Filion Kristian B, Delaney J A Chris, Brophy James M, Ernst Pierre, Suissa Samy
McGill University, Division of Clinical Epidemiology, Royal Victoria Hospital, Montreal, Canada.
Pharmacoepidemiol Drug Saf. 2007 Jan;16(1):1-4. doi: 10.1002/pds.1314.
The United Kingdom (UK) government changed the prescription policy of statins, making low-dose simvastatin (10 mg) available as an over-the-counter (OTC) drug in August 2004. We assessed the impact of this policy change on statin prescribing.
We examined all statin prescriptions in the General Practice Research Database (GPRD), a well-validated database of approximately 3.5 million patients, from the first quarter of 2001 to the second quarter of 2005.
From 2001, the number of statin prescriptions written for GPRD patients was increasing by approximately 437 prescriptions per 100,000 people per quarter until the time of the policy change. Over the four quarters post-policy implementation, however, this trend changed abruptly (p < 0.0001) with a decrease of 281 prescriptions per 100,000 people per quarter. This decrease was not restricted to prescriptions of 10 mg statins but was also observed for statin prescriptions of >or=20 mg. Several other cardiovascular medications displayed a similar trend as that observed in the number of statin prescriptions. This trend was not observed among non-cardiovascular control medications.
Our study suggests that the policy allowing the OTC sale of 10 mg simvastatin has had a significant impact on statin prescriptions by general practitioners. However, this new policy may also be leading to less aggressive statin therapy. An alternative explanation for the observed decrease in statin prescriptions may be related to the unknown factors responsible for the overall decrease observed with other cardiovascular prescription drugs.
英国政府改变了他汀类药物的处方政策，使低剂量辛伐他汀（10毫克）于2004年8月成为非处方药。我们评估了这一政策变化对他汀类药物处方的影响。
我们检查了综合医疗实践研究数据库（GPRD）中从2001年第一季度到2005年第二季度的所有他汀类药物处方，该数据库对约350万患者进行了有效验证。
从2001年起，为GPRD患者开具的他汀类药物处方数量每季度以每10万人约437张处方的速度增加，直至政策变化之时。然而，在政策实施后的四个季度中，这一趋势突然改变（p<0.0001），每季度每10万人的处方数量减少了281张。这种减少不仅限于10毫克他汀类药物的处方，对于20毫克及以上的他汀类药物处方也有观察到。其他几种心血管药物的处方数量也呈现出与他汀类药物处方数量类似的趋势。在非心血管对照药物中未观察到这种趋势。
我们的研究表明，允许非处方销售10毫克辛伐他汀的政策对全科医生开具的他汀类药物处方产生了重大影响。然而，这一新政策可能也导致了他汀类药物治疗不够积极。观察到的他汀类药物处方减少的另一种解释可能与导致其他心血管处方药总体减少的未知因素有关。
