I recently returned from the Republic of Turkey where, for the third time, I was invited to serve as a mentor on the World Health Organization’s highly acclaimed Pharmaceutical Cold Chain Management on Wheels Course. It was an exhausting but invigorating weeklong, 750 km trek by motor-coach that meanders through the country’s tightly controlled pharmaceutical supply chain. The course focuses primarily on the vaccine supply — from the first to the last mile — with visits beginning at an import facility, then on to a co-op, a regional vaccine store, a public university hospital, a wholesaler, several primary healthcare facilities and finally, privately owned corner pharmacies. This year, the 14 course participants were an energetic and cohesive band of public health workers, drug manufacturers, wholesalers, federal regulators and industry suppliers from 10 different countries. They all came to Turkey to benchmark cold chain distribution practices.

Every year I return from this adventure culturally enriched and massively overloaded with information on Turkey’s astonishing ability to control its pharmaceutical supply chain processes. (Turkey rightfully boasts the only national drug track & trace program in the world.) I am equally impressed by the high level of cold chain practice, knowledge, expertise and dedication exhibited by those involved throughout the entire supply chain.

One practice that continues to grow in both frequency and sophistication in the Turkish pharma supply chain is temperature monitoring. While common upstream at the manufacturer, wholesaler, and regional healthcare level, where large volumes of expensive temperature-sensitive drugs are stored and distributed, I was pleasantly surprised to see such an extensive array of redundant monitoring systems at the primary health centers and at privately owned pharmacies. The technology at these “last miles” of the supply chain ranged on the one end from centralized monitoring systems with audible and visual alarms, and SMS notification, to continuous data-logging devices within refrigerators and freezers, and inexpensive electronic freeze indicators on the other. Scheduled maintenance, back-up power supplies and the use of cold-sinks inside small domestic refrigerators were also common practice. Employees that my team of students and I spoke with were very familiar with their systems’ operations; procedures were well documented and, when surveyed, employees seemed well informed on carrying out escalation procedures.

The staff at the Sağlik Bakanliği Primary Healthcare Facility in Balikesir was especially memorable. One of the six doctors assigned to the facility and her nurse gave us free rein to inspect and photograph the entire center. The doctor is responsible for 4,000 patients and the administration of a vaccine regimen for all the children in her district from birth to age 14. First, we had tea. Then we spent nearly two hours with them as we poked and prodded and peered and served up an unending litany of questions — all of which were patiently answered even when language became an occasional barrier. We were all grateful for our hosts’ time at their bustling healthcare center. They, in turn, were equally gracious in accepting our comments and suggestions for improvement.
I found their attitude simply astonishing.

Shortly after returning to the U.S., I made arrangements with my doctor’s office to get a tetanus shot, which I needed for an upcoming trip to India. The nurse assigned to take my vitals cheerfully bounded into the examination room where I had been waiting. Setting the vaccination paraphernalia down on the counter she hurriedly directed me through the usual and customary “vitals” choreography. She became increasingly irritated and defensive when I sat down and began asking her questions about how their vaccines were stored and what systems they had in place to assure that the cold chain had not been broken.

“And where do you store your vaccines? I asked.

“We have a refrigerator back by the nurses station,” she replied.

“A household-type refrigerator like you’d get at an appliance store?”

“Yeah. Nothing fancy but, you know, like one you’d have in your kitchen. It’s a good one,” she assured me. “A Kenmore, I think.”

“Oh, sure, Kenmore. We could never afford one of those when I was a kid.” I said. “Do you monitor it for temperature?”

The nurse stopped filling out my chart momentarily; “we keep a thermometer on the shelf inside.”

“Oh?” I replied. “What does that tell you? I mean, how often do you look at it or log the temperature? A couple of times a day? At least you know that if it’s within range when you look at it that it’s right twice a day, right!”

She didn’t answer. She stepped over to me and wrapped a blood pressure cuff around my bicep.

“So, exactly how do you know if your refrigerator is working properly — within spec? Glaring down at me she snugged the cuff a little tighter.

“I mean, haven’t you ever been curious to know how varied the temperature in the fridge might be? Or to see if certain sections ever goes below freezing and what impact that might have on freeze-sensitive vaccines like tetanus?” I asked.

“No. It doesn’t freeze. I’ve never seen it freeze,” was her answer.

“My point exactly,” I shrugged.

“We receive our refrigerated drugs in Styrofoam coolers with these frozen gel pack things. We take them out of the box and put them directly into the refrigerator. No one freezes them,” she said, inflating the blood pressure cuff uncomfortably more than it needed to be. She slipped a stethoscope into the crook of my arm.

“Okay. But how do you know for sure that they weren’t — at one time — frozen? I’m sure you’re aware that if most vaccines ever become frozen they are, well, garbage, leaving the patient virtually unprotected,” I commented, looking at her over the top of my eyeglasses.

There was an awkward moment of silence as she slowly released the air valve and concentrated on the bouncing needle on the pressure dial. She hastily tore off the cuff.

“I don’t come to your office and tell you how to do your job, do I?” She snapped as she wrote her findings on my chart.
“Ma’am, these questions that I’m asking you? This is my job,” I said.

She turned towards me. “And when you go out to dinner at a restaurant do you ask the cook how he stores his food and what kind of refrigerator he has?” She asked tersely.

“No ma’am, I don’t. But he’s required to use a commercial-grade refrigerator, and he’s required to keep it monitored, and his facility is regularly inspected by the Health Department to make sure he complies. Who audits you?”

She flipped her stethoscope over her shoulders and slipped her pen back into her pocket.

I told her I meant not harm, that I was just concerned about their practices. Frankly, the deleterious short-term effects of Salmonella from one bad soufflé are of far less consequence to me than the long-term effects of Clostridium compliments of an ineffective tetanus shot.

She was having none of it, and quickly stepped toward the door. “Doctor will be with you in a moment,” she sighed, as she flung open the examination room door and stepped into the noisy corridor.

A few minutes later the doctor strolled in. “I hear you’ve been giving one of my nurses the third degree,” she said.

“Nothing personal. Just looking for some assurances. She certainly didn’t instill any confidence that what I was about to get injected into my arm wasn’t compromised as result of mishandling or temperature abuse,” I said.

“There are other places you can get your vaccination from, Mr. O’Donnell.”

I found their attitude simply astonishing.

As I slipped my shirt back on I asked, “Have you ever been to Turkey, Doctor? You really ought to go.” 

As a follow-up to this article, next month I plan on reporting the results of a small study that I have been conducting on temperature monitoring at the pharmacy/last mile level. I had hoped to have results in time for this deadline but I have met with an unexpected level of resistance and lack of cooperation from local pharmacies.