Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
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Friday, June 29, 2012

Threat to prescribed pain relief for failed device?

http://bit.ly/LzyYVT

How to intelligently prevent opioid abuse

Acute and chronic pain is bad. Proper pain management is essential and has been strongly emphasized by the American medical establishment for the past nearly two decades.
Simultaneously, during these years, both the quantity of opioids prescribed by physicians and dentists has increased dramatically and prescription opioid abuse has escalated at an alarming rate among chronic pain patients and the general population. Opioid analgesics now result in more American overdose deaths than cocaine and heroin combined.
What should physicians do? For treatment of chronic pain, non-opioid analgesics should be the first-line agents.
Physicians and nurses must discuss with patients common opioid side effects such as constipation and sedation, other risks such as addiction and overdose, and potential long-term risks such as hyperalgesia and sexual dysfunction.
Short-acting opioids such as Dilaudid (hydromorphone) and Vicodin (hydrocodone/paracetamol) may be helpful for initial pain relief, but longer-term dosing can lead to breakthrough pain and withdrawal, and these agents carry a relatively high abuse potential.
Oxycontin (oxycodone CR) is also widely abused, especially in rural areas; its elevated dosage means it is highly addictable, and coverage by insurance makes it cheaper than heroin.
Longer-acting opioid analgesics such as Suboxone (buprenorphine), methadone, and fentanyl have a much lower abuse liability. However, methadone is found in more overdose deaths than any other prescription opioid and should not be prescribed for opioid-naive patients. Because analgesic effects of methadone are of shorter duration (6 to 9 hours) than its half-life (36 hours), levels may accumulate, leading to respiratory suppression or cardiac events.
Patients should be instructed to keep controlled substances safe in a locked location to prevent use or sale by others.
If a physician intends to prescribe opioids for chronic pain, a narcotic protocol – medication contract, psychological evaluation, and urine toxicology – should be considered. Monitoring both urine toxicology and aberrant behaviors will detect more opioid abuse than either strategy alone.
Combining a clinical interview and the SOAPP (Screening and Opioid Assessment for Patients with Pain) yields the highest sensitivity (.90) for abuse detection.
A “universal precautions” approach to minimizing risk includes asking patients about history of substance abuse, written informed consent, and ongoing reassessment of the benefits of opioid therapy. Clinicians can thus triage patients to low-, medium-, and high-risk addiction potential. Treatment agreements should delineate rules such as having no early refills and requiring urine toxicology.
For patients who develop opioid addiction, substitution with buprenorphine or another abuse-deterrent formulation and adherence monitoring can be implemented.
The medical establishment should develop and use effective analgesics with lower abuse potential. Current research efforts to identify better methods to detect patients at heightened risk for developing addiction should be supported.
All prescribers of opioids must actively manage pain control while aggressively and intelligently attempting to prevent opioid abuse.
George Lundberg is a MedPage Today Editor-at-Large and former editor of the Journal of the American Medical Association. Maria A. Sullivan is an Associate Professor of Clinical Psychiatry in the Division on Substance Abuse at Columbia University and the New York State Psychiatric Institute.
 Comment by Joleen Chambers (FiDA blog)
So . . . those innocent patients who received prescription pain medication (e.g. long-term maximum dose hydrocodone) will be side railed into a "new" medical plan to EVALUATE their pain/addiction level (eliminate the current prescription).  How is this new program customized to a victim of a failed implanted medical device (FDA MedWatch #5009052)? The cascading damage of failed device, pharma evasion of untreated serious dry mouth side-effect on dental health,  medical abandonment, insurance abandonment, inaccessible justice, and now potential coercion into withdrawal or alternate medication so that the medical community can move on.  How is this patient-centered? The prescribing doctors need to experience this kind of treatment:  they have no concept.    

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