Pharmacists' Awareness of Drug Counterfeiting in Jordan

ABSTRACT

Objective: The purpose of the study is to identify the pharmacist's awareness and the contributing factors of drug counterfeiting in Jordan.

Method: The study used a descriptive cross-sectional design. Study participants included a convenience sample of 100 Jordanian pharmacists who worked in three different fields of pharmacy including community, industrial and quality control in Amman. The data were collected by a self report questionnaire which was developed by the authors and was composed of open and closed ended questions. The validity of questionnaire was assessed by experts in the field of the pharmacy working in the Jordan Food and Drug Administration with no modification and it was piloted and tested on four pharmacists. The response rate was 62%. The data were analyzed by using the Statistical Package for Social Sciences.

Results: The results showed that around 76% reported high awareness of drug counterfeiting problem and the current laws and regulations in Jordan and 54.8% perceived the regulations are extensive enough. The majority (63%) of the respondents did not come across any case of counterfeiting themselves, while 37% had come across counterfeit cases and 50% of them had come across several cases. About half (51%) of the respondents thought that drug counterfeiting is not a serious problem while 48.4% thought it is a very serious problem. In addition to that, 54.8% thought that it is difficult to invade the Jordanian market with counterfeit drugs while 35.5% think that Jordan could be invaded easily.

Conclusions: This study supports that drug counterfeiting is a major health problem and has a major impact worldwide on public, pharmaceutical companies as well as governments. It also emphasizes that more statistical databases and national research on the percentage of drug counterfeiting in Jordan are needed to analyze and facilitate monitoring the size of problem.

Key words: Awareness, Drug counterfeiting, Pharmacist

JRMS June 2013; 20(2): 57-70 /DOI: 10.12816/0000079

Introduction

Improving the quality of health services depends on many factors one of which is providing drugs; therefore they have to be available at all times and reachable to all population. Access to medicines especially for developing countries is still a big challenge because of their high prices, causing patients in these countries to seek alternative cheap sources thus making patients more vulnerable to counterfeit medicines.  On the other hand, the new technologies in developed countries expose their patients to criminals dealing with counterfeit medicines mainly through the internet by fake advertisement about medicines. 

The World Health Organization (WHO) estimates that medicines purchased over the internet from sites that conceal their physical address are counterfeit in over 50% of cases.⁽¹⁾ Counterfeit drugs are a global public health problem, causing death, disability and injury affecting both adults and children. However, defining the true extent of the problem is difficult and not really known since no global study has been carried out.  It is clear from individual country studies that counterfeiting is a major world problem, but the variety of information sources makes compiling and comparing statistics a difficult task, also some countries and drug companies keep information they have strictly confidential so as not to lose their reputation.⁽²⁾ In this respect, the capacity now to collect and analyze data has improved since the WHO launched a campaign to fight drug counterfeiting and a task force called International Medical Products Anti-Counterfeiting Task force (IMPACT) which was set up in 2006. For almost 20 years, the WHO has been fighting drug counterfeiting since it was first known around 1990 and it appears to be a growing problem in both developing and developed countries. No country is free of this problem. The phenomenon has been growing in recent years due to the fact that counterfeiting methods are becoming more sophisticated.⁽³⁾ Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50% as a result of lack legislations, poor enforcement of drug law, weak national drug regulatory authorities and shortage of drugs. One prediction is that global counterfeit drug sales will reach $75 billion by 2010 more than 90% since 2005.⁽⁴⁾

Figure 1 shows the increasing numbers of counterfeit cases reported in FDA Counterfeit Drug Task Force Report: 2006 update.

Counterfeiting can be applied to both branded and generic products; counterfeit products could include products without active ingredients (32.1%); with incorrect quantities of active ingredients (20.2%); wrong ingredients (21.4%); with correct amounts of active ingredients but false packaging (15.6%); copies of original products (1%) and products with high impurities and contaminant levels (8.5%) .⁽⁵⁾ These classes represent the different types of counterfeit drugs as shown in Figure 2.

Table I: The field of work of the respondents

There is no universal definition of counterfeit drugs; the definition varies from country to another, this limits the exchange of information between countries and limits the understanding of the true extent of the problem globally.⁽⁶⁾

As a consequence of this the WHO drafted a definition in 1999 which provides common universally accepted basis for drug counterfeiting to enhance understanding of the problem at global level: "А counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."

Therefore, this study was conducted to identify pharmacist awareness and the contributing factors of drug counterfeiting in Jordan.

Methodology

The study was designed to identify pharmacist awareness and the contributing factors of drug counterfeiting  in  Jordan  and to suggest possible ways to combat the problem. One of the most efficient ways to address this objective is to complete a questionnaire, in addition to collecting information from the Jordanian Food and Drug Administration (JFDA). However, there was difficulty in collecting the required information from the JFDA, in addition to the limited published data related to the actual situation in Jordan.

The study design was based on qualitative and quantitative evaluation collected from the questionnaire, then the data collected was analysed to come up with results and conclusions as shown in Figure 3.

The questionnaire consisted of open ended and close ended questions; a first draft of the questionnaire was piloted and tested on four respondent pharmacists from Jordan. The questionnaire is shown in Appendix 1.   The validity of the tool was assessed by experts in the field of the pharmacy with no modification. The study was conducted in Amman.   The method of data collection was by a self reported questionnaire through distribution of the questionnaire to the participants in the field.

The sample size for this study was a total of 100 pharmacists selected from three different fields of pharmacy including community, industrial and quality control.

Table II: Are there penalties for drug counterfeiting?

Table III: Penalties for drug counterfeiting

Most respondents were working in community pharmacies as shown in (Table I) and 51.6% of respondents were males and 48.4% were females. Their mean age was 35 years.  The questions were analyzed by using the SPSS system. The open ended questions were summarized first as shown in Appendix 2, and the most common answers were taken as variables as shown in Appendix 3.

Ethical Consideration

The proposal was submitted to the ethics committee of the Ministry of Health in Jordan for their formal permission and approval was secured.

Results

One hundred copies of the questionnaire were distributed by personal delivery with the assistance of four colleagues in Jordan. Sixty- two copies were completed and returned making the study response rate 62%.

Participant awareness of the drug counterfeiting laws and regulations:

The data analysis showed that 76% of respondents are aware of drug counterfeiting problems and the current laws and regulations in Jordan. However, there are differences in opinions about whether the regulations are extensive enough or not; 54.8% of respondents thought  that  they  are  while  43.5% thought that they are not enough. Of the 15 respondents out of 27 respondents that did not think that the current laws and regulations are enough made suggestions to improve the situation.  They suggested improving regulations on borders and performance of quality control tests, in addition to increasing the penalties (10 participants), increase the public awareness (3 participants), coordination between control bodies and more international efforts (1 participant), and finally fight favouritism (1 participant).

Around 63% of the respondents did not come across any case of counterfeiting themselves, on the other hand, 37% come across counterfeit cases of which more than 50% had come across several cases. Despite the pharmacists’ awareness about the drug counterfeiting laws and regulations being good, it is not reasonable that around one third of them after excluding the missed answers (Table II), believe that there are no penalties on trading of counterfeit drugs in Jordan and this could be a serious situations for these pharmacists, especially when we know that most of the respondents were community pharmacists which are the main target for counterfeiters. If the spread of such an idea is popular among a large group of pharmacists, there should be an urgent need for more efforts to increase the general awareness about the problem and its implications.

Table IV: The degree of seriousness of drug counterfeiting

Table V: The vulnerability of invasion by counterfeit drugs

The respondents who knew that there are penalties for drug counterfeiting gave different ranges of penalties that varied from the closure of the pharmacy to prison for a certain period of time and payment of a certain range of fine (Table III), but without giving the exact range of penalty for both time and fine payment. For the respondents who know that there are penalties for drug counterfeiting, around 61% of them believe that the existing penalties are enough while around 39% thought that they are not enough. Eight pharmacists, out of 22 respondents that did not think that the existing penalties for drug counterfeiting are enough, made suggestions to improve the situation by increasing fine payments and the period of imprisonment (4 participants), withdrawal of the licence of pharmacists who are involved in drug counterfeiting and not allowing them to work in this field again (3 participants), and finally only one pharmacist made a suggestion that the existing penalties are enough, but there is lack of strong commitment to their implementation.

Factors that might encourage drug counterfeiting:

The three major causes of drug counterfeiting according to the respondents were high prices of drugs (48%), lack of supervision and poor quality control lab tests (35.5%), and poor public awareness (16.5%). Regarding the degree of seriousness of the problem and vulnerability of invasion, the majority of the respondents thought that drug counterfeiting is a less serious problem (51.6%) while 48.4% thought it is a very serious problem. In addition to that, 54.8% thought that it is difficult to invade Jordan by counterfeit drugs while 35.5% thought that Jordan could be invaded easily (Table IV & V). These variations in opinions may be due to the differences of pharmacists' experience and exposure to drug counterfeiting. Drugs that are susceptible to be counterfeited varied between three major groups of drugs: most of the answers showed that the drugs used for chronic diseases such as hypertension, diabetes and hyperlipidemia are more susceptible for counterfeiting, followed by expensive drugs such as sex enhancers, antiplatelets, Central Nervous System drugs, anticancer and antipsychotic drugs, and finally fast moving drugs such as analgesics, Non Steroidal Anti Inflammatory Drugs (NSAID) and antibiotics.

Discussion

Drug counterfeiting is a global problem; it has been reported in developing countries such as India, Peru, Niger, Nigeria, Southeast Asia and Pakistan as well as first world countries such as Unites States which resulted in establishing the Counterfeiting Drug Task Force.

Drug counterfeiting is a major health problem and has a major impact worldwide on the public, pharmaceutical companies as well as governments.

The FDA estimates that counterfeits make up more than 10% of the global market.   Developing countries seem to be most affected,and counterfeiters invade most drugs, especially those which are used for the treatment of serious diseases. Jordan like many other countries has this problem; however its size is below the world average.

Table IV: Recent examples of counterfeit medicines:

Jordan like many other countries has a smuggling problem of counterfeit drugs; however no accurate statistics appear to be available; for example in a presentation for stakeholders Meeting of Transparency Alliance (MeTA) in London last year Nuseirat ⁽⁷⁾ (Head of National Drug Unit in JFDA) said that problems with counterfeit drugs was less than 5% of the world average and that no accurate statics were available but that it could be a growing problem. Arab Reporters for Investigative Journalism (ARIJ) mentioned that it is below the world average by 15% and pointed out that it is a decreasing problem due to the efforts from all concerned parties like MOH, JFDA, Jordanian Pharmaceutical Association (JPA), law enforcement agencies in collaboration with public security, Customs and health agencies. However, on these figures smuggling and counterfeit drugs on the Jordanian pharmaceutical market are below the world average.⁽⁷⁾

Overall, the problem does not lie in the exact percentage numbers, but in the harm caused by these counterfeit drugs through dangerous effects ranging from minor problems to death especially when they are given to those in dire need of a medical intervention and in saving lives.^(5-8) For example, a total of 192,000 Chinese patients are reported to have died in 2001 from fake drugs and in the same year Chinese authorities closed 1.300 factories while investigating 480,000 cases of counterfeit drugs worth 57 million USD and in 2004, Chinese authorities arrested 22 manufacturers of grossly substandard infant milk powder and closed three factories after the death of over 50 infants.⁽⁹⁾

In Europe, counterfeit medicines available originally focused upon ‘lifestyle’ medicines, including erectile dysfunction and weight loss medicines. Counterfeiters are now also focusing on ‘lifesaving medicines’ including cancer and heart medicines. The European Union's 2007 pharmaceutical counterfeiting data shows that almost 40 per cent of counterfeit medicines seized by the EU originated in Switzerland, making the country the biggest importer of counterfeit medicines into the EU; India and the United Arab Emirates were second and third, respectively. The total volume of counterfeit pharmaceuticals seized by EU officials rose 51% in 2007. The highest numbers of items were seized in Belgium, France, Britain, and Spain.⁽¹⁰⁾

Weight and hair loss tablets, antidepressants, painkillers, anabolic steroids worth more than a quarter million pounds ($350,000 USD) worth of counterfeit, unlicensed, withdrawn, and controlled drugs were seized in England by the Medicines and Healthcare products Regulatory Agency (MHRA). The drugs are believed to be linked to an illegal online pharmacy selling prescription-only medicines around the globe. A further 250,000 pounds worth fake drug stash seized in an undercover operation.⁽¹¹⁾ The problem of counterfeit drugs was addressed internationally in Nairobi at the WHO Conference of Experts on the Rational Use of Drugs in 1985 for the first time.⁽¹²⁾ Recent examples of counterfeit medicines are shown in Table VI.

Conclusion and recommendations

From the questionnaire and the information found, it is possible to propose the following recommendations and implications of findings for future research:

·   More statistical databases and national research on the percentage of drug counterfeiting in Jordan are needed to analyze and facilitate monitoring the size of problem.

·   There needs to be strong commitment, shared responsibility and coordination from all control bodies with special emphasis on the three major diseases in Jordan namely, hypertension, diabetes and hyperlipidimia.

·   There should be improved international collaboration to help in combating counterfeiting problem especially that the situation is not so good in the neighboring countries which have close borders with Jordan.

·   It would be beneficial to have improvement in the quality control departments, but this would require increasing resources and the use of new technologies to facilitate detection of counterfeit drugs.

·   A review should take place which determines whether the existing laws and regulations are extensive enough and the penalties are appropriate.

·   The JFDA should consider increasing the pharmacists and public awareness in this field by making better advertising campaigns.

Joint efforts of authorities at country level in Jordan have been increased recently including making regular raids not only on pharmacies but also on beauty salons, increasing the number of inspectors and making new amendments on the law of circulating drug counterfeiting by increasing penalties, all these contribute to the drop of drug counterfeiting in Jordan recently. However, it is suggested that the fight against drug counterfeiting is a shared responsibility between all parties to include: authorities, the industry, distributors and consumers and not the authorities’ responsibility only. To achieve this goal an increase in awareness through campaigns is needed to target all concerned parties with special emphasis on the general public who presently have little knowledge on detecting counterfeit medicines.

The public should then be encouraged to inform responsible authorities such as the JFDA and police, particularly when there is an adverse reaction after taking medication or when they suspect any person to be selling or supplying drugs illegally.

References

1.World Health Organization. Substandard and Counterfeit Medicines. World Health Organization, 2003; Fact Sheet No. 275.

2.Wertheimer, IA, Santella, MT, Chaney, MN. Counterfeit Pharmaceuticals – Update on Current Status and Future Projections. Business Briefing. Pharmageneric 2004; pp. 1-9.

3.World Health Organization. WHO launches taskforce to fight counterfeit drugs, Geneva, Switzerland, 2006.

4. Food and Drug Administration. Combating Counterfeit Drugs: A report of the Food and Drug Administration. U.S. Department of Health and Human Services, 2006.

5.World Health Organization. Counterfeit Drugs Kill. IMPACT final brochure updated May, 2008.

6.World Health Organization. General information on counterfeit medicines. World Health Organization, Geneva, Switzerland, 2006c.

7. Nuseirat A. Jordan presentation towards a medicines transparency. Available on line from www.dfidhealthrc.org/MeTA/documents/17%20april%20documents/Jordan%20presentation%20on%2017%20April.ppt, 2008. [Accessed 25th June 2009]

8.World Health Organization Jordan. Country cooperation strategy Available on line from: www.who.int/countries/jor/en/.2007, [accessed 1^st July 2009].

9.Cockburn, R, Newton, PN, Agyarko, KE, et al. The Global Threat of Counterfeit Drugs: Why Industry and Government Must Communicate the Dangers. Public Library of Science 2005; 2 (4).

10.Taylor N. 40% of EU counterfeit drugs seizures of Swiss origin: In-pharm.technologist.com. 2008.

11.Primo-Carpenter   J.   Matrix   of   drug   Quality Reports in USAID-assisted countries, U.S Pharmacopoeia Drug Quality and Information Program Updated June, 2009.

12.Shahverdi SH, Hajimiri M, Pourmalek F, et al. Iranian pharmacists’ knowledge, attitude and practice regarding counterfeit drugs. Iranian J Pharm Res 2012; 11(3): 963-968.