Every year a large number of new medicines receive marketing authorisation. It is the National Health Service (NHS) responsibility to decide whether the additional cost of purchasing these medicines is justified by the likely benefit to patients. For this reason, a multi-disciplinary activity known as the health technology assessment (HTA) has been created. In the UK, HTA mainly focuses on the clinical and cost-effectiveness of new medicines.
In this essay it was discussed the processes through which HTA appraise new medicines and how the different policy makers within the UK use the most available evidence-based information to decide which technologies are most effective and appropriate for use.
Before a new medicine can be licensed for use in the UK, a long-lasting research (12 years) needs to be carried out. During this time each new medicine is assessed for its safety, quality and efficacy. A pharmaceutical company can apply for a marketing authorisation either through Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA). MHRA is an authority in the UK that is responsible for the safety of medicines and medical devices while EMA evaluates the use of medicinal products across all member states within the European Union.
Once a medicine has been licensed, is being assessed for its clinical and cost-effectiveness for use in the NHS. In Scotland there is a national consortium of representatives of local drug and therapeutics committees known as the Scottish Medicines Consortium (SMC). SMC uses transparent decision making processes in order to assess the value of a new medicine. As soon as a medicine becomes available for use, SCM decides whether this medicine should be recommended in the...
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... proposed by the pharmaceutical companies and makes a recommendation to SMC prior to be accepted or not. Where PAS is approved for a medicine the SMC has to consider the offered discount. On the other hand, where a PAS is not considered achievable, the SMC estimates the value of the medicine on its standard cost. In that case the pharmaceutical company has the right to resubmit a revised PAS for acceptance.
Issues on the complexity of PAS processes have been raised. Risk sharing schemes would be of less inconsistency if a more straightforward process would be carried out in order to make a discount for expensive drugs.
All recommendations above have been made in order to make an open and transparent system where everyone will have the right to contribute on the decision making process regarding the clinical and cost effectiveness of newly licensed medicines.
The rise in demand is in part due to an aging population and is reinforced by the prevalence of long-term health conditions. The high cost of treatments is derived from advances in medical science whereby expensive sophisticated techniques are available and specialist medications are employed to control or cure conditions. The poor services offered by the NHS has caused a fall ...
The current Food and Drugs Regulations appear quite solid. Definitions are made for a variety of terms such as “daily value”, and rules are made with very specific scopes, breaking down stakeholders (consumers, producers/retailers) into groups so that there is s...
Before the vote, the “Leave Campaign” claimed that EU Clinical Trials Directive hindered innovation for Medical Devices in the UK. "Weaknesses in the 2001 Clinical Trials Directive significantly increased the administrative burden and cost of running academic clinical trials and saw a reduction in trials taking place in Europe." Stated a report from The Commons Science and Technology Committee. Even with the new rules of the MDR being implemented, people believe the UK’s freedom from the regulations of the EU would advance innovation significantly.
McLeod, M., Ahmed, Z., Barber, N., and Franklin, B. D. (2014). A national survey of inpatient medication systems in English NHS hospitals. BMC health services research, 14(1), p93.
For example, in Ms. News’s interview with Chief Information Officer at Lawrence Memorial Hospital (LMH), he affirms that CPOE is a great tool to reduce clinical errors, save cost, improve patient quality. However, the biggest barrier for LMH is getting physicians to buy-in. Most physicians are not practicing evidence based medicine. Instead, physicians workflow derives from concepts and principles taught in traditional medical schools. A patient needs a prescription, so naturally, a medical practitioner would write out a prescription. However, this could be a significant risk for both the doctor and the patient. The physician in times past took several hours filtering through reports to stay abreast the last approved drugs (DRG) and deleted DRGs, their actions, and adverse reactions. Obviously sifting through lofty reports is not the most efficient, information may not update or simply may be overlooked.
The practice of over prescribing medication is a recent problem facing many today. This is referred to as the prescribing cascade. Dr. Mehrdad Ayati an assistant professor of medicine at the Stanford University School of Medicine, describes Prescription cascade in the following statement “To put this simply, a patient goes to a doctor’s office with an illness and is given a prescription this prescription has a side effect that causes another illness, and now the patient, unaware that the prescription is the problem, visits the same, or another doctor and is given another prescription. Then this prescription result in a new side effect, which sends the patient to the same, or yet another doctor for the new symptom, and
The cost of medication in the United States can be very expensive. Finding ways to cut costs is important and necessary to many Americans. Buying generic instead of brand-name drugs is one way to save money. However, not all generic drugs are equal to their brand-name counterpart.
Competency Standard 4.2.2 revolves around the review of prescribed medicines. This involves understanding the therapeutic use for prescribed medicines, as well as using professional and clinical judgement to identify factors which can impact safety and adherence of treatment, and any potential or actual drug related problems which can warrant a change in the patient’s medication regimen.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
There are other guideline efforts that consider patient values and preferences in the process of developing recommendations. For example, the National Institute for Health and Clinical Excellence (NICE) also considers the impact of values and preferences on the strength of recommendation. The process includes asking patient representatives to reveal their experience in addition to reviews of qualitative research evidence and cross-sectional surveys. However, NICE does not operationalize values and preferences as the importance of outcomes
CEA proponents believe that the country’s increased health care spending and desire for the best in medical technology will eventually force us to strongly consider using CEA as a possible solution to our problems. Perhaps a middle ground would be to use CEA as one tool of many when it comes to health policymaking. It does provide a tool to inform decision making in a clear, explicit way. In addition to the many countries that use CEA, medical journals here in the US routinely publish them. CEA would be able to help managed care organizations, insurers, and policy makers make informed decisions. Supporters are optimistic that the increased involvement by the federal government in comparative effectiveness research will eventually lead to increased acceptance and the use of QALYS as a
of medications. In case of suggestion of novel and advanced protocoals regarding medications, approval by pharmacy and therapeutic committee is still required.
The United States is encountering a speedily accumulative incidence of drug shortages. This has caused abundant complications for health care facilities, clinicians, their patients, and federal regulators. Drug shortages are determined to be caused by multiple factors such as, business decisions, regulatory issues, disturbances within the supply chain, difficulties in acquiring raw materials, and manufacturing issues. These problems adversely affect patient care because it causes substitutions of effective and safe therapies with substitute treatments. This can delay or compromise medical procedures. This can cause medication errors. A management approach that includes clear policies as well as procedures for gathering information, making a decision, collaborative efforts and timely communication need to be established to handle such drug shortages in an effective manner (Ventola, 2011).
When studying for my Bachelor degree in Pharmacy, I received an interesting exposure to the basics of administration of Pharmaceutical industries which has further fueled my interest in learning the process of Approval from Food and Drug Administration and other laws that regulate Manufacturing, Marketing and advertising of Drugs, Pharmaceuticals and Health care devices to ensure that they are safe and effective. This has inspired me to opt for an MS program in this field and would also provide an intellectual, cultural, ethical understanding and awareness needed to become leaders and innovators in global society.
Over the centuries, ancients made use of several treatment methods. Two of them are modern medicine and traditional medicine. Alternative medicine is older than modern one. That effective therapy has used for many centuries on the patience when modern medicine has not occurred in the world. Because it has improved in China, it can be called Traditional Chinese Medicine. In contrast, modern medicine has been in used since 1900’s. In this system, drugs’ testes are done in safety laboratories with care and nicety, and their side effects are located before they are given to the patient. However, sometimes the side effects are not blocked so, people have to take another pill to get better. It makes people to take more chemicals into their bodies. Further, modern medicine has splendid efficacy on the fatal diseases. Even, alternative medicine which people’s ancestors utilized stayed in the background when modern medicine has just found, it works at the present time efficaciously. ****** Therefore, using alternative medicine is more helpful to get better than modern medicine because there are fewer drugs, side effects; there is placebo effect and holistic therapy.