Volume & Issue: Volume 5, Issue 3, Summer 2016, Pages 149-225 
Number of Articles: 15
Prescription to over-the-counter switches in the United States

Prescription to over-the-counter switches in the United States

Pages 149-154

Jongwha Chang, Allison Lizer, Isha Patel, Deepak Bhatia, Xi Tan, Rajesh Balkrishnan

Abstract As the role of the pharmacist becomes more patient and counseling-centered, the healthcare market is changing to keep pace with more modern needs, such as self-treatment. Self-treatment provides patients the ability to diagnose their own condition and pick an appropriate medication from the pharmacy to treat their symptoms. This process allows a certain freedom for consumers to actively engage in their own health. In order for patients to self-treat, access to over-the-counter (OTC) medication is of prime importance. Many medications that are available as OTC today were previously labeled as prescription medications. As more safety studies and trials are conducted for different drugs, they can be deemed appropriate for use without a prescription. This review study discusses the process of switching of prescription medications to OTC medications in the United States and the implications of switching on patients, practitioners, drug makers, and insurers.

Pharmaceutical laws and regulations in Iran: An overview

Pharmaceutical laws and regulations in Iran: An overview

Pages 155-161

Pardis Zaboli, Amir Hashemi-Meshkini, Mehdi Varmaghani, Hadi Gholami, Iman Vazirian, Hedieh-Sadat Zekri, Shahriar Eslamitabar, Abbas Kebriaeezadeh, Puttaswamy Ganashree, Krishnaswamy Bhuvana, Narayana Sarala

Abstract The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy.

Critical review of drug promotional literature using the World Health Organization guidelines

Critical review of drug promotional literature using the World Health Organization guidelines

Pages 162-165

. Puttaswamy Ganashree, . Krishnaswamy Bhuvana, . Narayana Sarala

Abstract Objective: Drug promotional literatures (DPLs) are used as a promotional tool to 
advertise new drugs entering the market to doctors. The objective of the present 
study is to evaluate the accuracy of DPLs by using the World Health Organization 
(WHO) criteria.
Methods: An observational study was conducted from March to August 2014. The DPLs 
were collected from various departments at R.L. Jalappa Hospital and Research Centre 
attached to Sri Devaraj Urs Medical College, Kolar, India. The literature was evaluated 
based on 11 criteria laid down by the WHO.
Findings: Two‑hundred DPLs were evaluated. Cardiovascular drugs (34 [17%]) were 
promoted the most, followed by antidiabetic drugs (31 [15.5%]) and antimicrobial 
agents (29 [14.5%]). Single drug was promoted in 134 (67%) and fixed drug 
combination in 66 (33%) brochures. Manufacturer’s name was mentioned in 
194 (97%), but their address was mentioned in 109 (54.5%) claims only. Drug cost 
was revealed only in 12 (6%) DPLs. Each ingredient’s generic name, brand name, 
and dosage form were mentioned in 197 (98%) brochures. Indication for use was 
stated in 193 (96.5%) claims. Contraindications, adverse effects, precautions, and 
drug interactions were listed in 68 (34.5%), 65 (32.5%), 65 (32.5%), and 58 (29%) 
advertisements. References were cited in 133 (66.5%) brochures. Only 63 (31.5%) 
literatures had relevant pictures of drugs being promoted and 59 (29.5%) had a 
graphical representation of pharmacological properties. A total of 131 (69%) DPLs 
followed 50% of the WHO criteria.
Conclusion: Majority of DPLs satisfied only half of the WHO criteria for rational drug 
promotion and none of them fulfilled all the specified criteria. Incomplete or exaggerated 
information in DPLs may mislead and result in irrational prescription. Therefore, 
physicians should critically evaluate DPLs regarding updated scientific evidence required 
for quality patient care.

Tenofovir in treatment of Iranian patients with chronic hepatitis B virus infection: An open‑label case series

Tenofovir in treatment of Iranian patients with chronic hepatitis B virus infection: An open‑label case series

Pages 166-170

. Behrooz Ataei, . Mahsa Khodadoostan, . Babk Pouria, . Peyman Adibi

Abstract Objective: Tenofovir is among the first‑line treatments for chronic hepatitis B (CHB) 
virus infection. We evaluated the efficacy and safety of Tenofovir in treatment of Iranian 
patients with CHB.
Methods: Forty treatment‑native patients with CHB but without concurrent hepatitis C or 
human immunodeficiency virus infections were treated with Tenobiovir(™) 300 mg/day. 
The hepatitis B virus (HBV) DNA load, hepatitis B e antigen (HBe Ag), anti‑hepatitis B 
e antibody (HBe Ab), liver enzymes, and creatinine were measured before and at least 
3 months after the treatment.
Findings: The mean age of patients was 38.1 ± 12.4 years and 65% of them were 
male. Seventeen (42.5%) patients were HBe Ag‑positive and 15 (37.5%) patients had 
alanine aminotransferase (ALT) of two times above the normal. The HBV DNA load was 
significantly decreased after the treatment(P < 0.001). Twenty‑seven (67.5%) patients 
had viral load of ≤2000 IU/ml and 22 (55%) patients had undetectable HBV DNA level 
after the treatment. Among positive HBe Ag patients, the HBe Ag became negative in 
15 (88.2%) patients after the treatment and HBe Ab became positive in 3 (17.6%) 
patients. Liver enzymes’ levels were significantly decreased after the treatment(P <0.05) 
and ALT transaminase level became normalized in 86.7% (13 out of 15) of cases with 
baseline levels twice the normal.
Conclusion: Treatment response rate to Tenofovir in Iranian patients with CHB was high. 
The virological and serological response rate and safety of Tenofovir in our population 
was comparable to other populations. Considering availability and costs, Tenobiovir(™)
could be recommended as the first‑line therapy of chronic HBV infection in Iran.

Effect of antiepileptic drug therapy on thyroid hormones among adult epileptic patients: An analytical cross‑sectional study

Effect of antiepileptic drug therapy on thyroid hormones among adult epileptic patients: An analytical cross‑sectional study

Pages 171-174

. Mangaiarkkarasi Adhimoolam, . Ranjitha Arulmozhi

Abstract Objective: The objective of the study was to evaluate and compare the effect of 
conventional and newer antiepileptic drugs (AEDs) on thyroid hormone levels in adult 
epileptic patients.
Methods: A hospital‑based, analytical cross‑sectional study was conducted among 
the adult epileptic patients receiving conventional AEDs (Group 2) or newer 
AEDs (Group 3) for more than 6 months. Serum thyroid hormone levels including free 
triiodothyronine (fT3
), free thyroxine (fT4
), and thyroid stimulating hormone (TSH) were 
analyzed and the hormonal status was compared with healthy control subjects (Group1).
Findings: Sodium valproate and phenytoin were commonly used conventional 
AEDs; levetiracetam and topiramate were common among the newer drugs. There 
was a statistically significant decrease in serum fT4 and increase in serum TSH 
levels (P < 0.0001) in patients on long‑term therapy with conventional antiepileptic 
agents than in the control group. No significant change in thyroid hormone levels (fT3

fT4, and TSH; P = 0.68, 0.37, and 0.90, respectively) was observed with newer 
antiepileptics‑treated patients when compared to control group. One‑way analysis of 
variance followed by post hoc Dunnett’s test was performed using SPSS version 17.0 
software package.
Conclusion: The present study showed that conventional AEDs have significant 
alteration in the thyroid hormone levels than the newer antiepileptics in adult epileptic 
patients.

Malaria rapid diagnostic test evaluation at private retail pharmacies in Kumasi, Ghana

Malaria rapid diagnostic test evaluation at private retail pharmacies in Kumasi, Ghana

Pages 175-180

. Rauf Audu, . Berko Panyin Anto, . George Asumeng Koffuor, . Akua Afriyie Abruquah, . Kwame Ohene Buabeng

Abstract Objective: Malaria rapid diagnostic test(MRDT) provides a good alternative to malaria 
microscopy diagnosis, particularly in resource‑constrained settings. This study therefore 
evaluated MRDT in private retail pharmacies (PRPs) as a critical step in community 
case malaria management.
Methods: In a prospective, cross‑over, validation survey at six PRPs in the Ashanti 
Region of Ghana, 1200 patients presenting with fever in the preceding 48 h were 
sampled. Fingerstick blood samples were collected for preparation of thick and thin 
blood films for malaria microscopy. Categorized patients (600 each) went through the 
processes of MRDT or presumptive diagnosis (PD) of malaria. The malaria disease 
prevalence of the study area was established. Selectivity (Se), specificity (Sp), positive 
predictive value (PPV) along with false discovery rate (FDR), and negative predictive 
value (NPV) along with the false omission rate (FOR), and diagnostic odds ratio (DOR) 
of MRDT were then calculated.
Findings: While 43.0% tested positive using the MRDT, 57.0% tested negative. However, 
62.0% MRDT‑negative patients in addition to all the MRDT positives were given 
artemether‑lumefantrine. Of those diagnosed by PD, 98.2% were prescribed with an 
antimalarial (microscopy however confirmed only 70.3% as positive). Se and Sp of the 
MRDT were 90.68 ± 11.18% and 98.68 ± 1.19%, respectively. Malaria prevalence was 
estimated to be 43.3%. PPV was 98.0%, FDR was 2.0%, NPV was 98.0%, FOR was 2.0%, 
and DOR was 2366.43.
Conclusion: Results highlighted good performance of MRDTs at PRPs which could 
inform decision toward its implementation.

Quality of life in relapsing‑remitting multiple sclerosis patients receiving CinnoVex compared with Avonex

Quality of life in relapsing‑remitting multiple sclerosis patients receiving CinnoVex compared with Avonex

Pages 181-185

. Nahid Hatam, . Peivand Bastani, . Rahil Sadat Shahtaheri

Abstract Objective: There is an increasing recognition among clinicians and researchers that 
the impact of chronic illnesses and their treatments must be assessed in terms of their 
quality of life (QoL) in addition to more traditional measures of clinical outcomes. The 
aim of this study was to compare the QoL in patients with relapsing‑remitting multiple 
sclerosis (RRMS) using Avonex or CinnoVex.
Methods: We conducted a cross‑sectional study on one hundred patients with 
RRMS, fifty and fifty patients were being treated with Avonex (Biogen Idec, USA) and 
CinnoVex (CinnaGen, Iran), respectively. We used a disease‑specific questionnaire for 
MS (Multiple Sclerosis Quality of Life‑54 [MSQoL‑54]). Both groups were tested for 
significant differences regarding sociodemographic. A multiple linear regression model 
was constructed to find factors that affected the different aspect of QoL of the whole 
sample of patients.
Findings: MS groups did not differ in physical and mental health composite scores 
as well as relative scales. The results of regression models for each subscale showed 
that age, marriage, and Expanded Disability Status Scale were associated with several 
subscales of the MSQoL‑54 (P < 0.05).
Conclusion: In this study, it was seen that there are no significant differences between 
QoL of Avonex and CinnoVex, but a limitation in our study the results may be different 
in other countries and even various areas in Iran.

Adherence to stress‑related mucosal damage prophylaxis guideline in patients admitted to the Intensive Care Unit

Adherence to stress‑related mucosal damage prophylaxis guideline in patients admitted to the Intensive Care Unit

Pages 186-192

. Niloofar Rafinazari, . Saeed Abbasi, . Shadi Farsaei, . Marjan Mansourian, . Peyman Adibi

Abstract Objective: Concern about adverse effects of the inconsistent use of stress‑related 
mucosal damage prophylaxis in intensive care unit (ICU) is increasing. Hence, this 
study was designed to prospectively evaluate the rate of inappropriate stress ulcer 
prophylaxis (SUP) administration upon ICU admission, at ICU discharge and determine 
the adherence to American Society of Health‑System Pharmacists (ASHP) guideline 
during ICU stay.
Methods: In this study, 200 patients were randomly selected from all ICU admissions 
during 9 months. Risk factors of stress ulcer were recorded daily during ICU stay and 
appropriateness of SUP administration was assessed according to the ASHP criteria.
Findings: Of all 160 (80%) patients who received SUP, 44.4% did not have indication; 
and among 95 patients with an indication for SUP administration, 6.3% did not receive 
it upon ICU admission. Consequently, 77 (38.5%) of 200 patients received inappropriate 
prophylaxis on ICU admission. In addition, 53.5% of patients had appropriate adherence 
to ASHP guideline during all days of ICU stay (44% and 2.5% of patients received SUP 
more than 120% and <80% of appropriate SUP duration, respectively). Moreover, 81.2% 
were continued on inappropriate prophylaxis upon transfer from the ICU.
Conclusion: We concluded that although SUP administration included both 
overutilization and underutilization in this ICU, but high prevalence of SUP 
overutilization caused unnecessary hospital costs, personal monetary burden, and may 
increase adverse drug reactions. Therefore, educating physicians and cooperation of 
clinical pharmacists regarding implementing standard protocols could improve patterns 
of SUP administration.

The use of sunscreen products among final year medicine and pharmacy students: A cross‑sectional study of knowledge, attitude, practice, and perception

The use of sunscreen products among final year medicine and pharmacy students: A cross‑sectional study of knowledge, attitude, practice, and perception

Pages 193-199

. Ammar Ihsan Awadh, . Shazia Jamshed, . Ramadan M. Elkalmi, . Hazrina Hadi

Abstract Objective: To evaluate the knowledge, attitude, perception, and practice of medical and 
pharmacy students toward the usage of sunscreen as protection for the skin against 
ultraviolet (UV) radiation.
Methods: This cross‑sectional study was conducted among final year medical and 
pharmacy undergraduates at the International Islamic University Malaysia. Validated 
questionnaires were distributed to 134 medical students and 100 pharmacy students. 
Descriptive and inferential statistics were used where appropriate.
Findings: One hundred and sixty‑one out of 234 participants completed the 
questionnaires. The participants comprised 101 medical students (75.4%) and sixty 
pharmacy students (60.0%). The majority of the respondents were females (102; 63.4%), 
and 59 (36.6%) were males. The median of the knowledge scores of the final year 
medical students was significantly lower than that of the final year pharmacy 
students (P < 0.001). The female students showed significantly higher knowledge scores 
than the male students (P = 0.027). This study reported that 24 (39.3%) pharmacy 
students were influenced by the media to use sunscreen, whereas 35 (34.7%) medical 
students were influenced the most by friends to use sunscreen. The final year pharmacy 
students had a better perception compared to the medical students, with the total 
perception score of the final year pharmacy students being significantly higher than 
that of the final year medical students (P = 0.020). Most of the participants were also 
aware of the harmful effects of UV radiation and had a positive reaction toward the 
usage of sunscreen to prevent those harmful effects.
Conclusion: The knowledge and perception of final year pharmacy students were 
significantly higher than the knowledge and perception of final year medical students 
with regard to the usage of sunscreen.

Evaluation of knowledge, attitude, and practice of community pharmacists toward administration of over‑the‑counter drugs for the treatment of diarrhea in children: A pretest–posttest survey

Evaluation of knowledge, attitude, and practice of community pharmacists toward administration of over‑the‑counter drugs for the treatment of diarrhea in children: A pretest–posttest survey

Pages 200-204

. Farzaneh Foroughinia, . Pedram Zarei

Abstract Objective: In this study, we aimed to assess knowledge, attitude, and practice of 
community pharmacists toward administration of over‑the‑counter (OTC) antidiarrheal 
drugs in our city pharmacies, Shiraz, Iran.
Methods: In this descriptive cross‑sectional study, 90 pharmacies among 128 pharmacies 
in our city were randomly chosen. The study was designed into two phases: A standard 
questionnaire to determine the level of knowledge and attitude of pharmacists and a 
simulated client method to evaluate practice among them. An educational pamphlet was 
then given to the pharmacists. One month later, knowledge, attitude, and performance 
of studied pharmacists were evaluated again using the same method.
Findings: Our results showed that an average consultation time by female pharmacists 
was considerably more than male pharmacists (P < 0.001). Before intervention, only 
37.8% of pharmacists performed appropriately by prescribing the proper medicine 
while this increased to 58.44% after intervention. The average score of pharmacists’ 
knowledge was statistically increased (P < 0.001) and the pharmacists’ performance 
was significantly improved (P < 0.001) after the educational intervention. In related 
to the attitude, pharmacists’ tendency toward prescribing oral rehydration salt 
solutions (ORS)(P < 0.001) and their belief about the great effect of ORS on the treatment 
of diarrhea increased significantly after the intervention.
Conclusion: It is concluded that training programs such as educational pamphlets and 
continuing educational seminars may play important roles in increasing pharmacists’ 
knowledge and therefore improving their performance in prescribing OTC medicines.

Clinical outcomes of a diabetes education program for patients with diabetes mellitus in the Micronesian community in Hawaii

Clinical outcomes of a diabetes education program for patients with diabetes mellitus in the Micronesian community in Hawaii

Pages 205-211

. Mok Thoong Chong

Abstract Objective: Hawaii has diverse population made up of a cultural mix of different races. 
Due to different cultural and social influences and language barrier, many of the 
under‑served population who migrated to Hawaii and having diabetes mellitus may 
be susceptible to long‑term complications due to uncontrolled hyperglycemia and 
medication nonadherence. The purpose of this study was to evaluate the impact of a 
diabetes education program on the clinical outcomes in patients with diabetes mellitus 
in the Micronesian community of Hawaii.
Methods: This study included patients over age 18 years, with a diagnosis of type 2 
diabetes mellitus. The diabetes education program was customized for its weekly 
classes to fit to the under‑served population. Data were collected on participants on 
the 1st day and then 6 months after attending the education program. Data on primary 
and secondary endpoints were collected and analyzed.
Findings: The mean glycosylated hemoglobin A1c, fasting blood glucose, and triglyceride 
levels of participants fell significantly from baseline after attending the diabetes 
education program for 6 months. No significant changes were observed in other 
secondary outcomes during the study time period.
Conclusion: Based on our findings, the diabetes education program that was tailored 
to the Micronesian population was successful in achieving glycemic goals, enhancing 
medication adherence, improving clinical outcomes, and also preventing long‑term 
complications among its participants.

Ganciclovir use evaluation in kidney transplantation departments

Ganciclovir use evaluation in kidney transplantation departments

Pages 212-214

. Maryam Mozaffar, . Shahrzad Shahidi, . Shirinsadat Badri

Abstract Objective: In this study, we evaluated certain aspects of the usage and administration 
of one lifesaving, high‑cost medication, i.e., Ganciclovir for the prevention and treatment 
of cytomegalovirus (CMV) infection in transplant patients.
Methods: This study was performed from 2013 to 2015 by conducting a medication use 
evaluation (MUE) program in the kidney transplantation departments of two tertiary 
care hospitals in Isfahan, Iran. The MUE criteria for the drug were developed by applying 
drug information references. In every category of data, the number (percent) of cases, in 
which drug therapy was in accordance with the predetermined criteria, was calculated.
Findings: During the study period, 67 cases were observed. The only documented drug 
interaction was the minor interaction of Ganciclovir with mycophenolate mofetil in 77% 
of the patients. In all patients, intravenous (IV) infusion was the route of administration, 
mainly in the peripheral veins. Four patients showed adverse drug reaction, which leads 
to Ganciclovir discontinuation. Ganciclovir was administered despite contraindication 
in 34.3% of the patients.
Conclusion: In this study, we faced a relatively unacceptable situation, in which 
Ganciclovir is handled somehow inappropriately. It seems necessary to develop an 
updated local guideline to approximate the administering pattern of such costly 
medications to standard protocols.

Dapsone‑induced pure red cell aplasia and cholestatic jaundice: A new experience for diagnosis and management

Dapsone‑induced pure red cell aplasia and cholestatic jaundice: A new experience for diagnosis and management

Pages 215-218

. Kamal Kumar Sawlani, . Shyam Chand Chaudhary, . Jitendra Singh, . Deep Chandh Raja, . Sanjay Mishra, . Madhu Mati Goel

Abstract Dapsone (4,4’‑diaminodiphenylsulfone) is the parent compound of the sulfones, and it 
has potent antiparasitic, anti‑inflammatory, and immunomodulatory effects. It is used 
in the treatment of leprosy, dermatitis herpetiformis, and prophylactically to prevent 
Pneumocystis pneumonia and toxoplasmosis in patients unable to tolerate trimethoprim 
with sulfamethoxazole. We hereby report a case of dapsone toxicity who developed pure 
red cell aplasia and cholestatic jaundice in a suspected case of dermatitis herpetiformis. 
Patient had an excellent response to corticosteroids after withdrawal of dapsone.

Attitude of nurses and pharmacists on adverse drug reactions reporting in selected hospitals in Sokoto, Northwest Nigeria

Attitude of nurses and pharmacists on adverse drug reactions reporting in selected hospitals in Sokoto, Northwest Nigeria

Pages 219-221

. Muhammad Tukur Umar, . Shaibu Oricha Bello, . Aminu Chika, . Oche Mansur Oche

Abstract Objective: Objective of this study was to assess the attitude of nurses and pharmacists 
towards adverse drug reactions (ADRs) reporting.
Methods: The questionnaire was designed based on extended “Inman seven deadly 
sins.” Two hundred and seventy‑two respondents were selected by stratified sampling 
technique. The questionnaires were delivered to the respondents at their places of 
practice. The data generated were analyzed by Sigma XL Software Inc.
Findings: There was no statistically significant relationship between demographic 
profiles and reporting attitude except for qualification. On extended “Inman seven 
deadly sins” awareness of reporting protocol and nearby center for ADRs reporting 
were low 27.3 and 7.5%, respectively. However, respondents’ score on components of 
attitude of ADRs reporting is generally encouraging. On comparative basis, no statistical 
significance exists between pharmacists and nurses.
Conclusion: The study showed that attitude of respondents towards ADRs reporting is 
good. However, there is a need for targeted health education intervention among these 
cadres of health‑care professionals, especially on aspects of awareness of reporting 
protocol and reporting center.

A study of medication‑related problems in stroke patients: A need for pharmaceutical care

A study of medication‑related problems in stroke patients: A need for pharmaceutical care

Pages 222-225

. Viswa Srujani Kanagala, . Annapareddy Anusha, . Bhukya Srinivasa Rao, . Siva Reddy Challa, . Krishna Sri Nalla, . Raja Sree Gadde

Abstract Objective: The study was aimed to assess the incidence and characteristics of 
drug‑related problems (DRPs).
Methods: A prospective, observational study was conducted among 133 patients with 
stroke disease who were aged 18 years or older and admitted to the general medicine 
ward. During the 6 months study period, the incidence of DRPs was identified using the 
Pharmaceutical Care Network Europe Foundation classification system, version 6.2.
Findings: A total of 133 patients were screened for DRPs. Among them, 120 patients 
have at least one DRP. A total of 254 DRPs were identified (on average, 2.015 DRPs per 
each patient case).
Conclusion: Increasing the evidence of the incidence of medication‑related problems in 
tertiary care hospitals indicates the need for the establishment of a clinical pharmacist 
in hospital settings.