FDA Finalizes Guidance on Assessing Abuse Potential of Drugs | RAPS

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs 

Posted 18 January 2017 By Zachary Brennan

A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.

More specifically, the US Food and Drug Administration (FDA) says the 37-page guidance offers recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs and whether they produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants.- See more at:

Assessment of Abuse Potential of Drugs: Guidance for Industry

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Sofosbuvir Pricing

Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C

Andrew Hill, 1 Bryony Simmons, 2 Dzintars Gotham, 2 and Joseph Fortunak 3

Author information ► Copyright and License information ►

Abstract
Objectives:
Novel treatments for hepatitis C demonstrate high cure rates, but current high prices can be a barrier to rapid global treatment scale-up. Generic competition can rapidly lower drug prices. Using data on exports of raw materials in 2015, we calculated currently feasible generic prices of sofosbuvir and daclatasvir.

Methods:
Data on per-kilogram prices of sofosbuvir and daclatasvir active pharmaceutical ingredients (API) exported from India were extracted from an online database. To the cost of the amount of API needed for a 12-week treatment course, we added cost estimates for formulation (40%), packaging (US$0.35/month), and a mark-up (50%).

Results:
Between 1 January and 15 October 2015, over 5 tons of sofosbuvir were exported, with prices decreasing by US$702/kg/month, and observed prices of US$2501/kg in early September. Over the same period, 84 kg of daclatasvir were exported, with prices decreasing by US$1664/kg/month to US$1897/kg. Using the price estimation algorithm, we estimated the price of a generic sofosbuvir–daclatasvir combination regimen at US$200 per patient for a 12-week treatment course.

Conclusion:
The costs of generic production of sofosbuvir and daclatasvir are rapidly decreasing. Sofosbuvir–daclatasvir combination treatment could be produced for US$200 per patient per 12-week course.

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Peru: Special Recipes Authorized by DIGEMID

Special Recipes Authorized by DIGEMID

A BOTICAS, PHARMACIES AND PHARMACY SERVICES all the Boticas, Pharmacies and Pharmacy Services Communicates that date, Health Facilities that have AUTHORIZED BY SPECIAL RECIPES DIGEMID (Art 25th º023-2001 DS N-SA) for the Prescription and dispensing of drugs containing the substances included in lists IIA, IIIA, IIIB, and IIIC of Supreme Decree No. 023-201- SA, are as follows:

for details

http://www.digemid.minsa.gob.pe/Main.asp?Seccion=511

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Ministry of Health promotes use of Digital Recipe from May 2017

January 3, 2017. The Digital Recipe System will be available to health professionals from May this year for the issuance and dispatch of digital prescriptions for drugs classified as narcotic and psychotropic (known as "green recipe" and " Blue recipe ").

Ministry of Health promotes use of Digital Recipe from May 2017
It facilitates the issuance of recipes and the dispatch of the same.
Eliminates unnecessary paperwork and the use of paper
Improves control of the issuance and dispatch of addictive drug prescriptions
The digital recipe will be mandatory for the issuance of prescriptions of narcotic and psychotropic drugs

January 3, 2017. The Digital Recipe System will be available to health professionals from May this year for the issuance and dispatch of digital prescriptions for drugs classified as narcotic and psychotropic (known as "green recipe" and " Blue recipe "). This platform will allow the Ministry of Health to improve controls in the prescription and dispatch of these drugs and health professionals, pharmacies and drugstores to automate monitoring and allow the efficient dispatch of prescriptions.


For users, the digital prescription offers a number of advantages: there is no risk of losing the prescription and allows a direct interaction between the patient and the doctor.

The implementation of the Digital Recipe System is regulated by Executive Decree No. 39984-S of November 9, 2016: "Regulation for the Use and Operation of the Automated System of Digital Recipe for Psychotropic and Narcotic Drugs," promulgated by the Ministry of Health.

The decree modifies the way in which psychotropic and narcotic drugs are registered, notified and monitored. This means that from now on you will stop using prescription paper and you will be able to access your medicines just by presenting your identity card to a Health establishment.

The Ministry of Health communicates to health professionals (dentists, pharmacists and doctors), pharmacies, drugstores, laboratories and medical centers that must be prepared for the use of the system. The Ministry of Health in conjunction with Digital Government will be carrying out the following actions:

for more information: 

https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2017/1069-ministerio-de-salud-impulsa-uso-de-la-receta-digital-a-partir-de-mayo-2017

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