Therapeutic Goods Administration - Term Paper Example

Word Count 3,600 Therapeutic Goods Administration (TGA) Therapeutic Goods Administration (TGA), a division of the department of Health and Ageing of the Australian government is medicines, medical devices, vaccines, blood and blood, implants and a range of other products, including sunscreens and every other product for which therapeutic claims are required. Every product in this category must be listed, registered or included in the Australian Register of therapeutic Goods (ATGA) before they are allowed in the Australian market. This means that TGA first have to evaluate therapeutic products before they enter the market, and keep them under regulatory control once they are in the market, assessing their performance and suitability for export from Australia. The TGA also regulates the manufacturing of therapeutic goods, making certain manufacturers abide by set quality standard. With a team of experts, the TGA inspects and examines manufacturing facilities around the world to ensure products supplied to Australia meet required standard. The TGA operates in alliance with consumers, health professionals, industry and its foreign counterparts to be effective in its function, especially to regulate products, which have become increasing complex as a result of fast rapid development in science and technology. The regulatory activities of the TGA are guided by the Therapeutic Goods Acts of 1989. The TGA comprises three core groups: a) Market Authorization Group (MAG) b) Monitoring and Compliance Group (MCG) c) Regulatory Support Group (RSG) The Market Authorization Group (MAG) is itself divided into five offices and units: i) The Office of Medicine Authorization (OMA) is responsible for evaluating and authorizing prescriptive and non-prescriptive medicines before they are allowed into the Australian market. ii) The Office of Complementary Medicines (OCM) evaluates and approves complementary medicines such as mineral supplements and vitamins, and traditional and herbal medicines. iii) Office of Device Authorization (ODA) is responsible for all medical devices. iv) Office of Science Evaluation (OSE) provides scientific advice to Market Authorization Group, and evaluates and approves clinical trials and special access arrangement for all types of therapeutic products v) Group Support Unit (GSU) provides planning coordination and administration service to all areas of the Group. The Monitoring and Compliance Group (MCG) is the office responsible for regulating how medicines and devices are manufactured, and is divided into four offices and unit. The offices and unit include: i) Office of Product Review (OPR) is responsible for ensuring that the quality, safety, and performance of all therapeutic goods remain at the proper level after entering the Australian marketplace, and also, for the administration of legislative request for advertizing of therapeutic goods in Australia, coordinating recalls where necessary. ii) Office of Labouratory and Scientific Service (OLSS) is in charge of testing, quality assessment, and test procedure development. iii) Office of Manufacturing Quality (OMQ) is in charge of making certain that manufacturers of medicines and medical devices meet set quality standard. iv) Group Support Unit (GSU) provides planning, coordination and administrative service to the group. Regulatory Support Group provides regulatory support service TGA needs to function well and is divided into five offices and units. Pharmaceutical Benefit Scheme Pharmaceutical Benefit Scheme (PBS) is a part of the wider National Medicine policy of the Australian government, and is the instrument through which the government subsidizes the cost of necessary medicines. While many of these medicines need to be dispensed at a pharmacy and administered at home, others require medical direction, making them accessible only at hospitals. Most of the subsidized medicines available to patients are displayed on the PBS schedule list, accessible on-line. PBS is administered by Medicare Australia and so is available to every Australian resident who carry a Medicare card. Foreigners who visit Australia may be eligible for PBS only if they are residents of countries with which Australia has a Reciprocal Health Care Agreement (RHCA). Issues Affecting the Viability of PBS When PBS first began, it cost the government about 7.6 million dollars the first year, but it now cost well over 6 billion dollars annually even though patients contribute about 1.3 billion dollars annually as co-payments. It is project to cost the government well over 56 billion dollars annually by 2041, and certain issues have been identified as factors contributing to growth in cost of PBS. Some of the issues include; i.) Ageing population ii.) The increasing prescription of new expensive medicines iii.) Inappropriate prescriptions Ageing Population The ageing population in Australians has increased from around 4% of the total population in the year PBS first began to around 12%, and it is projected to rise to 18% by 2021, and to 25% in 2051. What this means is that the population of aged people with chronic conditions that benefit from drug treatment has increased, and is likely to continue increasing, thus driving up the cost and future cost of PBS. The greater the cost of a program, the less sustainable it becomes. Increased Prescription of New Expensive Drugs New drugs are expensive and the Health Insurance Commission has pointed to the high rate of prescription of new expensive drugs as one of the major drivers of PBS cost. In an an effort to address this issue, the government has certain statutory and legislative price reduction policies in place. Inappropriate Prescriptions Prescription of new expensive drugs may be high, but the added PBS cost may amount to savings in cost in other areas. However, if prescriptions are made outside the PBS cost-effective guideline, such added cost would be a waste. For example, the arthritis drug, Celebrex, when it was first listed was projected to cost about 40 million dollars, but it ended up costing 160 million dollars obviously through inappropriate prescriptions. National Drug Policy National Drug Policy is a comprehensive framework presented by the government as an official statement contained in a single national policy document designed to be the basis of pharmaceutical activities in a country. It is normally framed after extensive consultation by the government with all primary actors in the pharmaceutical field from both the private and nonprofit sectors. A National Drug Policy embodies some basic components that clearly define objectives, set priorities, clearly developed strategies and commitment. The key components of a national drug policy then should include: i.) Access It is impossible for government boy or health insurance system to make every medicine in the market available, either by way of supply, or reimbursement to patients. It is necessary to define ways of selecting essential drugs as an important way of ensuring access and also as a means of promoting reasonable use of medicines. This involves a process of adoption of essential medicine concept by the government, so the objectives of government involvement in pharmaceutical sector can be prioritized, selection of essential medicines, defining the selection criteria, defining the selection process and putting in a place a selection mechanism for traditional medicines. Price is a critical aspect of a national drug policy, and affordable price is a factor that ensures that necessary medicines are within the reach of patient, their economic conditions notwithstanding. Access would still not be guarantied except there a is reliable and durable supply system for essential drugs. It is imperative on the part of the government, therefore, to encourage a mix of public and private sectors in the supply and distribution of necessary medicine, as a way of ensuring access of necessary medicines to all. Government also need to make a commitment to good procurement practice, publish prices of raw materials and finished products for all to see, ensure there is supply of medicine during emergency conditions, and take measures to control theft. ii.) Quality Drug regulation agencies are responsible for formulating and implementing laws and regulation upon which the pharmaceutical sector operate so that safety, quality and potency of medicines, and also the accuracy of product information, by ensuring that the manufacture, procurement, import, export, supply, sales, promotion, advertising, and clinical trial of pharmaceutical goods are done to set standard. iii.) Rational Use The rational use of pharmaceutical products means there has to be prescription and dispensing of medicine appropriate for the clinical need of patients, in doses that are proper and adequate for individual need over an adequate period and at the lowest cost possible. For these tasks to be well accomplished, there have to be a body authorized by law to coordinate medicine use, a clinical guideline that set the basis for the selection of essential medicines and training of health professionals. There also has to be problem based pharmacotherapy training in universities, continued in-service medical education as a basis for licensing medical practitioners. National Medicine Policy Under the National Medicine Policy, the Commonwealth Government having shifted focus to quality health outcome, put together a number of measures in meant to make all actors in the healthcare industry work together for the achieving better healthcare outcome for all Australians. The policy spells out a number of objectives and the roles every actor has to play to bring them about. As a paramedic, my roles regarding; “The Rational Use of Medicines”, “The Regulation and Quality Assurance” and “Monitoring and Evaluation” include: i.) The Rational Use of Medicines: It is my responsibility to use provided access to accurate information about medicines and their use in ways that equips me to educate users so they understand the cost, benefit and risk involved using the prescribed medicines. It is my duty to provide them with information and counseling promoting the quality of use of medicines. To adequately promote the quality use of medicine, it is my responsibility to make the right treatment choices, develop good communication with patient, and collaborate with other healthcare practitioners, even if it means dealing across professional boundaries. I must only use medicine on patients only when it is appropriate with absolutely no non-medical alternatives considered as needed. ii.) Monitoring and Evaluation: It is my responsibility to monitor the effectiveness medicine by observing and recording drug reaction, ensuring ongoing assessment of medicine safety, sending my observation to necessary points. iii.) Regulation and Quality assurance: It is my duty also to assess the evidence of potency and effectiveness of a medicine for specific conditions or indications and how the medicine is to be used. The involved observing, and sending observation made to the place for consideration in the regulatory process at the PBS. Quality Use of Medicine In the Quality Use of Medicines, the responsibility of health practitioners involves assisting people in making informed decision and learning about health issues and health care through information, education, and discussion. It also involves using objective information, resources, and services for making decision and taking actions that enable the wise selection and use of medicines when necessary. As health practitioners and paramedics, we need clinical judgment and decision-making ability as our ability to understand and diagnose clinical problems is pivotal to the outcome of health care (De Dombal, 1992). The concept of evidence-based practice has become critical to the quality and safety of health care delivery (National Institute of Clinical Studies, 2006). In the QUM policy, we, as paramedics are expected to make clinical decisions and take actions that enable the wise use of medicines, but the very nature of emergency service itself, suggests, that we may not, have, in given situation, the evidence-base for making clinical decisions. This being for the reason that paramedic as a profession is indeed novel in some respect (Lord, 2003). In a given situation, we are most often concerned with providing the best care possible considering the unpredictability and uncontrolled nature of the situation. In making sense of situation, and making clinical judgment, we have discovered that it is not always possible to perform our part of the QUM responsibility effectively when we have to deal with mentally ill patients. As paramedics, we face enormous problems dealing with mentally disturbed patients (Shaban, 2004a; Roberts, 2007). In Shaban’s (2005) report, it was asserted that paramedics work with considerable uncertainty and at very high personal professional distress when they have manage the mentally ill owing to a number of factors. Paramedic make decision regarding a situation of the mentally ill based mainly on intuition and patients with vague evidences without an obvious physical symptoms are always definitely taken to the clinic, conflicting with our responsibility of making certain, there is a non-medical alternative to consider before such medical decisions are made. The reason for this is simply a rigid clinical policy that is focused on psychotic illness instead of the more prevalent conditions of anxiety and depression. Policy in this regard would need to be reformed in ways that that make the distinction between chronically psychotic and with mild emotional disturbance, so that assessment of the risk and benefit of action taken and medicines administered be relevant to the Quality Use of Medicines broad objectives. Emotionally disturbed patients who would otherwise, have required a non-drug therapy, could end up, administered a drug-based therapy or taken to the hospital. In either case, avoidable cost, which may not be healthy for the future solvency of PBS is incurred. Drug Information resource In administering any drug to a patient, I need first be certain the medicine is right for the patient, and be certain to it is the right drug. Below is a list of drugs I have included in my personal list of appropriate drug information resources. 1.) Drug Guide for Paramedics by Richard A Cherry and Bryan Bledsoe This resource is particularly useful to me because the authors provided accurate, easily accessed extensive information about medication. It has an updated medicine profile of more than a hundred most commonly used emergency medicines. It also contain a list of home medicine with classification to enable quick referencing. Its convenient index gives me quick easy search by using the trade or generic name. 2.) Paramedic Drug Resource is a resource material I accessed online gives detail information about medicines, including actions, indications, contraindication, precautions, side effect, dosage, routes and pediatric dosage, all explained in concise easy to use format (hci.edu/PDF/druginfo.pdf 3.) Drug Guide for Paramedics by Rob Theriault is an online resource that gives detail information about emergency drugs including classification, pharmacodynamics, pharmacokinetics, indication, contraindication, precaution, drug to drug reaction, adverse effect, pediatric dosage, dosage and author’s notes that recommends observation and action to be taken after administering medicine. 4.) Paramedic Care Principles and Practice by Bryan Bledsoe, Robert Porter and Richard Cherry is a book that gives vivid introduction to advanced pre-hospital care, patient assessment, medical emergencies, and trauma emergencies 5.) Mosby Paramedic Textbook by Mick J. Sander is a resource from which I’ve been able to assess extensive medicine terminologies, refresh myself on the importance of medical legal issues. Mosby Paramedic Textbook also gives a lot of useful information therapeutic communication, patient assessment, clinical decision-making, venous access and medication administration, trauma system and mechanism of injury, hemorrhage and shock cardiology, and behavioral and psychiatric disorder. The limitation however is the absence of detailed information on specific emergency medicine, and recommendation on how it is to be used. Melatonin Circadin Melatonin is an important metabolic hormone found in animals, plants and microbes. In human, Melatonin is released into the body by the pineal gland in the brain. Melatonin helps trigger the body sleep response, and is responsible for helping the body go to sleep when it is time, and wake up when it is time. Circadin, a Melatonin prolonged-release tablet was approved for a short-term treatment of up to 3 weeks of primary insomnia that is reflected in poor quality sleep in patients aged 55 years and above. Non-drug therapy is the PBS approved first line of treatment for primary insomnia. Melatonin was approved as an alternative to a benzodiazepine or related hypnotic (zolpidem or zopiclone), only when drug therapy is necessary for persistent primary insomnia patients. Circadin is the trade name and it not listed on the PBS schedule, and may be taken only on prescription in Australia. Circadin has a Melatonin content of 2 milligrams. Manufacturer Circadin is manufactured by; Neurim Pharmaceutical 8 Hanechoset Street Tel-Aviv, Israel And licensed to Sigma Pharmaceutical Head Office 96 Merrindale Drive South Croydon    3136 Australia. The information provided by the manufacturers provides end users answer to six fundamental questions I consider satisfactory from my evaluation as a paramedic. The information covers; 1.) What Circadin is, and what is used for 2.) Health and living conditions under which Circadin must not be taken 3.) How to take Circadin 4.) Possible side effects of taking Circadin 5.) How to store Circadin 6.) Other information, that cover other subject such as the content analysis, manufacturers etc. Use of Melatonin for Children In Australia, Melatonin is approved for use only for adult aged 55 years above, however studies in the United States and Europe have shown that Melatonin has no adverse effect on children (Jan, Groenveld, Sykanda, and Hoyt, 1994). It has been proven to be effective in the treatment of severe sleep disorder in children (Jan, 1994). In a study conducted involving 15 children from the age 6 months to 14 years, with severe sleep disorder, Melatonin was administered to all 15 children, other form of traditional, non-pharmacologic therapy to improve sleep having failed. All of the children had clinical benefit, and 13 of them having favourable response to Melatonin. Palm (1997) published a report of a study on 8 blind children. Before the study, the children had severe sleep disturbance, they all responded with improved sleep conditions to Melatonin. Smith, Van der Heijden, Van Sumeren and Gunning (2001) having conducted a placebo-controlled study on 40 children with chronic insomnia, discovered that Melatonin has no adverse effect on children, but was rather helpful in the treatment of insomnia in children. While I would be careful to let the distraught mother know that Melatonin is approved in Australia only for treatment of patient aged 55 years and above, I would also present her with cases in Europe where Melatonin has been used successfully for the treatment of sleep disorder in children aged between 6 months and 15 years. Hawthorn Extract (Herb) Hawthorn extracts are made, or extracted from the leaves and flowers of Crataegus monogyna and C. oxyacantha, and are used for; 1.) Treatment of Mild Heart Failure (NYHA Class II): According to systematic review of randomized placebo-controlled trials, hawthorn extract is believed to improved subjective symptoms and certain other objectives signs such as exercise tolerance of patient with mild heart failure. However, most of the trails excluded patients with more critical conditions of heart failure, and accompanying use of normal cardiovascular drugs was not always well documented. 2.) Treatment of Symptomatic Heart Failure: Randomized studies have shown that hawthorn extract doses caused statistically significant reduction in subjective symptoms of heart failure. 3.) Treatment of High blood pressure. 4.) Treatment of Chest Pain. Recommended Use of Herb 1.) As a Dietary Supplement Hawthorn extract is not for dietary purpose, it is for the treatment of heart failure 2.) Treatment Purpose I would recommend that patient consider hawthorn only when condition is mild case of NYHA Class II or stable NYHA Class III type heart failure. Patient would need to remain under study for a long period of time when hawthorn is used for treatment of symptomic heart failure especially if there are claims of inotropic activities to determine potential adverse effect after survival. Hawthorn extract may not be used if condition of patient is critical, as study has shown that hawthorn is ineffective in this regard. High dosage of hawthorn may come with some occasional adverse effect. Aspirin Induced Asthma Aspirin induced asthma is a peculiar clinical disorder affecting asthma patient, and usually begins with an inflammation of nasal mucosa 30 minutes to 3 hours after ingestions of aspirin and could be very severe, even leading to a full blown asthma attack. Affected patients of aspirin induced asthma are cross sensitive to all NSAIDs owing to the inhibition of cyclo-oxygenase enzymes by the anti-steroidal anti-inflammatory nature of NSAIDs. However paracetamol, though a NSAIDs, is cross sensitive in patients of aspirin induced asthma. While studies have shown prevalence of cross sensitivity of aspirin in patients with aspirin induced to be between 4 and 44%, prevalence with paracetamol has been less than 2% in adults (Jenkins, Costello, and Hodge, 2002). The conclusion therefore is that patients with a high risk feature of aspirin induced asthma, or anyone who has ever experienced an asthmatic reaction to aspirin or NSAIDs, or even positively identified with aspirin induced asthma should avoid all products that contain aspirin or NSAIDs, and stick with paracetamol, unless contraindicated (Jenkins, Costello, and Hodge, 2002). My recommendation therefore to Karli would be for her to use paracetamol instead of Cardiprin R based on the considerations above. Bibliography J. E. Jan “Treatment of Sleep With Melatonin”. 1994. British Colombia Children Hospital. Kristiaan B. Van der Heijden, Marcel G Smits, Eus J.W. Someren, W. Boudewijn Gunning. ‘‘Circadian Rhythm Sleep Disorder‘‘. 2001. University Amsterdam. Christine Jenkens, John Costello, Linda Hodge. “Systematic Review of Aspirin Induced Asthma and Its Implication for Clinical Practice. 2002. British Medical Journal. J.J. Alastair, M.D. Wood, A.G.M. Peter, De Smet, D. Pharm. “Drug Therapy”. 2002. New England Journal of Medicine. Wed. Dept of Health and Ageing. “National Strategy for Quality Use of Medicine”. 2002. Commonwealth of Australia. Dept of Health and Ageing. “National Medicines Policy”. 1999. Commonwealth of Australia. Dept of Health and Ageing. “How to Develop and Implement a National Drug Policy”. 2003. Commonwealth of Australia. Dept of Health and Ageing. “Pharmaceutical Benefit Scheme”. 2011. Commonwealth of Australia. National Institute of Clinical Studies. “Quality Use of Medicine”. 2006. Commonwealth of Australia. Read More