Kevin O'Donnell07.09.10
The French poet and pilot Antoine de Saint-Exupry once famously said, "If you want to build a ship, don't drum up people to collect wood and don't assign them tasks and work, but rather teach them to long for the endless immensity of the sea."
As I recently witnessed, this is exactly the approach extended by the WHO in the design of their course on pharmaceutical and vaccine cold chain management. I had the privilege to be selected as one of six mentors on the 3rd Pharmaceutical Cold Chain Management On Wheels Course, a meticulously organized week-long experience - the brainchild of Dr. mit Kartoğlu of the World Health Organization, held in conjunction with the Parenteral Drug Association (PDA) and Tip Kurumu Dernegi (a Turkish health NGO). We were 25 in number representing 16 different countries, travelling through 555 km of western Turkey, from Istanbul to Izmir.
The purpose of this in-country experiential learning event was to provide key players within the pharmaceutical cold chain the insight into complete cold chain operation and oversight - from product manufacture (or arrival in a country) to administration to the patient. Why Turkey? The course is held in Turkey each year due the government's excellent supply chain practices, and Dr. Kartoğlu's close associations with the Turkish Ministry of Health and other governmental authorities, which allowed for unfettered access to each segment of the supply chain. It united a group of 16 selected "student participants" from various national regulatory authorities and the pharmaceutical, biopharmaceutical, vaccine industry who are involved in the supply, packaging, distribution, logistics and cold chain management, as well as industry members of immunization related equipment and device manufacturers. The "on wheels" concept provides for an immersive 24/7 experience encouraging personal interaction down the length of the cold chain.
This approach is designed to show participants how the theoretical background of pharmaceutical cold chain management is applied in a variety of storage and health care facilities - a practical application of experiential learning theory.
When it comes to a model country for vaccine distribution I doubt that the first place most people would think of would be the Republic of Turkey. It certainly wasn't my idea of one. My America-centric shortcomings initially led me to believe that the modern model for vaccine supply chain must be some western culture - maybe Canada or the UK or just about any western European country. Fact is, Turkey during the last decade has quietly and quite remarkably, become a leading and progressive country in many respects. As we reported in the June issue, Turkey is considered by IMS Health as one of the seven fastest "pharmerging" countries in the world, with comparable market growth that of Mexico and South Korea.
Too often we operate within our work-a-day worlds with little knowledge or consideration of our downstream supply chain partners before throwing our responsibilities over the wall to the next person in the supply chain. This is unfortunate. If we truly want to understand the needs of the patients who rely on the drugs we provide and supply, a bottom-up approach would reveal many undiscovered, unconsidered and uncontrolled lapses in the supply chain. This was the remarkable advantage of following drugs through the entire supply chain in Turkey.
We began our visits at a DHL warehouse and distribution facility 28 km west of Istanbul where no question went unanswered and no area was off-limits. It was amazing to see the thoroughness and precision of their cold chain operations for pharma customers. From there we toured FarmaLojistik, a joint purchasing and logistics pharmacist cooperative established in 2005, serving the entire country. This is a first attempt to centralize drug distribution in-country and today the wholesaler handles more than 3200 SKUs and 3,500 packages daily. Its network includes 25 branches throughout the country and a considerable portion of its business is maintaining the inbound, storage and dispatch of cold chain pharmaceutical products. Day three took us to the Provincial Health Directorate facility and day four to a Primary Healthcare Center where the national Expanded Programme on Immunization (EPI) supplies are distributed.
On day five we switched from the public sector to the private sector with a visit to Ege University Hospital. Our final visit was to EDAK, the country's largest pharmacists' cooperative, which serves about 20% of the nations pharmacies throughout western and southern Turkey. Among the many products they provide, there is a considerable pharmaceutical operation - spotlessly clean, modern and high tech. This was a model of modern-day Turkey - an intensive cold chain operation with great care and consideration given to time- and temperature-sensitive drugs. This facility also employs a fleet of refrigerated vans for remote shipments and services nearby pharmacies impressively via motorcycles.
Each passing day we penetrated deeper into the dry and beautiful Turkish mountains and back in time as we continued down the pharmaceutical cold chain. What became abundantly clear from our experience is that there is a significant difference in the storage and handling of temperature-sensitive drugs (such as vaccines) in the public sector than there is in the private sector. The biggest surprise came in discovering that the drugs handled and administered through the national healthcare vaccination program were far better controlled - and education far more prevalent - than in the private sector.
This can be attributed to education. The level of awareness and education regarding GXPs in the private sector is far below that of the government sector, where frequent education is administered and routinely scheduled audits are performed by various authorities. The private university hospital we visited was not under the same scrutiny. With few requirements, little enforcement and no accountability, education is lax, priorities get put aside and things get missed, or just plain ignored. Without accountability from regulators, profit becomes the primary motivator.
I have learned from first-hand experience that Turkey is a land of tremendous schisms. It is claustrophobic yet sprawling, subtle yet dramatic, secularly conservative yet socially progressive. It is an effusive blend of cultures, food and peoples. It is where east meets west, straddling two continents, Asia and Europe separated only by the narrow straits of the Bosporus. It is also the place I gained a new perspective on the advantages and disadvantages of a nationalized health program. It is where I began my enlightened journey through the entire pharmaceutical supply chain, not just snap-shots of specific segments, and where I witnessed "the longing for the endless immensity of the sea."
Day-by-day details and photographs of the 2010 Pharmaceutical Cold Chain Management on Wheels Course can be found under The Cold Chain Chronicles tab at the blog "Where Cooler Heads Prevail," at www.coolerheadsblog.com.
Kevin O'Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He can be reached at kevin.o'donnell@tegrant.com. He blogs at Where Cooler Heads Prevail.
As I recently witnessed, this is exactly the approach extended by the WHO in the design of their course on pharmaceutical and vaccine cold chain management. I had the privilege to be selected as one of six mentors on the 3rd Pharmaceutical Cold Chain Management On Wheels Course, a meticulously organized week-long experience - the brainchild of Dr. mit Kartoğlu of the World Health Organization, held in conjunction with the Parenteral Drug Association (PDA) and Tip Kurumu Dernegi (a Turkish health NGO). We were 25 in number representing 16 different countries, travelling through 555 km of western Turkey, from Istanbul to Izmir.
The purpose of this in-country experiential learning event was to provide key players within the pharmaceutical cold chain the insight into complete cold chain operation and oversight - from product manufacture (or arrival in a country) to administration to the patient. Why Turkey? The course is held in Turkey each year due the government's excellent supply chain practices, and Dr. Kartoğlu's close associations with the Turkish Ministry of Health and other governmental authorities, which allowed for unfettered access to each segment of the supply chain. It united a group of 16 selected "student participants" from various national regulatory authorities and the pharmaceutical, biopharmaceutical, vaccine industry who are involved in the supply, packaging, distribution, logistics and cold chain management, as well as industry members of immunization related equipment and device manufacturers. The "on wheels" concept provides for an immersive 24/7 experience encouraging personal interaction down the length of the cold chain.
This approach is designed to show participants how the theoretical background of pharmaceutical cold chain management is applied in a variety of storage and health care facilities - a practical application of experiential learning theory.
When it comes to a model country for vaccine distribution I doubt that the first place most people would think of would be the Republic of Turkey. It certainly wasn't my idea of one. My America-centric shortcomings initially led me to believe that the modern model for vaccine supply chain must be some western culture - maybe Canada or the UK or just about any western European country. Fact is, Turkey during the last decade has quietly and quite remarkably, become a leading and progressive country in many respects. As we reported in the June issue, Turkey is considered by IMS Health as one of the seven fastest "pharmerging" countries in the world, with comparable market growth that of Mexico and South Korea.
Too often we operate within our work-a-day worlds with little knowledge or consideration of our downstream supply chain partners before throwing our responsibilities over the wall to the next person in the supply chain. This is unfortunate. If we truly want to understand the needs of the patients who rely on the drugs we provide and supply, a bottom-up approach would reveal many undiscovered, unconsidered and uncontrolled lapses in the supply chain. This was the remarkable advantage of following drugs through the entire supply chain in Turkey.
We began our visits at a DHL warehouse and distribution facility 28 km west of Istanbul where no question went unanswered and no area was off-limits. It was amazing to see the thoroughness and precision of their cold chain operations for pharma customers. From there we toured FarmaLojistik, a joint purchasing and logistics pharmacist cooperative established in 2005, serving the entire country. This is a first attempt to centralize drug distribution in-country and today the wholesaler handles more than 3200 SKUs and 3,500 packages daily. Its network includes 25 branches throughout the country and a considerable portion of its business is maintaining the inbound, storage and dispatch of cold chain pharmaceutical products. Day three took us to the Provincial Health Directorate facility and day four to a Primary Healthcare Center where the national Expanded Programme on Immunization (EPI) supplies are distributed.
On day five we switched from the public sector to the private sector with a visit to Ege University Hospital. Our final visit was to EDAK, the country's largest pharmacists' cooperative, which serves about 20% of the nations pharmacies throughout western and southern Turkey. Among the many products they provide, there is a considerable pharmaceutical operation - spotlessly clean, modern and high tech. This was a model of modern-day Turkey - an intensive cold chain operation with great care and consideration given to time- and temperature-sensitive drugs. This facility also employs a fleet of refrigerated vans for remote shipments and services nearby pharmacies impressively via motorcycles.
Each passing day we penetrated deeper into the dry and beautiful Turkish mountains and back in time as we continued down the pharmaceutical cold chain. What became abundantly clear from our experience is that there is a significant difference in the storage and handling of temperature-sensitive drugs (such as vaccines) in the public sector than there is in the private sector. The biggest surprise came in discovering that the drugs handled and administered through the national healthcare vaccination program were far better controlled - and education far more prevalent - than in the private sector.
This can be attributed to education. The level of awareness and education regarding GXPs in the private sector is far below that of the government sector, where frequent education is administered and routinely scheduled audits are performed by various authorities. The private university hospital we visited was not under the same scrutiny. With few requirements, little enforcement and no accountability, education is lax, priorities get put aside and things get missed, or just plain ignored. Without accountability from regulators, profit becomes the primary motivator.
I have learned from first-hand experience that Turkey is a land of tremendous schisms. It is claustrophobic yet sprawling, subtle yet dramatic, secularly conservative yet socially progressive. It is an effusive blend of cultures, food and peoples. It is where east meets west, straddling two continents, Asia and Europe separated only by the narrow straits of the Bosporus. It is also the place I gained a new perspective on the advantages and disadvantages of a nationalized health program. It is where I began my enlightened journey through the entire pharmaceutical supply chain, not just snap-shots of specific segments, and where I witnessed "the longing for the endless immensity of the sea."
Day-by-day details and photographs of the 2010 Pharmaceutical Cold Chain Management on Wheels Course can be found under The Cold Chain Chronicles tab at the blog "Where Cooler Heads Prevail," at www.coolerheadsblog.com.
Kevin O'Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He can be reached at kevin.o'donnell@tegrant.com. He blogs at Where Cooler Heads Prevail.