Commentary: Opportunities to improve generic drug prescribing

Opportunities to improve generic drug prescribing

The international scenario in which generic drugs appeared in the 1970s was very different from the one we are currently contemplating. There were four main reasons for the appearance of generics: imminent patent expiration, a fall in the rate of important innovations, increased legislative control of new therapeutic substances, and a sudden decline in economic growth in western countries.¹ Fifteen years later, during the mid-1980s, a new era began: that of expensive drugs based on new products that were marketed at much higher prices in comparison to older drugs.¹ The angiontensin-converting enzyme inhibitors (ACEI) that appeared for hypertension differed markedly from diuretics and beta-blockers, and currently, angiotensin receptor agonists (ARA-II) represent a further increase in costs compared to ACEI. For hypercholesterolemia, statins have supplanted fibrates; for depression, selective serotonin-reuptake inhibitors have taken the place of tricyclic antidepressants; for gastric ulcer, proton pump inhibitors have substituted H2-receptor antagonists; for benign prostate hypertrophy, finasteride and alpha-blockers are used instead of plant extracts; in psychiatry, new neuroleptics take the place of traditional neuroleptics. The differences in price between the new and the old drugs is evident both in countries with price controls and countries such as the USA, where prices are set by the manufacturer.

In addition, life expectancies have increased, the economy has entered a growth phase, and generics actually appeared in Spain barely 4 years ago, in a setting very different from that of the 1970s.

On a worldwide level, the aim of the introduction of generics was --among others-- to help keep drug costs within acceptable limits.² The various structural measures implemented in Spain to control drug costs since 1997 are: an agreement with Farmaindustria (the pharmaceutical industry´s representative body in Spain) which led to a cost reduction of 18%; negative lists (pharmaceuticals excluded from public funding) (12% reduction in costs); reductions in wholesalers´ profit margins and discounts (43% reduction in costs); reductions in price (24%); and use of generics and reference prices (maximum amount per product the government is prepared to underwrite through the public health system).³ It will be appreciated that the contribution made by generics and reference prices to the overall savings in drug costs has been rather modest; however, of all the measures taken to date, it is the only one whose success requires active involvement on the part of physicians.

In the clinical setting, initial doubts about the quality of generics have been overcome in Spain, and the only significant difference between a generic and a brand-name equivalent is in the composition of the excipient⁴ or in morpholgy.⁵ After reference prices were introduced, the consumption of generics in Spain leveled off in 2001 despite efforts by the administration to facilitate the authorization process. Up until that same year prescribing rates varied widely between autonomous communities, with the highest figures being recorded for Madrid, Catalunya and the Balearic Islands.⁶

Measures aimed at the clinical setting have also been proposed to keep drug costs down. Some of these measures have been linked to incentives for family physicians, the practitioners ultimately responsible for distributing primary care resources. In Spain, prescriptions written by family physicians account for 80% of pharmaceutical costs to the national health system.⁷

The article by J.J. López-Picazo and colleagues⁸ reports on a program to evaluate and improve generic prescribing practices. Their program included the use of personalized reports, pocket cards with information on available generics, clinical training sessions and economic incentives. As the authors note, statistical quality control techniques were effective in evaluating and tracking the influence of the program on generic prescribing.⁸ The indicator these authors propose to determine generic prescribing rates in each clinic merits interest: the percentage of packages of generics prescribed. This information can reveal opportunities for improvement at each primary care clinic. However, the indicator should be used together with other complementary indicators, as it cannot itself provide information on the quality of prescribing practices, ie, the most sought-after opportunity for improvement. True quality in prescribing begins with the correct diagnosis of the patient, which is not a simple task. The second step is selection of the best medication. When this decision is made, further decisions about the type of drug and active principle are needed. It is at this point where discussions over whether to use a brand-name product, a generic produced by a specific manufacturer, or a «wholesale» generic can begin. A further issue that deserves consideration is prescription substitution.

Although the percentage of generic prescriptions can be high, this indicator may be subject to artifacts or manipulation through the indiscriminate use of antibiotics or the use of antibiotics for viral processes; prescribing generic cephalosporins rather than brand-name penicillins;⁹ prescribing generics of doubtful therapeutic usefulness; increasing the generic prescribing rate by prescribing packages that contain smaller numbers of pills or capsules, thereby duplicating the number of packages prescribed; or prescribing very cheap generics as analgesics.

The indicator of generic prescribing can provide evidence of efficiency when used in conjunction with other, complementary indicators of prescribing quality. Computerized systems for storing and retrieving patients´ records will provide the information needed for further studies of prescribing quality as it relates to diagnostic criteria, comorbidity associated treatments and individual factors.

In light of our awareness that noncompliance with treatment is frequent,¹⁰ that up to one-third of the packages of drugs not used by patients are intact,¹¹ that there is always some degree of risk in any intervention,¹² and that some drugs such as antibiotics are abused,¹³ it is clear that the main source of savings lies in prescribing drugs in accordance with their indications. However, this requires continued training and systems or tools that provide primary care physicians with access to information in the clinic where the patients are seen, and where primary care pharmacists aim to serve as a source of support.

Information systems will improve greatly in coming years, and different health services will act as catalysts for measures to support the rational, reasoned, efficient, judicious, evidence-based use of drugs. There are no unique, magic procedures to contain pharmaceutical costs and improve prescribing quality. The contribution of generics in the current health care milieu is modest, but there is still room for expansion.