Tag Archives: GMP warehousing

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The focus of our post this week is Parkinson’s Disease and treatment.  Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

FDA’s Know Your Source: Protecting Patients from Unsafe Drugs

Beware of Rogue Wholesale Drug Distributors

Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day.

While the U.S. health care supply chain is one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.

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Reduce the Chance of a Potentially Unsafe Drug Reaching Your Patients

In order to protect your patients from unsafe or ineffective drugs, the FDA urges health care professionals to verify that their supplier is licensed by the state. Drugs from rogue wholesale drug distributors may harm your patients and expose them to unknown risks or side effects.  The FDA advises health care providers to know the source for prescription drugs.

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Verify that Your Wholesale Drug Distributor is Licensed in Your State

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http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

For more information about Sentry’s pharmaceutical licensing, registration and international compliance program, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

2016-2017 Flu Season; Answers to Common FAQs

Sentry BioPharma Services provides vaccine product management services to a wide group of clients from U.S. Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.  This is Sentry’s second article concerning influenza this season with an emphasis on preventing the flu within the general population of the United States.  Sentry acknowledges the Centers for Disease Control and Prevention (CDC) and its continued efforts in disseminating important information to benefit the health and well-being of all Americans.

New Flu Information for 2016-2017

fluvaccineGetting an annual flu vaccine is the first and best way to protect yourself and your family from
the flu. Flu vaccination can reduce flu illnesses, doctors’ visits, and missed work and school due to flu, as well as prevent flu-related hospitalizations. The more people who get vaccinated, the more people will be protected from flu, including older people, very young children, pregnant women and people with certain health conditions who are more vulnerable to serious flu complications. This page summarizes information for the 2016-2017 flu season.

 

What’s new this flu season?

A few things are new this season:

  • Only injectable flu shots are recommended for use this season.
  • Flu vaccines have been updated to better match circulating viruses.
  • There will be some new vaccines on the market this season.
  • The recommendations for vaccination of people with egg allergies have changed.

What flu vaccines are recommended this season?

This season, only injectable flu vaccines (flu shots) should be used. Some flu shots protect against three flu viruses and some protect against four flu viruses.

Options this season include:

  • Standard dose flu shots. Most are given into the muscle (usually with a needle, but one can be given to some people with a jet injector). One is given into the skin.
  • A high-dose shot for older people.
  • A shot made with adjuvant for older people.
  • A shot made with virus grown in cell culture.
  • A shot made using a vaccine production technology (recombinant vaccine) that does not require the use of flu virus.

Live attenuated influenza vaccine (LAIV) – or the nasal spray vaccine – is not recommended for use during the 2016-2017 season because of concerns about its effectiveness.

Table 1 below illustrates all the influenza vaccines that are FDA-approved for use in the United States during the 2016-2017 season.  Also, Table 2 identifies Contraindications and precautions to the use of influenza vaccines — United States, for the 2016–17 influenza season:

 

TABLE 1. Influenza vaccines — United States, 2016–17 influenza season

 

Trade name Manufacturer Presentation Age indication Mercury (from thimerosal)
µg/0.5 mL
Latex Route
Inactivated influenza vaccine, quadrivalent (IIV4), standard dose
Fluarix Quadrivalent GlaxoSmithKline 0.5 mL single-dose prefilled syringe ≥3 yrs NR No IM§
Flulaval Quadrivalent ID Biomedical Corp. of Quebec (distributed by GlaxoSmithKline) 0.5 mL single-dose prefilled syringe ≥3 yrs NR No IM
5.0 mL multi-dose vial ≥3 yrs <25 No IM
Fluzone Quadrivalent Sanofi Pasteur 0.25 mL single-dose prefilled syringe 6–35 mos NR No IM
0.5 mL single-dose prefilled syringe ≥36 mos NR No IM
0.5 mL single-dose vial ≥36 mos NR No IM
5.0 mL multidose vial ≥6 mos 25 No IM
Fluzone Intradermal
Quadrivalent
Sanofi Pasteur 0.1 mL single-dose prefilled microinjection system 18 through 64 yrs NR No ID**
Inactivated influenza vaccine, quadrivalent, cell culture-based (ccIIV4), standard dose
Flucelvax Quadrivalent Seqirus 0.5 mL single-dose prefilled syringe ≥4 yrs NR No IM
Inactivated Influenza Vaccine, trivalent (IIV3), standard dose
Afluria Seqirus 0.5 mL single-dose prefilled syringe ≥9 yrs†† NR No IM
5.0 mL multi-dose vial ≥9 yrs††
(needle and syringe)
18 through 64 years
(jet injector)
24.5 No IM
Fluvirin Seqirus 0.5 mL single-dose prefilled syringe ≥4 yrs ≤1 Yes§§ IM
5.0 mL multi-dose vial ≥4 yrs 25 No IM
Adjuvanted Inactivated Influenza Vaccine, trivalent (aIIV3), standard dose
Fluad Seqirus 0.5 mL single-dose prefilled syringe ≥65 yrs NR Yes§§ IM
Inactivated Influenza Vaccine, trivalent (IIV3), High Dose¶¶
Fluzone High-Dose Sanofi Pasteur 0.5 mL single-dose prefilled syringe ≥65 yrs NR No IM
Recombinant Influenza Vaccine, trivalent (RIV3)***
FluBlok Protein Sciences 0.5 mL single-dose vial ≥18 yrs NR No IM
Live Attenuated Influenza Vaccine, quadrivalent (LAIV4)†††
FluMist Quadrivalent MedImmune 0.2 mL single-dose prefilled
intranasal sprayer
2 through 49 yrs NR No NAS

Abbreviations: ACIP = Advisory Committee on Immunization Practices; ID = intradermal; IM = intramuscular; NAS = intranasal; NR = not relevant (does not contain thimerosal).
*Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm . Availability of specific products and presentations might change and differ from what is described in this table.
Standard dose intramuscular IIVs contain 15 µg of each vaccine HA antigen (45 µg total for trivalents and 60 µg total for quadrivalents) per 0.5mL dose.
§For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration may be found in the ACIP General Recommendations on Immunization, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm.
Quadrivalent inactivated influenza vaccine, intradermal: a 0.1-mL dose contains 9 µg of each vaccine HA antigen (36μg total).
**The preferred injection site is over the deltoid muscle. Fluzone Intradermal Quadrivalent is administered using the delivery system included with the vaccine.
††Age indication per package insert is ≥5 years; however, ACIP recommends that Afluria not be used in children aged 6 months through 8 years because of increased risk for febrile reactions noted in this age group with Seqirus’ 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5 through 8 years who has a medical condition that increases the child’s risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of influenza vaccination with Afluria before administering this vaccine. Afluria may be used in persons aged ≥9 years. Afluria is licensed for administration by jet injector for persons aged 18 through 64 years only.
§§Syringe tip cap might contain natural rubber latex.
¶¶High-dose IIV3 contains 60 μg of each vaccine antigen (180 μg total) per 0.5mL dose.
***RIV3 contains 45 μg of each vaccine HA antigen (135 μg total) per 0.5mL dose.
†††ACIP recommends that Flumist (LAIV4) not be used during the 2016–17 season.

TABLE 2. Contraindications and precautions to the use of influenza vaccines — United States, 2016–17 influenza season*

Vaccine Contraindications Precautions
IIV History of severe allergic reaction to any component of the vaccine or after previous dose of any influenza vaccine Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
RIV History of severe allergic reaction to any component of the vaccine Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
LAIV For the 2016–17 season, ACIP recommends that LAIV not be used. Content below is provided for information.
History of severe allergic reaction to any component of the vaccine† or after a previous dose of any influenza vaccine
Concomitant aspirin or salicylate-containing therapy in children and adolescents
Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a health care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months
Children and adults who have immunosuppression (including immunosuppression caused by medications or by HIV)
Close contacts and caregivers of severely immunosuppressed persons who require a protected environment
Pregnancy
Receipt of influenza antiviral medication within the previous 48 hours
Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
Asthma in persons aged ≥5 years
Other underlying medical conditions that might predispose to complications after wild-type influenza infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)

Abbreviations: ACIP = Advisory Committee on Immunization Practices; IIV = Inactivated Influenza Vaccine; LAIV = Live-Attenuated Influenza Vaccine; RIV = Recombinant Influenza Vaccine.
* Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, and precautions. Package inserts for US-licensed vaccines are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm .
History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of IIV and LAIV. However, ACIP recommends that any licensed, recommended, and appropriate IIV or RIV may be administered to persons with egg allergy of any severity (see Influenza Vaccination of Persons with a History of Egg Allergy).

What viruses do 2016-2017 flu vaccines protect against?

There are many flu viruses and they are constantly changing. The composition of U.S. flu vaccines is reviewed annually and updated to match circulating flu viruses. Flu vaccines protect against the three or four viruses that research suggests will be most common. For 2016-2017, three-component vaccines are recommended to contain:

  • A/California/7/2009 (H1N1) pdm09-like virus,
  • A/Hong Kong/4801/2014 (H3N2)-like virus and a
  • B/Brisbane/60/2008-like virus (B/Victoria lineage).

Four component vaccines are recommended to include the same three viruses above, plus an additional B virus called B/Phuket/3073/2013-like virus (B/Yamagata lineage).

When and how often should I get vaccinated?

Everyone 6 months and older should get a flu vaccine every year by the end of October, if possible. However, getting vaccinated later is OK. Vaccination should continue throughout the flu season, even in January or later. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime, may need two doses of flu vaccine. A health care provider can advise on how many doses a child should get.

Can I get a flu vaccine if I am allergic to eggs?

The recommendations for people with egg allergies have been updated for this season.

  • People who have experienced only hives after exposure to egg can get any licensed flu vaccine that is otherwise appropriate for their age and health.
  • People who have symptoms other than hives after exposure to eggs, such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who have needed epinephrine or another emergency medical intervention, also can get any licensed flu vaccine that is otherwise appropriate for their age and health, but the vaccine should be given in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions. (Settings include hospitals, clinics, health departments, and physician offices). People with egg allergies no longer have to wait 30 minutes after receiving their vaccine.

Flu Activity

What sort of flu season is expected this year?

It’s not possible to predict what this flu season will be like. While flu spreads every year, the timing, severity, and length of the season varies from one year to another.

Will new flu viruses circulate this season?

Flu viruses are constantly changing so it’s not unusual for new flu viruses to appear each year. For more information about how flu viruses change, visit How the Flu Virus Can Change.

Will the United States have a flu epidemic?

The United States experiences epidemics of seasonal flu each year. This time of year is called “flu season.” In the United States, flu viruses are most common during the fall and winter months. Influenza activity often begins to increase in October and November. Most of the time flu activity peaks between December and March and can last as late as May. CDC monitors certain key flu indicators (for example, outpatient visits of influenza-like illness (ILI), the results of laboratory testing and flu hospitalization and deaths). When these indicators rise and remain elevated for a number of consecutive weeks, flu season is said to have begun. Usually ILI increases first, followed by an increase in flu-associated hospitalizations, which is then followed by increases in flu-associated deaths.

For the most current influenza surveillance information, please see FluView at Weekly U.S. Influenza Surveillance Report.

When will flu activity begin and when will it peak?

The timing of flu is very unpredictable and can vary in different parts of the country and from season to season. Seasonal flu viruses can be detected year-round, however, seasonal flu activity can begin as early as October and continue to occur as late as May. Flu activity most commonly peaks in the United States between December and March.

How many people die from flu each year?

CDC does not count how many people die from flu each year. Unlike flu deaths in children, flu deaths in adults are not nationally reportable. However, CDC uses mortality data collected by the National Center for Health Statistics to monitor relative levels of flu-associated deaths. This system tracks the proportion of death certificates processed that list pneumonia or influenza as the underlying or contributing cause of death of the total deaths reported. This system provides an overall indication of whether flu-associated deaths are elevated, but does not provide an exact number of how many people died from flu. For more information, see Overview of Influenza Surveillance in the United States, “Mortality Surveillance.”

CDC also uses modeling studies to estimate numbers of flu-related deaths, but these studies apply only to past seasons and are not done each year. For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States.

Why is it difficult to know how many people die from flu?

There are several factors that make it difficult to determine accurate numbers of deaths caused by flu regardless of reporting. Some of the challenges in counting influenza-associated deaths include the following: the sheer volume of deaths to be counted; the lack of testing (not everyone that dies with an influenza-like illness is tested for influenza); and the different coding of deaths (influenza-associated deaths are often a result of complications secondary to underlying medical problems, and this may be difficult to sort out). For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu.

Protective Actions

What should I do to protect myself from flu this season?

CDC recommends a yearly flu vaccine for everyone 6 months of age and older as the first and most important step in protecting against this serious disease.

In addition to getting a seasonal flu vaccine, you can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others. In addition, there are prescription medications called antiviral drugs that can be used to treat influenza illness. Visit What you Should Know About Flu Antiviral Drugs for more information.

What should I do to protect my loved ones from flu this season?

Encourage your loved ones to get vaccinated. Vaccination is especially important for people at high risk for developing flu-related complications, and their close contacts. Also, if you have a loved one who is at high risk of flu complications and they develop flu symptoms, encourage them to get a medical evaluation for possible treatment with influenza antiviral drugs. CDC recommends that people who are at high risk for serious flu complications who get flu symptoms during flu season be treated with influenza antiviral drugs as quickly as possible. People who are not at high risk for serious flu complications may also be treated with influenza antiviral drugs, especially if treatment can begin within 48 hours.

Some children 6 months through 8 years of age will require two doses of flu vaccine for adequate protection from flu. Children in this age group who are getting vaccinated for the first time will need two doses of flu vaccine, spaced at least 28 days apart. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime also may need two doses. Your child’s doctor or other health care professional can tell you if your child needs two doses. Visit Children, the Flu, and the Flu Vaccine for more information.

Children younger than 6 months are at higher risk of serious flu complications, but are too young to get a flu vaccine. Because of this, safeguarding them from flu is especially important. If you live with or care for an infant younger than 6 months of age, you should get a flu vaccine to help protect them from flu. See Advice for Caregivers of Young Children for more information. Also, studies have shown that getting the flu vaccine during pregnancy can protect the baby after birth for several months.

In addition to getting vaccinated, you and your loved ones can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others.

Vaccine and Vaccination

How much flu vaccine will be available this season?

Flu vaccine is produced by private manufacturers, so supply depends on manufacturers. For the 2016-2017 season, manufacturers projected they would provide between 157 million and 168 million doses of injectable vaccine for the U.S. market. (Projections may change as the season progresses.)

Will live attenuated intranasal influenza vaccine (LAIV) be available this season even though it is not recommended for use?

FluMist Quadrivalent is still an FDA-licensed product. As such, there may be some supply of FluMist Quadrivalent on the U.S. market during the 2016-2017 season. It is important for clinicians and the public to be aware that because of concerns about this vaccine’s effectiveness, CDC recommends that this vaccine not be used during the 2016-2017 influenza season.

Where can I find information about vaccine supply?

Information about flu vaccine supply is available at Seasonal Influenza Vaccine & Total Doses Distributed.

When will flu vaccine become available?

Flu vaccine is produced by private manufacturers, so the timing of vaccine availability depends on when production is completed. As of late September, more than 90 million doses of 2016-2017 flu vaccine had already been distributed in the United States. Vaccine supply updates are available at the link above.

When should I get vaccinated?

Getting vaccinated before flu activity begins helps protect you once the flu season starts in your community. It takes about two weeks after vaccination for the body’s immune response to fully respond and for you to be protected so make plans to get vaccinated. CDC recommends that people get a flu vaccine by the end of October, if possible. However, getting vaccinated later can still be beneficial. CDC recommends ongoing flu vaccination as long as influenza viruses are circulating, even into January or later. Children aged 6 months through 8 years who need two doses of vaccine should get the first dose as soon as possible to allow time to get the second dose before the start of flu season. The two doses should be given at least 28 days apart.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chaincontact Sentry via email or by phone at 1-866-757-7400.

For additional information please visit:

http://www.cdc.gov/flu/

http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

 

Bring Your Brave: Breast Cancer Awareness Month Begins Today!

braveDid you know that one in eight women in the U.S. will be diagnosed with breast cancer in her lifetime?  At that current rate, that means 13 million breast cancer deaths around the world will occur in the next 25 years.

The most significant risk factors for breast cancer are gender (being female) and age (growing older).  Other factors can be changed by making choices. By choosing the healthiest lifestyle options possible, you can empower yourself and make sure your breast cancer risk is as low as possible.

Reduce Risk Factors:

  • Do not smoke
  • Drink alcohol in moderation
  • Exercise at least three hours per week or about 30 minutes a day
  • Eat a nutritious, low-fat diet (30 grams or less) with plenty of fruits and green and orange vegetables

The National Breast Cancer Foundation launches the annual campaign by raising awareness during the month of October.  The endeavor begins today, October 1, 2016 and lasts through the end of the month.  Getting a high-quality screening mammogram and having a clinical breast exam on a regular basis are the most effective ways to detect breast cancer early.

Early Detection Strategies:

  1. Recognize signs & symptoms
  2. Perform a monthly breast self-exam (BSE)
  3. Have an annual clinical breast exam
  4. Screen for abnormalities with a mammogram

The American College of Radiology (ACR) has established a uniform way for radiologists to describe mammogram findings. The system, called BI-RADS, includes seven standardized categories, or levels. Each BI-RADS category has a follow-up plan associated with it to help radiologists and other physicians appropriately manage a patient’s care.

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Some state and local health programs and employers provide mammograms free or at low cost. For example, the Centers for Disease Control and Prevention (CDC) coordinates the National Breast and Cervical Cancer Early Detection Program. This program provides screening services, including clinical breast exams and mammograms, to low-income, uninsured women throughout the United States and in several U.S. territories. Contact information for local programs is available on the CDC website or by calling 1–800–CDC–INFO (1–800–232–4636).

Information about free or low-cost mammography screening programs is also available from the National Cancer Institute’s (NCI’s) Cancer Information Service at 1–800–4–CANCER (1–800–422–6237) and from local hospitals, health departments, women’s centers, or other community groups.

For more information:

Sentry’s Controlled Substance Program Strengthens the Reliable and Secure Pharmaceutical Drug Supply Chain

Regulatory oversight shapes every dimension of controlled substances: licensing, registration, storage, security, use, inventory and controlled drug disposal. Finding a Drug Enforcement Administration (DEA) licensed partner to store, distribute and manage returns and destruction of Schedule III-V controlled substances while maintaining regulatory and quality standards required for a secure pharmaceutical supply chain can be a challenge. Sentry BioPharma Services provides seamless product management required to safeguard controlled substances which are brought into Sentry’s custody and care.

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Features & Benefits of Sentry’s Controlled Substance Program

DEA Regulation Secure Storage – Inspected and approved by the Drug Enforcement Administration  in 2014, Sentry’s state-of-the-art controlled substance capacity provides secure and reliable storage to support your pharmaceutical supply chain needs.

Controlled Substance Importation/Exportation – Sentry’s controlled substance importation and controlled substance exportation capabilities provide pharmaceutical organizations unique flexibility in the drug supply chain. This coupled with Sentry’s high quality standards affords pharmaceutical companies a competitive advantage throughout the drug development process.

Redundant Systems and Extensive Security Measures Product safety, identity, strength, purity and quality (SISPQ) remain intact.  Sentry features which support this agenda include:

  • Auxiliary power feeds and back-up systems
  • Continuous (24/7) security monitoring
  • Foreign Trade Zone (FTZ) status which allows controlled substances to be internationally shipped directly to Sentry where DEA, Customs & Border Patrol (CBP) and FDA clearances can be obtained within the security provided by Sentry’s GMP facility
  • Physical plant security
  • Redundant HVAC systems
  • Secure data and document programs

Pharmaceutical Labeling and Packaging – Sentry’s light pharmaceutical manufacturing capabilities help streamline clinical trial distribution and commercial drug distribution with one stop shop GMP labeling and GMP secondary packaging.

Drug Product Return and Drug Disposal Services – Sentry completes the controlled substance supply chain with a full-service approach to product guardianship.  Our drug product return and drug destruction program ensures project integrity, reliable inventory tracking and public safety from development to launch.

For more information about how Sentry can provide controlled substance supply chain solutions for your project, contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org

Operation Silver Snake Sets CBP Field Operations Seizure Record in San Juan, Puerto Rico

Last month, the U.S. Customs and Border Protection (CBP) San Juan Field Operations announced that approximately 268 seizures were made of counterfeit products, valued at $2.4 million, which were illegally imported into Puerto Rico via international mail.  This is a record number of counterfeits seized by CBP in Puerto Rico during a single week.

A wide range of counterfeited products was seized during the week-long enforcement effort, called Operation Silver Snake, to include: consumer products, apparel, footwear, textiles, pharmaceuticals, and more.

CBP Operation SS (1)

International Mail packages are inspected by CBP to verify compliance with US laws

This is the second iteration of a week-long operation carried out in San Juan this year by the Mobile Intellectual Property Enforcement Team (MIPET), with the support of CBP’s Centers of Excellence and Expertise (CEEs), IPR-National Targeting & Analysis Group (NTAG), Homeland Security Investigations (HSI), and United States Postal Inspection Service (USPIS).

“Our dedicated CBP officers, Import Specialist, International Trade Specialists and Seized Property Specialists were key ingredients to this successful enforcement effort to protect the U.S. economy and consumers from counterfeit products,” said Edward Ryan, Assistant Director of Trade for Puerto Rico and the US Virgin Islands. “We are looking forward to conducting follow-up operations with our partners to further protect legitimate businesses and consumers from intellectual property thieves, said Ryan.

Various international mail packages inspected by CBP officers at the San Juan International Mail Branch revealed products that infringed intellectual property rights.  The products were shipped from vendors in China.

CBP protects businesses and consumers every day through an aggressive intellectual property rights (IPR) enforcement program.  CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR goods.

CBP Operation SS (2)

CBP Officers label counterfeit products seized during the operation.

To effectively enforce intellectual property rights, CBP relies heavily on the cooperation of the owners of these rights. If your intellectual property is registered with the Patent and Trademark Office, the Copyright Office or the subject of a United States International Trade Commission exclusion order, you will want to inform CBP.

Information about counterfeit merchandise being illegally imported into the United States can be submitted to the CBP using an on-line tool called E-Allegation.  The e-Allegation provides a means for the public to anonymously report to CBP any suspected violations of trade laws or regulations related to the importation of goods into the U.S.

For more information about how Sentry’s import/export team can add value to your international supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Source: https://www.cbp.gov/newsroom/local-media-release/2016-07-20-000000/cbp-stops-millions-unsafe-counterfeits

Sentry Strengthens the Pharmaceutical Supply Chain

Biological drugs are generally more delicate and sensitive to temperature than their
pharmaceutical counterparts, thus introducing risks into the global biopharma supply chain.
Longer transit times, extreme climate change between origination and destination, and shipping delays all increase the risk profile during transport.  Product compromise due to temperature fluctuation can cause millions of dollars in revenue loss and delay delivery of drugs and therapeutics to patients.  Sentry Biopharma Services strengthens the pharmaceutical supply chain by helping clients manage these risks.

MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT

15 years ago cold chain management was still a buzz phrase that only a few companies could actually deliver.  However, the unique transportation challenges of biopharma products have driven the need to control temperature variability throughout the drug supply chain which has transformed pharmaceutical cold chain management into a burgeoning industry.  Specialized providers like Sentry BioPharma Services now offer dedicated services designed to preserve the integrity of biological products throughout all phases of the pharmaceutical supply chain. Large and small biotech organizations increasingly turn to these specialized providers in a shift from the traditional in-house pharmaceutical logistics model to an outsourced one.

SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER

Although outsourcing to a pharmaceutical supply chain provider can provide many benefits, not every potential partner has the capability to provide services on a global scale. A qualified cold chain logistics expert must be experienced and compliant in all facets of biopharma cold chain management.  This includes domestic and international shipping, drug product handling and tracking, GMP storage and international drug distribution. The provider must have the experience, systems and processes in place to handle the diverse and changing needs of the global biopharmaceutical industry. Criteria that biopharma manufacturers should consider when evaluating potential partners include:

  1. A robust quality systemglobe
  2. Specialized GMP storage facilities and equipment
  3. A reputation for technological innovation
  4. Compliance with global pharmaceutical cold chain regulations
  5. An efficient and reliable biopharma and logistics network
  6. Anti-counterfeiting capabilities
  7. Impeccable customer service record

PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES

As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market.  Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.

In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.

REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE

A GMP-compliant third-party logistic (3PL) partner must be committed to excellence in quality control and customer service.  As an extension of the drug or vaccine manufacturer’s business, the pharmaceutical 3PL provider must operate as a vested stakeholder to protect product integrity as well as the manufacturer’s business viability and reputation in the marketplace. Measures of excellence in the pharmaceutical cold chain include:

  • A corporate culture of accountability and commitment to the mission
  • Knowledge of best practices for GMP storage, global drug distribution and vaccine management
  • Independent quality assurance personnel, processes and evaluations
  • Careful biological product handling and temperature-sensitive product shipping
  • A uniformed process for continuously improving quality, operations and customer service
  • A singular focus that allows the contract service provider to be an expert

SPECIALIZED GMP STORAGE FACILITIES

At various points in the pharmaceutical supply chain, active pharmaceutical ingredients (APIs), excipients, components, intermediates and finished pharmaceutical products may need to be stored for varying lengths of time, from a few days to a several months.  Short-term or long-term GMP storage facilities might be needed to temporarily house: inventory overflow from a primary GMP warehouse; primary or secondary packaging components that are awaiting assembly; finished drug products that are awaiting international drug distribution; and/or inbound pharmaceutical product shipments that are clearing U.S. Customs. While several pharmaceutical small molecule formulations remain stable at ambient temperature conditions, many biologic products must be maintained within tighter temperature tolerances in refrigerated (+2°C to +8°C), frozen (-10°C to -20°C) and ultra-low storage (-70 to -90°C). Traditional pharmaceutical supply chain facilities are not always designed to accommodate these conditions.

In these situations, a cold chain logistics partner can provide immediate access to a state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It must offer: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.

For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Attends CBP’s International Trade Meeting for Q2-2016

Several members of Sentry BioPharma Services’ compliance team voluntarily attended the Q2-2016 international trade meeting hosted by the U.S. Customs and Border Protection (CBP) on Wednesday, June 8, 2016 at the Indianapolis International Airport (IND).   James Moore presently serves as Port Director for Indianapolis, Indiana and opened the meeting by welcoming guests and reviewing the agenda.

The three main topics were discussed during the event:international

H.R. Bill 644 was passed by the 114th Congress on February 24, 2016.  Section 101 of the bill states, “This bill directs the U.S. Customs and Border Protection (CBP) to ensure that CBP partnership programs, such as the Customs-Trade Partnership Against Terrorism, provide trade benefits to importers, exporters, and certain other private sector entities that meet program requirements.”

Port Director Moore reinforced the CBP’s position by saying, the CBP port in Indianapolis, Indianapolis will make every effort to protect your brand and run as smoothly as possible.

Director Moore commented, “The U.S. Customs and Border Protection (CBP) enforces Intellectual Property Rights (IPR), most visibly by seizing products that infringe IPR such as trade­marks, copyrights, and patents. The theft of intel­lectual property and trade in fake goods threaten America’s economic vitality and national security, and the American people’s health and safety. Trade in these illicit goods funds criminal activities and orga­nized crime.

To protect both private industry and consumers, CBP has made IPR enforcement a priority trade issue. CBP has developed a multi-layered, strategic approach to IPR enforcement. In addition to seizing goods at U.S. borders, the strategy includes expanding the border through post-import audits of companies that have been caught bringing fake goods into the United States, collaboration with our trading part­ners, and partnering with industry and other federal agencies to enhance these efforts. CBP also issues civil fines and, where appropriate, refers cases to other law enforcement agencies for criminal investigation.

CBP uses technology to increase interdiction of fake goods, facilitate partnerships with industry, and enhance enforcement efforts through the sharing of information and intelligence. CBP is refining its risk modeling technology to more accurately identify sus­pected shipments of counterfeit and pirated goods for inspection.

Rights holders can use our web-based tool, e-Recordation, to record their trademarks and copyrights with CBP. Recordation makes information on protected rights available to CBP offices through­out the United States.

Our online trade violation reporting system, e-Allegations, makes it easier for the private sector to notify CBP of possible IPR violations and other trade violations.

In IPR audits, an innovative enforcement practice, CBP audits the business records of companies at high risk for importing counterfeits, issues penalties for infringing goods uncovered in the audits, and works with companies to improve their internal controls.

CBP is a partner at the interagency National Intellectual Property Rights Coordination Center (IPR Center). The IPR Center is designed to leverage the resources and authorities of partner agencies for criminal enforcement of IPR.”

Learn more about Customs and Border Protection and the Indianapolis port at https://www.cbp.gov/contact/ports/indianapolis.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.