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Wednesday, June 16

The Cold Chain Chronicles: Photography Contest Winners
by
Kevin O'Donnell
on Wed 16 Jun 2010 09:52 AM CDT
As promised, here are the winning photographs taken by the participants of the 2010 Pharmaceutical Cold Chain Management on Wheels Course Istanbul to Izmir Turkey, June 7-12, 2010. Congratulations Sandra and Apichai!
Category: "Learning"
Winner: Sandra Oosthoek, Merck Sharp & Dohme, Haarlem, The Netherlands. Taken with a Canon G7.

Category: "Turkey"
Winner Apichai Supasansatorn, Ministry of Public Health, Thailand. Taken with a Canon D450.

Sunday, June 13

The Cold Chain Chronicles: Public vs. Private Healthcare Reveal Dramatic Differences in Cold Chain Practices
by
Kevin O'Donnell
on Sun 13 Jun 2010 10:59 AM CDT
Daily reports from the WHO-PDA Pharmaceutical Cold Chain Management on Wheels Learning Experience
DAY FIVE:
IZMIR -
Weather holding. Up late last night working on the blog and I could hear singing and laughter drifting in through the open door to my balcony. It seemed to be coming from the pavilion down on the beach where we held our evening “evaluation of the day” exercise and discussion and watched the setting sun dip into the Aegean Sea. No doubt the revelry was coming from members from our group. It was around midnight. I decided I could use a break and I wandered down to the pavilion to investigate. A dozen or so were gathered around Paulo Froes, one of the more gregarious and animated of our group, currently working for UNICEF in Panama. Paulo was strumming away on a classical guitar in the brilliant style of his native Brazil while all the others were festively singing and dancing. Umit and Rafik insisted that I play a few songs and I obliged them and returned to my room around 1:00 AM to finish the previous day’s posting while the hootenanny was still going strong on the beach.
Today we left the old world arid coast (not far from Troy) to modern Ege University Hospital in the city of Izmir (pop: 3,525,200). Here we would see pharmacy distribution practices in the private sector. Our visits the previous few days were all part of the national public health program.
The hospital was a sprawling complex of chaotic activity. We drew a great deal of attention as the 26 of us marched like an army of rag-tag invaders down the broad corridors of the hospital to the pharmacy dispensing area. The room was a bit cramped and bustling with 17 pharmacists and 6 technicians taking orders on desktops in the central pharmacy and dispensing the prescriptions while couriers bundled them in plastic bags and delivered them to the appropriate wards across the three hospitals within the University’s complex.
To this point on our journey we have witnessed very good distribution and storage practices throughout the pharmaceutical cold chain in Turkey. That was all about to change. Many of us were very surprised to find that in this sector, those GDP’s and GSP’s appeared to have low priority. We found that by observing and asking relevant questions from knowledge we had gained in the previous day’s use of the ESM tool, many, many shortcomings in receiving and storage of medications, especially temperature-sensitive drugs. It’s not that the staff at the hospital didn’t care. They are committed professionals. The underlying reason is because the level of awareness and education regarding GXP’s in the private sector is far below that of the government sector where routine education and audits are performed by various authorities. Here, in this private hospital there is no accountability from regulators and profit is often the motivator. Hence, things get missed, put aside or ignored. Take for example the hospitals storage facility for drugs. Like most hospitals, receiving and storage occurs in the bowels of the building. There was overhead piping and drains, open basement windows with dumpsters in the ally which could attract vermin, direct sunlight beaming down on cases of antibiotic, no continuous temperature monitoring of the refrigerators and coolers (only cheap household mercury thermometers), inadequate shelving, no surveillance cameras, and easy, uncontrolled access to the facility. Upstairs in dispensing the coolers holding temperature-sensitive products looked nice but lacked continuous monitoring. They were neither locked nor alarmed and the dispatch and cross-checking system was a manual process, rife for mistakes by relying on the aptitude of those involved. But on the surface it looked like a well oiled machine. One of the pharmacists guiding our group through the process summed it up accurately when she said, “Upstairs we are small and pretty, downstairs it is huge and uncontrolled.”

Ege University Hospital "controlled room temperature" drug storage facility. Note the boxes of antibiotic in direct sunlight, overhead piping and open window.
Our final visit on our journey was to a new distribution warehouse opened by EDAK, the country’s largest pharmacist’s cooperative which serves about 20% of the nations pharmacies throughout western and southern Turkey. Among the many hygienic products, cosmetics and personal care items 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. Some of the more sublime activities include receipt and opening of cold chain items only within the cold storage room, temperature data loggers included with shipments are checked. If out of range, the shipment is rejected and returned to the drug manufacturer or importer. This facility has a fleet of refrigerated vans for remote shipments but service nearby pharmacies via motorcycles.

EDAK automated drug picking operation

EDAK motorcycle delivery for urgent requests. Non-temperature-sensitive drugs are put in the black carry-all. Cold chain products are put in EPS insulated containers with frozen gel packs and strapped to the back of the bike.
We left Izmir in the mid-afternoon for the seaside town Gümüldür, known as the land of tangerine, 80 km away. This would be the last leg on our incredible journey. Dr. Hakan Godednick, our logistics provider from Tip Kumuru (an accredited WHO learning center), deftly moved our merry band of cold-chainers across 550 km of Turkey without incident. He single-handedly arranged the bus, 5 different hotels, our hotel check-ins, all of our meeting locations, our dinners, lunches, stopovers, sightseeing tours and side trips, shuttles to the airport, all the course materials, our laptop bags, electrical outlets and beam projectors when we needed them for presentations, and any special personal or medical needs we encountered – all without missing a beat. Anything anyone needed, Hakan got it. He is truly an amazing organizer.
Our last place of residence was at Denizati (meaning Seahorse) Holiday Village on the Aegean Sea. After checking-in we were given 2 hours of free time. Most took advantage of the perfect weather and went swimming in the sea. Then, one more 90 minute presentation poolside by the mentors on risk management and a discussion on the EDAK facility. Had an early dinner (9:00 PM) and for the first time in 10 days I will get to bed before 1:00 AM. I am looking forward to wrapping things up tomorrow, with classroom style discussion until mid-day, a surprise afternoon activity, course evaluation, photo contest and gala dinner. Good Night.
Mentor Jim Vesper delivering a session on risk management poolside at Denizati Holiday Village. Dr. Umit Kartoglu documenting with camera.
Saturday, June 12

The Cold Chain Chronicles: Living la Vida Foca
by
Kevin O'Donnell
on Sat 12 Jun 2010 10:36 AM CDT
Daily reports from the WHO-PDA Pharmaceutical Cold Chain Management on Wheels Learning Experience
DAY FOUR:
FOCA –
Today we penetrate deeper into the dry and beautiful Turkish mountains and back in time as we continue down the pharmaceutical cold chain. Our first visit was to the Provincial Governor’s office where the Governor (and a host television media from Balikesir) welcomed us to the city - tea first, of course. This region of the country maintains a very successful model for healthcare distribution and administration, providing the benchmark for the rest of Turkey, a fact the Governor was pleased to point out. Upon leaving the Governor’s office we split into four groups and were driven by car to one of four of the nearly 20 Primary Health Centers in Balikesir to see how the Provincial Health Care Directorate (where we visited yesterday) further distributes vaccine to each individual primary health center (or hospital). This enabled us to assess how well storage and transport of cold chain products were maintained at the point prior to administration to the patient.
Vaccines are delivered twice monthly to the centers in temperature controlled trucks (those we saw yesterday) and monitored for temperature. The center stores them immediately. Patients are individually notified to come to the center for their scheduled inoculations, at no cost to them (it is a national program funded by the government). An outreach program is also administered whereby the doctor, nurse or midwife will go directly to the patient’s home.
We were warmly greeted by a swarm of nurses, doctors and midwives as we entered Health Center #11. The amount of pride these healthcare workers had in their facility and their patients was extraordinary. The center has 3 doctors and 15 nurses and each doctor sees about 150 patients a day. Cold chain storage and handling practices are very conscientiously maintained at this level of the supply chain.

Paulo Froes (foreground) asking questions of the doctor and nurses at Primary Health Center #11 in Balikesir

First, we have tea... discussion with staff following our visit the the Primary Health Center in Baliksir where the 2 doctors see as many as 150 patients a day
We had lunch with the Governor at a local kebab and our group conducted our afternoon warm-up on a busy sidewalk in front of the central railway station prior to getting back on the bus.
The next stop was to enjoy a little free time on the way to our next overnight destination at the ancient ruins of Pergamon,. Pergamon (3rd century B.C.) rose to prominence under the Romans in the 2nd century A.D. It is famed for its ancient medical center built to honor Asklopios, the god of healing. It is also the site of the world’s first psychiatric hospital. Many of its treatments came with a complement of sacred water (later discovered to be highly radioactive properties) and massage and herbal treatments still applied in today’s medical therapies. Quite unlike modern hospitals, many tried to become patients. It was more spa than hospital and patients included Hadrian, Marcus Aurelius and Caracalla.

The Sacred Way, Pergamon
On the way to Foca (pronounced foe-cha, by the way) we toured the manufacturing facility of StoroPack, an EPS and EPP molder who makes, among other things, insulated shipping boxes for temperature-sensitive medicinal products like those used in our Pharmaceutical Transport Challenge. Crossing over the mountains to the Aegean Sea we concluded the day with an evaluation of the day exercise on the beach. Tomorrow, it’s on to Izmir. Good night.

Group photo with StoroPack Managing Director Serhat Ozhan and Chief of Production Onder Cubukcuoglo, at their manufacturing facility near Izmir.
Thursday, June 10

The Cold Chain Chronicles: Bursa to Balikesir
by
Kevin O'Donnell
on Thu 10 Jun 2010 06:29 PM CDT
Daily reports from the WHO-PDA Pharmaceutical Cold Chain Management on Wheels Learning Experience
DAY THREE:
BURSA – BALEKISIR
As I was saying, we checked into our hotel around 10:00 PM, threw my bags into my room and immediately went to dinner. We walked for about a mile in a light rain (and downhill the entire way), through the busy streets of Bursa, Turkey’s fourth largest city. We came upon a narrow side street lined on either side with a series of restaurants and cafes teeming with patrons. This area of town is known as Arapsukru (Arab thanks). The din of laughter and live music trickled down the cobblestones like the subsiding rain. The owner of the Vira Restaurant greeted us. Vira, vira is a Turkish shanty of sorts, often chanted by local fisherman when hauling nets. The rain relented and we dined alfresco. Platefuls of calamari, salads, and snapper were passed in all directions as were bottles of red wine and Raki, the national drink - a clear liqueur made from Annis and usually diluted with water and one or two ice cubes. Joining us for dinner was a group of doctors who would host us at their facility in the morning. It wasn’t long before the Turkish in our party broke out in song. A local band tucked their chairs in with ours and entertained us all with a combination of music played at a schizophrenic pace: classical Turkish, gypsy and arabesque, prompting everyone in our party onto the dance floor. The partying continued long after I left (around midnight) and several of our group staggered “home” in the wee hours – some literally; others figuratively, roughly negotiating the mile-long hill back to the hotel.
Today was met with brilliant sunshine and we had a short bus ride to the Provincial Health Directorate Vaccine Storage facility in Bursa. We were escorted by our previous night's dinner colleagues to the office of the Provincial Health Director for tea. (Nothing ever seems to happen on our visits without first sharing in a glass of hot Turkish tea.) The PCCMoW participants were divided into groups to document the quality and performance of the vaccine store using a new Excel spreadsheet tool developed and used by WHO called Effective Vaccine Management, or EVM. The site scored very well. The pride pieces of equipment at this facility are a pair of custom cold chain vans specifically designed and built for the provincial health directorate for distribution of vaccines to the local primary health centers.

An EVM team admiring the new provincial cold chain van
Our afternoon remained sunny as we visited (in small groups) four retail pharmacies and assessed them using applicable sections of the EVM tool related to receipt and storage of cold chain products and equipment (such as refrigerator maintenance and monitoring.
We had a 150 km journey ahead of us to the next overnight destination and took a break at a roadside cafe to develop and present the days' findings. We unloaded from the hold of the bus the packages from the Pharmaceutical Transport Challenge that the participants assembled on Monday and exposed them to a few hours of long-awaited radiant heat before continuing on.
Arrived in Balikesir around 10:30. The mentors met in the lobby for a mid-course assessment and to gain feedback and constructive criticism from each other on sessions we conducted to date. This is the fourth night in a row that I have not gone to bed before 3:00 AM. Morning comes early. Good night...

Packages from the Pharmaceutical Transport Challenge intentionally
left in the sun on the road to Balikesir
Wednesday, June 9

The Cold Chain Chronicles: If it's Tuesday, This Must be Bursa
by
Kevin O'Donnell
on Wed 09 Jun 2010 05:59 PM CDT
Daily reports from the WHO-PDA Pharmaceutical Cold Chain Management on Wheels Learning Experience
DAY TWO:
BURSA –
Left Istanbul at 8:25 AM in a lashing rain, crossed the Bosporus and pulled into the parking lot of pharmacy wholesaler, FarmaLojistik one hour later.
FarmaLojistik was established in 2005 – a joint purchasing and logistics pharmacist cooperative serving the entire country. This is a first attempt to centralize drug distribution in-country and today the wholesaler handles more than 3200 SKU’s and 3,500 packages daily. A considerable portion of their business is maintaining the inbound, storage and dispatch of cold chain pharmaceutical products.
The management and staff, dressed in dark business suits and ties, received us in the rain as we bounded off the bus and welcomed us inside to a magnificent spread of food, tea and lemonade, large banners and an audience of several drug manufacturing representatives, hospital, pharmacy and supply chain manufacturers who came to share the experience and to answer questions we might have.

FarmaLojistik welcome reception. Foreground, L to R: Jeff Hawkins,
Bruce McCormick, Ajit Tamhane, Hamed Mahhmoud and Apichai Supasansatorn
We split into 3 teams for a facility tour and like DHL, they gave us an “all access pass” to their location.
FarmaLojistik’s cold chain processes are very well documented and organized; from IR temperature scanning on incoming product, to marrying and verifying product-shipper and data loggers together, a practice rigidly adhered to for every outbound insulated container. Locally produced (and beautifully molded) thermoformed durable containers in various sizes are those most often used in transport. They are insulated with PUR, completely reusable and controlled in a close-loop delivery system between FarmaLojistik’s 5 countrywide sites. Some have had as many as 180 turns and look nearly brand new. Their delivery routes are tightly controlled and they have never had an excursion using these containers in this system.

Turkish made Durable containers at FarmaLojistik
After sharing lunch at a local kabab with the warehousing and management staff and other local guests and dignitaries, we were back on the bus and headed south. The rain relented briefly as we boarded a ferry for the 30 minute crossing of Izmit Bay in the Marmara Sea.
Upon docking, the group convened for a warm-up – a twice daily ritual generally reserved for first thing in the morning and post lunchtime but rescheduled due to the rain in Istanbul. We motored southwest gradually gaining elevation for a work group session in the architecturally sublime village of Cumalikizik at the foot of Mt. Uludag.
We entered the tea house of a local merchant family who were very happy to see us. Removing our shoes and donning house slippers we climbed the narrow staircase of the 11th century home to the second floor containing three rooms ornately decorated with family memorabilia and photographs. The three teams staked out their cozy corner rooms on floor pillows and ottoman stools and wasted no time chiseling out their PowerPoint presentations from the FarmaLojistik visit. Behind the house in a rustic lean-to, a woman from the household dressed in traditional Islamic hijab,, rolled out flatbread on a stone table. Soon our rooms were filled with platefuls of “sandwiches” of cheese, potato and onion and fresh lamb warmed and rolled in the delicious and freshly prepared bread. Tea was also served in copious quantities.

Our shoes at the entrance to the tea
room in Cumalikizik
The presentations were given outside, where a white bed sheet was tacked up on the stone wall of the house and with several large umbrellas strategically placed about to shadow the wall. Much discussion followed and we descended the steep cobblestone streets at dusk to board the bus and head to our hotel in Bursa 18 km away.

Ute Rosekoph delivering her group's presentation in Cumalikizik
But the night was far from over! Details about dinner and the entertainment that followed I will have to describe tomorrow for two reasons: 1. it elapsed into day three and 2. because I’m really exhausted. These 18-20 hour days are beginning to catch up with me! Good night.
Tuesday, June 8

The Cold Chain Chronicles: The Journey Begins...
by
Kevin O'Donnell
on Tue 08 Jun 2010 07:13 PM CDT
Daily reports from the WHO-PDA Pharmaceutical Cold Chain Management on Wheels Learning Experience
DAY ONE:
ISTANBUL –
Turkey is a land of extraordinay dichotomy. Among other things it is claustrophobic and sprawling; subtle yet dramatic; secularly conservative though socially progressive. It is an effusive blend of cultures, food and peoples. It is where east meets west. The country boasts of its beaches comprised of four different seas and shares borders with eight countries. The ancient city of Istanbul has been inhabited for at least 8,000 years and occupies two continents (Europe on the west, Asia on the east), equally separated by a narrow strait called the Bosporus. It is here we begin our journey down the pharmaceutical supply chain.

Midnight in Istanbul
The Pharmaceutical Cold Chain Management on Wheels Course (PCCMoW) is a meticulously organized six day event – the brainchild of Dr. Umit Kartoglu of the World Health Organization, and held in conjunction with the Parenteral Drug Association and Tip Kurumu (a Turkish health NGO). We are 25 in number representing 16 different countries. We are course mentors, participants and industry observers – but it soon becomes obvious that we will soon become one big family.
To begin the course we were each issued laptop shoulder bags crammed full of materials we will need for this unusual learning experience: notebooks, pens, pencils, markers, post-it’s, tape, scissors, a calculator, a blank CD – (even a disposable raincoat!) and a personalized red binder that contains nearly every conceivable fact related to our journey; from detailed information of the places we will visit, to explanations about local geography and culture.
The morning began energetically at the Nippon Hotel in Istanbul with a uniquely devised introduction exercise. Everyone was handed a stringed bracelet of beads. There were 12 matching pairs. Participants had to seek out the individual with the identical bracelet and “interview” them - gather personal information unrelated to the course. We reassembled and name badges were drawn from a silver tray. Who ever interviewed the person whose name badge was drawn had to introduce them to the group by revealing the details of their interview. This set the tone that was to remain throughout the day. The rest of the morning was dedicated to a course overview and the week’s agenda and culminated with a group exercise called the “Pharmaceutical Transport Challenge” whereby five randomly selected teams (with little or no knowledge of insulated package design) had to develop, design and assemble a passive insulated shipping package from one of 5 different packaging technologies. Their designs had to be capable of maintaining 50 vials of vaccine within a refrigerated temperature range of 2-8°C for 72 hours during a simulated distribution process (stowed in the hold of our bus for 3 days). Internal package and external ambient temperatures would be recorded using electronic data loggers and milk chocolate (the significance of which will be revealed later in the week.). The temperature data would be downloaded onto a laptop computer for analysis at the conclusion of the exercise.
The purpose of this activity is to introduce participants to various insulated packaging material technologies, passive refrigerants and temperature conditioning in order to understand their various applications and limits. Through simulation, participants would discover performance variations of these materials when subjected to identical transport environments. At the end of the exercise on Thursday we will discuss the results and the economic and environmental considerations of material selection.

Bruce McCormick, Apichai Supasansatorn, and Roger
Sabat working on the Pharmaceutical Transport Challenge
After lunch we loaded the 5 insulated shippers for the challenge into the belly of the bus and drove though the pouring rain to a DHL warehousing facility 28 km west of Istanbul. The folks at DHL could not have been more gracious. No question went unanswered; no area was off-limits. It was amazing to see the thoroughness and precision of their cold chain operations for pharma customers. A Novo-Nordisk pharmacist, the responsible person for release of product at the facility, took us through the step-by-step procedures for customs quarantine, receipt, storage, pick-list, and dispatch of product for distribution throughout Turkey.

Pick-pack process at DHL Istanbul. L to R in orange
vests: Jeff Hawkins, Paulo Froes, Jose Rovira-Vilaplana,
Joseph Jayakar
When we returned to the city center we walked (still raining) to a nearby restaurant where in the wine cellar-turned-make-shift conference room, participants prepared and presented their findings and observations from our visit to DHL.

Standing: Alex de Beaupuy and Rafik Bishara delivering a group peresntation
A group dinner and a few adult beverages later, and everyone was ready to call it a night. A good night’s rest well deserved. All-in-all, a very satisfying start to the program. It’s back on the bus tomorrow at 8:00 AM as we head to Farmalojistik and on to Cumalikizik, a preserved 11th century Ottoman village.
It's nearly 3:00 AM here in Turkey so I'll bid you all a good night and hope to update you tomorrow.
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