PHARMA NEWS Daily Coverage Report

Aug, 25 2016Note: *- FOR GLOBAL COVERAGE

Date August 24, 2016, 08:00 Hrs

Publication Specialty pharmacytimes

Headline Debate Continues Around Biosimilar Naming Conventions *

Link http://www.specialtypharmacytimes.com/news/debate-continues-around-biosimilar-naming-conventions

Key Topic pharmacovigilance

Major disagreements persist regarding naming conventions for biosimilars, which has hindered their entrance to the US market.

Recently published in the Journal of Managed Care & Specialty Pharmacy (JMCP), researchers reviewed the advantages and disadvantages of various naming approaches for biologics and biosimilars in the United States. The researchers surveyed members of the Academy of Managed Care Pharmacy (AMCP) and the Hematology Oncology Pharmacists Association regarding preferences for biosimilars.

The findings revealed a preference for a distinct name for biosimilars, more specifically respondents preferred the use of a nonproprietary name with a designated suffix. However, of the respondents who preferred a nonproprietary name plus a suffix, 83.4% preferred a suffix tied to the manufacturer, compared with 16.6% who preferred a suffix devoid of meaning.

Additionally, the survey results showed that pharmacists reported more confidence in substituting interchangeable biosimilars when it shares a nonproprietary name, and that the confidence in substitution decreased when a unique name, such as a nonproprietary name plus a suffix, is used instead.

In the current review, researchers noted that the first approved biosimilar in the United States filgrastim-sndz (Zarxio) had a common United States Adopted Name (USAN) and a suffix (sndz) that reflected the manufacturer (Sandoz). But the second FDA approved biosimilar, infliximab-dyyb (Inflectra), manufactured by Celltrion, was named using a common USAN with an apparently random suffix devoid of meaning.

It was not until August 2015 that the FDA released its draft guidance for the naming of biological products. The draft called for all biologics to be named with a core name – which the FDA intends to be the USAN, if available– plus a designated hyphenated suffix unique and devoid of meaning or reference to the manufacturer, according to the study. This is an approach similar to World Health Organization (WHO) recommendations.

The rationale for the FDA naming convention draft guidance, which is consistent with the views expressed by pharmacists whose priority is the protection of patient safety and public health, is that there is a need for a method that distinguishes between biological products that are not interchangeable for pharmacovigilance purposes, the researchers wrote. In order to adopt the FDA draft guidance’s naming convention, it would require already approved reference biological products to be renamed by adding a suffix. - See more at: http://www.specialtypharmacytimes.com/news/debate-continues-around-biosimilar-naming-conventions#sthash.uDyelwIH.dpuf

Date August 24, 2016, 08:00 Hrs

Publication outsourcing

Headline New PH I-IV data Management System to provide access to clinical trial data in Real Times *

Link http://www.outsourcing-pharma.com/Clinical-Development/Data-management-system-accesses-clinical-trial-data-in-real-time

Key Topic

Date August 24, 2016

Publication Gponline

Headline Drug shortages are 'harming' patients, say GPs *

Link http://www.gponline.com/drug-shortages-harming-patients-say-gps/article/1406728

Key Topic Adverse Drug Reactions

In the GPonline survey of 441 GPs, 82% said drug shortages had forced them to prescribe a second-choice drug in the past 12 months. Just 12% said they had not, while 6% indicated they did not know.

One in five (18%) of the GPs who had prescribed a second-choice drug said that patients had gone on to experience negative effects as a result, including harm or slower recovery.

Another 43% said they were not aware of any adverse effects, and 39% said they did not know.

Many GP respondents expressed their frustration at the situation, which several reported had happened on a number of occasions.

One said a patient had suffered because the medicine they needed was not manufactured for a time. Another said that, while no patients had experienced major effects, ‘some have complained of increased side effects’.

One GP said the problems were causing patients ‘inconvenience rather than harm’, while another warned that some patients were being delayed treatment.Drug shortages

Dr Andrew Green, chairman of the GPC clinical and prescribing subcommittee said: ‘The issue of secure drug supply is an on-going problem that no one has been able to adequately address.

‘Sometimes problems can be very localised, so you can have difficulties in one part of the country and not in others. That makes informing GPs really quite a difficult task to do.

‘That’s an absolutely key issue. The first thing a GP knows about a drug shortage is when a patient returns disgruntled from the community pharmacy saying that the

chemist can't get hold of a particular medicine. And even when that happens, you can't be sure if it’s a problem that’s widespread or limited instead to that particular pharmacy chain.

‘I think that GPs would welcome some sort of central system of alerting, but it doesn’t help patients who are on a regular medication. Obviously, if there's a sudden shortage of one particular cream, then for acute medications you can change it if you know about it. But if someone is on a repeat medication, the inconvenience to the GP and the patient really is quite large.

‘There's no doubt patients find changes in medication inconvenient, and whenever you change a patient from a medication on which they are settled there's always a chance of introducing new adverse drug reactions.’

Date August 24, 2016

Publication Wgnsradio

Headline Controlled Substance Monitoring Database Making a Difference in Tennessee *

Link http://wgnsradio.com/controlled-substance-monitoring-database-making-a-difference-in-tennessee--cms-34576

Key Topic Adverse Drug Reactions

It happens thousands of times every day in Tennessee. Healthcare providers securely access critical information to know if a person may be at risk for an overdose, an adverse drug interaction or treatment for a substance use disorder. The information they're reviewing is within Tennessee's Controlled Substance Monitoring Database, an online resource that is literally changing lives across the state.

In 2012, with the support of Tennessee's healthcare community, the Tennessee General Assembly passed the Prescription Safety Act of 2012. Its provisions included an effective database of information about prescriptions written for powerful drugs and convenient online access to empower clinicians in their prescribing decisions. The act was proposed by Governor Bill Haslam's public safety sub-cabinet and went fully live in April of 2013. After three years, the act was to sunset if it had not demonstrated success.

"It has proved to be remarkably helpful in our state's efforts to address our opioid challenges that the nation has now clearly recognized as a national epidemic, resulting in the Act being re-authorized and strengthened in 2016," said Tennessee Department of Health Commissioner John Dreyzehner, MD, MPH. "Timely, accurate information about our patients is a critical tool for clinicians, and in surveys of healthcare providers about how it is used, we know it has helped provide better and safer care."

Among the significant benefits recorded during the last three years of CSMD usage in Tennessee are:

One third of the state's clinicians report they are now more likely to refer a patient for substance abuse treatment after checking the CSMD.

The number of "doctor shoppers" - those who go to multiple healthcare providers seeking a prescription for certain narcotics - has decreased more than 50 percent.

The average amount of opioid pain relievers prescribed to those receiving them has decreased by 28 percent.

In the last three years, there has been a reduction of more than two billion morphine milligram equivalents prescribed across the state - and every county in the state has recorded a decrease from the 2013 prescribed amounts.

"The CSMD is a great tool to help clinicians and patients make the best decisions when considering treatment options," said TDH Chief Medical Officer David Reagan, MD, PhD. "After reviewing a patient's history and knowing what has been previously prescribed, a clinician may recognize a need to consider other treatment options. For many patients, simply prescribing more opioid pain medicine will do more harm than good, and other approaches need to be considered, such as using several types of therapy, including physical therapy, lifestyle adjustments, behavioral therapy, and non-opioid medicines. Sometimes it is best to refer the patient to a pain medicine specialist for further evaluation. The CSMD helps the patient and the prescriber to make good decisions about the wisdom of using powerful but risky opioid pain medications."

"The CSMD has certainly made a positive difference in how healthcare providers now work with patients requesting pain relief," said Tennessee Department of Mental Health and Substance Abuse Services Commissioner E. Doug Varney. "It's helping more people live healthier lives, free from the unintended dependence on opioid pain medicines. We encourage all Tennesseans to have conversations with their healthcare providers about alternatives to opioids."

The Tennessee Department of Mental Health and Substance Abuse Services funds a toll-free information and referral line for those seeking assistance with addictions. Administered by the Tennessee Association of Alcohol, Drug and other Addiction Services, the Tennessee REDLINE -- 1-800-889-9789- provides guidance and encouragement to people in all counties of the state.

Date 25 Aug 2016

Publication Pharmabiz

Headline DCGI initiates slew of measures to streamline conducting clinical trials

Link http://pharmabiz.com/NewsDetails.aspx?aid=97076&sid=1

Key Topic Clinical Trials

The Drugs Controller General of India (DCGI) Dr GN Singh has initiated a slew of measures to streamline for conducting clinical trials in the country by creating strong regulatory platform for ensuring safety, rights and well beings of the trial subjects.

The DCGI decided to consolidate functions in such a way that India may become a favourable destination for doing clinical trials and create conducive environment. That may enable the sector to enter swiftly into drug discovery and address issues of emerging diseases and assist the patients to get safe and high quality medicines at affordable prices.

In this regard, the DCGI already removed the restrictions on the number of clinical trials an investigator can undertake at a time. At present, no investigator should conduct more than three trials at any given period of time. Removing the restriction, the DCGI empowered the Ethics Committee to take a final call on the number of clinical trials an investigator can do at any given time after examining the risk and complexity involved in the trials.

Close on the heels of this decision, the DCGI removed another bottleneck by allowing clinical trials in less than 50-bedded hospitals. Currently, no clinical trials can be conducted at site having less than 50-bedded hospitals. After doing away with this provision, the DCGI decided that the Ethics Committee will examine and decide whether the clinical trial site is suitable for trial or not, irrespective of number of bed. However, the DCGI suggested that the site should have emergency rescue and care arrangements along with all other necessary facilities required for that particular clinical trial.

In yet another measure, the DCGI also removed the bottleneck of requirement of no objection certificate (NOC) from DCGI for addition of new clinical trial site or investigator in clinical trials. Instead, the DCGI decided that the respective Ethics Committees after due deliberations can approve proposals for addition of sites and investigators and no NOC from DCGI, in the normal course, should be necessary. However, the applicant

would inform DCGI about any such addition or deletion and thereafter, if no objection is received from DCGI, it would be deemed to have concurrence of CDSCO.

The DCGI measures to streamline the conductance of clinical trials do not end there. As regards requirement of approval of Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs like insulin, monoclonal antibody, etc, it was decided that the applicant may submit parallel application to RCGM and DCGI seeking approval to conduct clinical trial. However, the DCGI shall complete the scrutiny of application and permission only after RCGM clearance was received.

Date 25 Aug 2016

Publication The Hindu

Headline ‘Dengue dangerous for heart patients’

Link http://www.thehindu.com/news/national/other-states/dengue-dangerous-for-heart-patients/article9028163.ece

Key Topic Clinical Research

Dengue can be deadly for those who have heart disease, says a research study conducted by Upendra Kaul, dean and executive director, Clinical Research and Academics, Fortis Healthcare Limited.

The research states that if someone has dengue fever coupled with chest discomfort, shortness of breath, unnecessary fatigue, the doctor must get ECG or ECHO done to rule out the possibility of heart involvement.

Reports shows ECG and ECHO changes in patients admitted with dengue fever, but with no prior heart ailments.

“We found that those having heart problems were affected by dengue at large and hence creating a double challenge for us to treat them. Simultaneously, those who had dengue, their ECG & ECHO were showing some temporary malfunction of the heart. However, these were corrected with supportive treatment. But it is very important not to overlook any symptoms in both cases.”