Many doctor-patient encounters result in the writing of a prescription, hence the standard of drug prescribing is paramount. I’d like to pose a question: “What is good practice in relation to antibiotic prescribing?”

The Medical Council’s Guide to Professional Conduct and Ethics states that medical practitioners “have a duty to assist in the efficient and effective use of healthcare resources”. It encourages medical practitioners to prescribe bioequivalent generic medicines where they are safe and effective. Medical practitioners are asked not to rely excessively on literature distributed by pharmaceutical companies for information about particular drugs, but “should seek independent evidence based sources of information on the benefits and risks associated with medicines before prescribing.”¹

More specifically, in the Strategy for the Control of Antibiotic Resistance (SARI) guidelines² all the antibiotics listed are generic. By default, there is the expectation that prescribing should be generic. These guidelines were disseminated to every general practice in Ireland in 2011. They are evidence based and thorough, and there has been no update to them as yet. 

In agreement with this, the Northern Ireland antimicrobial guidelines for primary care 2010 state that one should “use generic antibiotics whenever possible”.

At a European level, the European Observatory on Health Systems and Policies regulates drug prescribing and recommend that good prescribing must start with the patient and be appropriate for that individual.³ The importance of relying on evidence based medicine and unbiased information is vital in prescribing drugs in medical practice.  

It is important to be cognisant of this, as we are continuously reminded about it by the HSE, which places a big emphasis on the drug budget and cutting costs. The HSE Primary Care Reimbursement Service states: “Medical practitioners have been asked for their co-operation in securing whatever economies are possible without reducing the effectiveness of the service or affecting the best interests of patients. We have been asked to consider, when prescribing, whether there is an equally effective but less expensive medicinal product available.”⁴

The overall expenditure for the provision of medicines in the community increased sixfold between 1998 and 2008.² This growth in expenditure is unsustainable. The Barry report for the National Medicines Information Centre (NMIC) addressed this and examined potential economies in drug usage in Ireland. One recommendation was to promote and facilitate generic prescribing by GPs.⁵ The price of generics and branded drugs currently varies significantly.⁶ This makes it difficult to be certain about cost-effectiveness. The price of antibiotics continues to fluctuate. 

Antibiotic licensing

In the UK, generics account for about 80% of antibiotic prescriptions. These agents underpin recommended prescribing guidance for most infections in primary care and for many indications in hospital practice. These antibiotics are disproportionately cheap in comparison to proprietary compounds and are preferred by a cash-conscious health service; in the US they have even been marketed free of cost.⁷ Because of their widespread use, generic antibiotics have become increasingly resistant to many common pathogens. For example, about 70% and more than 20% of Escherichia coli isolates causing community or hospital-associated infections are resistant to amoxicillin and trimethoprim, respectively.⁷

This raises several issues relating to antibiotic licensing and regulation. To be granted a licence, a manufacturer of a generic agent has simply to show satisfactory pharmaceutical quality and bioequivalence to the original agent. There is currently no regulatory requirement to demonstrate efficacy of approved indications or to target pathogens, despite major changes in prevailing rates of resistance. There is also no requirement in the UK to monitor antibiotic resistance trends and no quality assurance by which resistance triggers a review of prescribing indications. Prescribers need reassurance that licensed agents remain fit for purpose. The current regulation of drug licensing in the UK appears suboptimal and provides a false sense of security.⁷

Antibiotic use

In relation to Irish guidelines on use of antibiotics, the SARI² guidelines have three main aims:

• To provide a simple approach to treatment of common infections
• To promote the safe and effective use of antibiotics 
• To minimise the emergence of bacterial resistance in the community.

The guidelines outline that one should “only prescribe an antibiotic when there is clear clinical benefit”.² In addition they recommend “a no or delayed antibiotic strategy for acute sore throat, common cold, acute cough and acute sinusitis’.²

Audit

In the context of the debate on generics versus branded antibiotics, I carried out an audit on the prescribing habits of the five GPs in a Co Kildare practice, with the aim of:

• Evaluating current practice in relation to prescribing of antibiotics to compare this with best practice, with a view to informing a policy on generic prescribing
• Assessing the rate of generic prescribing in general among all GPs in the practice with their consent
• Determining the rate of prescribing of acute antibiotics as generic versus branded
• Determining the percentage of generic antibiotics and branded antibiotics prescribed
• Reassessing the impact of education on the rate of prescribing of generic antibiotics versus branded antibiotics 
• Comparing the overall cost of generic versus branded prescribing
• Ensuring that the audit is followed through by continuous monitoring of the prescribing of acute antibiotics and that the practice is aware of any changes that may need to be made to prescribing practices as a result of this audit
• Encouraging the practice to continue this audit and to expand it to include other classes of drugs in the future.

Methodology

I carried out a literature search using PubMed to establish current guidelines on prescribing of antibiotics in general practice. A preliminary audit was carried out considering the rate of prescribing of generic versus branded antibiotics by all five GPs on one day in October 2011, using Health One software. Subsequently, the total number of antibiotics prescribed was recorded for each doctor from November 2011 to January 2012. The number of generic and branded antibiotics prescribed was calculated and recorded as a percentage of the total antibiotics prescribed. 

A meeting was held with all GPs in the practice explaining the aims of this study and how to prescribe generically using Health One. The practitioners were advised that for each drug prescribed, there was the option to ‘prescribe as generic’ using the electronic Health One system. They were given a handout with Medical Council guidelines, which was explained in detail, and the SARI handbook on prescribing in primary care. The rationale for generic prescribing was explained by highlighting that the SARI guidelines² (where generics only are listed) follow an evidence based approach and references for each of the guidelines was provided. The GPs were encouraged to refer to these and to keep up to date by examining the Health Protection Surveillance Centre website (www.hpsc.ie).

Following this meeting, each GP was audited on a weekly basis for a month, and monthly thereafter, between November and January to assess their rate of prescribing of antibiotics, both generically and non-generically. The prescriptions given by each practitioner to each patient they saw on a given day each month were examined by checking patients’ files to see if an antibiotic had been prescribed and, if so, whether it was generic or non-generic. The doctors were each identified by a letter (A to E) and the information was recorded on an Excel spreadsheet. 

Antibiotics prescribed

The following antibiotics were prescribed in the practice over the period of the audit: Augmentin, Amoxil, Calvepen, Klacid, Erythroped, Fluclox, Suprax, Keflex, Macrodantin, Monotrim, Fucidin and Flagyl. 

The average cost of a generic antibiotic was 23 cents versus 25 cents for an original/branded drug. Of note however, 33% of the total antibiotics prescribed fell into the category of ‘antibiotics without a generic equivalent’, ie. this included Calvepen 666, Suprax, Fucidin and Flagyl. The average difference in price was 4 cents.

A preliminary audit revealed that only one GP prescribed generically (38% of the time) while all of the remaining GPs prescribed branded antibiotics only. However, following an educational meeting, the total percentage of generic antibiotics prescribed by all doctors in the practice increased from 28% to 65%. In other words, doctors A to E collectively prescribed 37% more generic antibiotics in the week after the educational meeting. 

In total, over the entire study period, 48 (42.1% of total) of the antibiotics prescribed were generic and 66 (57.89% of total) were branded. In the first week, Dr D prescribed generically 28.6% of the time; Dr E prescribed generically 57.8% of the time; and Drs A, B and C prescribed zero generic antibiotics. After this their prescribing patterns varied. Looking at the prescribing patterns in more detail, Dr A prescribed generically 4.3% of the time, Dr B prescribed generically 0% of the time, Dr C prescribed generically 24% of the time, Dr D prescribed generically 59% of the time and Dr E prescribed generically 73% of the time. 

Conclusion

Regular reviews of best practice by looking at the evidence is advisable. Also advised is that the practice carry out regular cost analyses in parallel with meetings, given that the cost of drugs will be changing in the near future in line with changes planned by the Minister for Health.

From a practice point of view, the structure has been set in place for ongoing auditing of the prescribing patterns of the doctors of this practice in relation to antibiotics. In time, this should be applied to other medications. 

There are no clear recommendations about whether to prescribe generically or non-generically as each time an antibiotic is prescribed, a patient-tailored approach is required. However the SARI guidelines are an excellent way to rationalise prescribing. 

Continuation of the audit would gain a larger body of data so as to make more robust conclusions. In addition, it would be useful to interview the doctors about the factors that influence their prescribing of antibiotics. While we are all under pressure to cut costs, it is necessary to question health policy when cost is the main theme or driver. 

References

1. Barry et al. Expert Review of Pharmacoeconomics and Outcomes Research 2010 June;10(9) 239-245
2. http://www.hpsc.ie/hpsc/A-Z/MicrobiologyAntimicrobialResistance/StrategyforthecontrolofAntimicrobialResistanceinIrelandSARI
3. Mossialos E et al. Regulating Pharmaceutical in Europe:striving for efficiency, equity and quality. European Observatory on Health Care Systems Series. Open University Press;2004
4. Primary Care Reimbursement Service (PCRS); 2006, pp. 77-78
5. Barry et al. Generic Prescribing. National Medicines Information Centre (NMIC) 2009;15(1)
6. http://www.stjames.ie/GPsHealthcareProfessionals/Newsletters/NMICBulletins/NMICBulletins2000/VOL6-3Generic%20prescribing.pdf last accessed 22/05/13
7. Finch R et al. Generic antibiotics, antibiotics prescribing and drug licensing. Lancet Infect Dis 2010 Nov;10 (11): pg 754