Friday 14 August 2015

Orphan Drug Act

Rare diseases (RDs) are significant public-health issue and they pose a challenge to the medical community. These rare diseases are called ‘health orphans’, because research and developments have neglected them for years due to many RED challenges. Amendments were made to the existing law in the 1960s, mandating that every drug must be proven to be safe and effective through ‘adequate and well-controlled studies’ before getting market approval. Then raising drug development cost ended in drugs for small disease populations being ‘orphaned’ by many top drug companies.

Congressional Findings for the Orphan Drug Act
(1) There are many diseases and conditions, such as Myoclonus, Huntington's disease, ALS (Lou Gehrig's disease), muscular dystrophy and Tourette syndrome, which affect a few individuals residing in the United States that the diseases and conditions are regarded as rare in the United States
(2) Satisfactory number of drugs for treatment of many of such diseases and conditions has not been developed
(3) Drugs for such diseases and conditions are generally referred to as "orphan drugs"
(4) Because very few individuals are affected by such rare diseases or conditions, a pharmaceutical company which develops an orphan drug may expect the drug to generate moderately small sales when compared with the cost of developing the drug and consequently to incur a financial loss
(5) There is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and it is in the public interest to provide such changes and incentives for the development of orphan drugs.


The Orphan Drug Act began many years ago and now, many believe that this is not the best use of resources. Attend the webinar “Orphan Drugs: The Conundrum” by Marybeth Regan, to learn more about the topic.

Thursday 13 August 2015

State-Wise Rules on Mail Order Pharmacy in the USA

Many pharmacies are developing and expanding compounding practices. Based on the uniqueness of the practice, these pharmacies can increase earnings substantially by developing a mail order component and marketing their practice to patients in other states. This program would serve as a guide to enable these pharmacies to expand into mail order. 
Here are the state-wise rules on Mail Order Pharmacy in the USA.

California and Texas
California and Texas require nonresident pharmacies to register with the regulatory board, but do not require them to submit prescription data. 

Georgia and Pennsylvania
Georgia and Pennsylvania neither require nonresident pharmacies to submit prescription data nor dothey require them to be licensed to do business in the state.

Nebraska and Wisconsin
Nebraska and Wisconsin require nonresident pharmacies to be licensed, permitted and/or registered in their state; however, neither Nebraska nor Wisconsin has regulations in place at this time regarding submission of PMP data.

Massachusetts
Massachusetts requires nonresident pharmacies to submit prescription information to the state PMP by rule.  However, there is no corresponding requirement for a nonresident pharmacy to be licensed, registered or permitted by the regulatory board.  Therefore, the Massachusetts PMP has no authority to require nonresident pharmacies to report prescription data.

Alabama
Alabama law requires every mail-order house (also known as a “nonresident pharmacy”)located outside of Alabamathatdispenses drugs or medicines to anywhere inside the state of Alabama obtain a permit from the State Board of Pharmacy.  Alabama regulation requires that every nonresident pharmacy comply with all statutory and regulatory requirements for controlled substances

New Jersey
All pharmacies permitted by the New Jersey Board of Pharmacy are required to submit information about controlled substance prescriptions to the state PMP.  All nonresident pharmacies that ship, mail, distribute or deliver in any manner into the state of New Jersey are required to be registered with the board.

New Mexico
The New Mexico Board of Pharmacy shall monitor the dispensing of all Schedule II, III, IV and V controlled substances by all pharmacies licensed to dispense such substances to patients in the state of New Mexico.  No nonresident pharmacy shall ship, mail or deliver prescription drugs to a patient in New Mexico unless it is first licensed by the Board. 

Washington
Nonresident pharmacies located outside of Washington that ship, mail, or deliver, in any manner, controlled substances, legend drugs, or devices into Washington must be licensed by the department of health and must submit all transactions involving patients with a Washington zip code to the PMP.


http://bit.ly/PharmaRegulatoryCompliance Attend this webinar to know more on the advantages and pitfalls for pharmacy and pharmacist licensure in other states.