Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine

Qatmosh, Sandra A.; Koni, Amer; Qeeno, Baraa G.; Arandy, Dina A.; Abu-Hashia, Maysa W.; Al-hroub, Bahaa M.; Zyoud, Sa’ed H.

doi:10.1186/s12889-017-4782-x

Cited by 11 publications

(24 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Inadequate information in PPIs has been the scope for many studies around the world. A Palestinian study carried out 2017 comparing the PPIs of local and imported anti-hypertensive drugs concluded similar findings regarding adverse drug reaction, date of last revision, and inactive ingredients [17]. Another study conducted in Southern India indicated that the information mentioned in the analysed inserts were not sufficient to ensure safe drug utilisation, and it recommended to review current PPIs based on scientific guidelines [16].…”

Section: Discussionmentioning

confidence: 99%

“…The presence of any of the previously mentioned statements in either PPI was scored as one and its absence as zero, and then the calculation of total score for all anti-diabetic agents was done. Another method was used to evaluate PPIs by applying simple word counting of the major headings [11, 12, 17–19], which is an important method for evaluation of PPIs. Therefore, 17 heading and subheadings of both local and imported PPIs were evaluated for the quantity of information by using simple word counting.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

A comparative evaluation of medicine package inserts for oral antidiabetic agents in Palestine

2019

Self Cite

View full text Add to dashboard Cite

Background Patient package inserts (PPIs) should provide accurate, sufficient, and clear information for patients as well as health care professionals. The goal of this study was to evaluate and compare the PPIs of local and imported anti-diabetic agents in the Palestinian market. Methods Eighteen leaflets were collected and analysed based on the completeness of 31 criteria using a scoring method, then the quantity of information was assessed by applying word counting of 17 headings and subheadings. Statistical comparisons of the word count for all products were performed using the Mann-Whitney U test with mean ranks. Then the mean ranks for differences in word counts were adjusted to calculate the fold-difference statistic by dividing the higher mean rank by the lower mean rank. Results In general, the PPIs of imported agents scored better than local PPIs, but none of the inserts fulfilled the whole criteria. Thirteen out of thirty-one criteria were available in all products. None of these agents had provided any information about duration of use, instructions to convert tablets into liquids forms, pharmacokinetics, or shelf life. Moreover, mechanism of action and maximum dose were deficient in all local PPIs (0.0%), while they were included in 37.5 and 62.5% of imported PPIs, respectively. Furthermore, 90.0% of local PPIs lacked information about drug dose, 80.0% didn’t mention any instructions regarding effects on ability to drive or possibility of tablet splitting, and 60.0% didn’t involve orders about possibility of tablet crushing. Local PPIs provided inadequate and less detailed instructions regarding many aspects, since the estimated mean rank of local and imported PPIs demonstrated a range of difference from 1.04-fold for missing dose to 2.64-fold for warning and precautions. Conclusions Significant differences were being identified, with excellence being assigned to imported PPIs. So, it is worth suggesting some necessary modifications in PPI topography and sequence structure of local diabetic agents. Experts in Palestinian Ministry of Health should implement regulatory guidelines to improve the quality and quantity of information provided by local PPIs. This optimisation could become a step forward toward optimal health practice in our society.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

A comparative evaluation of medicine package inserts for oral antidiabetic agents in Palestine

2019

Self Cite

View full text Add to dashboard Cite

show abstract

“…The Palestinian Ministry of Health (MOH) requires that medication inserts be bilingual, in both Arabic and English, but does not give any recommendations about specific DIL designs, the quality of information or length of text [17–19]. It was noted that DILs of Palestinian-marketed medications contained incomplete and limited information compared with their counterparts marketed in other countries [5, 20–22]. Although some research has been done of the DILs of medications available in Palestine [5, 20], no study compared the the information provided by local and imported NSAIDS.…”

Section: Introductionmentioning

confidence: 99%

“…It was noted that DILs of Palestinian-marketed medications contained incomplete and limited information compared with their counterparts marketed in other countries [5, 20–22]. Although some research has been done of the DILs of medications available in Palestine [5, 20], no study compared the the information provided by local and imported NSAIDS. The reasons that NSAIDs were selected in this study is that they are among the most commonly dispensed medications in the Palestinian pharmacies, and these medications are usually dispensed as self-medications or sold over-the-counter (OTC) [23–25].…”

Section: Introductionmentioning

confidence: 99%

Comparative evaluation of drug information leaflets for non-steroidal anti-inflammatory drugs in Palestine: local versus imported products

Arandy

Abu-Hashia

Al-hroub

et al. 2019

BMC Health Serv Res

Self Cite

View full text Add to dashboard Cite

BackgroundDrug information leaflets (DILs) are written for patients and health care providers to show how to use the medications safely and effectively, in order to reach the required therapeutics outcomes. This comparative study was conducted to evaluate various DILs of non-steroidal anti-inflammatory drugs (NSAIDs) that are produced in Palestine, along with their imported equivalents.MethodsThirty-five DILs of NSAIDs were analyzed and evaluated in a cross-sectional comparative study. Thirty-one statements were obtained from literature and used; evaluation was performed on basis of both any presence or absence of these statements in the leaflets. 23 of the 31 statements that were available in both local and imported DILs were also evaluated in terms of total word-counts: the median (interquartile range) word-count for each statement was determined separately for the two groups and then compared. For the remaining 8 statements, this was not performed,either because they were not present in any leaflet, or because counting the number of words would not be meaningful.ResultsA total of 35 DILs for nine different active ingredients of NSAIDs were analyzed. In 97% of leaflets, “Instructions to convert medication into liquid forms” were missing and 94% did not provide any information about “Pharmacokinetics”. 83% of DILs provided no information about “Mechanism of action” and 74% did not mention any reliable references. 66% of the analyzed inserts did not include any instruction about the possibility of a tablet splitting. And in 63%, the “Date of last revision” was missing. Further, “Duration of using” and “Inactive ingredients” were not found in 51% of leaflets. In terms of word-count, the related sections of the 23 selected criteria were expressed with more words by imported leaflets compared with the local ones, significant differences were found in 12 categories, the highest significance of > 42.4-fold difference was found in “Geriatric considerations” category whereas 1.4-fold difference was found in “Shelf life,” being the lowest one.ConclusionsThis study shows that local products provide less information than imported products, so we recommend that appropriate measurements be taken by both Palestinian authorities and manufacturers to improve both quantity and quality of local DILs.

show abstract

“…Similar findings regarding the superiority of information in both the quality and quantity of imported over local medications were found in a recent study in Palestine. [23]…”

Section: Discussionmentioning

confidence: 99%

Evaluation of medication package inserts in Iran

et al. 2019

View full text Add to dashboard Cite

Objective: Package inserts (PIs) provide information for the safe and effective use of medication. There is no study on the evaluation of PIs in Iran. The purpose of this study was to evaluate the completeness of PIs supplied with the 100 top-selling medications in Iran. Methods: This cross-sectional observational study was conducted during 3 weeks in January 2017. One hundred medications were chosen from a list supplied by the Iran Food and Drug Administration (IFDA). The PIs were assessed for the presentation and completeness of quality criteria, which was consisted of two parts. The first part was the criteria required by the IFDA, mentioned in Chapter 16 of the Pharmaceutical Regulations and Instructions provided by the IFDA. The second part of the criteria was defined according to the critical comments of clinical and industrial pharmacists. Findings: Thirty-seven out of 100 medications included no PIs. None of the PIs met all the criteria required by the IFDA. The highest score for completeness was 18 out of 21 (85.7%). Medication name, description, and adverse reaction were mentioned in all PIs. Other items such as patient counseling information (98%), warnings (95.2%), precautions (95.2%), pregnancy/lactation (95%), and storage condition (90.5%) have been mentioned in a high percentage of PIs. Conclusion: PIs have improved in recent years in Iran, but there is an absolute need for more accurate and up-to-date information. The IFDA should supervise pharmaceutical companies more strictly in this regard and should revise its regulations requiring PIs to conform to the FDA regulations.

show abstract

Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine

Cited by 11 publications

References 42 publications

A comparative evaluation of medicine package inserts for oral antidiabetic agents in Palestine

A comparative evaluation of medicine package inserts for oral antidiabetic agents in Palestine

Comparative evaluation of drug information leaflets for non-steroidal anti-inflammatory drugs in Palestine: local versus imported products

Evaluation of medication package inserts in Iran

Contact Info

Product

Resources

About