Named patient basis

Further cases of congenital malformations were reported in 1994 due to lax control of thalidomide use (Lancet 343 433 and 344 196). Thalidomide is available in the UK on a named-patient basis only, with a detailed patient information leaflet and with signed patient consent. 

Sertindole is available only on a named patient basis, f Licenced indications for thioridazine were severely restricted in 2000 after evidence emerged of cardiovascular toxicity. 

Medroxyprogesterone acetate and its metabolites are excreted in breast milk, so women who breastfeed should wait until 6 weeks post partum before starting Depo-Provera, when the infant s enzyme system should be more mature. Norethisterone enantate 200 mg (Noristerat) is shorter acting than Depo-Provera, 8 weeks, and is used to provide contraception after administration of the rubella vaccine, and until a partner s vasectomy has taken effect. It can also be used in the longer-term but only on a named patient basis. 

Section 25 Exemption for medical practitioners and dentists to supply any medicine on a named-patient basis for administration to a patient under their care. 

When the application on a named-patient basis is for several patients under one doctor, one application form can be used for all the patients. The necessary information in Section D on the respective patients must be collated and attached to the application. 

Section D must be filled by the requesting doctor only when appl)dng for import of a product on a named-patient basis. The doctor is also to certify in Section D that he will take full responsibility for the use of this product on the named-patient as the product has not been registered with the Ministry of Health. 

SECTION D—for named-patient basis (To be completed by Doctor)... 

I Currently only available on named patient basis in the UK. 

Probenecid (available on a named-patient basis only) and sulfinpyrazone lower the uric acid level in blood by increasing the amount of uric acid passed in the urine. They do this by competing for the transport mechanism responsible for mbular reabsorption of uric acid in the kidney. 

Many anthelmintics are available in the United Kingdom only on a named-patient basis. These are unlicensed medicines that have not been given a Marketing Authorization by the Medicines and Healthcare Products Regulatory Agency and can only be obtained from the pharmaceutical company or manufacturer. 

Praziquantel (available on a named-patient basis) is a highly effective anthelmintic, which induces muscular contraction and spastic paralysis in trematodes and cestodes by increasing calcium ion fluxes. 

Ivermectin has occasional use against round worms, hookworms and whip worms and is available on a named-patient basis in the United Kingdom. 

Infection with parasitic worms in the United Kingdom is usually confined to round worms or thread worms. In tropical and subtropical parts of the world, infection with parasitic worms is common and widespread. There are many drugs available (in the United Kingdom on a named-patient basis) to treat parasitic worm infection. Most anthelmintic drugs work by interfering with neuromuscular transmission causing paralysis of the worm. 

The majority of prescription, supply and administration of medicines should be provided on a named patient basis. Under a PGD (National Health Service, 2000), the supply and administration of medicine should apply only when this route offers advantages to the patient without compromising safety. Only specific professional groups can work... 

Named patient basis A mode of supplying an unlicensed drug for use by a physician for a given named patient usually for compassionate grounds where the drug would not otherwise be available. Sometimes patients are allowed to continue at the end of a trial on this basis. Various regulations cover such use. Also known as treatment IND is the USA. 

When a company supplies a product for which no product licence exists, it is usually supplied on a named patient basis, meaning that the consultant s name, patient s name and the conditions that the drug is being used to treat are all recorded. 

Unlicensed medicines are medicines, including pharmacy preparation, that don t have a Marketing Authorisation. Patients who suffer firom a disease, for which no licensed medicinal product is available, may exceptionally get unlicensed medicines from a manufacturer. This happens on the legal basis of a compassionate use program either on a named patient basis or to cohorts of patients. This regulation applies to patients with a chronically or seriously debilitating disease or whose disease is considered to be life threatening. Reimbursement has to be clarified firom case to case (see Sect. 3.3.2 Reimbursement). 

The use of extemporaneous preparation should be limited to situations where there is no product with marketing authorization (MA) available. This could be prepared based upon a prescription for a named patient (magistral preparation) or a production based upon a formula and prepared on a regular basis. The latter is a... 

Preparation and dispensing of radiopharmaceuticals is limited to dedicated radiopharmacies. Radiopharmaceuticals for patient use are usually prepared, controlled and dispensed in a hospital radiopharmacy department, but can also be dispensed on a named patient base by a centralised radiopharmacy ( compounding centre ) that operates on a commercial basis or by a centralised hospital pharmacy. The hospital (radio)pharmacist has the final responsibility for the quality of radiopharmaceuticals, also when purchased from an external (commercial) site. The responsible hospital pharmacist has to audit the external site and obtain a quality agreement, clarifying the mutual responsibilities. 

This positivist attitude is well-established in the biomedical world, and, to be sure, it was hard-won and hardly to be disparaged. However, at the same time, the price for objectifying disease has diluted, if not too often replaced medicine s ancient calling of care. I mean by care, attention to each facet of the individual, namely, treating the patient as a person, as a whole. A medicine that fails to address those elements of personhood that have no scientific basis - the social, the emotional, the moral - is ultimately fractional and therefore incomplete. Only by the physician committing to comprehensive care can the multifarious elements of being ill be addressed effectively. There is no one else to assume that responsibility, and we must invoke the ethics of responsibility to re-define the entire enterprise.5... 

Life Events and the Two-Hit Hypothesis of Psychiatric Disorders. One theory that tries to explain this combination of genetic vulnerabilities and environmental factors as the basis of many psychiatric disorders is the two-hit hypothesis. That is, in order to manifest an overt psychiatric disorder, one must not only sustain the first hit, namely all the critical genetic vulnerabilities, but one must also sustain a second hit of some type from the environment (Figs. 4-2 through 4-5). Thus, psychiatric disorders are increased in incidence in first-degree relatives of patients with a wide variety of psychiatric disorders but not to an extent that allows one to predict which specific individuals will or will not eventually develop a specific psychiatric disorder. 

There is usually no fixed medicine for a particular disease in Homeopathy. Medicines are selected on the basis of symptoms of individual patients. This comes in the way of collecting clinical evidences in support of Homeopathy. Homeopathy would simply show that diseases, whatever their name is, are cured or ameliorated by potentized medicines. If we look for evidences from this angle we would certainly have plenty of clinical evidences in favour Homeopathy. 

Mandatory drug product selection on the basis of price is common practice in the USA as third-party payers (insurance companies, health maintenance organizations, etc) enforce money-saving regulations. If outside a managed care organization, the prescriber can sometimes override these controls by writing "dispense as written" on a prescription that calls for a brand-named product. However, in such cases, the patient may have to pay the difference between the dispensed product and the cheaper one. 

The development of the excitotoxicity hypothesis of ischemic damage along with the advent of potent glutamate antagonists provided the theoretical basis of what has been named neuroprotection. The failure of more than 40 clinical trials that have applied neuroprotectants to stroke patients, to show a clear clinical benefit has, however, raised concerns about... 

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