Patient access

Since Raltegravir was a critical new tool to address the worldwide HIV/AIDS epidemic, in order to further increase global patient access, an even more efficient, economical and environmentally friendly synthesis was desired. 

Accelerated Assessment The EU introduced the accelerated assessment in November 2005. The aim is to speed up the regulatory procedure to enable patients access to new medicines. The EMEA review time for accelerated assessment is 150 days. See Exhibit 8.9 for the approval of Soliris (eculizumab),... 

The new Regulation allows Member States to supply, on compassionate use grounds to certain groups of patients, unauthorised human medicinal products that are required to use the centralised procedure. This wiU allow patient access to certain imauthorised products, provided there are adequate public health and safety grounds. In addition, for centrally authorised products, a new provision will be introduced that allows the conditional authorisation of medicinal products in defined circumstances, provided there are justified reasons (such as the products of public health interest). The conditions imder which the authorisation is made would be reassessed on an annual basis. The EC has also agreed to estabhsh the circumstances in which small and medium-sized companies may pay reduced fees, defer pa)nnent of fees or receive administrative assistance. 

These realities of the current state of healthcare have caused healthcare policy-makers to use several methods to regulate the supply and demand of health services and thereby control the cost of those serv ices. Attempts to reduce the supply of services include a reduction in the reimbursement for services or a reduction in the number of physicians and specialists. These approaches may contain the growth of healthcare costs but a reduction in the capacity of the healthcare system also limits the patient access to services, resulting in longer waits for non-emergency services. Attempts to reduce the demand for services include ... 

This legislation amended the Federal Food, Drug, and Cosmetic Act to improve the regulation of prescription drugs (as well as medical devices and food). The law notes that the PDUFA of 1992 successfully reduced review times and reauthorized the user fees to expedite the review process. Other provisions aimed to give some patients access to experimental drugs. Beyond that, the law made several other changes. 

Comments. The clearest lesson from the butorphanol experience is that when a drug is introduced to a new population, it is important to determine whether extant abuse-liability studies will generalize to that population. If not, then clinical trials should be designed to detect signs of abuse in that population, and careful postmarketing surveillance should occur. The goal is not to prevent patient access to necessary medications, but to ensure that providers and patients have adequate information about the risks of such medications. 

Many prominent people and organizations have supported the legalization of medical marijuana, including the American Public Health Association, former U.S. Surgeon General Joycelyn Elders, national associations of prosecutors and criminal defense attorneys, and the editorial boards of numerous newspapers, among others. Public opinion polls conducted by TIME/CNN in October 2002 report that approximately 80 percent of the American public supports patient access... 

Conjunction ( ) merges two policies by returning their intersection. For instance, consider an organization in which divisions share certain documents (e.g., clinical folders of patients). Access to the documents is to be allowed only if all the authorities that have a say on the document agree on it. Intuitively, while addition enforces maximum privilege, conjunction enforces minimum privilege. 

Factors influencing pharmacist involvement in disease management Patient access... 

Anon. Survey reveals patient concerns about medication-related issues. ASHP calls for increased patient access to pharmacists in hospitals and health systems. Bethesda, MD American Society of Health System Pharmacists 2002. (Internet at http // WWW.ashp.org/news/ShowArticle.cfm id =2996.)... 

The third ordinance. No. 96/346, guarantees patient access to quality care and security in accord with the objectives set by parliament. 

Pharmaceutical Research and Manufacturers of America. Facts and Figures and Publications, www.phrma.org/facts and www.phrma.org/patients (accessed 1999 Oct. 1). 

Have the availability of the new medicinal products and patients access to such products been improved by the introduction of the new Community system and are they satisfactory at the present time ... 

Patients access to medication should not be limited by the frequency of relapses, age, or level of disability. 

Early intervention is important in the treatment of SAD. Pharmacotherapy can dramatically improve QOL. Patients treated with fluvoxamine, sertraline, paroxetine, or escitalopram showed a significantly greater improvement in functioning, disability, and QOL compared with placebo-treated patients. In a relapse prevention study, patients treated with escitalopram experienced a better health-related QOL and more cost-effective therapy than placebo. The acquisition cost of escitalopram was more than offset by a decrease in total costs of care. Health care professionals can assist patients who quahfy for pharmaceutical manufacturer patient access-to-care programs to ease the burden of drug costs. 

J. J. Cimino, V. L. Patel, and A. W. Kushniruk. 2002. The patient clinical information system (PatCIS) technical solutions for and experience with giving patients access to their electronic medical records. International Journal of Medical Informatics 68 113-127. 

Grabowksi, H., Medicaid Patients Access to New Drugs, Health Affairs 7 102-1 14, Winter 1988. 

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