Tag Archives: GMP storage

EMA Announces Brexit Business Continuity Plan

In a press release issued on August 1, 2017, The European Medicines Agency (EMA) announced that it “has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation”. It was indicated the plan is intended to “preserve Agency’s ability to protect public and animal health”.

The plan outlines 3 categories of EMA activities and prioritizes them “according to their impact on public health and the Agency’s ability to function”.

Category 1, the highest priority activities, includes those related to the assessment and safety monitoring of medicines such as actions taken to protect patient safety and inspections across the EU, or activities vital to maintaining the infrastructure and functionality of the EU regulatory system for medicines such as security of critical IT applications. EMA stated, “It is absolutely crucial to uphold these activities as any disruption would almost immediately have a detrimental effect on the health and well being of citizens in Europe and would also jeopardize production and distribution of medicines in the EU”.

Category 2 activities include the proactive publication of clinical data, various initiatives aimed at promoting availability of medicines, and projects such as EMA’s contribution to the fight against antimicrobial resistance or the Agency’s interactions with Health Technology Assessment (HTA) bodies. EMA indicated, “These activities will be maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines”.

However, in order to reallocate personnel for preparations for the UK’s withdrawal from the EU and EMA’s relocation, EMA has already begun to suspend activities in what it terms category 3 including:

  • the development of the European Medicines Web Portal, a new publicly-available online information intended to be a single-source for information on all medicines marketed in the EU; 
  • EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorization requests for human and veterinary medicines in a secure and efficient way; 
  • the development of a transparency roadmap for EMA that lays out future transparency measures of the Agency; and 
  • participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.”

EMA said it was also reducing the number of audits, some corporate governance and support activities, EMA meetings and workshops, and participation of EMA staff in external meetings or conferences.

EMA said it will consider “how long these activities can be put on hold before they start to seriously undermine the quality of the Agency’s work and its planning, and the expectations of stakeholders”. However, the press release concludes rather ominously stating, “Further iterations of the business continuity plan will also take into account various scenarios for staff losses and how these may affect the delivery of category 1 and 2 activities. Unexpected higher, faster or more permanent loss of staff as a consequence of the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.”

Source: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/07/news_detail_002789.jsp&mid=WC0b01ac058004d5c1

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

map

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

CDC Report: First cases of Candida auris reported in U.S.

On Friday, November 4, 2016 the U.S. Centers for Disease Control and Prevention (CDC) announced the first cases of Candida auris were reported in the United States (U.S.).candida_strain

A strain of Candida auris cultured in a petri dish at CDC.
Photo Credit: Shawn Lockhart, CDC

Thirteen cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally, have been identified in the United States, according to the CDC. Seven of the cases occurred between May 2013 and August 2016 and are described today in CDC’s Morbidity and Mortality Weekly Report (MMWR). The other six cases were identified after the period covered by the report and are still under investigation.

The following map displays where Candida auris cases have been identified in the United States as of November 4, 2016.

candida

Source of map: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

The report is the first to describe U.S. cases of C. auris infection. C. auris is often resistant to antifungal drugs and tends to occur in hospitalized patients. In June 2016, CDC issued a clinical alert describing the global emergence of C. auris and requesting that laboratories report C. auris cases and send patient samples to state and local health departments and CDC. Since then, CDC has been investigating reports of C. auris with several state and local health departments. The agency expects to continue to investigate possible cases as awareness of the emerging infection increases.

“We need to act now to better understand, contain and stop the spread of this drug-resistant fungus,” said CDC Director Tom Frieden, M.D., M.P.H. “This is an emerging threat, and we need to protect vulnerable patients and others.”

Among the seven cases detailed in the report, patients with C. auris were reported in four states: New York, Illinois, Maryland and New Jersey. All of the patients had serious underlying medical conditions and had been hospitalized an average of 18 days when C. auris was identified. Four of the patients died; it is unclear whether the deaths were associated with C. auris infection or underlying health conditions.

In two instances, two patients had been treated in the same hospital or long-term-care facility and had nearly identical fungal strains. These findings suggest that C. auris could be spread in healthcare settings.

Six of the seven cases were identified through retrospective review of hospital and reference laboratory records. Identifying C. auris requires specialized laboratory methods because it can easily be misidentified as another type of Candida infection, in which case patients may not receive appropriate treatment. Most of the patient samples in the current report were initially misidentified as another species of Candida.

Most of the C. auris strains from U.S. patients (71 percent) showed some drug resistance, making treatment more difficult. Samples of C. auris strains from other countries have been found to be resistant to all three major classes of antifungal medications. However, none of the U.S. strains in this report were resistant to all three antifungal drug classes. Based on laboratory testing, the U.S. strains were found to be related to strains from South Asia and South America. However, none of the patients travelled to or had any direct links to those regions. Most patients likely acquired the infections locally.

“It appears that C. auris arrived in the United States only in the past few years,” said Tom Chiller, M.D., M.P.H., chief of CDC’s Mycotic Diseases Branch. “We’re working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people.”

CDC recommends that healthcare professionals implement strict Standard and Contact Precautions to control the spread of C. auris. Facilities should conduct thorough daily and after-discharge cleaning of rooms of C. auris patients with an EPA-registered disinfectant active against fungi. Any cases of C. auris should be reported to CDC and state and local health departments. CDC can assist in identifying this particular type of Candida if needed.

In 2013, CDC issued a report describing antibiotic resistance threats in the United States that needed prompt action, including Candida infections. CDC’s Antibiotic Resistance Laboratory Network is providing additional lab support in four regional laboratories to test fungal susceptibility of Candida species and identify emerging resistance. CDC is also expanding tracking of this fungus through the Emerging Infections Program. Information gathered through these networks plays a key role in tracking resistance and informing policies and interventions.

The challenge of emerging antibiotic resistant threats like C. auris highlights the need for urgent, coordinated federal, state, local, and international public health response and the importance of CDC’s AR Solutions Initiative. The timely investments in the AR Solutions Initiative empower CDC to rapidly detect, investigate, and respond to emerging threats, like C. auris; prevent resistant infections from occurring and spreading across healthcare settings and the community; and innovate, supporting development of new diagnostics and drugs to test, treat, prevent infections, and save lives.

For more information about how Sentry can implement a custom solution to meet your unique pharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

For more information: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

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

 

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.

September is Charcot-Marie-Tooth (CMT) Awareness Month, Spread the Word!

CMT affects 1 in every 2,500 people worldwide, (a total of 2.8 million). That’s 1 too many.

What if each of those 2.8 million people ALL told five people about CMT?  Fourteen million new people would learn about CMT!  This is why the Charcot-Marie-Tooth Association (CMTA) declared September as CMT Awareness Month six years ago!

What is CMT? 

Charcot-Marie-Tooth Disease, or CMT, is a group of inherited disorders that affect the peripheral nerves, which are the nerves outside the brain and spinal cord. There are 90 kinds of CMT. Each kind is caused by a different kind of mutation, and more causes are being discovered every year.

CMT is just one kind of neuropathy (also called peripheral neuropathy), meaning simply that the peripheral nerves are damaged. There are many other causes of neuropathy, including the most common cause—diabetes.

CMT affects about 2.8 million people worldwide, of all races and ethnic groups.

Where Did the Name CMT Come From?

Charcot-Marie-Tooth is named after the three physicians who were the first to describe it in 1886: Jean-Martin Charcot, Pierre Marie and Howard Henry Tooth.

Charcot        Marie        Tooth

Inherited Disorders

CMT is inherited. It is not contagious, nor is it caused by anything in the environment. The most common forms of CMT are passed down from one generation to the next, meaning that it is dominantly inherited.

Some forms of CMT are recessively inherited—a person may be affected even though his or her parents do not have CMT. In this case, each of the parents harbors a mutation in one of their two copies of a CMT gene. If a child inherits one mutated CMT gene from each of their parents (the chance of this happening is one out of four), the child will develop CMT.

Sometimes the mutation that causes CMT happens spontaneously during the process that produces the eggs or sperm. In these rare cases, a child will have CMT even though neither parent has CMT. If a child has such a spontaneous mutation, he/she may pass that mutation down to his/her offspring.

Symptoms

Some types of CMT cause damage to the covering (myelin sheaths) that surrounds nerve fibers. Other kinds of CMT directly damage the nerves fibers themselves. In both cases, the damaged nerve fibers result in neuropathy. The nerves in the legs and arms, which are the longest, are affected first. Nerve fibers that create movement (called motor fibers) and nerve fibers that transmit sensations (called sensory fibers) are both affected. CMT causes weakness and numbness, usually starting in the feet.

In the most common kinds of CMT, symptoms usually begin before the age of 20 years. They may include:

  • Foot deformity (very high arched feet)
  • Foot drop (inability to hold foot horizontal)
  • “Slapping” gait (feet slap on the floor when walking because of foot drop)
  • Loss of muscle in the lower legs, leading to skinny calves
  • Numbness in the feet
  • Difficulty with balance
  • Later, similar symptoms also may appear in the arms and hands
  • CMT almost never affects brain function

foot

The foot of a person with CMT. The lack of muscle, a high arch, and claw toes are signs of this genetic disease. 

Diagnosis

A diagnosis of CMT is established through a thorough neurological evaluation by an expert in neuropathy, including a complete family history, physical exam, and nerve conduction tests, and appropriate genetic testing.

A physical exam may show:

  • Difficulty lifting up the foot while walking
  • Difficulty with dorsiflexion of the toes and ankles (upward movement, away from the ground) and other foot movements
  • Reduced or absent deep tendon reflexes (like the knee-jerk reflex)
  • Loss of muscle control and atrophy (shrinking of the muscles) in the feet and lower legs (and later the hands)

Genetic testing can provide the exact cause for most people who have CMT.

Prognosis (Expectations)

CMT usually gets worse, slowly, with age; rapid progression is rare, and should motivate a prompt re-evaluation. The problems with weakness, numbness, difficulty with balance, and orthopedic problems can progress to the point of causing disability. Pain can be an issue, either as a direct result of the neuropathy (neuropathic pain) or as consequence of orthopedic problems. Other potential complications include the following:

  • Progressive inability to walk from weakness, balance problems, and/or orthopedic problems
  • Progressive inability to use hands effectively
  • Injury to areas of the body that have decreased sensation

Treatments

There are no known treatments that will stop or slow down the progression of CMT, but the CMTA is funding research to find these treatments.

Physical therapy, occupational therapy, and physical activity may help maintain muscle strength and improve independent functioning.

Orthopedic equipment (such as braces, inserts, AFOs or orthopedic shoes) may make it easier to walk.

Orthopedic surgery on the feet can often maintain or even restore function to enable walking.

Clinical Trials

Although there is no cure for CMT, there are many clinical trials both completed and ongoing currently.  As many as 199 according to the website clinicaltrials.gov.

Participating in a clinical trial is an invaluable way to get involved in helping the research community cure CMT and related inherited neuropathies (INs). There are various types of clinical trials. Clinical trials are sometimes referred to as clinical studies or clinical research involving human volunteers that have been Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved, the regulatory agencies for the U.S. and Europe. These agencies require that a potential therapy be extensively tested in large groups of human volunteers before it can receive approval for commercialization.

Clinical trials are a vital part of the scientific research process and essential for developing therapies to prevent, treat, reverse and cure CMT. 

Strict adherence to clinical trial material management protocols, in combination with proven GMP storage, clinical trial labeling, secondary packaging and global drug distribution allows Sentry to provide clinical trial outsourcing clients with a variety of flexible services.

For more information about how Sentry BioPharma Services can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

For more information please visit the following websites:

http://www.cmtausa.org/

https://clinicaltrials.gov/

Sentry Opens New Qualified Shipping Lane to Puerto Rico

Sentry BioPharma Services announced the successful opening of a qualified shipping lane for pharmaceutical drug product between its facility in Indianapolis, Indiana and San Juan, Puerto Rico.

On August 17th, 2016 a dry ice shipment of drug product was delivered to San Juan, PR, 00926 via FedEx International Priority Service.  The -80º Celsius product arrived next day in San Juan within the qualified temperature range.

Background.  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. 

Ship-To 08-17-16

Custom Pharmaceutical Product Management, Distribution and Patient Support

Sentry provides scalable clinical trial and commercial pharmaceutical drug distribution globally. As with all programs, Sentry maintains regulatory compliance and transparency in fulfilling orders placed by clinics, hospitals, pharmaceutical distributors and other licensed recipients.

Clinical and Commercial Drug Distribution Support

  • 24/7 order receipt
  • Client ERP integration possible
  • Destructions program
  • Returns program
  • Single point of contact
  • Transparent business support

Sentry, as a cold chain logistics partner can provide immediate access to its state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It offers: 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.

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

FDA Releases Flu Vaccine Lots for the 2016-2017 Season

Cumulative 2016/2017 Season Lot Release Status (Updated 8/3/2016)

Flu vaccine lots that have been released by the U.S. Food & Drug Administration (FDA) and are available for national distribution by the vaccine manufacturers.

Manufacturer Total Number of Lots Released by FDA
Afluria – Seqirus Pty. Ltd. 19
Fluad – Seqirus, Inc. 0
Fluarix Quadrivalent – GlaxoSmithKline Biologicals 23
Flublok – Protein Sciences Corporation 0
Flucelvax Quadrivalent – Seqirus, Inc. 0
FluLaval Quadrivalent – ID Biomedical Corporation of Quebec 3
FluMist Quadrivalent – MedImmune, LLC 3
Fluvirin – Seqirus Vaccines Limited 9
Fluzone High Dose – Sanofi Pasteur, Inc. 2
Fluzone Quadrivalent – Sanofi Pasteur, Inc. 14

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver vials_v1Spring, Maryland, on March 4, 2016, to select the influenza viruses for the composition of the influenza vaccine for the 2016-2017 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2015-2016 vaccines, and the availability of candidate strains and reagents.

The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2016-2017 influenza season contain the following:

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

The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:

  • a B/Phuket/3073/2013-like virus (B/Yamagata lineage)

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 global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For information on seasonal flu vaccine distribution schedules, please contact the manufacturers listed in the table above directly.