Tag Archives: acetaminophen

Stop Overpaying for Pharmaceuticals

Legislators in all jurisdictions have attempted to rein in the cost of pharmaceuticals in workers’ compensation in an effort to reduce insured employers’ workers’ compensation premiums.

California, in particular, passed legislation between 2002 and 2007 to reduce pharmaceutical costs, yet expected reductions have not been forthcoming. Attention needs to focus on whether claims administrators have taken full advantage of this legislation and whether they could be doing more to help reduce the cost of pharmaceuticals.

A recent Workers Compensation Research Institute (WCRI) study titled “Are Physician Dispensing Reforms Sustainable?” found that the average price paid in California for 5mg and 10mg Cyclobenzaprine, a muscle relaxant, ranged from $0.35 to $0.70 per tablet (from the first quarter of 2010 through the first quarter of 2013). An independent study of Medi-Cal pharmaceutical prices used for California Workers’ Compensation found, however, that since 2009, 10mg Cyclobenzaprine has been priced at $0.10 per tablet and as low as $0.05, while 5mg Cyclobenzaprine has been priced at $0.16 per tablet and has also been as low as $0.05. The comparison suggests that claims administrators have overpaid.

The 2006 California Commission on Health and Safety and Workers’ Compensation (CHSWC) study titled “Impact of Physician-Dispensing of Repackaged Drugs on California Workers’ Compensation, Employers Cost, and Workers’ Access to Quality Care” also showed significant cost differences. For example, an insured employer’s estimated total cost for each tablet dispensed at the correct Medi-Cal price of $0.10 was $0.29 per tablet. For each tablet dispensed at a price of $0.35, estimated total costs increased by between $0.70 and $0.99. When dispensed at $0.70 per tablet, estimated total costs increased by between $1.69 and $1.98 per tablet. This significant increase is directly caused by claims administrators paying far more than the published Medi-Cal price.

What can claims administrators do to ensure they do not overpay for medications?

First: Monitor medications dispensed. Second: Ensure that no more than the legislated maximum price is paid.

The California Department of Industrial Relations (DIR) website provides a medication pricing inquiry screen requiring entry of a National Drug Code (NDC) and other details taking approximately 10 seconds to obtain the price of a medication on the date it was dispensed. In addition, current pharmaceutical pricing data is available that can be loaded into a claims administrator’s computer system or program, such as a spreadsheet. To complement the DIR’s offerings, the U.S. Food and Drug Administration (FDA) website also provides NDC inquiry and download facilities, plus a downloadable file of suppliers of medications showing their labeler code(s) along with their company name. The labeler code is the first of three parts associated with the NDC identifying the supplier of the medication. For claims administrators wanting to know more about medications, the FDA offers the “Orange Book” for download, listing all FDA-approved medications along with therapeutic equivalence evaluations. With all this free information, California workers’ compensation claims administrators have no excuse for overpaying.

For jurisdictions that utilize the average wholesale price (AWP) to set their maximum price for a medication, claims administrators will need to license pricing information from sources such as Medi-Span (Wolters Kluwer Health) or Red Book (Truven Health Analytics). Both offer extensive pharmaceutical information for download into a claims administrator’s computer system or, alternatively, use of the vendor’s inquiry facilities.

The passing of legislation in California that set the same prices for medications regardless of dispenser (i.e. pharmacy, mail order/PBM or physician) has provided opportunities for medications to be dispensed by a physician without paying a higher price and for more accurate and timely details relating to medications being available to claims administrators.

The invoice a physician submits (either paper or electronic), includes services rendered at the person’s medical appointment with a report outlining their current medical conditions and other pertinent information, including the date of their next medical appointment. Receiving billing details on the same invoice for medications dispensed, which would include the NDCs, quantities dispensed and prices charged, provides the claims administrator with an excellent opportunity to review the appropriateness of the medication against the diagnosis and treatment plan as well as the prices charged, all in one step. In addition, there is the opportunity to review any physician treatments that differ from the norm (i.e. guidelines), which may be necessary so as not to interfere with any non-work-related treatments under the control of the person’s own physicians.

In cases of pain management and where step-therapy is used, the claims administrator can ensure that physician-dispensed medication quantities are limited to the next medical appointment and assist in determining when the person may be able to either return to work or stay at work during their recovery. In many cases, acute pain is treated with acetaminophen (aka paracetamol) and nonsteroidal anti-inflammatories (NSAIDs), allowing a person to either stay at work or return to work earlier. At times, however, narcotic analgesics may be required to control pain that blocks pain receptors to the brain, slowing the person’s cognitive function and reaction times, possibly restricting their ability to either stay at work or return to work early.

Claims administrators also have the opportunity to monitor a physician’s pharmacy formulary to ensure they are dispensing medications from suppliers with the lowest or the average lowest price for a medication. Claims administrators should never have to pay the “no substitution” price for a physician-dispensed medication. For some medications, the Medi-Cal “no substitution” price can be much higher than the regular price.

Considering that claims administrators currently perform some form of medical bill review, to include pharmacy price and utilization verification would add minimal additional effort to the overall medical bill payment process, regardless of whether the physician’s invoice is received on paper or electronically.

Claims administrators with computer systems that monitor medications through the NDC have the opportunity through physician dispensing to invoke timely automated processes based on the NDCs shown on the physician’s invoice. For example, if claims administrators use an adaptation of the biopsychosocial and shared-decision making frameworks (i.e. collaboration) to address a stay at work (SAW) or early return to work (ERTW), a more empathetic approach to claims handling is required. This SAW/ERTW approach can be enhanced through invoking processes based on the physician’s submitted NDCs, which may include: a pre-defined questionnaire associated with distress and risk, focusing on somatic and emotional symptoms: a pre-existing anti-depressant medications questionnaire that establishes whether the person is already taking anti-depressants’ as well as a cultural sensitivity questionnaire relating to a person’s religious or spiritual beliefs and their cultural and language preferences. The results from these questionnaires can directly influence the medical treatment pre-authorized by the claims administrator as well as assist in determining when the person is likely to return to “normality.” All this information directly influences the cost of the claim, which in turn determines the future premiums paid by the insured employer. For claims administrators who do not have capabilities such as these in their computer systems, there are systems available.

Having physician-dispensed medications billed in a timely way on the same invoice as other medical services improves both transparency and accountability. This recent WCRI study has highlighted that insured employers in California may have paid higher premiums for policy periods from 2011 through 2014, caused by claims administrators overpaying for the 5mg and 10mg Cyclobenzaprine medications, which was only brought to the attention of the workers’ compensation community in 2015.

Considering that expected savings from the enacted California legislation relating to pharmaceuticals have not been forthcoming, it is only a matter of time before insured employers conduct their own studies investigating how much has been overpaid for dispensed medications and how much this overpayment may have increased their premiums since 2007. Depending on the findings from this type of study, a possible outcome could result in California workers’ compensation insurers being forced to restate their claims costs associated with pharmaceuticals and all pharmaceutical overpayments by their claims administrators to be treated as an expense outside of their workers’ compensation insurance portfolio.

When Is It Right to Prescribe Opioids?

Opioids have been used for thousands of years in the treatment of pain and mental illness. Essentially everyone believes that opioids are powerful pain relievers. However, recent studies have shown that taking acetaminophen and ibuprofen together is actually more effective in treating pain. Because of this, it is helpful for medical professionals and patients to understand the history of these opioid medications and the potential benefits of using nonsteroidal anti-inflammatory drugs (NSAIDs) instead.

Extracted from the seedpod of the poppy plant, opium was the first opioid compound used for medicinal purposes. The active ingredients of opium are primarily morphine, codeine and thebaine. Opium and its derivatives have had more impact on human society than any other medication. Wars have been fought and countless lives have been lost to the misuse, abuse and overdose of opioids. It is also clear, however, that many received comfort from pain when there was no other alternative. For thousands of years, opium products provided the only effective treatment of pain and were also used to treat anxiety and depression. Tolerance, dependence and addiction were identified early as a problem with opioids.

In 1899, Bayer produced and introduced aspirin for wide distribution. It became the first significant alternative to opioids for treating pain. Aspirin not only relieves pain but also reduces inflammation and is in the class of NSAID medications. Aspirin was commonly used for mild pain such as headache and backache. Other NSAID medications followed with the development of ibuprofen in 1961, indomethacin in 1963 and many others over the next 20 years. While these drugs are not addictive or habit-forming, their use and effectiveness were limited by side effects and toxicity. All NSAID medications share some of the same side effects of aspirin, primarily the risk of gastrointestinal irritation and ulcer. These medications can also harm renal function.

Acetaminophen was created in 1951 but not widely distributed until 1955 under the trade name Tylenol. Acetaminophen is neither an opioid nor an NSAID. Tylenol soon became another medication that was useful in the treatment of pain, offering an alternative to the opioid medications and to aspirin. Acetaminophen avoids many of the side effects of opioids and NSAIDs b­ut carries its own risk with liver toxicity.

Efficacy in acute pain

Since the development of acetaminophen, medical professionals have had the choice of three different classes of medications when treating pain. Those decisions are usually made by considering the perceived effectiveness of each medicine and its side effects along with the physical status of the patient. For example, acetaminophen should not be taken by someone with advanced liver damage; NSAIDs should not be given to an individual with advanced kidney disease or stomach ulcers; and opioids pose a potential risk to anyone with a personal or family history of addiction.

Although many have long been believed that opioids are the strongest pain medications and should be used for more severe pain, scientific literature does not support that belief. There are many other treatments that should be utilized for treating pain. Studies have shown NSAIDs are just as strong as the opioids.

Number needed to treat

When considering the effectiveness or the strength of pain medications, it is important to understand one of the statistical measures used in clinical studies: the number needed to treat (NNT). NNT is the number of people who must be treated by a specific intervention for one person to receive a certain effect. For example, when testing pain medications, the intervention is the dose of pain medication, and the effect is usually 50% pain relief. That is considered effective treatment, allowing people increased functional abilities and an improved quality of life (Cochrane. org, 2014). So the question becomes, how many people must be treated with a certain dose of a medication for one person to receive 50% pain relief (effective relief)?

A lower NNT means the medicine is more effective. A product with an NNT of 1 means that the medicine is 100% effective at reducing pain by 50% — everyone who takes the medicine has effective pain relief. A medicine with an NNT of 2 means two people must be treated for one to receive effective relief. Or, alternatively, one out of two, or 50%, of people who take the medicine get effective pain relief. An example of a medicine that would not be a good pain reliever would be one with a NNT equal to 10. In such a case, you would have to treat 10 people for one to receive effective pain relief. Basically, the medication with the lowest NNT will be the most effective. For oral pain medications, an NNT of 1.5 is very good, and an NNT of 2.5 would be considered good.

Treating chronic pain

Despite the widespread use of opioid medications to treat chronic pain, there is no significant evidence to support this practice. A recent article reviewing the evidence regarding the use of opioids to treat chronic non-cancer pain concluded, “There is no high-quality evidence on the efficacy of long-term opioid treatment of chronic nonmalignant pain.” (Kissin, 2013, p. 519) A recent Cochrane review comparing opioids with placebo in the treatment of low back pain came to a similar conclusion. This review said that there may be some benefit over placebo when used for short-term treatment, but no evidence shows that opioids are helpful when used for longer than four months. There is no evidence of benefit over non-opioid medications when used for less than four months. (Chaparro et al., 2014)

Several other reviews have also concluded that no evidence exists to support long-term use – longer than four months – of opioids to treat chronic pain. (Kissin, 2013; Martell et al., 2007; McNicol, Midbari, & Eisenberg, 2013; Noble et al., 2010)

Epidemiologic studies have also failed to confirm the efficacy of chronic opioid therapy (COT) for chronic non-cancer pain. A large study from Denmark showed that those with chronic pain who were on COT had higher levels of pain, had poorer quality of life and were less functional than those with chronic pain who were not on COT. (Eriksen, Sj.gren, Bruera, Ekholm, & Rasmussen, 2006)

In the last 20 years in the U.S., we have increased our consumption of opioids by more than 600%. (Paulozzi & Baldwin, 2012) Despite this increase, we have not decreased our suffering from pain. The Burden of Disease study in the Journal of the American Medical Association (JAMA) showed that Americans suffered as much disability from back and neck pain in 2010 as they did in 1990 before the escalation in the prescribing of opioids. (Murray, 2013) A study in JAMA in 2008 found, “Despite rapidly increasing medical expenditures from 1997 to 2005, there was no improvement over this period in self-assessed health status, functional disability, work limitations or social functioning among respondents with spine problems.” (Martin et al., 2008, p. 661)

It is currently estimated that more than 9 million Americans use COT for the treatment of chronic nonmalignant pain (Boudreau et al., 2009). When we consider the proven benefits of this treatment along with the known risks, we must ask ourselves how we can ethically continue this treatment.

The reality is we really don’t know if COT is effective. Anecdotal evidence and expert opinion suggest it may be beneficial in a few, select people. However, epidemiologic studies suggest that it may be doing more harm than good.

Terminal care

The treatment of incurable cancer, end-stage lung disease and other end-of-life situations are notable examples where opioid medications are absolutely indicated. Although opioid painkillers are not very good medications for the treatment of pain, they are very strong psychotherapeutic agents. They are excellent at relieving anxiety and treating depression for a limited time. Opioids cause beneficial changes to brain serotonin, epinephrine, norepinephrine, dopamine and endorphins. For short-term, end-of-life situations, these neuropsychiatric effects are likely beneficial. For terminal care, opioids are the medications of choice.

Conclusion

The opioid medications are often referred to as “powerful painkillers.” In fact, the evidence shows that they are mild to moderate painkillers and less effective than over-the-counter ibuprofen. They have, however, powerful side effects that harm hundreds of thousands of individuals every year in the U.S. Even if one disregards the public health problems created by the use of opioid painkillers, these medications still are not a good choice for the treatment of acute pain — regardless of the severity. In some situations, limited use is appropriate. But in the majority of situations in which opioid painkillers are used today, they are not appropriate.

The standard of care in the practice of medicine today is to provide the best treatment that causes the least harm. When there is a treatment that is proven to be both more effective and safer, it is the treatment of choice. The implication of this data for policymakers is critical. By implementing policy that puts restrictions on opioid prescribing to protect public health, policymakers will also improve the treatment of pain by guiding prescribers to use medications that are more effective. It is also important for the medical and dental communities to address this inadequate and unsafe treatment of pain and change practice standards to guide care that is more appropriate for what our patients need and deserve.

This is an excerpt from a paper that can be downloaded in its entirety from the National Safety Council.