Mohamed Izham Mohamed Ibrahim

Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia

Background Malaysias stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. Methods and Findings The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%–76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high—25%–38% and 100%–140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a months treatment for peptic ulcer disease and hypertension people have to pay about a weeks wages in the private sector. Conclusions The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.

The role of pharmacists in developing countries: the current scenario in Pakistan.

During the past few years, the pharmacy profession has expanded significantly in terms of professional services delivery and now has been recognized as an important profession in the multidisciplinary provision of health care. In contrast to the situation in developed countries, pharmacists in developing countries are still underutilized and their role as health care professionals is not deemed important by either the community or other health care providers. The aim of this paper is to highlight the role of pharmacists in developing countries, particularly in Pakistan. The paper draws on the literature related to the socioeconomic and health status of Pakistans population, along with background on the pharmacy profession in the country in the context of the current directions of health care.The paper highlights the current scenario and portrays the pharmacy profession in Pakistan. It concludes that although the pharmacy profession in Pakistan is continuously evolving, the health care system of Pakistan has yet to recognize the pharmacists role. This lack of recognition is due to the limited interaction of pharmacists with the public. Pharmacists in Pakistan are concerned about their present professional role in the health care system. The main problem they are facing is the shortage of pharmacists in pharmacies. Moreover, their services are focused towards management more than towards customers. For these reasons, the pharmacists role as a health care professional is not familiar to the public.

Medicine utilisation and pricing in Malaysia: The findings of a household survey

The objectives of this study were to identify the most commonly used medicines for mainly prevalent ailments and to compare retail sector prices (RSPs), public sector prices (PSPs) and international reference prices (IRPs). A convenient sampling method was employed to survey 33 households in a metropolitan city. Each family was followed once a week for eight weeks to observe their diseases and medication usage. The RSPs and PSPs for per unit doses and defined daily doses (DDDs) were compared with the IRPs. The most common ailments identified were cardiovascular and endocrine disorders followed by central nervous system and musculoskeletal disorders. Accordingly, the most common drugs used were for the treatment of the above ailments. Among 81 commonly used medicines, 63 were branded and 18 were generic. Of the 81 drugs, 26 were essential drugs. Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers and calcium channel blockers were among the most commonly used medicines. The differential between the prices of branded medicines and IRPs were found to be remarkable. This study further revealed that the majority of patients also used traditional medicines and nutritional supplements alongside their modern medicines. Wide variations were observed in RSPs and IRPs, warranting critical evaluation, regulation and emphasis on the economic aspects of drug policy. Widespread use of branded medicines in the absence of a national health insurance programme can lead to high out-of-pocket expenditures. Concomitant use of traditional medicines and nutritional supplements may have drug interaction potential, invoking detailed investigation for relevance.

Parent´s knowledge and management of their children´s ailments in Malaysia

Minor ailments like sore throat, fever, cough and diarrhea can be relieved with over-the-counter (OTC) medications such as paracetamol or other traditional remedies, without seeking for consultation from general practitioners. Parents usually take the responsibility to come up with some kind of treatment for their children. Objective (1) to evaluate the parents’ medical knowledge about OTC medicines which are usually used by the parents to treat their children and (2) to evaluate the parents’ management in dealing with their children’s ailments, and (3) to evaluate the association between medical knowledge and the management of children’s ailments related to medicine use among the parents. Methods A cross-sectional survey was conducted to measure the parents’ knowledge about their children’s ailments. Subjects were selected and information was obtained in September 2008. Non-probability convenient sampling method was used. Parents were recruited from the general public to answer the questionnaires. Results 197 parents filled in the questionnaires. From the total respondents, 48.2% of them were male. This study showed that most respondents have medium knowledge (6.11 SD=3.6) and a moderate management (4.39 SD=2.7). The results showed that there is a significant difference between the knowledge and the management level of ailments (P=0.033). Regarding the education level of the parents and the socioeconomic status, the p-value showed there was a significant difference between parents’ knowledge and their education level (P=0.012). Conclusion This study showed that parents have inadequate knowledge and some misconception about how to go about treating their children when they are unwell. It is hoped that by identifying weak areas in parents’ management to their children’s ailments, better planned educational and behavioral modification efforts can be made to elevate the knowledge level among the parents when they medically treat their children.

Introducing social pharmacy courses to pharmacy students in Malaysia

SUMMARY Faculty in the Social Pharmacy area believe that curricular changes accommodating components or subject-matter in social/behavioral courses would constitute a substantial increase in the quality of pharmaceutical education and in students’ competency. Based on the fact that students must be provided with more opportunities and exercises that elevate communication competence, critical thinking, problem solving, and analytical and ethical reasoning, a list of social pharmacyrelated courses was introduced into the undergraduate curriculum. This paper is intended to describe the signi® cance and relevance of a sample program in social pharmacy‐ `Drugs in Developing Countries’. It has two components: (1) mid-term projects;, 30%; and (2) ® nal exam, 70%. The use of various learning modalities in this course as well as the introduction of new topics aims to provide students with a better understanding of the application of social pharmacy-related concepts to the Malaysian health care system.

Pattern of adverse drug reactions reported by the community pharmacists in Nepal

The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR) reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP) of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61) KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4) maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males) were reported. Antibiotics/ antibacterials caused 42% (n=37) of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20), followed by generalized edema [8.6 % (n=10)]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49) of the cases. Over two third (69%) of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4%) were of ‘mild (level 2)’ type. Nearly two third [64.7 % (n=46)] of the ADRs were ‘definitely preventable’. Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen/ Paracetamol combination use of the drug was responsible for more number of ADRs and the most common ADRs were related to dermatological system. Strengthening this program might improve safe use of medicines in the community.

Pharmacovigilance Activities in Nepal

We read with great interest the article by Olsson et al. published in a recent issue of Drug Safety. The authors have clearly identified certain barriers and challenges in strengthening pharmacovigilance programmes in developing countries. We hereby share our experiences with the recently developed National Pharmacovigilance Programme inNepal. Nearly two-thirds of the drugs in Nepal are imported from foreign countries and the country has limited capacity in terms of drug manufacturing. Prior to marketing a drug, the Department of Drug Administration (DDA), the national drug regulatory authority, evaluates the drug thoroughly and then approves it on the basis of data available from other countries. In the past, the DDA has banned several drugs, such as amidopyrine (aminophenazone), phenacetin, clioquinol, analgin (metamizole [dipyrone]), amphetamine, chlorphentermine, oxyphenbutazone,methaqualone, phenylbutazone, santonin, sulphaguanidine and meprobamate, in order to ensure medicine safety. In addition, registration of products such as gatifloxacin, cyclo-oxygenase 2 inhibitors, etc., was denied due to safety concerns. However, no system existed tomonitor adverse drug reactions (ADRs) within the country. Recognizing the importance and benefits of pharmacovigilance as an important tool towards safety monitoring and rational use of medicines, the Government of Nepal initiated the pharmacovigilance programme in 2002. The Government decided to become a member of the WHO Programme for International Drug Monitoring in October 2004 and nominated the DDA as the national centre. Nepal was given full membership of theWHOprogramme in July 2006. Followingmembership, the DDA has established four regional centres that report ADRs to the DDA. These regional centres are located at the Manipal Teaching Hospital, Pokhara; Tribhuvan University Teaching Hospital, Kathmandu; Nepal Medical College Hospital, Kathmandu; and KISTMedical College, Lalitpur. The regional centres report the ADRs to the national centre via the web-based system for ADR management, ‘Vigiflow’. The first two centres were set up in 2004 and 2006, respectively, and the third and the fourth centres were established during 2007 and 2008, respectively. The Manipal Teaching Hospital was the pioneer in starting pharmacovigilance in Nepal. Since its inception, the centre has received a total of 355 ADR reports from the hospital (September 2004 toAugust 2005: 98; September 2005 toAugust 2006: 38; September 2006 to August 2007: 45; September 2007 to February 2008: 174). The ADR reporting forms are placed in the wards, outpatient departments and the Drug Information Center (DIC) of the hospital. Doctors, nurses and pharmacists report ADRs, if any occur, to the pharmacovigilance cell, a unit of the DIC of the hospital. Activities of the Pharmacovigilance Centre at the Tribhuvan University Teaching Hospital are coordinated by the Drug Information Unit of the Clinical Pharmacology Department. The centre regularly reports the ADRs to the national centre. To date, 50 ADRs have been reported to the national centre. Pharmacovigilance activities at the Nepal Medical College Hospital were initiated voluntarily by the Department of Clinical Pharmacology in July 2007. When the centre was started, the ADR reporting form was given to the doctors of all clinical departments of the hospital. The ADR reports are then sent to the DDA. The centre has received 11 ADR reports, the majority of which are from the Dermatology Department, followed by the Paediatrics Department. At KIST Medical College, pharmacovigilance activities were started with the encouragement and support of the hospital’sMedicine and Therapeutics Committee in July 2008. The department of Clinical Pharmacology and Therapeutics runs the programmewith support fromother departments. All faculty members and house officers from clinical science departments are encouraged to report adverse reactions. As of 3 February 2009, a total of 29 ADRs have been reported from various departments. The majority of reports (23 of 29) are from theMedicine Department but there are also reports from other departments, such as Paediatrics, Gynaecology and Radiology. This regional centre has already started reporting ADRs to the national centre. CORRESPONDENCE Drug Saf 2010; 33 (10): 889-890 0114-5916/10/0010-0889/

Possible Metformin-Induced Otorrhoea: A Rare Case

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Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal

Ear problems attributed to metformin use are not documented in the literature.

Consumers' views on generic medicines: a review of the literature.

Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries. Objectives: To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal. Methodology: Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008) were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE) guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals. Results: During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34%) were related to case reports and letters. The median (interquartile range) age of the patients described in the case reports was 46.5 (21.7-51.2) years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2). Majority of the published case reports were related to skin (n=13; 72.2%). Antimicrobials were responsible for 27.8% (n=5) of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were missing in few of the cases. Conclusion: A high percentage of the scientific communications were ‘case reports’. A high proportion of the case reports produced by the center were of international standards. There were lacunae in ‘patient disposition’ in few of the reports.