Tag Archives: pharmaceutical cold chain management

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 auris cases

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

vaccine storageSentry’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.

New CDC Study: Influenza Vaccination Reduces Risk of Hospitalization by More Than Half Among Seniors

Influenza season is upon us, so now is an appropriate time to remind ourselves to line up for our flu shots.  Sentry BioPharma Services provides vaccine product management services to a wide group of clients from the US Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.

Recently, the US Center for Disease Control (CDC) published a study on the beneficial effects of influenza vaccines on older populations within the USA.  We have provided an overview of the study below for your review and consideration.Influenza Vaccination Reduces Risk of Hospitalization

August 2, 2016—A new CDC study published today in the journal Clinical Infectious Diseases (CID) provides more evidence on the benefits of flu vaccination among older adults. The study looked at flu-associated hospitalizations among people 50 and older during the 2010-2011 flu season and found that people who had received a flu vaccine reduced their risk of flu-associated hospitalization by half.

People 65 and older are at high risk of serious flu complications and account for the majority of flu hospitalizations and deaths each year. The CID study “Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010-11,” cites data from three recent influenza seasons, during which an estimated 115,000 to 630,000 hospitalizations and 5,000 to 27,000 deaths occurred. It’s estimated that people 65 and older accounted for between 54 percent and 71 percent of hospitalizations and between 71 percent and 85 percent of deaths.

The study, which compared 368 flu-hospitalized patients and compared them against case controls selected from the community, found that vaccinated people 50 years and older were 57 percent less likely to be hospitalized from flu than unvaccinated people. The benefits were similar by age group, including adults 75 years and older. This is a notable finding since flu effectiveness studies that have looked at how well vaccine protects against flu-related doctor’s visits have generally found that effectiveness is declines with age. This study indicates that protection against hospitalization was level among older people.

Annual influenza vaccination has been recommended for adults 65 and older in the U.S. since the 1960s and for adults 50 years and older since 2000. Since 2005, CDC has conducted annual influenza vaccine effectiveness studies to assess how well the vaccine works in preventing medically attended illness. Until recently, there have been few studies that look at how well the vaccine works in preventing more serious outcomes, like hospitalization. The CID study adds to a growing body of evidence that supports the importance of vaccination in order to prevent these more serious outcomes.

Study findings also support current U.S. recommendations for annual influenza vaccination among adults, especially among adults 65 years of age and older who are at high risk of influenza-associated complications. During 2015-2016, an estimated 66% of people 65 and older got a flu vaccine. While this is the highest vaccination rate among the public for any age group, that still leaves nearly one-third of people 65 and older unvaccinated.

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

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.

controlled substance program

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.

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. 

pharmaceutical cold chain distribution

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 IndustryForeign Trade Zone

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 inspection

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 label counterfeit products

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

Guidelines for US Citizens and Residents Living in Areas with Ongoing Zika Virus Transmission

Secure vaccine storage and distribution services protect your inventory throughout the supply chain. Sentry BioPharma Services ensures proper vaccine storage, rotation, accurate tracking and proper distribution of vaccines for routine fulfillment or pandemic response. Standard operating procedures (SOPs) and validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to inadequate storage methods.  Although today there is no vaccine available for Zika, several Sentry biotech clients are working to develop a vaccine for fast track clinical trials.   Sentry is providing the following information from the U.S. Centers For Disease Control and Prevention (CDC) on the Zika virus in order to update our readers concerning the prevention of the spread of this worldwide epidemic.

What is Zika?

Zika is disease caused by a virus that is primarily spread to people through the bite of an infected mosquito. Many people who get infected never have symptoms. In people who get sick, symptoms (fever, rash, joint pain, and red eyes) are usually mild and resolve completely.

Zika can cause serious birth defects in babies born to women who were infected with Zika Zika Virusvirus during pregnancy. Zika has also been linked to Guillain-Barré syndrome (GBS), a rare disorder that can cause muscle weakness and sometimes paralysis. Most people fully recover from GBS, but some have permanent damage and, in some cases, people have died.

Zika can also spread when a man who has Zika has sex with female or male sex partners. A man can pass Zika to his partners even if he does not have symptoms at the time, or if his symptoms have gone away. We do not know how long a man who has had Zika can pass it on to his partners from sex. The mosquitoes that spread Zika usually do not live at elevations above 6,500 feet (2,000 meters). People who live in areas above this elevation are at a very low risk of getting Zika from a mosquito unless they visit or travel through areas of lower elevation. Because there is no vaccine or treatment for Zika, people living in areas with Zika should take steps to prevent infection.

Prevent Mosquito Bites

All residents living in areas where Zika is spreading should take steps to prevent mosquito bites:

  • Cover exposed skin by wearing long-sleeved shirts and long pants.
  • Use insect repellents that are registered with the Environmental Protection Agency (EPA) and contain DEET, picaridin, oil of lemon eucalyptus, para-menthane-diol, or IR3535. Always use as directed.
    • Pregnant and breastfeeding women can use all EPA-registered insect repellents, including DEET, according to the product label.
    • Most repellents, including DEET, can be used on children older than 2 months of age. To apply, adults should spray insect repellent onto hands and then apply to a child’s face.
  • Use permethrin-treated clothing and gear (boots, pants, socks, tents). You can buy pre-treated items or treat them yourself.*
  • Stay and sleep in screened-in or air-conditioned rooms.
  • Sleep under a mosquito bed net if air conditioned or screened rooms are not available or if sleeping outdoors.
  • Mosquito netting can be used to cover babies younger than 2 months old in carriers, strollers, or cribs to protect them from mosquito bites.

*Permethrin should not be used in Puerto Rico.

Pregnant Women and Zika

Zika virus can pass from a pregnant woman to her fetus and can cause a serious birth defect of the brain called microcephaly in babies of women who had Zika virus while pregnant. Babies with microcephaly often have smaller brains that might not have developed properly. Other problems, such as eye defects, hearing loss, and impaired growth, have been detected among fetuses and infants infected with Zika virus before birth.

Pregnant women should not travel to any area with Zika. If you must travel to one of these areas, talk to your doctor or other healthcare provider first and strictly follow steps to prevent mosquito bites and practice safe sex during your trip.

For more information about pregnancy and Zika, visit https://www.cdc.gov/zika/pregnancy/.

Practice Safe Sex

Condoms can reduce the chance of getting Zika from sex. To be effective, condoms must be used correctly from start to finish, every time during vaginal, and oral sex. A man can pass Zika to his partners even if he does not have symptoms at the time, or if his symptoms have gone away. Not having sex can eliminate the risk of getting Zika from sex.

  • Men with pregnant partners should use condoms every time during sex or not have sex during the pregnancy.
  • All pregnant women with male sex partners who live in or have traveled to an area with Zika should use condoms or not have sex during their pregnancy, even if their partners do not have Zika symptoms, or if their symptoms have gone away.
  • All men who live in or have traveled to an area with Zika should consider using condoms to protect their sex partners.

For more information about Zika and sexual transmission, visit https://www.cdc.gov/zika/transmission/sexual-transmission.html.

Zika Testing for Pregnant Women

  • All pregnant women who have visited areas with Zika should receive routine prenatal care, including an ultrasound at 18–20 weeks.
  • Pregnant women who have symptoms of Zika (fever, rash, joint pain, red eyes) and have visited areas with Zika should be tested as soon as symptoms start.
  • Pregnant women who do not have symptoms and have visited an area with Zika can be tested 2–12 weeks after travel.

Pregnant women with possible exposure to Zika virus from sex should be tested if either they or their male partners develop symptoms of Zika.

Discuss Pregnancy Planning with Healthcare Provider

Women and their partners should discuss pregnancy planning with a trusted doctor or healthcare provider. Women who want to get pregnant should talk with their healthcare provider about their goals for having children. They should also talk with their healthcare provider about the potential risk of Zika virus infection during pregnancy as well as their male partner’s potential exposures to Zika virus. As part of counseling with healthcare providers, some women and their partners living in areas with active Zika virus transmission might decide to delay pregnancy.  CDC has guidance to help doctors counsel women who live in an area with Zika who want to get pregnant. The recommended times to wait before trying to get pregnant, based on whether either partner has had symptoms, are described below:

How Long to Wait Before Trying to Have a Baby When Living in an Area with Zika Transmission
Women Men
   Zika symptoms At least 8 weeks after symptoms start At least 6 months after symptoms start
  No Zika symptoms Talk with doctor or healthcare provider Talk with doctor or healthcare provider

Women who do not want to get pregnant should talk with their doctor or healthcare provider about ways to prevent unintended pregnancy, including birth control methods. Women should consider safety, effectiveness, availability, and acceptability when choosing a birth control method.

If You or Your Partner Becomes Pregnant, Talk with Your Doctor

  • You are at risk of getting Zika throughout your pregnancy. For this reason, CDC recommends testing at the first prenatal visit and a second test in the second trimester.
  • If you have symptoms of Zika (fever, rash, joint pain, or red eyes) at any time during your pregnancy, you should be tested for Zika. A healthcare provider may also test for similar diseases, like dengue or chikungunya.
  • CDC has guidance to help doctors decide what tests are needed for pregnant women who may have been exposed to Zika.

For More Information, go to www.cdc.gov and search Zika Virus.

All Countries & Territories with Active Zika Virus Transmission

As of July 26, 2016All Countries & Territories with Active Zika Virus

Americas
  • Anguilla
  • Argentina
  • Aruba
  • Barbados
  • Belize
  • Bolivia
  • Bonaire
  • Brazil
  • Colombia
  • Commonwealth of
    Puerto Rico, US territory
  • Costa Rica
  • Cuba
  • Curacao
  • Dominica
  • Dominican Republic
  • Ecuador
  • El Salvador
  • French Guiana
  • Grenada
  • Guadeloupe
  • Guatemala
  • Guyana
  • Haiti
  • Honduras
  • Jamaica
  • Martinique
  • Mexico
  • Nicaragua
  • Panama
  • Paraguay
  • Peru
  • Saba
  • Saint Barthélemy
  • Saint Lucia
  • Saint Martin
  • Saint Vincent and the Grenadines
  • Sint Eustatius
  • Sint Maarten
  • Suriname
  • Trinidad and Tobago
  • U.S. Virgin Islands
  • Venezuela
Oceania/Pacific Islands
  • American Samoa
  • Fiji
  • Kosrae, Federated States of Micronesia
  • Marshall Islands
  • New Caledonia
  • Papua New Guinea
  • Samoa
  • Tonga
Africa
  • Cape Verde

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.

Content source:

Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Division of Vector-Borne Diseases (DVBD)

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 systemPharmaceutical Supply Chain
  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:CBP’s International Trade Meeting

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.