Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

Abstract

BACKGROUNDLittle research has assessed the quality of manufacturer-provided prescribing information or documented differences in key aspects of drug information among different marketed generic products of the same drug, particularly in the Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of the Middle East.METHODSWe assessed the correctness and completeness of information pertaining to indications, dosage, cautions/contraindications, side effects and drug interactions in 37 package inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), metformin (7 inserts), and omeprazole (9 inserts). We also described deficiencies in the quality and quantity of manufacturer-provided information that could be misleading to patients and prescribers.RESULTSWe found substantial disagreement in information between generic package inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumulative average of 63±16% of drug information indicators were in agreement with these standard references. Section headings with the least conformity with study references were those related to dosage (57± 28%) and side effects (54±30%).CONCLUSIONOur results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts.

Attitudes of consumers and healthcare professionals towards the patient package inserts-a study in Palestine

“…Inadequate information in the PPIs has been reported by authors in different countries. In a study carried out in Saudi Arabia, the authors found that there was substantial disagreement in information between generic package inserts and the British National Formulary and the package inserts of the brand products marketed in Saudi Arabia 6. In the USA, it was shown that PPIs do not fully meet the federal regulations 20.…”

“…In developing countries, the PPI is considered an important source of drug information for healthcare providers as well, because of a limited ability to access up to date drug information resources. Even though it is an important source of information, several studies from different countries have shown a need to improve the content and readability of the PPI 1,2,3,4,5,6,7,8. Despite efforts to improve the readability and comprehensibility, by both the drug regulatory authorities and the manufactures, package inserts are still criticized 1,3,4,5.…”

Key transmission parameters of an institutional outbreak during the 1918 influenza pandemic estimated by mathematical modelling

“…However, this figure was actually the total number of men who died in the camp in 1918 from all causes as reported by the Principal Medical Officer at the camp [3]. Further examination of data on the cause of death and date-of-death suggests the total mortality attributable to this outbreak was 163 [5]. This revision gives a fairly conservative figure for the mortality impact and it is the one that we have used in this analysis.…”

A systematic review of counterfeit and substandard medicines in field quality surveys

“…Some studies, particularly in the Middle East, have found disagreement between patient information leaflets in some medicine samples when compared with national formularies. 106,107 Therefore, the addition of patient information leaflets to examination of medicine samples in medicine quality survey studies is open for debate among the scientific community.…”