Increasing access to medicines

Antimicrobials provide huge benefits to individuals and society, but they are unlike other drugs in that they target microorganisms and not pathology related to the host. Microorganisms develop resistance to these drugs, and this can affect agents in the same class and other classes. This phenomenon is a serious threat to public health, and it necessitates wide ranging counter initiatives. These have included efforts to reduce the use of antimicrobials in both animals and humans and to improve prescribing practices.1

Recent amendments to pharmaceutical policies in the United Kingdom have included giving patients greater access to medicines. Although this has many positive benefits, the policy has sparked debate,2 particularly because three initiatives may inadvertently be countering efforts to control antimicrobial resistance, unless further safeguards are introduced. The first initiative is to increase the range (and therefore number) of trained prescribers to include nurses, pharmacists, podiatrists, and optometrists; the second is to allow patients who meet specific criteria to be given prescription only medicines by a healthcare professional who is not trained to prescribe; and the third initiative, which is of particular concern, is to make prescription only medicines available over the counter if this is considered safe.

The over the counter initiative is proving attractive; 69 products have been reclassified from prescription only medicines to pharmacy only (P) medicines by the Medicines and Healthcare Products Regulatory Agency. There have been four recent applications to reclassify antimicrobials; chloramphenicol eye ointment and azithromycin tablets have already been deregulated; and a decision about trimethoprim and nitrofurantoin tablets is pending.

Examination of the responses to consultation shows that the debate continues.3 Many people think that increased access to antimicrobials will benefit patients and the pharmacy profession and reduce the number of consultations with general practitioners. Others, including the Advisory Committee on Antibiotic Resistance and the British Society for Antimicrobial Chemotherapy, are concerned about the effect on resistance and the lack of a strategic framework for assessing applications relating to antimicrobials (www.bsac.org.uk/).4

Although the guidance on relicensing acknowledges the indirect danger to human health posed by antimicrobial resistance, each application is considered independently. No overarching mechanism exists to take account of the potential overall effect on resistance. If one agent in a class is reclassified it is likely to set a precedent for related agents within the same class and those from different classes with similar indications. This has been seen with the recent applications for urinary tract infection.

Unlike other drugs, resistance continuously compromises the efficacy of antimicrobials after they have been licensed. Even though the licensed indications may no longer be appropriate, there is rarely any discussion of the need to change the marketing authorisation. Companies requesting reclassification must provide postmarketing safety data, but new efficacy data are not needed if the application is for the existing licensed indication. Furthermore, drugs tend to be reclassified at the later stages of their life cycle when they are generic; for antimicrobials this means that ample time will have elapsed for resistance to have developed. For example, 25% of Escherichia coli are now resistant to trimethoprim,5 which would probably preclude marketing authorisation if the drug were considered today.

Although a risk management strategy has been implemented for azithromycin in the treatment of chlamydia, diagnostic confirmation is not a prerequisite for reclassification applications. Even with this strategy in place, the sexual contact does not need to be tested before treatment, susceptibility testing is not required, and the purchase is not routinely included in the patient’s medical record. There is no independent data collection system to monitor overall usage and selective pressure on bacteria, let alone the appropriateness of sale.

The effect on current efforts to improve surveillance in primary care could be catastrophic. Furthermore, there has been no central effort to monitor the effect of reclassifications, including changes in prescribing patterns. The failure of current arrangements to effectively monitor appropriate prescribing and resistance problems is well appreciated. The fact that the proposals for reclassification are no worse than the current system is not a suitable defence for a new initiative; new initiatives should provide an opportunity to redress the balance.

International concerns exist regarding antibiotic resistance. Both the World Health Organization6 and the European Council7 8 have adopted policies to maintain antimicrobials as prescription only medicines in the face of hard evidence on continued misuse. Although it can be argued that these recommendations do not take into account the availability of a P licensing category, as in the UK, many of the safeguards would still in effect be removed. One such safeguard is direct to consumer advertising, which increases demand9 and contravenes current European Union policy relating to antimicrobials (although this may be irrelevant if the current EU proposals to allow prescription medicines to be advertised go ahead).7 10 Recent changes in pharmaceutical policy threaten strategies to control antibiotic resistance. There is a clear case for antibiotics to remain prescription only medicines, or at the very minimum for safeguards to be strengthened should further reclassification be implemented.