Author Archives: Sentry

Sentry representatives attend DCAT week

Sentry BioPharma Services is pleased to announce delegates from Sentry’s Business Development team will be in New York City attending the Drug, Chemical & Associated Technologies Association (DCAT) Week March 19th -22nd. The four-day conference brings together key sourcing, procurement and business development stakeholders within the industry’s top life science organizations.  The Sentry team’s focus will be to connect with current clients and prospective pharmaceutical development and manufacturing companies requiring first-in-class temperature-sensitive product management and global distribution support.

President Tim Mitchell and Business Development Manager Alex Mitchell are looking forward to discussing Sentry’s GMP pharmaceutical storage expertise and expanded service offerings coming throughout 2018 and 2019. They along with representatives from our marketing team will be sharing information regarding Sentry’s services to include:

  • Six validated storage environments
    • +15°C to +30°C
    • +2°C to +8°C
    • -15°C to -25°C
    • -33°C to -43°C
    • -40°C to -60°C
    • -70°C to -90°C
    • Custom Temperature Solutions from 0°C to -90°C
  • Controlled Substance Storage and Security
  • Secondary Labeling and Packaging
  • Foreign Trade Zone Import/Export Support
  • Government, Seasonal/Pandemic, Vaccine and Bio-defense Stockpile and Distribution Support

API Sampling and Dispensing

  • Commercial Fulfillment

Schedule a strategic meeting with the Business Development team to learn how Sentry can optimize GMP solutions for your clinical and commercial project needs.

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.

EU Countries Contend to Be New Host Country of the European Medicines Agency

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 European Medicines Agency, (EMA), oversees medicine regulation within the EU and evaluates applications for medicines to receive marketing authorization across the bloc. It has been based in London since it was founded in 1995.

However, as Brexit is completed the regulatory body will move from its current headquarters in London and as many as 20 EU countries may bid to host the headquarters of the EMA and its staff of almost 1000.

Portugal is the latest to join the competition and other contenders include the Netherlands, Ireland, Sweden, Austria, Denmark and Spain. Potential interest has also been expressed by Belgium, France, Germany, Luxembourg, Finland, Cyprus, Malta, Greece, Portugal, Slovenia, Slovakia, Poland and Hungary. Only the Czech Republic and Estonia have said they would not be vying for the EMA headquarters.

No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision. Rather, representatives of the EU Member States will vote to determine the outcome.

Hosting the headquarters should be financially attractive. In addition to the large permanent staff, regulators from member countries are constantly in attendance at the headquarters for meetings and work. It could also be expected that established international big pharma companies as well as emerging European pharmaceutical businesses might locate offices or headquarters in the EMA host city.

However, a number of potential problems loom as the relocation is considered. Pharmaceutical companies fear there could be drug approval delays when the headquarters makes its move. Reportedly a large number of senior staff have left EMA since the Brexit vote and EMA is also likely to suffer a further loss because of the significant amount of review and approval work done by the UK Medicines & Healthcare Products Regulatory Agency (MHRA). And, the MHRA will face a challenge of how closely to continue to harmonize its regulations with those of the EMA which some UK critics say would allow EMA to continue to dictate the content of the regulations.

As with much of the economic and political adjustments being made during the transition period after Brexit, the one constant at this time seems to be uncertainty.

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.

Sentry Hosts Local Congressman Hollingsworth and BIO Health Care Representatives

JULY 6, 2017 INDIANAPOLIS, IN 

Sentry BioPharma Services recently hosted a round table discussion with Congressman Trey Hollingsworth (IN 9th District) and representatives of BIO and the Indiana Health Industry Forum (IHIF).  BIO organized the event as a part of its “535 Congressional Initiative 2017”.

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.  Sentry is a long standing corporate member of BIO.

IHIF is Indiana’s statewide trade association representing Indiana’s health science business community.  The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry.  IHIF’s mission is to connect key stakeholders to: enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation.

About Sentry:   Sentry BioPharma Services is a biopharmaceutical contract service provider offering an exceptional regulatory history, flawless quality record and superior customer service with a global reach. Sentry’s FDA compliant packaging solutions and supply chain management services to global pharmaceutical, biotechnology and medical device firms ensure product integrity throughout the pharmaceutical supply chain.

Drug development and commercialization require continuous temperature monitoring and control.  Sentry’s validated software, GMP storage and distribution facility, industry expertise and stringent quality standards support this objective throughout manufacturing, labeling, packaging, and temperature-sensitive storage and distribution.

For more information on how Sentry can help with your pharmaceutical supply chain needs contact us via email or by phone at 1-866-757-7400.

Emergency Preparedness and You

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.

Many people are concerned about the possibility of a public health emergency such as a natural disaster, act of terrorism, or disease outbreak. You can take steps now to help you prepare for an emergency and cope if an emergency happens. To help you prepare, we’ve provided step-by-step actions you can take beforehand to protect yourself and your loved ones.

Gather Emergency Supplies

Are you Prepared

If a disaster strikes in your community, you might not have access to food, water, or electricity for several days. You may think that you will have enough time to run to the grocery store, but stores quickly sell out of important supplies following emergency warnings. Unfortunately, about half of adults in the United States do not have the resources and plans in place for a possible emergency. Preparing emergency kits for your family is an important step in keeping them safe and healthy during a disaster.

Pack an emergency supply kit. Here’s what you’ll need:

At Least a 3-day Supply of Food and Water

  • Water – one gallon per person, per day
  • Food – foods that are easy to make and won’t spoil, like canned soup, dry pasta, and powdered milk
  • Manual can opener
  • Basic utensils to prepare and serve meals

Health Supplies

  • 3-day supply of all medicines, at a minimum
  • Medical supplies like syringes, a walking cane, or hearing aids with extra batteries

Personal Care Items

  • Soap
  • Toothbrush and toothpaste
  • Baby wipes
  • Contact lenses or glasses

Safety Supplies

  • First aid kit
  • Emergency blanket
  • Multipurpose tool (that can act as a knife, file, pliers, and screwdriver)
  • Whistle

Electronics:

The National Oceanic and Atmospheric Administration (NOAA) provides weather updates during emergencies. Look for a radio labeled “NOAA Weather Radio.”

  • Flashlight
  • Radio (battery-powered, solar, or hand-crank) for updates on the situation
  • Cell phone with chargers
  • Extra batteries

Documents

Keep copies of your important documents, cash, spare keys, and maps in your emergency supply kit.

  • Copies of important documents such as insurance cards and immunization records
  • Paperwork about any serious or ongoing medical condition
  • Your completed family emergency plan, complete with family and emergency contact information.

You should also keep

  • Extra cash
  • Maps of the area
  • Extra set of car keys and house keys

Taking Care of Others

You may need additional supplies to make sure the whole family is ready

For Children

  • Baby supplies like bottles, formula, baby food, and diapers
  • Games and activities for children

For Pets

Plan ahead so you’re ready to take care of your pet during an emergency.

  • Food and Water:
    • A 3-day supply of food and water for each pet. A cat or a dog will generally need 1 gallon for three days.
    • Bowls or bottles
    • Manual can opener
  • Cleaning Supplies:
    • Depending on the pet, you may need a litter box, paper towels, plastic trash bags, grooming items, and household bleach.
  • Health and Safety:
    • Medicines and medical records stored in a waterproof container
    • First aid kit with a pet first aid book
  • Transport supplies:
    • A sturdy leash, harness, and carrier to transport pets safely. A carrier should be large enough for the animal to stand comfortably, turn around, and lie down. Your pet may have to stay in the carrier for several hours.
  • Comfort Items:
    • Pet toys and the pet’s bed, if you can easily bring it, to reduce stress.
  • Paperwork:
    • Current photos and descriptions of your pets to help others identify them, and to prove that they are your pets, in case you become separated from them.
    • Information on feeding schedules, medical conditions, behavior problems, and the name and telephone number of your veterinarian in case you have to board your pets or place them in foster care.

Keep these tips in mind!

Check and replace your supplies throughout the year.

Personalize

Every family is unique. You may have emergency needs not included in this list. Also, remember to update your kit according to changing needs of your family.

Be sure it’s ready to use

In a disaster situation, you may need to get your emergency supply kit quickly, whether you are sheltering at home or evacuating.

  • Once you have gathered your supplies, pack the items in easy-to-carry containers.
  • Clearly label the containers and store them where you can reach them easily.
  • Remember that certain items, like medications and paper documents, need to be kept in waterproof containers.

Keep it Fresh

Check the expiration dates on food, water, medicine, and batteries at least two times per year. It’s extremely important that all items in your kit are functional at the time of an emergency.

Involve Children

Families can make emergencies less stressful by preparing in advance and working together as a team. Ask your kids to think of items that they would like to include in an emergency supply kit, such as books, games, and pre-packaged foods.

  • Your kids can mark the dates on a calendar for checking emergency supplies. Tell them to remind you when it’s time to check the supplies.
  • Include kids in planning and creating disaster kits for family pets.

Know Your House

Find out where your gas, electric, and water shut-off locations are, and how to turn them off.

Prepare For Everywhere

Emergencies can happen anywhere. Remember to prepare supplies for home, work, and vehicles.

For more information about how Sentry can help optimize your solutions for biopharmaceutical product storage, distribution, packaging, project management and commercial fulfillment, contact Sentry via email or by phone at 1-866-757-7400.

PIC/S Committee Meeting

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 Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee met recently on February 9-10, 2017.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as a non-binding, informal co-operative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. PIC/S presently comprises around 50 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia) including the U.S. FDA, Australia’s Therapeutic Goods Administration (TGA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA), and the EMA is a recognized partner of PIC/S working closely with the group to provide training and develop harmonized guidance documents. A committee of the participating authorities’ representatives (PIC/S Committee) supervises the organization’s activities and all decisions are taken unanimously.

PIC/S intent is to harmonize inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating cooperation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.

At the meeting in February, the PIC/S Committee reviewed a strategic plan (Road Map) for 2017-2019 which includes an objective to and ensure the full implementation of the PIC/S Inspectorates’ Academy (PIA).

The PIA is a PIC/S initiative to set up a web-based educational center under the PIC/S umbrella, which aims at harmonizing and standardizing GMP training at an international level through a certified qualification system. PIA delivers not only general or advanced training but also serves as a platform for discussion and sharing among regulators. It offers a single point of access to all PIC/S training activities and is being implemented in various stages.

The training of GMP inspectors has been at the core of PIC/S activities since its inception, however, PIC/S has also opened some of its training tools to inspectors active in other areas such as Good Distribution (GDP) and Good Clinical Practices (GCP).

In addition to the PIA, PIC/S offers an annual Training Seminar for inspectors, with each Seminar dealing with a specific topic. The Seminars are hosted by a different PIC/S regulatory authority each year and results in the setting up of a Drafting Group, which develops new or amends existing GMP guidance documents.

Other avenues for training and exchange supported by the organization include the PIC/S Joint Visits Programme which teams up inspectors from three different countries to observe GMP inspections in each country, as well as “Expert Circle” groups to enable inspectors to discuss and exchange information on specific technical areas of GMP, develop draft guidance documents, and to provide for training opportunities in their field of expertise. Expert Circles on Human Blood, Tissues, Cells and Advanced Therapy Medicinal Products (ATMPs), Computerised Systems, Active Pharmaceutical Ingredients (APls), Good Distribution Practices (GDP) and Quality Risk Management (QRM) are currently active and meet regularly.

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 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.

DEA Warns Public of Extortion Scam by DEA Special Agent Impersonators

Sentry BioPharma Services is helping the Drug Enforcement Administration to warn the public about criminals posing as DEA Special Agents or other law enforcement personnel as part of an international extortion scheme.

The criminals call the victims (who in most cases previously purchased drugs over the internet or by telephone) and identify themselves as DEA agents or law enforcement officials from other agencies. The impersonators inform their victims that purchasing drugs over the internet or by telephone is illegal, and that enforcement action will be taken against them unless they pay a fine. In most cases, the impersonators instruct their victims to pay the “fine” via wire transfer to a designated location, usually overseas. If victims refuse to send money, the impersonators often threaten to arrest them or search their property. Some victims who purchased their drugs using a credit card also reported fraudulent use of their credit cards.

Impersonating a federal agent is a violation of federal law. The public should be aware that no DEA agent will ever contact members of the public by telephone to demand money or any other form of payment.

The DEA reminds the public to use caution when purchasing controlled substance pharmaceuticals by telephone or through the Internet. It is illegal to purchase controlled substance pharmaceuticals online or by telephone unless very stringent requirements are met. And, all pharmacies that dispense controlled substance pharmaceuticals by means of the internet must be registered with DEA. By ordering any pharmaceutical medications online or by telephone from unknown entities, members of the public risk receiving unsafe, counterfeit, and/or ineffective drugs from criminals who operate outside the law. In addition, personal and financial information could be compromised.

Anyone receiving a telephone call from a person purporting to be a DEA special agent or other law enforcement official seeking money should refuse the demand and report the threat using the online form below. Please include all fields, including, most importantly, a call back number so that a DEA investigator can contact you for additional information. Online reporting will greatly assist DEA in investigating and stopping this criminal activity.

Suspicious activity  may also be reported on-line by visiting the DEA’s website:

https://www.deadiversion.usdoj.gov/pubs/pressreleases/extortion_scam.htm

Sentry urges the public to use the link above to learn more about what basic pieces of information will help the DEA investigate extortion scams.

For more information about how Sentry can meet safety and regulatory demands for packaging, storage, global drug distribution and disposal of controlled substances, contact Sentry via email or by phone at 1-866-757-7400.

CDC’s 2016 National Influenza Vaccination Week (NIVW)

The Centers for Disease Control and Prevention’s (CDC’s) National Influenza Vaccination Week (NIVW) is scheduled for December 4-10, 2016.  The CDC established National Influenza Vaccination Week (NIVW) in 2005 to raise public awareness about the importance of flu vaccination.  The 2016 national awareness week focuses on highlighting the importance of influenza vaccination and continuing flu vaccination through the holiday season and beyond.  To learn more about what is new for the 2016-2017 flu season, view the CDC’s Factsheet by clicking HERE.

It's National Influenza Vaccination Week (NIVW)! Did you know that flu season can begin as early as October, it usually peaks between December and February, and it can last as late as May? As long as flu virsues are spreading, it's not too late to get a flu vaccine to protect yourself and your loved ones through fall, winter and into spring. #GetAFluVax

NIVW Timing

Flu vaccination coverage estimates from past years have shown that influenza vaccination activity drops quickly after the end of November.

CDC and its partners choose to December for NIVW to remind people that even though the holiday season has arrived, it is not too late to get your flu vaccine.  As long as flu viruses are spreading and causing illness, vaccination can provide protection against the influenza virus and should continue.

Even if you haven’t yet received a vaccine and have already gotten sick with one flu virus, you can still benefit from vaccination since the flu vaccine protects against three or four different flu viruses (depending on which flu vaccine you get).

Flu Vaccination for People at High Risk

Another goal of NIVW is to communicate the importance of flu vaccination for people who are at high risk for developing flu-related complications.  People at high risk of serious flu complications include young children, pregnant women, people with certain chronic health conditions like asthma, diabetes, heart disease or lung disease, and people aged 65 years and older.  For people at high risk, getting the flu can mean developing serious flu-related complications, like pneumonia, or a worsening of existing health conditions, which can lead to hospitalization or death.

For more information about how Sentry’s 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.

To contact CDC by phone call (800) 232-4636 (800-CDC-INFO) or visit the website at

www.cdc.gov/flu/nivw .

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.

kys

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.

kypd

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