Kheirollah Gholami, Professor
Journal of Pharmaceutical Care is an open access journal officially published by the Research Center for Rational Use of Drugs (RCRUD) of the Tehran University of Medical Sciences, and Iranian Society of Clinical Pharmacists which is focused on experimental and clinical pharmaceutical practices to present researches, hot topics, requirements and regulations of the pharmaceutical practice area. Manuscript in Clinical Pharmaceutical Practice, Pharmaceutical Care Regulations, Pharmaceutical Care in hospitals and community pharmacies, Pharmacotherapy, Pharmacoepidemiology, Pharmacogenomics, Pharmacokinetics, Pharmacoeconomics, Clinical pharmacokinetics, Drug Utilization Evaluation review, Medication safety, Drug and Poison Information Services and Health services research are welcome.Content includes Original Articles, Systematic Review or Meta-Analysis, Review Articles, Case Reports and Letters to the Editor.
JPC is an open access, peer-reviewed, and quarterly journal that considers for publication articles in all fields and specialties ofpharmaceutical care in English language. This journal has both online and print versions and no charges are levied for publication.
A Cross Sectional Study to Analyze Drug Utilization Pattern of Pain Clinic in a Tertiary Care Hospital of Central India
Background: Pain is associated with increased prevalence of chronic diseases which adversely affects the quality of life of patients. This also leads to increased demand of drugs for chronic pain relief. Drug utilization pattern studies of pain clinic are therefore important to ascertain rational use of medicines in healthcare system.The study aims to evaluate drug utilization pattern in pain clinic of a tertiary care teaching hospital.
Methods: A cross sectional study was done by analyzing prescriptions of patients at pain clinic of MYH Hospital of Indore, MP, India, for a period of 3 months from November 2021 to January 2022. Total 260 prescriptions were analyzed on the basis of WHO core prescribing indicators, FDC (Fixed Dose Combinations) & NLEM (National List of Essential Medicines) list by using descriptive statistics.
Results: Study results showed that analgesics were most commonly prescribed in the age grou p 41-60 years. Lower back pain (28.8%) was the most common indication for prescribing analgesics in pain clinic with a female preponderance of 57.7%. Out of total 639 drugs, Fixed Dose Combinations (FDC)(76.2%) were more than single drugs (24.8%). 59.3% of drugs were concomitant medications. 80% (220) FDCs were generic and Gabapentin+Nortryptiline (31.8%) was the commonest FDC. Pregabalin was the most commonly prescribed single drug preparation. Average number of drugs per encounter were 2.45 and generic prescribing was 85.7%. Total 46% of medicines were prescribed from NLEM.
Conclusion: We found that FDC, generic prescribing and concomitant medications use was higher in our study. The study guides for rational prescribing of analgesics to maximize pain relief and minimize adverse effects associated with it.
An Investigation of Insulin Resistance and Cachexia Relation in Patients with Metastatic Gastrointestinal Malignancies
Background: Insulin resistance has been suggested as one of the known metabolic disorders during cachexia. This study hypothesized that cachexia in cancer patients might be related to insulin resistance as early as cachexia development.
Methods: This study was performed on 46 patients with metastatic gastrointestinal cancer. Anthropometric characteristics and biochemical markers were assessed at baseline, second and third month. Insulin resistance was assessed using the homeostasis model assessment-estimated insulin resistance (HOMA IR) method. SFQ-36 questions were used to assess the patients' quality of life at baseline, second and third months.
Results: Anthropometric characteristic was significantly associated between pre-cachectic and non-pre-cachectic patients in third month. Cholesterol (P-value = 0.93), albumin (P-value: 0.82), and serum creatinine (P-value = 0.88) in pre-cachectic patients decreased over three months. There was an increasing trend of insulin resistance between pre-cachectic and non-pre-cachectic patients in third month. Cholesterol had an upward trend with a significant relation in cachectic patients [(P-value = 0.00), (P-value = 0.03), (P-value = 0.01)]. We detected a decreasing trend of insulin resistance between cachectic and non-cachectic patients from second to third month (P-value = 0.04). SFQ evaluation had no significant relation with cachectic status.
Conclusion: Previous studies showed that the use of NSAIDs, progesterone’s, corticosteroids, COX-2 inhibitors, anabolic agents and drugs targeting inflammatory cytokines may be beneficial for improving of symptoms of cachexia. Significant relation between anthropometric variables with pre-cachexia and cachectic conditions was concluded. Patients' outcome and its relation with insulin resistance demonstrated a significant relation between the cachectic and non-cachectic patients in the third month. We also detected the increased serum cholesterol level in cachectic patients, moreover, higher cholesterol levels in expired cachectic patients than in the living.
Background: Varicella-Zoster virus (VZV) is the causative agent of herpes zoster, or "shingles." Most cases of acute herpes zoster are self-limiting, although the pain can cause significant suffering, and experience postherpetic neuralgia (PHN), particularly in older adults. Early treatment of herpetic neuralgia in the subacute phase may prevent PHN progression. This study aimed to evaluate the efficacy of memantine in the treatment of subacute neuropathic herpes zoster.
Methods: This randomized clinical trial was performed on sixteen patients aged 18-75 years with subacute herpetic neuralgia. Patients were randomly assigned to the intervention or control group according to the inclusion and exclusion criteria (8 in each group). The duration of the study was eight weeks. Patients in the memantine group received Gabapentin 300 mg per day and memantine 5 mg twice a day. Then, after one week, the memantine dose was tapered up to 10 mg twice a day. In the control group, patients received only Gabapentin from the first week to the end of the study. DN4 questionnaire is used to measure the severity of nerve pain. The patients of both control and intervention groups completed the questionnaire before starting the treatment and it was done again after the end of the treatment period (8 weeks).
Results: The results showed improvement in pain in patients who received Memantine along with Gabapentin in comparison with Gabapentin alone (P =0.001). Moreover, the DN4 questionnaire score evaluation indicated a significant difference only for the intervention group's Q1 variable in within-group analysis (P =0.031).
Conclusion: Co-administration of memantine with Gabapentin reduced the severity of subacute neuropathic herpes. In addition, memantine is expected to be a viable option for treating and relieving subacute and chronic nerve pain in patients.
Study of Drug Utilization Pattern during Second Wave of Covid-19 in a Tertiary Care Centre: A Retrospective Cross Sectional Study
Background: To study the drug utilization trends among patients with COVID-19 disease during the second wave in a tertiary care hospital.
Methods: A retrospective cross-sectional study was conducted in patients admitted in COVID-19 wards during second wave of SARS – COVID-19 pandemic from 1st March 2021 to 30th June 2021. A total of 300 prescriptions were analysed. Assessment of prescription patterns were done as per the WHO-The International Network for Rational Use of Drugs (INRUD)drug use indicators.
Results: A total of 3106 drugs were analysed.The average number of drugs prescribed was 11±5.1. The most frequent prescription was that of analgesic and antipyretic drug Paracetamol (95.26%) followed by vitamin C (94.74%) and multivitamins(87.89%) . Nearly all patients in this study received antibacterials, 68% received antivirals. Antibacterials commonly used were cephalosporins, amoxicillin- clavulanic acid combination and pipercillin –tazobactam combination. Antiviral drug Remdesivir was also used extensively in our study (54.21%). Other class of drugs which were commonly prescribed to more patients were Dalteparin (73.16%) and corticosteroids like methyl prednisolone (52.63%) and dexamethasone (51.05%). 35.68% of the drugs were prescribed with generic name .45.43% of the drugs were injectables . 2.96% of the drugs were prescribed as fixed dose combinations.
Conclusion: In summary, the drug utilization for hospitalized patients with COVID-19 was diverse but generally complied with the ongoing guidelines. The drug were mostly prescribed from WHO essential drug list and percentage of fixed dose combination prescription was low. However not prescribing the drugs by generic name and large encounters of injectable was matter of concern. To get a better glimpse of drug utilization a more extensive study needs to be undertaken.
Background: Non-alcoholic fatty liver disease (NAFLD) is one of the important health issues with high prevalence worldwide. However, there is no approved medication for that. As one of the indicators of metabolic syndrome, uric acid might play a role in the pathogenesis of NAFLD. In this study, we aimed to determine the correlation between serum uric acid level, liver enzymes, and ultrasonographic grading of NAFLD.
Methods: This cross-sectional study included patients aged 18-65 with NAFLD. Patients with other metabolic disorders and a history of using alcohol or medications that alter uric acid levels were excluded. The patients' serum uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels, and ultrasonographic grading of NAFLD at baseline, third month, and sixth month were collected.
Results: Of the 3000 patients, 500 patients met the eligibility criteria. The results showed that there is a significant positive relationship between ALT and serum uric acid level at the first (P = .01), third (P = .01), and sixth month (P = .01). Furthermore, there was a significant positive correlation between AST and serum uric acid level at the sixth month (P = 0.001). The comparison of 249 patients' ultrasonographic grading showed no significant correlation with serum uric acid levels.
Conclusion: To conclude, the serum uric acid level significantly correlates with ALT and AST over six months but not with the ultrasonographic grading. Further studies are required to determine the role of uric acid-lowering agents in the treatment of NAFLD.
Development of Thalassemia Medication Questionnaire (TMQ): An Instrument for Measuring Major Thalassemia Patients’ Knowledge and Practice Regarding their Medications
Background: Thalassemia is a congenital disease and Iran is as one of the countries in the thalassemia belt. It has a huge burden in Iranian national health budget. The aim of this study was to develop a questionnaire to assess the knowledge and practice of thalassemia patients toward their medications.
Methods: This is a methodological research, which was done from April 2020 to November 2021 in Tehran, Iran, to develop a valid and reliable instrument for measuring major thalassemia patients’ knowledge and practice regarding their medications, a questionnaire based on three iron chelating medications (deferoxamine, deferiprone, and deferasirox) developed. This process done by holding several expert panel meetings. This questionnaire was consisting of some aspects such as: administration, self-monitoring, miss dose, common interactions, and adverse events. Content validity index (CVI) and internal consistency and reliability were calculated.
Results: The CVI was as 0.76 for deferoxamine, 0.80 deferiprone and 0.88 for deferasirox questionnaire. Further analysis for internal consistency demonstrated satisfactory results with Cronbach’s alpha coefficients ranging from 0.743 to 0.781. Results showed Thalassemia Medication Questionnaire (TMQ) demonstrated acceptable validity and reliability for application.
Conclusion: It was concluded that TMQ could be a useful instrument to measure knowledge and practice about iron chelation therapy. The reason is the diverse range of questions and the simplicity, validity, reliability, and the practicability.
Polypharmacy is a growing public health problem which is affecting multitudes worldwide. This emerging public health problem is defined as the routine use of five or more medicines by an individual patient. Many researchers believe that the prevalence of polypharmacy is going to keep increasing since more people are being diagnosed with chronic diseases. Polypharmacy is known to cause many problems such as adverse drug reactions, drug to drug interactions, wastage of resources and increased treatment costs. Countries should raise awareness of polypharmacy and find solutions to this problem. Healthcare professionals should be educated on the dangers of polypharmacy, medication safety and polypharmacy management. Polypharmacy management means a whole systems approach which avoids the use of unnecessary medication for multimorbid patients while maximizing pharmaceutical care. There is ongoing research to investigate polypharmacy because very little is known in the existing literature. This article describes polypharmacy in detail, including the prevalence of polypharmacy, the economic impact of polypharmacy, medication safety and polypharmacy management. This article aims to give a much deeper insight into polypharmacy.
A Survey of Off-label and Unlicensed Antibiotic and Respiratory Medications Prescribed for Toddler Patients
Background: Many medications are unlicensed for use in toddlers and many drugs are prescribed as off-label in this age group. Different studies showed high prevalence of prescribing such medications in children. Prescribing off-labeled or unlicensed drugs can cause adverse drug events (ADEs) and harm to the patients. To evaluate the rate of off-label and unlicensed drugs prescribed for toddlers.
Methods: Out-patient prescriptions within the electronic database from a main governmental health insurance company in Tehran, Iran were evaluated for off-label and unlicensed drugs in a two-month period (November-December 2019).
Results: 5358 prescriptions for toddlers reached to the insurance database, of these, 461 prescriptions were randomly selected. Three hundred and fifty prescriptions contained antibiotics and/or respiratory medications, from them, 183 (52.3%) had at least one off-labeled or unlicensed medication.
Conclusion: Our study showed high rates of off-label and/or unlicensed medication use in pediatric population.
Stevens Johnson Syndrome is a rare autoimmune disorder which includes skin and mucous membrane. In India, the incidence of Stevens Johnson Syndrome (SJS) is 1.2 to 6 million patients per year. SJS is a very serious and life-threatening hypersensitivity reaction that can occurs due to infections (mycoplasma pneumonia) or as side effects of drugs (Sulfa Drugs, Phenytoin, Carbamazepine, Lamotrigine, Phenobarbital, Allopurinol, Piroxicam, Nevirapine and Diclofenac). Antibiotics can cause SJS and their contribution is around 40%. Fluoroquinolones are prescribed globally (11%) to treat lower respiratory tract infections, gastrointestinal and genitourinary infections. Norfloxacin and Ciprofloxacin are rarely associated with drug induced SJS. Most of the informative data, available on drugs induced SJS are based on case reports or case series. Here, we present three case reports of Fluoroquinolones induced SJS. In the following cases, patients had developed symptoms of SJS within two days. Whereas in Antibiotic induced SJS, it is reported that symptoms of SJS can appear within few days or even after a single dose of taking antibiotics. Therefore, we alleged that Fluoroquinolone could be the possible causative agent in our cases. The causality assessment had done based on the WHO-UMC causality scale and it was probable in all three cases of Fluoroquinolone induced SJS. This assessment generates a strong evidence that Fluoroquinolone induced SJS in all three cases. These patients were treated symptomatically with corticosteroids, parenteral solution and other non-pharmacologic agents and discharged after complete recovery.
The brain is one of the most sensitive organs to hypoxia and the most vulnerable to ischemia and vascular events. Zolpidem, as a GABA-A receptor agonist, has an inhibiting effect on the central nervous system. In this study, the possible side effects of zolpidem on brain perfusion were reported in a patient with zolpidem addiction. Moreover, the correlated literature has been reviewed. The patient was a 33-year-old man who was referred with a complaint of cognitive impairment, gait disturbance, confusion, and seizure. The patient reported taking the daily dose of 270 mg of zolpidem. He developed acute dystonia, rigidity, and bradykinesia during treatment with haloperidol in the psychiatric ward. Brain MRI and EEG were requested due to the prolongation of cognitive impairment and parkinsonism symptoms. The Neurologist utilized Brain MRA to determine the source of microvascular lesions found in the brain MRI. Unexpectedly, a reduction in Anterior Cerebral Artery (ACA) perfusion was detected after a comprehensive evaluation by Brain MRA. In addition, impairment of several cognitive domains was observed in the follow-up visit. Zolpidem could reduce cerebral perfusion in various vascular territories. It seems that in patients who take zolpidem with higher than therapeutic doses, vascular complications and a decreased cerebral perfusion have occurred, resulting in more neurological complications, including cognitive disorders and vascular events. A holistic investigation of the patient with zolpidem abuse and neurological symptoms would be recommended to determine the probable vascular complication of zolpidem.
Cycloserine Induced Psychosis, Insomnia and Suicidal Attempts in a Young Female Patient with Pre-Extensively Drug Resistant Tuberculosis
The World Health Organization classifies cycloserine as a group four second line anti tubercular drug for the treatment of drug resistant tuberculosis. Neuropsychiatric adverse drug reactions associated with cycloserine need more attention as they may compromise treatment success. Here, we report a case of cycloserine induced psychosis, insomnia and suicidal attempts in a young female patient with pre-extensively drug resistant tuberculosis (pre-XDR-TB). A 20-year-old female patient was prescribed longer oral XDR-TB regimen (high dose of moxifloxacin, cycloserine, linezolid, clofazimine, bedaquiline and pyridoxine). After fifteen days of treatment, patient developed changes in behaviour with frequent episodes of spontaneous and excessive laughing or crying. She also developed insomnia, started to hear voices and made two attempts of suicide. Following this, cycloserine was discontinued. Clonazepam and clomipramine were prescribed to her. Patient gradually recovered over a period of one month. Extreme caution with regular and close monitoring should be exercised while administering cycloserine because psychiatric adverse drug reactions could be associated with increased risk of poor drug adherence in drug resistant tuberculosis.
Appropriate levothyroxine (LT4) dosing is essential in hypothyroid patients to maintain biochemical and clinical euthyroidism, but achieving appropriate plasma concentration of LT4 can be complicated by numerous disease states, foods, supplements, and commonly prescribed medications such as calcium supplements, pantoprazole etc. that potentially interfere with intestinal LT4 absorption. About one-third of treated patients are not receiving adequate treatment, leading to decreased quality of life, increased morbidity, and even increased mortality. Hypothyroid patients treated with LT4 must be careful to avoid concomitant ingestion of such medicines or optimal gap must be ensured between ingestions to prevent drug-drug interactions and reduce absorption of LT4. We describe two such real life cases managed in our clinical pharmacology consultation facility to highlight the importance of systematically evaluating the drug-drug interactions of levothyroxine with commonly used concomitant medications and how deprescribing of the same can result in attainment of optimum thyroid replacement with lesser doses of LT4 with better patient outcome.