Tag Archives: drugs

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

Beware of Rogue Wholesale Drug Distributors

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

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

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Reduce the Chance of a Potentially Unsafe Drug Reaching Your Patients

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

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Verify that Your Wholesale Drug Distributor is Licensed in Your State

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https://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: https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

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.

Sentry Raises Public Awareness for DEA’s National Prescription Drug Take-Back Day Initiative

As part of the U.S. Drug Enforcement Administration’s (DEA’s) National Prescription Drug Take-Back Day Initiative (NTBI), people will be able to dispose of expired, unwanted or unused prescription drugs on Saturday, October 22, 2016 from 10:00 a.m. to 2:00 p.m. at numerous collection sites around the U.S.

The DEA collected a record amount of meds during the 11th annual National Prescription Drug Take-Back Day on April 30, 2016.  According to the DEA’s May 6, 2016 press release, the DEA and over 4,200 of its state, local, and tribal law enforcement partners collected 893,498 pounds of unwanted medicines—about 447 tons—at almost 5,400 sites spread through all 50 states, beating its previous high of 390 tons in the spring of 2014 by 57 tons, or more than 114,000 pounds.

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The top five states with the largest collections, in order, were:

  1. Texas (almost 40 tons)
  2. California (32 tons)
  3. Wisconsin (31 tons)
  4. Illinois (24 tons)
  5. Massachusetts (24 tons)

“I am very proud of our state officials and residents,” said Ms. Jennifer Marcum, Sentry BioPharma Services’ chief executive officer.  Ms. Marcum continued, “Indiana’s authorities collected 29,125 pounds (14.6 tons).  That’s an enormous amount of unwanted prescription drugs and controlled substances to be safely removed from the pharmaceutical supply chain.  The statistics best illustrate how much the people of Indiana care about this important matter; no question about it.”

Marcum continued, “During the event, people can anonymously bring unwanted prescription pharmaceuticals and over-the-counter (OTC) medications to a participating drop-off site for proper drug disposal by law enforcement authorities with no questions asked.  The service is free and an ideal way to preserve the environment from pharmaceutical contamination.  This is a terrific opportunity to safely dispose of accumulated prescription drugs and medications that may have expired or are simply unwanted.”

The FDA’s Ilisa Bernstein, Pharm.D., J.D., offers a few more helpful tips when discarding drugs:

  1. Scratch out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.
  2. Do not give your medicine to friends. Doctors prescribe medicines based on your specific symptoms and medical history. Something that works for you could harm another person.
  3. When in doubt about proper drug disposal, ask your pharmacist.

For more information about the DEA’s National Prescription Drug Take-Back Day Initiative, general public inquiries can be made by calling the DEA toll free at: 1-800-882-9539.

If you would like to learn more about Sentry’s pharmaceutical drug destruction services, please 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.

The CDC & Sentry Gear Up for the 2016 Flu Season

Even though nearly half of the United States (U.S.) population gets a flu vaccine annually, the impact of influenza remains high. According to the Centers for Disease Control & Prevention (CDC), the flu costs the U.S. more than $87 billion annually and is responsible for the loss of close to 17 million workdays each flu season. Tens of thousands of people are hospitalized and thousands die from flu-related illnesses each year in the U.S.

Sentry BioPharma Services gears up for the 2016 flu season by promoting three strategies to combat illness:

  1. Get the 2016 flu vaccine.
  2. Exercise good health habits.
  3. See your doctor for an antiviral medication to treat the flu if you get sick.

August 29, 2013, Atlanta, GA - Chris Summerrow (left), Director of Business and Continuity Management, UPS, speaks with Dr. Ali Khan, Director, Office of Public Health Preparedness and Response, in the Emergency Operations Center at the CDC.

Flu Vaccine Facts

The seasonal flu vaccine protects against the influenza viruses that research indicates will be most common during the upcoming season. Trivalent vaccines are made to protect against three flu viruses; an influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. Quadrivalent vaccines protect against four viruses; the same viruses as the trivalent vaccine as well as an additional B virus.

Flu vaccines CANNOT cause the flu. Flu vaccines are made with either killed or weakened viruses.

Flu vaccines are safe. Serious problems from the flu vaccine are very rare. The most common side effect that a person is likely to experience is either soreness at the injection site, or runny nose in the case of nasal spray. These side effects are generally mild and usually go away after a day or two. Visit Influenza Vaccine Safety for more information.

Can the flu be treated?

Yes. There are prescription medications called “antiviral drugs” that can be used to treat influenza illness.

What are antiviral drugs?

Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against the flu in your body. Antiviral drugs are not sold over-the-counter. You can only get them if you have a prescription from your doctor or health care provider. Antiviral drugs are different from antibiotics, which fight against bacterial infections.

What should I do if I think I have the flu?

If you get the flu, antiviral drugs are a treatment option. Check with your doctor promptly if you have a high risk condition and you get flu symptoms. Flu symptoms can include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Your doctor may prescribe antiviral drugs to treat your flu illness.

Should I still get a flu vaccine?

Yes. Antiviral drugs are a second line of defense to treat the flu if you get sick. A flu vaccine is still the first and best way to prevent influenza.

What are the benefits of antiviral drugs?

When used for treatment, antiviral drugs can lessen symptoms and shorten the time you are sick by 1 or 2 days. They also can prevent serious flu complications, like pneumonia. For people with a high risk medical condition, treatment with an antiviral drug can mean the difference between having milder illness instead of very serious illness that could result in a hospital stay.

What are the possible side effects of antiviral drugs?

Some side effects have been associated with the use of flu antiviral drugs, including nausea, vomiting, dizziness, runny or stuffy nose, cough, diarrhea, headache and some behavioral side effects. These are uncommon. Your doctor can give you more information about these drugs or you can check the CDC or the Food and Drug Administration (FDA) websites.

When should antiviral drugs be taken for treatment?

Studies show that flu antiviral drugs work best for treatment when they are started within 2 days of getting sick. However, starting them later can still be helpful, especially if the sick person has a high risk health condition or is very sick from the flu. Follow instructions for taking these drugs.

What antiviral drugs are recommended this flu season?

There are three FDA-approved influenza antiviral drugs recommended by CDC this season to treat influenza. The brand names for these are Tamiflu® (generic name oseltamivir), Relenza® (generic name zanamivir), and Rapivab® (generic name peramivir). Tamiflu® is available as a pill or liquid and Relenza® is a powder that is inhaled. (Relenza® is not for people with breathing problems like asthma or COPD, for example.) Rapivab® is administered intravenously by a health care provider.

How long should antiviral drugs be taken?

To treat the flu, Tamiflu® and Relenza® are usually prescribed for 5 days, although people hospitalized with the flu may need the medicine for longer than 5 days. Rapivab® is administered intravenously for 15 to 30 minutes.

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.

Sentry BioPharma Services Offers Clinical Trial Support for Muscular Dystrophy

Sentry BioPharma Services serves pharmaceutical and biotechnology firms developing drugs for multiphase clinical trials for various indications.  One such indication is muscular dystrophy (MD).   According to the Muscular Dystrophy Association’s (MDA’s) website, “Muscular dystrophy, amyotrophic lateral sclerosis (ALS) and related muscle-debilitating diseases take away a person’s physical strength, independence and life.”

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Source: https://www.cdc.gov/ncbddd/musculardystrophy/freematerials.html

The National Institute of Neurological Disorders and Stroke (NINDS) indicates there is no specific prescription drug, biological product or vaccine to prevent, stop or reverse any form of MD. Treatment may include physical therapy, respiratory therapy, speech therapy, orthopedic appliances used for support, and corrective orthopedic surgery. Drug therapy includes corticosteroids to slow muscle degeneration, anticonvulsants to control seizures and some muscle activity, immunosuppressants to delay some damage to dying muscle cells, and antibiotics to fight respiratory infections.  Some individuals may benefit from occupational therapy and assistive technology.   Some patients may need assisted ventilation to treat respiratory muscle weakness and a pacemaker for cardiac abnormalities.

Some of the life-threatening diseases are as follows:

According to ClinicalTrial.gov, an on-line service provided to the public by the U.S. National Institutes of Health (NIH), there are approximately 125 open clinical studies in process currently.

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.

Sentry Strengthens the Pharmaceutical Supply Chain

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

MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT

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

SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER

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

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

PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES

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

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

REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE

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

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

SPECIALIZED GMP STORAGE FACILITIES

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

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

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

Sentry Goes Purple in June for Alzheimer’s & Brain Awareness Month

Sentry is going purple! On Friday, June 24, 2016 Sentry BioPharma Services invites employees to wear the color purple in recognition of Alzheimer’s and brain awareness month.

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Alzheimer’s disease is the sixth leading cause of death in the United States; it kills more citizens annually than prostate and breast cancer combined. Worst of all, there presently is no cure for Alzheimer’s disease. Researchers possess great hope that there will be treatments that can stop or slow Alzheimer’s in the near future.

The National Institute on Aging (NIA), one of the 27 Institutes and Centers of the National Institutes of Health (NIH), leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. NIA is the primary Federal agency supporting and conducting Alzheimer’s disease research. For more information about Alzheimer’s disease, please watch the video below.

Several medications are approved by the U.S. Food and Drug Administration to treat symptoms of Alzheimer’s. Donepezil (Aricept®), rivastigmine (Exelon®), and galantamine (Razadyne®) are used to treat mild to moderate Alzheimer’s (donepezil can be used for severe Alzheimer’s as well). Memantine (Namenda®), is used to treat moderate to severe Alzheimer’s.

These drugs work by regulating neurotransmitters, the brain chemicals that transmit messages between neurons. They may help maintain thinking, memory, and communication skills and help with certain behavioral problems. However, these drugs don’t change the underlying disease process. They are effective for some but not all people and may help only for a limited amount of time.

For more information about how Sentry can implement a custom solution to meet your unique GMP storage and pharmaceutical cold 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.

DEA’s 2016 Controlled Substance Distributor Conference

Sentry BioPharma Services attended the Controlled Substance Distributor Conference, hosted by the Drug Enforcement Administration (DEA), Office of Diversion Control, in Indianapolis, Indiana on May 10 – 11, 2016. The topics presented include prescription drug and chemical trends, ARCOS/record keeping, drug disposal and effective controls against drug diversion.

Jennifer Marcum, Sentry’s CEO, says, “Overall, the controlled substance distributors’ conference was informative with much emphasis being placed on the addiction epidemic, controlled substance trends and the emergence of illegal pain management clinics.”  Ms. Marcum continued, “The DEA is very clear about compliance with 21 CFR 1306.04(a).  The DEA wants to enable practitioners to issue prescriptions for legitimate medical purposes.  The DEA expects all members of the pharmaceutical supply chain to manufacture according to GMPs, to tightly control inventory and to maintain accurate records.”

James A. Arnold, Acting Chief Liaison & Policy Section, addressed the opioid prescription problem, the public health epidemic and the impact on society.

OPIOID PROBLEM

Between 2000 and 2014, there has been a 137% increase in unintentional deaths due to a prescription overdose.  28,647 deaths involved an opioid in 2014.  The number of deaths per year exceeds that of motor vehicle accidents.  Opioid addiction and abuse is a very serious situation in the U.S.   Heroin, an illegal highly addictive analgesic drug derived from morphine, usage and death rates skyrocketed in 2015.  However, heroin is only part of the problem.  More and more people are getting hooked on prescription painkillers, laced illicit drugs and lethal drug cocktails like the “Holy Trinity” consisting of hydrocodone, carisoprodol and alprazolam.  Heroin mixed with fentanyl creates a deadly drug combo that is 100 times more potent than morphine.  Just one-fourth of 1 mg of fentanyl is enough to be potentially fatal.  Read more about the DEA’s 2015 Drugs of Abuse Report: https://www.dea.gov/pr/multimedia-library/publications/drug_of_abuse.pdf

PUBLIC HEALTH EPIDEMIC & TRENDS

An opioid and prescription drug abuse epidemic is sweeping the U.S., impacting all segments of society. Opioid-related hospitalizations and infections from contaminated needles have caused the total opioid-related healthcare costs to rise significantly.  Read the DEA’s Drug Fact Sheet for the latest information on substances:  https://www.dea.gov/druginfo/factsheets.shtml

IMPACT ON SOCIETY

The Federal Bureau of Investigation (FBI) and DEA have an effective enforcement program for arresting people and attacking the supply of the opiates.  But to reduce the demand for the drugs, the FBI and DEA are collaboratively deploying outreach programs to educate the public about what lies in wait for somebody who experiments opioids. 

To help increase awareness about this epidemic and to help educate young people on the dangers of addiction, the FBI and DEA have released the documentary Chasing the Dragon: The Life of an Opiate Addict, a compilation of heart-wrenching first-person accounts by addicts, and family members of addicts, about their experiences.

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