תוצאת חיפוש

Use of Unlicensed and Off-Label Drugs in Hospitalized Children

M. Lifshitz, V. Gavrilov, R. Gorodischer

Toxicology Unit, Pediatrics Dept. A, Soroka Medical Center, and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

Many drugs used in children are based on pharmacological data obtained in adults. Therefore, many drugs are either unlicensed for use in children or are prescribed outside the terms of the product license (off-label). This pilot study assessed use of unlicensed or off-label drugs in hospitalized children.

Drug orders of patients admitted to a general pediatric ward were reviewed retrospectively in a random sample. Assessment was based on the data of the Physicians' Desk Reference and the Israel Drug Compendium. 80 different drugs and 278 drug orders were written for 92 patients (0.5 months - 11 years old, mean 26.9 months) in 97 admissions. Of these 52.9% were either off-label or unlicensed. Patients received 1 or more unlicensed or off-label drugs in 64.9% of admissions. They were more often off-label than unlicensed. The main reasons for use of off-label drugs were unusual doses and inappropriate age. The main reason for unlicensed drugs was modification of a particular formulation of a licensed drug.

This pilot study indicates that use of drugs in an off-label or unlicensed manner in children is probably quite frequent in Israel. Our data emphasize the need for licensing a large number of drugs for use in children, based on the same scientific principles as in adults. Further collaborative studies in different pediatric centers in Israel, involving different types of pediatric settings (ambulatory and in-hospital), is required to evaluate comprehensively the magnitude of this preliminary finding.

Reactive Increase in Blood Pressure on Immobilization, but not Hypertension, Prevents Pressure Ulcers

Vladimir Shats, Silvio Kozacov

Geriatric Dept., Rebecca Sieff Hospital, Safed

Of 135 geriatric patients immobilized for at least 2 days, 37 (27.4%) had pressure ulcers (PU). Those without PU were the control comparison group. Gender, length of immobilization, number of blood pressure determinations and proportion with hypertension were similar in those with and without PU. Those with PU were slightly older than those in the comparison group: 75.5±8.8 and 74.7±9.6 years, respectively (p>0.05).

Of 66 patients with acute ischemic stroke, reactive increase of systolic or diastolic blood pressure to 140/90 mm Hg or above following immobilization, was seen in 60.6% and 22.7% of patients, respectively, and there were PU in 12.1%. Of 17 with recurrent ischemic stroke, corresponding figures were: 41.2%, 23.5% (p>0.05), and 47.1% (p<0.01). In 7 patients with previous ischemic stroke corresponding figures were: 14.3% and 0% (p<0.01) and 100% (p<0.001). In 36 operated for fracture of the femur, corresponding figures were: 50%, 11.1% (p>0.05), and 27.8% (p>0.05). For 9 patients with severe infections, sepsis or pneumonia, the corresponding figures were: 22.2% and 0.0% (p>0.05), and 44.4% (p<0.04).

The proportion of patients with reactive increase in systolic blood pressure on immobilization was lower in the PU group than in the controls, 27% vs 59.2%, (p<0.001). The corresponding figures for reactive increase in diastolic blood pressure were similar, 8.1% and 20.4%, respectively (p>0.05).

The mean systolic blood pressure on immobilization was higher in the control than in the PU group, 145.4±21.7 and 130.8±14.9 mm Hg, respectively (p<0.001). The corresponding figures for the mean diastolic blood pressure were similar, 81.2±10.5 and 75.7±8.9 mm Hg, respectively (p<0.01). An increase in systolic blood pressure on immobilization reduced the risk of developing PU (p<0.05).

There was no significant statistical relation between diagnosis of hypertension and proportion of patients with PU (p>0.05). Of 67 patients with hypertension, in 23.9% and 74.6% of them there was no increase in systolic or diastolic blood pressure, respectively. Statistical difference between lack of diastolic or systolic response was very significant (p<0.001).

Reactive increase of blood pressure, but not hypertension, predicts reduced risk of PU on immobilization in the hospitalized elderly. Diminished reactive increase of blood pressure in response to stress of any kind may be a criterion of frailty and reduced physiological reserves. Efforts to reduce elevated blood pressure when a patient is immobilized appear irrational.

Open Reduction and Internal Sternal Fracture Fixation

Y. Kluger, Y. Paz, N. Gebart, B. Sagie, A. Kremer

Rabin Trauma Center and Dept. of Cardiothoracic Surgery, Tel Aviv-Souraski Medical Center and Sackler Faculty of Medicine, Tel Aviv University

We describe a 63-year-old woman who sustained a sternal fracture after a motor vehicle crash. Due to persistent pain, open reduction and internal fixation of the sternal fracture were performed; recovery was uneventful.

Chylothorax following Penetrating Injury

Y. Kluger, B. Sagie, Y. Chemo, A. Ravid, Y. Paz, J. Klausner

Dept. of Surgery, Rabin Trauma Center and Sourasky-Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv

We describe a 19-year-old man with 9 stab wounds of the chest. Initial evaluation revealed paraplegia at the D-10 level and bilateral hemothorax. 2 days after admission right-sided chylothorax was diagnosed. Fasting and total parenteral nutrition resulted in complete clearance. Chylothorax can cause major metabolic consequences, but prompt treatment results in full recovery.

Treating Hospitalized Children in Severe Pain with Oral Methadone

Yoram Shir, Victor Shvelzon, Gila Rosen

Pain Treatment Service, Dept. of Anesthesiology, Hadassah University Hospital, Jerusalem

Pain relief is usually inadequate in hospitalized patients, especially in children, either after surgery or with various medical conditions. Among other reasons, this is due to suboptimal use of available analgesic drugs. In the past 2 years oral methadone has become our opioid of choice for severe pain in hospitalized children who can take oral medication. More than 70 babies and children, aged 8 months to 9 years, who suffered mainly from pain due to burns or cancer, were treated by the in-hospital pain service. They received 0.1% methadone syrup, 0.2-0.4 mg/kg/day, for from a few days to more than a month. In most there was significant pain relief with no serious side-effects. In some, treatment could be changed to parent-controlled analgesia after a few days, with no adverse effects. We describe 5 of the children who present the advantages of oral methadone over other opioids.

Skeletonized Internal Mammary Arteries for Coronary Bypass Grafting

Jacob Gurevitch, Yosef Paz, Menachem Matsa, Amir Kramer, Dimitri Pevni, Oren Lev-Ran, H. Locker, Raphael Mohr

Dept. of Thoracic and Cardiovascular Surgery, Sourasky-Tel Aviv Medical Center

The skeletonized internal mammary artery (IMA) is longer, and its immediate spontaneous blood flow is greater than that of the pedicled IMA, thus providing increased versatility for complete, arterial myocardial revascularization without the use of saphenous vein grafts. From April 1996 to May 1997, 583 patients underwent coronary artery bypass grafting here and in 415 (71%) complete arterial revascularization was achieved using bilateral skeletonized IMA. The right gastroepiploic artery was used in 57 (13%); there were 329 males (79%) and 86 women (21%); average age was 64 (30-87) and 175 (36%) were older than 70; 131 (32%) were diabetics. Average number of grafts was 3.2 (range 2-6 grafts). At 30 days, 5 (1.2%) had died and there had been 6 perioperative infarcts (1.4%), 5 CVA's (1.2%), and 6 had sternal wound infections (1.4%). Up to 1-12 months of follow-up was achieved in 409 (99%). Late mortality was 1.4% (of which 3 were noncardiac). 394 (97%) were angina-free at latest follow-up. We conclude that arterial revascularization using bilateral skeletonized IMA is safe, as postoperative morbidity and mortality are low, even in old and diabetic patients.

Acquired Torticollis in Hospitalized Children

Alexander Blankstein, Felix Pavlotsky, Hector Roizin, Abraham Ganel, Aharon Chechick

Depts. of Orthopedics, Dermatology, Pediatrics and Pediatric Orthopedics, Chaim Sheba Medical Center, Tel Hashomer and Sackler School of Medicine, Tel Aviv University

Torticollis results from various pathological mechanisms, and its elucidation depends on identifying diseases of musculoskeletal, neural and ocular tissues. This study characterized the underlying diseases of children hospitalized with torticollis, excluding congenital torticollis. Records of 36 children with torticollis seen during 4 years were reviewed and categorized according to presumed etiology. Most could be classified into 2 categories: in 39% it was due to trauma and in 36% to upper respiratory tract infection. Most girls were in the first group and most boys in the second group. There were 3 cases of ocular torticollis due to superior-oblique muscle palsy, 1 with a post-burn eschar, 2 with neurological disorders (intramedullary cervical astrocytoma and leukodystrophy with macrencephaly), and in 3 no associated cause was found. There was a clear seasonal trend with 58% of cases presenting from November through February, 33% from April through July, and the rest, of neurological or ocular origin, during the rest of the year. In cases of post-traumatic torticol21% had neurological symptoms such as weakness of the limbs, headaches or incontinence. Only a few had prior upper respiratory tract infection. All children whose torticollis was assigned to infection had had fever. Only 8% had had neurological complaints or vomiting, half of whom presented with fever exceeding 37.5oC. 46% had restriction of movement and 38% had tenderness. In over 60% of those in this group there were signs of an upper respiratory tract infection, such as lymphadenopathy or a white blood cell count exceeding 15,000/microliter. 3 patients with recurrent torticollis were diagnosed as having severe neurological diseases. Mean hospitalization time was 4 days (range 1-28). Hospitalization periods were similar for all kinds of patients and treatment by traction or fixation did not affect this period.

Should Physical Restraints be used in an Acute Geriatric Ward?

Svetlana Barazovski, Arnold Rosin

Geriatric Dept., Shaare Zedek Medical Center, Jerusalem

A prospective study was carried out in an acute geriatric ward to determine the incidence of the use of physical restraints, the reasons for using them and the consequences. Over a period of 8 months an independent observer documented all cases in which a restraint was used and followed them until it was removed. A questionnaire was submitted to the nurses as to why they applied the restraints. 16% of patients had some form of restraint applied, in 2/3 of them for up to half of their stay in the ward. In over 90% of those restrained, functional (Barthel) and cognitive (mini-mental) scores were between 0-5. In unrestrained patients, the functional score was 0-5 in 79% and the cognitive score 0-5 in 72%. The main reason for applying restraints, usually sheets or body binders, was to prevent the patient from falling out of, or slipping from chairs, rather than to stop them from rising out of them. Other important reasons, which overlapped, were to prevent the patient from interfering with nasogastric tubes, catheters, and IV cannulas, each in 1/3 of the group. Restraints were discarded when deterioration did not allow the patient to sit out of bed, to decrease agitation, to allow enteral or parenteral treatment, and in 12%, when there was supervision by the family. Of 33 families interviewed, none opposed application of restraints, and most left the decision to the responsible ward staff. We conclude that restraints cannot be avoided in some acutely ill, old patients with severe physical and mental dysfunction. However, ways should be sought to minimize their use, as recommended in the literature, by demanding from the staff a specific reason, signed agreement of a physician, close follow-up, and favorable environmental conditions such as suitable chairs, occupational activity, and staff cooperation in removing the restraints.

An In-Hospital Pain Service: Present Activity and Future Trends

Y. Shir, V. Shavelzon, G. Rosen, S. Cotev

Anesthesia Dept. and Intensive Care Unit, Hadassah Hospital, Jerusalem

Although significant progress has been made in the past 2 decades in our understanding of pain pathophysiology and in the development of new analgesic drugs and techniques, many patients still experience considerable pain during hospitalization. Unrelieved pain is common not only among patients undergoing surgery, but also in those with a variety of other medical problems. These findings led to the development of our in-hospital acute pain service. This in-hospital pain service has been active since the late eighties, treating both postoperative pain and non-surgical pain in hospitalized patients. During 1995, 2140 patients were treated totaling 8717 treatment days in 18 different medical units and departments. Overall success was more than 75%. We review our experience in treating in-patients who suffer from pain and discuss future trends and need for such a specialized service.