MAHARASHTRA NATIONAL LAW UNIVESITY

EXECUTIVE M.B.A.{MEDICAL LAW AND HOSPITAL

MANGMENT}
ASSIGMENT SUBJECT = LOGISTICS AND SUPPLY CHAIN
MANAGEMENT IN HEALTHCARE SERVICES
TOPIC
ANALYZING THE ROLE OF LOGISTICS IN ENSURING
TIMELY DELIVERY OF HEALTHCARE SUPPLIES TO REMOTE
AREAS

FACULTY INCHARGE: PROF. DR SANTANU ROY

NAME CANDIDATE—DR. KAVITA TAMASKAR

M.B.B.S., D.G.O. {GYNEACOLOGIST}

ROLL NO. :- 2023/EMBAMLHM/05

introduction
When it comes to medicine, on-time delivery can literally save someone’s life.
Not only do medical products have to be transported on schedule, they must
also be stored and handled correctly at every stage of the journey. To make
sure hospitals and clinics have what they need to treat patients, medical supply
chains must be closely managed and optimized for utmost performance.
This article talks about the unique challenges of healthcare logistics
management and explains how technology can make it more efficient. So
whether you are a medical/pharma company looking for ways to enhance your
supply chain or a logistics business expanding your range of services, we hope
you’ll get valuable insights from reading.

What is healthcare logistics

Healthcare logistics involves managing the flow of medical supplies,
pharmaceuticals, and medical devices from manufacturers to healthcare
facilities and, ultimately, to patients. It also relates to handling other
healthcare-related items such as lab specimens, organs, veterinary medicinal
products, etc.Logistics is a critical part of the healthcare system because it
ensures that the right products arrive in the proper condition, at the right time,
and in the right place. This is vital for patient care, as delays or errors can lead
to disrupted treatment, increased healthcare costs, or even harm to patients.
For you as a company that deals with medical shipments, mishandling can also
have serious business outcomes, impacting your bottom line, brand image, and
market share. So setting up the right supply chain workflows is crucial – and
that’s where technology comes to the rescue.s? Healthcare logistics needs
and challenges
As medical shipments travel from the manufacturing plant or other place of
origin to their destination, they pass through a variety of environments and
handlers. The healthcare industry is unique in terms of the numerous
regulations that define strict handling guidelines for every stage of their
lifetime. Many medical products are temperature-dependent, some are
hazardous, and some have a very short shelf-life.
Because of their variety, different healthcare items heve multiple journey
scenarios. For example, blood samples or other specimens obtained in a clinic
must be packaged right there and transported to the nearest lab with no
storage needed. On the other hand, say, pharmaceuticals are manufactured in
a factory, packaged, transported to a warehouse for storage, and then shipped
to a hospital, pharmacy, or patient.

How cold chains work in general

How cold chains work in general
However, whatever their journey stages are, there are some common pain
points relevant to almost any type of medical product, i.e.,
control of temperature and other conditions,
respecting the expiration dates,
tracking shipments and monitoring their condition, and
regulatory compliance.
Please note that in our overview, we’ll focus on the industry-specific
challenges, but it’s important to be mindful about other complexities typical for
any supply chain, such as demand planning, space optimization, or supplier
management.
You can refer to the Transportation section of our blog to gain insights into
tech-driven warehouse management, inventory management, transportation
management, and other logistics aspects.

Control of temperature and other conditions

As per MarketResearch.com, over 95 percent of all approved biologics and 90
percent of all vaccines are temperature-sensitive. It means that it’s critical to
maintain strict temperature requirements when storing, handling, and
transporting such medical products.
There are several standard temperature ranges:
controlled room temperature – 15° to 25°C (59° to 77°F),
cool storage – 8° to 15°C (46.4° to 59°F),
cold storage – 2° to 8°C (35.6° to 46.4°F),
fridge storage – -4˚C to 2˚C (24.8° to 35.6°F),
frozen storage – -15˚C to -20˚C (5° to -4°F),
ultra-frozen storage – -70˚C to -80˚C (-94° to -112°F), and
cryo storage – -160˚C (-256°F).
In addition to temperature limitations, humidity, ventilation, light, vibration,
and other requirements often exist. Not to mention sterility, of course.
Plus you might also be dealing with highly active, radioactive, and hazardous
materials that present special risks and require additional safety and security
measures.
All these requirements are extremely difficult to comply with. Nearly half of
Biopharma ColdChain Logistics Survey respondents reported multiple
temperature excursions annually. The same research also mentions that IQVIA
Institute for Human Data Science estimated loss in the pharma industry to be
about $35 billion annually due to improper handling of temperature-sensitive
medical shipments.
Respecting the expiration dates
Expired medical products are, at best, less effective, and at worst, present a
significant danger for the patients. For pharma and medical companies, expired
medicine is also a source of substantial financial losses. For example, just one
drug – Pfizer’s antiviral medication Paxlovid – cost the EU over a billion dollars
because millions of doses were left unused by their expiration date.
When you deal with large volumes of various medical supplies, expiration
management becomes a complex issue. To minimize losses, inventory
management suggests implementing the FEFO (first expired, first out) and/or
FIFO (first in, first out) approaches. There are also various practices such as
cycle counting and inventory rotation that help monitor expiration dates.
However, when performed manually, all these techniques aren’t perfectly
reliable as they are too prone to human error.
Tracking shipments and monitoring their condition
Closely related to the previous two, there’s a big need for real-time, accurate
tracking of medical shipments' location and condition. In 2024, calling drivers
and asking them to check the temperature inside the container and report
where they are just doesn’t work. You have to obtain precise information at any
moment in time to be able to react in case of disruptions.

Regulatory compliance
Regulatory compliance in healthcare logistics is extremely complex because of
the critical nature of medical products, the global landscape of supply chains,
and the diverse regulatory environments across different jurisdictions.
Here are the most important global regulations that relate to medical supply
chains.
Good Distribution Practices (GDP) ensure the quality of medicinal products is
maintained throughout the supply chain, from the point of production to the
point of sale or distribution to the end user.
Good Storage Practices (GSP) are a part of GDP, focusing on the proper storage
conditions and management of pharmaceutical products.
Good Manufacturing Practices (GMP) are about compliance with quality
standards in all aspects of production – from the starting materials, premises,
and equipment to the training and personal hygiene of staff.
EU Falsified Medicines Directive (FMD) aims to protect the pharmaceutical
supply chain from counterfeit medicines in the EU. It includes measures such as
safety features and a unique identifier for prescription drugs.
ISO 9001 and ISO 13485 Standards provide guidelines for the quality
management of medical products and devices. You might need to obtain the
corresponding certificates together with Drug Distributor Accreditation
(formerly VAWD).So one of the biggest challenges of healthcare logistics is
maintaining the proper conditions throughout the entire shipment journey.
Here’s what happens at different stages.
Storage. Depending on which type of medical products you deal with, your
warehouse facility must have robust climate control to comply with standards.
In most cases, there must be certified storage and loading areas that maintain
the required conditions, such as walk-in cold rooms (WICR) or ultra-low
temperature (ULT) freezers.
Also, many storage facilities implement a dry ice production system to supply
this common cooling agent constantly.
Packaging. To transport temperature-sensitive medical products safely, they
must be put in special containers. There are two main options.
Passive containers are basically insulated boxes that maintain the internal
temperature with the help of special coolants (e.g., dry ice, gel packs, gel
bottles, liquid nitrogen, etc.). Active containers, however, have electrically
controlled cooling systems. They monitor the internal temperature with a
connected sensor and automatically adjust the conditions to maintain a stable
environment.
Transporting. In addition to proper packaging, sometimes, medical shipments
demand specialized equipment known as reefers or freezers. Depending on the
mode of transportation, it can be refrigerated trucks, railcars, cargo ships, and
aircraft. If not only temperature but also humidity must be controlled, such
equipment has to be capable of that as well.
There are also WHO’s Guidelines on the international packaging and shipping
of vaccines, IATA’s Perishable Cargo Regulations and Temperature Control
Regulations, the FDA’s Hazard Analysis Critical Control Point (HACCP), and many
other provisions. All of them ensure that healthcare logistics operations are
conducted in a manner that preserves the integrity and safety of medical
products – which is great, but complying with them is a constant pain in the
neck.Now that we’ve highlighted the main hardships of handling medical
shipments, let’s see how technology can help you deal with them.
How modern technologies enhance healthcare logistics
Today, a number of technologies and software systems can be implemented to
enhance logistics processes and build a more resilient supply chain.

IoT for proactive temperature monitoring

As we said, temperature control is perhaps the most critical challenge for
healthcare logistics – especially during last-mile delivery when temperature
fluctuations happen most often.
The use of specialized storage, packaging, and transportation equipment is
essential, but digital technologies can also be of great value. They help
continuously monitor temperature, humidity, and sometimes even vibration,
giving stakeholders information that a safe and stable environment is
maintained.Data loggers are devices placed inside the container or storage area
that record temperature data at specified intervals. They have to be scanned to
retrieve a detailed storage and transit conditions history for compliance and
quality assurance.
Though most cost-effective, data loggers aren’t capable of real-time
monitoring, so they are mainly used for non-critical shipments such as standard
pharmaceutical products.
IoT infrastructure based on BLE (Bluetooth Low-Energy) or other types of
sensors is a more advanced solution. A system of connected devices attached
to containers or packages collects temperature measurements and location
data in near real-time and wirelessly transmits all the records to the cloud
storage. There, information is processed and can either be retrieved when
needed or sent as live updates to a user-facing app or platform.
The value of real-time monitoring lies in automatic alerts in case of
any deviations from predefined temperature ranges (or other conditions),
allowing for immediate corrective actions.
Going a step further, you can also employ machine learning (ML) to analyze
collected data and find deviation patterns, for example, if temperature
breaches happen regularly at a specific stage. It can help you define
bottlenecks or process inefficiencies, improve operations – and thus minimize
costly incidents.

Predictive maintenance for equipment support

One more way to prevent temperature breaches is to ensure all storage
equipment like coolers, freezers, or ice machines functions properly at all
times. But just like any other piece of machinery, it’s evident that equipment
requires consistent maintenance or repair in case of failures.
To foresee the need for repair and minimize downtime, employ a predictive
maintenance approach. Just like temperature control, it requires developing an
IoT infrastructure with connected sensors continuously monitoring equipment
health, analyzing collected data, and alerting maintenance staff of required
actions.

Inventory software for expiry management

To manage the expiry of medical products, it’s worth implementing the
practical methods we mentioned (inventory rotation, FEFO approach, etc.) and
supporting them with inventory management software. This way, you’ll
automate part of the workflows, improving their speed and accuracy.
For example, using asset tracking solutions like barcode, RFID, or BLE tags will
allow you to capture essential product information, such as production date,
expiration date, lot number, location, and status. Having all this data in one
system, you’ll be able to track product expiry and see which items must be
moved first. Moreover, you can set up alerts that will automatically notify you
about upcoming expirations so that you can act accordingly.
Inventory management software also helps analyze inventory levels and
optimize replenishment by applying advanced, ML-based demand forecasting
techniques. If you are a distributor, optimal stock levels will allow you to
efficiently use storage space and ensure medical product freshness.

Telematics and GPS for real-time tracking

For peace of mind regarding the location of your time-critical medical
shipments, leverage GPS tracking technology. If you truck healthcare products,
you can get real-time location data from telematics devices installed in
vehicles.
If you ship by air or sea, you can get tracking data from the carrier. In most
cases, it’s provided on their website, but if you want more detailed, real-time
information, you can integrate with their system and get status updates
automatically.

Quality management software to ensure compliance

Regulations provide guidelines regarding all logistics aspects, e.g., warehousing
and handling practices, temperature monitoring activities, disposal process,
human resources, reporting, etc. In addition, these regulations sometimes
change, which makes compliance even more complicated. To ensure consistent
conformity with all the essential healthcare provisions, you can implement
quality management software or QMS.
QMS is a digital platform that helps healthcare organizations manage and
improve the quality of their services and operations. Its functionality supports
quality assurance, compliance, risk management, performance improvement,
and other essential operational aspects. Here are some of its features related
to logistics.
Documentation management. QMS helps keep quality standards, policies, and
procedures up to date and accessible to authorized personnel.
Compliance management. Tracking changes in regulations, the QMS helps
ensure that logistics and other practices are aligned with current standards and
requirements.Risk management. QMS provides tools for identifying, assessing,
and managing risks throughout the organization. This helps in prioritizing risks
based on their potential impact on patient safety and organizational
performance.
Supplier management. QMS helps manage supplier qualifications, performance
evaluations, and quality audits.
Audit management. QMS supports the planning, execution, and
documentation of internal and external audits. This ensures that the
organization regularly reviews and improves its quality and compliance
processes.
There are definitely many other types of digital tools that can enhance different
aspects of your supply chain. For example, automated sorting systems speed
up and increase the accuracy of picking and packing processes. Meanwhile,
access control systems help prevent the handling of important shipments by
unauthorized staff and give you an understanding of personnel activities.
To choose the right set of tools, you must first define your key pain points and
inefficiencies. Then, as you implement software, configure it to address your
specific needs and cover the problematic workflows.
For maximum efficiency, integrate all your IT components (data sources, digital
tools, processing units, etc.) into one connected structure. It will allow you to
establish seamless information flow throughout your organization, ensure end-
to-end visibility, and enable data analytics.
Digitizing healthcare supply chains: success stories of Pfizer,
Eli Lilly, and Novartis
Many logistics service providers today offer comprehensive supply chain
management to medical organizations, so a lot of them leverage the
professional expertise of 3PLs. The recent UPS Pharmaceutical Industry Study
states that 42 percent of manufacturers in the healthcare industry prefer to
outsource temperature control, while 34 percent are willing to handle it on
their own.
However, even in spite of outsourcing logistics operations, big pharma
companies tend to digitize their supply chain-related operations as part of the
overall transformation. Let’s look at some of the examples.
Pfizer has introduced the Pfizer Global Supply – Digital Operations Center
(DOC) to support its manufacturing and entire value chain as COVID-19 struck.
The DOC leverages the most innovative technologies, including AI, augmented
reality, and IoT. As a result, the pharma giant has an end-to-end view of
manufacturing and can predict and address issues before they appear.
In addition, Pfizer partnered with Controlant, a specialized pharma tech
provider, to set up the IoT infrastructure for real-time shipment tracking and
condition monitoring along the entire supply chain. All these efforts enabled
the delivery of billions of vaccines worldwide with a close to 100 percent
success rate.
Eli Lilly has been investing in developing big data infrastructure for years now to
enable predictive analytics in all business aspects. They are also continuously
working on their Digital Plant project to build the most advanced, technology-
based manufacturing facility.The company uses robots in its plants and
warehouses and relies on IoT for condition monitoring and predictive
maintenance. It also implements blockchain and digital twin technologies to
improve supply chain traceability, logistics and inventory management, and
quality and regulatory compliance.
Novartis, another leading pharma and biotech company, has been actively
cooperating with the biggest global tech providers, such as Microsoft and
Amazon, to build an enterprise-wide data platform, enable advanced data
analytics, and make information accessible to every associate. Novartis applies
AI/ML techniques to make accurate demand predictions and increase
preparedness for any market fluctuations.
Novartis has also been working continuously on digitizing and automating its
supply chains. For example, it partnered with warehousing solutions expert
Mecalux to build a fully-automated storage and distribution facility in Poland.
Such a holistic automation approach resulted in increased security, reduced
maintenance costs, control of all movements, expanded storage capacity, and
lower personnel costs.It was also one of the companies that implemented
Kinaxis’ RapidResponse platform to establish end-to-end visibility, support the
planning processes, and enhance overall supply chain resilience.