mrm.pharmacist.com R4... · Web viewIn the United States, benzodiazepines and/or barbiturates were reportedly used for nonmedical purposes by 2% of the population over 12 years

Region 4 Midyear Regional MeetingMadison, Wisconsin

November 9th - 11th, 2018

Proposed Resolutions

Proposing APhA-ASP ChapterPolicy Numb

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Page Numb

erButler University College of Pharmacy & Health Sciences R4.1 2Cedarville University School of Pharmacy R4.2 4Concordia University Wisconsin School of Pharmacy R4.3 6Ferris State University College of Pharmacy R4.4 8Manchester University College of Pharmacy, Natural & Health Sciences

R4.5 11

Midwestern University Chicago College of Pharmacy R4.6 14Northeast Ohio Medical University College of Pharmacy R4.7 15Ohio Northern University Raabe College of Pharmacy R4.8 16Purdue University College of Pharmacy R4.9 18Roosevelt University College of Pharmacy R4.10 20Rosalind Franklin University College of Pharmacy R4.11 22Southern Illinois University – Edwardsville School of Pharmacy R4.12 24Sullivan University College of Pharmacy & Health Sciences R4.13 25The Ohio State University College of Pharmacy R4.14 27University of Cincinnati James L. Winkle College of Pharmacy R4.15 29University of Illinois at Chicago College of Pharmacy R4.16 31University of Kentucky College of Pharmacy R4.17 32University of Michigan College of Pharmacy R4.18 36University of Toledo College of Pharmacy and Pharmaceutical Sciences

R4.19 39

University of Wisconsin – Madison School of Pharmacy R4.20 41Wayne State University Eugene Applebaum College of Pharmacy & Health Sciences

R4.21 42

APhA Academy of Student Pharmacists Region 4 Midyear Regional Meeting 2018

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R4.1

Proposing APhA-ASP Chapter: Butler University College of Pharmacy & Health Sciences

Proposed Resolution Title/Topic: Dispensing of Pharmaceutic and Therapeutic Substitution

Proposed wording:

APhA-ASP encourages state boards of pharmacy to allow pharmacists to dispense therapeutic and pharmaceutical substitutions without authorization from the doctor who wrote the prescription, if it is due to a medication back-order or patient formulary requirement. It is then their duty to inform the doctor of a therapeutic substitution formedical records.

Background Statement:

Currently, if a pharmacist gets a prescription for a patient and the insurance rejects it because it is nonformulary they must call the doctor to get the ok to switch it. This can take days to possibly weeks depending on the doctor especially if they have multiple offices. This causes the patient to go without there needed medication which could cause withdrawal, unwarranted side-effects, worsened condition, and possibly life-threatening effects. Another issue is the costs associated with this. Between the years of 2010 and 2012 over $73 billion dollars were spent on brand name medications when there was a generic available. Furthermore, patients who had insurance still spent 24.6 billion dollars out of pocket because it was not adequately covered. 2 If the pharmacist was able to use their clinical knowledge and professional judgement, all these issues could be prevented for the healthcare system.

A pharmaceutical alternative are drug products that contain the same active ingredient but differ in their salt or dosage forms. A pharmaceutical substation is when a pharmacist would switch Amoxicillin tablets to Amoxicillin capsules when the doctor wrote for tablets per formulary requests.

A therapeutic alternative is drug products that contain different active ingredients that are indicated for the same therapeutic/clinical objectives. These must be from the same pharmacologic class and have the same therapeutic effect. An example of a therapeutic substitution would be switching Arnuity to Qvar. While it is switching from fluticasone to beclomethasone, they are both an inhaled corticosteroid used for asthma.

Arkansas was the first state to have a law even remotely close to this. While the APA Assembly did want to revisit this law, it wasn’t used directly for the reasons outlined above. Most pharmacists only did this if there was a lower cost drug for a higher priced, brand-name medication that was in the same therapeutic class. Additionally, this law was created in 2013, when the resistance for clinical roles within

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the job title of a pharmacist was much higher. Now that pharmacists are being recognized as easy to reach and ready to help professionals, other healthcare providers and lawmakers may see the advantage of this law.

Additionally, many states are now allowing for a pharmacist to go ahead with one of these pharmaceutical/therapeutic changes, the doctor must have signed on the “may substitute” line of the prescription. Additionally, the pharmacist must complete a short survey with the patient to obtain all allergies, current medications including supplements, and pertinent health conditions to ensure the change is in the patient’s best interest. After checking the “may substitute” line and the survey, the pharmacist then must explain to the patient that their medication was changed from what the doctor wrote due to formulary requirement or medication on back-order. Lastly, it is then the pharmacist’s duty to contact the doctor’s offices to inform them of this change within 48 hours.

Advantages of allowing pharmacists to do this include better therapeutic outcomes, better clientele satisfaction, and savings in cost and time. There are better therapeutic outcomes because the most common reason for therapeutic substitution is non-availability. The pharmacist is the healthcare provider that knows first-hand if the medication is unavailable to back-order or is nonformulary for that patient.

References:

1. Grossman, Sara. He, Andy. Nathan, Joseph. Zerilli, Tina. “To Substitute or Not to Substitute: That

Is the Question” 14 Mar 2011.

https://www.pharmacytimes.com/publications/issue/2011/march2011/genericfeature-0311

2. Johansen ME, Richardson C. Estimation of potential savings through therapeutic substitution.

JAMA Intern Med. 2016;176(6):769-775

3. Kairi, Jayant. Sharma, Ashok. “Substitutes of Prescription Medicines- A Review of Concerns

Relevant to Doctors and Patients”. Journal of Clinical & Diagnostic Research. Vol 11(8). Published:1 Aug 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620794/

4. Moran, Mark. “Assembly Responds to Arkansas Law on Therapeutic Substitution”Psychopharmacology. Vol 2(13). Published: 5 Aug 2016.https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2016.PP8a2

Are there any adopted resolutions currently on the books related to this Proposed Resolution? Yes ___ No_X_

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https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2016.PP8a2

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620794/


Author of Proposed Resolution: Laura Sosinski

Author Phone Number: 219-898-5486

Author Email Address: [email protected]

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R4.2

Proposing APhA-ASP Chapter: Cedarville University School of Pharmacy

Proposed Resolution Title/Topic: Narcan Availability to Non-medical Emergency Personnel

Proposed wording:

APhA-ASP encourages the training and dispensing of Narcan and/or naloxone products to non-medical emergency personnel


The Opioid Epidemic is a major problem in the United States. Opioid death rates have risen every year since 2002, and opioid related deaths were estimated at 49,068 in 2017. These deaths are predominately led by fentanyl, which in 2017 were responsible for almost 60% of opioid-related deaths.1 A useful tool in combating deaths have been emergency naloxone. Naloxone is an opioid-receptor antagonist that can reverse the dangerous effects of high dose opioids. Narcan nasal spray is now more widely available than ever to EMTs, non-emergency personnel and the layperson.2

In 2014 the state of Massachusetts wanted to increase naloxone availability. They decided to do so by implementing an Overdose Education and Naloxone Distribution (OEND) program to assist in training of non-medical personnel on prevention of opioid overdose, recognition, response, and the administration of intranasal naloxone. Various municipalities in the state opted to have their firefighters and officers trained with this program, and as a result saw significant use in 3 years, specifically 114 uses by firefighters in Revere and 201 uses by police in Quincy.3 A separate study in the same state looked at 19 separate communities that implemented OEND programs. Analysis showed that communities where more than 100 people per 100,000 enrolled into these programs had a reduced risk of opioid overdose death rates.4 There is also a disparity of naloxone use in rural communities, because historically EMT-basics have not been trained in naloxone use, despite the fact rural communities have the highest rates of opioid related death.5 Because of these studies among others, the White House stated in 2013 that “a life-saving overdose reversal drug… should be in the patrol cars of every law enforcement professional across the nation.”6

Providing these resources to non-medical emergency personnel is vital in fighting this epidemic. EMTs are not always the first responders at a scene, and arrival of a firefighter or law enforcement officer who can administer naloxone can save patients vital minutes and increase likelihood of survival. When law enforcement officers were surveyed after taking a naloxone training course, 89.7% said using naloxone at the scene of an overdose was not difficult, and 82.9% thought it is important for officers to be trained in this area.7 Pharmacists have a large role in this

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issue as well, because pharmacists are often performing this training. The VA has implemented an OEND where in an article they state “pharmacists can play a major role in facilitating this process owing to their integration across health care systems, influence on prescribing behaviors, ability to prescribe naloxone, provide patient education and dispense.”8 Pharmacists are the accessible health care providers, and have the potential to assist in the implementation of these programs and help train emergency responders in their communities.

Resources1. National Institute on Drug Abuse. Overdose Death Rates. NIDA.

https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. Published August 9, 2018. Accessed October 10, 2018.

2. National Institute on Drug Abuse. Is naloxone accessible? NIDA. https://www.drugabuse.gov/publications/medications-to-treat-opioid-addiction/naloxone-accessible. Accessed October 10, 2018.

3. Davis CS, Ruiz S, Glynn P, Picariello G, Walley AY. Expanded access to naloxone among firefighters, police officers, and emergency medical technicians in Massachusetts. Am J Public Health. 2014;104(8):e7-9.

4. Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis. BMJ. 2013;346:f174.

5. Faul M, Dailey MW, Sugerman DE, Sasser SM, Levy B, Paulozzi LJ. Disparity in naloxone administration by emergency medical service providers and the burden of drug overdose in US rural communities. Am J Public Health. 2015;105 Suppl 3:e26-32.

6. Announcing the Opioid Overdose Toolkit. National Archives and Records Administration. https://obamawhitehouse.archives.gov/blog/2013/08/28/announcing-opioid-overdose-toolkit. Accessed October 10, 2018.

7. Ray B, O'donnell D, Kahre K. Police officer attitudes towards intranasal naloxone training. Drug Alcohol Depend. 2015;146:107-10.

8. Oliva EM, Christopher MLD, Wells D, et al. Opioid overdose education and naloxone distribution: Development of the Veterans Health Administration's national program. J Am Pharm Assoc (2003). 2017;57(2S):S168-S179.e4.


Author of Proposed Resolution: Austin Lail



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R4.3

Proposing APhA-ASP Chapter: Concordia University Wisconsin School of Pharmacy

Proposed Resolution Title/Topic: Student/Faculty/Administration – Input on Curriculum

Proposed wording:

APhA reaffirms resolution 1982.3 and supports the requirement of mandatory career counseling meetings each semester.


When it comes to career options for pharmacists, many students recognize the retail, community, and hospital settings, as they are easily exposed to these fields in the everyday world. However, a Doctorate of Pharmacy degree can provide students with job opportunities in many other areas outside of these choices. While there are helpful resources, such as APhA’s career profiles and pathway program, many students may not be aware of these resources or have all of their questions answered by using them. Additionally, these resources may not always provide up-to-date information or practical insight on the career paths available. Due to this dilemma, many pharmacy candidates may not fully understand the opportunities they have or choose to pursue these specific areas of focus.

In addition to this, although four years of education may seem like a long enough time to focus in on a specific career path or field, it is important for students to have direction early and start gaining experience in the field they want to end up. By doing so, students are able to have hands-on training and develop an interprofessional network of contacts early. Learning about the multitude of opportunities that exist for pharmacists can give students the chance to thoroughly explore these options and find a job that best matches the skill set they possess. Finally, it is important for candidates to understand the various career options available before attending rotations, as rotations are a crucial part of finding an individual’s best fit.

Many schools offer career counseling services for students. However, in order to ensure that students are being guided properly and prevent any lack of knowledge when it comes to career opportunities, PharmD programs should implement a mandatory career counseling meeting each semester. By doing this, we can help educate students about the career paths that exist outside of traditional retail, community, and hospital settings, such as academia, industry, regulatory affairs, home health, long term care, etc., as many are not fully aware of these opportunities. While discussing these options, students would learn about the details, logistics, and outlook of each field, as well as how their skill sets fit into each career. These meetings would also serve as a platform for students to have all of their outlying questions answered. Additionally, these meetings would also be beneficial for students who are confident in their career path. They would still be given the chance to discuss

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and reaffirm their decisions, as well as make sure they have the experience and knowledge needed to succeed in the path that they’ve chosen.

Are there any adopted resolutions currently on the books related to this Proposed Resolution? Yes _X_ No___

If yes, please provide the number and title of the adopted resolution(s) as well as your rationale for the addition of this Proposed Resolution:

1982.3 – While this active resolution encourages pharmacy schools to provide career counseling services, requiring students to attend at least one mandatory career counseling meeting each semester would ensure that students have adequate knowledge of the career opportunities available, resources to gain experience, and a clear future-focused plan.

Author of Proposed Resolution: Jason Chladek & Emily Huynh



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R4.4

Proposing APhA-ASP Chapter: Ferris State University College of Pharmacy

Proposed Resolution Title/Topic: Benzodiazepine Control Reschedule

Proposed wording:

APhA-ASP supports rescheduling benzodiazepines from Schedule IV substances to Schedule II controlled substances.


Benzodiazepines are CNS depressants typically used for treatment of anxiety and sleep disorders. They work by increasing the endogenous activity of an inhibitory neurotransmitter, known as gamma amino butyric acid (GABA). Side effects of this class of medications include drowsiness, sedation, slurred speech, blurry vision, impaired motor coordination, and euphoria. Long-term use has also led to tolerance, psychological and physical dependence, as well as withdrawal.1 Because of this potential, people who take benzodiazepines (medically or non-medically) over a long period of time are at a high risk of developing Substance Use Disorder (SUD). Withdrawal symptoms from abrupt discontinuation of benzodiazepines can be mild to life-threatening. These withdrawal symptoms include seizures, hallucinations, severe cravings, and overactive reflexes.2

As of now, benzodiazepines are classified federally Schedule IV by the Drug Enforcement Agency (DEA). The DEA defines Schedule IV medications as substances with “a low potential for abuse relative to substances in Schedule III.” Substances in the Schedule II category “have a high potential for abuse which may lead to severe psychological or physical dependence.”3 According to the National Institute on Drug Abuse, benzodiazepines are among the three most commonly abused classes of medications, along with opioids and stimulants, both of which contain medications classified as Schedule II substances.2

In 2013, 5.6% of Americans were prescribed a prescription for a benzodiazepine.4 Although considered safe and effective at low-doses and for short-term medical uses, benzodiazepines are increasingly being used long-term and at higher doses to overcome tolerance. Additionally, they are regularly used non-medically and in conjunction with other substances. In the United States, benzodiazepines and/or barbiturates were reportedly used for nonmedical purposes by 2% of the population over 12 years old.5 Although benzodiazepines are less likely to be abused on their own, they are commonly taken by polydrug users to enhance and/or prolong the effects of other abused substances, such as alcohol and opioids.6 However, nonmedical uses are not the only area of misuse. In 2016, approximately 22 million doses of benzodiazepines were prescribed to patients with current opioid prescriptions, and, on the flipside, patients regularly using benzodiazepines were prescribed nearly 26 million doses of opioids.7 Due to the concurrent use of these

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medications, overdose is a major concern; benzodiazepines share responsibility for 30% of opioid overdose mortalities in the United States. Because both classes of medications possess sedation and respiratory suppression effects, the combination can be detrimental to a patient’s health.8 While efforts are being made to decrease overdoses during the current opioid epidemic, less attention is being devoted to combat the prescribing of benzodiazepines to patients on opioids. Rescheduling benzodiazepines would extend limitations on the prescribing of this class. Schedule II substances are limited to a 30 day supply per prescription, with no refills, and expire in 90 days.3 Rescheduling may increase the prescribers’ involvement in monitoring the safety and efficacy of benzodiazepine use. It could also aid in curbing the use of benzodiazepines for long-term treatment of patients that would be good candidates for alternative treatments.

A potential downfall to rescheduling any medication class is the risk of decreasing access to these medications for patients. By increasing regulations, however, prescribers may be encouraged to seek other methods of treatment before utilizing benzodiazepines. Because benzodiazepines have shown efficacy for the treatment of insomnia and anxiety, prescribers use them as the first-line treatment for these disorders, although there is substantial evidence supporting antidepressants as better first-line and long term treatments. SSRI and SNRI antidepressants are considered safe and effective in treating general anxiety disorder. Other treatment options include agents such as hydroxyzine and buspirone which have shown clinical effectiveness.9 For insomnia, medications such as doxepin, trazadone, Elavil, Remeron, and Rozerem have been proven to be safe and effective alternatives to benzodiazepines.10 If patients fail therapy alternatives to benzodiazepines, rescheduling will not make them completely inaccessible. The increased regulation will encourage prescribers to be more cautious and deliberate with selecting appropriate therapy and to monitor treatments. The end goal is to curb the tendency of abuse that occurs with long-term use of benzodiazepines. In addition, with both federal and state laws becoming more strict for Schedule II medications, the use of Prescription Drug Monitoring Program (PDMP) may also keep better track of this class.

Benzodiazepines are most effective and safe when used short-term for the treatment of anxiety and insomnia. These medications have a high likelihood of abuse in long-term users as well as in polydrug users. With long-term use, tolerance and withdrawal are also likely. Because of their sedating and respiratory effects, they pose a great threat for overdose when combined with opioids or alcohol. By rescheduling from Schedule IV to Schedule II, prescribers may recognize the abuse potential and seek alternative therapies before prescribing this class of medications. In the midst of the opioid epidemic, overdoses have become increasingly common and steps should be taken to decrease preventable casualties within the United States. If the overall supply of benzodiazepines available is decreased, the subsequent amounts available to nonmedical drug abusers will be limited. Overall, this may help to prevent the potential for overdose mortalities in patients taking this class of medications in conjunction with other abused substances.

References:

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1. Griffin, C. E., Kaye, A. M., Bueno, F. R., & Kaye, A. D. (2013). Benzodiazepine Pharmacology and Central Nervous System–Mediated Effects. The Ochsner Journal, 13(2), 214–223.

2. NIDA. (2018, March 6). Prescription CNS Depressants. Retrieved from https://www.drugabuse.gov/publications/drugfacts/prescription-cns-depressants on October 5, 2018

3. Rannazzisi, J. T., & Caverly, M. W. (2006). United States Department of Justice: Drug Enforcement Administration. Retrieved from www.DEAdiversion.usdoj.gov

4. Bachhuber, M. A. (2016). Increased benzodiazepine use and overdose mortality in US. Reactions, 1591, 12-5.

5. Kang, M., & Ghassemzadeh, S. (2018). Toxicity, Benzodiazepine. 6. Ashton, C. H. (2002). Benzodiazepine abuse. Drink, drugs and dependence. London:

Routledge, 197-212.7. McDonald, J. V., ASCJ, V. A., & Paquin, J. (2017). Practical Considerations for

Prescribing Benzodiazepines and Opioids. Rhode Island Medical Journal, 100(7), 30.

8. Karaca-Mandic, P., Meara, E., & Morden, N. E. (2017). The growing problem of co-treatment with opioids and benzodiazepines.

9. Abejuela, H., & Osser, D. N. (2014). Psychopharmacology algorithm for management of generalized anxiety disorders.

10. Longo, L. P., & Johnson, B. (2000). Addiction: Part I. Benzodiazepines-side effects, abuse risk and alternatives. American family physician, 61(7), 2121-2128.


Author of Proposed Resolution: Samantha Wagner



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R4.5

Proposing APhA-ASP Chapter: Manchester University College of Pharmacy, Natural & Health Sciences

Proposed Resolution Title/Topic: Advocating for proper drug information education for pharmacist regarding prescription drug interactions with medical marijuana.

Proposed wording:

APhA-ASP supports education on drug information regarding possible contraindications, drug-to-drug interactions, and adverse drug effects seen with medical marijuana and prescription medications.


Medical marijuana is now legalized in 30 out of the 50 states and 5 US territories. Pharmacists are not fully educated to handle questions regarding marijuana used for medical purposes. Marijuana long classified a schedule I narcotic, even with the changes in attitude both of the public and state legislators, the U.S. Department of Justice (DOJ) reaffirmed this status in the federal agencies last review of the substance in 2016. There have been limited studies performed on the effects of marijuana and prescription drug use. Based on the exponential increase of medical marijuana prescriptions, it is reasonable to justify proper education for pharmacists on the subject. It is important for us to be ahead of the game, to better suit our patient’s needs. Action is needed for more literature and research on this topic based on how many states currently have legalized marijuana use. This is not to say that pharmacists are expected to advocate for legalized marijuana use, but rather better understand the possible adverse drug effects associated with it. We are extensively educated on the negative effects of smoking; however, that is not the only formulation marijuana is available in. There are several methods to take the active metabolite found in the marijuana plant. Scientific evidence has been deduced for the treatment of multiple sclerosis pain, epilepsy, and chemotherapy induced nausea. It is valuable for pharmacists in these states to be able to give answers based on scientific evidence, rather than bias or misinformation. The stigma of certain substances of which dependency is a perceived issue, has historically limited thoughtful considerations for their therapeutic potential. It is important to show a level of empathy with patients on medical marijuana and ensure they are receiving the same level of care that we show to all our patients.

Regardless of our personal beliefs on this controversial topic, it is important as pharmacists to be indisputably equipped for every situation we may encounter with our patients. With the opioid epidemic only getting worse, should we as healthcare providers dismiss possible scientific evidence based solely on unbiased opinions?

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We know based on the drug enforcement agency that Schedule I drugs such as medical marijuana meet the criteria for substances that currently have no accepted medical use in the United States. As we are all aware, they also have a very high potential for abuse. (Mead, 2017) In 2016, 63,632 people died of a drug overdose in the United States; 42,249 of those deaths were attributed with an opioid. (Puja, 2018) It has become abundantly clear that we are experiencing an immeasurable abuse of Schedule II drugs. It is important to fully understand medical uses of marijuana. What we do know is there have been both negative and positive effects witnessed in the geriatric population. In one case, a patient was smoking medical marijuana three to four times per week while taking warfarin. It was noted that the warfarin was seen in higher concentrations, ultimately increasing the patient’s INR level. The patient was hospitalized more than once when his INR values were acutely supratherapeutic. (Yamreudeewong, et. al., 2009) Marijuana may interact with warfarin by inhibiting its hepatic metabolism and displacing it from protein binding sites, thus resulting in a transient increase in unbound plasma concentrations of warfarin. (Yamreudeewong, et. al., 2009). Warfarin has a laundry list of drug interactions, this is just one isolated case. How many more prescription drugs show these type of adverse drug reactions? In a recent study done by “The Consultant Pharmacist”, they reiterated the need of further clinical trials and testing to determine drug-to-drug interactions and possible adverse effects related to medical marijuana. A lack of large formal pharmacokinetic studies on cannabinoids means that information related to relevant drug interactions is scarce. (Mahvan, et. al., 2017). Manchester’s APhA-ASP chapter is in favor of more information and research on the topic and for student pharmacists to be educated on the possible adverse effects.

Pros: Cons:Accessibility to education on medical marijuana based on unbiased scientific data.

Lack of initiative to further learn of possible medical needs with medical marijuana.

The capability of running drug-to-drug interactions with medical marijuana. i.e. Micromedex & Lexicomp

Lack of clinical studies performed with patients taking regular medications and using medical marijuana.

The capability of knowing specific contraindications of marijuana use and prescription drug use. i.e. DUR’s & MTM’s

Lack of FDA regulations on medical marijuana.

Assisting our patients improving their overall health outcomes.

It is challenging to perform scientific studies on this drug with its federal status of a class 1 drug; FDA cannot fully investigate health benefits.

Creating a safe space for medical marijuana users and not having a negative stigma towards the patient.

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References:

1. Mahvan, Tracy D., et al. "Marijuana use in the elderly: implications and considerations." The Consultant Pharmacist®32.6 (2017): 341-351.

2. Mead, Alice. "The legal status of cannabis (marijuana) and cannabidiol (CBD) under US law." Epilepsy & Behavior 70 (2017): 288-291.

3. Seth, Puja, et al. "Overdose deaths involving opioids, cocaine, and psychostimulants—United States, 2015–2016." American Journal of Transplantation 18.6 (2018): 1556-1568.

4. Yamreudeewong, Weeranuj, et al. "Probable interaction between warfarin and marijuana smoking." Annals of Pharmacotherapy 43.7-8 (2009): 1347-1353.


Author of Proposed Resolution: Blain Thayer & Joseph Brown



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R4.6

Proposing APhA-ASP Chapter: Midwestern University Chicago College of Pharmacy

Proposed Resolution Title/Topic: Pharmacy Benefit Manager (PBM) Practices (2012.4)

Proposed wording:

Addition to 2012.43. APhA-ASP opposes any actions by pharmacy benefit managers to prevent the funds used to pay a prescription copayment from being applied to a patient’s deductible or out of pocket maximum, either when a copay assistance card is used or when a patient pays for the medication out of pocket.


Preventing the money paid through a copay assistance card to be used toward the deductible may cause loss of access to care. With high deductible plans and copay assistance cards with low annual benefits, patients may not be able to afford their medication.


Author of Proposed Resolution: Aaron Graham



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R4.7

Proposing APhA-ASP Chapter: Northeast Ohio Medical University College of Pharmacy

Proposed Resolution Title/Topic: Opioid Alternatives

Proposed wording:

APhA-ASP supports pharmacist and student pharmacist involvement in recommendations regarding education related to opioid alternatives to help decrease and prevent substance abuse. Thereby moving beyond substance abuse education to decrease the quantity of patients exposed to opioid medications initially by working in accord with other healthcare professionals including but not limited to: dentists, NPs, PCPs, and their corresponding students.


According to the National Institute on Drug Abuse, as of March 2018 more than 115 people in the US die daily from overdosing on opioids, a crisis that is costing the US 78.5 billion a year not to mention tearing apart families. Also, roughly 21-29% of patients prescribed opioids for chronic pain misuse them and 80% of people who use heroin first misused prescription medications. Specifically, the Midwest is being ravaged by this crisis with a 70% increase in opioid overdoses from 2016-2017. This crisis is expanding daily and as pharmacists on the front lines of opioid dispensing, it is our duty to educate and provide alternatives for our patients. All healthcare providers are coming together to combat the opioid epidemic, but pharmacist questioning of opioid prescribing could cause strained relationships between prescribers and their pharmacists. However, our duty is primarily to our patient’s and we must advocate when called upon.



2010.2 Substance Abuse Education: This addition is fundamentally necessary due to the increased prevalence of the opioid addiction in this country. With the development of this crisis, more and more individuals will be seeking opioid alternatives for historically prescribed scenarios (Ex: wisdom teeth removal, dental procedures, and athletic injuries). This represents an unprecedented opportunity for pharmacists to become patient advocates and provide information on all their therapeutic options.

Author of Proposed Resolution: Mary Cherveny

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Author Phone Number: Upon request


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R4.8

Proposing APhA-ASP Chapter: Ohio Northern University Raabe College of Pharmacy

Proposed Resolution Title/Topic: Whole Person Care

Proposed wording:

APhA-ASP encourages pharmacists and student pharmacists to incorporate the idea of whole person care in the patient care plan of patients.


Reasons:1. As the most accessible healthcare professionals, pharmacists and student

pharmacists have the opportunity to provide care to the patient as a whole rather than tunneling our efforts towards only physical healthcare needs. Patients seeking improvement in their mental or spiritual health often come to pharmacists for help due to lack of healthcare professional accessibility.

2. The mental and spiritual health of patients in the United States of America is overlooked, underserved, and a huge area of need for patients.

3. It is near impossible for patients in immediate need of mental healthcare to quickly find a healthcare professional to address their needs.

4. Spiritual care of patients is generally overlooked, yet shown to be beneficial in patients.

5. It is ethically, morally, and legally reasonable to assess and care for the patient as a whole.

Pros:1. Better patient outcomes.2. Pharmacists and student pharmacists join the fight against mental illnesses.3. Minimal training is required to make a huge difference.4. Provides a non-pharmacologic option for patient care of depression, anxiety, and

other mental illnesses.5. Pharmacists and student pharmacists can shine a light on spiritual health, a

severely ignored and unheard of area of health.

Cons:1. Requires a significant amount of time for effective care.2. Spiritual healthcare would require finding a pharmacist or student pharmacist

with a similar religious background, which may be difficult for patients.3. Pharmacists and student pharmacists may be uncomfortable caring for patients

mentally and spiritually, which may require engaging in a more personal, open relationship with the patient.

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4. Others may see our efforts as “stepping on the toes” of hospital chaplains, psychiatrists, and other healthcare professionals who specialize in these related fields.

References/Resources:1. Lack of healthcare professional accessibility in the USA

a. http://login.onu.ohionet.org/login?url=https://search.ebscohost.com/ login.aspx?direct=true&db=a9h&AN=22778012&site=ehost-live

2. Mental Health of USAa. http://login.onu.ohionet.org/login?url=https://search.ebscohost.com/

login.aspx?direct=true&db=a9h&AN=131949556&site=ehost-liveb. http://login.onu.ohionet.org/login?url=https://search.ebscohost.com/

login.aspx?direct=true&db=a9h&AN=128758053&site=ehost-live3. Spiritual Health of USA

a. http://www.ajhp.org/content/63/2/169.long?sso-checked=true b. https://link.springer.com/article/10.1007/s10943-014-9974-4

4. Psychiatrist average wait time = about 25 daysa. https://www.psychiatryadvisor.com/practice-management/long-wait-times-

typical-for-psychiatry-appointments/article/377654/5. Suicide Rates Increasing

a. http://login.onu.ohionet.org/login?url=https://search.ebscohost.com/ login.aspx?direct=true&db=a9h&AN=129997267&site=ehost-live

6. Benefits of Spiritual Healtha. http://login.onu.ohionet.org/login?url=https://search.ebscohost.com/

login.aspx?direct=true&db=a9h&AN=128085101&site=ehost-liveb. Medical Strategic Network

7. Ethics of Providing Spiritual Healthcarea. Medical Strategic Network


Author of Proposed Resolution: Ryan Waldschmidt



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http://login.onu.ohionet.org/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=128085101&site=ehost-live




https://www.psychiatryadvisor.com/practice-management/long-wait-times-typical-for-psychiatry-appointments/article/377654/

https://www.psychiatryadvisor.com/practice-management/long-wait-times-typical-for-psychiatry-appointments/article/377654/

https://link.springer.com/article/10.1007/s10943-014-9974-4

http://www.ajhp.org/content/63/2/169.long?sso-checked=true








R4.9

Proposing APhA-ASP Chapter: Purdue University College of Pharmacy

Proposed Resolution Title/Topic: Pharmacist services in correctional facilities

Proposed wording:

APhA-ASP supports the utilization of pharmacists in all levels of correctional facilities.


Pharmacists have a vital and well-established role in healthcare throughout all portions of American society with one notable exception: state and local correctional facilities. The Federal Bureau of Prisons (BOP) recognizes the essential nature of this role and already employs pharmacists within their facilities. However, incarcerated patients in other areas of corrections (state prisons, local jails, home detention) do not always receive care from pharmacists. In these facilities, physicians or other health care providers are contracted to diagnose and treat incarcerated patients, sometimes with the assistance of a nurse. Medications are dispensed but held securely by staff within prisons who may view access to these medications as a revocable privilege. According to a study conducted by physicians at Cambridge Health Alliance and Harvard Medical School (HMS), incarcerated patients with health conditions such as diabetes often had medications stopped after their incarceration. This included one-quarter of chronically ill incarcerated patients in state correctional facilities and over a third of their local jail counterparts. In addition to aiding in the appropriate dispensation of medication, pharmacists can play an important public health role as they prepare incarcerated patients to return to their lives within the community. There are many difficulties that people face once they leave the prison system, and being unable to access medications due to poor transitions of care should not be among them. With incarceration due to substance abuse, especially opioids, being among the biggest problems facing society today, the expertise of pharmacists working alongside mental health and social work professionals is sorely needed in our prisons. Through medication therapy management, the development of medication-assisted addiction treatment plans, and the provision of education regarding the safe use of potentially addictive medications, pharmacists can help get these patients the care that they need to avoid recidivism and relapse.

It is time for all levels of correctional facilities to recognize this, follow the example of the federal prison system, and incorporate pharmacists into their healthcare model. And for those facilities for which this type of physical integration is not possible, there are still other options. Advances in telehealth provide an opportunity for pharmacists to be involved in at least some aspects of incarcerated patients’ care. The UI Health Telemedicine Clinic has proven this modality of care to be successful as they’ve provided HIV and HCV services to incarcerated patients in the Illinois Department of Corrections with rates of remission reaching

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nearly 100%.People being incarcerated in all levels of correctional facilities should have

access to pharmacy services provided by those who have been specifically trained to provide them: pharmacists. When these people are denied these services, they “...are denied their constitutionally guaranteed right to care,” according to Andrew Wilper, a professor at the University of Washington School of Medicine. Whatever the modality, pharmacists can provide care to incarcerated patients, and these patients deserve access to that care.

References:Badowski M, Nyberg C. Establishing a telemedicine clinic for HIV patients in a correctional facility. Am J Health Syst

Pharm 2012; 69(19): 1630, 1632-3.Butler B. Prescribing and Dispensing Medications within Correctional Environments: The Role of Health

Information Technology. Oakland, CA: Community Oriented Correctional Health Services. May 2018.

Erickson AK. Advancing pharmacy practice behind prison bars. Pharmacy Today. Available at: https://www.pharmacist.com/advancing-pharmacy-practice-behind-prison-bars. Accessed October 12, 2018.

Giberson S, Yoder S, Lee MP. Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the U.S. Surgeon General. Office of the Chief Pharmacist. U.S. Public Health Service. Dec 2011.

Wilper AP, Woolhandler S, Lasser KE, et al. The Health and Health Care of US Prisoners: Results of a Nationwide Survey. Am J Public Health 2009; 99(4): 666-72. DOI: 10.2105/AJPH.2008.144279.


Authors of Proposed Resolution: Madelaine Ambrose, Michael Campbell, Anthony Haddad & Carolanne Wartman



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R4.10

Proposing APhA-ASP Chapter: Roosevelt University College of Pharmacy

Proposed Resolution Title/Topic: Asthma Rescue Medication Access in Schools

Proposed wording:

To be added to 2000.3APhA-ASP supports legislation which protects the rights of students with asthma, provided they have proper medical documentation, to carry rescue medications on their person and self-administer rescue medications, including but not limited to meter dose inhalers, in educational institutions.


In the United States, every student has the right to have their asthma rescue medication with them at school. However, many school districts retain policies restricting where these rescue medications may be kept – usually in nurse’s or administrative offices – restricting the student’s access to the medication. Accommodations for students with asthma is required by all schools under protection of IDEA, Section 504 and Title II of ADA. These accommodations are restricted in many districts by school policies, however, and students do not have immediate access to their rescue medications, commonly meter dose inhalers. Time and distance can be critical for students with asthma, who may not be able to reach the nurse’s office for administration of their rescue medication if they are outside the school building or across the building for classes. This restriction of access poses a potentially dangerous barrier to these students that should be protected by having all school districts allow students to carry these rescue medications on their person, given they have demonstrated with a provider that they are competent in self-administration and have this documentation on file. This policy serves to encourage states to enact legislation, such as Illinois’s SB3015, which amend school codes to allow students self-carry of rescue medications on their person and self-administration of these medications.

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2000.3Since 2000.3 was passed, student access to rescue medications within schools

has remained unchanged in many districts across the country. While all states allow students to have inhalers at school, many school policies restrict where the inhaler can be kept within the school. It remains critical that we support students’ ability to carry their rescue medications on their person rather than relying on school personnel to ensure this life-saving access. Illinois recently passed SB3015, amending school code to protect the rights of students to self-carry and self-administer asthma rescue medications while at school. There are many states where schools are still free to restrict this access to students with asthma, usually requiring the medication be kept in the nurse’s or administrative office, despite the potentially dangerous medical consequences of the time it may take for the student to have rescue medication administered to them. This policy is designed to take 2000.3 a step further by pushing legislatures to amend school codes allowing students with asthma nationwide to self-carry and self-administer without interference from schools regarding where the medication must be kept given that there is proper documentation on file.

Author of Proposed Resolution: Jenna Barillas Addams



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R4.11

Proposing APhA-ASP Chapter: Rosalind Franklin University College of Pharmacy

Proposed Resolution Title/Topic: Prescription Substitution Authority

Proposed wording:

APhA-ASP encourages allowing pharmacists to perform prescription changes, such as strength changes for when medications go on backorder or changes in medication formulation due to patient preference or inability to swallow capsules or tablets. This will ensure patients are able to obtain necessary medications ensuring continuity of care and well-being.


Pharmacists are the medication experts in the healthcare profession and have earned this title by undergoing rigorous education focusing on medications and their uses in various disease states. However, when it comes to clinical practice, our scope of practice is limited. With this proposal, pharmacists will be able to dispense strength changes in response to medication backorders and change formulations due to patient formulation preference.

As defined by the American Society of Health-System Pharmacists (ASHP), a drug shortage is “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”1 Based on this definition, ASHP reported 514 drug shortages between the years 2006 and 2009.2 Furthermore, of the 194 current ASHP-recognized shortages, 45 of them are medications typically dispensed from community pharmacies, thus their absence directly affects the functions of a community pharmacy.3 Drug shortages are of concern for patients as they can lead to increased medical and labor costs, as well as safety issues. Implementation of this resolution will allow pharmacists to substitute the same medication for different strengths when a medication is on backorder or a shortage exists. For example, when spironolactone 50 mg went on backorder this past year, pharmacists were legally required to call prescribers to switch every patient to the 25 mg twice daily strength and frequency. This frequently left the patient without their medication while awaiting prescriber response.

Lastly, upon implementation of this resolution, pharmacists will be permitted to switch the route of administration for certain medications and based on a proper evaluation of patient-specific factors. An example is a child who refuses to swallow an amoxicillin capsule, but will drink a suspension. The pharmacist will be able to switch the prescription from the capsules to the suspension without prescriber approval.

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We must establish a systematic approach before a change like this can be implemented. The pharmacist must notify the prescriber of the changes within 48 hours of the prescription modification through electronic records or fax. This will help ensure that the medical record is updated in the prescriber’s database as well. If the pharmacist requires additional information prior to implementing the change, as per standard of care, he or she will communicate with the prescriber beforehand. There are extensive benefits, including decreased patient costs, decreased overall healthcare costs, improved patient adherence, and increased patient satisfaction. Adoption of this resolution will allow pharmacists to provide adequate patient care in a timely manner and the ability to practice at their full potential.

References:

1. Fox ER, Birt A, James KB, et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66:1399-1406. doi: 10.2146/amjhp090026

2. Ventola CL. The drug shortage crisis in the United States: Causes, Impact, and Management Strategies. P T. 2011;36(11):740-742. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278171/. Accessed October 11, 2018.

3. American Society of Health-System Pharmacists (ASHP). Current Drug Shortage Bulletins. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortages-List?page=CurrentShortages. Accessed October 12, 2018.


Author of Proposed Resolution: Glenn Chanitthikul, José Ortiz & Katelyn Wees



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R4.12

Proposing APhA-ASP Chapter: Southern Illinois University Edwardsville School of Pharmacy

Proposed Resolution Title/Topic: Medical Marijuana Curriculum (APhA-ASP Resolution 2018.1)

Proposed wording:

APhA-ASP encourages pharmacy schools to include information about medicinal marijuana in the curriculum for pharmacy students.

Background Statement:In 1996, California was the first state to exempt patients from legal implications

for using marijuana 1. Since then, there are now only 6 states in the country that do not allow public access to marijuana1. It has been shown to safely and effectively treat symptoms for cancer, glaucoma, epilepsy, multiple sclerosis, pain, and other conditions 2. With a study last conducted in 2015, rates of medicinal marijuana use have risen to 9.5 percent in the United States. More and more patients are seeing the benefits of marijuana and switching to the use of this drug to help treat their symptoms 3. Preliminary studies have found that the use of marijuana has been associated with decreased opioid use and death from overdose. The National Institutes of Health estimates hundreds of millions of dollars are currently being spent on marijuana research and therapeutic benefits of the drug 4. The American Journal of Public Health has published guidelines on lower-risk cannabis use 5. Schools like the University of Maryland School of Pharmacy have trainings that have been developed to prepare those for working in the medical marijuana industry 6.

In our lifetime as pharmacists, marijuana has been legalized as an alternative therapy for multiple disease states. As experts in medicine, we should be aware of the active effects of this drug on our patients. Education about this alternative therapy will help diversify pharmacists and future pharmacists’ knowledge in the areas in which cannabis can be used. References:

1. http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx 2. https://medicalmarijuana.procon.org 3. https://www.nih.gov/news-events/news-releases/prevalence-marijuana-use-

among-us-adults-doubles-over-past-decade 4. https://www.drugabuse.gov/drugs-abuse/marijuana/nih-research-marijuana-

cannabinoids 5. http://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.2017.303818 6. http://www.baltimoresun.com/health/bs-hs-medical-marijuana-training-

20170703-story.html

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http://www.baltimoresun.com/health/bs-hs-medical-marijuana-training-20170703-story.html

http://www.baltimoresun.com/health/bs-hs-medical-marijuana-training-20170703-story.html

http://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.2017.303818

https://www.drugabuse.gov/drugs-abuse/marijuana/nih-research-marijuana-cannabinoids

https://www.drugabuse.gov/drugs-abuse/marijuana/nih-research-marijuana-cannabinoids

https://www.nih.gov/news-events/news-releases/prevalence-marijuana-use-among-us-adults-doubles-over-past-decade

https://www.nih.gov/news-events/news-releases/prevalence-marijuana-use-among-us-adults-doubles-over-past-decade

https://medicalmarijuana.procon.org/

http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx



Author of Proposed Resolution: Catherine Gilmore



R4.13

Proposing APhA-ASP Chapter: Sullivan University College of Pharmacy & Health Sciences

Proposed Resolution Title/Topic: Establishing a Mandatory 1 year post-graduate training

Proposed wording:

APhA-ASP recommends the requirement that all pharmacy graduates must complete a minimum 1-year post-graduate residency/fellowship after obtaining their PharmD


Requiring a one-year post-graduate residency after matriculation is pertinent in the advocation of provider status. Through assessments, care plans, and monitoring, pharmacists are considered the experts in drug therapy management. Many physicians lack the complete drug knowledge, struggling to stay up-to-date with the everchanging drug market. Pharmacy residency is where the bulk of one’s clinical skills can be refined and learned. One year of residency can emphasize the education pharmacists have already received and help gain credibility for recognition as full providers.

Residency is often associated with inpatient care but can offer edification regarding community pharmacy. Pharmacy schools often lack the room for flexibility in the curriculum to amply ensure managerial/leadership competencies. Therefore, a mandatory residency will provide critical additional learning on how to deal with common challenges encountered throughout the transition from student to pharmacist.

The Institute of Medicine (IOM) reported that medication errors injure at least 1.5 million people annually in USA hospitals2. Along with injuries, there are significant economic costs adding up to approximately 21 billion dollars nationwide. Unlike hospitals, in community settings pharmacists are the last checkpoint before the patient receives the medication. Therefore, the potential for harm is higher considering the high volume of prescriptions. These staggering statistics shed light

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mailto:[email protected]


onto the importance of pharmacist knowledge but also highlights the significance of post-graduate learning.

Clearly, pharmacists are imperative in the care of patients but are robbed from the opportunity to hold provider status. The liabilities regarding medication and dispensing errors are left on the shoulders of pharmacists, making it vital for post-graduate learning.

References:1. Barker, A. (2016). 5 Shocking Truths Physicians Don't Want Pharmacists to Know. Pharmacy Times. Retrieved October 21, 2018, from https://www.pharmacytimes.com/contributor/alex-barker-pharmd/2016/03/5-shocking-truths-physicians-dont-want-pharmacists-to-know?p=1.2. Campbell, P. J., Patel, M., Martin, J. R., Hincapie, A. L., Axon, D. R., Warholak, T. L., & Slack, M. (2018). Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993–2015. BMJ Open Quality, 7(4), e000193. http://doi.org.suscorp.idm.oclc.org/10.1136/bmjoq-2017-0001933. How Long Does It Take to Become a Doctor? (2018, June 18). Retrieved October 21, 2018, from https://www.kaptest.com/study/mcat/how-long-does-it-take-to-become-a-doctor/4. Kehrer, J. P., Eberhart, G., Wing, M., & Horon, K. (2013). Pharmacy’s role in a modern health continuum. Canadian Pharmacists Journal : CPJ, 146(6), 321–324. http://doi.org/10.1177/17151635135063705. Yap, D. (2018). State provider status advances in 2017. Pharmacy Today,24(3), 58. Retrieved October 21, 2018, from https://www.pharmacytoday.org/article/S1042-0991(18)30262-7/fulltext#back-bb0015.


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2008.3 - Residency and Postgraduate Training 1. APhA-ASP supports the Joint Commission of Pharmacy Practitioners (JCPP) vision that pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes. 2. APhA-ASP encourages PharmD graduates to pursue postgraduate training as a means to achieve this vision. 3. APhA-ASP encourages public and private efforts to create additional and diverse residency and other postgraduate training programs to ensure availability for all PharmD graduates.

Author of Proposed Resolution: Hayley Craven



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R4.14

Proposing APhA-ASP Chapter: The Ohio State University College of Pharmacy

Proposed Resolution Title/Topic: SNOMED/ICD-10 training (Curriculum)

Proposed wording:

APhA-ASP encourages SNOMED/ICD-10 training to be incorporated into pharmacy school curriculums


The impetus for this proposal was mainly based on finding a way for pharmacists to be able to contribute more to the healthcare of a patient. During this process, the team wanted to focus on antibiotics and controlling the increase of antibiotic resistance. During this process we realized there was more the pharmacists could contribute to patient and population health.

For pharmacists to help optimize medications and verify that doses are optimized for the correct indications, they need to know what those indications are. Allowing pharmacists access to diagnosis codes on prescriptions with the patient’s weight would allow pharmacists to contribute to the tenants of antimicrobial stewardship and increase their involvement in positive outcomes of patients.

The code that would be made available to pharmacists would be ICD-10 codes that are used by the WHO to gather data on antibiotic resistant bacterial outbreaks, disease incidence, population health data, and etc. This information is used to further population health management.

Because of the information that can be collected, stratified, and conveyed with diagnosis codes, there is a new push to integrate these codes into EHRs. There is a system of codes referred to as SNOMED codes which are used for medical billing and interoperability of EHRs, these codes can also be transcribed or converted to relevant ICD-10 codes. This will be the future of EHRs, medical treatment, and data gathering for population health implementation.

Pharmacists MUST have an exposure and proper training on how to utilize SNOMED/ICD codes to optimize patient care. As pharmacists are integrated into clinical care teams, continue to improve patient outcomes, and become increasingly recognized as providers, we need to be well aware of and competent in the tools used by other health care providers to implement patient care.

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References:The World Health Organization (WHO) released a report on antimicrobial resistance in 2015 highlighting the alarming rate at which antibiotic resistance is spreading throughout the world.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3865615/

Then in 2015 WHO released 5 strategic objectives, one of them being: To optimize the use of antimicrobial agents. http://www.who.int/antimicrobial-resistance/global-action-plan/en/

“ICD-9-CM to ICD-10-CM Codes: What? Why? How?”https://www.nlm.nih.gov/research/umls/mapping_projects/snomedct_to_icd10cm.html

“SNOMED CT to ICD-10-CM Map”https://www.pharmacyhit.org/


Authors of Proposed Resolution: Sheriff Benson, Alisha Bias, Natalie Hagey, Lindsay Ingold,

Katilin Merriam & Andrew Meyer



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https://www.pharmacyhit.org/

https://www.nlm.nih.gov/research/umls/mapping_projects/snomedct_to_icd10cm.html

http://www.who.int/antimicrobial-resistance/global-action-plan/en/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3865615/


R4.15

Proposing APhA-ASP Chapter: University of Cincinnati James L. Winkle College of Pharmacy

Proposed Resolution Title/Topic: Ensuring Therapeutic Outcomes

Proposed wording:

APhA-ASP supports legislation requiring that the dispensing pharmacy follow-up after the initiation of any new therapy to provide patient education, assess adherence, monitor efficacy, and ensure therapeutic efficacy.

Background Statement:Healthcare in the United States is predicated on the general principle of

diagnosis followed by treatment. Treatments, especially for chronic conditions, include prescription drug therapy in most circumstances. However, unlike getting stiches for a laceration, walking out of the doctor’s office with a prescription to be filled is only the start of treatment. The success of any prescription regimen is limited by the patients’ adherence to the regimen, which can be affected by a multitude of variables. While many states mandate counseling at the point of sale, countless questions arise after the patient has begun taking the medication. A pharmacist follow-up program that requires the pharmacist to reach out to the patient would eliminate a multitude of problems that may lead to poor adherence such as side effects, forgetfulness, knowledge gaps, and financial considerations (1). If this were instituted universally, adherence rates would increase as evidenced by the multitude of studies showing the impact of follow-up counseling on adherence (2, 3). Also, hospital admission rates for people with chronic illnesses would dramatically decrease (1). While a follow-up counseling opportunity on new medications is simplistic, the potential cost savings for the healthcare system are extraordinary. Our healthcare model is missing an important component and pharmacists, being the medication experts, are best suited to fill this role.

1. Fikri-Benbrahim N, Faus MJ, Martinez-Martinez F, Sabater-Hernandez D. Impact of a community pharmacists' hypertension-care service on medication adherence. The AFenPA study. Res Social Adm Pharm. 2013;9:797-805.

2. Park H, Adeyemi A, Roane T. Impact of A Telephonic Outreach Program on Medication Adherence In Medicare Advantage Prescription Drug (Mapd) Plan Beneficiaries. Value in Health. 2015;18:A611.

3. Seabury SA, Lakdawalla DN, Dougherty JS, Sullivan J, Goldman DP. Medication adherence and measures

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Pro● Simplicity● Resources needed are minimal● Potential cost savings is large● Helps to establish pharmacists’ role in treatment● Prevents discontinuations due to side effects, cost issues, and knowledge gaps● Focuses on patient-centered care

Con● No current reimbursement routes● Existing component of MTM programs

o If this was made universal without reimbursement, they would likely stop pay for this intervention.

oAre there any adopted resolutions currently on the books related to this Proposed Resolution? Yes ___ No_X_

Author of Proposed Resolution: Bradley Becker



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R4.16

Proposing APhA-ASP Chapter: University of Illinois at Chicago College of Pharmacy

Proposed Resolution Title/Topic: Genetic Testing in Chronic Pain

Proposed wording:

APhA-ASP encourages the use of genetic testing in developing personalized medication therapies for treatment of chronic pain conditions.

Background Statement:The use of opioids in pain management is widely accepted as the standard of

care, and misuse of prescription pain relievers is a major contributor to the current opioid crisis. Utilization of genetic testing and application of pharmacogenomic tools can help determine which patients have increased risk for opioid overdose. This then allows for those patients to be more carefully monitored in order to avoid overdose, especially in those that require long-term opioid treatment. Implementing such measures can contribute to reversing the opioid crisis and lowering annual costs associated with pain management and treatment for associated opioid overdose costs. In addition, the current “trial-and-error” approach to prescribing medication for pain management is time-consuming and costly for all parties involved. Through utilization of genetic testing and other pharmacogenomic tools, these issues can be alleviated by allowing for more effective medication selection and dosing based on genetic predispositions of patients.

Reference links: 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5447546/2. https://www.jmcp.org/doi/full/10.18553/jmcp.2017.16265



None Attached

Author of Proposed Resolution: Jessica Ni



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R4.17

Proposing APhA-ASP Chapter: University of Kentucky College of Pharmacy

Proposed Resolution Title/Topic: Rescheduling of Cannabis spp. From Schedule I to Schedule II.

Proposed wording:

APhA-ASP encourages legislators to support federal reclassification of Cannabis from Schedule I to Schedule II drug under the Controlled Substance Act (CSA) in order to facilitate research needed to assess further medical potential, establish safety profiles, and strengthen the practice of evidence-based medicine.


Cannabis, a genus of flowering plants, is a gray area in today’s arena where law meets patient care. Cannabis sativa is a well-known species of the plant that gives rise to two strains, one used for medical marijuana and one for hemp. The difference between medical marijuana and hemp is the concentration of psychoactive components, mainly tetrahydrocannabinol (THC), within each plant. Medical marijuana is considered to contain high THC, high cannabinoids, while hemp is considered to have low THC, high cannabinoids.1, 2

All Cannabis plants, like Cannabis sativa, and their components are currently classified by the DEA as Schedule I drugs. Schedule I drugs are defined as “drugs, substances, or chemicals as drugs with no currently accepted medical use and a high potential for abuse.”3 The use of Cannabis and products derived from the plant, such as cannabidiol (CBD) oil, has remained a controversial legal issue. This is especially true for health care professionals, as both medical marijuana and hemp products have potential medical benefit. The legality and use of the products varies on a state to state basis, with some states allowing recreational use, some only allowing low THC products, and others banning all products completely.1

In Cannabis sativa alone, there are over 60 putatively active cannabinoids, yet there are significant barriers to conducting scientific research on these compounds, as simply obtaining legal Cannabis samples is difficult due to its classification as a Schedule I drug.4,5 The National Institute on Drug Abuse (NIDA) is the gatekeeper of research-grade medical marijuana. With this classification, marijuana for research must be obtained from the only federally approved source/grower at the University of Mississippi.6 Additionally, researchers must apply for and receive a DEA license, and receive study approval from the FDA, all while navigating paperwork and red tape. There are more options to obtain and study hemp, but in some states, federal

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approval must be given to both the state and researcher to grow or work with the product. Rescheduling Cannabis to a Schedule II would aid the research process by allowing the scientific community less guarded access to the plant. This would allow for the increased research needed to determine the potential therapeutic benefits of all cannabinoid components of the plant, the optimal dose and delivery route, and indicated conditions. As a field that supports the practice of evidence-based medicine, facilitating the research of Cannabis for advancement of medical purposes should be supported.

The American Medical Association (AMA) House of Delegates in 2017 passed a resolution supporting the relabeling of Cannabis derived products to exclude “no scientifically proven, currently accepted medical use for preventing or treating any disease process in the US,” leaving only “marijuana has a high potential for abuse.”4 There is clear support for rescheduling among medical professionals across the board, including organizations like the aforementioned AMA, American Cancer Society, the American Academy of Pediatrics, and the American College of Physicians, to name a few, for research on the medical benefits of cannabinoids.7

Aside from research, reclassification of Cannabis is needed because it does not fully fit the current CSA definition. There seems to be disagreement among federal agencies regarding marijuana’s “lack of a currently accepted medical use” that is suggested by its classification. For example, individual chemical components from the plant, such as cannabidiol (CBD), have been approved by the FDA, which directly contradicts this definition. Specifically, the FDA granted approval in June 2018 to Epidiolex® (CBD) for treatment of Lennox-Gasteaut and Dravet syndromes for ages 2 and above. Epidiolex® is the first FDA approved non-synthetic drug with a purified drug substance derived from marijuana.8 However, CBD under the CSA is normally considered a Schedule I substance because it is a cannabinoid, and all cannabinoids are umbrellaed under the DEA Schedule I classification, but without any scientific evidence for psychoactiivty or abuse liability. Additionally, more research is needed to assess the indications for marijuana and its derivatives as alternatives to current treatments. Currently, evidence supports Cannabis use for chronic pain, especially in patients with cancer, multiple sclerosis, rheumatoid arthritis, or neuropathic pain.9,10,11 More support surfaces from the AMA stating Cannabis products have been assessed to have “statistically significant evidence... supporting Cannabis use in patients with chronic pain” as well as “potential positive outcomes include reduction in pain sensation, antispasticity, increased appetite, and antiemesis.”12 Most recently, the DEA labeled Epidiolex®, as mentioned above, as a Schedule V drug having low abuse potential; this only further blurs the lines for health care professionals as to what Cannabis derivatives should be classified as.13 The contradiction thus emerges as a result of the Epidiolex® FDA approval, citing a clear medical benefit for the compound, while the DEA has Cannabis and its derivatives as Schedule I substances. Clarification is therefore needed within the CSA because Cannabis does not fit the

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definition of its class. Rescheduling Cannabis from a Schedule I to a Schedule II substance would offer much needed clarity to confidently practice as a health care professional, while facilitating research opportunities, scientific evaluation of cannabinoid therapeutic benefits, and safety profiling.

Allowing more research of Cannabis and its products may aid pharmacy in other ways. As professionals, pharmacists are in a unique position to understand the medicinal chemistry, effects, and use of the plant. The value of a pharmacist and their role in the dispensing and counseling on marijuana and other related products cannot be overstated. Arkansas serves as a real-world example, as a state with legalized medical marijuana, the state Board of Health mandated dispensaries be managed by licensed pharmacists. Other states with legalized medical marijuana share similar views, requiring the presence of a pharmacist during the dispensing of marijuana to patients.14,15

However, the therapeutic benefits and administration guidelines can only be assessed with rigorous research that generates overwhelmingly convincing data. This would be much easier to complete if Cannabis was rescheduled. The plant and its derivatives hold promise, and may even help combat serious issues, like the opioid epidemic. In conclusion, there is no foreseeable harm in rescheduling Cannabis from Schedule I to Schedule II for purposes of facilitating research. It would provide much needed clarification for health care providers nationally and would provide consistency between the DEA and FDA.

References

1. Balick, R. 2018 Jan. Pharmacy Today. Retrieved from https://www.pharmacytoday.org/article/S1042- 0991(17)31966-7/pdf

2. Farag, S., Kayser, O. Chapter 1 The Cannabis Plant: Botanical Aspects. Handbook of Cannabis and Related Pathologies. Elsevier 2017. Retrieved from https://www.sciencedirect.com/science/article/pii/B9780128007563000016

3. United States Drug Enforcement Administration. Drug Scheduling. Retrieved from https://www.dea.gov/drug-scheduling

4. American Medical Association House of Delegates. 2016 Sept 2. Clinical Implications and Policy Consideration of Cannabis Use: Resolution 907 (I-16). Retrieved from https://assets.ama- assn.org/sub/meeting/documents/i16-resolution-907.pdf

5. Hanus LO, Meyer SM, Munoz E, Taglialatela-Scafati O, Appendino G. Phytocannabinoids: a unified critical inventory. Nat Prod Rep. 2016 Nov 23;33(12):1357-1392. Review.

6. Ferro, S. 2013 April 18. Why it’s so hard for scientists to study marijuana. Popular Science. Retrieved from https://www.popsci.com/science/article/2013-04/why-its-so-hard-scientists-study-pot#page-2

7. American College of Physicians. Supporting Research into the Therapeutic Role of Marijuana. Philadelphia: American College of Physicians; 2008: Position Paper.

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Retrieved from https://www.acponline.org/acp_policy/policies/supporting_research_therapeutic_role_of_marijuana_ 2016.pdf

8. United States Food and Drug Administration. 2018 June 6. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm

9. Allan Gm, Ramji J, Perry D, et al. Simplified guideline for prescribing medical cannabinoids in primary care. Can Fam Physician 2018; 64:111-20

10. TheNationalAcademiesofSciences,Engineering,andMedicine.Thehealtheffectsofcannabisand cannabinoids: current state of evidence and recommendations for research (2017). https://www.nap.edu/catalog/24625/the-health-effects-of -cannabis-and-cannabinoids-the-current- stat. (Accessed Sept. 19 2018)

11. LynchME,ClarkAJ.Cannabisreducesopioiddoseinthetreatmentofchronicnon-cancerpain.JPain Symptom Manage 2003; 25:496-8

12. HillKP.MedicalMarijuanaforTreatmentofChronicPainandOtherMedicalandPsychiatricProblems:A Clinical Review. JAMA. 2015 Jun 2330;313(24):247483. doi: 10.1001/jama.2015.6199. Review. PubMed PMID: 26103031.

13. T.Mathias.2018September27.GWPharmacannabisdrugsettohitmarketfollowingDEAnod.Reuters Health News. https://www.reuters.com/article/us-gw-pharma-dea/gw-pharma-cannabis-drug-set-to- hit-market-following-dea-nod-idUSKCN1M71WI

14. Fortier,J.2018July10.BoardOfHealthVotesToRequireAPharmacistInMedicalMarijuana Dispensaries. KGOU. Retrieved from http://www.kgou.org/post/board-health-votes-require- pharmacist-medical-marijuana-dispensaries

15. MinnesotaDepartmentofHealth.2014Aug11.MedicalCannabisManufacturerSelectionQuestions and Answers. Retrieved from http://www.health.state.mn.us/topics/cannabis/manufacture/selection/mfrqa.html#pharm2



1973.12 – Marijuana Legislation1973.13 – Decriminalization of Marijuana1973.14 – Experimentation of Marijuana

All adopted resolutions that are related to our proposal deal with steps that need to be taken to support the idea that marijuana does not fit the definition as a Schedule I

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drug and should be rescheduled. While decriminalization and experimentation of marijuana certainly align with our proposal, we are directly addressing the conflicting definitions of a Schedule I drug when it comes it Cannabis, and therefore believe it should be rescheduled.

Author of Proposed Resolution: Alexsandra L. Nilges



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R4.18

Proposing APhA-ASP Chapter: University of Michigan College of Pharmacy

Proposed Resolution Title/Topic: Inclusion of indication on prescriptions and prescription labels

Proposed wording:

APhA-ASP recommends that all prescriptions, written for medications treating chronic conditions, include the indication on the prescription as well as the prescription label.


Empowering patients to be more involved and educated about their health has been an ongoing strategy to improve overall health outcomes and patient satisfaction with the care they receive. One way for pharmacists to ensure that patients feel more in control of their own health is to educate and counsel on why patients are taking their medications. According to Lenahan et al, “A patient's ability to accurately identify their daily medications is crucial for optimal health.” This is especially important for patients with chronic diseases and elderly patients as these patient populations are more likely to see several providers and specialists and therefore, are at higher risk of polypharmacy.

In addition to patients receiving several medications for multiple indications, it is also quite common to see different manufacturers of generic drugs being dispensed. This makes it even more difficult for patients to keep track of their correct medications and regimens. Providing the indication of the medication in a standardized manner (ie.: all pharmacies using the same terms) and patient-friendly language (ie.: Hypertension vs. High Blood Pressure) on the prescription label will not only increase patients’ understanding and adherence to their medications, but will also alleviate stress when it comes time for medication histories and reconciliation.

To ensure that pharmacists are able to accurately provide this information to patients, we additionally propose to reinstate the currently inactive policy 1997.9 titled “Inclusion of Disease State/Intended Use on Prescriptions” which suggests that providing pharmacists with an indication for medications, through the use of ICD-9 codes on prescriptions, can greatly improve patient care.

Including the indication on all prescriptions is already common practice in many European countries to increase patient health literacy and improve communication between physicians and pharmacists.With indications noted on prescriptions, pharmacists will be able to better assess the use of over-the-counter medications and supplements that often are not reported to physicians during office visits.

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Overall, understanding why a patient is prescribed a certain medication is crucial for a pharmacist to ensure correct dosing, evaluate contraindications and to appropriately counsel the patient on non-pharmacological or over-the-counter therapies to maximize patient outcomes.

Benefits:Increasing patient health literacyPossible reduction of medication errors due to look-alike sound-alike medications

or generic substitutionsPossible increasing adherence and improve overall health outcomesPossible reduction in dosing errors, adverse events or inappropriate use of over-

the-counter medications.Pharmacist ability to review medication profiles and optimize therapies based on

indicationDestigmatizing of highly stigmatized conditions

Concerns:Overcrowding of prescription labelConcern for patient privacyStandardization of wordingCost of label redesignPharmacists will need to be able to interpret ICD-9 codes

References:

1. Effects of including medication indications on prescription labels. Burnside, Nicole L.Tuttle, Jeanne A. et al. Journal of the American Pharmacists Association , Volume 47 , Issue 6 , 756 - 758

2. A Drug by Any Other Name: Patients’ Ability to Identify Medication Regimens and Its Association With Adherence and Health Outcomes. Lenahan, Jennifer L. et al. Journal of Health Communication 18.Suppl 1 (2013): 31–39. PMC. Web. 22 Sept. 2018.

3. What Do Australian Consumers, Pharmacists and Prescribers Think about Documenting Indications on Prescriptions and Dispensed Medicines Labels?: A Qualitative Study. Garada, Mona et al. BMC Health Services Research 17 (2017): 734. PMC. Web. 22 Sept. 2018.

4. Assessing the effect of providing a pharmacist with patient diagnosis on electronic prescription orders: a pilot study. Warholak TL, Rupp MT, Leal S, Kurniawan G, Patel N. Res Soc Adm Pharm. 2014;10:246–251

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Inactive resolution 1997.9 titled “Inclusion of Disease State/Intended Use on Prescriptions” is partially included in our proposal. While resolution 1997.9 focused on including disease states on prescriptions to allow pharmacists to provide more efficient patient care, we wanted to pay special attention to increasing patient’s health literacy by additionally proposing the inclusion of indications on prescription labels. By adding this additional component, reiterating the importance of communication between physicians, pharmacists and patients, we are hoping to move proposal 1997.9 back to active status.

Author of Proposed Resolution: Hannah Hendricks



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R4.19

Proposing APhA-ASP Chapter: University of Toledo College of Pharmacy and Pharmaceutical Sciences

Proposed Resolution Title/Topic: Women’s Reproductive Health

Proposed wording:

APhA-ASP supports legislation that allows pharmacists to modify and renew prescriptions on women's contraceptive medications, such as birth control medications.

Background Statement:By supporting national and state legislations regarding the role of the

pharmacist in women’s preventative health care measures, pharmacists can become a resource for women in their health care journey with preventative care. In an article written for Pharmacy Times, it is made aware that there will be 27% shortage of primary care providers in the US over the course of the next ten years. With this, women may have decreased access to physicians and health care providers who see to their contraception medications—pharmacists can aid in bridging this gap in providers by having the ability to renewing standing birth control prescriptions. Simply alone, this would save women time and be of easier convenience to keep their birth control medication without having to go see a PCP each time. In this, patient adherence could be increased. In order to ensure women are still undergoing regular and annual testing, the patient would have to provide evidence of a physician visit within 3 years of the prescription given by the pharmacist (Jesse C Vivian 2016). Additionally, women may stop taking a birth control medication due to undesired side effects—allowing a pharmacist to make a modification change (such as dose or monophasic to triphasic) would create an easily accessible health care provider to make the proper modification to continue pursuing treatment. All treatments and documentations would be done to ensure any referrals to a physician for further care would be properly made; should a health red flag be made or an issue identified by the pharmacist, the pharmacist can aid in directing the patient to the proper provider, preventing any dangerous health events or undesired impacts. Overall, the health and wellness of women, increased medication adherence, and increased access to care can be pursued with the support of legislation. Some states (California, Oregon, Washington and New Jersey) already allow pharmacists to prescribe hormonal contraception in the state to patients similar to the procedure above. However, this resolution does not address supporting full prescribing of hormonal contraception on a national level as not all states recognize pharmacists as providers, which would create billing and documentation challenges for those providing hormonal contraception prescribing and point of care testing.

References:

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https://www.pharmacytimes.com/publications/issue/2016/november2016/pharmacists-prescribing-birth-control-improving-access-and-advancing-the-professionhttps://www.uspharmacist.com/article/pharmacists-prescribing-birth-control https://naspa.us/2017/05/pharmacists-authorized-prescribe-birth-control-states/



2016.4 Increasing Patient Access to Pharmacist-Prescribed MedicationsRationale for addition of proposed resolution: this resolution puts more focus on the specificity of women’s health in regards to contraception and hormonal care, and asks for support of legislation that does not directly require prescribing rights or provider status to do so.

Author of Proposed Resolution: Regann Geise



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https://naspa.us/2017/05/pharmacists-authorized-prescribe-birth-control-states/

https://www.uspharmacist.com/article/pharmacists-prescribing-birth-control

https://www.pharmacytimes.com/publications/issue/2016/november2016/pharmacists-prescribing-birth-control-improving-access-and-advancing-the-profession

https://www.pharmacytimes.com/publications/issue/2016/november2016/pharmacists-prescribing-birth-control-improving-access-and-advancing-the-profession


R4.20

Proposing APhA-ASP Chapter: University of Wisconsin – Madison School of Pharmacy

Proposed Resolution Title/Topic: State Pursuance of Provider Status

Proposed wording: APhA-ASP reaffirms and amends resolution 1999.2 to encourage State Pharmacy Organizations to individually pursue provider status, and to recognize pharmacists under state Medicaid programs to better serve all patients.

Background Statement: None Provided



1999.2: No rationale provided

Author of Proposed Resolution: Michael Heltne



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R4.21

Proposing APhA-ASP Chapter: Wayne State University Eugene Applebaum College of Pharmacy & Health Sciences

Proposed Resolution Title/Topic: Additional Labelling Requirements for Dietary Supplements

Proposed wording:

APhA-ASP encourages the expansion of DSHEA to include enforceable regulations regarding the inclusion of the following on dietary supplement product labels:

1. The statement “This supplement may interact with medication that you may be taking. Visit www.fda.gov/food/dietarysupplements for more information.”

2. A symbolic indicator of contraindication in pregnancy.3. The statement “Excessive supplement consumption may cause serious

adverse effects.”4. The statement “To report adverse events, visit

www.safetyreporting.hhs.gov.”

Background Statement:Currently, the FDA requires the following must be listed on dietary supplement labels1:

General InformationName of the product (including the word “supplement” or a statement that the product is a supplement)Net quantity of contentsName and place of business of the manufacturer, packer, or distributorDirections for use

Supplement Facts PanelServing size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV) if establishedIf the dietary ingredient is a botanical, the scientific name of the plant or the common or usual name standardized in the reference Herbs of Commerce (1992 edition) and the name of the plant part usedIf the dietary ingredient is a proprietary blend (i.e., a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight

Other IngredientsNondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders; listed by weight in descending order of predominance and by common name or proprietary blend

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http://www.safetyreporting.hhs.gov/

http://www.fda.gov/food/dietarysupplements


Supplement manufacturers can include health claims, nutrition content claims, and structure/function claims on supplement labels. These claims must include the statement “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”.1

Additionally, the FDA issued Good Manufacturing Practices for dietary supplements in 2007, with the goal of setting the expectation of guaranteed identity, purity, strength, and composition on supplement manufacturers.1

It is a common practice of supplement manufacturers, packers, and/or distributors to refer consumers to their physician to determine whether or not the supplement is considered safe to take by that individual, especially during pregnancy. Due to low health literacy2, growing issues regarding healthcare accessibility3, and the large amount of medically underserved areas throughout the US4, the current practice of referring the customer to their physician is not enough to inform the consumer of potential risks or adverse effects that supplement use may cause. Given the amount of misinformation regarding supplements on the internet5, the word-of-mouth nature of supplement use and its impact on decision making6, and the lack of health literacy within the general population, it is not likely that placing the burden of determining safe use on the consumer will always result in healthy or safe outcomes, especially in consumers who are taking prescription or OTC medications. With these issues in mind, the addition of the statement “This supplement may interact with medication that you may be taking. Visit www.fda.gov/food/dietarysupplements for more information” would be beneficial for aiding consumers in making a more informed decision through providing them with a convenient, unbiased, and evidence based source of information. A specific example of where this may help is with the supplement Red Yeast Rice. Individuals taking cholesterol lowering medications may like the idea of adding a natural means of further lowering cholesterol, however they may not know that red yeast rice essentially contains the drug Lovastatin, which can lead to adverse dose-related side effects. Additionally, due to the lack of regulation of dietary supplements, people taking red yeast rice may potentially be getting different doses (up to a 120 fold difference in the manufacturer’s daily serving recommendations) every time they take it, which has been shown to happen regardless of changes in the FDA’s Good Manufacturing Standards7 which are essentially only guidelines, especially for manufacturers that operate outside of the US.

One of the highest risk populations for supplement use is pregnant women. One survey shows that 97% of pregnant women use public search engines to find health information, and that 83% of them use that information to influence their decision making concerning pregnancy-related nutrition8. While there are many reliable sources that illustrate the safety of using a given supplement during pregnancy, there are also many that are misleading, which could lead to potentially serious risk to the mother and/or to the fetus. For this reason, it should be made completely clear as to whether a supplement is contraindicated during pregnancy. Currently these risks are often labeled in small print on the back of the bottle, making it easy to be overlooked. Due to the potential risks of teratogenicity, this method of information is inadequate. A solution to this is the addition of a symbol indicating contraindication in pregnancy to

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the front of the bottle or other direct product label (a “P” with a red slash through it, for example) in order to make the contraindication abundantly clear and to mitigate the risk of the warning being overlooked, especially in younger and/or less educated pregnant women who may not even know to look for it in the first place.

Another potential issue concerning dietary supplements, especially vitamins and minerals, is the potential for overuse, especially in athletes that take them in order to boost performance9. It is well known that electrolyte disorders can cause severe and potentially deadly conditions, however the association of these conditions with the overuse of vitamins and other supplements is not often considered prior to use. Further risk occurs when people are taking supplements for symptoms that may be caused by an excess of that very supplement. An example of this is an athlete being directed to take potassium supplements for muscle cramps. A symptom of hypokalemia is muscle cramping, but it is also a symptom of hyperkalemia10. Additionally, the use of supplements can cause a variety of other conditions or physiological issues including liver damage, which has been increasing due to supplement use at an alarming rate11. While supplement use may be beneficial, the risks of overuse are often overlooked. In order to mitigate these risks, adding the statement “Excessive supplement use may cause serious adverse effects.” will provide a means to guide consumers to research whether or not their supplement use is necessary or could be detrimental to their health.

Through current legislation, dietary supplements do not have to be deemed safe and effective by the FDA in order to enter the market, meaning that the FDA is reactive (as opposed to being proactive as it is with drugs) in terms of allowing the marketing of dangerous substances. Currently there are mechanisms in place by which to report adverse effects of supplements to the FDA and to the manufacturer on which the FDA acts to remove dangerous supplements from the market. These include the adverse event submission form on the FDA website (which is currently not advertised) and the requirement of including a complete phone number or complete domestic address of a responsible party to be listed on all supplement labels for reporting purposes, as per the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 200612. There are issues with the latter, as the law does not require the statement of why that information is on the label, but rather solely that the information be present on the label. Unless a consumer is very well informed, there’s no reason to believe that any consumer would connect the presence of that information to it being there for adverse effect reporting purposes. With that in mind, and with knowing that consumer adverse effect reporting is the only mechanism by which the FDA can determine if a supplement or compound within a supplement poses a risk to consumers, it is apparent that additional clarity regarding reporting mechanisms is required. The additional requirement of adding the statement “To report adverse events, visit www.safetyreporting.hhs.gov.” to supplement labels is a clear and concise method to inform consumers that these events should be reported and give them knowledge of a means by which to conveniently report them, with the added benefit of these reports being sent directly to the FDA.

The burden of adding these statements to supplement labelers and the modest increase in price that it may cause to offset the cost of additional labelling is a small

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http://www.safetyreporting.hhs.gov/


price to pay for the added safety benefits provided through these additional requirements. As it stands, DSHEA is currently insufficient in preventing potential harm to consumers. It is well known that vitamin and supplement lobbying efforts were successful in effectively gutting DSHEA of the meaningful dietary supplement regulation for which it was originally intended. Additionally, the Dietary Supplement and Nonprescription Drug Consumer Protection Act is not adequately explicit and does not adequately provide information regarding adverse event reporting to consumers. Until we reach the time where legislation grants the FDA full responsibility over dietary supplements, as DSHEA was originally aimed toward doing and which is supported by APhA-ASP (active resolution 1998.8), it is important that consumers are provided with these additional statements in order to increase safety regarding consumer utilization of dietary supplements, to pressure manufacturers to both manufacture and market products more responsibly, and to increase the collection of adverse event data with the goal of preventing unsafe supplements from remaining on the market.

References1. What information is required on a dietary supplement label? U.S. Department of

Health and Human Services. (2011) Retrieved from https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/#h6

2. America’s Health Literacy: Why We Need Accessible Health Information. An Issue Brief from the U.S. Department of Health and Human Services. (2008) Retrieved from https://health.gov/communication/literacy/issuebrief/

3. New Research Shows Increasing Physician Shortages in Both Primary and Specialty Care. AAMC News. (2018) Retrieved from https://news.aamc.org/press-releases/article/workforce_report_shortage_04112018/

4. Thompson, CA. Provider Status Coming to Medically Underserved Areas? ASHP Intersections. (2014) Retrieved from http://www.ashpintersections.org/2014/03/provider-status-coming-to-medically-underserved-areas/

5. Tips for Dietary Supplement Users. U.S. Food and Drug Administration. (2018) Retrieved from https://www.fda.gov/food/dietarysupplements/usingdietarysupplements/ucm110567.htm

6. Soderstrom, S, Uzzi, B, Rucker, DD, et. al. The Science Behind Word-of-Mouth Recommendations. Kellogg Insight. (2017) Retrieved from https://insight.kellogg.northwestern.edu/article/why-we-share-opinions-and-word-of-mouth-marketing

7. Husten, L. No One Knows What’s Actually In Red Yeast Rice Supplements. Cardio Brief. (2017) Retrieved from http://www.cardiobrief.org/2017/06/23/no-one-knows-whats-actually-in-red-yeast-rice-supplements/

8. Lagan, BM, Sinclair, M, Kernohan, WG. Internet Use in Pregnancy Informs Women’s Decision Making: A Web-Based Survey. Birth 37-2. (2010) Retrieved from https://onlinelibrary.wiley.com/doi/full/10.1111/j.1523-536X.2010.00390.x

9. Maughan, RJ, Greenhaff, PL, Hespel, P. Dietary supplements for athletes: Emerging trends and recurring themes. Journal of Sports Sciences 29 S57-S66.

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https://onlinelibrary.wiley.com/doi/full/10.1111/j.1523-536X.2010.00390.x

http://www.cardiobrief.org/2017/06/23/no-one-knows-whats-actually-in-red-yeast-rice-supplements/

http://www.cardiobrief.org/2017/06/23/no-one-knows-whats-actually-in-red-yeast-rice-supplements/

https://insight.kellogg.northwestern.edu/article/why-we-share-opinions-and-word-of-mouth-marketing

https://insight.kellogg.northwestern.edu/article/why-we-share-opinions-and-word-of-mouth-marketing

https://www.fda.gov/food/dietarysupplements/usingdietarysupplements/ucm110567.htm

https://www.fda.gov/food/dietarysupplements/usingdietarysupplements/ucm110567.htm

http://www.ashpintersections.org/2014/03/provider-status-coming-to-medically-underserved-areas/

http://www.ashpintersections.org/2014/03/provider-status-coming-to-medically-underserved-areas/

https://news.aamc.org/press-releases/article/workforce_report_shortage_04112018/

https://news.aamc.org/press-releases/article/workforce_report_shortage_04112018/

https://health.gov/communication/literacy/issuebrief/

https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/#h6


(2011) Retrieved from https://www.tandfonline.com/doi/full/10.1080/02640414.2011.587446?src=recsys

10. Abe, K. A Patient Developed Painful Muscle Cramps due to Overeating Mangos. Case Reports in Neurological Medicine. (2012) Retrieved from https://www.hindawi.com/journals/crinm/2012/742125/

11. Cooper, L. Liver Damage from Supplements is on the Rise. Consumer Reports. (2017) Retrieved from https://www.consumerreports.org/health/liver-damage-from-supplements-is-on-the-rise/

12. Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. U.S. Food & Drug Administration. (2009) Retrieved from https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm179018.htm



1998.8 FDA Regulation of Complementary and Alternative Medicines and Dietary Supplements1999.6 Label Accuracy of Complementary Products2001.3 Herbal and Other Dietary Supplement Sign in Pharmacies2008.1 Poison Control Centers Hotline

Author of Proposed Resolution: Derek Volgyi



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https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm179018.htm

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm179018.htm

https://www.consumerreports.org/health/liver-damage-from-supplements-is-on-the-rise/

https://www.consumerreports.org/health/liver-damage-from-supplements-is-on-the-rise/

https://www.hindawi.com/journals/crinm/2012/742125/

https://www.tandfonline.com/doi/full/10.1080/02640414.2011.587446?src=recsys

https://www.tandfonline.com/doi/full/10.1080/02640414.2011.587446?src=recsys