The document summarizes Maryland's medical cannabis program, including:
1) The program was created in 2013 and is overseen by the Natalie M. LaPrade Medical Cannabis Commission. The statute and regulations govern growing, processing, dispensing and use of medical cannabis.
2) Strict security and safety measures are in place, including background checks, video surveillance, inventory tracking from "seed to sale", and limits on the number of growers and dispensaries.
3) The program is funded entirely through license fees, not taxpayer money. Licenses have been awarded for growing, processing and dispensing medical cannabis.
Cannabis Science & Policy Summit - Day 2 - ReuterCannabisSummit
1) Canada is taking a sensible approach to legalizing cannabis by planning in advance, articulating specific goals, developing an evaluation process, and coordinating federal and provincial governments.
2) A report from CAMH advocates for a government monopoly over supply to allow for adjustments to product mix as understanding of harms increases, and argues this approach promotes health equity by reducing arrests of minorities and poor people under prohibition.
3) However, the report is criticized for not adequately recognizing potential benefits of cannabis use or considering whether pleasure should count in policymaking, and relying too much on a health model without considering other social harms.
Cannabis Science & Policy Summit - Day 1 - HallCannabisSummit
This document discusses complications that arise when comparing the risks of alcohol and cannabis. While cannabis appears less harmful than alcohol in some ways, its legal status and patterns of use are confounded by prohibition. Additionally, risks may increase with legalization, such as from more potent products, and cannabis use has been correlated with poorer cognitive and social outcomes from sustained daily use. Finally, there are regulatory and health education challenges to legalizing cannabis in a way that minimizes risks of dependence and impairment while developing credible public health advice.
Cannabis Science & Policy Summit - Day 2 - NovakCannabisSummit
This document summarizes a study that used latent class analysis to identify patterns of medical cannabis consumption among 50 patients in San Francisco. The analysis identified 4 classes: pure therapy (10%), pure euphoria (10%), mixed motives (55%), and smoked euphoria (25%). Characteristics like gender, medical conditions, and socioeconomic status were associated with class membership. Probability of consumption varied by day of week and payday cycles, with higher use on weekends and paydays. The findings suggest medical cannabis is used more for euphoria than purely medical reasons for most patients.
Cannabis Science & Policy Summit - Day 1 - WetterauCannabisSummit
1. ASAM supports decriminalizing marijuana possession for personal use and treating it as a civil offense linked to contingencies like mandated clinical assessment and treatment.
2. ASAM does not support legalizing marijuana and recommends caution in jurisdictions that have not legalized it yet until more is learned from places that have.
3. The document outlines several recommendations from ASAM for regulating legalized recreational marijuana and expanding access to treatment and prevention services for marijuana use, especially among youth.
Cannabis Science & Policy Summit - Day 1 - PeyraubeCannabisSummit
Uruguay has reformed its drug policy based on a framework of security, public health, and human rights. It prioritizes human rights conventions and national sovereignty over international drug conventions. Uruguay regulates cannabis to reduce the negative impacts of drugs and incarceration for possession. The regulation creates a domestic cannabis industry and allows medical use and research. Adults can access cannabis through self-cultivation, cannabis clubs, or purchasing up to 40 grams per month from pharmacies. Production is licensed and regulated by the government.
Cannabis Science & Policy Summit - Day 1 - CaulkinsCannabisSummit
This document discusses different aspects of legalizing marijuana, including defining levels of legalization and comparing marijuana legalization to other regulated substances and markets. It also provides statistics on current marijuana use patterns in the US, highlighting that most use is concentrated among relatively heavy users and those with substance abuse problems. The potential public health impacts of legalization are uncertain and will depend on how regulations shape the legal market.
Cannabis Science & Policy Summit - Day 1 - SeiverightCannabisSummit
Jamaica has recently passed legislation decriminalizing possession of small amounts of cannabis and legalizing its medical use. This represents progress toward reforming cannabis laws, which were made stricter under British rule and international treaties, despite cannabis having traditional medical and religious uses in Jamaica. The new law allows possession of up to 2 ounces, cultivation of up to 5 plants per household, and imports/exports for medical or scientific purposes. However, regulations are still pending and challenges remain regarding banking restrictions and reactions from other countries.
This document discusses laws enacted as a result of parental advocacy around substance abuse issues. It summarizes Casey's Law, a law passed in Kentucky that allows involuntary substance abuse treatment. It was inspired by the death of Matthew Casey Wethington from a heroin overdose at age 23. The law allows parents, relatives or friends to petition the court to require someone to undergo treatment if they are unable to recognize their need for treatment due to impairment. It outlines the petition process, required evidence, evaluations, hearings, and possible outcomes including court-ordered treatment. The presenters aim to help advocates identify laws in their states, explain their components, and apply successful models elsewhere.
Cannabis Science & Policy Summit - Day 2 - ReuterCannabisSummit
1) Canada is taking a sensible approach to legalizing cannabis by planning in advance, articulating specific goals, developing an evaluation process, and coordinating federal and provincial governments.
2) A report from CAMH advocates for a government monopoly over supply to allow for adjustments to product mix as understanding of harms increases, and argues this approach promotes health equity by reducing arrests of minorities and poor people under prohibition.
3) However, the report is criticized for not adequately recognizing potential benefits of cannabis use or considering whether pleasure should count in policymaking, and relying too much on a health model without considering other social harms.
Cannabis Science & Policy Summit - Day 1 - HallCannabisSummit
This document discusses complications that arise when comparing the risks of alcohol and cannabis. While cannabis appears less harmful than alcohol in some ways, its legal status and patterns of use are confounded by prohibition. Additionally, risks may increase with legalization, such as from more potent products, and cannabis use has been correlated with poorer cognitive and social outcomes from sustained daily use. Finally, there are regulatory and health education challenges to legalizing cannabis in a way that minimizes risks of dependence and impairment while developing credible public health advice.
Cannabis Science & Policy Summit - Day 2 - NovakCannabisSummit
This document summarizes a study that used latent class analysis to identify patterns of medical cannabis consumption among 50 patients in San Francisco. The analysis identified 4 classes: pure therapy (10%), pure euphoria (10%), mixed motives (55%), and smoked euphoria (25%). Characteristics like gender, medical conditions, and socioeconomic status were associated with class membership. Probability of consumption varied by day of week and payday cycles, with higher use on weekends and paydays. The findings suggest medical cannabis is used more for euphoria than purely medical reasons for most patients.
Cannabis Science & Policy Summit - Day 1 - WetterauCannabisSummit
1. ASAM supports decriminalizing marijuana possession for personal use and treating it as a civil offense linked to contingencies like mandated clinical assessment and treatment.
2. ASAM does not support legalizing marijuana and recommends caution in jurisdictions that have not legalized it yet until more is learned from places that have.
3. The document outlines several recommendations from ASAM for regulating legalized recreational marijuana and expanding access to treatment and prevention services for marijuana use, especially among youth.
Cannabis Science & Policy Summit - Day 1 - PeyraubeCannabisSummit
Uruguay has reformed its drug policy based on a framework of security, public health, and human rights. It prioritizes human rights conventions and national sovereignty over international drug conventions. Uruguay regulates cannabis to reduce the negative impacts of drugs and incarceration for possession. The regulation creates a domestic cannabis industry and allows medical use and research. Adults can access cannabis through self-cultivation, cannabis clubs, or purchasing up to 40 grams per month from pharmacies. Production is licensed and regulated by the government.
Cannabis Science & Policy Summit - Day 1 - CaulkinsCannabisSummit
This document discusses different aspects of legalizing marijuana, including defining levels of legalization and comparing marijuana legalization to other regulated substances and markets. It also provides statistics on current marijuana use patterns in the US, highlighting that most use is concentrated among relatively heavy users and those with substance abuse problems. The potential public health impacts of legalization are uncertain and will depend on how regulations shape the legal market.
Cannabis Science & Policy Summit - Day 1 - SeiverightCannabisSummit
Jamaica has recently passed legislation decriminalizing possession of small amounts of cannabis and legalizing its medical use. This represents progress toward reforming cannabis laws, which were made stricter under British rule and international treaties, despite cannabis having traditional medical and religious uses in Jamaica. The new law allows possession of up to 2 ounces, cultivation of up to 5 plants per household, and imports/exports for medical or scientific purposes. However, regulations are still pending and challenges remain regarding banking restrictions and reactions from other countries.
This document discusses laws enacted as a result of parental advocacy around substance abuse issues. It summarizes Casey's Law, a law passed in Kentucky that allows involuntary substance abuse treatment. It was inspired by the death of Matthew Casey Wethington from a heroin overdose at age 23. The law allows parents, relatives or friends to petition the court to require someone to undergo treatment if they are unable to recognize their need for treatment due to impairment. It outlines the petition process, required evidence, evaluations, hearings, and possible outcomes including court-ordered treatment. The presenters aim to help advocates identify laws in their states, explain their components, and apply successful models elsewhere.
Cannabis Science & Policy Summit - Day 1 - FortinCannabisSummit
1) The document analyzes cannabis policy and markets in Colorado following legalization of recreational cannabis.
2) It finds evidence that the recreational market is cannibalizing the medical market, especially in tourist counties, but is also expanding overall demand.
3) A dual pricing scheme, with lower prices for medical patients and higher prices for recreational users, has successfully achieved price discrimination and appears optimal for balancing economic and social outcomes.
A powerpoint about the issue revolving around marijuana use and legalization. More specifically about how it effects the economy and people when you legalize it's recreational use, but classify it as an illicit drug in drug tests.
This document summarizes a panel discussion on lessons learned from prescription drug supply-side interventions. The panel included experts from Brown University, a policy advocacy group, and a law firm. They discussed research evaluating the impact of Florida's crackdown on "pill mills" that distributed oxycodone. Preliminary findings suggest supply-side interventions reduced drug availability and increased prices, with no evidence of recovery in supply. There was also no increase in other drugs, and interventions may have reduced abuse and improved public health. The panel then outlined strategies to protect consumers from black market prescription drugs, such as educating prescribers, reducing available supply of drugs for abuse, and developing abuse-deterrent formulations.
Dealing with Substance Abuse in the WorkplaceCase IQ
Security expert Timothy Dimoff discusses tips for dealing with substance abuse in the workplace. To view the webinar recording, visit: http://i-sight.com/webinar-substance-abuse-in-the-workplace/
The document discusses alcohol and drug testing in the construction industry. It provides statistics on alcohol-related deaths and injuries in Western Australia. It promotes an alcohol and drug testing policy and program from Alcolizer Technology, discussing the benefits of testing, different testing methods, developing a policy, and the rights and obligations of employers and employees. Alcolizer Technology presents itself as a leader in alcohol and drug testing solutions, offering testing equipment, programs, training, and support.
Organisations – large or small, private or public sector – can expect to have to tackle
problems relating to drug and alcohol misuse amongst employees at some time.
The cost to industry has been estimated at £800 million per year and problems caused
by drug and alcohol misuse not only affect the health, safety and welfare of staff but
also business continuity and financial stability.
All managers have a duty of care to their employees. Drug and alcohol misuse can not
only destroy the individual concerned, but can also have an extremely detrimental effect
on the wider workforce, clients and customers and the organisation’s performance.
Organisations must be aware of the potential problem and be confident that they
have the background knowledge and policies in place to deal with individual cases.
The object should be to drive drugs and alcohol, not the people,
out of the organisation.
Prevention is as important as dealing with the consequences
of misuse.
Drug and alcohol misuse should be seen as a health problem and the employee should
be supported as far as possible, with disciplinary action being used only as a last resort.
There is evidence that the most effective way of achieving this is to introduce
and maintain a comprehensive, unequivocal and effective drugs and alcohol
policy that is established at the top and known throughout the organisation.
Managers should therefore ask themselves the following questions:
• Does my organisation have a drugs and alcohol policy?
• If not, why not?
• If yes, how effective is it?
• What are the legal implications?
• How accessible is it to employees?
According to research conducted in 2002 by the Chartered Management Institute,
one in five managers believe that alcohol misuse has increased in their organisation
over the past few years while 16 per cent feel that drugs misuse has increased.
However, while the signs of alcohol misuse are familiar to most (85 per cent),
a large proportion of managers (46 per cent) are not confident they would
recognise the signs of drug misuse.
This leaflet seeks to raise awareness of the issues to be tackled, and suggests
how a policy may be implemented and a support network provided.
Risky Business: The Transition of High Risk Pool Enrollees to Other Coverage ...soder145
The document summarizes findings from a 2012 survey of enrollees in Minnesota's high risk health insurance pool, the Minnesota Comprehensive Health Association (MCHA), regarding their potential transition to other coverage options under the Affordable Care Act in 2014. Key findings include that the majority of MCHA enrollees will likely not qualify for financial assistance to purchase coverage, many are unfamiliar with the ACA's changes and worried about costs increasing, and mail is the preferred method of receiving information about coverage options. Outreach efforts will need to address concerns over affordability and promote new protections to encourage enrollment in appropriate plans.
Behind Bars II: Substance Use and America’s Prison PopulationCenter on Addiction
The document is a report by CASAColumbia that analyzes substance use among America's prison population. Some key findings are that in 2006, 85% of inmates were substance-involved, 65% met criteria for substance use disorders, and only 11% received treatment. Failure to treat addiction increases crime and government costs. The growth in the substance-involved inmate population from 1996 to 2006 increased faster than the general US and total inmate populations.
Rx16 federal wed_1230_1_kelly_2bohn-killorinOPUNITE
1) The National HIDTA Program provides assistance to law enforcement agencies in critical drug trafficking regions through 28 regional HIDTA programs. It facilitates cooperation among federal, state, local, and tribal law enforcement.
2) Each HIDTA program has an executive board that identifies threats, develops strategies, and requests funding for initiatives. It brings together over 7,400 federal agents, 15,700 state and local officers, and 500 agencies across the country.
3) In response to the opioid epidemic, HIDTA employs law enforcement targeting of heroin and fentanyl trafficking, public health prevention efforts, and training on investigating heroin organizations. It has committed additional funds to enhance intelligence sharing and public health partnerships.
This document summarizes a presentation on state and federal responses to the opioid epidemic. It discusses innovations from the Kentucky Attorney General including legislative measures targeting pill mills and heroin, programs to expand treatment and recovery, and education initiatives. It also describes the federal response through the Organized Crime Drug Enforcement Task Force (OCDETF), including their national heroin initiative targeting criminal organizations trafficking illegal opioids and heroin, and partnerships with other agencies to address public health and public safety aspects of the epidemic. The presentation outlines strategies at both state and federal levels aimed at improving access to treatment while also enforcing penalties on dealers through investigation and prosecution efforts.
The study analyzed crash data from over 3,000 drivers in Virginia Beach over 20 months to determine the crash risks associated with alcohol and drug use. Drivers with a 0.08% breath alcohol level were 4 times more likely to crash than sober drivers, while those at 0.15% were 12 times more likely. Marijuana users were 25% more likely to crash than sober drivers, though other factors may account for this increased risk. The study aims to further refine the understanding of crash risks from marijuana use.
This document presents a needs assessment and strategic prevention plan for Midland County, Michigan. It identifies underage drinking, alcohol-related crashes, increased illicit drug use, and smoking as priority substance abuse problems based on an analysis of local data. Intervening factors like peer pressure and personal views of the future are also examined. Based on this analysis and a review of current prevention efforts, the plan proposes expanding asset-based programs through local agencies to reduce substance abuse among youth.
Survey of likely 2014 likely voters in Arkansas, Colorado, Georgia, Kentucky, Louisiana, Michigan, Montana and North Carolina measuring opinion of the proposed EPA carbon emissions regulations.
This document summarizes a national dialogue on drug-impaired driving that took place in April 2012. It discusses policy goals of identifying impaired drivers and distinguishing impairment from medication use. Statistics show that in 2009, over 13,000 drivers who died in crashes tested positive for drugs. The document outlines the dangers of drug-impaired driving and different state laws addressing this issue. It also notes challenges with drug evaluation programs and drug testing. Suggestions are made to improve prevention of drug-impaired driving.
This document summarizes a presentation given by Demetra Ashley of the DEA about regulations and efforts to address the prescription drug abuse epidemic. It discusses how most prescription drug abuse involves obtaining medications from friends and family, not through criminal means. The DEA works with various groups to educate on responsible prescribing and dispensing through initiatives like take-back events and conferences. The goal is to curb abuse while ensuring access to needed medications through enforcement as well as prevention and treatment efforts.
CFIF National Swing States Survey Executive SummaryJeff Mazzella
The survey found that voters are most concerned about COVID-19, the economy/jobs, and health insurance costs in deciding how to vote for president. On health care specifically, voters said the most important issue is the cost of health insurance coverage. Most voters believe the government's role should be providing oversight and incentives to lower costs rather than directly setting prices. Measures targeting specific cost drivers like wasteful spending saw strong support, while a single government insurance plan was opposed by many groups including seniors. On prescription drugs, voters favored incentives over requirements for domestic manufacturing but felt avoiding supply disruptions was important during the pandemic.
This document discusses the benefits of creating a healthy work environment free of substance abuse. It provides data showing that alcohol, tobacco, and drug use increases healthcare costs and reduces productivity through absenteeism and accidents. Employers can realize cost savings through education programs, cessation services, and policies that support treatment and recovery. The document recommends steps for employers like establishing employee assistance programs, adopting comprehensive substance abuse policies, and ensuring health plans provide treatment coverage.
The document summarizes key findings from the UNODC's World Drug Report 2016. It finds that while the number of women arrested for drug offenses has increased, the proportion of women in drug cases has decreased. It also discusses trends in drug production, use, and related health issues. Additionally, it examines the relationship between development levels, socioeconomic status, and drug use. The report concludes that development initiatives and responses to drug problems must work in tandem to be effective and minimize unintended impacts. Drug policies should be evidence-based, sensitive to vulnerable groups, and aim to reduce stigma and imprisonment for minor drug offenses.
This webinar will provide an overview of current FDA regulation of pharmacy compounding in the wake of the 2012 meningitis outbreak. It will discuss the legislative efforts taken by Congress to clarify the FDA's authority over compounding pharmacies. The webinar will cover the FDA's traditional approach to regulating compounding, its current policy statement, recent enforcement trends, and two pieces of pending legislation - HR 3089 and HR 3204. Pharmacists, pharmacy technicians, and those in regulatory affairs and quality control in the pharmaceutical industry would benefit from attending.
This document outlines a conference for building cases across state lines related to pharmaceutical drug crimes. It discusses the roles of various practitioners, authorities, investigators and prosecutors involved in these types of cases. It also covers the evolution of the prescription drug epidemic and how prescription drug monitoring programs can aid in multi-state investigations. The document identifies common roadblocks to effective multi-state investigations and the prosecutor's role in working with investigators during early case development.
Cannabis Science & Policy Summit - Day 2 - TrautmannCannabisSummit
The national cannabis policy in the Netherlands has swung like a pendulum since the 1990s, moving between more liberal and restrictive approaches. Originally, a more liberal policy developed in response to social changes and protests in the 1960s, allowing for regulated cannabis sales. However, international criticism and issues like drug tourism led to a more restrictive approach focused on supply reduction and public order from the 2000s onward. Stricter measures unintentionally increased street dealing and organized crime involvement. More recently, support has increased for a less restrictive approach, including some cities exploring regulated cannabis production. Current national policy still prohibits production but condones retail sales through "coffeeshops" under local regulations.
Cannabis Science & Policy Summit - Day 2 - OrensCannabisSummit
This document summarizes outcomes from the legalization of marijuana in Colorado over two years. Key findings include an increase in past month marijuana use prevalence and demand, with casual users accounting for more use. Prices have decreased while concentrate sales have risen. Legalization has had a strong positive economic impact, creating thousands of jobs and over $1 billion in revenue. The regulated market now serves nearly three-quarters of total marijuana demand in Colorado.
Cannabis Science & Policy Summit - Day 1 - FortinCannabisSummit
1) The document analyzes cannabis policy and markets in Colorado following legalization of recreational cannabis.
2) It finds evidence that the recreational market is cannibalizing the medical market, especially in tourist counties, but is also expanding overall demand.
3) A dual pricing scheme, with lower prices for medical patients and higher prices for recreational users, has successfully achieved price discrimination and appears optimal for balancing economic and social outcomes.
A powerpoint about the issue revolving around marijuana use and legalization. More specifically about how it effects the economy and people when you legalize it's recreational use, but classify it as an illicit drug in drug tests.
This document summarizes a panel discussion on lessons learned from prescription drug supply-side interventions. The panel included experts from Brown University, a policy advocacy group, and a law firm. They discussed research evaluating the impact of Florida's crackdown on "pill mills" that distributed oxycodone. Preliminary findings suggest supply-side interventions reduced drug availability and increased prices, with no evidence of recovery in supply. There was also no increase in other drugs, and interventions may have reduced abuse and improved public health. The panel then outlined strategies to protect consumers from black market prescription drugs, such as educating prescribers, reducing available supply of drugs for abuse, and developing abuse-deterrent formulations.
Dealing with Substance Abuse in the WorkplaceCase IQ
Security expert Timothy Dimoff discusses tips for dealing with substance abuse in the workplace. To view the webinar recording, visit: http://i-sight.com/webinar-substance-abuse-in-the-workplace/
The document discusses alcohol and drug testing in the construction industry. It provides statistics on alcohol-related deaths and injuries in Western Australia. It promotes an alcohol and drug testing policy and program from Alcolizer Technology, discussing the benefits of testing, different testing methods, developing a policy, and the rights and obligations of employers and employees. Alcolizer Technology presents itself as a leader in alcohol and drug testing solutions, offering testing equipment, programs, training, and support.
Organisations – large or small, private or public sector – can expect to have to tackle
problems relating to drug and alcohol misuse amongst employees at some time.
The cost to industry has been estimated at £800 million per year and problems caused
by drug and alcohol misuse not only affect the health, safety and welfare of staff but
also business continuity and financial stability.
All managers have a duty of care to their employees. Drug and alcohol misuse can not
only destroy the individual concerned, but can also have an extremely detrimental effect
on the wider workforce, clients and customers and the organisation’s performance.
Organisations must be aware of the potential problem and be confident that they
have the background knowledge and policies in place to deal with individual cases.
The object should be to drive drugs and alcohol, not the people,
out of the organisation.
Prevention is as important as dealing with the consequences
of misuse.
Drug and alcohol misuse should be seen as a health problem and the employee should
be supported as far as possible, with disciplinary action being used only as a last resort.
There is evidence that the most effective way of achieving this is to introduce
and maintain a comprehensive, unequivocal and effective drugs and alcohol
policy that is established at the top and known throughout the organisation.
Managers should therefore ask themselves the following questions:
• Does my organisation have a drugs and alcohol policy?
• If not, why not?
• If yes, how effective is it?
• What are the legal implications?
• How accessible is it to employees?
According to research conducted in 2002 by the Chartered Management Institute,
one in five managers believe that alcohol misuse has increased in their organisation
over the past few years while 16 per cent feel that drugs misuse has increased.
However, while the signs of alcohol misuse are familiar to most (85 per cent),
a large proportion of managers (46 per cent) are not confident they would
recognise the signs of drug misuse.
This leaflet seeks to raise awareness of the issues to be tackled, and suggests
how a policy may be implemented and a support network provided.
Risky Business: The Transition of High Risk Pool Enrollees to Other Coverage ...soder145
The document summarizes findings from a 2012 survey of enrollees in Minnesota's high risk health insurance pool, the Minnesota Comprehensive Health Association (MCHA), regarding their potential transition to other coverage options under the Affordable Care Act in 2014. Key findings include that the majority of MCHA enrollees will likely not qualify for financial assistance to purchase coverage, many are unfamiliar with the ACA's changes and worried about costs increasing, and mail is the preferred method of receiving information about coverage options. Outreach efforts will need to address concerns over affordability and promote new protections to encourage enrollment in appropriate plans.
Behind Bars II: Substance Use and America’s Prison PopulationCenter on Addiction
The document is a report by CASAColumbia that analyzes substance use among America's prison population. Some key findings are that in 2006, 85% of inmates were substance-involved, 65% met criteria for substance use disorders, and only 11% received treatment. Failure to treat addiction increases crime and government costs. The growth in the substance-involved inmate population from 1996 to 2006 increased faster than the general US and total inmate populations.
Rx16 federal wed_1230_1_kelly_2bohn-killorinOPUNITE
1) The National HIDTA Program provides assistance to law enforcement agencies in critical drug trafficking regions through 28 regional HIDTA programs. It facilitates cooperation among federal, state, local, and tribal law enforcement.
2) Each HIDTA program has an executive board that identifies threats, develops strategies, and requests funding for initiatives. It brings together over 7,400 federal agents, 15,700 state and local officers, and 500 agencies across the country.
3) In response to the opioid epidemic, HIDTA employs law enforcement targeting of heroin and fentanyl trafficking, public health prevention efforts, and training on investigating heroin organizations. It has committed additional funds to enhance intelligence sharing and public health partnerships.
This document summarizes a presentation on state and federal responses to the opioid epidemic. It discusses innovations from the Kentucky Attorney General including legislative measures targeting pill mills and heroin, programs to expand treatment and recovery, and education initiatives. It also describes the federal response through the Organized Crime Drug Enforcement Task Force (OCDETF), including their national heroin initiative targeting criminal organizations trafficking illegal opioids and heroin, and partnerships with other agencies to address public health and public safety aspects of the epidemic. The presentation outlines strategies at both state and federal levels aimed at improving access to treatment while also enforcing penalties on dealers through investigation and prosecution efforts.
The study analyzed crash data from over 3,000 drivers in Virginia Beach over 20 months to determine the crash risks associated with alcohol and drug use. Drivers with a 0.08% breath alcohol level were 4 times more likely to crash than sober drivers, while those at 0.15% were 12 times more likely. Marijuana users were 25% more likely to crash than sober drivers, though other factors may account for this increased risk. The study aims to further refine the understanding of crash risks from marijuana use.
This document presents a needs assessment and strategic prevention plan for Midland County, Michigan. It identifies underage drinking, alcohol-related crashes, increased illicit drug use, and smoking as priority substance abuse problems based on an analysis of local data. Intervening factors like peer pressure and personal views of the future are also examined. Based on this analysis and a review of current prevention efforts, the plan proposes expanding asset-based programs through local agencies to reduce substance abuse among youth.
Survey of likely 2014 likely voters in Arkansas, Colorado, Georgia, Kentucky, Louisiana, Michigan, Montana and North Carolina measuring opinion of the proposed EPA carbon emissions regulations.
This document summarizes a national dialogue on drug-impaired driving that took place in April 2012. It discusses policy goals of identifying impaired drivers and distinguishing impairment from medication use. Statistics show that in 2009, over 13,000 drivers who died in crashes tested positive for drugs. The document outlines the dangers of drug-impaired driving and different state laws addressing this issue. It also notes challenges with drug evaluation programs and drug testing. Suggestions are made to improve prevention of drug-impaired driving.
This document summarizes a presentation given by Demetra Ashley of the DEA about regulations and efforts to address the prescription drug abuse epidemic. It discusses how most prescription drug abuse involves obtaining medications from friends and family, not through criminal means. The DEA works with various groups to educate on responsible prescribing and dispensing through initiatives like take-back events and conferences. The goal is to curb abuse while ensuring access to needed medications through enforcement as well as prevention and treatment efforts.
CFIF National Swing States Survey Executive SummaryJeff Mazzella
The survey found that voters are most concerned about COVID-19, the economy/jobs, and health insurance costs in deciding how to vote for president. On health care specifically, voters said the most important issue is the cost of health insurance coverage. Most voters believe the government's role should be providing oversight and incentives to lower costs rather than directly setting prices. Measures targeting specific cost drivers like wasteful spending saw strong support, while a single government insurance plan was opposed by many groups including seniors. On prescription drugs, voters favored incentives over requirements for domestic manufacturing but felt avoiding supply disruptions was important during the pandemic.
This document discusses the benefits of creating a healthy work environment free of substance abuse. It provides data showing that alcohol, tobacco, and drug use increases healthcare costs and reduces productivity through absenteeism and accidents. Employers can realize cost savings through education programs, cessation services, and policies that support treatment and recovery. The document recommends steps for employers like establishing employee assistance programs, adopting comprehensive substance abuse policies, and ensuring health plans provide treatment coverage.
The document summarizes key findings from the UNODC's World Drug Report 2016. It finds that while the number of women arrested for drug offenses has increased, the proportion of women in drug cases has decreased. It also discusses trends in drug production, use, and related health issues. Additionally, it examines the relationship between development levels, socioeconomic status, and drug use. The report concludes that development initiatives and responses to drug problems must work in tandem to be effective and minimize unintended impacts. Drug policies should be evidence-based, sensitive to vulnerable groups, and aim to reduce stigma and imprisonment for minor drug offenses.
This webinar will provide an overview of current FDA regulation of pharmacy compounding in the wake of the 2012 meningitis outbreak. It will discuss the legislative efforts taken by Congress to clarify the FDA's authority over compounding pharmacies. The webinar will cover the FDA's traditional approach to regulating compounding, its current policy statement, recent enforcement trends, and two pieces of pending legislation - HR 3089 and HR 3204. Pharmacists, pharmacy technicians, and those in regulatory affairs and quality control in the pharmaceutical industry would benefit from attending.
This document outlines a conference for building cases across state lines related to pharmaceutical drug crimes. It discusses the roles of various practitioners, authorities, investigators and prosecutors involved in these types of cases. It also covers the evolution of the prescription drug epidemic and how prescription drug monitoring programs can aid in multi-state investigations. The document identifies common roadblocks to effective multi-state investigations and the prosecutor's role in working with investigators during early case development.
Cannabis Science & Policy Summit - Day 2 - TrautmannCannabisSummit
The national cannabis policy in the Netherlands has swung like a pendulum since the 1990s, moving between more liberal and restrictive approaches. Originally, a more liberal policy developed in response to social changes and protests in the 1960s, allowing for regulated cannabis sales. However, international criticism and issues like drug tourism led to a more restrictive approach focused on supply reduction and public order from the 2000s onward. Stricter measures unintentionally increased street dealing and organized crime involvement. More recently, support has increased for a less restrictive approach, including some cities exploring regulated cannabis production. Current national policy still prohibits production but condones retail sales through "coffeeshops" under local regulations.
Cannabis Science & Policy Summit - Day 2 - OrensCannabisSummit
This document summarizes outcomes from the legalization of marijuana in Colorado over two years. Key findings include an increase in past month marijuana use prevalence and demand, with casual users accounting for more use. Prices have decreased while concentrate sales have risen. Legalization has had a strong positive economic impact, creating thousands of jobs and over $1 billion in revenue. The regulated market now serves nearly three-quarters of total marijuana demand in Colorado.
Cannabis Science & Policy Summit - Day 2 - MacCounCannabisSummit
This document summarizes research on the Dutch approach to cannabis policy, known as "de facto legalization". Key points include:
- During the first decade after policy change in 1976, cannabis use prevalence did not increase, but sharply rose in the second decade due to commercialization of coffeeshops.
- The Dutch system maintains high cannabis prices through prohibition on growers/traffickers while allowing sale to users, unlike potential US legalization with aggressive marketing and minimal price controls.
- Experts note the Dutch policy was a product of addressing the heroin threat in the 1970s but the policy window has since closed, with unintended consequences like street dealing and production shifting elsewhere.
Cannabis Science & Policy Summit - Day 2 - BlickmanCannabisSummit
The document summarizes the debate around regulating the cannabis supply system in the Netherlands. It outlines that mayors, judges, and public opinion favor regulation over the current policy of tolerance. The mayors revolt argues that tolerance is bankrupt and increases crime, while judges are increasingly uneasy about contradictions in current policy. The document proposes regulating cultivation and supply to reduce crime and better protect public health.
Cannabis Science & Policy Summit - Day 2 - HopeCannabisSummit
The document discusses issues related to cannabis policy in Mexico. It provides statistics on homicides, drug cases, eradication and seizures of marijuana from 2005-2015. It shows that 50% of homicides with firearms from 2007-2014 occurred in regions known for marijuana production. The document also shows data on the percentage of inmates in state penitentiaries that were incarcerated for drug retail sales (5%), crimes against health (7%) and other crimes (88%). It acknowledges that precisely estimating the effects of changing drug policy is impossible and that displacement effects are unknown. It concludes by thanking the audience and providing contact information for Alejandro Hope who presented the information.
Cannabis Science & Policy Summit - Day 2 - de KortCannabisSummit
The document summarizes the origins and development of Dutch cannabis policy from the 1970s to the present. Key events included the recommendations of committees in the late 1960s and early 1970s to decriminalize cannabis, the introduction of heroin in 1972 which led to stricter drug laws, and the rise of coffee shops in the 1970s-1980s which established a system of toleration for soft drugs like cannabis. The coffee shop system developed pragmatically rather than through a formal policy and expectations of legalization were not met. Over time coffee shops faced some regulation to address issues like advertising, hard drugs, nuisances, and minors.
Cannabis Science & Police Summit - Day 1 - ZinsmeisterCannabisSummit
The document discusses public opinion and the UN drug conventions regarding drug policy reforms. It summarizes that legalization is still a minority position at the UN as the majority of member states still favor prohibitionist approaches. Several polls and surveys cited show that public opinion in Europe and Latin America also generally opposes marijuana legalization and favors maintaining prohibition. When asked about decriminalization, reaction is still mixed. The Latin American public sees drugs as both a security and public health issue.
Cannabis Science & Policy Summit - Day 2 - FlasterCannabisSummit
The document summarizes a panel discussion on adulterants in cannabis regulation and testing, with panelists from various cannabis industry organizations. The panel discusses issues around growing practices, ensuring quality and consistency of cannabis products, and the importance of testing for contaminants and validating test methods to verify constituents and ensure consumer safety. Proper growing, accountability through testing, and transparency were emphasized as important to building trust in the cannabis industry.
Safe Food for Canadians Regulation – Are You Ready?
The Safe Food Canadians Act is a bit of a ‘sleeping’ giant, as the regulations came into effect January 15, 2019. Many food companies both within Canada and outside its borders are still trying to figure out what they need to do in order to comply.
This informative webinar featuring Cameron Prince with The Acheson Group discusses:
- Top 3 pillars of the Safe Food Canadians Regulations and how they compare to FSMA
- What companies should have in place, or work towards quickly, to ensure compliance – relative to licensing, traceability and preventive controls
- The long term impact these regulations will have on food companies, and predictions on enforcement
Learn more at https://safetychain.com
This document provides an overview and summary of Canada's new Safe Food for Canadians Regulation (SFCR) which comes into effect on January 15, 2019. It outlines the key elements of the new regulation including licensing requirements, preventive control measures, traceability rules, and the steps companies need to take to transition. The regulation aims to modernize and consolidate Canada's food safety rules and better protect consumers from foodborne illness.
Introduction to quality assurance and qualtiy controlAmruta Balekundri
Quality assurance and quality control are important functions to ensure pharmaceutical products meet required standards of quality.
Quality assurance aims to prevent defects through establishing good manufacturing processes and quality systems, while quality control identifies defects by testing final products. Together they help fulfill quality requirements.
The history of quality evolution in pharmaceuticals shows how regulations were strengthened in response to safety issues. Milestones include the 1906 and 1938 acts in the US and 1978 GMP standards, aiming to ensure drug safety and efficacy. Quality assurance and quality control play key roles in implementing these standards and continually improving pharmaceutical quality.
This document discusses standard operating procedures (SOPs) at Grifols, a pharmaceutical company that produces plasma-derived medications. It contains the following key points:
1) Grifols has written SOPs that provide guidance for every task and are derived from regulations like the Code of Federal Regulations and EU Guidelines. SOPs ensure safety and quality.
2) The CFR requires that SOPs include procedures for donor eligibility, equipment calibration, sterilization methods, quality control, and other production steps.
3) Strict adherence to SOPs and documentation is required at every stage of production from donor screening to distribution to ensure plasma-derived medications meet quality standards.
A BRIEF OVERVIEW ABOUT CDSCO.
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The Massachusetts Medical Use of Marijuana Program underwent a multi-step process to select dispensaries to distribute medical marijuana across the state. They received over 200 applications, conducted extensive background checks, had applications reviewed by experts and a selection committee, and the executive director provisionally approved 28 applicants. The approved dispensaries will now begin inspections before receiving final registration to open and distribute medical marijuana to patients. The program will continue to regulate dispensaries and the medical marijuana industry to ensure patient access and public safety.
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
This document discusses standard operating procedures (SOPs) at Grifols plasma centers. It provides several key points:
1) SOPs are written procedures that are followed for every task and are derived from regulations like the Code of Federal Regulations and EU Guidelines.
2) SOPs create uniform guidelines to ensure safety for donors and recipients of plasma-derived medications. They must comply with regulatory standards.
3) The CFR requires that SOPs include procedures for donor eligibility criteria, quality control, equipment maintenance, labeling, and more. Strict adherence to SOPs is important to maintain quality and safety.
The document discusses several ethical issues in forensic pharmacy, including quality assurance and good manufacturing practices in pharmaceutical production. It outlines laws and regulations that manufacturers must follow to ensure drug quality, safety, and efficacy. It also discusses good storage and distribution practices, including maintaining cold chains for temperature-sensitive drugs. The document emphasizes that pharmacists must handle product complaints, recalls, and imports/exports of controlled substances ethically and according to documented procedures to protect patient safety.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Regulating the manufacture of therapeutic goodsTGA Australia
View this presentation for information on:
*how the manufacture of therapeutic goods is regulated
* how the quality of therapeutic goods is checked
* differences for higher, medium and lower risk products
* inspections of manufacturers, both in Australia and internationally
* international harmonisation.
A presentation by Matthew van den Honert B-tech, Owner, CereusSA (Pty) Ltd, South Africa.
Delivered during the 38th annual SAPICS event for supply chain professionals in Sun City, South Africa.
What is the risk of non-compliance to certification schemes and audit standards in the food industry? There are many certification schemes available on the global stage. Each of these have been designed to better the organisation, however many companies merely implement these in order to have a certificate. The risk of non-compliance is potentially catastrophic to the manufacturer. The presentation will look at a case by case basis where the effective lack of management and adherence to the management systems resulted in outbreaks which destroyed national and global supply chains, effected economies and sunk organisations.
Topic: The Labrynth of the drug approval processes in Canada; what you should know. The presentation was created by Ryan Clarke of Advocacy Solutions for CCSN's webinar series. Please see www.survivornet.ca for a recording of the presentation.
Chapter 7 Assuring Safety and Security in Healthcare Insti.docxmccormicknadine86
Chapter 7: Assuring Safety and
Security in Healthcare Institutions
Safety and Security – Risk?
• Health facilities that experience adverse
events due to safety or security issues can
incur penalties ranging from large fines to loss
of accreditation.
• An aggressive and well-organized safety and
security management program can help
minimize risk of and adverse event.
Regulation and Accreditation
• Medicare and Medicaid require a participating
healthcare organization to satisfy the
Conditions of Participation (CoP) relevant to
the management of safety and security.
– Accreditation by the Joint Commission, DNV
Healthcare Inc. or HFAP ensures that the facility
meets the CoP requirements
• State Departments of Health also regulate
safety and security in healthcare organizations
Safety vs. Security
• Safety can be a broad category with standard
policies and procedures throughout a facility or
system.
– Hand-washing policy
– Use of Personal protective gear
– Hazardous waste disposal
• Security must be more site specific.
• Safety and security policies sometimes conflict.
High Risk Events
• A facility may incur major penalties if a
“never” adverse event occurs (an event that
should not occur if appropriate safety/security
measures were in place)
• CMS may not reimburse costs of a never event
and many third party payers have a non-
reimbursement program as well.
Techniques for Managing
Safety and Security
• Risk Assessment Estimate
• Failure Modes and Effects Analysis (FMEA)
• Root-cause Analysis (RCA)
• Technological Redundancy
• Crew Resource Management
• Red Rules
Potential Environmental Hazards
• OSHA has a list of the types of hospital-wide
hazards and provides information on how to
prevent and respond to them
• Three categories of hazardous materials
– Biological
– Chemical
– Radioactive
Security: Unwanted Intruders
• Use of high-tech solutions to manage visitor
and employee access
– Automated turnstiles with card swipe readers for
employee entrances
– Visitor areas/desk where all visitors enter and
sign-in.
– Employee ID badges
– Secured areas
Potential Security Hazards
• Theft of Patient Valuables/Employee theft
• Infant abduction
• Workplace Violence
• Gangs
Patient Valuables
• Provide a safe in the building to house
valuables
• Provide receipts for any valuable stored by
facility
• Encourage patients to leave valuables at
home or give to family to take home
Violence in the Workplace
• Patients have a right to treatment but staff
have a legal right to a safe workplace
• Watch for signs that may lead to violence
(in patients, visitors and staff)
– Anger
– Stress
– Under the influence of drugs/alcohol
Gangs
• Many health facilities treat victims of gang
violence and occasionally the dispute
continues upon arrival at the facility.
• Use of metal detectors is increasing to prevent
entrance of weapons into the health facility
Information ...
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
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Cannabis Science & Policy Summit - Day 2 - Sterling
1. Enforcement?
Medical Cannabis in Maryland
A presentation to
Cannabis Science and Policy Summit
New York University
April 18, 2016
By
Eric E. Sterling, J.D.
Chair, Policy Committee
Maryland Medical Cannabis Commission
mmcc.maryland.gov
2. Background
• In 2013, Maryland General Assembly created
Natalie M. LaPrade Medical Cannabis
Commission to carry out a program to
dispense cannabis to Maryland patients
• Statute has been amended in 2014, 2015 and
2016.
3. Background
• Link to compiled statute on Commission
website: mmcc.maryland.gov
• http://mmcc.maryland.gov/pages/law/docum
ents/Subtitle%2033_Sept2015_Corrected.pdf
4. Appreciation
• Delegates Dan Morhaim, M.D. and
Cheryl Glenn
• Senator Jamie Raskin
• The key advocates in General Assembly
throughout development of program
5. Commission
• 16 Commissioners now
• Secretary of Health and Mental Hygiene
• Representative of Comptroller
• 14 appointees of Governor
– Variety of backgrounds
– Staggered terms
– Chair appointed by Governor
6. Code of Maryland Regulations
• COMAR Title 10: Department of Health
and Mental Hygiene
• Subtitle 62: Natalie LaPrade Medical
Cannabis Commission Regulations
• Chapters 1 to 35
• Link to regulations on Commission
website: mmcc.maryland.gov
• Took effect September 14, 2015
7. Program Principles
• Principles of Maryland’s Medical Cannabis
Program:
– Ensure proper security and protection of public
safety
– Assure the highest quality medicine is produced
and distributed
– Expedite patient access
8. Funding
• Program costs not funded by Maryland
taxpayers
• Program costs entirely paid for by fees from
licensees
10. Funding
• No fees to be paid by physicians
• No fees to be paid by patients to register or to
obtain a written certification
• If patient wishes to obtain an identification card
from the Commission, fee $50
• Independent testing laboratory registration fee
$100, valid for 2 years
• Independent testing laboratory agent fee $200
11. Application for license
• For Growers, Dispensaries and Processors,
there are two stages in applying:
First stage – Pre-approval:
• Detailed application
• Application reviewed, scored and ranked by
independent third party reviewer
• Commission considers scored & ranked
applications to issue a pre-approval of license
to successful applicants
12. Application for license
Second stage – Qualify for License:
• Pre-approved applicant completes financing,
construction, hiring, training, etc.
• Commission investigates financial background
• Applicant tells Commission that it is ready for
inspection of premises and operation
• Commission inspects premises, reviews S.O.P.s,
training
• If inspection passed , Commission awards
license to start operating
13. Current Status of Program
• Deadline for applications was November 6,
2015
• Commission received 1081 applications:
• 146 grower applications
• 124 processor applications
• 811 dispensary applications
14. Current Status of Program
• Independent third party now reviewing
applications to score and rank
15. Current Status of Program
• Commission now registering physicians
• 117 physicians registered as of last week
• Registry for patients being subjected to load
testing before going online
16. Security - Safety
• Shaping the Program:
– Commission includes Chief of Police
(representative of law enforcement)
– A State’s Attorney
– A representative of the Comptroller
17. Security - Safety
• Limited number of growers and licensees
– No more than 15 licensed growers
– Growers may operate one dispensary
– Additionally, other licensees may operate a
single dispensary. No more than two such
dispensaries in each of the 47 senatorial
districts
– Maximum number of dispensaries statewide –
109
18. Security - Safety
• Personnel in industry
– Fingerprint-based criminal history check of all
investors, managers, employees
– Background investigations of all applicants,
including investors, managers
– Detailed financial investigation of investors
– No one with a felony drug conviction can be part
of the program
– Pre-employment urine testing for all personnel
– All personnel must be trained in safety and
security
– Licensees need drug-free workplace policy
19. Security - Safety
• No one can obtain cannabis from a licensed
dispensary without a written certification
from a Maryland physician who is registered
with the Commission
20. Security - Safety
• Premises used for production, dispensing &
processing:
• Constructed to prevent unauthorized entry
• 24 – 7 recording surveillance cameras
throughout
• Security lighting
• Security alarm systems
• Must meet local zoning and planning codes
• Procedure to control public access
21. Security - Safety
• Control of cannabis
– Demanding inventory controls from “seed to sale”
– Any diversion reported to Maryland State Police
– All transactions recorded
– Strict transportation security
– Strict control in dispensaries
– Vaults for cannabis
– Exclusion of persons other than patients
– Commission review of security plans
22. Security - Safety
• Commission will regularly inspect all licensees
• Licenses can be revoked for violations
• Commission can fine violators up to $10,000
• Any possession, distribution or use of
cannabis diverted from the program can be
prosecuted with penalty up to five years in
prison and a $10,000 fine in addition to other
CDS penalties
23. Security - Safety
• Commission very aware that it can seek
assistance of U.S. Department of Justice to
investigate and prosecute activities outside
those permitted by regulation
24. Security - Safety
• Patients, and patient use of cannabis, not
excluded from offenses of:
– Operating vehicles under the influence
– Smoking cannabis in a motor vehicle
– Smoking cannabis in a public place
Patients must acknowledge these restrictions
every time the obtain medicine
25. Security - Safety
• Cannabis products packaging:
– Plain, opaque and, if requested, child-resistant
(Many patients may be handicapped and need
easy-to-open package)
– No feature that might mislead anyone about the
contents
– No cartoon, color scheme, image, or feature that
might make the package attractive to children
26. Security - Safety
• Cannabis products packaging:
– No resemblance to trademarked or product-
specialized packaging of candy, snack, baked good
or beverage
Note: Regulations do not authorize production
or distribution of Cannabis products in
“edible” form
28. Security - Safety
• Packages must bear warnings:
– Keep away from children
– Illegal for any person other than the patient to
possess or consume the contents
– Illegal to transfer (other than caregiver to transfer
to patient)
– Poison Control Center telephone number
– Telephone number to report adverse patient
event
29. Quality
• Regulatory goal: produce medicine that is
consistent, batch to batch, lot to lot
• Growers and processors encouraged to
produce cannabis in a range of means and
routes of administration
• Growers and processors to produce plant
varieties and products containing high CBD
levels, in addition to other plants & products
30. Quality
• Detailed written Standard Operating Procedures
for all cultivation, processing and dispensing
• Licensees required to follow S.O.P. as a condition
of the license
• Every batch of cannabis and every lot of
cannabis-infused product must be uniquely
identified and tracked at all production stages
• Records of production must be retained to
enable a review of all stages of production of
every batch and lot
31. Quality
• Strict horticultural control required
• Incoming materials must be segregated and
inspected to prevent contamination
32. Quality
• Every batch and lot must be analyzed by a
registered, accredited Independent Testing
Laboratory
• Every batch and lot must have a certificate of
analysis from Independent Testing Laboratory
33. Quality
• Every batch and lot must be analyzed and labeled
with cannabinoid ingredients:
– THC
– THCA
– CBD
– CBDA
– Certain terpenes
– CBG
– CBN
34. Quality
• Prevention of contamination essential
• Analysis must look for presence of:
– Heavy metals, mercury, lead, arsenic, cadmium
– Foreign matter (insects, hair, other adulterants)
– Microbiological impurity
35. Quality
• Prevention of contamination essential
• Analysis must detect and report any
microbiological impurity:
– Total aerobic microbial count (TAMC)
– Total yeast mold count (TYMC)
– Pseudomonas aeruginosa bacterium
– Aspergillus spp. molds
– Staphylococcus aureau bacterium
– Aflatoxin B1, B2, G1 & G2 mycotoxins
– Ochratoxin A toxin (produced by molds)
– Pesticide residue
36. Quality
• No batch or lot may be released unless it
meets the pre-established specification
• Producers must do stability testing
• Producers must retain samples sufficient for
follow-up testing
37. Quality
• Complaints, adverse events and recalls
– All licensees and registered physicians must be
prepared to receive, organize, record and respond
to complaints and reports of adverse events
– All substantive complaints and reports of serious
adverse events must be investigated
– If re-analysis reveals that the retention sample
does not meet specification, producers must order
a recall
38. Physician Registration
• Before issuing “written certifications” to
qualifying patients, a physician must register at
Commission website
• No Registration fee
– Registration valid for two years
– No specialized or minimum additional training
required
• Maryland medical license must be Active,
Unrestricted, and In Good Standing
• Must be registered to prescribe Controlled
Dangerous Substances in Maryland
39. Physician Registration
• Registering physician affirms to follow detailed
practice standards including
• Will complete standard patient evaluation
• Will assess patient outcome
• Will provide follow-up care
• Will collect and analyze data
40. Physician Registration
• Check off medical conditions for which
physician might issue certifications for medical
cannabis
• Identify other patient inclusion criteria
• Specify any reasons physician may deny
issuing a certification to a patient
41. Physician Registration
• Physicians encouraged to register to treat:
• Chronic or debilitating disease or medical
condition, or treatment, that causes:
– Cachexia
– Anorexia
– Wasting Syndrome
– Severe or chronic pain
– Severe nausea
– Seizures
– Severe or persistent muscle spasm
– Glaucoma
– Post Traumatic Stress Disorder (PTSD)
42. Physician Registration
• Sec. 13-3304(e) “The Commission may approve
applications that
• Include any other condition that is severe and
• For which other medical treatments have been
ineffective
• If the symptoms reasonably can be expected to be
relieved by the medical use of cannabis.”
43. Qualifying Patients
• Patient must register with Commission before
physician can issue written certification
• Patient must
– Live in Maryland; or
– Be physically present in Maryland for the purpose
of receiving medical care from a medical facility
in Maryland
• If younger than 18 years old, parent or guardian
must be caregiver
• No fee for patient unless patient desires ID card
44. Qualifying Patients
• Physician and patient must have a “bona fide”
relationship:
• Treatment or counseling relationship
• Physician has
– Reviewed patient’s relevant medical records
– Completed an in-person assessment of the patient’s
medical history and current medical condition
– Created and maintained records of patient condition
in accord with medically accepted standards
45. Qualifying Patients
Bona fide relationship (Continued)
• Reasonable expectation physician will
– Monitor patient progress while using medical
cannabis
– Take medically indicated action
• To provide follow-up care
• Regarding efficacy of medical cannabis as
treatment
• Report any adverse event associated with use
of medical cannabis
46. Written Certification
• Written Certification is issued by logging onto
commission website and entering
– Physician’s name, license number, telephone
number
– Patient’s name, DoB, address, county
– Condition(s) requiring medical cannabis
– Date patient is qualified
(Optional) Print out certification for patient use
47. Written Certification
• Basic quantity limit of 30-day supply
• 30-day supply defined as:
– 120 grams of usable cannabis or
– 36 grams of Delta9-THC in a medical cannabis
infused product
• Physician may authorize greater quantity on
determination that those amounts inadequate
to meet patient’s medical needs
48. Written Certification
• Physician shall terminate certification if
– Patient meets exclusion criteria
– Treatment no longer medically necessary
– Adverse effects outweigh medical benefits
– Evidence patient is diverting cannabis
• May terminate for abuse of any substance
• Notify Commission of termination in one (1)
business day
49. Written Certification
• Patient may seek renewal not less than 30
calendar days after issuance
• Physician may renew if
– All criteria are met
– Medical benefits likely outweigh health risks
• Cannot renew without full in-person patient
assessment within 365 days before renewal
50. Dispensaries
• Dispensaries to be located throughout the
state:
–Up to two per each of 47 state senatorial
districts
–Up to 15 associated with licensed growers
(not counted in senatorial district
allocation)
51. Dispensaries
• Extensive training of dispensary agents in:
– Pharmacology of cannabis
– Potential therapeutic and adverse effects of
cannabis
– Dosage forms and pharmacodynamics
– Potential drug interactions
– Recognition of symptoms of substance use
disorders and acute intoxication
• Patient consults trained dispensary agent on
appropriate medication
52. At Dispensary
• Patient or caregiver goes to the dispensary, or
contacts dispensary for delivery by dispensary
• Patient or caregiver presents proof of identity
• Dispensary logs onto Commission database
– Confirm validity of written certification
– Determine amount of Cannabis that can be
dispensed
– Record amount of Cannabis that is dispensed
53. At Dispensary
• Every time cannabis is dispensed
• Patient must acknowledge that the patient is not
immune from liability or prosecution for:
– Operating a vehicle under the influence of medical
cannabis
– Smoking in a public place
– Smoking in a motor vehicle
– Acting under the influence in a manner that would
constitute negligence or professional malpractice.
– Smoking cannabis on private property where not
allowed
54. At Dispensary
• Every time cannabis is dispensed
• Patient must also acknowledge:
– It is illegal to transfer the cannabis to any person
– Obtaining medical cannabis does not exempt
patient from prosecution under federal law
– Scientific research has not established the safety
of medical cannabis by pregnant women
– Use of medical cannabis to treat a medical
condition is not approved by the U.S. FDA
55. Federal role
• Since 2009, U.S. Department of Justice has
issued three memoranda that it will not
prosecute physicians, patients, dispensaries
and growers who comply with their state’s
medical cannabis law
– 2009 Ogden Memorandum (Oct. 19, 2009)
– 2011 Cole Memorandum (June 29, 2011)
– 2013 Cole Memorandum (Aug. 29, 2013)
56. Federal role
• Feb. 2014 – U.S. Treasury issued
memorandum that said “financial institutions
can provide services to marijuana-related
businesses” operating under state law
57. Federal role
• In 2014, Congress enacted a law barring the
U.S. Department of Justice from interfering in
the implementation of state medical cannabis
laws (Section 538 of Continuing
Appropriations Act of 2016, P.L. 114-53, sec.
103, 129 Stat. 502 (2015))
• Re-enacted on Dec. 18, 2015 for 2016 (Sec.
542 of P.L. 114-113)
58. Federal role
• In October 2015, interpreting the
Appropriations Act rider, a Federal Court
blocked U.S. Department of Justice from trying
to stop a California dispensary from operating
(U.S. v. Marin Alliance for Medical Marijuana,
U.S.D.C., No. Dist. Cal., Case No. C-98-00086-
CRB, Oct. 19, 2015)
• Affirmed by 9th Circuit, April 2016
59. MMCC Responsiveness
Regular updates and answers to FAQs at
mmcc.maryland.gov
Questions can be sent to
dhmh.medicalcannabiscommission@maryland.gov
Presenter today: Eric E. Sterling, J.D.
Chair, Policy Committee, MMCC
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