Forged medical prescriptions in a community pharmacy network in midi-pyre' ne' es area: assessment of a falsification ratio. French health authorities have begun a prescription forgeries survey within several community pharmacy networks. This system provides information about potential abuse liability of marketed drugs in france.
Forged medical prescriptions in a community pharmacy network in midi-pyre' ne' es area: assessment of a falsification ratio. French health authorities have begun a prescription forgeries survey within several community pharmacy networks. This system provides information about potential abuse liability of marketed drugs in france.
Forged medical prescriptions in a community pharmacy network in midi-pyre' ne' es area: assessment of a falsification ratio. French health authorities have begun a prescription forgeries survey within several community pharmacy networks. This system provides information about potential abuse liability of marketed drugs in france.
C. Damase-Michel J.L. Montastruc Forged medical prescriptions in a community pharmacy network in Midi-Pyre ne es area: assessment of a falsication ratio Received: 23 July 2001 / Accepted in revised form: 31 October 2001 / Published online: 29 January 2002 Springer-Verlag 2002 Keywords Forged medical prescriptions Pharmacy Drug abuse Introduction Following the report of Bergmann et al. from Sweden [1], the French Centres for Evaluation and Information on Pharmacodependence (CEIP), created by the French health authorities in 1990, have begun a prescription forgeries survey within several community pharmacy networks [2, 3]. This system provides information about potential abuse liability of marketed drugs in France. In order to compare the dierent medications between each other, Baumevieille et al. rst proposed, in 1997, as- sessment of a falsication ratio [2]. This ratio is obtained by dividing the number of falsication reports for a specic drug by the sale data of this drug during the same period. Sales data are easily available from wholesalers in the area. Their use leads to extrapolation of the number of falsied prescriptions in the whole area from a few reports potentially exposing to a lack of precision. Moreover, this method of calculation could also be biased by the representativeness of participating pharmacists. Another method consists of obtaining sales data directly from the sample of pharmacists enrolled in the survey. Thus, the aim of the study was to compare the results obtained from these two dierent sources of sales data collected during an intensive survey of pre- scription forgeries. Methods Of 1090 pharmacies located in the Midi-Pyre ne es area (South- western France), a sample of 62 community pharmacies was en- rolled in the prescription survey as previously described [3]. Between January and March 1999, they were requested to collect and report all forged prescriptions with falsication criteria iden- tied by the pharmacy sta [3]. For each drug, two falsication ratios were calculated with sales data obtained independently from two dierent sources: the 62 pharmacies enrolled in the study and wholesalers of the area concerning all the 1090 pharmacies. Sales data were expressed as treatment-months [4] using the dened daily dose (DDD). When DDD was not available or if the French in- dication was a country-specic one (example: buprenorphine high dosage), the DDD was the daily dose recommended in the French Drug Formulary (Dictionnaire Vidal). Demographic data were expressed as meanSD. Assuming a small number of expected cases of falsication, the two-tailed 95% condence interval (CI) of falsication ratio was calculated ac- cording to Poisson distribution [4]. Falsication ratios were com- pared using the v 2 test with continuity correction or two-tailed Fischer exact test. Results and discussion The participation ratio (98%) was very high during the whole 3-month period. Seventy falsied prescription forms were collected; the men (56%) who falsied pre- scriptions were noted to be younger than the women (307 years versus 4021 years, P<0.05). Criteria of falsication reported by pharmacists were mainly writ- ing over (20%), self-lled prescription form (18%), ab- normal dosage (13%), spelling mistake (8%), robbery (6%), copy (5%). According to the Anatomic, Thera- peutic and Chemical (ATC) classication system, the 95 dierent drugs belonged to nervous [61%; including analgesic (8.5%) and psychotropic (61%) drugs], respi- ratory (10%), cardiovascular (5%) or musculo-skeletal (5%) systems. Flunitrazepam (40%), bromazepam (4%), acetylsal- icylic acid (2%), fenoprofen (2%), buprenorphine (2%) and salbutamol (2%) were the most frequently requested drugs. Flunitrazepam, morphine sulfate and ergotamine Eur J Clin Pharmacol (2002) 57: 911912 DOI 10.1007/s00228-001-0412-7 M.E. Llau M. Lapeyre-Mestre (&) L. Plas C. Damase-Michel J.L. Montastruc Service de Pharmacologie Clinique, Centre Midi-Pyre ne es dEvaluation et dInformation sur la Pharmacode pendance, Centre Hospitalier Universitaire, Faculte de Me decine, 37 alle es Jules Guesde, BP 7202, 31073 Toulouse Cedex 7, France E-mail: lapeyre@cict.fr Tel.: +33-5-61145903 Fax: +33-5-61255116 exhibited the highest falsication ratios when sales data provided by participating pharmacists were used (Table 1). Drugs with the highest ratios were known for their abuse potential. Flunitrazepam was largely in- volved in drug abuse among opioid abusers [5], leading the French authorities to a reduction of prescription duration and delivery in January 2001 [6]. Morphine sulfate abuse had already been described in other nearby areas of Southern France [7]; however, this was the rst time in the Midi-Pyre ne es area. Although it is dicult to conclude from one citation, these data may suggest an extension of morphine sulfate abuse in the Southern French area. Using both approaches, falsication ratios were not statistically dierent. Although in the calculation of falsication ratios from wholesalers data the number of falsication reports needs to be extrapolated, results are not dierent from those obtained with more accurate data given directly by participating pharmacists. Results with unitrazepam are reliable due to the high number of citations. For other drugs, comparison must be made with caution since the number of citations is low and the 95% CIs have wide ranges. However, the falsication ratios of buprenorphine and bromazepam obtained during surveys performed in 2000 were in the same range of values for pharmacists sales data as for wholesalers data [8]. Data from wholesalers are more easily available than data from pharmacists. Thus, this kind of approach could be extended to other areas, allowing geographical and temporal comparisons. In few cases, wholesalers data cannot be totally exhaustive. Several medications are provided directly to pharmacies from pharmaceuti- cal rms or central purchasing oces, in a signicant way for some drugs with a mass of sale, such as for acetylsalicylic acid. For this drug, the falsication ratios were not comparable between pharmacists [3.9 (0.514)] and wholesalers [198 (140277)] data (P<0.001). Thus, results of this type of survey must be carefully analysed and conrmed by specic study on suspected drugs. In conclusion, this study shows that, except for a few cases, the falsication ratios are similar, regardless of what method of calculation is used (wholesaler data or pharmacy sales data). Thus, regional sales data from wholesalers and national sales data could be used in the systematic survey of falsication prescriptions. This ex- tension may permit comparison of geographical partic- ularities. References 1. Bergman U, Dahl-Puustinen ML (1989) Use of prescription forgeries in a drug abuse surveillance network. Eur J Clin Pharmacol 36:621623 2. Baumevieille M, Haramburu F, Be gaud B (1997) Abuse of prescription medicines in southwestern France. Ann Phar- macother 31:847850 3. Lapeyre-Mestre M, Damase-Michel C, Adams P, Michaud P, Montastruc JL and community pharmacists of Midi-Pyre ne es (1997) Falsied or forged medical prescriptions as an indicator of pharmacodependence: a pilot study. Eur J Clin Pharmacol 52:3739 4. Be gaud B, Pe re JC, Miremon G (1992) Estimation du de no- minateur en notication spontane e. In: ARME-Pharmacovig- ilance (eds) Analyse dincidence en pharmacovigilance. Application a` la notication spontane e, Bordeaux, pp 5373 5. Simmons MM, Cupp MJ (1998) Use and abuse of unitraze- pam. Ann Pharmacother 32:197199 6. Ministe` re de lemploi et de la solidarite (2001) Arre te du 1 er fe vrier 2001 relatif a` la dure e de prescription et au fractionn- ement de la de livrance des me dicaments a` base de unit- raze pam administre s par voie orale. J Ociel de la Re publique Franc aise 32:2073 7. Blayac JP, Pinzani V, Hillaire-Buys D, Peyrie` re H, Alric R (2000) An original method for estimating a possible geographic abuse or misuse of a drug: application to morphine sulfate (Ske nan) (abstract). Therapie 55:418 8. Lapeyre-Mestre M, Souchet E, Lacroix I, Damase-Michel C, Llau ME, Montastruc JL and the French CEIP network (2000) Survey of falsied drug prescription (OSIAP). A method to estimate a falsication ratio as an indicator of pharmacode- pendance (abstract). Proceedings of the meeting Drug de- pendency in Europe: new goals, new challenges in Public Health, 2324 November, Paris Table 1 Falsication ratios [and their 95% condence intervals (CI)] calculated from pharmacists and from wholesalers sales data, expressed as 1000 treatment-months with dened daily dose (DDD) for all drugs and also with mean French dosage for buprenorphine Drug involved DDD Number of citations Falsication ratio (95% CI) (1) From pharmacists (2) From wholesalers P value Flunitrazepam Rohypnol 1 mg 1 mg 38 40 (2855) 28 (2630)* 0.06 Morphine sulfate Ske nan 100 mg 0.1 g 1 23 (0.7125) 60 (3595) 0.49 Ergotamine-caeine Gynerge` ne cafeine 4 mg 1 18 (0.5101) 36 (2258) 0.71 Bromazepam Anxyrex 10 mg 1 14 (0.479) 27 (1644) 1.00 Fenoprofen Nalge sic 1.2 g 2 10 (137) 20 (1428) 0.58 Mefenamic acid Ponstyl 1 g 1 7 (0.240) 11 (718) 1.00 Buprenorphine** Subutex 1.2 mg a 2 5 (0.114) a 7 (511) 0.77 8 mg b 0.8 (0.012.1) b 1 (0.81.6) Salbutamol Ventoline 0.8 mg 2 0.6 (0.12.1) 0.9 (0.61.3) 0.77 Furosemide *** Lasilix 40 mg 1 0.24 (0.011.3) 0.40 (0.20-6) 1.00 *For unitrazepam, 95% CI was calculated according to the standard normal distribution **For buprenorphine, falsication ratios were calculated from a DDD and b mean French dosage ***Drug with the lowest falsication ratio of the study 912