Amendment to Controlled Substances Act: Hydrocodone

Amendment to Controlled Substances Act: Hydrocodone H.R. 1285: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone a Schedule II Drug Jill Garreth Abstract This paper describes H.R. 1285, a bill proposed to amend the Controlled Substances Act to make any substance containing hydrocodone a Schedule II drug. It explores the historical, sociocultural, ethical, economic and the political/legislative environment in which the bill was introduced. Some of the difficulties encountered include the bill being referred to the House Committee of Judiciary and the House Committee of Energy and Commerce (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). Since being referred to both committees, there has been no further action taken on this bill by Congress (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). Stakeholders in the passage of this bill include physicians, pharmacists, advanced practice nurses, patients and long term care (LTC) facilities. The likelihood that H.R. 1285 will pass is very small due to the fact that the Drug Enforcement Agency (DEA) recently made a ruling that changed hydrocodone to a schedule II drug (Drug Enforcement Administration, 2014). Because of the DEA’s actions, it seems unnecessary to push forward with H.R. 1285. Keywords: hydrocodone, schedule II drugs, controlled substances, DEA H.R. 1285: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone a Schedule II Drug Introduction H. R. 1285 is a bill introduced March 20, 2013 to amend the Controlled Substances Act to make any substance containing hydrocodone a Schedule II drug (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). H.R. 1285 â€Å"amends the Controlled Substances Act to remove dihydrocodeinone (hydrocodone) from classification as a schedule III controlled substance. Directs the Attorney General to immediately allow manufacturers and distributors to store hydrocodone compound products in accordance with the physical security requirements for schedule III, IV, and V controlled substances for three years beginning on the date enactment of this Act. Requires the Comptroller General to submit a report on the reclassification of hydrocodone products under this Act, including: (1) an assessment of the degree to which the reclassification of such products under this Act impacts the ability of patients with legitimate m edical needs, particularly those in rural areas and nursing home facilities, to access adequate pain management; and (2) recommendations necessary to address any issues relating to patient access to adequate pain management† (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). H.R. 1285 is a piece of legislation that could directly affect the prescriptive authority of an advanced practice nurse (DEA Issues Info, 2012). Some states only allow an advanced practice nurse the authority to write prescriptions for drugs rated Schedule III and below and because of that, H.R. 1285 has the potential to affect advanced practice nurses in at least nine states (DEA Issues Info, 2012). Environment Historical Title 21 of the United States Code Controlled Substances Act classifies drugs based on three criteria (U.S. Code: Title 21-Food and Drugs, 2012). The criteria used to determine the schedule of the drug is the potential for abuse of the drug, whether the drug has an acceptable medical purpose and the type of dependence the drug may perpetuate (U.S. Code: Title 21-Food and Drugs, 2012). Between 2004 and 2009 products containing hydrocodone had an increase in demand of approximately 125% (Drug-Related Hospital Emergency Room Visits, 2011). Florida Congressman Vern Buchanan introduced this bill to help combat the growing prescription drug epidemic in his home state of Florida and wants to make hydrocodone combination products more difficult to obtain and prescribe (Congressman Vern Buchanan representing Florida, 2014). Sociocultural There are more than just health concerns that have brought this issue to forefront. There have been many studies done that show a direct link to drug abuse and crime. According to the Bureau of Justice, 30% of offenders in state detention facilities stated that they would likely commit crimes in order to get money for drugs (Bureau of Justice Statistics, 2004). In Florida, at least 7 people die daily from prescription drug overdoses (Congressman Vern Buchanan representing Florida, 2014) and at least 75 people die daily nationwide (Drug Enforcement Administration, 2014). Crime and drug overdoses are just a few of the sociocultural considerations that caused Congressman Buchanan to introduce H.R. 1285. Ethical One ethical implication that pushes H.R. 1285 to the forefront of legislation is that because hydrocodone is a prescription medication, prescribers have an ethical responsibility to assist in combatting the misuse and abuse of this drug (Hamburg, 2014). H.R. 1285 is not designed to make it more difficult for patients with a legitimate need to obtain the medication but it is designed to assist the providers in making better educated decisions when prescribing medications that have such a high potential for abuse (Drug Enforcement Administration, 2014). Economic Economic factors that have made this issue important is not necessarily related to the cost of the drug but the cost of the effects of abuse of the drug. â€Å"Prescription opioid abuse costs were about $55.7 billion in 2007. Of this amount, 46% was attributable to workplace costs (e.g., lost productivity), 45% to healthcare costs (e.g., abuse treatment), and 9% to criminal justice costs† (Centers for Disease Control, 2014). In 2010 there were 49 million uninsured people in the United States (US Census Bureau, 2011). Rising healthcare costs and uninsured people need to be a consideration when legislators review H.R. 1285. Political/Legislative H.R. 1285 has been assigned to the House Committee on Energy and Commerce and the House Committee on Judiciary (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). The House Committee on Energy and Commerce has the responsibility of reviewing the Food and Drug Administration’s (FDA) ability to establish the effectiveness and safety of prescription and over-the-counter (OTC) drugs in the United States (Longest Jr., 2010). The House Committee on Judiciary has jurisdiction over revision to existing codes so it has an important role regarding amending the existing drug scheduling (United States House of Representatives Judiciary Committee, 2014). Despite the fact that both committees have a Republican majority, there has still been no movement on this bill. Difficulties Encountered H.R. 1285 was introduced on March 20, 2013 by Florida Republican Representative Vern Buchanan (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). This bill has 54 co-sponsors of which 32 are Republican and 22 are Democrat (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone a Schedule II Drug, 2013). H.R. 1285 has been referred to the House Committee of Judiciary and the House Committee of Energy and Commerce and the committee chair makes the determination on whether the bill moves forward (H.R. 1285-113th Congress: To Amend the Controlled Substances Act to Make Any Substance Containing Hydrocodone A Schedule II Drug, 2013). One difficulty noted in regards to H.R. 1285 is the fact that there has been no action taken since its introduction to Congress. There is no optimistic timeline to predict if H.R. 1285 is going to be passed. Speaking pess imistically, H.R. 1285 will not pass at all. As of October 6, 2014 a Drug Enforcement Administration’s (DEA) ruling took effect that is essentially in the same spirit as H.R. 1285 (Drug Enforcement Administration, 2014). This ruling reschedules hydrocodone from a schedule III drug to a schedule II drug (Drug Enforcement Administration, 2014). Since the DEA has already changed the schedule of hydrocodone and it has already been implemented, there is no need for further movement of H.R. 1285. Stakeholders in the passage of H.R. 1285 include physicians, pharmacists, advanced practice nurses, long term care (LTC) facilities and patients. LTC facilities have been especially vocal on this topic due to the fact they believe that any further regulation or change in the scheduling of certain narcotics will have a negative effect on patients in their facilities and the ease in which these patients will have access to them (Garrison Mitty, 2010). Nurses who work in these types of facil ities are encouraging others to join professional organizations and write to their legislators to make their voices heard (Garrison Mitty, 2010). Effects Some positive effects of H.R. 1285 are increased awareness for prescribers of the dangers of opioid dependence related to hydrocodone and a decrease in â€Å"doctor shopping† related to the tighter regulation and monitoring of hydrocodone (Phillips, 2013). Negatives of H.R. 1285 include increased difficulty for patients in LTC facilities to access physicians and obtain prescriptions needed to adequately address their pain needs (Garrison Mitty, 2010). Because of the tighter prescriber restrictions related to refills and the types of prescriptions accepted, those who reside in LTC facilities could have to wait longer to receive refills on much needed pain medication (Garrison Mitty, 2010). International The U.K. has similar problems to the U.S. when it comes to prescription drug abuse (Weisburg et al., 2014). The U.K. has the Health Act of 2006 which created Accountable Officers that track and audit the prescriptions written (Weisburg et al., 2014). The U.K. also has trialed a real-time monitoring system to be able to monitor irregular prescribing practices for certain drugs (Weisburg et al., 2014). Although it was only a trial of a computerized system, it showed great promise in assisting real-time monitoring of prescriptions written. Change to the Bill As with anything, there are always improvements that could be made. One way to refine H.R. 1285 is to implement mandatory education for prescribers. Requiring education in areas of opioid pain management, pain management alternatives and safe prescribing practices is one way that could improve policy outcomes (Weisburg et al., 2014). Another improvement that could be made is by establishing a universal standard to pain management and the dispensing of medication because by using a universal standard, improved outcomes can be expected (Gourlay et al., 2005). Another way to improve H.R. 1285 would be to include a plan to implement a national prescription drug monitoring program (PDMP) (Drug Enforcement Administration, 2014). Many states already have a PDMP in place but it only monitors statewide activity (Drug Enforcement Administration, 2014). In order for a PDMP to be effective, it would need to be nationwide and offer up to date information (Drug Enforcement Administration, 2014). Conclusions H.R. 1285 is a bill introduced to Congress to change the schedule of hydrocodone from a schedule III to a schedule II drug. Congressman Vern Buchanan introduced this bill because of the growing drug epidemic he witnessed in his home state of Florida (Congressman Vern Buchanan representing Florida, 2014). He describes seeing more pain management clinics that dispense prescriptions for drugs than McDonald’s restaurants (Congressman Vern Buchanan representing Florida, 2014). Although H.R. 1285 was referred to two separate committees, the likelihood that the bill will be passed is very slim. There has been no further action taken on the bill by either committee. Prescribers, patients and LTC facilities have a stake in whether or not H.R. 1285 passes. All have concerns regarding difficulty in prescribing medication to those who truly need it and maintaining access for the patients who are living in a LTC facilities. Due to the recent ruling of the DEA that changed hydrocodone conta ining products from a schedule III drug to a schedule II drug, it seems unnecessary for H.R. 1285 to move forward (Drug Enforcement Administration, 2014). References Bureau of Justice Statistics 2004 Bureau of Justice StatisticsBureau of Justice Statistics (2004). Bureau of Justice Statistics. 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