Use of Non-Formulary Medicines at a Kenyan Private Hospital

Background: Hospital formularies are used to encourage the use of safe, ef-fective and most affordable medications. Institutions need to make provi-sions for non-formulary medicines (NFM) due to the dynamic nature of dis-eases and their management. The aim of this study was to describe the pat-terns of non-formulary medicine prescriptions at the Nairobi Hospital, the reasons for their purchase as well as the duration taken to avail them. Methods: A descriptive review of all the non-formulary medicine prescrip-tions from January 2021 to June 2022. The medicines were listed and catego-rized according to the WHO Anatomical Therapeutic Chemical (ATC) classi-fication system. Correspondence between pharmacy and procurement was reviewed to understand the reason for the requests and the duration it took to avail the medicines. Results: A total of 183 NFM were purchased, with a general increase in the number from January 2021 to June 2022. Vitamins, Mineral supplements and General nutrients accounted for 41 (22.4%) of the NFM. Dermatologicals 27 (14.6%), Genito-urinary system drugs and sex hormones 20 (10.9%), Ophthalmologicals 14 (7.6%) and Antineoplastic and Immuno-modulating agents 12 (6.6%) were also frequently purchased out of formulary. The main reasons for NFM purchases were: having no therapeutic equivalents in the hospital formulary 72 (39.3%) and prescriber or patient preference 69 (37.7%). It took a median (IQR) of 4 (2 - 7) days for the phar-macy to avail these drugs;with 18.6% being availed in 1 day and 55.2% tak-ing more than 3 days. For the NFM where no alternative was available in the hospital formulary, sales amounted to USD 63,362 which was 79.1% of the value of all the NFM sales. Conclusion: There’s a need to regularly update the hospital formulary and to emphasize to the prescribers the importance of adhering to it, as much as possible.

Rethinking bioequivalence and equivalence requirements of orally inhaled drug products

Orally inhaled drug products(OIPs),such as corticosteroids and bronchodilators,are at the forefront of asthma and chronic obstructive pulmonary disease treatments,two diseases that afflict worldwide populations.Introducing generics of these products is essential,as the pricing of these medications remain a barrier to adequate patient care.Currently,there is no consensus between regulatory bodies as to the bioequivalence and equivalence requirements of OIPs that are intended for local action in the lungs.This manuscript critically reviews these requirements and presents future directions for clinicians,scientists,and regulators to consider to optimize the development and approval of OIPs.

Thrapeutic equivalence in the treatment of hypertension:Can lercanidipine and nifedipine GITS be considered to be interchangeable?

AIM: To undertake a review of the evidence that nifedipine GITS and lercanidipine are therapeutically equivalent in the management of essential hypertension.METHODS: A systematic review of the published literature was prompted by the findings of two meta-analyses which indicated that there was a lower incidence of peripheral(ankle) oedema with lercanidipine. However,neither meta-analysis gave detailed attention to comparative antihypertensive efficacy or cardiovascular protection. Accordingly,a systematic,detailed and critical review was undertaken of individual published papers. The review started with those studies incorporated into the 2 meta-analyses and then all other salient and directly relevant papers identified through the following search criteria: all randomized controlled trials in which the therapeutic profile and antihypertensive effects of lercanidipine were directly compared with those of nifedipine GITS(in hypertensive patients). The searchstrategy was focused on the reports of clinical trials of lercanidipine vs nifedipine GITS,which were identified through a systematic search of PubMed(from 1966 to October 2012),Embase(from 1980 to October 2012) and the Cochrane library(from 1 October 2008 to end October 2013). The search combined terms related to lercanidipine vs nifedipine GITS(including MeSH search using calcium antagonists,calcium channel blockers and dihydropyridines).RESULTS: With regard to blood pressure(BP) control and the consistency of BP control throughout 24-h,there is limited published evidence. However,two studies using 24 h ambulatory blood pressure monitoring clearly identified the dose-dependency of BP lowering with lercanidipine and its variably sustained 24-h efficacy. In contrast,there is evidence of a consistent antihypertensive effect throughout 24 h with nifedipine GITS. The incidence of the most common "side effect",i.e.,peripheral(ankle) oedema can be estimated as follows. For every 100 patients treated with lercanidipine,2.5 will report oedema compared to 6 patients treated with nifedipine GITS. However,98 or 99 patients will continue treatment with nifedipine GITS,compared with 99.5 patients on lercanidipine. Finally,with regard to outcome studies of cardiovascular(CV) morbidity and mortality,there is definitive outcome evidence for nifedipine GITS but there is no evidence that treatment with lercanidipine leads to reductions in CV morbidity and mortality.CONCLUSION: There is no evidence in terms of longterm BP control and CV protection to justify the contention that lercanidipine is therapeutically equivalent to nifedipine GITS.

The introduction of therapeutic equivalence evaluation codes and its influence on the selection of the reference listed drugs in China

The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.