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Background: The continued toll of opioid-related overdoses has motivated efforts to expand availability of naloxone to persons at high risk of overdose, with 2016 federal guidance encouraging clinicians to co-prescribe naloxone to patients with increased overdose risk. Some states have pursued analogous or stricter legal requirements that could more heavily influence prescriber behavior., Methods: We conducted a systematic legal review of state laws that mandate or recommend that healthcare providers prescribe naloxone to patients with indicators for opioid overdose risk. We coded relevant statutes and regulations for: applicable populations, patient criteria, educational requirements, and exemptions., Results: As of September 2019, 17 states had enacted naloxone co-prescribing laws, the earliest of which was implemented by Louisiana in January 2016. If patient overdose risk criteria are met, over half of these states mandate that providers prescribe naloxone (7 states, 41.1 %) or offer a naloxone prescription (2 states, 11.8 %); the remainder encourage prescribers to consider prescribing naloxone (8 states). Most states (58.8 %) define patient overdose risk based on opioid dosages prescribed, although the threshold varies substantially; other common overdose risk criteria include concomitant opioid and benzodiazepine prescriptions and patient history of substance use disorder or mental illness., Conclusions: A growing minority of states has adopted a naloxone prescribing law, although these policies remain less prevalent than other naloxone access laws. By targeting higher-risk patients during clinical encounters, naloxone prescribing requirements could increase naloxone prescribed, destigmatize naloxone use, and reduce overdose harms. Further investigation into policy effectiveness, unintended consequences, and appropriate parameters is warranted., Competing Interests: Declaration of Competing Interest None., (Published by Elsevier B.V.)

Background and Purpose: MyDispense is an innovative, web-based program which simulates a community pharmacy. Use of this software may assist students' comprehension of validating controlled substance prescriptions by determining if prescriptions contain errors or omissions., Educational Activity and Setting: Fourteen MyDispense practice exercises were created and implemented into a required second-year pharmacy law course. Completion of the MyDispense exercises and performance on the pharmacy law midterm exam were recorded. A questionnaire was administered to students to receive feedback on the exercises., Findings: There were complete data on all 94 student pharmacists enrolled in the didactic course. Thirty-five students (37%) completed all MyDispense exercises, 15 students (16%) completed some of the exercises, and 44 (47%) did not complete any of the exercises. Linear regression results indicate that students who completed more MyDispense exercises were significantly more likely to score higher on the midterm than those who completed fewer exercises (β = 0.28, p = 0.02). Students reported moderate to high exercise value and a willingness to use the software in preparation for future pharmacy law examinations., Summary: MyDispense provided a platform for students to apply controlled substance laws to the prescription validation process in the community pharmacy setting. Completion of practice exercises in MyDispense was shown to positively impact student performance on a pharmacy law midterm. Students valued the innovative simulation tool and were willing to access the tool again to prepare for future examinations., Competing Interests: Declaration of competing interest None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To determine the association of medical marijuana legalization with prescription opioid utilization., Methods: A 10% sample of a nationally representative database of commercially insured population was used to gather information on opioid use, chronic opioid use, and high-risk opioid use for the years 2006-2014. Adults with pharmacy and medical benefits for the entire calendar year were included in the population for that year. Multilevel logistic regression analysis, controlling for patient, person-year, and state-level factors, were used to determine the impact of medical marijuana legalization on the three opioid use measures. Sub-group analysis among cancer-free adults and cancer-free adults with at least one chronic non-cancer pain condition in the particular year were conducted. Alternate regression models were used to test the robustness of our results including a fixed effects model, an alternate definition for start date for medical marijuana legalization, a person-level analysis, and a falsification test., Results: The final sample included a total of 4,840,562 persons translating into 15,705,562 person years. Medical marijuana legalization was found to be associated with a lower odds of any opioid use: OR = 0.95 (0.94-0.96), chronic opioid use: OR = 0.93 (0.91-0.95), and high-risk opioid use: OR = 0.96 (0.94-0.98). The findings were similar in both the sub-group analyses and all the sensitivity analyses. The falsification tests showed no association between medical marijuana legalization and prescriptions for antihyperlipidemics (OR = 1.00; CI 0.99-1.01) or antihypertensives (OR = 1.00; CI 0.99-1.01)., Conclusions: In states where marijuana is available through medical channels, a modestly lower rate of opioid and high-risk opioid prescribing was observed. Policy makers could consider medical marijuana legalization as a tool that may modestly reduce chronic and high-risk opioid use. However, further research assessing risk versus benefits of medical marijuana legalization and head to head comparisons of marijuana versus opioids for pain management is required.

Purpose: Cardiovascular safety alerts about rosiglitazone resulted in regulatory actions in several countries in 2010, but the Food and Drug Administration eliminated access restrictions in 2013, reflecting new evidence concerning the drug safety. We investigated the effects of safety signals and regulation shifts concerning rosiglitazone on prescribing of antidiabetic drugs (ADs)., Methods: Patient data were extracted from the Korean health insurance claims database for 2007 to 2015. Linear regression and interrupted time series analyses were performed to examine drug utilization trends and the impact of 5 milestone events regarding rosiglitazone safety on AD utilization., Results: A steady growth was observed in the AD consumption, with metformin preserving its dominant market share throughout the period. Pioglitazone use has increased since 2008 in response to safety issues surrounding rosiglitazone. A significant decline in rosiglitazone use was observed after Nissen's meta-analysis and safety warnings (2007) and after restriction/suspension of access to rosiglitazone (2010), associated with a drop in prevalence by 29.5%/year and 99.5%/year, respectively. The most common AD newly started among users who discontinued rosiglitazone in 2010 was pioglitazone, followed by dipeptidyl peptidase-4 (DPP-4) inhibitors. Our concomitancy analysis showed that DPP-4 inhibitors have overtaken sulfonylureas since 2014 as the most common add-on to metformin., Conclusions: The most frequently added AD in diabetes patients who had switched off rosiglitazone in 2010 was pioglitazone, followed by DPP-4 inhibitors. Despite new evidence from a long-term clinical trial and the Food and Drug Administration's subsequent decision to eliminate access restrictions on rosiglitazone in 2013, domestic regulations were left intact; hence, its use remained negligible in Korea., (Copyright © 2017 John Wiley & Sons, Ltd.)

Recently momentum has been building behind pharmacist prescriptive authority for certain products such as oral contraceptives or naloxone. To some, prescriptive authority by pharmacists represents a departure from the traditional role of pharmacists in dispensing medications. Nearly all states, however, currently enable pharmacist prescriptive authority in some form or fashion. The variety of different state approaches makes it difficult for pharmacists to ascertain the pros and cons of different models. We leverage data available from the National Alliance of State Pharmacy Associations (NASPA), a trade association that tracks pharmacy legislation and regulations across all states, to characterize models of pharmacist prescriptive authority along a continuum from most restrictive to least restrictive. We identify 2 primary categories of current pharmacist prescriptive authority: (1) collaborative prescribing and (2) autonomous prescribing. Collaborative prescribing models provide a broad framework for the treatment of acute or chronic disease. Current autonomous prescribing models have focused on a limited range of medications for which a specific diagnosis is not needed. Approaches to pharmacist prescriptive authority are not mutually exclusive. We anticipate that more states will pursue the less-restrictive approaches in the years ahead., (© The Author(s) 2016.)

Rising mortality rates, increased opioid prescription abuse, and a perceived need to provide practitioners with structured guidance in opioid prescribing have prompted the Washington State Legislature to establish new legal standards of practice regarding chronic non-cancer pain management. Clinicians are required to conduct a detailed physical examination and health history prior to treatment. Risk assessments for abuse and detailed periodic reviews of treatment are required at least every 6 months. Those considered "high risk" or who have significant psychiatric comorbidities will be required to sign and follow a written agreement or pain contract, obtain their pain prescriptions from a single provider, and submit to biological drug screening. Unless an exemption exists, patients prescribed > 120 mg of morphine-equivalents daily, considered severe pain nonresponders, necessitating dosage escalation, diagnosed with multifaceted mental health-related comorbidities, demonstrating diagnostic ambiguity, and/or requiring significant treatment individualization are referred to a pain specialist. Episodic care settings should refrain from supplying opioids to chronic pain patients whenever possible. The ER is for Emergencies coalition instituted the Seven Best Practices program throughout the state to reduce unnecessary visits, coordinate prescribing practice, reduce Medicaid expenditures, and improve overall patient care. The state reported approximately $33.65 million in savings in 2013 through the use of these practices and converting Medicaid participants from fee-for-service to managed care plans. Similar legislation to complement clinical practice guidelines is expected to be enacted in other states. It is vital that practitioners comprehend the new guidelines and make appropriate adjustments in their opioid prescribing habits., (© 2015 World Institute of Pain.)

Background: In 2010, Mississippi became the second state to require a prescription to purchase pseudoephedrine-based medications. Proponents of "prescription-only" laws argue that they are necessary to disrupt methamphetamine markets, but critics note the costs to legal consumers of cold medications may offset some of the laws' intended benefits., Objective: We evaluated the effect of prescription-only restrictions for methamphetamine precursors on state-level methamphetamine lab seizures and methamphetamine prices., Methods: We used a synthetic control approach to create a control state comparable to Mississippi and then used permutation testing to determine if the resulting difference was statistically significant., Results: We found that Mississippi's prescription-only law removed 2637 small methamphetamine labs in the two years after the law became effective, which represents a 77% reduction in small labs relative to the synthetic counterfactual. We found no evidence that the law impacted methamphetamine prices., Conclusion: We conclude that while prescription-only laws can reduce the number of domestic small methamphetamine labs in operation, methamphetamine availability is unlikely to be materially impacted., (Copyright © 2015 Elsevier B.V. All rights reserved.)

In June, 2012 the United States Food and Drug Administration (FDA) developed a "blueprint" for prescriber education as a means of directing Certified Medical Education (CME) activities that included content which would meet the regulatory requirements of the class-wide, longacting/ extended-release (LA-ER) opioid Risk Evaluation Mitigation Strategies (REMS). Within the blueprint is the suggested adoption of Patient-Provider Agreements (PPAs) to be used in association with opioid prescribing, but, to our knowledge, there have been no reported evaluations of the role played by opioid-agent PPAs in clinical practice, or of the perceptions of this regulatory mandate by clinicians. Therefore, we conducted a survey regarding PPA perceptions by opioid prescribers that was posted for five weeks on a well-trafficked online CME service provider (Medscape). Of the 1,232 respondents (reflecting a 99.5% completion rate), 52.4% treat acute or chronic pain with opioids. The survey identified an improvement of opioid safe-use education (21% of respondents) as the most frequently selected beneficial element of PPAs. Conversely, the challenges to adoption included time constraints (21% of physicians) as well as lack of evidence that PPAs will reduce drug misuse, and the lack of a uniform, patient-friendly PPA. Based on our survey, clinicians consider the PPA of potential value, but data regarding the utility of such an instrument are lacking.

It is a continual challenge trying to improve the quality of prescribing while concurrently trying to address increasing pharmaceutical development, utilization and expenditure. National and regional reforms and initiatives in Sweden have moderated growth in ambulatory drug expenditure to 2.7% per annum in recent years despite increasing volumes. National reforms include mandatory generic substitution and value-based pricing alongside devolution of drug budgets to the regions. Regional initiatives include strengthening the role of the regional Drug and Therapeutic Committees, further budget devolution as well as strategies incorporating prescribing guidance and monitoring coupled with financial incentives. The extent and nature of the regional initiatives vary depending on their characteristics. In this article, we compare initiatives undertaken in two major counties, Stockholm and Ostergötland, and their outcomes. Outcomes include annual drug budget savings while achieving agreed quality as well as increased adherence to prescribing targets and guidance; the latter associated with savings. Appraising these multifaceted reforms can provide guidance to other countries and regions in view of their diversity. Future steps must incorporate measures to improve the utilization of new expensive drugs, which should include horizon scanning and forecasting activities as well as post-launch activities involving monitoring of prescribing and registries. This may well require cooperation with other European countries.

In a recent press release Joseph A. Califano, Jr., Chairman and President of the National Center on Addiction and Substance Abuse at Columbia University called for a major shift in American attitudes about substance abuse and addiction and a top to bottom overhaul in the nation's healthcare, criminal justice, social service, and eduction systems to curtail the rise in illegal drug use and other substance abuse. Califano, in 2005, also noted that while America has been congratulating itself on curbing increases in alcohol and illicit drug use and in the decline in teen smoking, abuse and addition of controlled prescription drugs-opioids, central nervous system depressants and stimulants-have been stealthily, but sharply rising. All the statistics continue to show that prescription drug abuse is escalating with increasing emergency department visits and unintentional deaths due to prescription controlled substances. While the problem of drug prescriptions for controlled substances continues to soar, so are the arguments of undertreatment of pain. The present state of affairs show that there were 6.4 million or 2.6% Americans using prescription-type psychotherapeutic drugs nonmedically in the past month. Of these, 4.7 million used pain relievers. Current nonmedical use of prescription-type drugs among young adults aged 18-25 increased from 5.4% in 2002 to 6.3% in 2005. The past year, nonmedical use of psychotherapeutic drugs has increased to 6.2% in the population of 12 years or older with 15.172 million persons, second only to marijuana use and three times the use of cocaine. Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world's supply of all opioids and 99% of hydrocodone. Opioids are used extensively despite a lack of evidence of their effectiveness in improving pain or functional status with potential side effects of hyperalgesia, negative hormonal and immune effects, addiction and abuse. The multiple reasons for continued escalation of prescription drug abuse and overuse are lack of education among all segments including physicians, pharmacists, and the public; ineffective and incoherent prescription monitoring programs with lack of funding for a national prescription monitoring program NASPER; and a reactive approach on behalf of numerous agencies. This review focuses on the problem of prescription drug abuse with a discussion of facts and fallacies, along with proposed solutions.

This paper discusses the origins of the over-the-counter (OTC) drug category and presents information about the process of switching a drug from prescription (Rx) to OTC status. It also reviews past and current drug laws in terms of how they relate to OTC drugs.

The physician who prescribes controlled substances is faced with an array of laws, regulatory policies, and professional attitudes about their use. Prescriptions for these scheduled drugs are furthermore monitored by the pharmacists who dispense them. Certain drugs, such as the opioids and the benzodiazepines, are considered so potentially abusive that special programs have been recommended to track the behavior of physician prescribers. Multiple copy programs have been implemented in some states. More recent proposals recommend electronic data transfer (EDT) of pharmacy information to centralized processing points so that misprescribing physicians and doctor-shopping patients can be identified. Regulators concerned about physician behavior and confronted by demands of nonphysicians to prescribe controlled substances may find EDT a good solution. Physicians should be concerned about being censured for misprescribing, because such actions may lead to inclusion in the National Practitioner Data Bank. With all of the regulatory concerns about controlled substances, those physicians who would employ long-term opioid therapy for their chronic pain patients must follow certain basic guidelines to be able to defend themselves against allegations of deviant professional behavior. Such procedures as conducting a history and physical examination, maintaining a written treatment plan, consulting with knowledgeable colleagues, and assessing for addictive behavior can provide the practitioner with safeguards.