Legally permitted and qualified independent prescribers are responsible for the clinical assessment of a patient, the establishment of a diagnosis and decisions about the appropriateness of a medication, treatment or appliance, including the issuing of a prescription [12, 13]. Prescribing usually takes place from a limited formulary - a list containing a limited and defined number of medicines that can be prescribed - or an open formulary. This type of prescribing is also referred to as initial, autonomous, substitutive and open prescribing [4, 14]. Where nurses are able to independently prescribe medicines, with a fair range of prescribing freedom concerning medicine choice, we considered both the nursing and the medical profession to hold equal and full jurisdiction over prescribing, according to Abbott's classification (see Figure 1). It should be noted however that this is an exceptional case, as it is very rare for two groups to hold equal jurisdiction in a particular task area [7].
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The following six electronic databases were searched without any limitation as to date of publication or language: PubMed, Embase, CINAHL, Web of Science, EBSCO Academic Search Elite and the NIVEL-catalogue. Searches were highly sensitive, using the following search strategy for PubMed: ("Nurse prescribing") or (Nurs* [tiab] AND Prescri* [tiab]) or (Nurses [MeSH] AND "drug prescriptions" [MeSH]) or (Nurses [MeSH] AND formulary [tiab]). Suitable search strategies were developed for the other databases, using adaptations of the PubMed search. All detailed search strategies can be found in additional file 1 'Search strategies'.
In addition to the electronic databases, the following relevant websites were searched: the website of the Virginia Henderson International Nursing Library , the website of the World Health Organization , websites for health professionals -prescriber.co.uk, , , and Google Scholar Since most of these websites lacked advanced search facilities, the following keywords were used to search for relevant publications: "nurse prescribing", "independent (nurse) prescribing", "autonomous prescribing" "supplementary (nurse) prescribing", "dependent (nurse) prescribing", "collaborative prescribing", "group protocols" "patient group directions", "time and dose prescribing", "nurse formulary" and combinations of these keywords. All detailed search strategies can be found in additional file 1 'Search strategies'. Additionally, we consulted experts in the field to identify any studies that might have been missed.
The organizational conditions under which nurses are allowed to prescribe medicines in Western European and Anglo-Saxon countries are much less discussed in the literature than educational and legal conditions for nurse prescribing. It is nonetheless clear that most countries operate some sort of mandatory registration system in which nurse prescribers have to be registered before they are allowed to prescribe. In Australia, nurses have to submit a formulary of all the medicines they may prescribe to their respective Nursing Boards as part of their endorsement process [5, 88]; in the Netherlands prescribing nurses must be registered in the 'BIG' registration system kept by the Ministry of Health [117, 118]; and in Ireland [5, 115, 139], New Zealand [5, 6, 79], the UK [5, 22, 23, 29, 38, 42, 71, 77, 85, 91, 92, 95, 116, 142] and the USA [134] nurse prescribers must register their qualification with their respective national regulatory nursing bodies.
In the United States, pharmaceutical companies are able to set the price of a prescription drug at whatever they believe the market will bear. As a result, the prices of prescription drugs are not tied to the value those drugs provide to patients, as they are in many of our peer nations. Countries such as Germany and Australia use value-based pricing, ensuring that the price of a drug is based on the benefit provided to patients in terms of quality of life or efficacy; this pricing approach makes their drugs cheaper and more valuable to the patients taking them.
As policymakers weigh various proposals that would lower drug prices and limit excessive price increases, the pharmaceutical industry has asserted that high prices are necessary to promote innovation and develop new drugs. The reality, however, is that there is not a significant relationship between the prices charged by pharmaceutical companies and either their research and development (R&D) spending or the clinical benefit of their products.
Switching to a value-based pricing system would better serve patients and improve the efficiency of health care spending in the United States. Importantly, making such a switch would promote, rather than hinder, pharmaceutical innovation, especially into the health needs that are currently unmet.
Value-based pricing refers to paying for drugs in proportion with the benefits they provide to patients over existing drug options.43 Rather than allow pharmaceutical companies the ability to charge whatever high price they have concluded will maximize their profits, the value-based framework ties the price to whether and to what extent the drug helps patients more than current treatment options. It also works to ensure that patient access to innovative drugs is included when determining the appropriate price for a drug.44
Value-based pricing has the potential to effect lower health care spending by the health system, alter the health conditions into which the pharmaceutical industry invests research funds, and create better patient outcomes. This section outlines three different ways that value-based pricing can be used to accomplish these goals: 1) limiting spending on drugs without a proven benefit, 2) promoting research into underinvested health conditions, and 3) advancing health equity.
One of the most significant ways that value-based pricing can realign incentives in the pharmaceutical industry is by limiting the prices that drug companies can charge for drugs without a proven clinical benefit to patients. There are two ways a drug may not have a demonstrated clinical benefit.
When a prescription drug is being developed, it goes through clinical trials, research studies designed to test safety and effectiveness.103 Three trial phases are required for FDA approval: Phase I trials test a drug on a small population to determine its safety and side effects; Phase II trials involve a slightly larger population to determine the efficacy of the drug and continue to monitor its safety; and Phase III trials are the largest, studying the effects on different populations, at different dosages, and in combination with other drugs.104 After approval by the FDA, pharmaceutical companies are sometimes required to continue monitoring a drug for long-term side effects that might not have been apparent during the first three phases.105 These Phase IV trials are also required for drugs approved under the accelerated approval pathway.106 2ff7e9595c
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