__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use facilitated this phenomenon. OxyContin contains a larger amount of high-potency opioid than short- acting opioid formulations. The delayed-release mechanism was easy to circumvent by chewing and swallowing or by crushing the pill and then injecting or snorting the powder. This produced a rapid, pow- erful opioid effect on par with heroin. Large profits were also possible from illicit sales of OxyContin, which generally commanded a black-market value of $1 per milligram (with higher prices in more rural areas) [51]. In addition, the original product labeling warned against crushing the tablets because rapid release of a potentially toxic amount of oxycodone would ensue, alerting abusers on how to best achieve maximum drug effect. The original labeling also included the FDA-condoned statement that the extended-release (ER) mechanism of OxyContin presented a lower abuse potential than other oxyco- done products. Perhaps most importantly, its release coincided with the growing acceptance of opioids in pain treatment and the aggressive sale and marketing tactics of its producer, Purdue Pharma [43]. pain, partially a result of the stigma surrounding morphine. OxyContin was introduced in late 1995, at the point in time when prescriber attitudes were shifting from fearing iatrogenic addiction to devel- oping a sense of security with prescribing opioid analgesics [43]. To help ensure product success, innovative approaches were employed to elevate visibility and encourage OxyContin prescribing, as well as highly aggressive marketing and sales tactics. The amount of money spent in promotion, marketing, and sales was unprecedented for an opioid, exceeding $200 million in 2001 alone [52]. Marketing and promo- tion efforts and the timing of the product launch resulted in a tenfold increase in OxyContin pre- scribing and sales revenue in just three years’ time ( Table 6 ) .
In addition to the usual doctor-directed ads in medical journals, a novel indirect marketing campaign involving “nonbranded education” was implemented. Direct-to-consumer advertising of opioid drugs was prohibited, so the concept of pain relief from opioids was promoted to consumers without explicit mention of OxyContin. The public- education program Partners Against Pain (PAP) was launched, with videos, patient pain journals, and an elaborate website that marketed (to prescribers and patients) the message that pain was widespread and treatable with opioid analgesics [43; 53]. The FDA later stated that the PAP website did provide information about OxyContin specifically and also contained a “Find a Doctor” feature to link consum- ers to physicians in their geographic area known to be willing to prescribe OxyContin [43].
The timing of product launch was fortuitous. Until the 1990s, Schedule II opioids were primarily lim- ited to use in operating rooms and inpatient settings because they required intravenous or intramuscular administration. This posed a serious obstacle to patients with chronic pain who required high- potency opioids. In response to the increasingly per- missive climate and by genuine unmet patient need, several high-dose ER formulations of pre-existing opioids were introduced to market. MS Contin, an ER version of morphine sulfate, was introduced in 1985 but was primarily limited to use in cancer
OXYCONTIN SALES AND PRESCRIBING, 1996–2002
Year
Sales
Increase from Previous Year
Number of Prescriptions
Increase from Previous Year
1996 1997 1998 1999 2000 2001 2002
$44,790,000 $125,464,000 $286,486,000 $555,239,000 $981,643,000 $1,354,717,000 $1,536,816,000
N/A
316,786 924,375
N/A
180% 128%
192% 107%
1,910,944 3,504,827 5,932,981 7,183,327 7,234,204
94% 77% 13% 13%
83% 69% 21%
7%
Source: [43]
Table 6
13
MDMS1526
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