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February 7, 2023

Differentiating 7 Topical Antifungal Medicines – Pharmacist Consult

maximios / News /

Similarly to how different types of viruses can cause multiple different viral infections, there are many types of fungi that can cause different types of fungal infections. 

It is often a difficult task to determine which antifungal product may be the most appropriate to utilize for a specific situation. Although there are many different types of fungi that can cause infections, tinea infections are the fungal infections that are most treatable by non-prescription medicines. So, those infections are especially highlighted in this article. The purpose of this article is to aid in product selection once it is determined that a fungal infection may be present.

This article does not discuss how to identify if an infection of unknown cause may be of fungal origin. The following are examples of credible resources that may help to decide if experienced symptoms may point toward the direction of a fungal infection.

  • This resource from the Centers for Disease Control and Prevention (CDC) provides a quality introduction to fungal infections and their etiology
  • This resource from MedlinePlus (US National Library of Medicine) provides further background on diagnostics and signs and symptoms to be aware of
  • This resource from an academic medical center details tinea infections specifically
  • Your local pharmacist and physician are essential resources

Remember, for many minor fungal infections, it is appropriate to utilize an antifungal medicine that can be purchased over-the-counter at a pharmacy or online. But, for more serious fungal infections, it is recommended to see a physician to obtain a specific recommendation.

All OTC antifungal products discussed here are products that are applied topically to the skin and/or vaginal area. Topical OTC antifungal products tend to have similar indications, and they commonly can be substituted for one another. However, the list below describes popular topical OTC antifungal medicines and it provides an introduction on how to differentiate between products.

1. Clotrimazole

Clotrimazole is one of the most common topical antifungal medicines sold at pharmacies. Clotrimazole is commonly sold as a generic product, but it is also available under the brand names of Alevazol, Lotrimin AF, Gyne-Lotrimin, etc.  

Clotrimazole can be used to treat either skin-based or vaginal fungal infections. It is used to treat tinea corporis (ringworm), tinea cruris (fungal infection in the groin or buttocks area; often called “jock itch”), tinea pedis (fungal infection on the foot; often called “athlete’s foot”), or vulvovaginal candidiasis (vaginal fungal infection; often called a “yeast infection”). 

Clotrimazole is available as a skin cream, ointment, external liquid solution, and vaginal cream. Clotrimazole is very similar to miconazole, discussed below. Clotrimazole and miconazole fall into the same category of antifungals. 

2. Miconazole

Miconazole is another common antifungal agent, and it is available as a generic product and under many different brand names (Desenex, Micaderm, Monistat, etc). 

Miconazole is an antifungal drug of choice for vaginal yeast infections. It can also be used to treat ringworm, jock itch, or athlete’s foot. 

Miconazole is available as an aerosol, aerosol powder, skin cream, vaginal cream, ointment, powder, external liquid solution, and vaginal suppository. Creams and solutions for nonprescription antifungals are typically more effective than powders and aerosols. 

Miconazole is very similar to clotrimazole, discussed above. Thus, the effectiveness of miconazole is comparable to clotrimazole. Clotrimazole is utilized more commonly for skin infections and miconazole is utilized more commonly for vaginal infections, but both can be used for either purpose. 

Clotrimazole and miconazole are both used twice per day for up to 4 weeks. Both of these products can be used in individuals 2 years of age or older. 

FAST FACT: A frequently asked question relates to the difference between Monistat 1, Monistat 3, and Monistat 7. All three are vaginal miconazole products. Monistat 1 is a single-day, single-dose regimen with a miconazole dose of 1200 mg. Monistat 3 is a three-day, three-dose regimen that has a concentration of 200 mg per dose of miconazole. Monistat 7 is a low dose, seven-day, seven-dose regimen that contains an even lower concentration of miconazole (100 mg per dose). All regimens are noted to be equally effective, but it is recommended to ask a local pharmacist about which regimen may be most appropriate for a specific individual. 

3. Tolnaftate

Tolnaftate is commonly sold as a generic product, but it is an antifungal medicine also available under brand names such as Fungi-Guard, Tinactin, Tinaspore, etc.

Whereas the other medicines prior mentioned have been noted to be used for treatment, tolnaftate can be used for both prevention and treatment of athlete’s foot. It can also be used for the treatment of ringworm and jock itch. 

Tolnaftate is available as an aerosol, aerosol powder, cream, powder, and external liquid solution. Creams and solutions for nonprescription antifungals are typically more effective than powders and aerosols. Tolnaftate is used twice per day for up to 4 weeks. Tolnaftate can be used in individuals 2 years of age or older. 

However, there is little evidence that prioritizes its use over clotrimazole or miconazole. Clotrimazole, for example, is noted to be a newer medicine that is slightly more effective than tolnaftate. 

4. Butenafine 

Butenafine is an antifungal medicine with common brand names of Lotrimin Ultra and Mentax, although it is often sold as a generic product. 

Butenafine is used for skin-based fungal infections. It is used to treat ringworm, jock itch, or athlete’s foot. Butenafine is available as an external cream.

Butenafine and terbinafine fall into slightly different antifungal medicine categories, but they are similar and largely interchangeable for most purposes. More about their relationship is described below. 

5. Terbinafine

Terbinafine is an antifungal medicine with the common brand names of Lamisil Advanced and Lamisil AT. 

Terbinafine is also used for skin-based fungal infections. It is used to treat ringworm, jock itch, or athlete’s foot. Terbinafine is available as a cream, gel, and external liquid solution. 

Both butenafine and terbinafine may be preferable options compared to clotrimazole, miconazole, and tolnaftate for athlete’s foot specifically. Butenafine and terbinafine are often more expensive than clotrimazole or miconazole. If cost is an issue (namely for the treatment of athlete’s foot), a switch to clotrimazole or miconazole is appropriate. However, their effectiveness is comparable to clotrimazole and miconazole regarding ringworm and jock itch.

For athlete’s foot primarily on the sides and bottoms of the feet, the creme is the preferred formulation for both butenafine and terbinafine. Butenafine and terbinafine are used 1-2 times daily for up to 4 weeks. Both of these products can be used in individuals aged 12 years or older. 

6. Undecylenic acid

Undeclylenic acid is an antifungal medicine commonly sold under its generic name, but it is also sold under the brand names Fungi-Nail, Myco Nail A, etc. Undecylenic acid is also used for skin-based fungal infections.

Undecylenic acid is available as a gel, external liquid solution, ointment, spray, and solution. Although it can be used for ringworm or jock itch, undecylenic acid is commonly used around the nail cuticles and/or the skin around the nails to prevent fungal growth. It may also be used to treat athlete’s foot. It is applied twice daily for 4 weeks, and the minimum age for use is 2 years. 

7. Ketoconazole 

Ketoconazole is available in many different dosage forms, but the OTC version of ketoconazole is a shampoo sold under the brand name Nizoral A-D. 

Nizoral A-D is a medicine that is used to help control dandruff. Ketoconazole is a potent antifungal agent, but other dosage forms of ketoconazole require the advice and direction of a physician. Nizoral A-D can be applied every 3-4 days for up to 8 weeks.

Resources:

  1. Fungal Diseases. Centers for Disease Control and Prevention (CDC). Last updated 19 March 2020. Accessed 28 March 2020. 
  2. Ely JW, Rosenfeld S, Seabury Stone M. Diagnosis and Management of Tinea Infections. Am Fam Physician. 2014 Nov 15;90(10):702-711.
  3. Crawford F, Hollis S. Topical treatments for fungal infections of the skin and nails of the foot. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001434.
  4. Weinstein A, Berman B. Topical Treatment of Common Superficial Tinea Infections. Am Fam Physician. 2002 May 15;65(10):2095-2103.
  5. Hart R, Bell-Syer SE, Crawford F, Torgerson DJ, Young P, Russell I. Systematic review of topical treatments for fungal infections of the skin and nails of the feet. BMJ. 1999;319(7202):79–82. doi:10.1136/bmj.319.7202.79
  6. McKeny PT, Zito PM. Antifungal Antibiotics. [Updated 2020 Feb 14]. In: StatPearls [Internet].Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538168/
December 1, 2022

Breaking the Stigma of HIV/AIDS – Pharmacist Consult

maximios / News /

Stigma is defined as “a mark of disgrace associated with a particular circumstance, quality, or person”. More specifically, “social stigma” refers to the disapproval of, or discrimination against, a person based on perceivable characteristics that distinguish them from the rest of society.

Some common examples of innate traits that are associated with stigma include race, age, gender identity, sexual orientation, and age. In addition to these traits, stigma is also prevalent in people with various health conditions. While there are many conditions that can have stigma attached to them (such as mental illness, substance use disorders, diabetes, etc.), one of the most heavily stigmatized conditions over the course of many decades has been Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS). HIV is the virus that, if left untreated, can lead to AIDS. AIDS is an assortment of syndromes and conditions.

It is reported that over 50% of people living in countries with available data have discriminatory attitudes towards those with HIV. The Centers for Disease Control and Prevention (CDC) describes the main components of HIV stigma as:

  1. Believing that only certain groups of people can get HIV
  2. Making moral judgements about people who take action to prevent transmission of HIV
  3. Feeling that those who get HIV are at fault due to their own life choices

Regardless, HIV stigma affects those living with HIV on an even wider scale than solely discriminatory remarks and judgements. Barriers to health care, isolation from family and friends, and difficulty finding employment or educational opportunities are all major consequences that can result from HIV stigma.

Health Outcomes in Stigmatized People with HIV

HIV stigma is present in many communities across the globe. However, it is not just harmful words and prejudices – HIV stigma can have significant effects on the health and well-being of individuals with HIV. A 2016 study showed higher rates of depression, lower levels of social support, lower levels of adherence to antiretroviral medications, and lower access to and usage of health and social services amongst patients who reported stigma from their diagnosis. Relationships were also observed between HIV-related stigma and anxiety, quality of life, physical health, emotional and mental distress, and sexual risk practices.

A different study from 2018 investigated health outcomes and stigma among a group of patients in an urban HIV clinic. The researchers found evidence of an association between reported stigma and viral non-suppression, which can lead to treatment failure and worsening of disease. Eventually, this could lead to development of AIDS-related illnesses. These are defined as illnesses caused by organisms such as parasites, fungi, and bacteria that can cause severe disease in people with HIV/AIDS due to having a weakened immune system. Poor cognitive and mental health outcomes found in the previously mentioned study were also discovered in addition to psychosocial measures such as level of physician trust and social support.

Both of the studies mentioned, as well as a handful of other studies, help illustrate the impact that HIV stigma has on people living with it. Hopefully these studies will also generate further investigation into the topic.

The question then becomes – how and why does stigma lead to such significant differences in health?

Unfortunately, the answer is not a simple resolution. There are many layers to this issue – the below diagram from Avert, an international HIV/AIDS advocacy group, summarizes the progression from diagnosis to detrimental outcome(s):

Image 1: How Stigma Leads to Sickness

As seen in Image 1, many factors play into not only the initial stigmatization (including race, gender identity, and sexuality), but also the effects of that stigmatization.

One of the most concerning and significant ways that stigma manifests is through our healthcare system and its providers. This is where pharmacists, and other healthcare professionals in general, need to ensure we understand our role in the perpetuation of these outcomes as well as ways to prevent them.

Prevalence of HIV Stigma in Healthcare

As healthcare providers in this country, it is highly important to be constantly aware of how our own implicit biases lead to real consequences for people with HIV. This is particularly important with HIV/AIDS given the complexity of the condition itself combined with the aforementioned worsening of health outcomes.

A 2016 review led by the CDC assessed healthcare providers’ likelihood of stigmatizing their patients with HIV by looking at 3 different criteria: attitudes/beliefs/behaviors, quality of care, and education/training. The researchers found that providers who underwent less HIV-stigma training were more likely to show stigmatizing behaviors. This training is becoming more standardized across the healthcare industry, but is still likely not as robust as it should be in order to appropriately meet patients’ needs.

Another study conducted in the southern United States in 2016 evaluated healthcare personnel’s attitudes towards HIV patients via a questionnaire. They discovered several specific factors that had a stronger correlation to HIV stigma than others did: Protestant religion, white race, and certain characteristics of the clinic (i.e., STD-treating vs non-STD-treating). The authors of the study suggested that healthcare institutions implement policies and procedures to prohibit discrimination specifically against HIV patients.

After better understanding the potential negative impacts our underlying biases/stigma toward patients with HIV can cause, we must then learn how to act upon them.

Ways to Help Reduce Stigma

The CDC’s Let’s Stop HIV Together campaign promotes many evidence-based and reasonable strategies to help reduce stigma against HIV patients. One primary component of stopping the stigma against HIV is by eliminating problematic language when we talk about people with HIV. The CDC has created a language guide for this, which is summarized below in Table 1.

Table 1: Correcting Problematic Language

The use of language is something that everyone can fully control on an individual level and it can make a positive impact on people with HIV.

There are also system-level changes that can occur which may also help alleviate stigma of HIV. Specific training/education for providers about HIV stigma, policies and procedures that can prohibit discrimination against HIV patients, and regular educational sessions about HIV (such as “Grand Rounds” presentations, topic discussions with students, staff development modules, etc.) could all be beneficial.

Overall, people living with HIV have significant stigma placed upon them from society. This can be related to innate traits such as race, gender identity, and sexuality. It can also equally be due to choice of employment (such as sex work) or sexual behavior. Ultimately, all forms of stigma against people with HIV have been shown to lead to poor health outcomes, particularly mental health-related. There is evidence to show stigma also affects overall disease progression.

It is crucial for healthcare professionals and non-healthcare professionals alike to understand the potential consequences of our unconscious biases and our uses of stigmatizing language. More importantly, it is crucial to act upon these realizations.

Education and awareness is only the first step in stopping HIV stigma – it is important to enact system-wide changes such as new and revised policies and procedures to truly make an impact for all patients.

Resources to Learn More

References:

  1. HIV Stigma and Discrimination. AVERT Global Information and Education on HIV and AIDS. Found at: https://www.avert.org/professionals/hiv-social-issues/stigma-discrimination. Last updated 10 October 2019. Accessed 9 April 2021.
  2. Ways to Stop HIV Stigma and Discrimination. Centers for Disease Control and Prevention’s Stop HIV Together Campaign website. Found at: https://www.cdc.gov/stophivtogether/hiv-stigma/. Last updated 2 February 2021. Accessed 9 April 2021.
  3. Standing Up to Stigma. HIV.gov website. Found at: Standing Up to Stigma | HIV.gov. Last updated 24 February 2020. Accessed 9 April 2021.
  4. JFS Stories that Matter, 2016. Ending the Mental Illness Stigma. [image] Available at: [Accessed 22 April 2021].
October 3, 2022

Opzelura: The New Treatment for Vitiligo – Pharmacist Consult

maximios / News /

Vitiligo is a skin condition characterized by patches of skin losing their pigmentation which results in having areas that are lighter than normal skin color. Melanocytes, or pigment producing cells, are attacked and destroyed which can leave white patches on the skin, mucous membranes, eyes, inner ears or hair. This condition is rare, affecting about one percent of the world’s population. Vitiligo may not affect the health directly, however, patients who have it may be affected psychologically as this is usually traumatic for them. 

Vitiligo typically starts on the hands, feet or face and becomes progressive throughout the body. It is thought that vitiligo is an autoimmune disorder since certain white blood cells can directly destroy the melanocytes and can be prone to other autoimmune diseases. Cause of vitiligo is unknown but it is believed that it is a hereditary condition. 

Although vitiligo cannot be controlled, there are ways to restore the skin’s color by restoring healthy melanocytes (repigmentation) to the skin to regain normal appearance. 

  • Prescription steroid creams and non-steroid anti-inflammatory creams (tacrolimus and pimecrolimus) are the safest and simplest most initial treatment. 
  • Psoralen & Ultra-Violet Light A light (PUVA) which is light treatment typically done in a physician’s office. 
  • Autologous skin grafts 
  • Lasers 

What is Opzelura? 

Opzelura (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for topical treatment of nonsegmental vitiligo in both adults and pediatric patients 12 years and older. Previously, Opzelura was first approved for short term treatment of mild to moderate atopic dermatitis, however, recently has gained approval for treatment of non segmental vitiligo. 

Opzelura works by inhibiting JAK1 and JAK2 which are responsible for mediating the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function and may have a role in producing vitiligo. However, the mechanism is not known. 

Patients who have received Opzelura have seen at least 75% improvement in their skin at 24 weeks. 

How is Opzelura taken? 

Opzelura comes in a 1.5% cream formulation and in either 60 or 100 gram tubes. A thin layer should be applied twice daily to affected areas. 

What are the side effects of Opzelura? 

For patients using for non segmental vitiligo adverse effects are: 

  • Application site acne, pruritus and erythema (redness)
  • Nasopharyngitis 
  • Headache 
  • Urinary tract infection
  • Pyrexia (fever)

What are the warnings and precautions of Opzelura? 

There is a black boxed warning for Opzelura for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. 

  • Serious infections may lead to hospitalization or death. Some reported infections are: active tuberculosis, invasive fungal infections, bacterial and viral infections. 
  • Mortality 
  • Malignancies, specifically lymphoma and other types of malignancies have been reported with JAK inhibitors. 
  • Major adverse cardiovascular events (MACE) with oral JAK inhibitors. 
  • Thrombosis and thromboembolic events were observed in Opzelura trials. Pulmonary embolism (PE), deep vein thrombosis (DVT), and arterial thrombosis have all been reported in patients receiving JAK inhibitors medications. 

Vitiligo can be a psychological detrimental disease for the patient, but being able to provide options for treatment is crucial. This might not be a cure for the disease but it can slow the progression and allow relief for patients suffering from this condition. 

Reference: 

  1. Opzelura. [package insert]. Wilmington, DE. Incyte, Inc. 2022
September 21, 2022

Azstarys: The New Treatment for ADHD? – Pharmacist Consult

maximios / News /

Attention-Deficit/Hyperactivity Disorder (ADHD) is one the most common neurodevelopmental disorders of childhood. According to the CDC, in 2016 about 6.1 million (9.4%) of children were diagnosed with ADHD. However, what is also interesting about this condition is that it not only affects children but also adults. About four to five percent of adults in the United States are actually diagnosed with ADHD, but there are many more that are undiagnosed and untreated. 

What are the signs and symptoms of children and adult ADHD? 

The signs and symptoms in children and adults might seem similar but can also differ at the same time. 

In children: 

In children it is best to note what they experience under both inattentiveness and hyperactivity and impulsivity, because many times ADHD may manifest as behavioral problems. 

Inattentiveness Hyperactivity and Impulsivity 
Having short attention span and easily distracted Being unable to sit still 
Appearing forgetful or losing things Constantly fidgeting
Being unable to stick to tasks that are tedious or time-consuming Being unable to concentrate on tasks
Appearing unable to listen to or carry out instructions  Excessive physical movement or talking
Constantly changing activity or tasks Not able to wait their turn
Having difficulty organizing tasks Acting without thinking 
Interrupting conversations
Little or no sense of danger 

In adolescents and adults: 

Signs and symptoms of adolescent and adult ADHD are slightly different from what children may experience. The following to look out for are: 

  • Impulsiveness 
  • Disorganizing and problems prioritizing 
  • Poor time management 
  • Problems focusing on tasks
  • Excessive activity or restlessness
  • Poor planning
  • Frequent mood swings
  • Problems following through and completing tasks
  • Troubles coping with stress 

How is ADHD treated? 

Usually if diagnosed in children and adolescents, behavioral therapy is one of the first steps in helping with the management of ADHD. However, sometimes behaviors become such a problem both at home and school and other people around them are affected by their disruptions, that medication is needed. 

There are two different types of ADHD medications, stimulants and non-stimulants. Stimulants are the most widely used. The benefits of these are they are fast-acting and 70-80% of children with ADHD have experienced fewer symptoms. The disadvantage is it can cause the patient to experience insomnia if taken too late during the day. Non-stimulant medications do not work as quickly as stimulants but their effects last up to 24 hours. The disadvantages that patients may experience are typically decreased appetite and sleep issues with these medications. 

What is Azstarys? 

Azstarys is a central nervous system (CNS) stimulant indicated for ADHD in patients 6 years and older. Approved in 2021, Azstarys contains both serdexmethylphenidate and dexmethylphenidate and this combination allows it to work in a different way than other stimulant medications. The dexmethylphenidate ingredient works by providing immediate release of the stimulant in the morning. Whereas, serdexmethylphenidate is a prodrug and needs to be metabolized in the body to its active form, dexmethylphenidate, in order for it to exert its effects and allows for extended release of the stimulant throughout the day. Therefore Azstarys provides both immediate release in the morning and continuous release throughout the day. 

How is Azstarys best taken? 

Unlike other stimulant ADHD medications, Azstarys is taken without regard to food, therefore it can be taken with breakfast in the morning. The starting dosage for patients aged 6 and up are 39.2mg/7.8mg and increased to the maximum dosage of 52.3mg/10.4mg or can be decreased to 26.1mg/5.2mg. Azstarys capsules should be swallowed whole or contents of capsules can be emptied and placed in applesauce. 

What are the side effects of Azstarys?

Just like other methylphenidate products, the most common adverse effects experienced are:

  • Appetite decrease
  • Insomnia 
  • Nausea and vomiting
  • Dyspepsia 
  • Abdominal pain
  • Weight decreased 
  • Anxiety 
  • Dizziness
  • Irritability 
  • Tachycardia
  • Increased Blood pressure 

What are contraindications and warnings/precautions? 

The contraindications of Azstarys are known hypersensitivity to sermethylphenidate, methylphenidate products and concurrent treatment with monoamine oxidase inhibitors (MAOI), or use of MAOI within preceding 14 days. 

Warnings and precautions of Azstarys are: 

  • Serious cardiovascular reactions
  • Blood pressure and heart rate increases 
  • Psychiatric adverse reactions
  • Priapism
  • Peripheral vasculopathy, including Raynaud’s Phenomenon
  • Long-term suppression of growth

It should be noted as well that Azstarys, just like other ADHD is considered a CII medication which means it does have a high potential for abuse and dependence. 

Reference: 

  1. Azstarys [package insert]. Grand Rapids,MI: Corium Inc.; 2021.
August 25, 2022

Inner Components of Tablets and Capsules – Inactive Ingredients – Pharmacist Consult

maximios / News /

When a baker prepares chocolate chip cookies, the main component of the cookies arguably are the chocolate chips. But, many other ingredients are needed to create the cookies – butter, eggs, flour, sugar, etc. 

In tablets and capsules, there’s a similar trend. There is an active ingredient, similar to chocolate chips found in chocolate chip cookies. The active ingredient refers to the part of the tablet or capsule that elicits pharmacologic activity. But, it would be impossible to form a pill without other ingredients also incorporated. These other inactive ingredients make it possible to form a pill and make it chemically stable. Inactive ingredients in medications are called excipients.  

Pharmacists are commonly asked about excipients contained within various medications. Patients taking a medication may be curious about its excipients. 

Excipients may vary from manufacturer to manufacturer for a certain medication. For example, the generic medication amlodipine besylate is produced by various generic manufacturers: Apotex, Cipla, Hebei Changshan, Lupin, Mylan, Strides Pharma, Watson Labs, etc. All of these manufacturers have the same chemical component of amlodipine besylate contained as the active ingredient in their tablets, but each manufacturer may have slightly different excipients within their tablets otherwise. Albeit being much more regulated for uniformity, this is similar to how different chocolate chip cookies can have slightly different recipes.

As excipients can vary from medicine to medicine and from manufacturer to manufacturer, some individuals are curious about excipients themselves. Some individuals may have an allergy or dietary restrictions related to certain excipients found in one medication, but not another. Some individuals may think that a certain manufacturer of a medication is more effective than another manufacturer even though the FDA views them to be equivalent products. Other individuals who analyze ingredients in various products may simply be curious about the role each excipient plays within the tablet or capsule. 

Listed below are common excipient categories, examples of ingredients within each category, and what they are used for. Various ingredients can serve multiple roles, and that is reflected in the list below. 

This discussion focuses specifically on tablets and capsules. Other excipients can be present for oral liquids, IV medications, creams, ointments, and gels. This list is not all inclusive. 

Binders

Binders can also be referred to as adhesives or granulating agents. Binders help all of the ingredients within a tablet, both active and inactive, stick together to form a viable pill and help it to remain stable over time. Binders also allow the active ingredient(s) within a medicine to release once ingested. This can be done with or without a disintegrant (discussed below).

Examples:

  • Gum acacia
  • Hydroxypropyl methylcellulose (HPMC)
  • Polyethylene glycol (PEG)
  • Povidone
  • Starch paste
  • Sucrose syrup, liquid glucose (caution in diabetes)

Coating

Coating layers, be it sugar-coating or film-coating, on the exterior portion of tablets and capsules prevent tablet/capsule degradation due to a number of possible environmental factors. These factors are most commonly light, oxygen, and moisture. Coatings can also be used to mask unpleasant tastes. 

Coatings can also be used to alter the timing of release, or medication activation, in the body. For example, if a physician wanted a medication to wait until arriving in the duodenum (small intestine) to begin working, an enteric-coated tablet could make this possible. An enteric-coated tablet primarily protects the core of the medicine against stomach acid. Without an enteric coating, a medication taken orally may begin to activate in the stomach. 

FAST FACT: if a medication has a suffix of “DR” or “EC”, it has an enteric coating. For example: aspirin EC, naproxen EC, omeprazole DR.

Examples:

  • Cellulose acetate phthalate
  • Gelatin (commonly pig-derived; should be avoided in anybody who wishes to avoid pork)
  • Gluten (should be used in caution for patients with celiac disease)
  • Gum acacia 
  • Hydroxypropyl methylcellulose (HPMC)
  • Polyethylene glycol (PEG)
  • Povidone
  • Shellac 
  • Sucrose (caution in diabetes)
  • Talc
  • Titanium dioxide

Diluents & Fillers

Diluents and fillers add size and volume to tablets and capsules to make them viable dosage forms. By themselves, active ingredients in many medications would be far too small to administer and dispense as a single component. By adding diluents and fillers, medications became possible to physically hold and work with. 

Examples:

  • Bentonite
  • Calcium salts
  • Cellulose products (various)
  • Corn starches, rice staches, wheat starches, etc (wheat-based starches should be avoided in individuals with celiac disease)
  • Gelatin (commonly pig-derived; should be avoided in anybody who wishes to avoid pork)
  • Lactose (should be used in caution in patients that are lactose intolerant)
  • Mannitol (should be used in caution in patients with intracranial hypertension)
  • Sorbitol (should be used in caution in patients with irritable bowel syndrome)

Disintegrants

After a tablet or capsule is swallowed, the body begins to digest the medication to allow it to exert its intended effect while concurrently breaking it down to excrete it out of the body. Disintegrants are ingredients within medications that help to control this release rate as a medication works its way and dissolves through the gastrointestinal tract. 

Some medications work by becoming active in a certain part of the body, and disintegrants help to control the release rate. This is a similar phenomenon to enteric-coated tablets and capsules, discussed above. For example, if a medication has an intended pharmacologic effect on a person’s large intestine, then the disintegrant would be one of the factors that would help to allow the medication to optimally become active within the large intestine specifically.

Examples:

  • AC-Di-Sol
  • Alginic acid
  • Amberlite
  • Cellulose products (various)
  • Compressible sugar 
  • Corn starches, rice starches, wheat starches (wheat-based starches should be avoided in individuals with celiac disease)
  • Explotab
  • Gelatin (commonly pig-derived; should be avoided in anybody who wishes to avoid pork)
  • Polacrilin potassium

Flavoring, Sweetening, and Coloring Agents

Medicines that dissolve in the mouth typically contain flavoring agents and/or sweetening agents. Occasionally, other oral medications may also incorporate these agents to improve palatability if the medicine has a poor taste. Additionally, medications may contain coloring agents for aesthetic purposes.

Coloring Agent Examples:

  • Caramel
  • D&C Red No. 3
  • Ferric oxide
  • Magnesium carbonate
  • Yellow No.6

Flavoring/Sweetener Examples:

  • Aspartame (sugar-free)
  • Dextrose
  • Glycerin
  • Lactose (should be used in caution for patients that are lactose intolerant)
  • Maltitol
  • Mannitol
  • Monk fruit extract 
  • Phenylalanine (should be used in caution in patients with phenylketonuria)
  • Saccharin (sugar-free)
  • Sorbitol (should be used in caution for patients with irritable bowel syndrome)
  • Stevia
  • Sucrose (caution in diabetes)
  • Xylitol (should not be ingested by dogs)

Lubricants

Lubricants are primarily used for the tablet and capsule creation process. Lubricants help keep ingredients from sticking to each other and to equipment during the manufacturing process. 

Examples:

  • Calcium
  • Glycerin
  • Magnesium stearate
  • Mineral oil 
  • Polyethylene glycol (PEG)
  • Talc

Example – Metformin 500 mg tablets: see below.

Metformin 500 mg tablets (Ascend Laboratories, LLC). Corresponding NDC codes: 67877-0561-01, 67877-0561-05, 67877-0561-10, 67877-0562-01. This is a medication commonly used to control blood sugar levels in individuals with type 2 diabetes mellitus. 

The active ingredient contained in this medication is metformin hydrochloride. The tablets also contain the following inactive ingredients:

  • Blackberry – flavoring agent
  • Corn starch – binder, filler
  • Hydroxypropyl methylcellulose 2910 – binder
  • Magnesium stearate – lubricant
  • Maltodextrin – filler 
  • Polyethylene glycol – binder/lubricant
  • Povidone K30 – granulating agent
  • Povidone K90 – granulating agent
  • Triacetin – humectant/plasticizer 

References:

August 14, 2022

Male Birth Control Pill? The New Way to Protect Against Pregnancy? – Pharmacist Consult

maximios / News /

Birth control. Typically when we hear these words we either think of condoms or hormonal medications that women use to prevent pregnancy. However when it comes to birth control, it seems as though there has always been an “unofficial” responsibility of women to be more in control of this than men. Methods such as male condoms, “pulling-out”, and vasectomies are the only ways that men commonly use to protect against unwanted pregnancy. Everything else such as, female condoms, spermicides and hormonal medications are mainly all used on women. However, there may be an option on the horizon for men to take on more responsibility in regards to birth control.

Source: https://www.invitra.com/en/birth-control-methods/ 

Although still in the early stages of animal trials, the compound YCT529 seems to be effective in lowering sperm count and is up to 99% effective in preventing pregnancy. The mechanism behind this novel compound is it targets a protein called retinoic-acid receptor alpha (RAR-ɑ) which is responsible for cell growth, differentiation (including  sperm formation) and embryonic development. Therefore, blocking or inhibiting this protein will make men sterile without any observable side effects. The interesting part about YCT529 is that within 4-6 weeks after taking the compound, mice in the trials can father pups again. Since this compound is not affecting testosterone or any other hormones at all, there are little to no side effects being seen. 

If this passes through the human trials set to begin at the end of 2022/early 2023, YCT529 can help to relieve the burden of females taking on most responsibilities of birth control and therefore leads to less women having to deal with the side effects produced by hormonal contraceptives. Once approved, it seems as though this compound will be good to take along with a form of barrier birth control such as condoms for the maximum protection against pregnancy. 

August 10, 2022

V-Go Insulin Patch: The Future of Insulin Delivery – Pharmacist Consult

maximios / News /

Insulin is an important hormone in the body because it is produced by the pancreas in order to allow cells to utilize sugar (glucose) molecules in the bloodstream for either energy or storage. However, what happens when the pancreas is not able to function properly? 

Diabetes is a condition that occurs when the pancreas either is nonfunctional (Type I diabetes) or partially functional (Type II diabetes) which leads to high amounts of glucose in the bloodstream. It is estimated that 37.3 million Americans (11.3%) of the population in 2019 had diabetes and out of that amount 8.5 million were undiagnosed. Diabetes is serious because it can further lead to complications of the heart, kidneys, eyes and even can cause amputations of feet as well. 

When it comes to treatment of diabetes, there is a slight difference when treating Type I versus Type II. For Type I, outside (exogenous) insulin is needed since the pancreas cannot produce insulin at all. For Type II, however, insulin may be needed depending on the severity of the patient’s hemoglobin A1C and blood glucose levels, otherwise noninsulin oral and injectable antidiabetic drugs are typically the staple of treating this form of diabetes. 

Insulin treatment typically comes in injection form, where the patients inject below the skin, or subcutaneously, and can either inject in the morning, bedtime or before meals depending on if it is a long-acting or fast acting insulin. In addition, patients, especially if they have Type I diabetes, might prefer continuous glucose monitors (CGM). CGMs basically work as both an insulin pump and glucose meter (glucometer). CGMs, such as Dexcom, both monitor glucose levels in the blood and depending on the readings will automatically inject insulin in order to bring the levels back to normal. Many of them will also have alarms alerting patients when their blood glucose is too low. Patients will still have to obtain a prescription for insulin to put in the monitors. Mainly the monitors are attached to the stomach where the insulin vials are injected in and then will go from the monitor into the stomach when needed. 

What is V-Go? 

V-Go is a disposable, wearable insulin delivery device that delivers continuous basal rate of insulin and also on demand mealtime insulin. However, the unique part about V-Go is that the delivery system is not your usual pump but a credit card-sized patch that adheres to the skin. The best part is that V-Go does not require batteries, infusion sets or programming done by a healthcare provider. 

Source: https://www.mdpi.com/2226-4787/8/4/215

How can V-Go be worn? 

This can be worn either on the stomach or on the back of the arm as long as there are no signs of irritation, infection or excess hair. The fast acting insulin will be administered with a touch of a button on the patch before meals to cover any blood glucose spikes that are experienced after meals. V-Go is to be worn day, night and during any condition. Therefore patients can shower and swim with it on as well. However, the only times it needs to be removed are during imaging tests, such as X-rays and MRIs, and also if going in a hot tub, sauna and jetted tubs. Also it should be worn under clothing and not be exposed to the sun. 

What insulin dosages can the V-Go administer? 

There are currently three versions: V-Go 20, V-Go 30 and V-Go 40 and each deliver a certain amount of units per 24 hours. 

  • V-Go 20 delivers 20 units of insulin per 24 hours
  • V-Go 30 delivers 30 units of insulin per 24 hours 
  • V-Go 40 delivers 40 units of insulin per 24 hours

V-Go 20 requires two vials of U-100 insulin per prescription and both V-Go 30 and V-Go 40 require three vials of insulin. Only fast-acting insulin approved for V-Go is Humalog (insulin lispro) and Novolog (insulin aspart). One push delivers two units of insulin and only up to 18 clicks (36 units) per day of bolus (as needed) insulin. Therefore after 18 clicks, the bolus delivery will pop out and lock to prevent future bolus deliveries for the day. 

What are the side effects and warnings associated with V-Go? 

The main side effects associated with V-Go are skin irritations that are mainly caused by the adhesive of the patches. Also infection or abscess may occur with the patch if skin is extra sensitive and at this point it is better to remove the patch and place it on a different area of the skin. Rotating areas each time a new patch is applied will prevent these side effects from occurring. 

As far as warnings are concerned, there is a risk of hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). This product would not be appropriate for patients who have to frequently change their long-acting and fast-acting insulin. Therefore while on V-Go it is advisable to monitor blood glucose levels at least two to three times a day and to watch out for signs of hypoglycemia, shaking, sweating and dizziness are typically experienced the most. 

All in all, the V-Go patch is a safe and effective way to control glucose levels in patients with uncontrollable diabetes. An insulin pump that is a patch is a very innovative way to deliver insulin and it may be convenient for patients who do not want to worry about batteries or having to see their physician to set their devices. There might also be less pain associated than with traditional insulin delivery when syringes and needles are used. Technology will continue to help advance medicine for many years to come. 

Reference: 

  1. Barbie Cervoni MS, R. D. (2021, August 25). Should you try V-go? an insulin pump patch for type 2 diabetes. Verywell Health. Retrieved April 2, 2022, from https://www.verywellhealth.com/what-is-an-insulin-patch-pump-1087254#toc-dosage  
  2. Lajara, R., Fetchick, D. A., Morris, T. L., & Nikkel, C. (2015). Use of V-GO® insulin delivery device in patients with sub-optimally controlled diabetes mellitus: A retrospective analysis from a large specialized diabetes system. Diabetes Therapy, 6(4), 531–545. https://doi.org/10.1007/s13300-015-0138-7 
  3. National Institutes of Health. (n.d.). VGODISPOSABLE insulin delivery. U.S. National Library of Medicine. Retrieved April 2, 2022, from https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=30610026-4fa7-45a1-96a5-41e9e1a278eb&type=display#S2P3-5
August 9, 2022

A Pharmacist’s Guide To Naloxone – Pharmacist Consult

maximios / News /

The opioid epidemic has been ravaging across the United States, leading to overdose deaths from prescription opioids, heroin, and more. In fact, the mortality rate quadrupled since 1999 with an average of 38 deaths each day from overdoses involving prescription opioids in 2019. To combat the epidemic, federal and state legislations have given more resources to health care professionals in the form of an important tool known as naloxone.

What is Narcan?

Naloxone, also known as Narcan®, is an opioid antagonist medication approved by the Food and Drug Administration (FDA) to rapidly reverse an opioid overdose. 

Naloxone works by binding highly to opioid receptors, displacing any opioids currently bound and reversing their effects. It is administered when a patient is showing signs of an opioid overdose such as unresponsiveness, very slow or abnormal breathing, limp body, pin-point sized pupils, and cold/clammy skin. Naloxone should be administered to anyone who is either presenting signs of or is suspected of an opioid overdose.

Source: Eastern Idaho Public Health

The onset of action is about 2-15 minutes after exposure. Naloxone is only active in the body for 30 to 90 minutes but the effects of most opioids last longer. This means that the effects of naloxone are likely to wear off before opioids are removed from the body, which can cause an overdose relapse and breathing to stop again. The CDC recommends more than one dose of naloxone may be needed to revive someone who is overdosing and to call 911 so the individual can receive immediate medical attention. To maintain stability, constant attention should be given for 2 hours after the last dose of naloxone is given to make sure breathing does not slow or stop. 

Although its effects do not last long, it is a life-saving medication that stabilizes the patient before emergency personnel arrives and from 1996 through June 2014, there have been more than 26,000 opioid overdose reversals in the United States.

Is naloxone safe? 

According to National Institute on Drug Abuse, “There is no evidence of significant adverse reactions to naloxone.” People who have a dependency on opioids may exhibit opioid withdrawal effects with naloxone including headaches, changes in blood pressure, rapid heart rate, sweating, nausea, vomiting, and tremors. It is rare to have side effects from naloxone but some people might have an allergic reaction. Naloxone reverses an overdose in people with opioids in their systems and will not reverse overdoses from other drugs like cocaine or methamphetamine.

There were about 50,000 people who died from an opioid-involved overdose in 2019 where a bystander was present in more than one in three overdoses involving opioids. Unintentional drug overdoses are a leading cause of preventable death but bystanders may not call for medical assistance out of fear of criminal charges. As a result, states have created “Good Samaritan” laws to create immunities and legal protections for people who call for help during an event of an overdose. These laws can have broad or comprehensive protection and some states have passed laws that consider providing and seeking medical help for a person as a mitigating factor during sentencing. 

A more detailed resource for each state’s Good Samaritan laws can be found on the Prescription Drug Abuse Policy System’s website. 

Most states have standing orders to allow pharmacists to fill prescriptions for naloxone. Naloxone has become widely used by emergency medical providers in all 50 states with pharmacists and other health professionals leading education and training. 

Source: National Institute on Drug Abuse

Overdose Education and Naloxone Distribution (OEND) has been shown to increase the reversal of potentially fatal overdoses. Studies have shown that pharmacist-provided training has reduced the opioid overdose death rates between 27 to 46 percent lower in communities where OEND was implemented.

Although naloxone has been critical in avoiding opioid overdose-related deaths, the amount of prescriptions filled as a preventive measure is severely lacking in comparison to the number of prescription opioids filled on average. This is mostly due to the stigma around naloxone and substance use disorders in general. Patients may be hesitant to get a prescription and it can often be difficult for pharmacists to recommend it. 

What is the best way to counsel patients on this medication?

The best way to combat this is to destigmatize the life-saving medication and educate pharmacists on how best to approach counseling and recommendations. 

An example conversation: 

Pharmacist: Good evening, I am the pharmacist that will be helping you today. I would like to talk to you about some of the prescriptions that your doctor has sent over to us. Along with your pain medication, your doctor has prescribed naloxone, also known as Narcan.. Have you had a chance to talk to your prescriber about what this medication is used for?

Patient: Yes, I do not remember exactly but I thought that is used for overdoses. I don’t know why he prescribed it to me, I take my medications when I am supposed to as needed. 

Pharmacist: It is true that Narcan is used to reverse a breathing emergency caused by effects from opioid pain medications. It is becoming more common for incidents of accidental overdoses of pain medications and it is important to have the right tools in emergency situations. Think of it as similar to an Epi-Pen or a fire extinguisher, you may never need to use it but it’s always a good idea to have it just in case. 

Patient: Okay, that makes sense.

Pharmacist: It is important to talk to a trusted family member that will be a bystander on how to administer naloxone. Opioid overdose can be abrupt and a bystander should watch out for the  common signs such as shortened or stopped breathing, pinpoint-sized pupils, cold/clammy skin, and unresponsiveness. 

Narcan should be administered into the nasal pathway with one spray into one or each nostril, depending on the device. The medicine will take effect within a few minutes after exposure and will last about 30-90 minutes. This will give the bystander enough time to call for medical assistance. But, keep in mind opioids last longer and there is a risk of relapse after the medicine wears off so that’s why there are two devices included.

Patient: Wow, that sounds scary.

Pharmacist: I hear your concern. We want you to stay safe and healthy and by being educated and aware of prescription medicine, we can achieve that! What are some of your expectations for this drug? 

Patient: That will help me if I am having an overdose, I feel like it is more important to have this than I thought of before. 

Pharmacist: That is correct, naloxone doesn’t have any adverse reactions besides the effects someone might feel after opioid withdrawal. These can include headaches, changes in blood pressure, rapid heart rate, sweating, and nausea. In rare cases, some people might have an allergic reaction that can include hives or swelling in the face, lips, or throat. If anything similar happens to you, let your doctor know right away. 

Patient: Okay, I understand.

Pharmacist: Also quick question, where do you think you will store the medication?

Patient: Would it be okay to carry in my purse?

Pharmacist: Yes, I would recommend having it near you for quick access and to let someone you trust about where you keep it too. Be careful about having moisture near prescription medicines, we want to keep them away from moisture as best as we can. 

Patient: Okay, I understand. 

Pharmacist: So I know we’ve reviewed a lot, but give me a quick summary of what we talked about so I can help further.

Patient: Well, naloxone is used to stop the effect of an opioid overdose. Signs I should watch for are cold skin, tiny pupils, and feeling shortness of breath. It should be administered into one or each nostril and I should call for help as there is a risk for relapse. I will make sure to share this with my family. 

Pharmacist: Perfect! Naloxone has some stigma and I would want you to feel comfortable. It is a preventive medicine, try to think of it as a fire extinguisher in your house, you may never use it but it’s always a good idea to have it just in case. 

If you have any questions, don’t be afraid to call the pharmacy. It was a pleasure to talk to you. 

End of example. 

Naloxone is covered by most insurances at no cost to the patient. The most common delivery system is the nasal spray. There are three versions of this medication:

Table 1: Different brands of naloxone:

Brand Narcan®  Evzio®  Generic naloxone atomizer 
Dosage Two 4 mg/0.1 mL nasal spray 2 mg/0.4mL Auto Injection 1 mg/mL
Administration Nasal spray Injection (Similar to Epi-pen) Nasal spray
Cost (Good Rx) About $130 About $140 About $50
Pros No specialized training Recorded message to talk you through giving the medication. Cheapest- Most used by first responders
Cons Co-pay about $40 for some insurances Syringe and most expensive Complex assembly

An additional guide sheet can be found here. 

Source: National Harm Reduction Coalition 

While we know naloxone saves lives, the challenge comes in getting it to the patient. Pharmacists must take the extra step of destigmatizing the medication, educating others, and recommending naloxone to patients where indicated. Going above and beyond in this manner benefits patients, combating the epidemic and making the world safer, one nasal spray at a time. 

Resources for Pharmacists

References

1. Johnson M. Drug Overdose Prevention Program Main. Eiph.idaho.gov. https://eiph.idaho.gov/Health%20Education/Drug%20and%20Alcohol/Drug%20Overdose%20Prevention%20Program%20Main.html. Published 2019. Accessed March 27, 2022.

2. Understanding the Opioid Overdose Epidemic. Centers for Disease Control and Prevention. https://www.cdc.gov/opioids/basics/epidemic.html. Published 2021. Accessed March 27, 2022.

3. Help Save Lives: Co-Prescribe Naloxone To Patients At Risk Of Overdose. 1st ed. New York: American Medical Association; 2017. https://www.aafp.org/dam/AAFP/documents/patient_care/pain_management/co-branded-naloxone.pdf. Accessed March 27, 2022.

4. Naloxone for Opioid Overdose: Life-Saving Science | National Institute on Drug Abuse. National Institute on Drug Abuse. https://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science#ref. Published 2022. Accessed March 27, 2022.

5. Overdose Death Rates | National Institute on Drug Abuse. National Institute on Drug Abuse. https://nida.nih.gov/drug-topics/trends-statistics/overdose-death-rates. Published 2022. Accessed March 27, 2022.

6. Is naloxone accessible? | National Institute on Drug Abuse. National Institute on Drug Abuse. https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/naloxone-accessible. Published 2022. Accessed March 27, 2022.

7. Crocker A, Bloodworth L, Ballou J, Liles A, Fleming L. First Responder knowledge, perception and confidence in administering naloxone: Impact of a pharmacist-provided educational program in rural Mississippi. Journal of the American Pharmacists Association. 2019;59(4):S117-S121.e2. doi:10.1016/j.japh.2019.04.011

8. Responding to Opioid Overdose – National Harm Reduction Coalition. National Harm Reduction Coalition. https://harmreduction.org/issues/overdose-prevention/overview/overdose-basics/responding-to-opioid-overdose/. Published 2020. Accessed March 27, 2022.

9. Naloxone. SAMHSA. https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/naloxone. Published 2022. Accessed March 27, 2022.

10. SAMHSA Opioid Overdose Prevention TOOLKIT. 18th ed. New York: SAMHSA; 2013. https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf. Accessed March 27, 2022.

11. Good Samaritan Overdose Prevention Laws. Pdaps.org. https://www.pdaps.org/datasets/good-samaritan-overdose-laws-1501695153. Published 2022. Accessed March 27, 2022.

12. Lifesaving Naloxone. Center for Disease Control and Prevention. https://www.cdc.gov/stopoverdose/naloxone/index.html. Published 2020. Accessed March 27, 2022.

13. Overdose Death Rates | National Institute on Drug Abuse. National Institute on Drug Abuse. https://nida.nih.gov/drug-topics/trends-statistics/overdose-death-rates. Published 2022. Accessed March 27, 2022.

Faizan Ali is a P1 student pharmacist with an interest in community, managed care, and critical care pharmacy. In his free time, Faizan enjoys participating as a student researcher for a research project entitled, Assessment of Analgesics and Sedatives in Ventilated Patients with COVID-19, staying involved in professional pharmacy organizations, and learning as much about the world of pharmacy as he can. Faizan is a proud student pharmacist in the Doctor of Pharmacy (PharmD) program at the Wilkes University Nesbitt School of Pharmacy.

August 1, 2022

MonkeyPox: The Next Outbreak? – Pharmacist Consult

maximios / News /

It seems as though as COVID-19 is starting to subside in regards to the number of cases, hospitalizations and deaths, another virus outbreak finding its way into our somewhat normal lives again: Monkeypox. 

What is MonkeyPox? 

According to the CDC, monkeypox is a rare disease caused by infection of the monkeypox virus which is part of the variola virus family, which is actually what causes smallpox. Although monkeypox does have similarities to smallpox, monkeypox is rarely fatal. The first human case was recorded in 1970 and prior to the now 2022 outbreak it had only been found in several African countries. 

What are the signs and symptoms to look out for? 

The signs and symptoms to look out for in regards to monkeypox are: 

  • Fever
  • Headache 
  • Muscle and back ache
  • Swollen lymph nodes
  • Chills 
  • Exhaustion 
  • A rash that may be located on or near the genitals, anus or other areas such as hands, feet, chest, face or mouth. The rash may also look like pimples or blisters and may be painful or itchy. 

Rash may present in different people. Some may experience a rash first followed by other symptoms, some may get a rash after symptoms, or some may just experience a rash without other symptoms occurring. Monkeypox can start about three weeks after exposure and can generally last from 2 to 4 weeks. 

How is Monkeypox spread? 

Monkeypox can spread to anyone through: 

  • Close, personal or skin-to-skin contact which can include direct contact with scabs, rash or bodily fluids; touching objects and fabrics used with someone that has the virus; and contact with any respiratory secretions. 
  • Direct contact with anyone intimately which includes oral, anal and vaginal sex or through touching genitals; hugging, massaging or kissing; and prolonged face to face contact.
  • Pregnant women spreading the virus to their fetus through the placenta. 

What are ways to prevent monkeypox? 

Currently, there are no treatments for monkeypox virus infections. The best way is to prevent the virus from infecting you and to stop the spread. 

  • Avoid close, skin-to-skin contact with people who have a rash that may look like monkeypox. 
  • Avoid contact with objects and materials that a person with monkeypox has used or touched. 
  • Wash your hands with soap and water and use alcohol-based hand sanitizer. 

What are some myths associated with monkeypox? 

The following myths and stigmas that have been associated with monkeypox and have been debunked are not true. 

  • Monkeypox is a new virus.
  • Monkeypox is a sexually transmitted infection.
  • Monkeypox only affects gay and bisexual men.
  • Monkeypox is the next COVID-19 virus. 
  • Monkeypox only affects people in African countries. 

It is important to continuously stay up-to-date with news regarding monkeypox because similar to the beginnings of the COVID-19 outbreak, updates and guidelines are changing daily. Protect yourself and others from spreading monkeypox by being aware of the signs and symptoms and preventing contact from anyone who has it or you if you are infected.

July 1, 2022

Behind-the-Scenes Process to Fill a Prescription – Pharmacist Consult

maximios / News /

Over the years, prescription volume has increased at most pharmacies. This is due to a number of reasons, but one of the biggest reasons is due to expanded insurance coverage. In many cases, this has led to a decrease in patient satisfaction due to longer wait times at the pharmacy. 

To understand why there may be delays at a pharmacy, it’s helpful to know the pharmacy’s general workflow. Exact proceedings vary from company to company, but the process is described below. By being aware of what goes on, it’s easier to appreciate which steps take longer than others and where delays may occur in the filling process. 

Many organizations and companies work diligently to identify strategies to improve efficiency at pharmacies, but pharmacies in the United States commonly can become straddled by limitations in staffing. Without adequate staffing, it may take longer to implement new changes to the pharmacy workflow to decrease fill times while also maximizing patient safety and prescription accuracy.

The list below describes the workflow for an outpatient or community pharmacy. Processes are slightly different inside of a hospital’s pharmacy (or similar institution). 

The list below is broken into 7 simple, sequential steps. Each step may require an intense amount of time and effort depending on the prescription, insurance plan, and/or patient’s overall situation.

1. Pharmacy Receives the Prescription

Prescriptions can be transmitted electronically, via telephone, via fax, and/or via hard copy. 

When a prescription is received from a prescriber, issues can arise related to a prescription being fraudulent, a prescription may simply not be valid, or certain required bits of information may be omitted. If any of these incidents occur, it takes time to work to resolve the issue(s) with the prescriber. 

Pharmacists tend to prefer electronic prescriptions over the alternative forms due to decreased incidence of fraud, increased levels of safety, and less time spent interpreting sloppy handwriting. In some states like New York, it has even been mandated since 2016 that all prescriptions must be sent electronically directly from the prescriber to the pharmacy (with certain exceptions).

2. Data Entry

Whenever a prescription is received (no matter the receipt mechanism), the prescription must then be entered into the pharmacy’s computer system. 

This step is mostly self-explanatory. A pharmacy staff member (pharmacist, pharmacist intern, or technician) can perform data entry. 

For every prescription, the pharmacy staff member must accurately enter the correct drug with its corresponding strength, the directions for use must be described and easily interpreted, the quantity and days supply must be calculated, the correct prescriber needs to be selected, and the billing information must be triaged (see step #3 for more details about triaging claims). 

Often, there are issues with prescriptions having missing and/or confusing information that is caught during data entry. For example, a prescriber may write for one tablet of medicine X to be taken 3 times a day for 30 days, but then only prescribe 30 tablets. At that time, the pharmacy staff member must take the time to contact the prescriber to see if they intended for a quantity of 90 tablets of medicine X to be dispensed or if they meant to prescribe only a 10-day supply of medicine X.

This is just one example – issues can take many forms. However, correcting these types of simple issues for multiple patients throughout the day (while also waiting to get in contact with these other busy healthcare providers) can cause significant delays. 

These sorts of issues can cause a delay for the patient at-hand, but it can also cause delays for other patients as the pharmacy employee is dedicating extra time to solve an issue rather than working on other tasks to be accomplished for other patients. This same trend is true for other issues encountered throughout the pharmacy.

3. Triage the Claim 

This step is an extension of data entry. To triage a claim after the medicine details have been typed in, a pharmacy staff member must either bill the prescription to a patient’s insurance plan, bill it to a discount savings card, or have the prescription filled on its cash price designated by the product manufacturer (typically as a last resort option). 

Billing a prescription to an insurance plan can be one of the biggest headaches for both pharmacists and patients. Prescription insurance, at its core, is vital – it makes expensive medicines more affordable and possible to receive. Without it, many medicines would be financially unrealistic to purchase. However, dealing with prescription insurance issues is also the task that arguably steals away the most time from a pharmacy’s workflow. 

First, the pharmacy must identify the patient’s insurance plan. It is commonplace to encounter issues obtaining the proper billing information for a patient’s specific insurance plan, especially for first-time patients. If a patient is contacting a pharmacy to provide updated insurance information, be sure to have the following four numbers at-hand so the pharmacy can identify the correct plan: Member ID #, RxGroup #, BIN #, and PCN #.

Once the correct insurance plan is identified and selected in a patient’s profile, in the community pharmacy world, there is a luxury of being able to utilize instantaneous adjudication. That is, once a prescription is entered into the pharmacy’s computer system, the pharmacy staff member can immediately know if a patient’s insurance plan will pay for a medicine and for what cost. 

Conversely, the pharmacy team member also immediately learns if a medicine is rejected by a patient’s insurance plan. Medicines can be outright rejected if they are simply not on an insurance formulary. At that point, the pharmacy team member must then inform the patient of the issue and proceed to reach out to the prescriber to work on getting an alternative medicine prescribed. Or, as an alternative, the pharmacy team member may elect to find a discount card to utilize for the patient. 

However, many medicines are conditionally rejected by an insurance plan rather than outright rejected. Working through these conditional rejections can be arduous. Examples of conditional rejections are prior authorizations (sometimes called preauthorizations), quantity limits, the need for step therapy, etc. To solve these types of rejections, it is typically a tri-fold conversation between the pharmacy, the prescriber, and the patient’s insurance company. These can add significant delays to filling a medication for a patient.

Countless hours are spent toward resolving insurance issues for patients. This is the root cause of many delays in pharmacies.

FAST FACT: for prescriptions billed to an insurance plan, the patient’s copay is determined by the insurance plan – not the pharmacy. The insurance tells the pharmacy what to charge the patient at the register.

4. Pharmacist Checks the Entered Prescription for Appropriateness (1st Check)

This step, alongside step #6, is where the pharmacist demonstrates their value and necessity. 

As a baseline requirement, prior to a prescription being filled, the pharmacist must double check that a prescription has been accurately typed into the pharmacy’s computer system (correct drug, correct strength, correct quantity, etc). Similarly, the pharmacist double checks that the insurance information has been accurately selected for the patient as applicable. 

At this point, the pharmacist assesses the patient’s clinical picture utilizing their drug knowledge. The pharmacist analyzes the current prescription at-hand and compares it to the rest of the patient’s profile. A pharmacist asks themselves many questions to confirm that the prescription being analyzed is safe and effective for the patient. 

Does the patient have any medical conditions that contraindicates the use of the medicine? What drug interactions, if any, will the patient experience between this medicine and their other medications? Are there any duplications in therapeutic drug classes? Is this a medication that has abuse potential, especially if they have other medicines that also have abuse potential? What side effects might the patient have if they take this medicine? Will those side effects be manageable? Will this medicine actually be worth the cost for the patient? Will it actually treat their disease state or illness? Would a different medication be better for them? Would a different dosage form be more preferable? 

These are just a few possible questions that a pharmacist may assess for every patient. Answering these types of questions takes time, and it’s important to allow a pharmacist the time to make these important clinical decisions. 

Once the pharmacist decides that a medicine will be safe and effective for a patient, they then allow for the prescription to be filled. Making these types of decisions for patients mandates advanced education and training, so a Doctor of Pharmacy degree is a required prerequisite to become a licensed pharmacist. 

5. Send the Prescription to Fill

At this point, the prescription has been entered into the pharmacy’s computer system and its use is considered to be appropriate. The prescription can now be filled. At most pharmacies, pharmacy technicians or pharmacist interns are the individuals that physically fill prescriptions. 

There typically is a long queue of medications to fill at every pharmacy. Most pharmacies measure their prescription volume in terms of prescriptions per week. A high-volume pharmacy can fill many thousands of prescriptions per week, whereas a low-volume pharmacy may fill only hundreds of prescriptions per week. 

The higher volume a pharmacy is, the more prescriptions they have to fill. If there are many prescriptions to fill, there can be delays getting certain medications filled as every prescription in the fill queue needs to be honored and filled in a timely manner.

If a pharmacy concurrently has staffing shortages, it may be difficult for a limited amount of staff to fill a large number of prescriptions in a timely manner while also attending to other necessary duties in the pharmacy. This can lead to delays. 

Another common issue encountered during the filling process is not having enough medicine in stock to fill a prescription. In many cases, medicines that are out-of-stock are ordered for the next business day to be filled. However, specialty medicines or medicines that have a certain control schedule may take well more than one business day to arrive. This adds time to the prescription filling process. 

6. Pharmacist Verifies the Prescription (2nd Check)

In step #4, the pharmacist completed the important clinical decision-making process to ensure that the prescription is accurate while also appropriate, safe, and effective for the patient. 

Here, the pharmacist physically verifies that the labeled medicine is in fact filled for the correct medication, strength, and quantity.

Given the sheer number of prescriptions to be filled, it can be easy for a pharmacy colleague to accidentally mislabel a bottle or fill the wrong medicine/strength for a prescription. However, these errors are caught by the pharmacist prior to verifying and completing the order for the patient. 

When an error is caught by the pharmacist, the prescription is sent back to the filling station and the error is corrected by the technician or intern that is assigned to fill prescriptions. 

7. Prescription Given to the Patient

Once the prescription(s) are filled, then the medicine can be given to the patient. Patients can obtain their medicine via in-person pickup, drive-thru, and/or delivery depending on the pharmacy. This is the easiest and quickest step of the process. 

This step is typically only slowed down if the patient requests for a prescription to be rebilled to a different insurance plan or alternative discount card from what was originally billed during step #3. If this is the case, then steps #3 through #6 must be repeated by the pharmacy. 

All of this occurs while concurrently answering a horde of unrelated phone calls, attending to patients at the counter, answering many off-the-wall questions, and completing other required pharmacy tasks. However, this simply adds to the fun and controlled chaos of the community-based pharmacy. 

Reference:

1. James P. Amerine, Pharm.D, Tippu Khan, Pharm.D., M.H.A, Brett Crisp, Pharm.D., M.S, Improvement of patient wait times in an outpatient pharmacy, American Journal of Health-System Pharmacy, Volume 74, Issue 13, 1 July 2017, Pages 958–961, https://doi.org/10.2146/ajhp160843

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