A day in the life of a pharmaceutical sales representative encompasses a lot of different roles. From teacher and presenter to a rolling pharmacy on wheels, reps are responsible for delivering multiple sample prescription products to doctors. Besides spending a good deal of time in an office during the week, a much greater amount of time will be spent driving back and forth to visit different clients, sometimes as much 150 miles or more in one given day.
While it is essential that a drug representative knows everything there is to know about the product they are promoting for their company, a crucial element that can be forgotten in the reps training regimen or daily activity schedule is the effects of temperature on their product over time.
If a rep lives anywhere in the Southern United States, as I do, they know that often times the temperature in the summer can reach 100 degrees or more. In a parked un-air-conditioned car, however, these temperatures can reach 120 to 140 degrees Fahrenheit.
So what does the compliance side of the discussion look like?
Drug samples fall under the same guidelines as the FDA, Health Canada, and other agencies. US Pharmacopeia quality standards require regulated storage conditions (containers and refrigeration), qualified vehicles, and trained personnel.
The Prescription Drug Marketing Act of 1987 and the ensuing regulations in 21 CFR Part 203, Prescription Drug Marketing, and Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, provide the necessary regulations and guidance for several legs of the distribution chain for the prescription drug. Some states even have additional controls in place. The State of Washington, for example, adds to national standards, giving specifics to drug representative distribution practices by adding manufacturer’s liability, penalties, and seizure of drug samples.
A big concern, however, is what is in practice versus stated regulation. Without proper education and storage equipment many consumers, doctors, pharmacists and even the sales representatives themselves don’t realize the gaps that begin when the samples are shipped from the manufacturer/wholesaler to the sales rep homes. This gap is where companies can get into some serious trouble.
How do manufacturers and wholesalers transport pharmaceuticals safely
Generally, extreme temperature conditions (like excessive heat and freezing) should be avoided. This requires careful selection of distribution systems that take into account basic operational constraints, including accountability and timeliness. The manufacturer’s FDA-approved storage conditions should be printed on the product labeling and the shipping container.
Your logistics team is most likely already shipping your drug samples to reps in qualified packaging. If they aren’t or these costs are too high, consult a cold chain services professional.
If a rep is receiving more samples than are needed in a single day, as is typically the case, they will need a qualified, monitored refrigeration system in their home. By qualified, we mean, not a dorm refrigerator or your kitchen refrigerator, but a regulated, temperature monitored unit set up in a temperature regulation environment (inside, not the garage). There are quite a few options available through distributors. contact us for a reference.
If you estimate a sales rep will meet with 12 doctors in a day, the cooler needs to be able to handle 12 daily openings. You also should assure the cooler is qualified based on the temperature requirements of drugs in transport as well as the temperature conditions of the storage environment. Look for lightweight, prequalified coolers that can use PCMs and withstand multiple openings. The amount of refrigerant contained is based on an anticipated exterior condition approximating controlled room temperature. For example, if your rep is based in Arizona, they may have a different need than one based in Philadelphia. Engel makes a rugged, lightweight cooler that can withstand any punishment and has been qualified for up to 30 openings in a single day. This makes it ideal for most environments.
Download our new paper and infographic on pharmaceutical transport risk.
If you are not sure which type of container, refrigerator or cooler to use, contact us for more information.
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