Healthcare Logistics

Healthcare
Logistics that are
ALL IN.

The handling of medical supplies and life-saving pharmaceuticals require a high standard of quality and attention. Omni Logistics has a track record of meeting and exceeding those standards with strict adherence to industry standards. Omni provides top-tier services to the healthcare industry including warehousing, air, ocean, and ground transport for time-critical or scheduled delivery type shipments. End-to-end visibility all the way. Our global infrastructure allows Omni to achieve best in class service at the right price.

 

High level of security at every step.

At Omni Logistics, we understand the need for a secure chain of custody control considering the potential for theft of high-value medical equipment and pharmaceuticals. Our state-of-the-art equipment and technology with Geo-Fencing capability in “real time” ensures your high-value products get to the right place at the right time.

 

Logistics IT Security
healthcare worker using machine

Healthcare Logistics for Multiple Sectors.

Omni Logistics designs solutions for medical and pharmaceutical manufacturers, authorized distributors, independent specialty distributors, group purchasing organizations, as well as consumer organizations such as hospital systems, physician practices, surgery centers, dental & animal health practices, and pharmacy chains.

Logistics for Multiple Sectors including:

  • Pharmaceuticals & Over-The-Counter Medications
  • BioTech-BioPharma
  • Medical Devices
  • Medical Supplies
  • Dental Supplies
  • Animal Health

Specialized Services for the Healthcare Industry.

  • DQSA, PDMA, FDA, PHMSA, GxP, DEA Compliance
  • GPS Tracking & Geo-Fenced Routes
  • Barcode Scanning & POD Credentials Imaging
  • Reverse Logistics for expired pharmaceuticals including Tote/Pallet Returns
  • Clinical Trials & Samples Distribution Globally
  • CII to CV Controlled Substances Transport & Monitoring
  • LTL Cold-chain Transport
  • Blood Transport & Bio-Hazardous Waste
  • White Glove Medical Equipment Delivery and Assembly
  • Inner carton GPS tracking for high-value or high-theft potential products
Warehouse for healthcare
healthcare worker

Dedicated Solutions.

Omni’s healthcare logistics solutions are dedicated to your specialized needs. We pride ourselves in providing:

  • Dedicated Contract Carriage for any size and type equipment
  • Dedicated or Share Warehousing (storage, assembly, kitting, pick n pack, labelling)
  • Transportation Management or TMS as a stand-a-lone service
  • Global Parcel, LTL & FTL Transport
  • National Time-Definite Expedited LTL transport
  • Global Air & Ocean Transport
  • Cold-chain transport & monitoring for LTL, FTL, LCL, FCL
  • 24/7 Control Tower Operations & Customer Support

Healthcare Logistics Glossary:

Climate-Controlled Solutions

For storage and shipping of high value, temperature sensitive cargo, Omni Logistics provides a lockable, portable, validated, temperature-controlled environment with up to 150 hours of autonomously powered hold time. These mobile refrigerated shipping and storage containers provide precise temperature control performance. With tracking and reporting features to improve FDA regulatory compliance, these units dramatically improve cold chain integrity and security, and simplifies storage for freeze-sensitive, controlled room temperature, refrigerated and frozen medications, specimens, equipment, and more.
These units provide an operating validated temperate range for payload from -4° F (-20° C) to 120° F (49° C) for shipping within our national LTL or FTL networks one-way or round-trip. Omni Logistics provides 24/7 real­-time temperature-controlled pallet shipper positioning, tracking, payload compartment and ambient temperature monitoring.
• Considerable savings in comparison to traditional dedicated refrigerated shipping through Omni Logistics dedicated national LTL system
• Consolidate loads of temperature-sensitive goods with traditional dry shipping
• Reduce losses in transit with consistent temperature control
• Minimal product handling (loading and unloading)

With a built-in two-sided slot base, these units can be moved with a forklift throughout a warehouse or trailer and can be plugged into a standard 110 electrical outlet. Displacing 2 pallet positions per unit, the dimensions are as follows:

External Dimensions: 80”L x 49”W x 84”H
Tare Weight: 1,975 lbs

Inside “payload” Dimensions: 51”L x 42”W x 48”H
Max Cargo Weight: 1,800 lbs

 

Key Healthcare Logistics Trade Associations

Healthcare Distribution Alliance (HDA) represents 36 distribution companies — national, regional and specialty — as well as more than 130 manufacturer and more than 50 service provider/international members, respectively. HDA – Home

The Pharmaceutical Cargo Security Coalition (PCSC), subsidiary of the HDA, offers supply chain security intelligence; access to contacts from industry, government, and vendor trade disciplines; physical and supply chain security assessments; a reference library of supply chain security publications, articles and related documents; as well as opportunities to attend educational events. HDA Pharmaceutical Cargo Security Coalition – Home (hdapcsc.org)

The Health Industry Distributors Association (HIDA) is the trade association representing medical products distributors and logistics providers. HIDA | Health Industry Distributors Association

The Association for Health Care Resource & Materials Management (AHRMM) of the American Hospital Association is the leading membership group for health care supply chain professionals. AHRMM – Homepage | AHRMM

The Cargo Security Alliance (CSA) provides tools, techniques, technologies and thought leadership in logistics security to mitigate risk and optimize cargo flow across the global air, sea and land supply chains. Cargo Security Alliance (securecargo.org)

 

PDMA – Prescription Drug Marketing Act

The PDMA, which was signed by the President on April 22, 1988, was enacted to ensure that prescription drug products purchased by consumers would be safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, sub-potent, or expired drugs were being sold to the American public.

Congress decided that legislation was necessary because there were insufficient safeguards in the prescription drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs and that a wholesale drug diversion submarket had developed that prevented effective control over, or even routine knowledge of, the true sources of drugs.

Goals & Objectives

  • Supply Chain Transparency
  • Identify the source “Pedigree”
  • Further certification for non-authorized distributors and authorized distributors dealing with secondary distributors and non-core manufacturers or suppliers.
  • Tighter Chain of Custody Control through Information Technology.

Net Result

  • Improved visibility and control of pedigree information
  • Favors providers with GPS and barcode-scanning technology.

DQSA – Drug Quality Security Act of 2013

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013, due to a 2012 meningitis outbreak caused by tainted drugs manufactured by the New England Compounding facility. The meningitis outbreak resulted in more than 100 deaths. .

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system within the next 10 years to identify and trace certain prescription drugs as they are distributed in the United States. This includes unique identifiers on each drug unit sold.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.

Currently, the industry uses a patchwork of central databases based on the EDI standard that features point-to-point connections between manufacturer and distributor; that system is costly and makes large-scale interoperability almost impossible. The central database approach is also open the risk of diversion, counterfeit and a trust gap between siloed systems.

Blockchain, a decentralized network that shares information in real time with participants, is being piloted by the pharmaceutical industry as a solution to tracking and tracing the drugs they manufacture and ship. By 2023, the DQSA will require an electronic interoperable system that can pass serial numbers between trading partners.

As a result, the Healthcare Distribution Alliance (HDA) two years ago began developing The MediLedger Project, a blockchain-based network created to meet the track-and-trace demands of DGSA regulations.
The network combines a “Look-Up Directory” accessed through distributed ledger technology (DLT) with a permissioned messaging network that allows companies to securely request and respond to product identifier verification requests.

Today, MediLedger is being piloted by nine of the top 20 global pharmaceutical companies and two of the top three U.S. wholesaler distributors.

 

DEA – Drug Classifications & Diversion Regulations

Controlled Substance Classifications – 21 CFR Part 1300 to End

Schedule I (CI) Substances : The controlled substances in this schedule are those that have no accepted medical use in the U.S., are not accepted as safe for use under medical supervision, and have a high abuse potential.

Schedule II (CII) Substances (oxycontin, Vicodin – Requires Form 222 to Dispense): The controlled substances in this schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the U.S. CII controlled substances consist of certain narcotic, stimulant, and depressant drugs.

Schedule III (CIII) Substances: The controlled substances in this schedule have an abuse potential and dependence liability less than those in CI and CIII, and have an accepted medical use in the U.S.

Schedule IV (CIV) Substances: The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the U.S.

Schedule V (CV) Substances: The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the U.S. They are often available without prescription.

DEA Form 222 Diversion Control Form 21 CFS Part 1301.74 & 76

All dispensing facilities must provide a paper form or on-line form in order for controlled substances to be released to the carrier.
The majority of dispensing facilities have converted to the on-line DEA form (DCP) which typically covers both Federal and State requirements. A distributor or Authorized Distributor must deal with both.
Carriers are responsible for picking up the 222 paper forms during their normal delivery routes and returning them to the distributors DC in order for the drugs to be released for transport. This requirement is imposed on the carrier by the distributor or manufacturer, not the DEA or state agencies.

Theft or Significant Loss DEA Form 106 – 21 CFR Part 1301.74 & .76

All participants in the chain of custody must notify the DEA local field office in their area in writing of any theft or significant loss of any controlled substances within one business day of discovery. Form 106 must be completed.

Carriers providing transportation on behalf of a distributor are typically required to report theft or significant loss within 1 hour of discovery.

Breakage, spillage, or other damage must additionally be reported on DEA Form 41 by the carrier.
Disposal can be performed by a DEA approved disposal agent or you can call the local DEA field office for disposition.

 

PHMSA – DOT Pipeline Hazardous Material Safety Administration

Prescribes requirements for training hazmat employees.

All vehicles and Employees must have an emergency response guidebook.

General awareness/familiarization training. enable the employee to recognize
and identify hazardous materials.

Function-specific training. Each hazmat employee must be provided function-specific
training.

Safety training. Each hazmat employee shall receive safety training concerning emergency response

Security awareness training – awareness of security risks associated with hazardous materials transportation and how to recognize and respond to possible security threats.

In-depth security training. Each hazmat employee of a person required to have a security plan in accordance with subpart I of this part must be trained concerning the security plan and its implementation. Security training must include company security objectives, specific security procedures, employee responsibilities, actions to take in the event of a security breach, and the organizational security structure.

 

Healthcare Industry Emerging Technology

Emerging technologies present new opportunities for pharmaceutical manufacturers, distributors, and integrated delivery networks to continue to improve performance while fulfilling their mission to support patient access.

Blockchain
Blockchain technology can boost supply chain integrity and transparency by recording immutable information at every stage of the process, and by using permission rights to limit data access to trusted stakeholders. A blockchain project launched in 2017 is bringing together leading pharmaceutical manufacturers and distributors to build an industry-owned, permissioned blockchain network based on open standards and specifications.

Artificial Intelligence (AI) / Robotics
AI and robotics capabilities have the potential to drive down warehouse operational costs and minimize human error. IT automation, natural language processing, quality control, and cybersecurity likely present the greatest opportunity for distributors to leverage these technologies.

Internet of Things (IoT)
Adoption of IoT technology can help distributors provide real-time updates to their pharmacy and provider customers, allowing them to spend more time providing a reliable delivery schedule. IoT technology can also help with diversion identification by applying algorithms to determine if the delivery route is no longer being followed or if there is an unexpected delay.

 

 

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