STUPID Inc. is an acronym for Strategic Topical Use of Pancron for Individual Dosage Incorporated. The company makes the drug Pancron (chemical name: xyolgygol) for individual use in treating Urinary Dysfunction Disease (UDD) – in direct opposition to FDA recommendations. While the FDA has not banned ‘over-the-counter’ Pancron, it has advised STUPID managers that the drug has not been objectively tested for general long-term safety or side-effects. This means that the drug must be labeled in accordance to FDA guidelines for over-the-counter sales of non-tested drugs. Pancron is one of 20 drugs marketed by various drug companies to treat UDD. In solution, each dose contains 5% xyolgygol, and 10% aspirin as active ingredients, and 10% alcohol, 5% sucrose, and 70% distilled water as inactive ingredients. Adults can take up to two tablespoons per day, while the drug is not recommended for children or pregnant women. This means that the label must contain:
1- The chemical and common name(s) for the drug.
2- Dosage recommendations for both Adults and Children.
3- Active ingredients and % of volume for each ingredient.
4- Inactive ingredients and % of volume for each ingredient.
5- Calorie and nutrition information.
6- Any possible side-effects that have been discovered by the company
that affect more than 1% of test subjects.
7- Emergency contacts and procedures.
8- Company name and manufacturing location (Country and City).
9- Possible drug and/or allergic interactions affecting more than 1% of
test subjects.
The drug has been on the US market for 6 months and has made a ‘mint’ for STUPID. Pancron costs $10 per bottle to manufacture in Hong Kong, China, while it sells for $185.00 wholesale in the US. Prior to selling the drug, STUPID tested the drug for 6 months on 300 college-age students. During this test, they found that Pancron was effective in treating UDD, but it was correlated with a skin rash on 5% of subjects; caused severe nausea and vomiting in 7 cases; death in 1 case; miscarriage in 10 cases; and a worsening of UDD symptoms in 2 cases. The label indicated that in case of side-effects, a customer should call 1800-MOR-ESTUPid (Monday – Friday 9am – 5pm, EST).
STUPID researchers also found that,
a- a topical application of 1% Cortisone healed the skin rash in 100% of the effected cases;
b- the only death occurred in a 45-year old male with heart disease after his blood-pressure had risen above 160/100 within one hour after taking the drug;
c- the severe nausea and vomiting went away in 5 of the 7 cases within 5 minutes after the test subjects ingested one glass of whole milk (the other 2 cases required immediate hospitalization to replenish fluids and ease the vomiting);
d- nothing the researchers tried stopped the miscarriage in pregnant women; and
e- the 2 test subjects with ‘worsening UDD cases’ improved within 24 hours after ceasing to take the drug.
STUPID’s managers have agreed to meet only the minimum FDA requirements for labeling and emergency contact.
INSTRUCTIONS:
1- Develop a Product Service Agreement for Pancron customers. (Communicating a PSA on a commodity product is accomplished through the product labeling.) Use only the information provided in the case to answer this question.
2- Assume that STUPID is in the process of developing a call center for the emergency number included in its PSA (product label). You must develop a Flow Chart to train call center workers in how calls should be routed to handle emergencies – the process begins when a person calls 1-800-MOR-ESTUPid? Limit your answers to information contained in the case, but use your experience with call centers to do a good job. Limit your flow chart to 40 symbols. THINK THROUGH THIS CAREFULLY.
3- Critique STUPID and suggest ten things that the company might improve in its CRM process and other processes mentioned in the case.
