Name Patient Program

Name Patient Program is focused to deliver or dispense medications which are under the Orphan drugs, pre-approved drugs, Unlicensed Drugs or Special drugs to patients and doctors to assist rare disease treatment or treatment under special condition.

It is common in certain cases, that drug/s are already discovered, but not marketed in every global region due to ongoing approval processes or products are under the late-stage of clinical research. Name Patient Program breaks the gap between such medications accessibility to physicians and patients. Name Patient Program gives the freedom to the physician to prescribe medication that is available in well-established pharma- markets. Both physicians and patients can order these medications by providing necessary documentation required to prove the actual need of the drug/s.

Name Patient Program has the accessibility to all well-established pharma- markets and sponsors for sourcing the necessary medications. Name Patient Program ensures both patients and doctors safe dispensing of the drug for appropriate use. Name Patient Program brings the global marker under one umbrella for physicians, patients as well as for sponsors. Name Patient Program maintains all the regulatory and logistics requirements to provide hassle-free service to all the consumers.

Name Patient Program is useful for all the pharma sponsors also. Usually, sponsors want to launch their products in the popular markets where they get more patients and well-established pharma markets of the USA, Europe, and Japan or other such vast markets. But Name Patient Program gives them a scope to market their products beyond commercialization.

Establishing product in other countries is a challenging job. Sponsors often hesitate to start their business in new locations due to country-specific regulatory restrictions. The experienced staff of Name Patient Program helps sponsors to deliver their products in new locations. Interested sponsors who want their product availability in the region/s where the drug/s has not yet get approval can establish their products by opting Name Patient Program.

Name Patient Program Process

The patient from any country who is recognized as ‘the Named Patient’ and suffering from the chronic, serious, or life-threatening disease has the right to access, procure, and import medicines which have life-saving potentiality or improve the quality of life of the patient.

But rules and regulations for importing innovative medications are different in every country. Every country has to follow its own regulation to import such medications. Different programs are already existed such as Named Patient Import, Early Access Program, and Compassionate Use Program specifically available to import such medications. However, every country follows its own program.

Any patient who requires service to import medications to improve their quality of life or increases the survival duration, then he/she can avail the Name Patient Program Process in coordination with his/her consultant doctor. In normal practice, only approved medications are marked and allowed to treat patients. This is a general rule for every country. But in the national law, some specific legal exceptions are stipulated which allows patients to import unavailable medicines in their home country. The Name Patient Program Process is under such type of specific legal exceptional allowance which ensures every patient can obtain the benefit of globally innovated medicines to improve their health condition. The essential requirements to access the Name Patient Program Process to procure or import medicines are as follows:

The ordered medicine is not available or not approved in the home country, but has market approval in another country.

No other alternative medicine available on the market of the home country.
Imported medicine is for personal use, but not for commercial purposes.
The patient has a prescription and a letter from his/her doctor in their home country.
A pharmacy will take responsibility to dispense medicine to the patient.

Additional requirements may apply depending upon the national legislation of the specific country. Some country requires approval from the Health Ministry. The Name Patient Program Process supplies a limited amount of medicine depending upon the set limit on the imported amount of medicine.

Communication for order inquisition and further processing

Patient when contacted with our team for inquiry for order placement, the support team communicates with the patient and discusses the requirement to place the order. Our support team will consult the patient’s physician to ensure the prescribed medicine is the best treatment option for the patient and no alternative treatment is available which is available in the local region. After ensuring the fact, our team starts working on necessary documentation processing and manage every aspect to deliver the drug to the patient. Sourcing to shipping, custom to delivery are the responsibility of our team. We continue to serve the contacted patient until he/she does not receive the order in perfect condition.

We take proactive initiation for patient satisfaction from start to end. We resolve all questions raise by the patients and update information related to shipping and delivery. The goal of launching the Name Patient Program Process is to provide customized service to every patient and their physician to resolve the treatment medication unavailability issues. Our team has pharmacists, lawyers, and physicians to support our client’s hassle-free service.

From supplier to pharmacy

Our team first verify that the receiving prescription order from the contacted patient can be legally deliverable or not. If no legal dispensing issue has found out, then we start processing to place the order to the supplier. For this, we work with the pharmacy and physician to ensure the provided prescription and patient data has authenticity and match with the patient’s condition. Before we place the order to the supplier, our team communicates with the best supplier of the medication in terms of quickest, safest, and economic. Medication transportation requires some special care like breakage control, temperature management during shipping. We have a cold chain transportation service which involves time-sensitivity but often requires for pharmaceutical goods supply. We select the supplier who ensures the appropriate transport method and delivers the medication to the partner pharmacy.

From the pharmacy to the patient

After reaching the medication to our pharmacy, professionals prepare to transport the medication to the local or international shipment. Logistic managers of our team take necessary action to supply the medication depending upon the pre-decided site which can be the patient’s door or a local pharmacy in the patient’s hometown. Our broad network and expertise staffs take every possible way to ensure the expedite, hassle-free, safe, and secure supply of medication to our customers.

However, cooperation requires the patient and the patient’s doctor also to provide all the necessary medical proof and paperwork within timelines to follow the accurate procedure which is varied from country to country. Our support team always available to guide and support our clients in submitting the required documents. The vision of the Name Patient Program Process is to supply the latest and best healthcare without considering the patient location.

Apply Online for Name Patient Program / Supply

Before online application, click on the guideline link of the website to understand the requirements to apply for the importing required medication.

The patient has to fill up each application form for every ordered medicine.
Patient cannot directly request, but the doctor, dentist, pharmacist, or the healthcare institution has the right to request for the unregistered therapeutic product and considered as Requester.
A maximum of two requests is accepted for the same product and for the same application type (means Named-patient or Buffer-stock) in one application.
Each application form must be duly filled and signed by the Requester.
Changes are not allowed after submission of the application form. In case of any error, then requester should withdraw the application and resubmit a new application.
Notify the Name Patient Program in case of any withdrawal and mention the application number.
The consignment approval is valid for six months from the date of approval.

Requirements for Application

A separate application requires for every unregistered medication.
Every section mentioned in the application form must be completed by the applicants who are importing the unregistered medications.
The Requester of the product must have a clinical association, who may be a doctor, pharmacist, dentist, or healthcare institution.
Different Online forms are available for downloading the Signed Request form for Named-Patient Application and the Signed Request Form for Buffer Stock Application. The applicant needs to download and fill up the right form for specific requirements.
Every application form must have a sign of the requester. Along with this, the Requester also needs to provide a signed copy of a declaration to mention that he or she takes complete responsibility for the administration of the unregistered medication on the patient.
The applicant has access to the application form. But the applicant must get the signature from the Requester to fill up the blank of the Signed Request before submitting the online application.
During the first application, outer and inner product labels must be attached, though subsequent applications for the same product not require repeated attachment. However, in case of any change in the product label for the same need to updated during further application of the product. The written language of the product label must be in English along with the following details:
Generic name of the medication
Active ingredient quantity (if any specific)
Declaration if the product contains benzoic acid, sodium benzoate, or tartrazine (if applicable)
Appropriate control number like batch number, serial number, lot number, etc.
Expiry date

Submission of a successful application is notified through an email acknowledgment that will mention the application details and a unique reference number. This will help applicants in corresponding communication with the team.

References:

https://www.hsa.gov.sg/therapeutic-products/register/special-access-routes/import-for-patients
https://form.gov.sg/#!/5dcbaa41f350d8001272640d
https://thesocialmedwork.com/blog/supporting-the-named-patient-how-we-do-it