Gender-Affirming Hormone Therapy Background

As pharmacists, we have the opportunity to experience a vast variety of patients with different cultures, social factors, and histories. In our education and practice, we have been trained to understand the science and mechanisms behind medication therapy, but our role in patient care is far-reaching reaching and extends beyond understanding complex medication regimens.

Gender-affirming hormone therapy, or GAHT, is a medically necessary treatment for many of our patients who are seeking to align their physical characteristics with their gender identity. However, access to compassionate and affirming care continues to be uneven throughout the population and healthcare system. For example, transgender individuals are often denied insurance coverage for GAHT treatment as well as experience significant barriers in access to quality healthcare.¹  In our role, we have the unique ability to help fill these gaps by supporting our patients through our pharmacological knowledge, understanding the experiences of our transgender and nonbinary patients, and most importantly, creating respectful and safe environments for all of our patients.

Throughout this post, we will examine the fundamentals of GAHT. This will include necessary distinctions between definitions used, common GAHT regimens, and how to best support your patients during an often very exciting and potentially nerve-wracking time in their transition journey.

Foundations of Gender-Affirming Hormone Therapy

Definitions

One of the first steps in understanding our patients who are seeking GAHT is to be able to distinguish the definitions used in this landscape and to use them properly. Proper use of language is essential in fostering a respectful and safe environment for our transgender and nonbinary patients. The following definition list is not comprehensive; however, a basic level of understanding of these concepts will go a long way.

Gender Identity and Related Terms

Gender-affirming hormone therapy is a pharmacological method for aligning a person’s physical characteristics with that of their gender identity and is supported by major medical organizations such as the Endocrine Society. The goal of therapy for GAHT is very individualized. Generally speaking, the goals of GAHT are to promote physical changes that align with the patient’s affirmed gender, reduction of gender dysphoria, and improve psychological well-being. The foundation of GAHT is routed in informed consent and with an emphasis on autonomy and shared decision-making between patients and medical professionals.¹

Types of Therapy

Gender-affirming hormone therapy is characterized by feminizing and masculinizing therapy. Feminizing therapy utilizes the use of estrogen and also often includes anti-androgens such as spironolactone, which promotes physical changes that are characteristically female. Some of these characteristics include breast development, redistribution of body fat, reduced body and facial hair, reduction in muscle mass, and many others. Masculinizing therapy utilizes testosterone to promote physical changes that are characteristically male. Examples of these characteristics include facial and body hair growth, increased muscle mass, voice deepening, and many others.¹

What Should Patients Expect with GAHT?

An important counseling point for patients who are beginning GAHT is the fact that the physical changes associated with the therapy often take months to years for maximal effect. For example, a transgender man who begins testosterone therapy may not see changes in their vocal pitch for 3-12 months, with the full effect around 1-2 years.¹ Of course, every patient is different, but it is incredibly important that as pharmacists we are realistic with our patients about the timeline of physical changes so our patients can be better prepared.   

Pharmacological Agents & Mechanisms

The following information describes the standard treatments for GAHT:

Feminizing Therapy

• Estrogen
  • Mechanism of action: binds to estrogen receptors which alters gene expression that drives feminizing effects, exerts negative feedback on the hypothalamus-pituitary-gonadal (HPG) axis resulting in decreased testosterone production, and competes with testosterone at receptor sites
  • Dosage forms and dosing: oral, transdermal patches and gel, parenteral
  • Dose adjustments: titrated to targeted 17-beta-estradiol levels of 100-200 pg/mL
  • Contraindications: cardiovascular disease, severe liver dysfunction, breast cancer, and VTE

• Spironolactone (anti-androgen)
  • Mechanism of action: a mineralocorticoid receptor antagonist that is a competitive inhibitor of testosterone at the androgen receptor and an inhibitor of testosterone biosynthesis
  • Dosing: 100-300 mg by mouth once daily
  • Considerations:
    • Often used in conjunction with estrogen therapy in transgender women due to further androgen suppression
    • Requires blood pressure and electrolyte monitoring

• Gonadotropin releasing hormone (GnRH) agonists
  • Mechanism of action: downregulation of GnRH receptors which suppresses gonadotropin hormone release and ultimately results in decrease in endogenous sex hormones
  • Dosing:
    • Leuprolide: 3.75-7.5 mg IM depot monthly or 11.25 mg IM depot every 3 months
    • Goserelin: 3.6 mg subQ implant monthly
  • Considerations:
    • Historically was second-line therapy due to cost, however they are becoming more popular
    • Very expensive, especially goserelin, and often not covered by insurance in the US²

Masculinizing Therapy

• Testosterone
  • Mechanism of action: binds to androgen receptors which alters gene expression that drives masculinizing effects and exerts negative feedback on the hypothalamus-pituitary-gonadal (HPG) axis resulting in decreased estrogen production
  • Dosage forms and dosing: transdermal and parenteral
  • Dose adjustments: dosing is titrated to a physiologically male serum testosterone level of 320-1000 ng/dL³

Cultural Competence, Affirming Practice, & Key Takeaways

Pharmacology aside, providing gender-affirming care extends far beyond understanding complex treatment regimens and requires a strong understanding of cultural competence. Cultural competence is the ability for someone to recognize and be able to respond to diverse values, needs, and values of individual people. In the setting of GAHT, this involves acknowledging previous healthcare experiences, not making assumptions, avoiding bias, and doing our best to tailor treatments to the patient’s experience.

A key component in delivering quality gender-affirming care is through respectful and effective communication with your patient. Ensure that you are using correct names and pronouns, and sincerely apologize if you made a mistake. Avoid assumptions about the purpose or goals of therapy, and ask open-ended questions when possible.⁴

Ultimately, as pharmacists, we have the opportunity to experience a vast variety of patients with differing cultures, social factors, and histories, and we play an important role in delivering quality and compassionate gender-affirming hormone therapy. We are often the ones who dispense a person’s first course of GAHT, so it is important that we not only know the pharmacology of the medications but also foster an environment of mutual respect and safety.

Emily Heutmaker, APPE Student

References

1. Hembree, W. C., Cohen-Kettenis, P. T., Gooren, L., Hannema, S. E., Meyer, W. J., Murad, M. H., Rosenthal, S. M., Safer, J. D., Tangpricha, V., & T’Sjoen, G. G. (2017). Endocrine treatment of gender-dysphoric/gender-incongruent persons: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism, 102(11), 3869–3903. https://doi.org/10.1210/jc.2017-01658
2. Deutsch, M. B. (2025). Transgender women: Evaluation and management. UpToDate. Wolters Kluwer. Available from https://www.uptodate.com/contents/transgender-women-evaluation-and-management
3. Safer, J. D. (2025). Transgender men: Evaluation and management. In J. E. Arbo (Ed.), UpToDate. Wolters Kluwer. Available from https://www.uptodate.com/contents/transgender-men-evaluation-and-management
4. Bass B, Nagy H. (2023). Cultural Competence in the Care of LGBTQ Patients. In: StatPearls. StatPearls Publishing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK563176/

Tobacco Background

The use of tobacco products, including electronic cigarettes (vapes/e-cigarettes), remains the leading cause of death and preventable diseases in the US. Smoking tobacco leads to many diseases including lung disease, cardiovascular disease, and many types of cancer. The smoking of combustible tobacco forms such as cigarettes, are responsible for the most tobacco-related diseases and deaths in the US.¹ Nicotine replacement therapy (NRT) is considered a first-line therapy for smoking cessation and nicotine dependence. NRT is often combined with other first-line agents such as varenicline and bupropion; however, NRT can also be used alone.³ Due to the prevalence, potential for disease burden, and difficulty in ceasing tobacco use, proper NRT pharmacotherapy is crucial for successful cessation. 

Adults who use tobacco products often have difficulties quitting due to dependence on the main addictive component of cigarettes: nicotine. Nicotine is an alkaloid that is produced in tobacco plants and can also be chemically synthesized as an additive in e-cigarettes and smokeless tobacco products. When nicotine is consumed, it diffuses into tissues and selectively binds to nicotinic cholinergic receptors that are located throughout the body. The binding of nicotine to these receptors ultimately results in a dopamine release, among other neurotransmitters, stimulating the reward pathway within the limbic system, which produces pleasure, stimulation, and mood modulation.

Long-term use tobacco products create nicotine dependence and quitting “cold turkey” can cause intense withdrawal symptoms such as increased urges, irritation, restlessness, difficulty concentrating, insomnia, increased appetite, anxiety, and depression among others. Because of this, the choice of therapy selection is crucial in increasing the chance of success in smoking cessation.²

NRT Pharmacotherapy Overview

As discussed above, the proper use of NRT greatly increases the likelihood for patient success in smoking cessation. There are many different dosage forms for NRT and choosing the one most suitable for individual patients is crucial for successful treatment. The following information examines the variety of treatment options available that can be tailored to patients based on their characteristics.

Goal of therapy: to minimize and relieve nicotine withdrawal symptoms through the use of nicotine without the use of tobacco or e-cigarettes.

Therapy Selection:

• Tailored to patient preference, accounting for contraindications and comorbidities
• Combination NRT: consists of the use of a long-acting agent (patch) and a short acting agent (lozenge, gum, nasal spray, etc.)

Nicotine Patches:

• Initial dose selection: based on how many cigarettes are smoked daily
  • >10 cigarettes/day: 21mg/day for 6 weeks (step 1), THEN 14 mg/day for 2 weeks (step 2), THEN 7 mg/day for 2 weeks (step 3)
  • ≤10 cigarettes/day: 14 mg/day for 6 weeks (step 2), THEN 7 mg/day for 2 weeks (step 3)
• Administration: remove backing and apply one patch to clean, dry, and hairless site on skin on the upper body in the morning
  • Remove the old patch prior to applicaon of a new one
  • Rotate administration sites to avoid skin irritation
• Dose titration: can increase to higher dose if experiencing withdrawal symptoms or decrease dose if experiencing side effects
• Dosage form related side effects: skin irritation, insomnia, vivid dreams
• Dose tapering: patches are marketed to be tapered over 12 weeks; however, dosing customization can be conducted with best clinical judgement

Nicotine Lozenges:

• Initial dose selection: based on how soon after waking the first cigarette is smoked and is used as needed for cravings
  • <30 minutes: begin with 4 mg lozenges
  • ≥30 minutes: begin with 2 mg lozenges
• Administration: place in mouth between gums and cheek, let dissolve over 30 minutes. Do not chew
  • Avoid acidic beverages (eg. carbonated drinks, coffee, etc.) before and during lozenge use as this reduces nicotine absorptionDo not eat or drink 15 minutes before using gum or when lozenge is in use
  • Minimize swallowing while dissolving, occasionally switch lozenge side to side in mouth
• Patient specific factors: may be better suited for patients with dentures, poor dentition, or temporomandibular joint (TMJ) disease as compared to gum formulations
• Dose titration: can increase to higher dose if still experiencing withdrawal symptoms
  • For best initial results, use at least 9 lozenges per day
• Dosage form related side effects: mouth ulcers or irritation
• Dose tapering: reduce number of lozenges used daily gradually over 6 weeks

Nicotine Gum:

• Initial dose selection: based on how soon after waking the first cigarette is smoked and is used as needed for cravings
  • <30 minutes: begin with 4 mg gum
  • ≥30 minutes: begin with 2 mg gum
• Administration: “Chew and park” – chew the gum until nicotine can be tasted (tingling sensation) then “park” gum in the side of the cheek until the taste goes away. Chew the gum again to release more nicotine. Repeat steps for 30 minutes, then spit gum out
  • Avoid acidic beverages (eg. carbonated drinks, coffee, etc.) before and during gum use as this reduces nicotine absorption
  • Do not eat or drink 15 minutes before using gum or when gum is in use
• Patient specific factors: may exacerbate TMJ, damage and/or adhere to dentures and other dental appliances
• Dose titration: can increase to higher dose if still experiencing withdrawal symptoms
  • For best initial results, use at least 9 pieces of gum per day
• Dosage form related side effects: sore jaw, mouth ulcers or irritation
  • Side effects of excess nicotine release due to over-chewing: constipation, headaches, hiccups, nausea, vomiting, abdominal pain, etc.
• Dose tapering: Use as needed and gradually reduce pieces chewed daily over 6 weeks for a minimum duration of treatment of 3 months  

Nicotine Nasal Spray

• Initial dose: 1 to 2 doses per hour, adjusted based on patient response
  • 1 dose is 1 spray per nostril (2 sprays total)
• Administration:
  • Prime pump before first use or if bottle has not been used for ≥24 hours
    • Pump bottle until fine mist appears (6-8 times usually)
    Blow nose prior to administrationSlightly tip head back, insert tip into nostril, breath through mouth and spray once into each nostrilDuring administration: do not swallow, sniff, or inhale through noseWait to blow nose until at least 2-3 minutes following administration
  • Avoid contact with mouth, eyes, and skin
• Dose titration: can increase up 5 doses per hour (10 sprays) with a maximum of 40 doses per day (80 sprays) based on patient response
  • For best initial results, use at least 8 doses (16 sprays) per day
• Dosage form related side effects: throat and nasal irritation (extremely common and limits tolerability), sneezing, tearing, and rhinitis
• Dose tapering/duration: Use beyond 6 months is not recommended, gradually reduce number of daily doses of 4-6 weeks

Duration of Therapy

As opposed to other treatments, NRT does not have a concrete recommendation for treatment duration and is very patient specific. Apart from the nasal spray, NRT can continue indefinitely as the use of NRT is safer than continued smoking. Ideally as NRT progresses, the dosage of the long-acting formulation (patch) is decreased and the dosage and frequency or short-acting formulations are gradually reduced as tolerated until NRT is no longer needed.

Key Takeaways & Tips for Success

Ensuring the appropriate initial doses of NRT is crucial in cessation success as well as proper administration techniques. Choosing the initial dose of long-acting patches based on the number of cigarettes smoked daily as well as the dosage of short-acting agents such as gum or lozenges based on first daily cigarette timing is very important in initiating proper NRT. Similarly, ensuring the patient uses enough short-acting NRT, such as a minimum of 9 pieces of gum daily, can drastically increase their chance of successfully quitting smoking.

Tobacco related complications are the leading cause of preventable disease and deaths in the US.¹ There are many potential pharmacological options for smoking cessation, with NRT being the first-line treatment.³ NRT can be tailored for individual patients for maximum efficacy and have been proven to aid in smoking cessation when initiated properly.

Emily Heutmaker, APPE Student

References

1. Centers for Disease Control and Prevention. (2024). Tobacco product use among adults — United States, 2022: 2022 National Health Interview Survey (NHIS) highlights (Publication No. OSH-NCIS-2024). U.S. Department of Health and Human Services. Available from https://www.cdc.gov/tobacco/media/pdfs/2024/09/cdc-osh-ncis-data-report-508.  
2. Sandhu A, Hosseini SA, Saadabadi A. (2023) Nicotine Replacement Therapy. In: StatPearls. StatPearls Publishing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK493148/
3. Rigotti, N. A. (2025). Pharmacotherapy for smoking cessation in adults. UpToDate. Wolters Kluwer. Available from https://www.uptodate.com/contents/pharmacotherapy-for-smoking-cessation-in-adults
4. UpToDate. (2025). Nicotine replacement therapy products: Drug information. Wolters Kluwer. Available from https://www.uptodate.com/contents/pharmacotherapy-for-smoking-cessation-in-adults

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For years, debates have swirled on whether aluminum-containing childhood vaccines could be linked to chronic health conditions such as allergies, autoimmune diseases, and neurodevelopmental disorders. Fueled by social media and misinformation, these concerns have persisted despite reassurance from scientists that vaccines are safe.

A massive Danish study was published on July 15, 2025 in the Annals of Internal Medicine that delivers some of the strongest evidence yet: aluminum in vaccines is not associated with chronic diseases in children.

Aluminum in Vaccines

Aluminum is not just for soda cans. It has been used in vaccines for generations. Aluminum salts, such as aluminum hydroxide and aluminum phosphate, are used as adjuvants in vaccines. Adjuvants work by improving the body’s ability to mount an immune response, thereby increasing vaccine potency. This enhanced immune response means reduced frequency of vaccinations and lower doses of antigen to achieve protection. As an adjuvant, aluminum is thought to bind vaccine antigen with great affinity resulting in the recruitment of immune cells to the injection site. Aluminum salts are used in a variety of vaccines including human papillomavirus (HPV), diphtheria, tetanus, and pertussis (DTap), haemophilus influenza type B (HIB), pneumococcus conjugates (PCV), and others.

Aluminum salts were first used as vaccine adjuvants in the 1920s. Despite their long history of safe use, some people remain concerned about a possible link between aluminum and chronic conditions. Regular ingestion of aluminum through food and water is generally considered safe. However, aluminum can be toxic when introduced in large quantities. At toxic levels, aluminum can interfere with physiologic processes, have neurotoxic effects, and deposit in bone and brain tissues. Aluminum in vaccines is given in small quantities far below toxic thresholds.

Vaccine Misinformation

Misinformation surrounding vaccines continues to circulate despite scientific evidence of safety and efficacy. In an age of social media, “fake news”, and politicalization of healthcare, misinformation surrounding vaccines spreads quickly resulting in negative impacts on health care. Misinformation can induce fear, influence health decisions, and lead to the distrust of healthcare experts. This is especially true among parents who are trying to make the safest choices for their children. Refusal of vaccinations puts patients at an increased risk for acquiring illnesses and creates a risk to public health.

Previous studies have also fueled fears about the safety of aluminum in vaccines. A study published in 2011 by the Journal of Inorganic Biochemistry concluded that aluminum from vaccines was linked to autism spectrum disorder. The study described aluminum as a neurotoxin and immune stimulator that has the potential to induce neuroimmune disorders. The World Health Organization’s Global Advisory Committee on Vaccine Safety (GACVS) later concluded the study was seriously flawed. They noted inappropriate study design, utilization of incorrect assumptions, and the use of questionable data.

New Evidence from Denmark

Public concern regarding a possible link between aluminum-containing vaccines and chronic conditions have persisted through the years. Moreover, robust studies on the safety of aluminum-containing vaccines are lacking. Researchers at Statens Serum Institute in Denmark set out to determine if there was a link between aluminum exposure from childhood vaccines and a variety of neurodevelopmental disorders, autoimmune disorders, and atopic or allergic conditions. Published on July 15, 2025, “Aluminum-Absorbed Vaccines and Chronic Diseases in Childhood: A Nationwide Cohort Study” examined data from over 1.2 million children and found no evidence that aluminum exposure increases the risk of chronic conditions.

This cohort study was conducted in Denmark between 1997 and 2020 utilizing Danish healthcare registries. The participants included 1,224,176 children born between 1997 and 2018. The study assessed the impact of cumulative aluminum exposure from early childhood vaccinations on 50 health conditions. Participants were analyzed for health conditions starting at age 2. They were followed though age 5, death, loss to follow-up, or until December 2020 (completion of the study). The intervention was assessed as cumulative aluminum exposure in 1 mg increments to account for variations in vaccines given per child, introduction of new vaccines, and changing vaccination recommendations.

Some examples of the health conditions studied are listed below.

Results

The results of the study found no association between aluminum-containing childhood vaccines and an increased risk of chronic health conditions.

For combined outcomes groups, adjusted hazard ratios per 1 mg increase in aluminum exposure were as follows:

• Autoimmune disorders: HR =0.98 (95% CI, 0.94 to 1.02)
• Atopic or allergic disorders: HR = 0.99 (95% CI, 0.98 to 1.01)
• Neurodevelopmental disorders: HR = 0.93 (95% CI, 0.90 to 0.97)

For most outcomes, the upper limits of the 95% confidence intervals rule out relative risk increases greater than 10-30%. This suggests the risk of these outcomes is unlikely to be increased due to aluminum exposure.

Researchers ruled out even small risk increases for the majority of conditions studied. When conditions were analyzed individually, the upper limits of 95% confidence intervals ruled out relative increases higher than 10% for 19 conditions, 30% for 7 conditions, and 31-79% for 4 conditions. These 4 conditions had much lower incidence rates.             

The results of the study are consistent and reassuring, there is no increased risk of chronic childhood disorders associated with higher aluminum exposure.

Strengths and Limitations

This was a robust study with a large patient population of over one million children and spanning more than two decades. Additionally, utilizing patients from the general population reflects real world conditions.

The study had some limitations. Since data was collected from national registry data, researchers did not review individual medical records which may contain bias or discrepancies. The study was conducted in Denmark whose healthcare system is different than those of other countries. The Danish Health Authority provides recommended childhood vaccinations free of charge to Danish residents. Childhood vaccination rates are high. In 2023, childhood vaccination rates were 94-97% among children through age two.

Conclusion

Despite scientific evidence supporting vaccine safety, myths continue to spread suggesting vaccines or vaccine ingredients are dangerous. This misinformation fuels vaccine hesitancy, lowers vaccination rates, and increases risks to public health.

In an age of misinformation and viral social media posts, studies like this are essential. This study confirms what science, and doctors have known for decades: aluminum adjuvants are not linked to chronic diseases. This study provides a much-needed, real-world confirmation that aluminum-containing vaccines are safe. Having robust, scientific data available can help ease fears around the safety of vaccines.

Terese H., APPE Student

Resources

1. Niklas Worm Andersson, Ingrid Bech Svalgaard, Stine Skovbo Hoffmann, et al. Aluminum-Adsorbed Vaccines and Chronic Diseases in Childhood: A Nationwide Cohort Study. Ann Intern Med. [Epub 15 July 2025]. doi:10.7326/ANNALS-25-00997
2. Djurisic S, Jakobsen JC, Petersen SB, Kenfelt M, Klingenberg SL, Gluud C. Aluminium adjuvants used in vaccines. Cochrane Database Systematic Review. 2018 Jul 2;2018(7):CD013086. doi: 10.1002/14651858.CD013086. PMCID: PMC6373706.
3. Vaccine misinformation and social media. Burki, Talha. The Lancet Digital Health, Volume 1, Issue 6, e258 – e259
4. Tomljenovic L, Shaw CA. Do aluminum vaccine adjuvants contribute to the rising prevalence of autism? Journal of Inorganic Biochemistry. 2011 Nov;105(11):1489-99. doi: 10.1016/j.jinorgbio.2011.08.008. Epub 2011 Aug 23. PMID: 22099159
5. World Health Organization. Adjuvants. Global Advisory Committee on Vaccine Safety, World Health Organization, www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/adjuvants. Accessed 8/26/25.

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Background

Hypertension is a leading global health issue and a major modifiable risk factor for cardiovascular disease, stroke, and chronic kidney disease. Despite numerous treatment options, blood pressure control remains suboptimal in the United States. According to the Centers for Disease Control (CDC), high blood pressure contributed to 664,470 deaths in the United States in 2023. They also report that only about 22.5% of Americans with hypertension have their blood pressure under control. This is a staggering statistic considering nearly half of U.S. adults have high blood pressure.

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Why is Blood Pressure Control So Difficult?

Many patients struggle to manage their blood pressure due to several key barriers. Particularly, poor medication adherence and limited support between clinic visits are two of the biggest challenges. The American College of Cardiology (ACC)/American Heart Association (AHA) 2023 hypertension guidelines recommend regular home blood pressure monitoring along with frequent follow-up by a multidisciplinary team of healthcare providers. Home monitoring of blood pressure often falls flat if not done correctly or if it is not combined with health coaching and professional interventions. If patients aren’t being seen on a regular basis by healthcare professionals, they are not getting regular blood pressure interventions. In addition, overwhelmed healthcare providers may not have the time to properly adjust medications or offer meaningful education during brief clinic visits.

Enter Pharmacists

Optimal blood pressure management requires a multidisciplinary team and interprofessional collaboration. Pharmacists should be part of this team to improve medication adherence and provide patient education. Pharmacist-led interventions have been shown to make a positive impact on blood pressure control and the management of cardiovascular disease. This is because pharmacists understand antihypertensive medications and can help with adherence issues.

Can Pharmacist Intervention Really Help?

A meta-analysis published by Circulation: Cardiovascular Quality and Outcomes in 2024 looked at interventions made by various healthcare providers and their impact on blood pressure lowering. The study wanted to determine which healthcare providers were most effective at making interventions to reduce blood pressure in patients with hypertension. The meta-analysis included 100 articles reporting 116 comparisons and included 90,474 patients. The study assessed the mean net change in systolic and diastolic blood pressure between baseline and follow-up.

The greatest reductions in systolic and diastolic blood pressure were seen with pharmacist-led interventions.

The study concluded that pharmacists are effective at titrating medications, providing medication support, and educating patients. Pharmacists boost patient compliance by identifying and resolving adherence issues and adverse effects, which are major reasons why patients don’t take their medications.

The authors of the study emphasized that team-based care consistently outperforms physician-only care. A team-based approach is most efficacious at lowering blood pressure when someone other than the physician can optimize medications. Physicians often don’t have time during short clinic visits to provide education and titrate medications. A team that includes pharmacists, nurses, and other providers in hypertension management yields stronger blood pressure reductions and better overall control. All healthcare professionals can take on some of the responsibilities in managing blood pressure while supporting and supplementing the care of physicians.

Need More Evidence?

In 2024, Scientific Reports published a systematic review and meta-analysis of randomized controlled trials looking at whether remote follow-up by pharmacists was effective at reducing blood pressure in patients with hypertension. Pharmacist-led remote monitoring combined patient self-monitoring with pharmacist follow-up through telephone, text, internet communication, and other telemonitoring tools.

The meta-analysis included 13 studies and 3969 participants located in seven countries. The study compared an intervention group to a control group. The intervention period varied between studies and ranged from 8 weeks to 12 months.

Combined data from the 13 studies showed that remote follow-up by pharmacists improved systolic blood pressure in patients with hypertension as compared to those who underwent usual care.

• The mean difference in systolic blood pressure between the intervention and control groups was −7.35 mmHg (95% Confidence Interval [CI] − 9.10 to − 5.59 mmHg, P < 0.0001).

Subgroup analysis was performed comparing systolic blood pressure reduction in patients who had regularly scheduled follow-up to those who had as needed follow-up. The results show that regular follow-up is an important factor in reducing systolic blood pressure.

• Mean difference in systolic blood pressure between intervention and control groups:
  • Regularly scheduled follow-up: −8.89 mmHg (95% CI − 10.11 to − 7.66 mmHg, P < 0.0001)
  • As needed follow-up: −3.23 mmHg (95% CI − 5.72 to − 0.74 mmHg, P = 0.01)

Additional subgroup analysis compared groups where pharmacists reported follow-up information to physicians versus pharmacist-only follow-up. Interestingly, this analysis showed that pharmacists can independently achieve significant outcomes.

• Mean difference in systolic blood pressure between intervention and control groups:
  • Physician communication group: −6.56 mmHg (95% CI −8.84 to −4.28 mmHg, P < 0.0001)
  • Pharmacist only group: −8.96 mmHg (95% CI −11.50 to −6.42 mmHg, P < 0.0001)

This study shows the importance of regular follow-up in blood pressure control. Successful follow-up can be done remotely allowing fewer in-person clinic visits. This is more convenient for patients. Utilizing pharmacists for follow-up is effective at reducing systolic blood pressure and alleviates physician workload.

Why does it Matter?

When it comes to hypertension, even small blood pressure reductions translate to a reduction in cardiovascular risk. The evidence is clear, pharmacist-led interventions, whether in-person or remote, significantly improve blood pressure outcomes. It leads to enhanced medication adherence and reduced cardiovascular risk. Pharmacists are trained, accessible, and positioned within the community to offer consistent, high-quality care. With the right support and regular follow-up, controlling blood pressure is possible.

Terese H., APPE Student

References

1. Matsumoto N, Nakai T, Sakakibara M, Aimiya Y, Sugiura S, Lee JK, Yamada S, Mizuno T. Remote follow-up by pharmacists for blood pressure control in patients with hypertension: a systematic review and a meta-analysis of randomized controlled trials. Scientific Reports. 2024 Jan 30;14(1):2535. doi: 10.1038/s41598-024-52894-8. PMID: 38291114; PMCID: PMC10827741.
2. Mills KT, O’Connell SS, Pan M, Obst KM, He H, He J. Role of Health Care Professionals in the Success of Blood Pressure Control Interventions in Patients With Hypertension: A Meta-Analysis. Circulation: Cardiovascular Quality Outcomes. 2024 Aug;17(8):e010396. doi: 10.1161/CIRCOUTCOMES.123.010396. Epub 2024 Jul 19. PMID: 39027934; PMCID: PMC11338746.
3. Jones, Daniel W., et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Hypertension, 14 Aug. 2025, Online ahead of print, American Heart Association, doi:10.1161/HYP.0000000000000249. Accessed 27 Aug. 2025.
4. Centers for Disease Control and Prevention. High Blood Pressure Facts. 28 Jan. 2025, www.cdc.gov/high‑blood‑pressure/data‑research/facts‑stats/index.html. Accessed 27 Aug. 2025.
5. Waszyk-Nowaczyk M, Jasińska-Stroschein M, Dymek J, Drozd M, Sierpniowska O, Stankiewicz A, Jędra A, Banach M, Gierlotka M, Jankowski P, Windak A, Osadnik T, Tomasik T, Wolf J, Guzenda W, Stryczyński Ł, Jóźwiak J. The Critical Role of Community Pharmacists in Blood Pressure Monitoring. Medical Science Monitoring. 2024 Aug 15;30:e944657. doi: 10.12659/MSM.944657. PMID: 39143725; PMCID: PMC11334671.

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Pharmacists are essential in ensuring safe and effective medication use, playing a critical role in antimicrobial stewardship. Antimicrobial stewardship involves the appropriate use of antibiotics to effectively treat infections while minimizing harm from incorrect or unnecessary antibiotic use. When antibiotics are misused, patients face risks such as allergic reaction or disruption of their natural microbiome without any clinical benefit. When used appropriately, antibiotics can cure bacterial infections, speed-up recovery, limit the spread of disease, and even save lives. Inappropriate antibiotic use fuels antibiotic resistance. Antibiotic resistance is a means by which bacteria evolve mechanisms to survive treatments that would normally kill them or prevent their growth. As a result, infections become harder to treat, leading to longer illness and greater risk of death. The spread of antibiotic-resistant organisms poses a serious threat to public health. This is where pharmacists can step in and help reduce the emergence of antibiotic resistance.

Pharmacist-led antimicrobial stewardship interventions improve antibiotic use, enhance patient outcomes, and reduce healthcare costs. By promoting and implementing current clinical guidelines, pharmacists can make evidence-based antimicrobial decisions and educate providers and patients about responsible antibiotic use.

Infectious Diseases Society of America (ISDA) is an association of physicians, scientists, pharmacists, and other healthcare providers who are experts in infectious disease. They promote patient care, education, and research in the area of infectious disease. IDSA recently published 2025 practice guidelines for the treatment and management of complicated urinary tract infections. Pharmacists should actively apply these guidelines to ensure patients receive the most effective and appropriate care for these infections.

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Background

In 2010, IDSA published International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. These guidelines focused on uncomplicated urinary tract infections and pyelonephritis in healthy women who were premenopausal, not pregnant, and with no structural or functional urologic abnormalities. The 2010 guidelines did not address urinary tract infections (UTI) in men or complicated urinary tract infections.

On July 17, 2025, IDSA released guidelines for the treatment of complicated UTI: Clinical Practice Guideline by Infectious Diseases Society of America (IDSA): 2025 Guideline on Management and Treatment of Complicated Urinary Tract Infections. These guidelines address the management and treatment of complicated urinary tract infections in both men and women for the first time. By broadening recommendations, the guidelines better reflect real-world practice and fill gaps in UTI management.

New Classifications

The 2025 guidelines lay out new classifications of uncomplicated and complicated UTI for both men and women.

Empiric Antibiotic Selection

Complicated UTIs often involve resistant pathogens or have systemic involvement, making appropriate empiric antibiotic selection crucial. Pharmacists play a key role in the selection of empiric therapies by ensuring coverage of the most likely pathogens and verifying the selection is suitable for the patient. Pharmacist interventions can improve time to optimal therapy by initiating empiric treatment in a timely manner.

The 2025 IDSA guidelines utilize a stepwise approach to selecting empiric antibiotic therapies for complicated UTI. These steps determine which antibiotics are appropriate based on presentation and patient-specific factors.

• Step 1: Determine the severity of illness – Is the patient septic or not?
• Step 2: Determine patient risk factors for resistant pathogens – Consider the patient’s prior antibiotic exposure and any recent resistant urine cultures.
• Step 3: Determine patient-specific factors for adverse effects – Consider drug-drug interactions, contraindications, and allergies.
• Step 4: If septic, utilize local antibiogram if relevant to the patient – Is the patient similar to the patient population utilized in the creation of the antibiogram?

Using this approach, pharmacists and clinicians can select appropriate initial therapies. IDSA guidelines prioritize antibiotic selection based on whether or not the patient is septic. Sepsis is the body’s extreme response to an infection. Patients with sepsis may present with fever and elevated heart rate, respiratory rate, and white blood cell count.

Some patients can be managed in the outpatient setting using oral antibiotics.

Definitive Antibiotic Therapy

Pharmacists can contribute to antimicrobial stewardship by optimizing the de-escalation of antibiotic therapies from broad-spectrum antibiotics to more targeted therapies. This reduces the patient’s exposure to broad-spectrum antibiotics, leading to fewer adverse effects and helps curb antibiotic resistance. Pharmacists should verify that definitive therapy is appropriate for the patient and is effective against the infectious organism.

In complicated urinary tract infection, IDSA guidelines recommend de-escalating antibiotic therapies once identification and susceptibilities are available from urine cultures.

IV to Oral Transition

In patients with complicated UTI, it may be favorable to transition IV antibiotics to oral. IV antibiotics require additional time and resources that oral antibiotics don’t. IV antibiotics require intravenous access which may result in IV-related complications and patient discomfort. Administration of IV antibiotics requires longer hospital stays, additional nursing resources, and greater healthcare costs. Oral antibiotics are more convenient for healthcare providers and for most patients.

2025 IDSA guidelines for complicated UTI recommend switching from IV to oral antibiotics once the following criteria are met:

• The patient is showing clinical improvement
• The patient is able to take medications by mouth
• An effective oral antibiotic is available

Pharmacists can help identify patients who are eligible to switch from IV to oral, ensure proper drug selection, and verify equivalent dosing. They can also educate patients, which has been shown to improve adherence.

Duration of Therapy

Treating infections for the proper length of time is another way pharmacists can be good antimicrobial stewards. Antibiotics should be used for the shortest effective duration. Research has shown that infections are often treated longer than necessary which can promote the development of drug-resistant organisms. Longer durations of therapy are more inconvenient to patients and increase the risk of adverse effects. Pharmacists should monitor for appropriate durations of therapy and adjust therapies that are too long. In addition to reducing antibiotic use, reduced duration leads to shorter hospital length of stay and reduced costs.

2025 IDSA guidelines recommend that in patients with complicated UTI, duration of therapy is based on whether or not the patient is clinically improving.

If patients are not clinically improving, it is important to do the following:

• Ensure the antibiotic covers the organism
• Assess for additional sources of infection
• Look for differential diagnoses
• Plan for a longer duration of therapy

There are exceptions that may require longer durations of therapy. For instance, men with acute bacterial prostatitis may benefit from a treatment duration of 10-14 days.

Conclusion

The 2025 complicated UTI guidelines create a framework for treating infections while optimizing antibiotic use. The four-step approach to antibiotic selection, emphasis on de-escalation, and shorter duration of therapy enforce the importance of patient care while promoting antimicrobial stewardship.

Pharmacists can take an active role in healthcare by advocating for the use of current guidelines and ensuring appropriate antibiotic use. With their knowledge of medications and antimicrobial stewardship, pharmacists are essential to optimizing patient care and antibiotic use.

Terese H., APPE Student

Resources

1. Infectious Diseases Society of America. Complicated Urinary Tract Infections (cUTI): Clinical Guidelines for Treatment and Management. Published 17 July 2025, Infectious Diseases Society of America, https://www.idsociety.org/practice-guideline/complicated-urinary-tract-infections/. Accessed 8/25/26.
2. Infectious Diseases Society of America. Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update. Infectious Diseases Society of America, 1 Mar. 2011, https://www.idsociety.org/practice-guideline/uncomplicated-cystitis-and-pyelonephritis-uti/. Accessed 8/25/26.
3. Centers for Disease Control and Prevention. Antibiotic Use and Stewardship in the United States, 2024 Update: Progress and Opportunities. National Center for Emerging and Zoonotic Infectious Diseases, 20 Nov. 2024, https://www.cdc.gov/antibiotic-use/hcp/data-research/stewardship-report.html Accessed 8/25/26.
4. World Health Organization. Antimicrobial Stewardship Interventions: A Practical Guide. World Health Organization, 2021.
5. Dighriri IM, Alnomci BA, Aljahdali MM, Althagafi HS, Almatrafi RM, Altwairqi WG, Almagati AA, Shunaymir AM, Haidarah GA, Alanzi MH, Hadadi AA, Suwaydi HM, Aqdi MJ, Alharthi HN, Alshahrani AF. The Role of Clinical Pharmacists in Antimicrobial Stewardship Programs (ASPs): A Systematic Review. Cureus. 2023 Dec 8;15(12):e50151.
6. Infectious Diseases Society of America. “About Us.” Infectious Diseases Society of America, www.idsociety.org/about-us/#:~:text=We’re%20committed%20to%3A,infectious%20diseases%20content%20and%20expertise. Accessed 27 Aug. 2025.
7. Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. PMID: 26903338; PMCID: PMC4968574.

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What is Genitourinary Syndrome of Menopause?

Genitourinary syndrome of menopause (GSM) describes a group of symptoms and physical changes that affect the genital, urinary, and sexual health of women during peri- and post-menopause. GSM is thought to affect over half of all women who are postmenopausal. However, it often goes underdiagnosed and undertreated. Women may find it difficult to discuss symptoms of GSM with their healthcare providers. To complicate matters, symptoms of GSM look like those of other genitourinary conditions which may lead to misdiagnoses and delays in treatment.

GSM is a chronic and progressive condition that affects the lower urinary tract, vagina, and vulva. During perimenopause and after menopause, there are declining levels of estrogen and androgen in the genitourinary tract. This hormonal shift leads to physical changes and atrophy of vaginal, valvular, bladder, and urethral tissues. Physical changes and symptoms often reduce quality of life. Symptoms of GSM are progressive and worsen if left untreated.

During menopause, the ovaries stop producing estradiol. This results in a 95% decline in estradiol, a form of estrogen. Estrogen plays a key role in maintaining the elasticity, moisture, and blood flow of the tissues of the vagina, vulva, bladder, and urethra. A decline in estrogen leads to vaginal and urogenital atrophy. Vaginal secretions and lubrication are also reduced leading to vulvovaginal dryness and painful intercourse.

Estrogen also maintains a healthy, balanced, vaginal flora. It supports the growth of lactobacilli, which creates an acidic environment that protects the vagina and urinary tract from infections. When estrogen levels fall, lactobacilli decrease, vaginal pH rises, and the risk of infection increases.

While GSM is often associated with natural menopause, it is important to note that other conditions can also lower estrogen levels. Surgical menopause or oophorectomy, chemotherapy, primary ovarian insufficiency, and hypothalamic amenorrhea can contribute to decreased hormone levels and onset of GSM symptoms.

Quality of Life

GSM does not just affect the body. It can take a toll on a person’s emotional, psychological, and social well-being. It can lead to depression, anxiety, lowered self-esteem, and negatively impact personal relationships. Often, patients don’t seek help because they think their symptoms are a natural part of aging or they feel too embarrassed to talk to their provider.

Sexual symptoms of GSM like dyspareunia (painful intercourse) and decreased libido (sexual desire) often cause people to avoid intimacy out of frustration or embarrassment. As a result, their partners can feel rejected or confused, putting strain on the relationship.

Physical changes to the genital area such as vaginal dryness or loss of elasticity, may result in women having a poor body image or lowered self-esteem. They may feel ashamed about their body or feel they are losing their womanhood.

Urinary symptoms may cause emotional and social distress. Urgency or incontinence in public can lead to embarrassment or avoidance of social situations. Women may avoid exercise for fear of leakage.

2025 Guidelines

The term genitourinary syndrome of menopause was first used in 2014. However, since that time, there has been little guidance on how to define or diagnose it. In 2025, the American Urological Association released formal GSM guidelines titled Genitourinary Syndrome of Menopause: AUA/SUFU/AUGS Guideline (2025). These guidelines aim to improve quality of life for patients with GSM while optimizing symptom control. The guidelines provide information to healthcare providers on the identification and diagnosis of GSM. The guidelines also discuss how to counsel patients and provide treatment options for GSM.

“One of the most rewarding parts of my clinical practice has been helping patients improve their quality of life by addressing symptoms of GSM. Through scientific evidence and the application of shared decision making, this AUA guideline will help clinicians educate, empower, and treat patients with GSM.”

– Dr. Una Lee, vice-chair of the GSM guidelines

The guidelines emphasize a patient-centered approach to treating GSM that focuses on shared decision-making between patient and provider. Providers should understand the patient’s treatment goals and preferences. Education on symptoms, diagnosis, and treatment options is paramount.

Diagnosis

Diagnosis of GSM encompasses a physical examination, collecting a thorough patient history, and a careful review of symptoms.

Patients should be screened for GSM symptoms. It is important for providers to lead the patient through a thorough screening of symptoms because patients may be reluctant to discuss symptoms or bring up symptoms on their own. Providers should reassure patients that symptoms are common. Providers should understand which symptoms are most bothersome to the patient.

A focused history of GSM symptoms should be collected. It is important to understand when symptoms started, the severity of symptoms, and whether the symptoms affect the patient’s quality of life.

A pelvic exam helps confirm signs of GSM, such as tissue atrophy or physical changes. The physical exam should look for the presence of other conditions to ensure differential diagnoses are treated appropriately.

Treatment

Treatment for GSM should be tailored to the goals and preferences of individual patients. When discussing treatment options, providers should clearly explain both risks and benefits.

In the treatment of GSM, the use of natural or herbal supplements is not recommended. The FDA does not regulate these supplements. Their quality and formulations may be variable, making their effects and risks not generally predictable. In addition, there is little scientific data available to support the use of supplements.

Patients should be advised to avoid the use of soap or cleansers that may cause irritation and increase the symptoms of GSM.

Follow-up is essential. Providers should check in regularly to assess whether the treatment is working or if adjustments are needed. Since GSM is progressive, treatment may need to be modified over time.

Conclusion

Genitourinary syndrome of menopause is common, often distressing, and frequently underdiagnosed. By raising awareness and educating patients, providers can create a safe space for open discussion. This can lead to timely diagnosis, effective treatment, and an overall improvement in quality of life.

Terese H., APPE Student

Resources

1. Kaufman MR, Ackerman LA, Amin KA, et al. The AUA/SUFU/AUGS Guideline on Genitourinary Syndrome of Menopause. J Urol. 0(0). doi:10.1097/JU.0000000000004589. https://www.auajournals.org/doi/10.1097/JU.0000000000004589
2. American Urological Association. American Urological Association Releases New Guideline on Genitourinary Syndrome of Menopause. 28 Apr. 2025, American Urological Association, www.auanet.org/about-us/media-center/press-center/american-urological-association-releases-new-guideline-on-genitourinary-syndrome-of-menopause. Accessed 27 Aug. 2025.
3. Carlson K, Nguyen H. Genitourinary Syndrome of Menopause. [Updated 2024 Oct 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559297/