What is a named patient basis?
“Named-patient basis” is another way of obtaining medicine before authorization where a doctor requests supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor’s direct responsibility.
What is named patient use?
A Named Patient Program (NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a NPP.
What is named patient supply?
NAMED PATIENT SUPPLY. In some cases doctors may approach a manufacturer directly to request the supply of a new medicine that does not have a UK product licence, to be used for a patient under their direct responsibility. This is often called supply on a “named patient basis”.
Why do we need these unregistered therapeutic products?
The use of unregistered therapeutic products should only be considered for life-saving therapies, where there is an unmet medical need such as in situations where a registered treatment option is absent, and the patient’s health will be clinically compromised without treatment with the unregistered therapeutic product.
What is the difference between compassionate use and named patient use?
Compassionate use should not be confused with ‘named-patient basis’ treatments, which see doctors obtain medicines directly from manufacturers before authorisation. This is done on an individual basis under the direct responsibility of the doctor, and the Agency does not need to be informed.
What are early access programs?
Early access programs are a means by which investigational therapies are made available, in certain circumstances, to treat patients with serious diseases who are unable to participate in an ongoing clinical trial or whose treatment options are otherwise limited.
Who pays for compassionate use drugs?
Some drug companies will supply a drug through compassionate use for free, but others might charge patients. Most insurance companies will not pay for the costs of the investigational drugs themselves, even with compassionate use.
What medications are banned in Singapore?
Prohibited in Singapore: anti-anxiety pills, sleeping pills and strong painkillers without a licence. Singapore has had a chewing gum ban since 1992 and prohibits medicinal chewing gums such as nicotine.
What is an exemption drug?
1. Subsection (h) provides that “”Exempt drug means a drug on the MTUS Drug List which is designated as being a drug that does not require authorization through prospective review prior to dispensing the drug, provided that the drug is prescribed in accordance with the MTUS Treatment Guidelines”.
What is a single patient IND?
Non-emergency Requests: In a non-emergency situation, a written request (IND) for individual patient use of an investigational drug must be submitted to the FDA. These non-emergency requests are known as individual patient INDs, or single patient expanded access requests.
What is compassionate special permit for drugs?
“It is clarified that a CSP is a special permit granted to physicians or hospitals to use investigational drugs or drugs which are not yet registered or in the process of registration here in the Philippines for the treatment of seriously ill patients,” the FDA said in its statement.