Aine Cryts

OTC medications are more accessible than ever before: according to the Consumer Healthcare Products Association, OTC analgesic products accounted for $4.5 million worth of retail health care product sales in 2020.

 But these easily accessible remedies come with their own set of potential problems. OTC pain relievers such as aspirin and ibuprofen can lead to gastrointestinal issues including nausea, diarrhea, and flatulence.

Additionally, adverse effects of naproxen, for example, can include upset stomach, nausea, heartburn, headache, or drowsiness. Pharmacists and pharmacy technicians have a role to play in educating and supporting patients seeking out OTC pain relief products, said Erin Pauling, PharmD, assistant dean for academic affairs at New York’s Binghamton University School of Pharmacy and Pharmaceutical Sciences.

Her advice: “Come out from behind the counter,” and approach patients who are lingering in the pain relief aisles at retail pharmacies. A good warm-up question, Pauling noted, is “Have you talked to your doctor about [the pain you’re experiencing]?”

The most important thing, Pauling said, is to get as much information as you can about the patient’s pain symptoms, current medications, and allergies. But the bigger picture is this: “You have to follow where the patient is.” Jenna Mills, PharmD, an assistant professor of pharmacy practice at the University of Findlay College of Pharmacy in Ohio, said it’s also important to ask about the other medications a patient is taking; these products may also include acetaminophen, and adding an additional acetaminophen product could put the patient over the maximum daily dose.

Exceeding the maximum daily dose can result in liver toxicity, she added. Acetaminophen can also be found in cough, cold, and allergy products, in addition to medications that address difficulty in falling asleep, said Mills.

“If the patient doesn’t realize that acetaminophen is in a pain reliever and their cough medicine and the medication they take to sleep at night, there’s a real risk for overdose.” Equally important is reading the back of the medication box, Mills added. Pharmacists should pay attention to the amount of acetaminophen in the specific product.

For example, she said, the regular dose could be 350mg, whereas the extra strength and extended-release versions could be 500-mg or 650-mg doses, respectively. Although the generally recommended maximum daily dose is 4000mg of acetaminophen, even doses close to that daily limit can be toxic to the liver, according to a 2020 article posted by Harvard Health Publishing.

Pauling further recommended asking patients who are interested in acetaminophen products about their alcohol intake, the combination of which can also result in liver damage. According to Cleveland Clinic,

 consistent, heavy alcohol use—more than 1 drink each day for women and more than 2 drinks each day for men—combined with ongoing daily acetaminophen dosing can predispose the liver to acetaminophen-associated toxicity.

Because OTC pain relievers are intended for short-term pain relief, it’s important to ask patients about their follow-up plan and to ensure they receive routine monitoring by their physician, said Mills. Pharmacists and pharmacy technicians can tell patients to take these medications along with food or milk to avoid an upset stomach.

Pauling, who is also a clinical assistant professor of pharmacy practice at Binghamton University, added that patients shouldn’t fall asleep right after taking the pain relievers. “Staying upright—not supine—allows the body to digest the medication, which can prevent gastrointestinal issues.”

Articles

Acetaminophen and ibuprofen are accessible over the counter, but do patients
know all the risks associated with these medications?

Patient Education Is Key to Reducing Adverse Effects of OTC Analgesics

Cigarette smoking stubbornly remains the leading cause of preventable disease, disability, and death in the United States.1 Each year, approximately 1 in 5 deaths—or more than 480,000 people—are attributed to cigarette smoking.

The good news is fewer people are smoking. Nearly 21% of US adults were smokers in 2005, and in 2019, approximately 14% of adults smoked cigarettes.

The bad news is that in July, Pfizer, Inc announced that it would recall certain lots of Chantix (varenicline), a nicotine-free prescription pill that can support smoking cessation, due to the presence of a nitrosamine that can cause cancer in patients who ingest it over a long period of time.3,4 On September 17, the FDA issued an update for patients and health care professionals that Pfizer is expanding its voluntary recall to include all lots of Chantix 0.5 mg and 1 mg tablets.

Erin Fox, PharmD, BCPS, FASHP, senior director, drug information and support services at University of Utah Health in Salt Lake City, said drug information services at University of Utah started tracking the shortage of Chantix in June.6 Within a span of 3 months, the FDA started to provide alternatives for smokers who wanted to quit. In July, the agency allowed for the import into the United States of Apo-Varenicline (varenicline tartrate), a non-FDA approved generic drug from Apotex Inc, a Canadian company.6 In August, the FDA approved a generic form of varenicline from US-based Par Pharmaceutical.

Although the generic product from Par Pharmaceutical isn’t currently available, the generic from Apotex is, said Fox.

The approval of a generic form of varenicline is just one of the generics approved by the FDA in the last year, during which the United States and world continued to struggle with the COVID-19 pandemic. In August, the FDA issued full approval of Comirnaty (COVID-19 Vaccine, mRNA), Pfizer’s 2-dose vaccine for people 16 years and older.8 The federal agency provided emergency use authorization for COVID-19 vaccines from Moderna, Inc. in December 20209 and Janssen in January 2021.10

Given the agency’s focus on authorizing the use of COVID-19 vaccines, Francis Palumbo, PhD, JD, professor and executive director of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy in Baltimore, described the rate at which the FDA approved generics during the last year as “impressive.” 

In 2020, the FDA approved or tentatively approved 948 abbreviated new drug applications.11 These applications contain data that are submitted to the FDA for the review and potential approval of a generic drug product. In 2019, the agency approved or tentatively approved 1014 generic drug applications.

Through July of this year, the FDA approved or tentatively approved 470 generics.

Palumbo highlighted 3 generics approved by the FDA over the last year for HIV, multiple sclerosis (MS), and mild to severe pain.

In June, Lupin Limited announced that the FDA had approved emtricitabine and tenofovir disoproxil fumarate tablets 200 mg/300 mg as a generic equivalent of Gilead Sciences’ Truvada.

According to Lupin Limited, this treatment is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections, in addition to being used for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection.

Approximately 1.2 million people in the United States have HIV, a condition that has a more significant impact on certain populations, including racial ethnic minorities and gay, bisexual, and other men who have sex with men.

Palumbo said the approval of a generic form of Truvada will “introduce competition in the marketplace. That’s going to reduce barriers to access [for this treatment,] which will ultimately improve [clinical] outcomes.” He added that another benefit of having a generic equivalent to Truvada for the treatment of HIV is the lower incidence of shortages because more than one company now manufactures the product.

Palumbo also pointed to the FDA’s approval in August 2020 of a generic equivalent of Biogen Inc’s Tecfidera (dimethyl fumarate) for the treatment of relapsing forms of MS as a defining generics approval.16 The generic will be manufactured by Mylan.

“Generic options will increase affordability of and access to MS disease-modifying therapies, which are the cornerstone of MS management,” said Kathy Costello, MS, ANP-BC, MSCN, associate vice president of clinical care at the National MS Society.

MS is potentially disabling disease of the brain and spinal cord; nearly 1 million people in the United States are living with MS.

The FDA’s December 2020 approval of Leucadia Pharmaceuticals’ generic form of Ofirmev (acetaminophen), an injectable form of pain relief used during surgical recovery,19 was a pivotal decision, said Palumbo. “It’s important to have access to [acetaminophen injection] because it’s not an opioid,” he noted.

In a Leucadia Pharmaceuticals’ news release about the approval, William Larkins, PhD, chief executive officer, said, “The release of this latest generic injectable once again demonstrates Leucadia’s strategic focus on expanding access to safe, effective pharmaceuticals at substantially lower costs.”

First FDA-Approved Interchangeable Biosimilar Insulin

Neil Gilchrist, PharmD, MBA, chief pharmacy officer at UMass Memorial Health in Worcester, Massachusetts, said the FDA’s July approval of insulin glargine-yfgn (Semglee)—which is biosimilar to and interchangeable with insulin glargine (Lantus), a long-acting insulin analog—is a “most notable” approval over the past year. What gives it that distinction, said Gilchrist, is the sheer number of patients with type 1 and type 2 diabetes who rely on the medication. 

Approximately 34 million Americans—slightly more than 1 in 10—have diabetes.20 There’s a higher incidence of new diabetes cases among non-Hispanic Blacks and people of Hispanic origin than other ethnic groups, according to the CDC’s 2020 National Diabetes Statistics Report.

The list prices of many common types of insulin have tripled during the past 10 years. According to a spokesperson for Novo Nordisk, however, approximately 80% of people in non–high-deductible plans pay $50 or less each month for one of the company’s insulin analogs.

Novo Nordisk’s NovoLog rapid-acting insulin product that lowers blood sugar spikes in adults and children with diabetes has 41% of the global market share by revenue.

The approval of an interchangeable biosimilar for insulin is important for patients because it means that, for the first time, a pharmacist can switch a patient’s prescription. The potential impact on patients: a lower copay at the pharmacy counter, said Gilchrist, who encouraged pharmacists to explain to patients that the interchangeable biosimilar insulin is an equally effective and safe drug that delivers the same clinical outcome. Equally important, he added, is educating prescribing clinicians to ensure effective care coordination.

Current cigarette smoking among adults in the United States. CDC. Updated December 20, 2020. Accessed August 27, 2021. 

https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm

The health consequences of smoking—50 years of progress. US Department of Health & Human Services. 2014. Accessed August 27, 2021. 

https://www.ncbi.nlm.nih.gov/books/NBK179276/pdf/Bookshelf_NBK179276.pdf

Pfizer issues a voluntary nationwide recall for twelve lots of Chantix (varenicline) tablets due to n-nitroso varenicline content. News release. Pfizer Inc. July 16, 2021. Accessed August 27, 2021. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso

Varenicline tablets (Chantix). American Society of Health-System Pharmacists. Updated July 21, 2021. Accessed August 27, 2021. 

https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=739&loginreturnUrl=SSOCheckOnly

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix). News Release. FDA; September 17, 2021. Accessed October 8, 2021. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix

Importation of Apotex Inc.’s Canadian approved Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg (based on free base equivalents) tablets to address drug shortage. FDA. July 6, 2021. Accessed August 27, 2021. 

https://www.fda.gov/media/150799/download

Varenicline. FDA. Accessed August 27, 2021. 

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201785

FDA Approves first COVID-19 vaccine. News release. FDA. August 23, 2021. Accessed August 27, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Moderna COVID-19 vaccine. FDA. Updated August 18, 2021. Accessed August 27, 2021. 

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine

Janssen COVID-19 vaccine. FDA. Updated August 2, 2021. Accessed August 27, 2021. 

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine

FDA. Office of Generic Drugs 2020 Annual Report. Accessed August 27, 2021. 

https://www.fda.gov/media/145793/download#page=8

2019 Office of Generic Drugs Annual Report. FDA. Updated August 26, 2021. Accessed August 27, 2021. 

https://www.fda.gov/drugs/generic-drugs/2019-office-generic-drugs-annual-report

Generic drugs program activities report - monthly performance. FDA. Updated August 11, 2021. Accessed August 27, 2021. 

https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drugs-program-activities-report-monthly-performance

Lupin launches emtricitabine and tenofovir disoproxil fumarate tablets in the United States. News release. Lupin Limited. June 25, 2021. Accessed August 27, 2021. 

https://www.lupin.com/lupin-launches-emtricitabine-and-tenofovir-disoproxil-fumarate-tablets-in-the-united-states/

Fast facts. FDA. Updated June 2, 2021. Accessed August 27, 2021. 

https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics

Dimethyl fumarate. FDA. Updated June 2, 2021. Accessed August 27, 2021. 

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210531

FDA approves generic form of Tecfidera for relapsing MS. News release. National Multiple Sclerosis Society. September 2, 2020. Accessed August 27, 2021. 

https://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Generic-Form-of-Tecfidera-for-Relapsi

How many people live with MS? National Multiple Sclerosis Society. Accessed August 27, 2021. 

https://www.nationalmssociety.org/What-is-MS/How-Many-People

Leucadia Pharmaceuticals Launches Acetaminophen Injection. News release. Accessed August 27, 2021. 

https://leucadiapharma.com/wp-content/uploads/2020/12/Leucadia-Pharma_Acetaminophen-Injection-Release.pdf

CDC. National Diabetes Statistics Report, 2020. Updated February 11, 2021. Accessed August 27, 2021. 

https://www.cdc.gov/diabetes/library/features/diabetes-stat-report.html

One chart reveals how the cost of insulin has skyrocketed in the US, even though nothing about it has changed. Insider. September 18, 2021. Accessed August 27, 2021. 

https://www.businessinsider.com/insulin-price-increased-last-decade-chart-2019-9

Knox R. Insulin insulated: barriers to competition and affordability in the United States insulin market. Journal of Law and the Biosciences. October 9, 2020. Doi: 

By July 2021, the FDA had approved or tentatively approved 470 generic versions of medications. 

Notable FDA Generic and Biologics Approvals During the Past Year 

According to Ann Philbrick, PharmD, FCCP, BCPS, BCACP, an associate professor in the Department of Pharmaceutical Care & Health Systems at the University of Minnesota in Minneapolis, the upcoming season may be “a big question mark.” Because there were so few incidents of the flu last year, it’s “really hard to make recommendations....It’s even possible that the flu vaccines won’t match the flu [strains] very well.”

The CDC reported 2038 flu cases in the United States between September 2020 and April 2021.1 In contrast, approximately 35.5 million individuals were sick with the flu during the 2019-2020 season, which the federal agency describes as “moderate severity.”

Flu Vaccine Options for the 2021-2022 Season

According to the CDC, health care providers can choose any licensed, age-appropriate vaccine with no preference for any vaccine over another. 

For the 2021-2022 flu season, the vaccine options include as follows:

high-dose shots for individuals aged 65 and older; shots made with adjuvant for individuals aged 65 and older;

shots made with virus grown in cell culture—eggs are not involved in the vaccine’s production;

shots made using vaccine production technology— specifically, a recombinant vaccine that doesn’t require having a candidate vaccine virus sample to produce; and

live attenuated flu vaccine, which is made with attenuated (or weakened) live virus and administered by nasal spray.

Manufacturers estimate that between 194,000,000 and 198,000,000 doses of flu vaccine will be available for the upcoming flu sea- son, according to the CDC. This is more than the 175,000,000 dose record set during the 2019-2020 flu season, the CDC noted.

Administering Vaccines for COVID-19 and Flu

Jason Mallada, PharmD, BCPS, BCIDP, a clinical pharmacy specialist in infectious diseases and internal medicine at Newton-Wellesley Hospital in Boston, Massachusetts, agreed that it’s almost impossible to predict the rate of flu infections during the upcoming season.

That said, communities are opening up and COVID-19 restrictions are starting to go away, which could mean Americans are at greater risk for both COVID-19 and flu if they’re not vacci- nated, Mallada said. As a result, pharmacists and other health care providers have to be prepared with vaccination programs, in addition to testing for both flu and COVID-19, he said. The CDC’s Advisory Committee on Immunization Practices also recently announced that COVID-19 vaccines can be given to patients at the same time as other vaccines. Health care providers should be mindful of the possibility of increased adverse reactions.

reported that COVID-19 vaccine manufacturers are developing and testing booster shots for new variants of the virus; it’s at the discretion of governments around the world as to whether the booster shots are purchased and offered to residents in those countries.

The news service also reported that the CDC is creating a risk assessment framework to determine the required evidence to recommend a modified vaccine. Both the CDC and other US health agencies are studying ways to assess vac- cine efficiency. Top of mind are the effectiveness of the vaccine among older populations and chil- dren and the impact of new variants.

The CDC hasn’t officially decided yet whether the US population will need a booster to the COVID-19 vaccine. But Mallada thinks a booster is likely, which means pharmacists need to be prepared to counsel and provide educational materials on COVID-19 and flu vaccines throughout the 2021- 2022 flu season.

In addition, Mallada anticipates increased demand for flu vaccines. To prepare, pharmacies have a sufficient inventory of personal protective equipment and swabs, in addition to vaccines for flu and COVID-19, he said.

Cleveland Clinic has ordered 2 different flu vaccines for its patients, accord- ing to Allison Riffle, PharmD, associate chief pharmacy officer. One vaccine is for patients aged 6 months to 64 years, whereas the second vaccine is for patients 65 years and older.“ Standardizing in this way was a safety decision. It minimizes errors in helping ensure providers, pharmacists, and caregivers select the appropriate vaccine.”

Riffle added that Cleveland Clinic uses a multidose vial presentation in ambulatory settings, which offers significant cost savings compared with a prefilled syringe. Theresa Tolle, BPharm, FAPhA, owner of Bay State Pharmacy in Sebastian, Florida, plans to start outreach to local employers to educate them about her pharmacy’s test- ing and vaccination capabilities for flu, just as she did for COVID-19 testing and vaccinations. During the upcoming flu season, Tolle expects to recruit retired nurses who can help vaccinate patients and other community members for patient intake, if needed.

Otherwise, she will prepare for the upcoming flu season the same way she has in the past. That includes promoting the flu vaccine through partnerships with senior centers and churches. Tolle started prebooking vaccine orders in January with 5 different suppliers. She plans to have a high-dose flu shot for patients aged 65 and older and a standard-dose shot for her younger customers.

Philbrick has 2 best practices for pharmacies that want to provide point-of- care testing for flu:	

Ensure that there’s a private area for testing in the pharmacy.		

Assume that the patients who enter the pharmacy for testing are infected; that means patients and pharmacy employees should wear masks and use hand sanitizer.		

In addition, pharmacies can participate in collaborative practice agreements, which requires planning, Phil- brick said. These agreements are beneficial for patients who test positive for flu because antivirals, such as oseltamivir (Tamiflu; Roche), which require a prescription, must be taken within 48 hours of the onset of symptoms to be effective.

Alternatively, pharmacies can set up referrals for video-based consults with physicians who can prescribe oseltamivir, according to Philbrick.

Although it’s more work for her employees, Tolle plans to do flu testing on patients in their cars. It takes approximately 20 minutes to get a result, she said. The patient calls the pharmacy from the parking lot, an employee goes out to do the test, and the patient receives the test result.

Florida is a “test-and-treat” state, which means pharmacists can treat patients who test positive for flu with oseltamivir. Pharmacists participating in “test-and-treat” in Florida must complete a 20-hour course approved by the board of pharmacy and carry liability insurance coverage of at least $250,000.

The future for Pharmacists and Public Health

Tolle points to the role of community pharmacies in West Virginia in bolstering COVID-19 vaccination rates as proof that pharmacists can have a meaningful impact on public health. By January 2021, almost 90% of the state’s vaccine inventory had been used, 

reported in March. At the same time, some states had only used 30% to 50% of their doses. West Virginia continued to outpace other states that month.

West Virginia had delivered its vaccine supply to 250 pharmacies; most of the pharmacies were small, independent stores; chain stores such as CVS and Walgreens aren’t common in the state, according to 

West Virginia was successful because many of its long-term care sites already were partnered with local pharmacies for vaccines and other medicines, in addition to regu- lar COVID-19 testing for residents and staff. The state leveraged those exist- ing partnerships, which helped West Virginia get “an early jump on most other states,” said Krista Capehart, PharmD, BCACP, director of profes- sional and regulatory affairs for the state’s board of pharmacy and chief architect of its COVID-19 vaccination distribution plan, in an interview with 

“The big picture is that this experi- ence [with COVID-19 vaccines] elevated the importance of pharmacy leaders in primary care in our communities,” Tolle said.“ A leader in a state allowed the independent pharmacists to step up....This is a great case model for how to do [vaccines] well.”			 				 

Although COVID-19 safety measures helped squash the number of influenza cases last season, pharmacists are revving up vaccination programs and testing.

Flu Season is Approaching, but Experts Don't Know What to Expect 

The number of independent pharmacies continued its decline in 2019, to 21,683 stores, according to the 2020 National Community Pharmacists Association’s Digest report.

® reported in July 2019 that there were 23,106 independent pharmacies in 2011, a number that fell to 21,909 in 2017.

Of course, there are efforts around the country by independent pharmacists—often orchestrated by the Community Pharmacy Enhanced Services Network—to provide services that not only affect the communities they serve but generate the revenue needed to support their businesses. However, it is an independent pharmacy’s relationship with a wholesale distributor that is pivotal to its success. Stacy Ramirez, PharmD, a clinical assistant professor at Oregon State University College of Pharmacy in Corvallis, explained that although the cost of drugs is part of the equation, many wholesale distributors also offer pharmacy software and inventory services, and facilitate arrangements with payers.

“If you get it wrong, it’s not just about switching to another wholesale distributor; it’s about switching your entire operation. That’s where the challenge is,” said Ramirez, who also serves as director of pharmacy at Community Health Centers of Benton and Linn Counties in Oregon. “You’d have to be really dissatisfied to take that step. If you’re a new independent pharmacist, you have invested a certain amount of time and capital into that decision. It makes it difficult to walk away,” she said.

It is an independent pharmacy’s relationship with a wholesale distributor that is pivotal to its success. 

Choosing a Wholesale Distributor

Warfarin, a lifesaving medication, is commonly used to treat blood clots and reduce their occurrence, thus preventing heart attack, stroke, or other serious conditions such as deep vein thrombosis in the legs or a pulmonary embolism in the arteries of the lungs.

Warfarin is a derivative of a naturally occurring substance originally discovered in 1940 as a compound in moldy hay.

 In 1948, the substance was marketed as rat poison. Because of its high degree of acute oral toxicity, warfarin is in the FDA’s Toxicity Category I, the most serious such designation.

Elizabeth Isaac, PharmD, a medication safety pharmacist at UMass Memorial Medical Center in Worcester, Massachusetts, said safe disposal of warfarin requires pharmacists to contract with a biomedical waste vendor. Patients taking warfarin are advised to go on birth control as warfarin can interfere with fetal development.

 It is also important for women who are pregnant or breastfeeding and men who want to become fathers to take precautions when handling this substance, Isaac added.

Pharmacists are busy but focusing on pharmacy waste must be a priority, said Isaac. “[For one thing] we know that pharmaceutical waste, if not disposed of correctly, can end up in our drinking water….The [Environmental Protection Agency (EPA)] has come out with guidance about not allowing pharmaceutical waste into our water supply,” she said.

 They’re classified as an antineoplastic drug, along with cytotoxic and oncology drugs. Working with these substances during pregnancy could impact a woman’s chance of miscarriage or having a child with a birth defect.

. This substance is formulated in low concentrations in shampoo to treat head lice and is only applied for brief periods of time. It’s highly toxic to humans, which means it has to be kept out of drinking water.

. Although the drugs inside inhalers aren’t considered hazardous, they are stored in compressed gas; this means they could be combustible.

, depending on the state where you practice. This substance was reevaluated by the Environmental Protection Agency in January 2020 for removal as hazardous, but not all states have adopted this change.

 showed that pharmaceuticals in treated wastewater released into streams and other bodies may affect fish. The pharmaceuticals included in the study were hydrocodone, methadone, oxycodone, tramadol, methocarbamol, fluoxetine, paroxetine, venlafaxine, and temazepam.

Isaac said pharmacists should work with waste management vendors and their colleagues in hospital-based environmental health and safety departments for guidance on appropriate disposal of drugs.

She also has some practical advice: Creating open and clearly labeled containers to capture pharmaceutical waste is a must. “You need to make it as easy as possible [for employees] to do the right thing.”

Understand the Relevant Federal and State Agencies

Chris Smith, RPh, director of product strategy for provider solutions at Inmar Intelligence, a Winston-Salem, North Carolina-based technology and data analytics services provider, observes that there are numerous federal and state agencies engaged in regulating pharmaceutical drugs.

Specifically, he recommends that pharmacists learn how the various drug lists published by the Resource Conservation and Recovery Act, the United States Pharmacopeial Convention (USP) USP 800, and the National Institute for Occupational Safety and Health (NIOSH) may affect their pharmacies.

“It’s super-important to understand the various lists of drugs because the EPA list is different from the USP 800 list. Additionally, NIOSH, [a] subsidiary of the CDC, has undergone extensive changes to their list and [has] published a new draft list in 2020 that is up for approval now.”

The implications of these changes are numerous, including additions and removals of various active product ingredients and their classifications, said Smith. NIOSH recently communicated that modifications to its list should be approved in 2021, he added.

Keep Track of Medication Expiration Dates

 showed that a form of tetracycline, an antibiotic that can be used to treat acne and skin infections, caused renal tubular acidosis when outdated. However, some researchers disputed4 this finding. Other medications lose their potency over time. Examples include oral nitroglycerin, insulin, anticonvulsant, warfarin, digoxin, thyroid preparations, and oral contraceptives.

 certain expired medications can succumb to bacterial growth, whereas antibiotics that have lost their potency may be unsuccessful in treating infections, which can result in more serious illness and antibiotic resistance.

Most medications expire when they get to approximately 90% effectiveness, said Timothy Burkart, PharmD, an assistant professor of clinical practice in pharmacy at the University of Findlay in Findlay, Ohio. After that, the chemicals start to break down and the medications become less stable.

Managing medication expiration dates is often done manually, explained Burkart. That means an intern pharmacist or a pharmacy technician will each be responsible for their own section of the pharmacy where they are tracking expiration dates. Once a month, they’ll look at the medications’ expiration dates and pull to the front medications that will expire after a year. An easy way to manage expiring medications is to flag them by marking the label with a bright dot, he said. Medications that are due to expire within a year should be pulled off the shelves and disposed of appropriately, advised Burkart.

Stephen Eckel, PharmD, MHA, associate dean for global engagement and associate professor at UNC Eshelman School of Pharmacy in Chapel Hill, North Carolina, said that although pharmacy interns and technicians can do this work, it is ultimately the pharmacist’s responsibility.

There are costs associated with having these medications incinerated, which is something pharmacy leaders should know, added Eckel. Expired medications are less likely to be an issue at retail pharmacies, where less inventory is kept on hand. By contrast, it is much more time-consuming and an ongoing process at hospital pharmacies where inventory is higher, he explained.

Isaac said hospital pharmacists should sustain relationships with team members in the environmental health and safety department who work closely with waste management vendors. It is just as important to work collaboratively with nurse managers throughout the hospital about proper medication disposal, she added.

Expired or unused medications can have a negative impact on the environment and their communities. For example, unused opioid medications that are not disposed of appropriately can be diverted and exacerbate the nation’s opioid crisis, said Burkart. Burkart has helped organize Drug Take Back Days, where members of the public can safely and easily turn in prescription drugs.

Overdose death accounts reached more than 86,000 people for the 12-month period that ended in July 2020, 

 Nora Voklow, MD, director of the National Institute on Drug Abuse, told 

, “2020 has by far the highest number of [overdose] deaths.”

Pharmacists can participate in National Prescription Drug Take Back Day, which occurs on April 24 this year. They can also plan events with local law enforcement, said Burkart.

Partnering with local law enforcement is a must because opioids are regulated by the United States Drug Enforcement Administration, among other federal and local agencies, he explained. “There are special rules about how you get rid of these drugs. They have to be taken out of circulation from the general population.”

Typically, opioid medications are destroyed through incineration at locations—sometimes old steel mills—at high temperatures. Filters are used to manage the release of smoke, which prevents the smoke from leaking into the environment, Burkart explained.

Smith advises pharmacists to conduct a thorough assessment of the pharmacy through the lens of regulatory compliance, employee and patient safety, and public safety. Also helpful is building a plan for handling exposures, spills, or other potentially harmful incidents; the plan should inform policies that deter abuse and diversion, he added.

Pharmacists must provide training for staff and patients, said Smith. Staff members need to know what to do if an incident occurs. Equally important, patients need to know about safe medication disposal techniques; advertising Drug Take Back Days helps, as does providing a drug take-back kiosk at the pharmacy, he said.

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 Published online December 14, 2017. doi:10.1038/nrcardio.2017.172

2. Mayo Clinic. Warfarin (Oral Route). IBM Micromedex. Updated February 1, 2021. Accessed March 4, 2021.

https://www.mayoclinic.org/drugs-supplements/warfarin-oral-route/precautions/drg-20070945

3. Understanding how pharmaceuticals in the environment affect fish. News release. U.S. Geological Survey. November 13, 2015. Accessed March 4, 2021. 

https://www.usgs.gov/news/understanding-how-pharmaceuticals-environment-affect-fish

4. Gross JM. Fanconi syndrome (adult type) developing secondary to the ingestion of outdated tetracycline. 

. 1963;58:523-528.
doi:10.7326/0003-4819-58-3-523

5. Drug expiration dates — do they mean anything? Harvard Health Publishing. Updated August 9, 2020. Accessed March 4, 2021. 

https://www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything

6. Shapiro M. The truth about expired meds. AARP. December 15, 2015. Accessed March 4, 2021. https://www.aarp.org/health/drugs-supplements/info-2015/expired-medication.html 

7. Don’t be tempted to use expired medicines. FDA. Updated February 8, 2021. Accessed March 4, 2021. 

https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines

8. Facher L. The ‘other’ epidemic: amid Covid-19, addiction experts fear Biden could back-burner the overdose crisis. 

https://www.statnews.com/2021/03/02/addiction-overdose-crisis-covid-biden-backburner/

9. Environmental Protection Agency. § 261.33. 40 CFR Ch. I (7–1–19 Edition). 2019. Accessed March 8, 2021. https://www.govinfo.gov/content/pkg/CFR-2019-title40-vol28/pdf/CFR-2019-title40-vol28-sec261-33.pdf

Pharmacists can take steps to ensure safe disposal of unused or expired medications.

Reducing Pharmaceutical Waste in the Store

Minh Dang, RPh, was in high school working as a cashier at an Osco Drug in a suburb of Boston, Massachusetts, in the late 1980s. A friendly kid who loved math and science, she wasn’t sure what career to pursue. One day, the store’s pharmacy manager pulled her aside and asked, “What do you think about a career in pharmacy?”

She was 16 or 17 years old at the time. Although there were doctors and nurses in her family, there wasn’t a single pharmacist. Dang now looks at that conversation as a pivotal point in her life.

Dang credits her success in the pharmacy profession today to the skills she learned working with patients early in her career. For example, during an internship at a pharmacy in Boston, she encountered a patient who insisted on speaking with a pharmacist instead of her. Dang calmly explained that she was the pharmacist, which confused him. Most pharmacists at the time were white men and she doesn’t remember knowing any Asian American women pharmacists at the time, she said. But Dang took the conversation in stride.

She asked how she could help, and that simple question persuaded the patient to open up to her. Dang’s advice for handling tense conversations with patients? “Be professional and kind and caring. They will convert.”

Since 2013, Dang has served as assistant dean for experiential education and professor of practice for clinical sciences at the School of Pharmacy and Health Sciences at Keck Graduate Institute in Claremont, California. This is a full-circle moment in her career because it’s now her mission to inspire students and connect them with real-world work experiences in pharmacy.

Women Are In the Majority, But Leadership Roles Lag

Dang is one of 5 women pharmacists featured in this story. Unlike her experience with the pharmacy manager at Osco Drug, most of the women featured had a role model in a relative who was a pharmacist. Some attributes shared by all of these women: an early passion and affinity for math and science and a desire to help people.

According to the American Pharmacists Association (APhA), 67% of its members are women. And the industry can look forward to welcoming many more women into its ranks in the future: As of fall 2019, 64% of pharmacy students were women, a metric that’s held steady for 20 years, according to Frank Fortin, CAE, senior vice president for communications, marketing, and media relations at APhA.

Debra Parker, PharmD, dean and associate professor at the College of Pharmacy at University of Findlay in Findlay, Ohio, looks to the 1960s as a decade when things started to change for women in professional roles, including pharmacists. In 1964, the Civil Rights Act was passed. The law made it illegal for most employers to discriminate against women in decisions about hiring and promotions; creating a work environment that’s hostile based on sex and sexual harassment was also rendered illegal. That was preceded in 1963 by the passage of the Equal Pay Act, which made it illegal to pay women a lower wage than their male colleagues when the decision is based on their sex.

That’s when you started to see women become more prevalent in many fields, said Parker, who noted that women represented only 15% to 16% of pharmacists in the mid-1960s. Although women will likely continue to form the majority of the pharmacist workforce, she said there are more men in leadership roles in pharmacy.

First Female Pharmacy School Dean in Ohio

In 2000, there were 82 pharmacy schools in the United States.

 Fifteen percent of them were led by a female dean, according to Parker. As of October 2020, there were 143 pharmacy schools

, 25% of which have a female dean, she said. That’s at odds with the number of pharmacy school graduates and women working as pharmacists.

The statistics about the percentage of women leading pharmacy schools were “startling” to Parker, she said. Parker is the only female dean among the 7 pharmacy schools in Ohio. She’s also the first female pharmacy school dean in the state. Although her counterparts at Ohio’s other pharmacy schools are all men, 2 of them have recently stepped down from their roles as dean and women have taken on those roles on an interim basis.

Parker didn’t have her sights set on a leadership role in academia. That said, she embraces the “lean in” approach, which, for her, means she doesn’t turn away from opportunities because she’s a mother. Instead, Parker focuses on how to make it work. She also credits her extremely supportive spouse.

While serving as a faculty member and an academic chair at the College of Pharmacy at University of Findlay, Parker was asked to take on the role of interim dean. “That was a little bit scary for me,” she said. “I had never aspired to being a dean, but I also felt that I knew the operations of our program and our university well enough that I could hold down the fort.”

But after serving on an interim basis starting in August 2014, she said to herself: “Why are you selling yourself short here? [You] can do this job.” She applied for it and was named dean in April 2015.

 published in a student newspaper at Findlay University after she was named dean, Parker stressed that the pharmacy program’s “family focus” is a distinguishing factor; it also makes her “confident and comfortable” in her role as dean.

Joy Vreeland, PharmD, BCPS, director of inpatient pharmacy at Boston Medical Center, had an uncle who was a pharmacist. That inspired her decision to work as a tech at CVS Pharmacy during her senior year of high school.

“I got a little taste of what retail pharmacy looks like,” she said. “The techs were wonderful. I had a lot of customer interaction. I thought, ‘This seems like it would be a good fit for my long-term interests.’”

During Women’s History Month, we celebrate the achievements of women in pharmacy practice. 