Journal of Pharmacovigilance & Drug Safety

Developments in Inhalational Devices: Consequences for the Treatment of Chronic Obstructive Pulmonary Disease

2025-01-16T12:28:33+00:00

Background: Inhaled therapies are essential for managing symptoms and preventing exacerbations of Chronic Obstructive Pulmonary Disease (COPD), a cause of morbidity and mortality that is prevalent throughout the world. In order to enhance patient outcomes, innovative inhaler designs have been developed in response to limitations in classic inhaler technologies, such as inadequate drug delivery and poor adherence. Objective: This review focuses on advancements in smart inhalers, particle engineering, and usability enhancements, aiming to explore recent breakthroughs in inhaler technology and their potential impact on the management of COPD. Methods: A thorough literature review was performed to locate peer-reviewed studies, clinical trials, and reviews published in the last ten years. Focus was directed towards technologies that improve drug delivery, adherence monitoring, and patient usability. Outcomes: Innovative technologies, like smart inhalers, incorporate digital feedback and adherence monitoring, facilitating personalized treatment. Innovations in device design, such as soft mist inhalers and advanced dry powder inhalers, improve drug deposition efficiency and tackle patient-specific issues, including diminished inspiratory effort in elderly individuals. Enhanced usability features, such as optimized dose actuation mechanisms, have shown promise in improving adherence and minimizing errors. Summary: Advancements in inhaler technology offer transformative potential in COPD management, aligning with trends toward personalized and patient-centred care. By addressing barriers to effective therapy, these innovations improve drug delivery, enhance adherence, and reduce exacerbation rates. Further research is needed to integrate these technologies into routine clinical practice and assess their long-term impact on patient outcomes.

A Case Series of Contact Irritant Dermatitis due to Latex Gloves: An Implication of Materiovigilance

2025-01-16T11:48:13+00:00

Most common reaction to latex products is irritant contact dermatitis caused by irritation from wearing gloves or by glove powder. Latex glove reactions have been shown to be an important cause of occupational morbidity among healthcare professionals because they use latex gloves on a frequent basis. In this case series we reported seven cases of irritant contact dermatitis due to the use of latex gloves. On using nitrile gloves, these symptoms subsided. There was no history of any drug allergy or eczema among these nursing staff. The causality category was probable as per WHO causality scale. These cases were reported to regional training centre materiovigilance under materiovigilance program of India.

Anaphylactic Reaction Caused by Co-administration of Diclofenac and Ofloxacin

2025-01-16T11:51:29+00:00

Anaphylaxis is the most severe form of an allergic reaction. Drug-induced anaphylaxis can be life-threatening after drug intake by any route, including non-therapeutic exposure due to accidental contact. The most common culprit drugs are non-steroidal anti-inflammatory drugs, beta-lactam antibiotics and other antibiotics such as quinolones. A 25-year-old female patient attended the dental clinic with the complaint of toothache and was prescribed Diclofenac 50 mg and Ofloxacin 200 mg twice a day. After a day patient was brought to the Emergency and Trauma Centre of the hospital with multiple erythematous macules and papules over both forearms, multiple erythematous macules present over trunk, itching over the lesions, fever and throat pain. The patient was diagnosed as a case of Anaphylactic Reaction associated with the co-administration of Diclofenac and Ofloxacin. Drugs were discontinued on the same day, and further management was started. The causality assessment of this case was possible as per the WHO-UMC causality assessment scale

Steroid-Induced Glaucoma in Asthma: A Case Report Highlighting the Steroid-Sparing and Disease-Modifying Potential of Allergen Immunotherapy

2025-01-16T11:55:42+00:00

Background: Glaucoma, a leading cause of irreversible vision loss, is a known adverse effect of corticosteroid therapy, including inhaled corticosteroids (ICS). This case highlights the rare occurrence of steroid-induced glaucoma in an asthma patient treated with ICS and the role of allergen immunotherapy (AIT) in achieving steroid-sparing and long-term disease control.

Case Summary: A 34-year-old male with asthma developed steroid-induced glaucoma twice while on budesonide/formoterol therapy, with elevated intraocular pressure (IOP) of 32 mm Hg and 28 mm Hg, respectively. Cessation of ICS led to normalization of IOP. Due to intolerance to ICS, he was initiated on subcutaneous immunotherapy (SCIT) for house dust mite allergens. Over three years of SCIT, the patient achieved effective asthma control without requiring ICS or other controller medications. Post-SCIT, he reported only two minor exacerbations managed with short-acting beta-agonists.

Discussion: Causality assessment using WHO-UMC criteria and the Naranjo algorithm confirmed the association between ICS and glaucoma. SCIT provided a steroid-sparing alternative, reducing the need for pharmacotherapy and preventing the recurrence of steroid-related ocular complications. This case underscores the importance of pharmacovigilance in ICS use and highlights AIT's disease-modifying potential in asthma management.

Conclusion: This case illustrates the rare occurrence of ICS-induced glaucoma and emphasizes the role of AIT in achieving long-term asthma control while minimizing adverse effects of corticosteroids. Future research should further evaluate AIT as a viable therapeutic option for selecting asthma populations intolerant to ICS

Comparison of Efficacy of Prolonged Release Diclofenac Tablet, Zerodol - SP tablet, and Hot fomentation with Salt in the management of Acute Gout Attack

2025-01-16T11:58:44+00:00

A male in his thirties experienced an acute gout attack. Initially, physicians prescribed a combination tablet of paracetamol, aceclofenac, and serratiopeptidase, along with a topical diclofenac spray, but it did not provide full relief. Subsequently, he attempted hot fomentation with salt, which exacerbated his pain. Finally, after consulting with an orthopaedic specialist again, he opted for a prolonged-release diclofenac tablet, which ultimately alleviated his pain entirely.

A Case Report of Delayed-Onset Cardiotoxicity Following Long-Term Use of 5-Fluorouracil: Underlining the Importance of Long-Term Pharmacovigilance

2025-01-16T12:39:08+00:00

Pharmacovigilance is vital for the identification, evaluation, and mitigation of adverse drug reactions, especially those with delayed onset. 5-Fluorouracil (5-FU) is a widely used chemotherapeutic agent that has been a cornerstone in the management of various tumors. While generally well-tolerated, 5-FU is associated with a relatively rare side effect, cardiotoxicity, being clinically significant due to its potential for severe morbidity and mortality. A 40-year-old female patient with adenocarcinoma rectum treated with FOLFOX regimen presented in an unconscious state with lower GI bleed, low BP, and poor GCS to the emergency. Symptomatic treatment and multiple blood transfusions were given. Investigations revealed cardiomegaly, left-ventricular hypertrophy, mild mitral regurgitation, and a reduced ejection fraction (35%). Causality assessment was done, and patient was identified as a case of delayed-onset cardiotoxicity following long term use of 5-Fluorouracil. Patient was accordingly managed. The causality assessment of this case was possible as per the WHO-UMC causality assessment scale.

Fourth National Pharmacovigilance Week Celebration by ADR Monitoring Centre, JNMC, AMU, Aligarh

2025-01-16T12:02:29+00:00

Ministry of Health & Family Welfare, Government of India, launched a nationwide Pharmacovigilance Programme of India (PvPI) to monitor the safety of medicinal product in Indian population. Indian Pharmacopoeia Commission (IPC) is functioning as national Coordination Centre (NCC) to collate ADR reports and recommends Central Drug Standard Control Organization (CDSCO) for regulatory intervention.^1,2

In line with a mission to safeguard health of Indian population, in 2021 Government of India has taken an initiative to celebrate Nation Pharmacovigilance Week from 17th to 23rd September every year, which serves as platform for communication and knowledge enrichment to the various stake holders in the field of safety of medicinal product for ultimate benefit of patients.³

ADR Monitoring Centre (AMC), Jawaharlal Medical College & Hospital (JNMCH), Aligarh Muslim University (AMU), Aligarh is one of the AMC running under PvPI since 2011. This year AMC, JNMCH, AMU celebrated the 4th “National Pharmacovigilance Week” from 17th -23rd September 2024 with the designated theme "Building ADR reporting Culture for patient safety" as per the directives of PvPI, IPC, Ministry of Health & Family Welfare, Government of India. A total of 1015 participants attended the week-long programme.⁴