practice of Medicine
Orthopedic Surgery Toolkit
Medication safety advisories
Safety spotlight: orthopedics and opioids…proceed with caution!
Opioid use has reached epidemic and deadly proportions in the U. S.; overdose deaths increased 124% from 1999-2007.  Opioids cause more deaths than cocaine and heroin deaths combined. The U.S. uses 80% of the global opioid supply and 99% of the global hydrocodone supply, yet only represents <5% of the global population. Hydrocodone, the most commonly worldwide prescribed opioid, has a consumption of 27,400,000 grams in the U.S. annually compared with 3,237 grams for the UK, France, Germany, and Italy combined.
- Orthopedists rank 3rd highest of prescribers for opioid prescriptions for patients age 40 plus, and account for approximately 7.7% of all opioid prescriptions in the US in 2009.
- U.S. patients tend to be prescribed more opioids post orthopedic surgery as compared with patients in the Netherlands according to one study.
- Orthopedists mainly prescribe Schedule II and Schedule III drugs, both with high abuse and dependence possibility. Hydrocodone was reclassified to a Schedule II drug in 2014 by the FDA due to the increasing opioid use and misuse.
- Orthopedic trauma patients who have had preinjury opioid use have been shown to be at higher risk for prolonged opioid use post trauma as well as postoperative “doctor shopping”.,,
Patient Safety Recommendations for Orthopedic Physicians
- Screen patients for “at risk” behavior and/or opioid abuse potential
Recognizing risk factors for abuse potential, as well as recognizing and monitoring aberrant behavior should be considered as part of an orthopedist’s standard protocol.
Some of these risk factors which may predispose a patient to opioid abuse include: a patient’s tendency to loose prescriptions, make early refill requests, dependency on nicotine, personal or family history of any substance abuse, history of psychiatric diagnoses, and lower education levels. Screening tools are available, especially for long term pain management, and include: Opioid Risk Tool, the Pain Medication Questionnaire, and the Screener and Opioid Assessment for Patients with Pain-Revised.
- Set reasonable expectations for pain control
Orthopedists should set reasonable expectations for pain control for each of their patients. Establishing standard protocols and regimens for the orthopedic practice will keep consistency among physicians in the group, as well as support staff dealing with phone calls, etc. This can include “opioid tapers” post – surgery.
- Utilize your state’s prescription drug monitoring program
Forty nine states currently have a prescription drug monitoring programs; data bases that collect data on controlled substance prescriptions to help curtail nontherapeutic opioid use and doctor shopping. However, not all states require physicians to utilize the data base prior to prescribing controlled substances, therefore data bases may be incomplete, resulting in somewhat limited practical benefit at this time.
- Consult with pain management specialists
Consultation with pain management physicians when pain control is not adequate, or for patients who appear to be headed toward chronic opioid use, is another proactive approach.
- Take advantage of Pain Management Continuing Education Programs
- Know and comply with State Medical Board opioid management rules and regulations.
Morris BJ, Hassan Mir: The opioid epidemic: impact on orthopaedic surgery. J AAOS 2015, Vol 23, No5:267-271.
 Bohnert AS, Valenstein M, Bair MJ, et al: Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011:305(13):1315-1321
 Manchikanti L, Singh A: Therapeutic opioids: A ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Physician 2008;11 (2suppl):S63-68
 Manchikanti L, Helm S II, Fellows B, et al: Opioid epidemic in the United States. Pain Physician 2012;15(3):194-202
 Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR: Characteristics of opioid prescriptions in 2009. JAMA 2011;305 (13):1299-1301
 Lindenhovius AL, Helmerhorst GT, Schnellen AC, Vrahas M, Ring D, Kloen P: Differences in prescription of narcotic pain medication after operative treatment of hip and ankle fractures in the United States and The Netherlands. J Trauma 2009;67(1):160-164.
 Throckmorton DC: Re-scheduling prescription hydrocodone combination drug products; An important step toward controlling misuse and abuse. FDA Voice. Posted on October 6, 2014. http://blogs.fda.gov/fdavoice/index.php/2014/10/
 Levy RS, Hebert CK, Munn BG, Barrack RI: Drug and alcohol use in orthopedic trauma patients: A prospective study. J Orthop Trauma1996;10(1):21-27
 Massey, GM, Dodds HN, Roberts CS, Servoss TJ, Blondell RD: Toxicology screening in orthopedic trauma patients predicting duration of prescription opioid use. J Addict Dis 2006;24(4):31-41
 Morris BJ, Zumsteg JW, Archer KR, Cash B, Mir HR:Narcotic use and postoperative doctor shopping in the orthopaedic trauma population. J Bone Joint Surg Am 2014;96(15):1257-1262
 Owen GT, Burton AW, Schade CM, Passik S: Urine drug testing: Current recommendations and best practices. Pain Physician2012;15(3 suppl):ES 119-ES133
 Owen GT, Burton AW, Schade CM, Passik S: Urine drug testing: Current recommendations and best practices. Pain Physician 2012;15(3 suppl):ES 119-ES133
Safety spotlight: managing anticoagulation therapy in orthopaedics
In September 2008, the Acting Surgeon General issued a Call to Action to reduce the number of cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the United States. Since that time, new anticoagulants have been developed that offer efficacy, safety and convenience when compared to traditional anticoagulants.
Total arthroplasty is one of the most common orthopedic procedures performed in the United States, with approximately 719,000 total knee arthroplasty (TKA) surgeries performed annually and 332,000 total hip arthroplasty (THA) performed annually. With the tremendous amount of patients undergoing total knee and hip arthroplasty and the risk of developing DVT, managing anticoagulation therapy in orthopedics can be challenging. The goal of which, is to prevent as much as possible, the occurrence of PE and DVT following total hip and knee arthroplasty.
Effective thromboprophylaxis after total knee or hip arthroplasty is essential in hospital and outpatient settings and clinical practice guidelines have been developed to help define optimal prophylactic strategies.’  Clinical practice guidelines to consider when performing total knee or hip arthroplasty include:
- American College of Chest Physicians (ACCP) https://www.chestnet.org/Guidelines-and-Resources/Guidelines-and-Consensus-Statements/Antithrombotic-Guidelines-9th-Ed
- American Academy of Orthopedic Surgeons (AAOS) http://www.aaos.org/research/guidelines/VTE/VTE_full_guideline.pdf
According to the AAOS clinical treatment guidelines; “Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty”, “in the absence of prophylaxis, DVT occurs in about 37 percent of patients, as detected by imaging.”
An additional resource to consider is a guideline synthesis written in 2009, revised in 2014. The document compares the AAOS, the ACCP and the Scottish Intercollegiate Guidelines Network (SIGN) addressing venous thromboembolic disease. Key elements of the synthesis include areas of agreement and difference, major recommendations, corresponding strength of evidence and recommendation rating schemes, and a comparison of guideline methodologies.
Also included in the guideline synthesis are the benefits and/or harms of implementing the recommendations and any associated contraindication. The document can be found at: http://www.guideline.gov/syntheses/synthesis.aspx?id=47770
Risk Management Considerations:
- Consider all total knee/hip arthroplasty patients as “high risk” for DVT or PE
- Obtain a thorough H & P prior to prescribing anticoagulation therapy
- Review and consider the published guidelines when prescribing anticoagulation therapy
- Discuss and document history of “fall risk”
- Take into consideration acquired factors, i.e. exposure to steroid hormones, oral contraceptive use, etc.
- Inquire about prior DVT or PE
- Conduct medication reconciliation at each patient encounter
- Instruct patients on anticoagulation therapy to communicate any changes in medication regime
- Discuss and document the risks, benefits and alternative treatments including the duration and type of preventative treatment
- Provide patients and their caregivers with educational tools. Consider a handout describing blood clot prevention. A sample video and handout can be found at: http://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/VTE/patients.html
- Effectively communicate the medication regimen and any specific needs of the patient with other care providers, i.e. nursing home, physicians, home health, family, etc.
- As appropriate,
- Order laboratory testing to monitor effects of anticoagulation therapy
- Track all laboratory testing and communicate results
- Discuss drug and food interactions including potential side effects of anticoagulation therapy with the patient and family
- Discuss dental care management
Additional physician and patient resources can be found at:
 Acting Surgeon General issues “call to action” to prevent deep vein thrombosis and pulmonary embolism. Press release, September 15, 2008 http://www.surgeongeneral.gov/news/pressreleases/pr20080915.html
 Centers for Disease Control and Prevention; http://www.cdc.gov/nchs/fastats/inpatient-surgery.htm, 4/29/2015
 American Academy of Orthopaedic Surgeons, Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty: evidence-based guidelines and evidence report (v10.0_092311). Sept 23, 2011.
Available at: http:www.aaos.org/research/guidelines/VTE/VTE_full_guideline.pd. Accessed September 5, 2015.
 Falck-Ytter Y, Francis CW, Johanson N, et al. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(suppl):e278S-e3255S.
Medication errors-- 8th top reported sentinel event
“Medications are the most common intervention in healthcare but are also most commonly associated with adverse events in hospitalized patients.”[i] A medication error may occur at any point along the ‘medication use process’ continuum, namely during prescribing, compounding, dispensing, drug administration, and monitoring process which is carried out after the provider makes a decision regarding the treatment for the patient.[ii]
High Alert Medications Anticoagulants Narcotics Sedatives Insulin
Frequency of Medication Errors
Medication errors were noted as the sixth chief medical factor in a cumulative analysis of malpractice claims for the time frame of January 1, 2003-December 31, 2012, according to the PIAA (Physician’s Insurers Association of America). Of the 4,965 malpractice claims that involved medication errors as the chief medical factor, 19.50% involved an indemnity payment in order to close the claim. [iii]
A number of agencies track medication errors including the Food and Drug Administration, Institute for Safe Medication Practices, U.S. Pharmacopeia, The Joint Commission and MedMARX. The Food and Drug Administration has received nearly 30,000 reports of medication errors since 1992.[iv] “Medication Error” is the eight most common sentinel event reported to The Joint Commission (TJC). During the time period of 2004-June 2013, approximately 400 medication-related sentinel events were reported to TJC. [v]
Based on the statistics, there is a clear understanding that too many medication errors are occurring and impacting the safety of patients.
High-Alert Medications and Population
The scope of reducing medication errors can be overwhelming, so prioritization is a must. Harm related to the use of high alert medications is more likely to be more serious, and they “have the highest risk of causing injury even when used correctly.” High-alert medications responsible for the majority of adverse medication events include insulin, anti-coagulants, narcotics and sedatives. [vi]
Patient populations that are vulnerable to medication errors include the elderly and pediatric patients. Medications and processes should be reviewed to ensure appropriate precautions are taken to prevent adverse events from occurring.
Physicians may help prevent harm caused by High Alert medications by examining their prescribing patterns, adding other therapies to minimize untoward drug side efforts, remaining alert to early problem development; standardizing orders, conducting focused patient follow-ups & providing patient education. Find additional strategies in the How-to Guide:Prevent Harm from High-Alert Medications published on-line by the Institute for Healthcare Improvement at IHI.org.
Risk Reduction Strategies
Numerous safe medication principles and error-reduction strategies are available to assist facilities with promoting patient safety. Strategies include standardization, checklists, double checks, automation, computerization, forcing functions, prevention of interruptions and distractions, unit dosing, removal of medications from certain settings, and precaution with storage of lookalike-soundalike medications.[vii]
The Institute for Safe Medication Practices (ISMP)has released the 2014-2015 Targeted Medication Safety Best Practices for Hospitals. The targeted best practices are based on specific medication safety issues that continue to cause fatal and harmful errors in patients, despite repeated warnings in ISMP publications.[viii]
The Joint Commission (“TJC”) has published the following patient safety goals applicable to medication safety[ix]:
- NPSG.01.01.01: Improve the accuracy of patient identification
- NPSG.01.03.01: Eliminate transfusion errors related to patient misidentification.
- NPSG.02.03.01: Report critical results of tests and diagnostic procedures to the right person in a timely manner.
- NPSG.03.04.01: Label all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings.
- NPSG.03.05.01: Reduce the likelihood of patient harm associated with the use of anticoagulant therapy.
- NPSG.03.06.01: Maintain and communicate accurate patient medication information.
Several types of medication-related Sentinel Event Alerts (Alerts) have been published by TJC. The Alerts are based upon sentinel events and/or trends and include evidence based actions to help avoid adverse events. Sentinel Event Alert topics include: safe use of opiods in hospitals, safely implementing health information and converging technologies, preventing errors relating to commonly used anticoagulants, preventing medication errors, using medication reconciliation to prevent errors, preventing vincristine administration errors, patient-controlled analgesia by proxy, and medication errors related to potentially dangerous abbreviations. [x]
Medication errors cause harm to patients daily.
In an effort to improve medication safety, healthcare organizations are encouraged to focus on processes occurring along the entire continuum of the medication treatment process. This means that an organization proactively reviews potential risks, institutes reduction strategies, responds to incidences, tracks the root causes, and implements strategies to prevent reoccurrence.
Dr. Lucian Leape of Harvard School of Public Health said it well, “Incompetent people are, at most, 1% of the problem. The other 99% are good people trying to do a good job who make very simple mistakes, and it’s the processes that set them up to make these mistakes.”
Would you have prescribed these medications for this patient?
Imagine the surprise of two physicians when they recently received a visit from detectives from the local Sheriff’s Department to inquire about their prescribing practices related to a particular patient. The physicians were asked to complete a questionnaire. The detectives explained that by completing the paperwork as requested, they would be spared from being subpoenaed to testify in court.
The questionnaire contained three questions:
- Did you know that the patient was seeing other doctors or practitioners?
- Did you know that the patient was prescribed the same medications?
- Had you known, would you have prescribed these medications?
The providers were also asked to note any additional comments. The detectives presented the physicians with a list of prescriptions the patient had filled between January 2013 and January 2014. According to the reports provided, over the 12 month period, the patient had met with 18 different health care providers and obtained 2,063 units of hydrocodone and 16 dosage units of buprenorphoine patches. [This is one of several similar inquiries MAG Mutual insured physicians have received from law enforcement officials related to their prescribing practices.]
The patient was subsequently charged with obtaining a controlled substance by defrauding a health care provider, among other drug-related charges.
Drug Diversion: Alarming Epidemic
Prescription drug diversion, abuse, and overdose have reached alarming levels in the United States. According to the Centers for Disease Control and Prevention:
- 100 people die from drug overdoses every day in the United States.
- Prescription drug overdose death rates in the United States have more than tripled since 1990.
- Prescription drugs were involved in more overdose deaths in 2008 than cocaine and heroin overdose deaths combined.
- The misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years.
The CDC reports that nearly three out of four prescription drug overdoses are caused by opioid pain relievers. This alarming epidemic has prompted many state medical boards to develop guidelines and rules related to managing patients with chronic pain. For example in Georgia, effective July 1, 2013, the State Composite Medical Board requires any “Pain Management Clinic” to be licensed by the Board. A “Pain Management Clinic” is defined as follows:
- Medical Practice advertising treatment of pain; OR
- Utilizing “pain” in the name of the clinic; OR
- Medical practice or clinic with > 50% of annual patient population for non-terminal conditions by use of schedule II or III drugs (narcotics)
Operating a “Pain Management Clinic” in Georgia without a license is a felony. Furthermore, law enforcement officers and medical examiners investigating deaths which may be the result of medication used for pain management are authorized to send records to the Composite Board. The Composite Board sets forth minimum requirements for continuing medical education that applies to all health care providers working in the clinic.
State Prescription Monitoring Programs
In most states, all practitioners with the authority to prescribe or order controlled substances are allowed to register and have access to the state prescription monitoring program. According to the Alliance of States with Prescription Monitoring Programs, as of October 16, 2011, 37 states had operational prescription drug monitoring programs that have the capacity to receive and distribute controlled substance prescription information to authorized users.
Some concern has been expressed that physicians’ access to the database might be accessible during discovery. Further, there is concern that the “standard of care” may eventually require physicians to routinely query such a data base any time patient drug-seeking behavior is noted.
A questionnaire from the Sheriff’s Department in the future might include the following questions:
- Do you have access to the state prescription monitoring program?
- Did you access the state prescription monitoring program prior to prescribing controlled substances for this patient?
State Medical Boards Respond
Many state medical boards have developed policies for the use of controlled substances and the treatment of pain. Some have modeled their policies on the Federation of State Medical Boards’ Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain.
Additionally, the majority of state medical boards have developed stringent guidelines for pain management. For example, among the requirement for pain management in Georgia, physicians:
- cannot delegate controlled substance dispensing to an unlicensed provider
- must have a medical history and documented physical examination of the patient; and
- must have obtained Informed Consent from the patient or legal guardian.
Only in the event of a documented emergency may a physician prescribe an amount of medication to cover a period of not more than 72 hours without a documented physical examination.
When prescribing a Schedule II or III controlled substance for 90 (ninety) consecutive days or greater for the treatment of chronic pain arising from conditions that are not terminal, or for patients in a nursing home or hospice, a prescribing physician must monitor compliance with the therapeutic regimen. This means that body fluid analysis (drug screens) must be performed at least four times a year on a random basis or done at the same frequency proportionate to the period of treatment.
These are but a few of the rules. A full copy of Georgia’s Rule 360-3-.06 Pain Management is available on the Composite Board’s website at www.medicalboard.georgia.gov
As the guidelines vary from state to state, you should contact your state medical board for state-specific guidance. If you hold licenses in more than one state, be sure to review the policies in each of these states for which you maintain active licensure and practice.
Continuing Education Resources for Physicians
An excellent publication, Responsible Opioid Prescribing: A Clinician's Guide, 2nd Edition, $16.95, offers practical strategies for reducing the risk of addiction and complying with the Federation of State Medical Boards Model Policy on Pain Management. By reading the publication and taking the on-line test, physicians can receive 7.25 AMA PRA Category 1 Credits, at no cost.
The American Medical Association developed a Pain Management Continuing Medical Education resource that contains 12 modules. The 2013 revision of the online training, totaling 14.5 AMA PRA Category 1 Credits™, is now available. Access to the course materials is free. Physicians can complete the modules that address the specific needs of their practices and patients. Those who are interested in obtaining CME credit must register, and a $6.00 fee will be charged per module.
These two courses offer over 21 AMA PRA Category 1 Credits™ for under $100.00
Prescription drug diversion has reached nation-wide epidemic proportions. States, Medical Boards, Pharmacy Boards and others have been developing strategies and tools for physicians to use in preventing drug diversion and breaking the tide of this epidemic. At the same time, physicians are challenged to provide effective pain management for their patients.
Consequently we strongly urge our policyholders to seek out continuing education opportunities in this area; continue to develop the skills needed to evaluate and manage patients with pain; make referrals to competent pain management physicians, as necessary; and use the systems and processes being developed to help counter prescription drug diversion.
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.