Dr. Abdulrahman Mohammad Al Jassmi

Chief Executive Officer

Dubai Hospital

Dubai Health Authority

CHALLENGES AND

OPPORTUNITIES IN COLD CHAIN:

HEALTH CARE RELATED DRIVERS

• Integrating stakeholders to create value for the end users

• Maintaining the integrity of cold chain drugs throughout the

supply chain

• Emphasis on high performance execution

• Challenges.

AGENDA

Standard MMU.3: Medications are properly and safely

stored.

Standard GLD.7.1: Hospital leadership seeks and uses

data and information on the safety of the supply chain

for drugs, medical technology, and supplies to protect

patients and staff from contaminated, fake, and diverted

products.

JCI STANDARDS

COLD SUPPLY CHAIN

•Physical changes:

•Appearance

•Melting point

•Clarity and color of solution

•Moisture

•Crystal modification (Polymorphism)

•Particle size •Chemical changes:

•Increase in Degradation

•Decrease of Assay •Microbial changes

WHAT ARE CHANGES?

IMPACT OF DRUG STABILITY ON THE

EFFICIENCY

•Regulatory Gap Analysis

•Personnel Training

•Review and Writing of SOPs (related to Cold Chain, Storage & Shipping) and

Documentation

•Temperature Mapping of Warehouse and Storage areas

•Qualification of Storage Equipment (Refrigerators/Freezers)

•Temperature Profile Studies in Transport (for uncontrolled transports)

•Test, Design and Qualification of Cold Chain Packaging Systems (outermost)

•Monitoring Solutions for Storage Conditions of Biosimilars/Drug products

•Maintenance of Cold Chain Management and Compliance.

COLD CHAIN COMPLIANCE

• Important for low- and middle-income countries

• Important for those vertically managed disease control

programs

• Each program owns the physical infrastructure for storing and

transporting health products within the health system.

• Some Programs are under increasing pressures to manage

larger volumes of higher-value products from the national to

service-delivery levels.

• > 50 countries had NO logistics systems that met the WHO

criteria of effective chain management.

• Many countries has chronic and enduring challenges of stock

management, vaccine distribution, and overall inefficiencies of

immunization supply chain and logistics systems.

WHY INTEGRATE SUPPLY CHAINS?

Medications may be stored within a storage area, in a pharmacy or pharmaceutical service, or on the patient care units in unit pharmacies or the

nursing station in the clinical unit.

a) Medications are stored under conditions suitable for product stability, including medications stored on individual patient care units.

b) Controlled substances are accurately accounted for according to applicable laws and regulations.

c) Medications and chemicals used to prepare medications are accurately labeled with contents, expiration dates, and warnings.

d) Concentrated electrolytes are not stored in care units unless clinically necessary, and when stored in care units there are safeguards in place to prevent inadvertent administration.

e) All medication storage areas, including medication storage areas on patient care units, are periodically inspected according to hospital policy to ensure that medications are stored properly.

f) Medications are protected from loss or theft throughout the hospital. (Also see FMS.4.1)

MMU.3

MEDICATIONS ARE PROPERLY AND SAFELY

STORED.

a) Hospital leadership identifies the supply chain of critical

supplies and medical technology.

b) Hospital leadership evaluates the integrity of each supplier in

that chain.

c) Hospital leadership makes resource decisions based on their

understanding of the risks in the supply chain.

d) Hospital leadership tracks critical supplies to prevent

diversion or substitution.

GLD.7.1

HOSPITAL LEADERSHIP SEEKS AND USES DATA AND

INFORMATION ON THE SAFETY OF THE SUPPLY

CHAIN FOR DRUGS, MEDICAL TECHNOLOGY, AND

SUPPLIES TO PROTECT PATIENTS AND STAFF FROM

CONTAMINATED, FAKE, AND DIVERTED PRODUCTS.

EXAMPLES OF FDA 483 CITATIONS

• Maintaining a secure “cold chain” for the benefit of the

patient.

• Maintaining a secure “cold chain” for the benefit of the

clinical trials.

• Industry and society benefit …

However:

• With excessive heat +/- freezing: Biotechnology Products are at

risk of loosing the therapeutic and financial value

VALUES

• 2020:The GCC’s market for European-made drugs and

medicines is expected to pass $10 billion. (reported by QNB

Capital)

• Annual drugs spending:

• Saudi Arabia: $2.8 billion

• UAE : $1.8 billion

• Kuwait: $374 million

GCC PHARMACEUTICAL MARKET

year Commercial

Biotechnology Industry

Global Market

1980s global biopharma market $200 billion

(13% of all biopharma

logistics spending)

2018 world sales of cold-chain

drugs and of biologics

such as vaccines and

blood plasma products

$300 billion

BIOPHARMA MARKET

* IMS Health

• A very substantial market for temperature-assured

transportation and packaging.

• Smaller quantities of products or test materials.

• a higher level of logistics services.

• Steady clinical-trial activity.

• Market size: under $3 billion in 2014.

CLINICAL TRIALS LOGISTICS

1. Strategy for a new market or climate zone to meet

new regulations, geographic distance and varying

validation processes.

2. How to mitigate risk with the lowest cost possible.

3. The rapid shift has led to confusion, waste and

inefficiency throughout the pharmaceutical supply

chain.

4. Risk on industry : exposure to theft, contamination,

counterfeiting and non-compliance.

CHALLENGES

5. The international pharmaceutical shipments often exchange

hands somewhere between 6 -15 times en route to a hospital,

clinic, pharmacy, doctor or patient.

6. Challenges on Manufacturers today

CHALLENGES

CONCLUSION

• Increased oversight, management, and control of environmental

conditions across the entire supply chain (from manufacturer to

consumer/patient)

• Global regulatory requirements have emphasized the importance

of assuring that product quality and integrity are not

compromised in the distribution channel.

• Responsibility for cold chain management ultimately resides with

the manufacturers

• Due to the presence of multiple uncontrolled variables in the

distribution process, developing an appropriate temperature and

humidity monitoring program is essential to protect the quality

of environmentally sensitive pharmaceutical product and ensure

patient safety.