Assessment of Adverse Drug Reactions to NSAIDs: A Hospital Survey

Pharmacovigilance:

Pharmacovigilance, a vital component of healthcare, involves the science and activities aimed at detecting, evaluating, understanding, and preventing adverse effects or other drug-related issues. The main objective is to ensure the safety and effectiveness of pharmaceutical products throughout their entire lifecycle. This field developed in response to the necessity for systematic drug safety monitoring, especially after significant incidents of adverse drug reactions, such as the thalidomide tragedy in the 1960s, which highlighted the critical need for thorough post-marketing drug surveillance. The World Health Organization (WHO) describes pharmacovigilance as "the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem," emphasizing its proactive approach to identifying not only adverse drug reactions (ADRs) but also other drug-related issues like medication errors, product quality problems, and reports of inefficacy. Various stakeholders, including pharmaceutical companies, healthcare professionals, regulatory authorities, and patients, participate in pharmacovigilance activities such as adverse event reporting, signal detection, risk assessment, and risk management. The integration of advanced methods like data mining and big data analytics has significantly enhanced the capability to identify potential safety signals from extensive and diverse data sets. By ensuring that marketed medicines are safe and effective, pharmacovigilance plays a crucial role in protecting public health. Ongoing monitoring and evaluation of drug safety data are essential for mitigating risks, promoting safe medication use, and ultimately improving patient outcomes[1,2].

Nonsteroidal Anti-inflammatory Drugs (NSAIDs):

Nonsteroidal anti-inflammatory drugs (NSAIDs) are a group of medications commonly used to alleviate pain, reduce inflammation, and lower fevers. These drugs are often prescribed for conditions like arthritis, muscle pain, headaches, and menstrual cramps. The mechanism of action for NSAIDs involves blocking the cyclooxygenase (COX) enzymes, which play a role in the production of prostaglandins, substances that cause inflammation, pain, and fever. Specifically, NSAIDs inhibit the activity of two COX enzymes: COX-1, which is important for protecting the stomach lining, kidney function, and blood clotting, and COX-2, which is more directly involved in inflammation and pain. By reducing the production of prostaglandins, NSAIDs help decrease inflammation and pain. However, this inhibition can result in side effects like gastrointestinal problems and an increased risk of bleeding.

Commonly Used NSAIDs:

Ibuprofen (Advil, Motrin): Commonly utilized for alleviating mild to moderate pain, reducing inflammation, and lowering fever.

Naproxen (Aleve, Naprosyn): Favored for its prolonged effects, especially for managing chronic conditions such as arthritis.

Aspirin: Extensively employed for pain and inflammation relief, also administered in low doses to help prevent heart attacks and strokes.

Diclofenac (Voltaren): Generally prescribed for inflammatory diseases and certain arthritis forms.

Celecoxib (Celebrex): A COX-2 selective inhibitor that aims to minimize gastrointestinal side effects while offering pain relief.

Therapeutic Uses:

• Osteoarthritis and Rheumatoid Arthritis: To alleviate joint pain and inflammation.
• Acute Pain Conditions: Including pain after surgery, dental pain, and injuries to muscles and bones.
• Chronic Pain Conditions: Such as persistent lower back pain and long-lasting headaches.
• Fever Reduction: To decrease high fevers in various febrile illnesses.
• Cardiovascular Protection: Low-dose aspirin is commonly used to prevent heart attacks and strokes in people at high risk.

Side Effects and Risks:

• Gastrointestinal Issues: Including stomach ulcers, bleeding, and gastritis. This is due to the inhibition of COX-1, which protects the stomach lining.
• Cardiovascular Risks: Increased risk of heart attack and stroke, particularly with long-term use of certain NSAIDs.
• Renal Impairment: Potential for kidney damage, especially in individuals with pre-existing kidney conditions.
• Hypersensitivity Reactions: Such as asthma exacerbations and allergic reactions.
• Increased Bleeding Risk: Due to the inhibition of platelet aggregation  .

Management of Side Effects:

• Concurrent Use of Gastroprotective Medications: Including proton pump inhibitors (PPIs) or H2 blockers to safeguard the stomach lining.
• Administration of Selective COX-2 Inhibitors: Medications like celecoxib are aimed at minimizing gastrointestinal side effects while offering anti-inflammatory benefits.
• Ongoing Monitoring and Check-ups : Regular assessments of kidney function and blood pressure, particularly for long-term NSAID users.
• Patient Education: Ensuring patients are informed about proper usage, potential side effects, and the significance of following prescribed dosages.

METHOD:

The Study was conduct from 14 Feb to 2 May, at three hospitals Yash Clinic, Spandan Hospital and Shree Clinic of Sangli and Kolhapur District of Maharashtra India, 1634 km from the capital city of New Delhi.

RESULT AND DISCUSSION:

Table No. 1 No. of patient having adverse effect

A total of 100 patients participated in the final analysis, with ages ranging from 28 to 56 years, and a male predominance of 62%. The study reveals that gastrointestinal problems such as indigestion, stomach pain, and acidity are the most frequent side effects of NSAIDs among users in India. Other commonly reported adverse effects include nausea, headaches, and abdominal burning sensations. The findings emphasize the need for monitoring and managing these side effects to enhance patient compliance and outcomes in NSAID therapy. Regular follow-ups and educating patients about the potential side effects of NSAIDs can help mitigate these adverse effects and ensure safer use of these medications. Vomiting was reported by 18.2% of the participants, which can be particularly distressing and may lead to discontinuation of NSAID therapy if not managed properly. Nausea was experienced by 25.32% of respondents, making it one of the more frequent side effects. This symptom often accompanies gastrointestinal disturbances and can significantly affect patient adherence to NSAID treatment. Swelling of the face, reported by 5.9% of participants, is a less common but notable side effect, possibly indicating an allergic reaction or hypersensitivity to NSAIDs. Skin rashes were reported by 10.75% of users, with these dermatological reactions varying in severity and potentially necessitating discontinuation of the drug if severe. Indigestion was the most commonly reported side effect, affecting 35.14% of participants, highlighting the significant impact of NSAIDs on the digestive system. Body swelling was reported by 3% of the participants; while less common, this side effect can indicate fluid retention and requires monitoring, especially in patients with cardiovascular conditions. Abdominal pain was experienced by 17.12% of participants, reflecting the gastrointestinal irritation commonly associated with NSAID use. Mouth ulcers were reported by 15.27% of respondents, which can be painful and may affect the patient's ability to eat and speak comfortably. Dyspnea was reported by 7% of participants; this side effect can be serious, especially in patients with pre-existing respiratory conditions, and warrants prompt medical attention. Stomach pain was reported by 30.60% of respondents, indicative of NSAID-induced gastrointestinal irritation and a common reason for discontinuation. Heartburn, affecting 9.11% of participants, is another gastrointestinal symptom that can significantly affect the quality of life. Acidity was reported by 28.13% of the respondents, underscoring the impact of NSAIDs on gastric acid production and the potential for developing peptic ulcers. Headaches were reported by 22.58% of participants. Although NSAIDs are often used to treat headaches, they can sometimes paradoxically induce headaches. Burning sensations in the abdomen were reported by 20.24% of participants, further highlighting the gastrointestinal side effects associated with NSAID use. Notably, 7% of the participants reported experiencing no side effects from NSAID use, suggesting that while side effects are common, a subset of users may tolerate these medications well.

Fig No. 1 NSAID Drug Prescribed by Doctors

This report conducts a comparative assessment of the effectiveness of several NSAID drugs: Combiflam, Naprosyn, Ibuprofen, Meloxicam, and Diclofenac. The study evaluates their effectiveness in terms of pain relief percentages, reflecting the extent of pain reduction experienced by patients after administration. Among the drugs analyzed, Ibuprofen showed the highest pain relief at 24%. Diclofenac was the second most effective with a 20% pain reduction, followed by Naprosyn with 14%. Combiflam and Meloxicam were less effective, achieving pain relief of 10% and 12%, respectively. The findings indicate that Ibuprofen is the most effective NSAID for pain relief, with Diclofenac and Naprosyn also providing significant relief. Nevertheless, individual patient factors and medical conditions must be considered when choosing an appropriate NSAID.

Table No. 2 Level of Adherence