, the literacy rate, which depicts the literacy (who kitty be infer and write) region of a populati on over the age 15, was very low. The prerequisites of labeling were depended on general public education and circumstances. After that, there was a not bad(p) improvement in both literary rate and the usage of OTC drugs. Stated by the surveys, India is currently in 11th position in the global OTC market, and it is believed to be in the 9th position in hobby five years. All these represents the need of modification which is inevitable in the medicine and Cosmetic Act established in 1945, in hostelry to improve the level of OTC drug labeling.History of OTC labelsThe manufacture, distribution, sale and issue of drugs and cosmetics in India are modulate by the following commandmentsThe Drugs and Cosmetics Act, 1940 (DCA) and its subordinate legislationDrugs and Cosmetics Rules, 1945 (DCR)Drug (Prices Control) Order, 1995Drugs (Magic Remedies) Objectionable Advertisement Act, 1954Pharmacy Act, 1948The above- insinuateed legislations are regulated by the Central Government (Minis try of Health Family Welfare) and are enforced finished Food and Drug Administration (FDA) the State Government. Even though, OTC drugs do not wound separate labeling requirements in India, all drug products should have a minimal information present on the label of the inward apprehender of any drug and on any former(a) layer in which the double backer is packed , as per rule 96 of the Drugs and Cosmetics Rules, 1945 (DCR), except homeopathic medicines. The following are the minimum labeling requirements Name of the drug Proper (generic) name, immediately followed by Trade (brand) name Net content of drug in the container capacitance of active ingredients/single dose or dosage unit Name, cite and license topic of the manufacturer Distinctive Batch number or Lot number for the product Manufacturing and Expiry date Maximum retail Price (inclusive of all taxes)In India, Peoples habit of taking drugs differs from place to place. Around30%-45% of pot prefer pharmacist and se lf treatment for their illness like cough, bleak, pain, fever, injuries and digestive disorders. India is famous for Ayurveda and some other long-established systems of medicine. The aim of the evaluation behaveed by Rama Krishna Chaitanya Aluri from Manipal College of pharmaceutic Sciences, base on nearly 200 OTC drug labels, is to chalk up the suitability of information on the labels for successful self-treatment by consumers.Recent changes in drug factsRecently, the FDA conducted extensive research on how consumers physical exertion OTC drug product labels, while comparing to the drug facts labels on advanced countries. The pellucidity of the labels was one major problem, e finickyly for older Americans, who purchase almost 30% of the OTC drugs, exchange in The United States. To determine the best carriage to order this information on OTC drug labels, a young research has been conducted. Vigilante and Wogalter (1997) pragmatically decided an ordering of OTC label compone nts based on users beliefs ab issue what was (?)Strength and weakness of Drug FactsHaving over-the-counter medication will save you time from visiting the doctor every time you have a critical sniffle or an ache or pain. thither are some(prenominal) safe drugs which can interest care of most of your everyday illnesses like the followingcoldscoughsaches and pains unbalanced stomachdiarrheaallergiesThese types of drugs are not the drugs themselves its the people A take of horribly unobservant people do not take the time to read directions in order to know how to take the medicine properly. There are many cases where people use over- the-counter medicines erroneously and poison themselves. refresh in IndiaHistory of drug regulationsDrug regulation organizations in public today, like Drug Laws, Drug Regulatory Agencies, Drug Evaluation Boards, QC Laboratories, Drug experience Centers, etc., have developed over time. Such suppurations began centuries ago in some countries, and i n others, they are comparatively recent, some of them having started only in the 1990s.The restrictions infra the Drugs (Price Control) Order, 1995 are not directly related to the question of categorisation of the drugs as OTC drugs or otherwise. But still, they are required to be considered, as restriction on pricing may influence the end to launch a drug as OTC drug. It is mandatory to entertain price approval from the Central Government, if the drug is classified as schedule formulation on a lower floor the Drug (Prices Control) Order, 1995. Also, Central Government can get a maximum price at which every manufacturer is required to sell his product. For Example, Aspirin and vitamin preparations are deliberated as OTC products for the purpose of marketing. However, under Drugs (Prices Control) Order, 1995, they are considered as scheduled formulations and are subject to price restrictions, unless these formulations are manufactured at SSI units.Difference mingled with pharm acy in India and USOTC in pharmaceutical industry dialect stands for over-the-counter (mainly with reference book to drugs). The purchase/sale of drugs across the counter without prescriptions is denoted by this. In fact, in India, every pharmaceutical product market is OTC. People can orally ask for any product and buy it across the counter. In US, there are prescription drugs and over-the-counter drugs. The prescription drugs are strictly sold only on showing the prescription (Rx). Once the products are lot as per Rx, a varnish is administered, to indicate that the Rx has been filled. If the patient goes in for fill again of the Rx, the pharmacist does it only if it is legally permissible. In much(prenominal)(prenominal) cases, a seal or stamp is put on the Rx again, to indicate that the Rx has been filled erstwhile again. But in India, such procedures are not strictly followed. Hence, in a way, the Indian retail pharmaceutical market is OTC or rather it is better to be c alledOTX(combination ofOTC and Rx).Strength and weakness of OTC drugs in Indian and USIn India, with the counter medication, there is no need to visit doctor every time for a little sniffle or pain or an ache, so drug facts are good. Several safe drugs are available which cures normal illnesses such as aches, colds, pains and coughs, allergies, and diarrhea and stomach upset.These types of drugs are the people but not the drugs themselves. People are terribly unperceptive and dont nonetheless care to read the directions mentioned on the drugs before consuming. Several cases happened when people took the counter medicines improperly and resulted in poisoning.MethodologyFollowing methods are consideredTo know in depth of a particular aspect case register method helps the researchers in many cases it selects specific location with very small portion as subject. significant time role model is considered with limited number of conditions and events for case force field investigation . consort to Yin 1984, 23 case pack definition a formula based calculations comparing with received world using many sources of evidence, relationships in between them are not accurately explained.Investigation of some case study is done by using longitudinal structures of single event which helps to observe sequence of data, events, reports and results from a long time, for example child language development investigation.According to Z advocateah, 2003 Firstly useful data is deeply investigated according to patch based upon particular activity. Case study is very utile example knowing the interesting subject for authentic use. Students an opinion has to be rivet during leisure hours the average number of particular subject is taken into the count. This potpourri of example values slightly deviates when n number of variable are consider.The examination of data is conducted within its context and alike within its stance wherein the activity takes place. A case study would always be implicated when subject makes it as an authentic text. In order to investigate, the researcher must(prenominal) be able in observing subject environment such as schooling in class room or else reading in leisure time. According to z cautionah 2003 it mostly focuses on limited number of variables.Results and DiscussionThe research literature consists of few studies in relations concerning medications that can be bought without any kind of aesculapian prescription alike named or over the counter as cold/flu medications etc. in spite of the fact that they are widely utilise and also represents if it is been utilize. As proposed by Ferguson, Dodds, and Flannigan, 1994 one such area in which they are been misused that which involves not only overdosing but also interaction with any other message. For instance some case studies have documented individuals who seek to tranquilize depression symptoms by inducing a state of euphoria with multi-symptom cold syrup which cont ains chlorphenhydramine, dextromethorphan, and phenylpropanolamine. These substances may induce behavioral and emotional reactions, especially in prone individuals, leading to potentially serious health risks and consequences (Mendez, 1992).The Dangerous substance interactions have received some attention in the psychiatric disorders area. A questionnaire administered to 139 patients diagnosed with either depression or social phobia revealed that 40% of them used OTC cold/flu remedies which had negative interactions with their prescribed medications (Sweet et al., 1995). Another study examined the rate of consumption of TV advertised OTC medications by 471 college students. The results showed that, in addition to frequently using one or more than such medications they did so without talking to their physicians about it or specifically determining the conditions under which they were taking such medications. These obtainings led the authors to emphasize the need to further study t he effects of the media on the use of potentially risky OTC medications (Burak and Damico, 2000)The Indian OTC pharmaceuticals market generated meat revenues of $2.5 billion in 2006,this representing a complex annual growth rate of 8.3%for the five year period spanning 2002- 2006. In comparison ,the US and Chinese OTC pharmaceuticals markets grew with CAGRs of 4.3% and 7% over the aforesaid(prenominal) period ,to reach respective values of $21.2billion and $11.9billion in 2006. Traditional medicines proven the most lucrative for the Indian OTC pharmaceuticals market in 2006, generating total revenues of $679.3 million. In comparison, sales of cough and cold preparations generated revenues of $492.6 million in 2006. house%ShareTraditional Medicine27Cough and cold preparations19.80Vitamins and Minerals11.60 medicative skin plants2.60Others26.03Indian OTC pharmaceuticals market Share % share, by value, 2004** go with%sharePfizer Inc5.10Sanofi Aventis5.10Johnson Johnson2.0Other85.10I norder to obtain a better way of get work done and make companies focus on packaging a better pharmacist approach by means of a better learning sessions. By having, better access through labellng and packaging of OTC drugs through disposal and other pharma companies ensuring a better sufficement of ailments through OTC medication. By developing a better approach of companies origination a better way of public education campaign fulfilling necessarily of OTC drugs and educating them to empower better way of medication. With all leading pharma companies launching their public education campaigns to fill the companionship gap in proper selection and use of OTC drugs, it can be a classic case of PPP where the ultimate winner will be the consumerSuggestions and improvements in OTC labeling in USBased on take of Medicine IOM, 2008 medication label standardization U.S pharmacopeia health literacy launched container label prescription for consumers advice. Gerald McEvoy and Schwar tzberg were the chairmans of American Society of Health System Pharmacists. According to them labels should contain the following principle1. Easy, understandable prescription and directions for consumers use.2. Worldwide medicines should contain prescription label based upon exported countrys standards and basic exporters are clinicians, health literacy experts, academic researchers, government health agency representatives and pharmists.According to IOM, 2008 every year millions of drugs are misused, even after mentioning source of information and safety precautions clearly on the label. sometimes written and oral consultations information may or may not present on the panel, in case of Rx container label should strictly contain doctors prescription for consumers safety.As per U.S. Pharmacopeia Health Literacy Instruction Container stigmatiseing Advisory embellish recommend the followingRecommendationsArrange the label prescription in such a way that it always stays as a move i n comforting the users. The direction of a drug is given neatly and orderly in making the customer easily understand the prescription and to make use of them in a safe and also effective use. usefull information is given on the label of drug and they are as followsUseful directions are present at the top of the panel.Medication lucubrate are present at bottom.Most important precautions like dosage.administrative instructions are placed with specific style.The proposed labeling consists of various components and they study these components by making use of certain facts of drug. And labeling format is as follows1. recording label to accommodate the Active ingredient all along with its strengthResultsAll the c labels are examined and mentioned in the active ingredients along with their potency/strength.2. Label to include Therapeutic syndicate/purposeIts 55% of labels are disclosed in therapeutic category.3. Label to include Uses /indications for which medicine can be utilizeEven though a significant percentage (75%) mentioned the indications intended for the medicine, 25% of the labels failed to do so.4. Label to include Warnings related to unwashed unpleasant effects, drug interactions, contraindications, precautions, over dosage, when it is appropriate to seek medical advice and also in special conditions like pregnancy breast-feeding. This also includes cautions in keeping them away from children.Results90% of the labels failed to enumerate the adverse effects of the medicine.86% did not state what is to be done in case of overdose92% gave no Information regarding usage in pregnancy and Breastfeeding87% of the labels did not mention of the accomplishable drug interactions, contraindications and precautions.73% labels did not even advise to seek medical guidance.Only 36% labels mentioned that the medicine is required to be kept out of the reach of children.5. Label to include Directions including how much to be take n, dosage interval, and maximum dos e allowed per day and the dose for childrenAlmost half of the medicines (46%) did not mention the amount to be used, while 34% did not mention the dosing interval. 85% of the medicines did not state the maximum dose allowed. Out of the 15% which did state the maximum dose, 20% were ambiguous with the details. It was also observed that 70% of the medicines failed to specify the dose for children. Only 1 label includedoperating instructions for use in Devanagiri script.6. Label to include The products inactive ingredients help the consumers in avoiding ingredients that may cause an allergic reaction.None of the labels included the inactive ingredients.7. Label to include Storage conditions.Even though a large percentage (88%) of the labels provided the storage conditions, 64% of them were imprecise and difficult to understand. Nearly 85% of the labels were nominate without a specific temperature. Furthermore, storage conditions were often mentioned using terms which the common man ar e not familiar with. The exact temperature was rarely mentioned.Besides, we also assessed the label for 2 more criteria 1. Label to include Legibility to find out whether the label is easily readable, read with difficulty or with the aid of a magnifying glass.40% of the medicine labels were clearly read only with the aid of a magnifying glass as the font size was too small. 22% of drug labels were read with difficulty leaving just around 38% whichcould be read easily. This suggests that 62% of the labels are read with much effort.1. Label to include Additional information through patient pile inserts, information on secondary packages (wherever applicable) Patient package inserts are useful for providing redundant information to the patient. Out of the 100 medicines examined, only 3 included a patient package insert. Many a times, secondary packagings of medicines are also given to the patient as additional protection for their medicines or as attractive packs. These secondary pack ages can also be used to convey valuable information to the patient. In 56% of the cases, a secondary package was found to be available to the patient, yet only 36% of them gave more information on its label than the primary package.ConclusionThe OTC drug offering is incomplete with out empowering public on its rational use through Well planed strategic marketing initiative revolving around the aliment, the knowledge to diagnose and manage the same. In this empowerment process which can be considered as CSR, the objective should be prevention and holistic awareness basis leading to health and wellbeing than just offering the minimum demand information to use ones products.Thus by educating public (consumer) on how to manage common ailments and finally how to prevent them, the pharma companies can achieve its real goal of health for all and improve the quality of peoples life In India, OTC products are marketed and advertised liberally, with a view of educating the maximum number o f consumers, and promoting treatment of minor ailments at home using OTC products as first line of defense. It can be anticipated that, more Rx to OTC switch will increase number of drugs in OTC category in near future. Hence it may be valuable to conduct more research on group of Consumers, who consume OTC Products freely and either switch from the existing brand or continue to preceding brand. A study on marketing of OTC products, used by post office and postman, can also be a canvas as a channel of marketing of OTC drugs at matter area.Since, the Customer and Consumer are being the same in the OTC drug marketing, companies must instantly address the information needs more in effect and uninterruptedly. Once the awareness level is enhanced, the acceptability of OTC drugs will improve. The knowledge about allopathic OTC drugs has to be disseminated by manufacturing companies, in order to ensure drastic reduction in the high information imbalance existing now-a-days, especially when the knowledge of the traditional medicine is rooted in the culture.BibliographyAjith, P., (2007). OTC Drug Marketing -. Global Trends and Indian Experiences.etal, C.P.B.., 1998. Patients Attitude to over the counter drugs possible professional response to self Medications. Oxford University Press, volume- 15, pp.44-50.Food and Drug Administration (FDA). 21 CFR Part 201, e.a., 1999. Over-the-Counter Human Drugs Labeling Requirements. Federal Register. .Sleath B, R.R.C.W.G.L.C.T., 2001. Physician-patient communicating about over-the-counter medications.. Social Sciences Medicine..Tracy Portner, M.C.S., 1994. College students knowledges of OTC Information. characteristics Journal, 8, p.142 to 161.Wilcox CM, C.B.T.G., 2005. Patterns of use and public perception of over-the-counter pain relievers. Focus on nonsteroidal antiinflammatory drugs..
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