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Cystic fibrosis (CF) is an autosomal recessive disorder with a multisystem impact on the body. One of the most common genetic disorders in America, CF is seen predominantly in people of European descent. It is estimated that 1 in every 35 Americans is a carrier of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, with equal rates seen in males and females.1 The incidence of CF is estimated to be 1 in every 3500 live births in North America.2 It is estimated to affect some 30,000 people in the US and 70,000 people worldwide.1 

Cystic fibrosis commonly affects organ systems including the lungs, sinuses, gastrointestinal tract, pancreas, and reproductive system, in addition to others.3 The illness is life-shortening, with a median life expectancy of 46.2 years, although the projected life span of patients continues to increase each year as treatments improve.1 In people with 2 mutated CFTR genes, the CFTR protein does not work properly. This defective protein leads to faulty or missing chloride channels, which results in the formation of a buildup of dense, viscous mucus in some areas of the body. The disease could be caused by any of more than 2000 different CFTR variant combinations. Unfortunately, it is not known which of these variants cause CF, but the most common of the identified variants is the F50del variant.4 Since there are so many different possible variant combinations, the specific protein variants that a patient carries can potentially determine the phenotype and severity of the disease, by determining the amount of CFTR present and the scale of the defect.1

Prognosis for Patients With Cystic Fibrosis

For many years, CF was considered exclusively a disease of childhood. This was true especially in the early years of the disease's discovery, when most patients died before their first birthday. Since the discovery of the CFTR gene in 1989, CF is no longer considered a disease of childhood; approximately 50% of patients are now adults.5 The identification of the specific mutation of the CFTR gene has allowed CF patients to start targeted treatment and interventions much earlier, keeping patients healthier for longer. The rates of CF have also gone down in recent years, likely because of the availability of genetic testing and counseling before conception in families at high risk of the disease.5 

When determining the prognosis of a patient with CF, it is important to look at factors that may affect their quality and length of life. The main prognostic predictor of poor survival rates is having reduced lung function.5 Other factors to considered when informing a patient or their family on the likely progression of this disease are sex, age at diagnosis, CFTR genotype, ethnicity, socioeconomic status, as well as manifestations of symptoms.5 Women tend to do worse than men, and patients who are diagnosed at an older age tend to have worse outcomes.5 Further, people with poor nutritional status, severe pancreatic insufficiency, diabetes, or early Pseudomonas aeruginosa infection are more likely to have worse outcomes.6 

Overall, the prognosis of CF is individualized because patients present with a wide variety of challenges or symptoms. Not only is the prognosis very individualized but it is also constantly changing. Life expectancy as well as average quality of life have improved dramatically in the last few decades and will continue to improve with the standardization of newborn screening and gene modulator targeted therapy becoming the gold standard of treatment.7 

Mental Health Concerns in Cystic Fibrosis Patients

Depression and anxiety are commonly seen in the general population, with about 9.2% of people in the US reporting being depressed. However, these disorders can be exacerbated by factors such as a chronic life-limiting diagnosis.8 Approximately 41% of patients with a chronic illness report being depressed.9 Patients with CF are 22.2% more likely to be depressed, and 42.4% more likely to have anxiety compared with the general population.9 This prevalence of depression leads to decreased quality of life and worse outcomes, with an increased mental and financial burden of disease.9

"
Comorbid anxiety and depression can have a major impact on a patient’s adherence to treatment and their overall desire to remain healthy.

Patients with depression are 3 times more likely to be nonadherent with their treatment regimen, which has substantial negative impacts for patients with demanding treatment regimens such as those required by CF.9 Depressive symptoms in this population have been shown to have a negative impact on a patient’s ability or desire to interact with peers or engage in daily activities, while anxiety symptoms have a negative impact on a patient’s self-image and confidence.10 

https://infogram.com/mcg_infogram_ca_cf_figure1-1h1749wlyvz9q2z

Health related quality of life (HRQOL) is an important factor in assessing patients with chronic illness. Measuring this variable allows health care providers to ensure that the management of a condition is beneficial physiologically and improves or maintains the patient’s quality of life. It was once believed that in CF patients physical health variables were strongly correlated with HRQOL, however, recent studies have shown that although physical health variables play a role in quality of life, mental health status has an even stronger correlation with HRQOL.10 It is crucial to screen for and manage anxiety and depression symptoms to improve the quality of life, particularly as physical health declines.10 

Screening and Treating for Mental Health Conditions

In individuals with CF, major depression is considered a treatable cause of disability, death, and suffering.11 Currently there are mental health screening guidelines established by the US Cystic Fibrosis Foundation and European Cystic Fibrosis Society for early detection of mental health comorbidities in this population. These guidelines include screening all patients aged 12 years and older annually for both depression and anxiety symptoms, as well as when it is clinically indicated for those falling outside of this population window.11 Screening should be initiated for caregivers of this population when the patient with cystic fibrosis is aged 0 to 17 years.12 This caregiver screening should include depressive as well as anxiety symptoms. The best screening tools for these populations are the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) for depression and anxiety, respectively.11 If the screening yields a positive result, it is important to further screen for risk of suicide using available tools such as the Columbia Suicide Severity Risk Scale (C-SSRS) screen11

Treatment for mental health conditions should start with evidence-based psychotherapy.11 Tailoring counseling sessions to include CF-specific concerns is an important aspect of care. It is extremely important that mental health providers be aware of topics such as the impact of CF on lifespan, relationships, parenting, fertility, financial burdens of illness, feelings on transplants, and end-of-life wishes.11 Addressing CF-specific triggers for anxiety and depression in these patients is crucial to helping ameliorate their mental burden of disease. 

Some patients may be unable to access psychotherapy, or may need additional help in managing their symptoms, so pharmacotherapy plays an important role. Selective serotonin reuptake inhibitors (SSRIs) are a mainstay of treatment in this patient population.11 These agents are generally well-tolerated, effective in the treatment of both depression and anxiety, and relatively inexpensive.

Behavioral modifications can also play a significant role in the treatment of comorbid depressive and anxiety symptoms. Simply forming routines can be extremely beneficial to these patients. These routines can include a routine in which treatments are done at the same time every day to help patients make this disease a normal part of daily life. Attending appointments with their health care provider regularly and completing all recommended screenings can help address physical symptoms early on and make this a regular part of life, which leads to increased adherence. Exercising daily and practicing good sleep hygiene are important in maintaining good mental health.13 Lastly, a well-balanced diet, along with making time for activities that the patient finds enjoyable, are important practices that are accessible and manageable for this population.11 

Conclusion

Comorbid anxiety and depression can have a major impact on patients’ adherence to treatment and their overall desire to remain healthy. When patients become nonadherent with treatment, they can have increased secondary complications such as decreased body mass index and lung function.11 Overall, a positive screen for depression is associated with increased rates of morbidity and mortality among CF patients.14 Poor mental health is a secondary complication that needs to be promptly addressed and treated in this population. 

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An 89-year-old White woman presents to her primary care provider (PCP) with an erythematous, flat, patchy rash on both forearms that has been present for about 10 days (Figure 1). The PCP diagnoses the rash as a photosensitivity rash following the attendance of an outdoor airshow 2 weeks prior. Triamcinolone cream is prescribed, and the rash fades slightly over 2 to 3 weeks with regular use.

Figure 1: Erythematous, flat, patchy rash on both forearms that has been present for about 10 days.

A month later, the patient returns to the PCP with an extremely pruritic rash that began on her back and has quickly spread to her trunk. The rash has progressively worsened despite reapplying the triamcinolone cream to the rash for 1 week without relief. She denies the use of new detergents, soaps, topical creams, food, medication, or new clothing. She has not traveled, been around sick contacts, or had any known insect bites.

She denies fever, chills, fatigue, weight loss, oral or nasal ulcers, dry mouth, swollen lymph nodes, dyspnea, chest pain, edema, nausea, vomiting, diarrhea, joint swelling, muscle aches, or numbness.

The patient’s medical history is significant for coronary artery disease with stent placement in 2017, aortic valve replacement in 2015, hypertension, hyperlipidemia, hypothyroidism, osteoarthritis, and osteoporosis. Her medical conditions are well controlled on medications, which have been consistent since 2017, and include atorvastatin (80 mg every night at bedtime), enalapril (2.5 mg/d), metoprolol (25 mg/d), levothyroxine (75 mcg/d), clopidogrel (75 mg/d), and subcutaneous denosumab (60 mg every 6 months). Her immunizations are up to date, including COVID-19, influenza, shingles, and pneumonia.

She has been widowed for 10 years and lives independently, prepares her own meals, and needs no assistance with medications. She does not drink alcohol, smoke, or use illicit drugs, and plays Rummikub with friends in her community several nights during the week. Her 3 adult children live nearby, visit regularly, drive her to medical appointments, and assist with grocery shopping and household chores.

Physical Examination

Physical examination reveals a pleasant older woman in no acute distress. She is awake, alert, and oriented to person, place, and time. The skin of her neck, chest, and arms presents with diffuse erythematous, raised, slightly scaled lesions with distinct edges, measuring approximately 3 cm to 4 cm, with no surrounding erythema. There are strikingly annular and hemi-annular erythematous lesions measuring 4 cm to 5 cm over the back, buttocks, and a few on the upper arms (Figure 2). No lesions are observed on the face or in the mouth or nose. The distal interphalangeal joints bilaterally reveal Heberden nodes but no erythema or swelling of any other joints. Heart and lung examinations are unchanged from baseline.

Figure 2. One month later, the patient presents with annular and hemi-annular erythematous lesions measuring 4 cm to 5 cm over the back, buttocks, and a few on the upper arms.

Differential Diagnosis

The differential diagnosis includes multiple cutaneous conditions that commonly present with erythematous, annular dermatologic lesions, such as erythema migrans, plaque psoriasis, granuloma annulare, erythema annulare centrifugum (EAC), pityriasis rosea, erythema multiforme, polymorphic light eruption, secondary syphilis, dermatomyositis, T-cell lymphoma, tinea corporis, lichenoid photo drug eruption, Lyme disease, and pemphigus foliaceus.1 Among these, the initial differentials are Lyme disease, EAC, and tinea corporis.2

Diagnostic Workup/Diagnosis

A Lyme titer is drawn at the first visit and was negative. Initial treatment with high-potency topical steroids and antifungals is not fruitful in resolution of the rash. The rash remains extensive and non-remitting, so the patient is referred to dermatology for consultation. A skin biopsy is performed 10 days after the initial primary care visit. Biopsy results include dermoepidermal junction smudging, interface dermatitis, and evidence of subacute cutaneous lupus erythematosus (SCLE) and drug eruption. Upon biopsy results, the patient’s enalapril was suspected as the offending agent and stopped immediately. The patient was started on a 16-day tapering dose of prednisone starting at 40 mg and ending with 5 mg, which improveds symptoms, but the rash returned within 2 weeks of prednisone cessation (Figures 3 and 4).

Figure 3. The patient is diagnosed with drug-induced subacute cutaneous lupus erythematosus. She is started on a 16-day tapering dose of prednisone. But the rash returns after treatment.
Figure 4. The rash returns 2 weeks after finishing a 16-day course of prednisone.

A second dermatologist is consulted for a second opinion 1 month later and performs laboratory testing. Skin biopsy and laboratory testing confirmed the patient’s diagnosis of drug-induced SCLE (DI-SCLE; Table).

Treatment and Disease Course

A rheumatologist is consulted and the patient is prescribed oral hydroxychloroquine 200 mg and 400 mg, to be taken on alternating days. Despite slight rash improvement, the medication was discontinued after 2 weeks because of adverse effects of diarrhea and nausea. Prednisone is restarted at 5 mg daily, and after 30 days, is lowered to a daily dose of 1 mg, which became the long-term regimen. Since diagnosis and treatment the patient has dramatically improved, but experiences occasional plaque formation that resolves with topical betamethasone. She now avoids direct sunlight, is back to playing Rummikub with her friends, is adherent with medications, and living life.

Discussion

Subacute cutaneous lupus erythematosus is a form of cutaneous lupus erythematosus that presents with erythematous, annular plaques or papulosquamous drug-related eruption in sun-exposed areas.2,3 The lesions typically occur in the V-neck area of the chest, back, shoulders, extensor sides of the upper extremities, and can extend to the face, scalp, and legs.4 Most patients with DI-SCLE are White women, with a mean age of 60 years.5,6 SCLE can be idiopathic (I-SCLE) or drug-induced (DI); both types have the same immunologic and histopathologic findings and are difficult to distinguish clinically.7

Since the first reported case of DI-SCLE in 1985, more than 50 medications have been implicated in this disorder, many associated with induction of photosensitivity reactions.3,8 In addition to proton pump inhibitors (PPI), nonsteroidal anti-inflammatory drugs (NSAIDs), chemotherapeutics, and anti―tumor necrosis factor (TNF) agents, the most common drugs correlated with DI-SCLE fall under the antihypertensive umbrella, particularly thiazides, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and calcium channel blockers. Other agents that have been implicated as a cause of DI-SCLE include carbamazepine, interferon alfa and beta, leflunomide, simvastatin, and terbinafine.2,3,8 Antihypertensives and antiepileptics have the longest incubation period, with a median time of 2 years’ use before SCLE symptoms appear.9

Patient medication profiles inclusive of several known causative agents implicated in DI-SCLE can complicate the diagnostic and treatment process. Although statins have also been found to cause DI-SCLE, in this case, the rash improved when enalapril was discontinued.

Research has found the age of disease onset to be higher in patients with DI-SCLE compared with I-SCLE. This is hypothesized to correlate with the increased use of medications with age.10 Thorough history taking and detailed attention to medication lists can aid in diagnosis.8

The laboratory findings include the presence of anti-Ro/SSA (Sjögren syndrome-A) and or anti-La/SSB (Sjögren syndrome-B) together with antinuclear antibodies (ANA) and antihistone antibodies.2,11 In this case, the patient was positive for ANA and anti-Ro/SSA, while negative for anti-La/SSB. Diagnosis can become complicated when there is pre-existing lupus and prior evidence of positive autoantibodies and serologies, as there are no additional formal diagnostic criteria for DI-SCLE.8

The incubation period for a DI reaction can be anywhere from 3 days to 11 years, with a median latency of 6 weeks.2 The diagnosis of DI-SCLE is usually made when one of the common medications known to cause the rash is taken prior to the eruption, and improves when the medication is stopped.3,10,12 The cornerstone of DI-SCLE treatment is identification and discontinuation of the suspected causative medication, which usually results in symptom resolution within 8 to 12 weeks.3,8,10 In the event of continued symptoms, the most common medications in the literature to treat DI-SCLE are topical steroids, oral prednisone, and the immunosuppressive drugs hydroxychloroquine and oral tacrolimus.3

Conclusion

Although DI-SCLE is relatively uncommon and often misdiagnosed, the root cause is likely a photosensitivity reaction from medications most commonly prescribed by PCPs. With careful history taking and attention to details of medication lists, particularly new medications prescribed for patients older than 60, identification of this disorder can occur on the front line. Withdrawal of suspected offending medications can promote resolution and prevent patients from enduring extended symptoms while awaiting specialist referrals and undergoing costly lab work and invasive tests for diagnosis. In this case, primary care referrals to dermatology and rheumatology helped make the correct diagnosis and treat the disease, limiting the patient’s side effects and hastening resolution.

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This month we revisit a case we looked at in June 2023, where a California nurse practitioner with a Doctor of Nursing Practice (DNP) who referred to herself as “Dr Sarah” was charged with fraud and fined $20,000. In the months that followed, there has been continued fallout from this case.

The Case

Ms E is a nurse practitioner who received her DNP in 2014 and a PhD in Mind-Body Medicine and Integrative Mental Health in 2020. In 2018, Ms E  had entered into a collaboration agreement with Dr M, an obstetrician-gynecologist located in Massachusetts, to open a women’s health clinic in her home state of California. In 2022, investigators with the California Department of Consumer Affairs began investigating Ms E for referring to herself as “Dr Sarah”, which led to the charge in 2023 with violating California’s Business and Professions Code because of unfair business practices and false advertising. Ms E settled the case and subsequently left California to practice in another state. But the fallout didn’t end there.

After the case against Ms E was settled, a California District Attorney in San Luis Obispo filed a complaint in early 2024 against her collaborating physician, Dr M, accusing her of failing to adequately supervise and collaborate with Ms E as required by their agreement and according to California guidelines.

The complaint alleged numerous failures on the part of Dr M regarding the collaboration agreement, including that it was prepared by Ms E, was “only skimmed” and signed by Dr M, and that Dr M spent “no time developing protocols before or during the time that the agreement was in effect.” The complaint also alleged that Dr M, having moved to Massachusetts in 2016, “spent little time investigating and evaluating the circumstances in which” Ms E would be providing medical services under the agreement.

California law specifies that standardized procedures are required for an NP who prescribes medications. Specifically, “the standardized procedure between a medical doctor and a nurse practitioner shall specify which drugs or devices may be furnished or ordered, under what circumstances, and under what physician supervision.” While the complaint noted that the collaboration agreement in this case included a protocol for Ms E’s prescription of medications, including Schedule III to V controlled substances, it did not specifically identify the permitted controlled substances that she could prescribe, as required by law.

"
The complaint alleged numerous failures by
Dr M regarding the collaboration agreement.
She agreed to pay civil penalties of $25,000.

According to the complaint, Dr M was not aware that Ms E was prescribing controlled substances, such as testosterone, to both female and male patients. Dr M was also unaware that Ms E had opened an independent practice, and the complaint alleged that Dr M never actually reviewed any medical records prepared by Ms E.

At the end of January 2024, the San Luis Obispo District Attorney announced a settlement with Dr M. While Dr M did not admit liability, she agreed to pay civil penalties of $25,000 and to follow California law if entering into future collaborative agreements.

Three DNPs Sue California

In mid-2023,  California DNPs preemptively sued the attorney general of California, the president of the medical board of California, and the executive officer of the California Board of Registered Nursing, citing that the California statute only allowing California-licensed allopathic and osteopathic physicians to use the term "doctor" is unconstitutional. The DNPs argued that forbidding them from using the title “Dr” violated their First Amendment freedom of speech. The complaint referred to the “Dr Sarah” case in great depth, and maintained that the DNP plaintiffs in this case, who all have DNP degrees, were afraid to use the title “Dr” for fear that the state would take action against them as it did against Ms E.

The California Medical Association and the American Medical Association filed amicus curiae briefs in support of the defendants in the case. The medical associations claimed that “scope creep” is causing confusion among patients who don’t know who is leading their care and is a patient safety issue. In August 2023, the defendants filed a motion to dismiss, arguing that the plaintiffs lacked standing because they had not suffered actual or threatened injury as a result of their fear of legal action.

In September 2023, the Federal District Court dismissed the case because 2 of the plaintiffs had not been using “Dr” as a title but allowed the third plaintiff to continue her case. The third DNP had been using the title “Dr” prior to the “Dr Sarah” case. At the family practice where she worked, the NP was referred to as “Dr P,” and her clinician’s jacket had her name embroidered with Dr before it and FNP-C after. She stopped using the title “Dr,” stopped signing her name with “Dr,” asked other employees at her job not to refer to her as “Dr,” and stopped wearing her clinician’s jacket after the “Dr Sarah” case.

The defendants claimed that the case against the third DNP should be dismissed because she was never sent a cease-and-desist letter threatening an enforcement action or any other threat of litigation. The court rejected that argument, holding that “where the state fails to disavow an intent to enforce the law, courts typically find a plaintiff’s alleged fear of prosecution ‘real.’” The case is proceeding with the remaining plaintiff.

Protecting Yourself

California has the most restrictive rule regarding use of the title Dr, but several other states also regulate how it may be used. Given this, it is wise to be clear with patients that you are an NP and to be very careful about what terms you use in advertising, marketing, and online.

A collaborative agreement is a contract and should not be entered into lightly. It’s extremely important when drafting a collaborative practice agreement to be as specific as possible about protocol, and to follow up once the agreement is in place to ensure the protocol is happening.

Ann W. Latner, JD, a former criminal defense attorney, is a freelance medical writer in Port Washington, New York.

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A 65-year-old man of Mediterranean descent is referred by his primary care physician for evaluation of lesions affecting his feet and calves. The patient states that the condition was first noted about 4 months ago and remained without symptoms until recently when 1 lesion began to bleed. His only treatment to date has been topical miconazole cream prescribed by a podiatrist for athlete's foot. He is currently on medication for control of his hypertension. Physical examination reveals scattered violaceous patches and firm, dusky red papules.

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